Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron secures U.S. rights to patent related to Traumakine 

Company announcement, 14 May 2021 at 9.00 AM (EEST)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that it has signed a sub-license agreement for the rights to U.S. patent US9,376,478, which currently extends to 2033.

The agreement clarifies Faron’s intellectual property position in the U.S. ahead of any launch of Traumakine for the treatment of capillary leak and systemic inflammatory response syndromes (SIRS) including acute respiratory distress syndrome (ARDS) in the U.S. (subject to marketing approval from the U.S. Food and Drug Administration).  Faron will pay a small signing-fee, as well as single-digit standard market royalties from future sales of its intravenous (IV) IFN beta-1a (Traumakine) in the U.S.  This sub-licence specifically covers a manufacturing patent valid only in the U.S. (no corresponding patents exist in other countries) and adds to Faron’s existing comprehensive patent portfolio for Traumakine which includes use and IV formulation patents, as well as market exclusivity in Europe as an orphan medicine.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are pleased to agree this sub-licence. We continue to believe in Traumakine’s potential as a much-needed new treatment for respiratory failure and organ protection.

“Several recent publications have connected type 1 IFN with the severity of COVID-19 infections^1,2. Multiple associations have been drawn across the literature including deficiency of type 1 IFN³; inborn errors of IFN-beta signalling⁴; and the presence of auto-antibodies that neutralise the protective effect of type 1 IFN in viral infections⁵. Patients who do not have an early IFN response appear to develop severe disease irrespective of the underlying reason for the deficiency^2,6. The continued further evidence supports the hypothesis that COVID-19 patients may become very ill because of an impaired interferon response.

“The administration of IFN is likely to benefit patients and relieve them from the hyper-inflammatory state that leads to severe disease^3,7,8. We believe intravenous administration of IFN-beta is the optimal route⁹ to compensate for this loss of first line viral defence and, in tandem induce CD73 a critical enzyme in organ protection during severe illness¹⁰.”

References:

1. C. Turk et al. Eur Rev Med Pharmacol Sci 10.26355/eurrev_202008_22660 (2020)

2. V. Feuillet et al. Trends in Immunology. 10.1016/j.it.2020.11.003 (2021)
3. J. Hadjadj et al. Science 10.1126/science.abc6027 (2020)
4. Q. Zhang et al. Science 10.1126/science.abd4570 (2020)
5.  P. Bastard et al. Science 10.1126/science.asd4585 (2020)
6. L. Walz et al. BMC Infect Dis 10.1186/s12879-020-05730-z (2020)
7. Z. Wang et al. Sig Transduct Target Ther. 10.1038/s41392-020-00306-4 (2020)
8. G. Schreiber et al. Front. Immunol. 10.3389/fimmu.2020.595739 (2020)
9. J. Jalkanen et al Crit Care. 10.1186/s13054-020-03048-5
10. Hanidziar and Robson Am J Physiol Lung Cell Mol Physiol 10.1152/ajplung.00304.2020 (2021)

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Peel Hunt LLP, Broker

Dr Christopher Golden, James Steel        

Phone: + 44 (0)20 7418 8900

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner,  Mark Rogers

Phone. +44 (0)20 7213 0880      

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel

Phone: +1 212 362 1200

Email: julie.seidel@sternir.com

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanised antibody, is an investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers by targeting myeloid function. This programme is currently in phase I/II clinical development as a potential therapy for patients with untreatable solid tumours. Bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint inhibitors. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global clinical trials as a potential treatment for hospitalised patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischaemia-reperfusion injury caused by a major trauma.  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”, “hope”, “seek”, ”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 within the anticipated timeframe or at all, 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. 

Faron secures US rights to patent related to Traumakine 140521

• Cholangiocarcinoma becomes fifth tumour cohort to show early signs of efficacy
• Increased bexmarilimab dosing schedule and high baseline regulatory T cell count associated with clinical benefit
• High levels of soluble Clever-1 observed in MATINS patients
• Soluble Clever-1 has the capacity to suppress T cell activation
• Increased bexmarilimab dosing frequency to counter high levels of soluble Clever-1 underway

Company announcement, 20 January 2021 at 9.00 AM PM (EEST)

Insider information
 

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company, today announces new observations from its ongoing MATINS trial and an update on the study.

