Faron, etusivu

Proposed Placing to raise approximately EUR 3m

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014

THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON PHARMACEUTICALS OY (“FARON”) OR ANY OTHER ENTITY IN ANY JURISDICTION. NEITHER THIS ANNOUNCEMENT NOR THE FACT OF ITS DISTRIBUTION, SHALL FORM THE BASIS OF, OR BE RELIED ON IN CONNECTION WITH ANY INVESTMENT DECISION IN RESPECT OF FARON.

THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT WOULD BE MADE PURSUANT TO A PRIVATE PLACEMENT EXEMPTION UNDER THE EUROPEAN DIRECTIVE 2003/71/EC (AND AMENDMENTS THERETO (THE “PROSPECTUS DIRECTIVE”), AS IMPLEMENTED IN THE MEMBER STATES OF THE EUROPEAN ECONOMIC AREA, FROM THE REQUIREMENTS TO PRODUCE A PROSPECTUS UNDER THE PROSPECTUS DIRECTIVE FOR OFFERS OF SECURITIES. FARON HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY SECURITIES OR ANY OTHER DOCUMENTS RELATING TO THE PROPOSED TRANSACTION TO THE PUBLIC IN FINLAND, SWEDEN, NORWAY OR DENMARK, OR IN ANY OTHER JURISDICTION IN ANY FORM WHICH WOULD CONSTITUTE AN OFFER TO THE PUBLIC.

THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”) OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO PUBLIC OFFERING OF THE PLACING SHARES IN THE UNITED STATES, THE UNITED KINGDOM OR ELSEWHERE. NO REPRESENTATION IS BEING MADE AS TO THE AVAILABILITY OF ANY EXEMPTION UNDER THE SECURITIES ACT FOR THE REOFFER, RESALE, PLEDGE OR TRANSFER OF THE PLACING SHARES. THE PLACING SHARES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE US SECURITIES AND EXCHANGE COMMISSION, ANY STATE SECURITIES COMMISSION OR OTHER REGULATORY AUTHORITY IN THE UNITED STATES, NOR HAVE ANY OF THE FOREGOING AUTHORITIES PASSED UPON OR ENDORSED THE MERITS OF THE PLACING OR THE ACCURACY OR ADEQUACY OF THIS ANNOUNCEMENT. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENCE IN THE UNITED STATES.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Proposed Placing and Subscription to raise approximately €3 million

TURKU – FINLAND, 26 March 2019 – Faron Pharmaceuticals Oy (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, is pleased to announce a proposed placing and subscription of new ordinary shares in the capital of the Company (the “Placing” and the “Subscription” respectively and together the “Fundraise”) to raise, in aggregate,  approximately €3 million before expenses.  

The Placing to institutional investors will be conducted by way of an accelerated bookbuild process (the “Bookbuild“) which will be launched immediately following this announcement. The Fundraise is expected to be conducted at or around the prevailing market price with the final price to be determined during the Bookbuild (“Issue Price“). 

KEY HIGHLIGHTS

·     Proposed placing of new ordinary shares (“Placing Shares“) at the Issue Price with institutional investors and proposed subscription for new ordinary shares (“Subscription Shares“) at the Issue Price by certain existing shareholders/investors to raise approximately €3 million (£2.5 million) in aggregate

·     Certain Directors and a member of the Scientific Advisory Board intend to subscribe for, in aggregate, approximately €0.5 million through the Fundraise

·     The net proceeds of the proposed Placing and Subscription would be used to, inter alia:

o  Advance the Clevegen clinical development programme, the MATINS trial

o  Further Traumakine development through the design and preparation of a global Phase III clinical trial, CALIBER

o  Advance partnering discussions in respect of both Traumakine and Clevegen

·     Approximate net proceeds of the Fundraise of approximately €2.8 million, if subscribed, are expected to provide the Company with working capital into Q3 2019

Panmure Gordon (UK) Limited (“Panmure Gordon“) is acting as Nominated Adviser, Sole Bookrunner and Corporate Broker to the Company.

Admission of the Placing Shares and Subscription Shares to trading on AIM is expected to be on or around 29 March 2019.

As soon as practicable after closing of the Bookbuild, an announcement will be made to confirm the Issue Price and the number of Placing Shares and Subscription Shares to be issued by the Company (subject still to, inter alia, binding letters of commitment being received and the Issue Condition as described further below). A further announcement will be made once the Placing and Subscription have been finalised and binding letters of commitment received, with such announcement being made by no later than 5.00 p.m on  29 March 2019. Further terms of the proposed Placing and Subscription are set out below.

