Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Updated corporate presentation

Company announcement, 22 June 2021 at 9.00 AM (EEST)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, has today published an updated corporate presentation on its website.

The presentation contains previously published Company information, views of Management and data from Faron’s development programmes.

Latest available data from the ongoing PhI/II MATINS trial investigating bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1, has been updated in the presentation to include positive incremental change to the previously reported disease control rate (DCR) in cutaneous melanoma patients. The previously reported DCR figure of 3/9 patients (33.3%) has, following the accumulation of new data, now increased to 4/11 patients (36.3%).

It should be noted that some information within the presentation may be presented in a different format or context to earlier versions. Readers are encouraged to read the corporate disclaimer on page two of the presentation. The Company may make additional non-material additions and updates to the presentation periodically, as deemed necessary, without making separate announcements of such updates.

The presentation is available to view in the Investors section of www.faron.com

Ends

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 its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. 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 molecules. 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 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 ischemia-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 b

Updated corporate presentation 220621

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Bexmarilimab granted key US patent

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

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that the United States Patent and Trademark Office has granted a new US Patent, No. 11,046,761, with claims protecting the composition of matter of bexmarilimab. The patent will be issued on 29 June, 2021.

Faron’s wholly-owned novel precision cancer immunotherapy drug candidate, bexmarilimab, targets the Clever-1 receptor, known to be expressed on immunosuppressive macrophages in the tumour microenvironment and circulating in soluble form, and which is capable of directly inhibiting T-cell activation. The reprogramming of these Clever-1 positive macrophages by bexmarilimab, from an immunosuppressive state to an immune-stimulating one, is believed to be a key immune defence against tumour growth and spread.

Bexmarilimab is currently being investigated in the ongoing Phase I/II MATINS trial as a potential monotherapy in patients with solid tumours who have exhausted all treatment options. Latest data from the trial have shown strong initial safety and tolerability, and promising anti-tumour activity in several refractory metastatic solid tumours – cutaneous melanoma, gastric cancer and cholangiocarcinoma.

The US composition of matter patent covers bexmarilimab’s binding sequences and Clever-1’s corresponding epitope – specific elements of the antibody-antigen binding site. The expiry date, not including any potential extensions, is expected to be 2037.

The same patent has been granted in Japan and applications are under review in other key territories including Europe and China.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are extremely pleased to receive this key patent approval which grants us market exclusivity up to 2037. This patent protection applies specifically to the binding process between bexmarilimab and its target, the Clever-1 receptor found on the surface of tumour associated macrophages in the tumour microenvironment. This novel binding is key to the conversion of these highly immunosuppressive macrophages to immune-stimulating ones that can target difficult-to-treat cancers, and key to the removal of soluble Clever-1 from remote locations, where it can prevent activation of immune cells. The patent is a welcome addition to our existing global IP portfolio for targeting Clever-1 and further strengthens the long-term potential of this next-generation macrophage reprogramming immunotherapy.”

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 its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. 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 molecules. 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 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 ischemia-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 announces bexmarilimab granted key US patent 140621

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

First-in-human bexmarilimab results published in Clinical Cancer Research

– Results reveal the role of Clever-1 receptor in supressing adaptive immunity

– Bexmarilimab’s macrophage-targeting approach activates T-cells and drives anti-tumour immune responses in cold tumours that are not otherwise responsive to immunotherapy

Company announcement, 3 June 2021 at 9.00 AM (EET)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces the publication of research supporting the immunotherapeutic blockade of Clever-1 to activate anti-tumour immune responses in advanced cancer patients. The research, published in Clinical Cancer Research, a journal of the American Association for Cancer Research, analyzes the mode of action of bexmarilimab, both in vitro and in heavily pre-treated metastatic cancer patients from Part I (dose-finding) of Faron’s ongoing Phase I/II MATINS study.

Bexmarilimab is Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1 (common lymphatic endothelial and vascular endothelial receptor 1), a receptor expressed on immunosuppressive macrophages in the tumour microenvironment. The humanised monoclonal antibody is currently being investigated as a potential monotherapy in patients with solid tumours who have exhausted all treatment options. The ongoing, open label Phase I/II multicenter MATINS study has treated more than 140 patients to date. A recent and previously communicated analysis of data from patients enrolled in the completed Part I and ongoing Part II of the study identified promising anti-tumour activity in multiple advanced solid tumours.