The phase I/II MATINS clinical trial is investigating the tolerability, safety and preliminary efficacy of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1, a receptor known to be expressed on immunosuppressive macrophages in the tumour microenvironment.

Working with Kaiku Health Ltd (“Kaiku”), a health data science company (www.kaikuhealth.com), Faron is using Kaiku’s artificial intelligence platform designed to analyse patient outcomes following treatment with cancer immunotherapies to undertake further efficacy analysis of patient data from Part I of the MATINS trial. This platform provides insight through data analyses of the immunological and disease characteristics of the MATINS patients to better define patients who respond to bexmarilimab and should enable further refinement of bexmarilimab’s clinical development. 

Latest scientific observations from the trial include the identification of a new role for soluble Clever-1, related to its capacity to control T-cell activation. This suggests that the inactivation of Clever-1 as an immune suppressive molecule could be even broader and more important than previously thought as the immune-stimulating effects are not only limited to tumour associated macrophages (TAM) but may also act systemically.

Dr. Markku Jalkanen, Faron’s CEO, said: “I am extremely happy about these results and wish to thank our team, our scientific network and the MATINS clinical group for the impressive work they have done, both progressing the trial and undertaking complex analyses of the data during challenging times in the face of the current pandemic. Never during my career have I seen that a high baseline count of regulatory T cells (Tregs) predicts a good response to a therapy. Until now, it has always been the opposite. This is remarkable. Such observations now provide us with a much better understanding of the next steps required for bexmarilimab’s clinical development in pivotal studies and support its potential as a breakthrough therapy to deliver optimal clinical results in patients with hard to treat cancers.

“The new discovery of the role of soluble Clever-1 as an immune suppressive molecule is striking, indicating the soluble part of this receptor could cause systemic inhibition of T-cells in all locations of body, therefore controlling the general immune capacity in cancer patients. We hope to be able to overcome this inhibition just by increasing the dosing frequency of bexmarilimab to provide maximal binding and the removal of Clever-1 from body fluids and tissues, including tumours.” 

Data details

Five solid tumour types showing early signs of efficacy

As previously communicated, four solid tumour cohorts in the first expansion stage (Part II) of the study (cutaneous melanoma, colorectal cancer (CRC), hepatocellular cancer and ovarian cancer) have demonstrated early signs of clinical efficacy from bexmarilimab therapy. This group is now joined by cholangiocarcinoma (also known as bile duct cancer) as a fifth responsive tumour cohort. The exact way how these cohorts will be taken forward into the protocol for Part III of the MATINS trial will be decided in Q3-2021 after further data on the effect of increased dosing frequency is available (recruitment currently ongoing). More frequent dosing either weekly or at two week intervals could increase bexmarilimab treatment efficacy further, compared to the original dosing interval of every three weeks, which has already led to some very promising results in several advanced cancer types.

Regulatory T cell (Treg) marker FOXP3 and increased bexmarilimab dosing associated with increased clinical benefit

Part I MATINS study patients had received a median of three previous cancer treatments (mainly various chemotherapy combinations). Half of the study patients had received four or more lines of therapy before joining the MATINS study. Patient blood samples have indicated reduced immune capacity reflected in low counts of effector immune cells. To better understand patient outcomes after bexmarilimab treatment around 50 biomarkers have now been analysed using Kaiku’s Immuno-Oncology platform resulting in the following findings:

• Increased bexmarilimab dosing level with three week interval was associated with a clinical response

• High baseline count of Treg cell marker FOXP3 was associated with a clinical response

These findings are consistent with the Company’s previous findings and understanding that cellular immune activation and the removal of immunosuppressive elements are required for clinical benefit from bexmarilimab. The association of clinical benefit in patients with a high baseline count of Tregs indicates that patients were significantly immunosuppressed before the treatment. In these subjects, removal of immunosuppression using bexmarilimab to inactivate Clever-1 positive myeloid cells could therefore result in removal of Tregs known to be supported by macrophages. The Company believes that increased dosing frequency has the potential to produce more complete inactivation of Clever-1, either expressed on the surface of myeloid cells or circulating in blood and lymph as a soluble immunosuppressive molecule.