Commenting on the proposed Placing and Subscription Dr Markku Jalkanen, CEO of Faron, said: “Our staff and scientific collaborators have done a treamendous job of identifying reasons behind the unexpected INTEREST study results, as well as advancing the MATINS trial to dose escalation stage. This provides Faron with the opportunity to further two significant clinical programmes, which aim to help people with serious life threatening conditions like organ damage and cancer. I am also extremely happy with the level of support indicated by exisiting shareholders, Company directors and employees in this financing round. We are very excited to have two cinical programmes to progress further towards effective treatments.”

REASONS FOR THE PROPOSED PLACING AND SUBSCRIPTION

In addition to providing working capital, the net proceeds of the Placing and Subscription will be used to fund the commercialisation preparation of Traumakine through:

·     The design and preparation of a new Phase III study, called CALIBER, based on INTEREST data post hoc analysis

·     Seeking approval for the CALIBER trial from both the FDA and EMA.

The regulatory feedback process with the EMA and FDA has been initiated in respect of the CALIBER trial design and feedback is expected in Q3 2019. The Company is exploring options for financing the study and intends to make a decision on this at a later stage.  

The net proceeds will also be used to fund further clinical development of Clevegen by:

·     Seeking pre-IND feedback from the FDA prior to filing a US IND to include US study sites in the MATINS trial

·     Preparing filing documents to expand Clevegen clinical development in additional cancers such as glioblastoma.

The Company is seeking to partner Clevegen in 2019 and is currently engaged in numerous potential partnering negotiations including with several large pharma companies. The Company is targeting a significant upfront licence fee as part of an overall potential licence deal. The Company expects to have Clevegen safety and surrogate biomarker data, and potentially initial efficacy observations in H1 2019. 

Shareholders and investors should note that the net proceeds of the Subscription and Placing are not expected to provide the Company with 12 months of working capital.

In addition to the Fundraise, the Company is exploring a variety of additional sources of funding and longer term funding arrangements, including discussions with potential licensees, grants, strategic investors, soft loans and an equity draw down facility. Discussions are ongoing across funding arrangements and further announcements will be made as and when required.

DETAILS OF THE PROPOSED PLACING AND SUBSCRIPTION AND ISSUE OF EQUITY

Subject to the Placing Shares and Subscription Shares being subscribed for in full, they will be issued by the Company at the Issue Price pursuant to the Directors’ existing authority to allot ordinary shares in the capital of the Company (“Ordinary Shares“) for cash on a non-pre-emptive basis, as approved by shareholders at the Company’s last annual general meeting which was held on 31 May 2018. The Company has received non-binding indications of interest from potential investors for the Placing and Subscription during a pre-marketing process.

In connection with the proposed Placing, the Company has entered into a placing agreement with Panmure Gordon (the “Placing Agreement“). Pursuant to the terms of the Placing Agreement, Panmure Gordon has agreed to use its reasonable endeavours to procure placees for the Placing Shares at the Issue Price. The Placing is conditional upon, inter alia:

·     the Placing Agreement having become unconditional in all respects;

·     the Company having performed, in all material respects, its obligations under the Placing Agreement and not being in material breach of the Placing Agreement;

·     legally binding commitments being received (in the form of placing letters) in respect of all of the Placing Shares and the Subscription Shares (the “Placee Condition“); and

·     the Placing Shares and the Subscription Shares being issued and being registered at the Finnish Trade Registry (the “Issue Condition“).

The Placing will be conducted by way of an accelerated bookbuild process (the “Bookbuild“) which will be launched immediately following this announcement. Panmure Gordon is acting as sole bookrunner in relation to the Placing. It is envisaged that the Bookbuild will be closed at 11:30 a.m. (GMT) on 26 March 2019, but Panmure Gordon reserve the right to close the book earlier or later, without further notice. Members of the public are not eligible to participate in the Placing.

Details of the results of the Placing, including the number of Placing Shares and Subscription Shares and the approximate gross proceeds will be announced as soon as possible following closure of the Bookbuild.  As set out above, a further announcement will then be made once the Placing and Subscription have been finalised and binding letters of commitment received, with such announcement being made by no later than 5.00 p.m on  29 March 2019.

The Placing Agreement contains customary warranties and an indemnity from the Company in favour of Panmure Gordon together with provisions which enable Panmure Gordon to terminate the Placing Agreement in certain circumstances before satisfaction of the Issue Condition in respect of each stage of the Placing, including where there has been a material breach of any of the warranties contained in the Placing Agreement (in the reasonable opinion of Panmure Gordon) or where there is a material adverse change in the business or financial affairs of the Company. The Company has agreed to pay Panmure Gordon certain commissions and fees in connection with the Placing. In order to comply with local securities law in Finland, the Issue Condition will be satisfied prior to the admission of the Placing Shares and Subscription Shares to trading on AIM (“Admission“). Accordingly, pursuant to the terms of the Placing Agreement, Panmure Gordon has agreed to underwrite the subscription for and payment to the Company of the Issue Price for the Placing Shares upon satisfaction of the Placee Condition.