The research published in Clinical Cancer Research was conducted by Dr. Maija Hollmén and colleagues at the University of Turku, Finland – part of Faron’s scientific network – and was supported by the investigators in the MATINS study. It explores the systemic immune signatures induced by bexmarilimab in advanced cancer patients with solid tumours and provides a mechanistic understanding of how a macrophage-targeted approach can promote robust activation of T-cells. In the cancer patients studied, it was found that administration of bexmarilimab successfully lowered the suppressive potential of macrophage precursors circulating in the blood. Treatment led to suppression of nuclear lipid signalling pathways and a proinflammatory phenotypic switch in blood monocytes. These effects were accompanied by a significant increase and activation of peripheral T-cells with indications of antitumour responses in some patients.

The researchers conclude that the therapeutic blockade of Clever-1 reveals a pathway linking the innate and adaptive immune system and that targeting macrophages can promote an immune switch, converting immunologically ignorant tumours to an immune activated state, supporting further exploration of Clever-1 as an immunotherapeutic drug target.

Commenting on the findings, Dr. Maija Hollmén, Turku University, Finland, said: “Macrophages have been proven to be critical in driving an immunosuppressive tumour microenvironment, which ultimately counteracts the effects of current T-cell targeting therapies. Successfully overcoming this suppression is critical to developing effective new cancer therapies. We have demonstrated through this research that adaptive immune activation can be achieved by modulating the behaviour of macrophages. “The notable immunological finding from this research is that anti-Clever-1 treatment can induce robust peripheral T-cell activation in patients with advanced cancer. This systemic immune activation is a promising feature of the clinical anti-tumour activity of bexmarilimab.”

The research, entitled “Systemic blockade of Clever-1 elicits lymphocyte activation alongside checkpoint molecule downregulation in patients with solid tumors” can be accessed via the link below:

https://clincancerres.aacrjournals.org/content/early/2021/06/01/1078-0432.CCR-20-4862

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

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

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

Email: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel, Alexa Comai

Phone: +1 (212) 362-1200

E-mail: julie.seidel@sternir.com

About bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. In mouse models, bexmarilimab has successfully blocked or silenced Clever-1, activating antigen presentation and promoting interferon gamma secretion by leukocytes. Additional pre-clinical studies have proven that Clever-1, encoded by the Stabilin-1 or STAB-1 gene, is a major source of T cell exhaustion and involved in cancer growth and spread. Observations from clinical studies to date indicate that Clever-1 has the capacity to control T cell activation directly, suggesting that the inactivation of Clever-1 as an immune suppressive molecule could be more broadly applicable and more important than previously thought. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

About MATINS

The MATINS (Macrophage Antibody To INhibit immune Suppression) study is a first-in-human open label phase I/II clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumour cohorts – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma –  which are all known to host a significant number of Clever-1 positive tumour-associated macrophages (TAMs). The completed Part I of the trial dealt with tolerability, safety and dose escalation. The ongoing Part II is focused on identifying patients who show an increased number of Clever-1 positive TAMs and exploring safety and efficacy. Part III will be focused on assessing efficacy. Data from MATINS have shown that bexmarilimab has the potential to be the first macrophage immune checkpoint therapy. To date, the investigational therapy has been shown to be safe and well-tolerated, making it a low-risk candidate for combination with existing cancer therapies, and has demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options.

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 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 its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. 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 molecules. 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 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 ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

210603 Faron_First-in-human bexmarilimab results published in CCR FINAL

 Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Bexmarilimab monotherapy shows promising anti-tumour activity in multiple advanced solid tumours

• Headline data reported from patients enrolled in completed Part I and ongoing Part II of MATINS study
• Strongest disease control rate (DCR) of 31% seen in cutaneous melanoma, gastric cancer and cholangiocarcinoma patients
• 100% six-month survival rate observed in DCR patients compared with 31.1 % for non-DCR patients
• Equivalent prior treatment durations for DCR and non-DCR patients suggests DCR with bexmarilimab is indicator of anti-tumour activity and survival benefit

Company announcement, 17 May 2021 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces promising new data from its ongoing bexmarilimab MATINS study, reporting combined headline data from 141 evaluable patients enrolled in the completed Part I and ongoing Part II of the study.