Cancer patient plasma can contain significant amounts of soluble Clever-1

The transient Clever-1 receptor occupancy observed in all MATINS Part I dose levels (0.1-10 mg/kg) supports the decision to increase dosing frequency from every three weeks to either weekly or two week intervals. Latest data show that MATINS patients’ plasma (blood devoid of cells) could contain up to a 10-fold increased level of soluble Clever-1 compared to healthy controls. These elevated values could explain the rapid uptake of bexmarilimab in cancer patients. This finding also supports the potential of higher administration frequency, which is currently ongoing in CRC patients, with first results expected in H1-2021.

Soluble Clever-1 has the capacity to suppress T cell activation

The role of increased soluble Clever-1 in the circulation was tested in experimental settings. The most interesting finding from this experimental work elucidated a new role for Clever-1:  it can control T cell activation directly, including naïve T cells. This is a significant finding because it proposes that by producing soluble Clever-1 the malignant process can also suppress T cell activation in remote locations and, by targeting naïve T cells, can prevent expansion of the T cell repertoire. Soluble Clever-1 can therefore be a substantial inhibitor of T cell activating therapies.

A new patent application has been filed seeking global protection for these findings and related applications.

The observations detailed in this statement are being prepared for peer-reviewed publication and/or presentation at future scientific congresses.

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

About bexmarilimab

Bexmarilimab is Faron’s investigative precision immunotherapy, a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules.

About the MATINS study

The MATINS study is the first-in-human open label Phase I/II clinical trial with an adaptive design to investigate the safety and efficacy of bexmarilimab in ten selected metastatic or inoperable solid tumours – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM).

Part I of the trial dealt with tolerability, safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report findings as the dosing progresses. The cohort expansion during Part II is focused on identifying patients who show an increased number of Clever-1 positive tumour macrophages and the safety and efficacy of the treatment. During Part III, the main focus will be on assessing the efficacy of Clevegen on study subjects who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone: +44 207 213 0880   

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel, Naina Zaman

Phone: +1 212 362 1200

E-mail: faron@sternir.com
 

About Faron Pharmaceuticals Oy

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the receptors involved in regulation of the immune response in oncology and organ damage. Clevegen (bexmarilimab), its investigative precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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”, “hope”, “seek”, ”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 within the anticipated timeframe or at all, 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.

Release

Company announcement, 23 November 2020 at 9.00 AM (EET)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today an update on the MATINS study and further details on the clinical expansion plans for bexmarilimab, its wholly-owned novel precision cancer immunotherapy, targeting Clever-1 positive tumour associated macrophages (TAMs) in selected metastatic or inoperable solid tumours.

The expanded clinical development programme is intended to generate data beyond existing hard-to-treat cancer cohorts, exploring new patient populations and investigating combinations with existing treatments, to build full understanding of bexmarilimab’s commercial potential dependent on this unique and proprietary myeloid cell target.

MATINS study update

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of bexmarilimab across ten different hard-to-treat solid tumour cohorts (cutaneous melanoma, uveal melanoma, ovarian cancer, colorectal cancer, hepatocellular cancer, ER+ breast cancer, pancreatic cancer, gastric cancer, cholangiocarcinoma, anaplastic thyroid carcinoma) in the first expansion stage (Part II) of the study. Latest data from four cohorts – cutaneous melanoma, ovarian cancer, colorectal cancer (CRC), and hepatocellular cancer – have demonstrated early signs of efficacy from bexmarilimab monotherapy which, according to the MATINS study protocol, allows them to move to Part III. Further data from all cohorts in Part II will enable the Company to evaluate which indications are most likely to achieve success and should be continued further in development.