The Subscription is not conditional on the Placing but is conditional on the receipt of binding commitment letters and issue of the Subscription Shares.

Subject to the Placing Shares and Subscription Shares (“New Shares“) being fully subscribed for and all conditions being met, an application will be made for admission of the New Shares to trading on AIM. It is expected that Admission will become effective and that dealings in the New Shares will commence on or around 8.00 a.m. on 29 March 2019. As noted above, further update announcements will be made in due course.

FURTHERING TRAUMAKINE DEVELOPMENT

As previously reported, detailed analyses undertaken by the Company and its scientific network during the last eight months have revealed the potential causes of the INTEREST trial results. Topline data from the trial was announced on 8 May 2018 and subsequent announcements in respect of post-hoc analysis include those made on 14 June 2018,  22 October 2018 and 5 December 2018.  In particular, these findings include that concomitant use of corticosteroids and Traumakine appeared to adversely affect both the mortality and biomarker appearance among INTEREST trial patients, indicating corticosteroid interference with Traumakine action. The Company has confirmed this interference in human ex vivo lung samples and expects similar results from the ongoing YODA study with healthy volunteers which is expected to conclude in Q2 2019.

The Company continues to await the outcome of the trial and clinical study report from the phase III Traumakine ARDS trial that has been conducted by Japanese partner, Maruishi. This data is expected to be received by the Company in March or April 2019, however the timing and presentation of the data is outside of the control of the Company. A further announcement will be made when the translated trial data has been provided to the Company however, as with the INTEREST trial, concomitant corticosteroid use is understood to have been high during the trial and accordingly, the topline results of the Japanese trial are expected to reflect those of the INTEREST trial whereby the study did not meet the primary composite end point for efficacy of Traumakine.  

Interim (futility) data from the phase II INFORAA study investigating Traumakine in post-operative Ruptured Abdominal Aorta Aneurysm (RAAA) patients are also expected in H1 2019 and will determine further clinical development. Corticosteroid use within the INFORAA trial is expected to be low.

The Company remains confident of the use of Traumakine for a subset of ARDS patients. Subject to completion of the Subscription and the outcome of the YODA trial, and to enable Faron to make a marketing approval application, the Company is planning for a new phase III trial of Traumakine in the treatment of ARDS. If approved, this double dummy CALIBER study will allow corticosteroid use within the standard of care (SOC) arm, but will be excluded from the treatment arm receiving Traumakine. This trial structure would allow physicians to choose their preference while creating a blinded readout between Traumakine and SOC patients.  It is currently intended that CALIBER will be a global trial and Faron hopes to partner with one or more pharma companies to support this planned trial.

CLINICAL PROGRESS OF CLEVEGEN

As recently announced on 21 February 2019 (“Matins Announcement”), the phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen, Faron’s wholly-owned novel precision cancer immunotherapy in selected metastatic or inoperable solid tumours, is advancing as expected at trial sites in Finland and soon in the UK and Holland.

The MATINS study has now recruited four subjects with no safety concerns at 0.3 and 1.0 mg/kg dosing. In the Matins Announcement the Company reported potential early clinical benefits in dosed patients together with a switch in their immune profile towards more immune stimulatory function. The Company has now also received a tumour imaging report on patient number 2 (colorectal cancer), indicating a partial response. This patient had previously been treated with six different anti-cancer drugs, which all had failed.


As the trial is an open label study, the Company receives new information on the progress of dose escalation and safety as the trial progresses and will announce material updates when appropriate.

Exchange rate

Unless otherwise specified, this announcement contains certain translations of Euros into amounts in Pounds Sterling for the convenience of the reader based on the exchange rate of £1.00 = €1.172, being the published exchange rate by the Bank of England at the close of business on 22 March 2019 (the latest practicable date prior to the date of this announcement).

MARKET ABUSE REGULATION

Market Soundings, as defined in the Market Abuse Regulation (“MAR“), were taken in respect of the proposed Placing and Subscription with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing and Subscription is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in a Market Sounding are no longer in possession of inside information relating to the Company and its securities.

Panmure Gordon (UK) Limited, which is regulated in the UK by the Financial Conduct Authority, is acting as Nominated Adviser, Sole Bookrunner and Corporate Broker to the Company and no one else in connection with the Placing. Accordingly, it will not be responsible to any person other than the Company for providing the regulatory and legal protections afforded to its clients nor for providing advice in relation to the contents of this Announcement or any matter, transaction or arrangement referred to in it.

Information to Distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”).

Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Placing. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Panmure Gordon (UK) Ltd has only procured investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Placing Shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the Placing Shares and determining appropriate distribution channels.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Consilium Strategic Communications

Mary-Jane Elliott

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s first candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking early clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

MATINS study update

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

MATINS study update

Substantial immune activation taking place post Clevegen administration

UK CTA approval

TURKU – FINLAND, 21 February 2019 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces an update on early observations on immunity and clinical response of MATINS patients post Clevegen administration.

The phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen, Faron’s wholly-owned novel precision cancer immunotherapy in selected metastatic or inoperable solid tumours, is advancing as expected at trial sites in Finland. Dosing has moved to the second level (1mg/kg) with no signs of toxicity.

Clevegen is a novel anti-Clever-1 antibody, which causes changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive macrophages to immune active macrophages. In pre-clinical models, inhibition of Clever-1 decreases tumour associated macrophages and myeloid derived suppressor cells within the tumour, and activates tumour-killing CD8+ cells leading to robust anti-tumour activity (Viitala et al. (2019) Clinical Cancer Research, on-line DOI:10.1158/1078-0432.CCR-18-3016).

Early immune biomarker data from the first two patients dosed in the MATINS trial at 0.3mg/kg indicate an increase in CD8+ and CD4+ T cells, which play a central role in cell-mediated immunity. A single dose of Clevegen increased patients’ blood CD8+ cells and their CD8+/CD4+ ratio by 24% and 15%, respectively (mean of two). These patients also experienced a 22% decrease in their blood regulatory T-cell content (T-reg) on day two, which are linked to immune suppression in cancer patients. This change in immune activation resulted in a material increase in natural killer (NK) cells on day 15, by 16% in the first patient and 148% in the second patient from the pre-dose level. These alterations returned to near pre-dose levels ahead of the second dose.

During the second dosing level (1mg/kg) of the third MATINS patient, similar responses were observed but at significantly faster and higher rates. On day two CD8+ cells had increased 100%, the CD8+/CD4+ ratio by 26% and NK cells by 191%, while T-regs had declined -10% from the pre-dose value.

The Company believes these findings, while limited to the trial’s first three patients (one case of melanoma and two colorectal cancers), are encouraging, alongside biochemical tumour and tumour load markers showing a decrease in carcinoembryonic antigen (CEA) and lactate dehydrogenase (LDH) serum levels. Both indicate the potential early clinical benefit provided by Clevegen for these late state cancer patients.

The Company is currently opening two UK sites (London, Birmingham) to expand the trial, following recent CTA approval by the UK regulator, the Medicines & Healthcare products Regulatory Agency (MHRA). The Company also intends to seek pre-IND advice from the US Food and Drug Administration (FDA) to open sites in USA prior to entering the cohort expansion part of the trial.

Due to high interest in potential new therapies in the immuno-oncology field, either as monotherapy or in combination, the Company is currently engaged in partnering discussions with several parties and hopes for a positive outcome from these negotiations during 2019.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “We have previously shown that Clevegen has the ability in experimental settings to convert the macrophage population from immune suppressive macrophages to immune active myeloid cells, which are believed to initiate the tumour fight by host immune cells. These initial data from the MATINS trial appear to confirm that this immune switch can also take place in cancer patients. We are very encouraged by these findings, and by the potential early clinical benefits indicated through the biochemical and tumour load indicators, following several lines of previous ineffective treatments. These biomarker data will prove valuable to help determine the optimal dose as the trial continues and we look forward to generating further data to assess durability of effect and efficacy in a larger number of patients.”

About the MATINS study

The MATINS study is a first-in-human open label Phase I/II clinical trial with an adaptive design to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours. The selected tumours under investigation are cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). All together these five target groups consist of approximately 2 million annual cases worldwide. The cancer patients with high Clever-1 expression will be identified with a simple blood myeloid cell staining with Clevegen (“liquid biopsy”).

The first part of the trial deals with safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report initial findings as the dosing progresses. The cohort expansion during part two will focus on identification of patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. During part three the main focus will be on assessing the efficacy of Clevegen on patients who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy. The treatment, if successful, may ultimately be used as a standalone therapy or in combination with other immunotherapies like PD-1 inhibitors.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (“MAR”).

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking early clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Traumakine update – YODA results

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Traumakine update

First YODA trial results confirm drug formulation not a factor in lowered bioactivity seen during INTEREST trial

TURKU – FINLAND, 19 December 2018 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, today announces interim results from its pharmacokinetic/dynamic “YODA” study, examining various formulations of recombinant human interferon-beta (“IFN-beta”).

Further to the Company’s announcement on 22 October 2018, the YODA study, in around 50 healthy volunteers, is being undertaken to understand the reduced biomarker response to Traumakine during the phase III INTEREST trial.  YODA trial results from the first 30 subjects indicate that IFN-beta, regardless of the method of solubilisation, produced the expected level of bioactivity suggesting that drug formulation was not a factor in the outcome of the INTEREST trial.  