The open label Phase I/II MATINS clinical trial is investigating the 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. In this trial bexmarilimab is being investigated as a potential monotherapy in patients with solid tumours who have exhausted all treatment options.

As previously communicated, the first expansion stage (Part II) of the study has progressed significantly with strong patient recruitment across the 10 different hard-to-treat solid tumours under investigation – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma. The latest data, as of the end of April, include results from 141 patients enrolled in the completed Part I (n=30) and ongoing Part II (n=111) of the study. Patients were dosed at five different levels (0.1, 0.3, 1.0, 3.0 and 10 mg/kg) and received one to 12 doses (median, three doses) of bexmarilimab every three weeks. Median follow-up was 2.1 months (range, 0.3 to 8.2 months).

Key Findings

• Across the 141 evaluable patients, median progression-free survival (PFS) was 59 days (95% confidence interval, 57 – 60) and median overall survival (OS) was 129 days (95% confidence interval, 115 – 178).
• Per RECIST 1.1 criteria, the DCR (partial response + stable disease rate) among responding patients was 11.4 % at cycle four of treatment across all ten solid tumour types.
• Among responding patients, OS and PFS were improved (hazard ratio for OS 0.19; CI 0.06-0.60 and hazard ratio for PFS 0.09; CI 0.04-0.23, respectively). This improved survival in responding patients was not associated with duration of previous therapy. Six-month survival rate was 100% for DCR patients compared to 31.1 % for non-DCR patients.
• Strongest results were observed in cutaneous melanoma (3/9 patients), gastric cancer (3/10 patients) and cholangiocarcinoma (3/10 patients) resulting in a 31.0 % DCR.
• Most common treatment emergent adverse events (TEAEs) were fatigue (25% of patients), abdominal pain (24%) and anaemia (20%) and only 10 out of the total 145 recorded serious TEAEs (14.1% of all TEAEs) were considered related to the study drug.

Dr. Markku Jalkanen, Faron’s CEO, said: “Bexmarilimab’s ability to increase survival in patients who have exhausted all treatment options is significant and demonstrates the importance of targeting myeloid cell control in the development of next generation immunotherapies. Bexmarilimab is designed to switch immunosuppressive macrophages in the tumour microenvironment to become immune stimulating and we believe its unique mechanism of action offers broad potential across a range of hard-to-treat cancers.

“These data demonstrate strong initial safety and tolerability, and promising anti-tumour activity in several refractory metastatic solid tumours – cutaneous melanoma, gastric cancer and cholangiocarcinoma – which helps us to determine in which cancer cohorts bexmarilimab offers the most promise. Together with the additional work underway investigating higher and more frequent dosing, biomarkers of efficacy and the potential for combination with earlier lines of therapy, we are building a clear path towards the next stage of the study.”

Further detailed analysis of the data will be presented at an upcoming scientific congress.

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 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

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

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

Email: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel, Alexa Comai

Phone: +1 (212) 362-1200

E-mail: julie.seidel@sternir.com

About bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. In mouse models, bexmarilimab has successfully blocked or silenced Clever-1, activating antigen presentation and promoting interferon gamma secretion by leukocytes. Additional pre-clinical studies have proven that Clever-1, encoded by the Stabilin-1 or STAB-1 gene, is a major source of T cell exhaustion and involved in cancer growth and spread. Observations from clinical studies to date indicate that Clever-1 has the capacity to control T cell activation directly, suggesting that the inactivation of Clever-1 as an immune suppressive molecule could be more broadly applicable and more important than previously thought. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

About MATINS

The MATINS (Macrophage Antibody To INhibit immune Suppression) study is a first-in-human open label phase I/II clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumour cohorts – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma –  which are all known to host a significant number of Clever-1 positive tumour-associated macrophages (TAMs). The completed Part I of the trial dealt with tolerability, safety and dose escalation. The ongoing Part II is focused on identifying patients who show an increased number of Clever-1 positive TAMs and exploring safety and efficacy. Part III will be focused on assessing efficacy. Data from MATINS have shown that bexmarilimab has the potential to be the first macrophage immune checkpoint therapy. To date, the investigational therapy has been shown to be safe and well-tolerated, making it a low-risk candidate for combination with existing cancer therapies, and has demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options.

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 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 its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. 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 molecules. 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 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 ischemia-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 - Bexmarilimab shows promising anti-tumour activity 170521