Of the cohorts in Part II, uveal melanoma, ovarian cancer, colorectal cancer, pancreatic cancer, and cholangiocarcinoma are now fully recruited and the rest, between 50-90 per cent recruited, except anaplastic thyroid carcinoma, which is a new cohort awaiting enrolment of the first patient.

Investigating alternative dosing schedules

As a result of key pharmacokinetic and pharmacodynamic biomarkers suggesting the potential for improved clinical response of bexmarilimab administered with a higher frequency than the current three week interval, regulatory authorities have approved an expansion of MATINS to include two additional CRC cohorts receiving 1 mg/kg dosed at either weekly or two week intervals. These cohorts have started recruiting with results expected during H1 2021. Data from these cohorts will support the design of new and pivotal trials for bexmarilimab.

Study of neoadjuvant bexmarilimab in colorectal and kidney cancers

Faron expects to initiate a neoadjuvant bexmarilimab study in colorectal cancer and clear cell renal cell carcinoma (ccRCC) patients soon after diagnosis and prior to any other treatments. The Company plans to evaluate bexmarilimab’s ability to induce an anti-cancer immune response in patients previously untreated or with minimal exposure to anti-cancer treatments. Disease-free survival will be also investigated to determine the clinical benefit for neoadjuvant treatment.

Lung cancer combination study with anti-PD-(L)1 therapy

The Company previously reported that bexmarilimab administration down regulates a range of immune checkpoint molecules (CTL-4, PDL-1 and PD-1) on the peripheral immune cells of cancer patients,  signalling immune activation and removal of T cell exhaustion. This finding is consistent with the current understanding that Clever-1 is major source of T cell exhaustion and treatment resistance against marketed checkpoint inhibitors¹. Based on these findings, Faron now plans to expand the bexmarilimab programme to evaluate its safety and efficacy in a pilot study in combination with anti-PD-(L)1 therapy in non-small cell lung carcinoma (NSCLC) patients, where PD-(L)1 inhibition has become the standard of care, though resistance develops in roughly 70 per cent of patients².

Potential of bexmarilimab in haematological cancers

Faron, together with Helsinki University Hospital, Finland, plans to initiate a phase I/II bexmarilimab study in combination with standard of care in acute myeloid leukaemia (AML)/ myelodysplastic syndrome (MDS) patients in H2 2021 to investigate the safety and preliminary efficacy of bexmarilimab in haematological cancers. Both AML and MDS originate from myeloid lineage of bone marrow cells and result in impaired haematopoiesis (the production of blood and immune cells). Due to this nature of cell origin, they also express cell surface Clever-1, which has been identified as a prognostic factor in AML³. Faron believes that controlling Clever-1 activity on malignant cells can also control their replication. This is evident in ex vivo experimental settings and could be potentiated with anti-apoptotic compounds like bcl-2 inhibitors³ which promote cell death. Diagnostics and ex vivo drug screen development for bexmarilimab will be included in the study to optimise patient outcomes for targeted bexmarilimab therapy.

Dr. Markku Jalkanen, Faron’s CEO, said: “Bexmarilimab is rapidly advancing through development and its exciting clinical activity across multiple cancer types continues to give us confidence in this asset’s potential as a next generation immunotherapy with broad opportunities. With the data we have seen to-date, we are pleased to expand our bexmarilimab development programme, giving us the opportunity to explore its potential to activate the immune system in early stage cancers and in combination with checkpoint inhibitors, a study of high interest for everyone in the field.”

“Our deep understanding of Clever-1 and its role in cancer immunotherapy has brought us to where we are today and we look forward to advancing this novel programme into haematological cancers, the neoadjuvant setting and combination trials, in addition to our ongoing robust basket study in late-line solid tumours, which produces continuous data and understanding of bexmarilimab as a foundational treatment for the removal of immune suppression and T cell exhaustion.”     

References:

1) Hollmén et al. Brit. J. Cancer 2020

2) Gandhi et al. N. Eng. J. Med. 2018; 378; 2078-92

3) Lin et al. Mol. Therapy Nucleic Acids 2019; 18; 476-484

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner,  Mark Rogers

Phone. +44 (0)20 7213 0880       

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 (0)20 7886 2500       

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel

Phone: +1 212 362 1200

Email: julie.seidel@sternir.com

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology and organ damage. Clevegen (bexmarilimab), its investigative precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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”, “hope”, “seek”, ”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 within the anticipated timeframe or at all, 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.