The YODA study will now examine concomitant administration of prednisolone and Traumakine in order to confirm, in vivo, the observed interference of corticosteroids on IFN-beta bioactivity in the INTEREST study and ex vivo lung samples. These YODA results are expected during Q1 2019. 

Dr Markku Jalkanen, CEO of Faron, said: “We believe these results confirm that the drug product used in the INTEREST study was robust and effective. While analysis continues, we believe the mixed results seen were due to a higher than anticipated placebo response due to high pneumonia portion, interference of corticosteroids on IFN-beta bioactivity and, as recently announced, the impact of a subgroup of patients’ single nucleotide polymorphism C/T mutation in their interferon alpha and beta receptor gene.”

The company continues to await top-line data from the Phase III ARDS trial with Japanese partner Maruishi (JapicCTI-163320) to help determine next steps for Traumakine’s development. These data, originally expected before the end of year, are now anticipated by Faron in early 2019.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (“MAR”).

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott,  David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: +44 207 886 2500 

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

First patient dosed in phase I/II MATINS study

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

First patient dosed in phase I/II MATINS study of Clevegen

TURKU – FINLAND, 14 December 2018 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces that the first patient has successfully been dosed in its phase I/II MATINS study of Clevegen, its wholly-owned novel precision cancer immunotherapy drug.

The study, being initiated now at Helsinki and Oulu University Hospitals in Finland, is a first-in-human open label phase I/II clinical trial to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours.

Clevegen is a novel anti-Clever-1 antibody, which causes changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive macrophages to immune active macrophages. Clever-1, a cell surface receptor expressed mainly by tumour vasculature and monocytes/macrophages, has been shown to promote tumour growth (Karikoski et al., 2014), to control cell-mediated immunity (Palani et al. 2016) and to participate in the control of B cell response and antibody production (Dunkel et al. 2018). In pre-clinical models, inhibition of Clever-1 decreases tumour associated macrophages and myeloid derived suppressor cells within the tumour, and activates tumour killing CD8+ cells leading to robust anti-tumour activity. The treatment, if successful, may ultimately be used as a standalone therapy or in combination with other immunotherapies like PD-1/PD-L1 inhibitors.

The initial dosing level in the study is 0.3mg/kg increasing to 1mg/kg, 3 mg/kg and 10mg/kg. The intention is to reach the maximum 10mg/kg dosing level during H1 2019 and to study Clever-1 occupancy in circulating monocytes from bone marrow to tumour. Breaking down this migration and converting the monocytes from an immune suppressive to immune activating phenotype are the main goals of the first part of the study, together with tolerability and safety observations. More details on the MATINS study structure is described on www.clinicaltrials.gov (reference number NCT03733990).

Faron’s scientific network has also informed the Company that Clever-1 presence in glioblastoma patients with very few treatment options associates with poor survival (n=146, p=0.0004). The Company therefore intends to file a separate protocol to study these cancer patients suffering from these aggressive brain tumours.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “We are delighted that Clevegen has advanced into the clinic. We have already seen promising pre-clinical and ex-vivo human data, and so this is a significant step in helping us to further understand the potential of this novel therapy. We are pleased to have achieved such rapid progress with our Clevegen programme so far and look forward to the opening of further trial sites and the expansion of the study in Europe and USA.”

About the MATINS study

The MATINS study has an adaptive design to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours. The first part of the trial deals with tolerability, safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report initial findings as the dosing progress.

The cohort expansion during part two will focus on identification of patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. During part three the main focus will be on assessing the efficacy of Clevegen on patients who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy.

The selected tumours under investigation in the MATINS study are cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). All together these five target groups consist of approximately 2 million annual cases worldwide. The cancer patients with high Clever-1 expression will be identified with a simple blood myeloid cell staining with Clevegen (“liquid biopsy”).

In addition to Finland and the UK, where the CTA is under final review following earlier conditional approval, the Company also plans to conduct the MATINS trial’s dose escalation part in the Netherlands (Erasmus University Medical Center in Rotterdam), and plans to increase the number of sites during the cohort expansion stage. The Company is also preparing a US IND to expand the study to the USA during parts two and three of the MATINS study.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (“MAR”).