Release

Faron Pharmaceuticals Oy
(“Faron” or the “Company”)

Company announcement, 16 October 2020 at 1.35 PM (EEST)
 

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company, today announces that the first results from the World Health Organization’s (WHO)  Solidarity trial have been made available as a preprint at medRxiv¹ while under review for publication in a medical journal. The results show that subcutaneous interferon (IFN) beta-1a was found to be safe, but ineffective to reduce overall mortality in hospitalized patients with COVID-19.

The WHO’s intent-to-treat analysis compared 1412 patients who received IFN beta-1a and 2050 control subjects not receiving IFN beta-1a. The use of corticosteroids was 50% across the study. Overall in-hospital mortality (the primary endpoint) was 12.9% in the IFN beta-1a group and 11% in the control group, RR 1.16 (95% CI, 0.96 – 1.39, NS). The WHO reports that patients mainly received subcutaneous IFN beta-1a (Rebif, Merck KGaA). At the time of the data-cut for this analysis, Traumakine, the Company’s intravenous (iv) formulation of IFN beta-1a, became available very late in the observation period and it is the Company’s understanding it had seldom been used. The WHO has not been able to verify how many patients received Traumakine at the time of this analysis. About half of the patients receiving IFN beta-1a also received concomitant corticosteroids.

Dr. Markku Jalkanen, Faron’s CEO, said: “These first results from the Solidarity Trial are disappointing, given the need for new therapeutics to support the global response to COVID-19. They do support our long held view that IFN beta-1a is likely to be ineffective when given subcutaneously. The science behind Traumakine and its potential to prevent multi-organ failure, through the upregulation of the key endothelial enzyme CD73, is compelling and we continue to believe that an intravenous formulation of IFN beta-1a is what patients need, to strengthen the body’s own IFN beta signalling – the first line of defence against viral infection – and provide optimal exposure to the lung vasculature².

“Compared to subcutaneous IFN beta-1a, the same amount of intravenous IFN beta-1a achieves over 150x higher peak concentration in the lung vasculature without higher systemic exposure³, which we believe makes this method of administration highly effective and safe. We will continue to pursue the science behind this.”

Traumakine continues to be investigated in the ongoing global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) trial, which is evaluating potential treatments for community-acquired pneumonia, including in COVID-19 patients, and is currently ongoing across more than 200 sites and 19 countries.

Faron is also supporting a US trial to investigate the potential of Traumakine to treat COVID-19.  HIBISCUS (Human Interferon Beta In Severe CoronavirUS), an investigator initiated study at Harvard Medical School’s Beth Israel Deaconess Medical Center (BIDMC), focused on ICU patients with ARDS caused by viral infection (e.g. COVID-19, influenza). Commencement of this Phase II/III pivotal, randomized, placebo-controlled study, remains subject to finalisation of funding arrangements and regulatory approval. The study will test Traumakine against both placebo and dexamethasone, which is now a part of the standard of care in the US.

References

1. https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1
2. Interferon beta-1a for COVID-19: critical importance of the administration route, Jalkanen et al., Critical Care (2020) 24:335 https://doi.org/10.1186/s13054-020-03048-5 
3. Buchwalder et al. Pharmacokinetics and Pharmacodynamics of IFN-b1a in Healthy Volunteers. Journal of Interferon and Cytokine Research 2020; 20:857-866.

Notes to editors

Further information on the results of the Solidary trial is available at https://www.who.int/news/item/15-10-2020-solidarity-therapeutics-trial-produces-conclusive-evidence-on-the-effectiveness-of-repurposed-drugs-for-covid-19-in-record-time .

The preprint is available at https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone: +44 207 213 0880 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel, Naina Zaman

Phone: +1 212 362 1200

E-mail: faron@sternir.com
 

About Faron Pharmaceuticals Oy

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology and organ damage. Clevegen (bexmarilimab), its investigative precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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”, “hope”, “seek”, ”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 within the anticipated timeframe or at all, 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.