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS).  An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

Holding(s) in Company

RNS Number : 1619K
Faron Pharmaceuticals Oy
11 December 2018
 

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:

Faron Pharmaceuticals Oy

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

x

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii: Disclosure as per Company´s Articles of Association

x

3. Details of person subject to the notification obligationiv

Name

Marko Salmi

City and country of registered office (if applicable)

4. Full name of shareholder(s) (if different from 3.)v

Name

City and country of registered office (if applicable)

5. Date on which the threshold was crossed or reachedvi:

7.12.2018

6. Date on which issuer notified (DD/MM/YYYY):

10.12.2018

7. Total positions of person(s) subject to the notification obligation

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights of issuervii

Resulting situation on the date on which threshold was crossed or reached

9,97%

9,97%

31,027,894

Position of previous notification (if

applicable)

10,03%

10,03%

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

FI4000153309

3,093,439

9,97%

SUBTOTAL 8. A

3,093,439

9,97%

B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Periodxi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Period xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

SUBTOTAL 8.B.2

9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii

x

Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary)

Namexv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

10. In case of proxy voting, please identify:

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional informationxvi

Place of completion

Turku

Date of completion

10.12.2018

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com or visit
www.rns.com.
 

END

 
 

HOLZMMMZVMDGRZM

Patient subgroup identified from INTEREST trial

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Optimal subgroup of ARDS patients for Traumakine treatment identified by genetic testing showing substantial reduction in mortality among INTEREST trial patients

TURKU – FINLAND, 5 December 2018 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces it has identified, by genetic testing, an optimal subgroup of acute respiratory distress syndrome (ARDS) patients for Traumakine treatment (intravenous interferon beta-1a) who showed a substantial reduction in mortality during the INTEREST trial.

Multivariate regression analyses that adjust for disease severity indicate that patients receiving interferon beta-1a treatment (Traumakine) and carrying the single nucleotide polymorphism rs9984273 (C/T) in subunit 2 of the interferon alpha and beta receptor (INFAR2) (n=46) had 5.7 times greater likelihood of survival at Day 28 (p=0.0057) than patients without this mutation (n=58). No similar survival effect was seen for the C/T polymorphism in the placebo group.

This suggests that together the C/T mutation and Traumakine treatment is the most favorable combination for patient outcome and interferon treatment efficacy. The D28 overall mortality of this group was 11.1% despite receiving, or not receiving, concurrent steroids. In patients with the C/T polymorphism who received Traumakine but not concurrent steroid treatment, mortality was only 4.2% (n=25).

Faron intends to file these data with regulatory authorities (EMA/FDA) in Q1 2019 and to seek advice on the future clinical development of Traumakine in the EU and the US for this precision treatment.

The prevalence of this unique polymorphism* is around 30-35% among Caucasians, 40-45% among African origin and 10% in Asian populations, indicating a target population of around one third of ARDS patients in Europe and North America for whom Traumakine treatment could potentially be most effective and life saving.

Dr Markku Jalkanen, CEO of Faron, said: “We have, and are continuing to build, a solid body of evidence which indicates that there is clearly a subgroup of patients for whom Traumakine treatment could potentially be very effective. The identification of these C/T patients is very easy with PCR-based analysis of a patient’s DNA sample and provides a way to target this precise group of ARDS patients, representing around one third of all ARDS patients. This finding has also allowed us to build further intellectual property for Traumakine as this association has not been previously reported. This protection has been filed and, if approved, could extend beyond 2040.”

Full details from the analyses will be submitted for publication in a peer-reviewed journal and presentation at a future scientific congress.

* Source: International HapMap Project

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (“MAR”).

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Freddy Crossley, Emma Earl

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology (“TIET”) may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com

Faron receives CTA approval for Clevegen

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron receives regulatory approval to initiate clinical MATINS trial for precision cancer immunotherapy Clevegen

TURKU – FINLAND, 03 December 2018 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces that its Clinical Trial Application (CTA) to conduct a Phase I/II study with Clevegen, its wholly-owned novel precision cancer immunotherapy drug, in development for the treatment of selected metastatic or inoperable tumours, has been approved by the Finnish Medicines Agency (FIMEA). Patient recruitment into the Phase I/II MATINS study is expected to commence shortly at Helsinki and Oulu University Hospitals in Finland.

The same CTA is also under review by the UK’s regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA) for opening sites in the UK (the Royal Marsden Hospital in London and the Queen Elisabeth Hospital in Birmingham).

Clevegen is a novel anti-Clever-1 antibody, which causes changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive macrophages to immune active macrophages. Clever-1, a cell surface receptor expressed mainly by tumour vasculature and monocytes/macrophages, has been shown to control tumour growth (Karikoski et al., 2014), cell-mediated immunity (Palani et al. 2016) and to participate in the control of B cell response and antibody production (Dunkel et al. 2018).

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “Approval of our CTA to conduct a Phase I/II study with Clevegen represents a significant milestone for the Company. Clevegen, our wholly-owned novel precision cancer immunotherapy drug, has already demonstrated promising pre-clinical results and provided human ex vivo data that supported earlier pre-clinical observations. We look forward to starting recruitment into the MATINS study soon and obtaining the first in vivo surrogate marker data from Clevegen treated patients during H1-2019.”

The MATINS study is a first-in-human open label Phase I/II clinical trial with an adaptive design to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours. The selected tumours under investigation are cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). All together these five target groups consist of approximately 2 million annual cases worldwide. The cancer patients with high Clever-1 expression will be identified with a simple blood myeloid cell staining with Clevegen (“liquid biopsy”).

The first part of the trial deals with safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report initial findings as the dosing progress. The cohort expansion during part two will focus on identification of patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. During part three the main focus will be on assessing the efficacy of Clevegen on patients who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy. The treatment, if successful, may ultimately be used as a standalone therapy or in combination with other immunotherapies like PD-1 inhibitors.

In addition to Finland and the UK, the Company also plans to conduct the MATINS trial’s dose escalation part in the Netherlands (Erasmus University Medical Center in Rotterdam), and plans to increase the number of sites during the cohort expansion stage. The Company is also preparing a US IND to expand the study to the USA during parts two and three of the MATINS study.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (“MAR”).

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS).  An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

PDMR Dealings

RNS Number : 5353G
Faron Pharmaceuticals Oy
06 November 2018
 

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

PDMR Dealings  

TURKU – FINLAND, 6 November 2018 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announces that on 6 November 2018 it was notified of the following PDMR dealing.

On 26 October 2018, Dr Matti Karvonen, VP Drug Development, Chief Medical Officer of Faron, had acquired 20,000 ordinary shares in Faron at a price of 82.90 pence per ordinary share.

The notification below, which has been made in accordance with the requirements of the EU Market Abuse Regulation, provides further detail.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (“MAR”).                                                                

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Matti Karvonen

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities
– VP Drug Development, Chief Medical Officer

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Purchase of ordinary shares

c.

Price(s) and volume(s)

Price(s)

Volume(s)

82.90 GBPp

20,000

d.

Aggregated information

– Aggregated Volume

– Price

N/A

N/A

e.

Date of the transaction

October 26, 2018

f.

Place of the transaction

London Stock Exchange, AIM Market

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com

Consilium Strategic Communications
Mary-Jane Elliott, Matthew Neal, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
 E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker
Emma Earl, Freddy Crossley
Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com


This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com or visit
www.rns.com.
 

END

 
 

DSHBFBATMBIMBPP

INTEREST trial update presented at ESICM

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

INTEREST trial update

Routine corticosteroid treatment correlates with increased mortality and decreased Traumakine efficacy

INTEREST trial results and statistical analyses to be presented at 31st ESICM (European Society of Intensive Care Medicine) meeting in Paris

TURKU – FINLAND, 22 October 2018 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces more detailed analysis of data from the Traumakine INTEREST study related to corticosteroids used in parallel to Traumakine treatment and their effect on Traumakine efficacy. This follows the Company’s announcement of 13 September 2018 where it was noted that analysis of the INTEREST trial data had shown that other concurrent and widely used acute respiratory distress syndrome (ARDS) treatments had had a significant effect on mortality in the trial. These data will be presented today by INTEREST study investigators, Professors Geoff Bellingan (University College London Hospitals), and Marco Ranieri (University of Rome) at the 31st ESICM (European Society of Intensive Care Medicine) meeting in Paris.

As previously reported, inconsistent interferon-beta (IFN-beta) biomarker (MxA and CD73) induction was observed across the treatment group, but a sub-group of patients with a biomarker response showed a reduced day 28 (D28) mortality. To further investigate this selective benefit among the Traumakine-treated ARDS patients, further post-hoc data analysis has been carried out by the trial investigators which has found that concomitant use of corticosteroids and Traumakine appeared to affect both the mortality and biomarker appearance in the INTEREST study patients.

The following key findings will be presented at ESICM:

·      Corticosteroid use was high among INTEREST trial patients (176/296, 59.5%)

·      Concomitant corticosteroid treatment had a significant impact on mortality in the Traumakine treatment group. Mortality was 10.6% (7/66) for those receiving Traumakine and not on corticosteroids, versus 39.7% (31/78) for those receiving Traumakine and on concomitant corticosteroids. This outcome is highly statistically significant (p<0.0001) and was a similar mortality to the treatment group in the phase I/II study

·      Concomitant corticosteroid use with Traumakine was also associated with worse outcomes measured by ventilator free days (VFD) compared to non-users (median 6 VFDs vs. 14 VFDs, p= 0.03)

·      IFN-beta has previously been demonstrated to increase CD73 expression in lung capillaries(1) which was associated with reduced mortality in ARDS patients in the phase I/II trial. However, concomitant exposure of human lung tissue samples to hydrocortisone in ex vivo culture conditions prevents Traumakine induced CD73 expression in lung capillaries