TURKU – FINLAND, 18 September 2020 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces details from an oral presentation being held at the European Society of Medical Oncology (ESMO) Virtual Congress 2020, showcasing data from the Company’s ongoing MATINS trial to the scientific community.

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM) in selected metastatic or inoperable solid tumours. During the on-demand mini oral session, Petri Bono, M.D., Ph.D., principal investigator of the MATINS study, presents data on all 30 patients in Part I of the trial with advanced solid tumours and who had exhausted standard therapeutic options. The presentation includes previously announced data, highlighting:

• Key pharmacokinetics (PK) and Clever-1 receptor occupancy data showing that exposure to bexmarilimab in the trial was more than dose proportional, that full (transient) Clever-1 receptor occupancy was achieved and, despite its relatively fast clearance from circulation, sustained pharmacodynamic effects by bexmarilimab were observed.
• Very good tolerability across all dosing levels with no observed dose limiting toxicity.
• Th1-weighted immune activation in all subjects measured following treatment with bexmarilimab. The patients also increased circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory T-cells (T-regs) or had a substantial increase in natural killer cells in the blood, all of which are considered as strong signs of this desired immune activation.
• Promising clinical anti-tumour activity including, 1) a long-lasting partial response of a heavily pre-treated microsatellite stable metastatic colorectal cancer patient who had previously been treated with six different anti-cancer drugs, which had all failed, 2) target lesion responses in heavily pre-treated melanoma and ovarian cancer patients.
• Conversion of immunologically non-inflamed (cold) tumours into inflamed (hot) tumours in patients traditionally not responsive to currently available checkpoint inhibitors.

Commenting on the presented data, Petri Bono M.D., Ph.D., Terveystalo, Helsinki, Finland and principal investigator of the MATINS trial, said: “The emerging tolerability profile and evidence of clinical anti-tumour activity for this novel anti Clever-1 antibody are promising. These data are from patients with difficult-to-treat cancers who had already failed all standard therapy options and received as many as six different lines of therapy, exhausting all future treatment options.  As this trial continues, we will learn more about this novel immunotherapy’s potential to help those cancer patients who desperately need new treatment options.”

Title: A phase I/II MATINS trial: Part 1 pharmacokinetic, safety and efficacy results of Clever-1 blockade in advanced cancer

Presentation number: 1024MO

www.esmo.org

ENDS

Release

Faron Pharmaceuticals to Present at the Virtual H.C. Wainwright 22^nd Annual Global Investment Conference

TURKU – FINLAND, September 9, 2020 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announced that Dr. Markku Jalkanen, Chief Executive Officer of Faron Pharmaceuticals, will present at the virtual H.C. Wainwright 22^nd Annual Global Investment Conference on Wednesday, September 16, 2020 at 11:00 a.m. ET.

To access a live webcast and subsequent archived recording of the presentation, please visit the “Investors” section on Faron’s website at https://www.faron.com/investors

ENDS

For more information please contact:

Stern Investor Relations, Inc.

Julie Seidel, Naina Zaman

Phone: +(1)212 362 1200

Email: faron@sternir.com

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. Faron is based in Turku, Finland. Further information is available at www.faron.com

• €2.5 million loan guarantee from Finnvera to further expand IV IFN beta-1a manufacturing process
• AGC Biologics selected as new commercial scale manufacturer
• COVID-19 trials continue to investigate Traumakine treatment

Company announcement, 18 August 2020 at 9.00 AM (EET)
Insider information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today provides an update on manufacturing plans for Traumakine, its investigational intravenous (IV) interferon (IFN) beta-1a, and the continuing clinical investigations in COVID-19 patients.

Commercial scale manufacturing

The Company has received a guarantee from Finnvera Oyj (“Finnvera”) for a €2,500,000 loan  (“Loan”) which will be provided by Danske Bank A/S Finland Branch.  The Loan is for a period of 7 years with Loan repayment only commencing after 2 years and is subject to certain financial covenants.  Interest cost equates to approximately 4.1% per annum over Euribor.  The Loan funds will be used to further expand the use of a new cell line planned to be established using the previously received Business Finland loan of €2,100,000, announced on 15 June 2020, and which will be used in the future commercial scale production of Faron’s IV IFN beta-1a.

Finnvera is a specialised financing company owned by the State of Finland and it is the official Export Credit Agency (ECA) of Finland. For more information see: https://www.finnvera.fi/eng/finnvera/finnvera-in-brief.

Faron also announces today that AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organisation (CDMO), has been selected as the new manufacturing house for the commercial scale production of the Company’s IV IFN beta-1a. As announced on 5 May 2020, AGC Biologics is also the commercial scale manufacturer of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy (Clevegen). Faron has been very satisfied with AGC Biologics’ work since that time.

“We are very happy to expand our partnership with Faron. Our priority has always been to serve our customers with a commitment to continuous innovation, aided by building strong, long term collaborative relationships,” said AGC Biologics’ CEO Patricio Massera.

Clinical investigations in COVID-19

Traumakine continues to be investigated as a potential COVID-19 treatment in global trials, including the World Health Organization’s (WHO) Solidarity trial. In July, WHO took the decision to remove the hydroxychloroquine and lopinavir/ritonavir treatment arms from the trial due to insufficient evidence of benefit. This leaves IFN beta-1a and remdesivir as the only two drugs remaining in the trial, subject to WHO announcing further new compounds for inclusion. IFN beta-1a had previously been included in a treatment arm testing it in combination with lopinavir/ritonavir. IFN beta-1a now remains as a monotherapy.

Traumakine is used in the trial’s severe patients for whom it is critical to rapidly provide high serum concentrations of IFN beta-1a and to maximise levels of the drug in the lung vasculature where peripheral circulation is slowed¹, a condition which can be life threatening for these virally-infected patients. Recent findings show that seriously ill COVID-19 patients have compromised interferon responses².

In addition to the Solidarity trial, Faron continues to investigate Traumakine in two other clinical trials, the ongoing global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) trial, and the US HIBISCUS (Human Interferon Beta In Severe CoronavirUS) trial. 

• The global REMAP-CAP trial is evaluating Traumakine as a potential treatment for community-acquired pneumonia, including in COVID-19 patients, and is currently ongoing across more than 200 sites and 14 countries.
• As previously announced, HIBISCUS will be an investigator-initiated study at Harvard Medical School’s Beth Israel Deaconess Medical Center (BIDMC), focused on intensive care unit (ICU) patients with ARDS caused by a viral infection (e.g. COVID-19, influenza). Commencement of the Phase II/III pivotal, randomized, placebo-controlled study, remains subject to finalisation of funding arrangements and regulatory approval. The study will test Traumakine against both placebo and dexamethasone, which is now a part of the standard of care in the US. Further announcements will be made in due course.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are very pleased to have secured additional resources that will enable us to progress Traumakine manufacturing to support its potential future commercial use. The science behind interferon (IFN) beta and its potential to prevent multi-organ failure in severe COVID-19 patients is compelling. Administering an IV formulation to strengthen the body’s own IFN beta production – its first line of defence against viral infection – provides optimal exposure to the lung vasculature, which is what we believe critically ill patients need. We are proud to be supporting global research efforts against COVID-19 and look forward to further data from these trials to support the potential use of IV IFN beta-1a in the future.”

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

References

1. Interferon beta-1a for COVID-19: critical importance of the administration route, Jalkanen et al., Critical Care (2020) 24:335 https://doi.org/10.1186/s13054-020-03048-5   
2. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients, J. Hadjadj et al., Science 10.1126/science.abc6027 (2020)

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson , Tony Rawlinson,  Mark Rogers

Phone. +44 207 213 0880           

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500           

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Stern Investor Relations, Inc.

Julie Seidel

Phone: +(1)212 362 1200

Email: Julie.Seidel@sternir.com

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. 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”, “hope”, “seek”, ”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 within the anticipated timeframe or at all, 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.