Of note, we also observed that the use of corticosteroids in the placebo group was associated with an increased mortality of 27.6% compared to no use of corticosteroids of 14.8% (p= 0.075). In the group receiving corticosteroids there was a significantly higher APACHE II (acute physiology and chronic health evaluation) score (23.4 versus 20.4, p=0.0007) and SOFA (sequential organ failure assessment) score (10.4 vs 9.5, p=0.0428) but this difference does not, we believe, explain the scale of mortality difference associated with corticosteroid use versus non-use. Additionally, in a genetic analysis of a subset of patients treated with Traumakine, Faron has identified an altered (polymorphic) regulatory motif for the glucocorticoid receptor of the interferon-alpha/beta receptor beta chain which Faron believes could be associated with those patients who responded to traumakine (p=0.007) and which may confer corticosteroid resistance and impact IFN-beta action.

The Company believed that the inconsistent FP-1201-lyo bioactivity observed in the INTEREST trial may well, in part, be due to corticosteroid interference of IFN-beta action. Therefore, further in vitro and ex vivo experiments with human endothelial HUVEC cells and human lung tissue samples were conducted.  Based on these results, no issues have been detected to date in the formulation of FP-1201-lyo used in the INTEREST trial and the formulation was as active as the formulation used in the phase I/II trial. In lung tissue samples, the concomitant corticosteroids prevented the CD73 induction by Traumakine, which indicates similar interference of corticosteroids on IFN-beta bioactivity as observed in the INTEREST study.

To understand the reduced biomarker response to Traumakine administration, even where corticosteroids were not administered in the INTEREST study, a new FP-1201-lyo pharmacokinetic/dynamic study, YODA, is already underway in approximately 50 healthy volunteers. This will determine the optimum mechanism of administration to achieve a full biomarker response with first results expected in Q4 2018. The YODA study may also be extended to examine concomitant use of Traumakine and corticosteroids to get final in vivo evidence for corticosteroid interference of interaction activity.

Dr Matti Karvonen, Chief Medical Officer of Faron, said: “At this stage it appears possible that unexpectedly high corticosteroid use in the INTEREST trial may have masked the treatment benefit of Traumakine in ARDS patients. Therefore, the Company and the investigators await data from the ongoing Phase III ARDS trial with Japanese partner Maruishi, expected later this year, and further experimental data on lung tissue samples and YODA results, to determine the next steps for Traumakine’s development.” 

Commenting on the results, Dr Geoff Bellingan, co-Principal Investigator of the INTEREST study, said: “The controversy around administration of corticosteroids to ARDS patients has been a puzzling topic for decades where there has been an ongoing debate as to whether corticosteroids have any beneficial role, early, late or for more severe un-resolving cases. These new findings from the INTEREST study, where some patients were also given corticosteroids as part of their treatment, now suggest that we should control or exclude corticosteroids from future clinical research in ARDS patients. Corticosteroids have been shown to interfere with interferon-beta signalling(2) hence their use could block any beneficial effects of endogenous IFN-beta and may be particularly important when dosing with Traumakine. This brings fresh hope to ARDS patients as the study of Traumakine continues.”

Dr Marco Ranieri, co-Principal Investigator of the INTEREST study, said: “Whilst we were disappointed with the initial results from the INTEREST study, we have now made a very important observation that corticosteroid use significantly disturbs both administered and endogenous interferon-beta activity making it possibly a harmful drug in the acute phase of ARDS. This knowledge, if supported by the YODA study as well, is extremely important for ARDS patients and current practice, and it will help plan successful studies in the future for the defeat of ARDS. The concomitant use of corticosteroids and type I interferons could be prevalent in several other conditions as well (e.g. MS disease) and we believe, therefore, that the whole medical community should be more diligent with regard to their combined use.”

The cited references:

(1) Bellingan G, Maksimow M, Howell DC, Stotz M, Beale R, Beatty M, Walsh T, Binning A, Davidson A, Kuper M, Shah S, Cooper J, Waris M, Yegutkin GG, Jalkanen J, Salmi M, Piippo I, Jalkanen M, Montgomery H, Jalkanen S (2014) The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73 expression and on acute respiratory distress syndrome mortality: an open-label study. Lancet Respiratory Medicine 2: 97-104.

(2) Flammer JR, Dobrovolna J, Kennedy MA, Chinenov Y, Glass CK, Ivashkiv LB and Rogatsky I (2010) The type I interferon signaling pathway is a target for glucocorticoid inhibition. Molecular and Cellular Biology 30: 4564.

Today’s presentation by INTEREST study investigators, Professors Geoff Bellingan and Marco Ranieri is available to view at www.faron.com 

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Matthew Neal, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

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