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Ex Vivo Data Presented at EHA2022 Congress

12 May 2022 15:50

RNS Number : 3341L
Faron Pharmaceuticals Oy
12 May 2022
 

Faron Pharmaceuticals Ltd.

("Faron" or "Company")

 

Ex Vivo Data Presented at EHA2022 Congress Suggest Critical Role for Clever-1 in

Hematological Cancer Outcome and Drug Resistance

 

· Clever-1 is expressed in patient bone marrow blasts and monocytes in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), with the highest levels observed in M4/M5 subtypes with poor outcome

· Blocking Clever-1 with bexmarilimab in these patients induced immune activation as observed through increased antigen presenting molecule, human leucocyte antigen DR (HLA-DR) expression and declined PD-1 expression

· The combination of azacytidine with bexmarilimab augmented HLA-DR induction and overcame the HLA-DR suppressing effect of the bcl-2 inhibitor venetoclax

 

Press release, May 12, 2022 at 17:50 PM (EEST) / 15:50 PM (BST) / 10:50 AM (EDT)

 

TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces that preclinical data to support the Company's upcoming clinical trials investigating the potential of bexmarilimab in combination with standard of care (SoC) in hematologic cancers will be presented at the European Hematology Association's hybrid EHA2022 Congress in Vienna, Austria, from June 9-12, 2022. These data (Abstract ID: EHA-3535) will be presented on Friday, June 10, 2022 in a session that begins at 16:30 CEST. The abstract can be found here: EX VIVO IMMUNE ACTIVATION WITH THE MACROPHAGE-TARGETING.... EHA Library. Aakko S. Jun 10 2022; 357243 (ehaweb.org)

 

Faron's wholly-owned novel precision cancer immunotherapy, bexmarilimab, targets Clever-1, a receptor known to be expressed on immunosuppressive tumor associated macrophages which make up nearly 50% of the tumor mass and limit the efficacy of currently approved cancer immunotherapies, including anti PD-1/L1. Faron is investigating the potential of this novel immunotherapy in combination with SoC in patients with relapsed acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CML), three hematologic cancers for which there are few treatment options.

 

The data being presented at EHA2022 profiles Clever-1 expression in blood cancer and tests bexmarilimab's growth inhibitory and immunomodulatory potential in preclinical models, as a monotherapy and in combination with azaciditine and/or venetoclax, two standard of care treatments used as in AML, MDS and CML. Results confirmed that Clever-1 is expressed in patient-derived monocytes and blasts. Ex vivo treatment with bexmarilimab, alone or in combination with azaciditine and/or venetoclax, demonstrated increased expression of the antigen presenting molecule, human leucocyte antigen DR (HLA-DR). Enhanced antigen presentation allows the immune system to better identify and kill cancer cells

 

Furthermore, natural killer (NK) cells and CD8+ T cells showed decreased expression of PD-1 and an increase of activation markers - important predictive biomarkers for overcoming resistance to existing immunotherapies. These results help confirm bexmarilimab's potential in hematologic malignancies.

 

"These results reinforce the strong scientific rationale behind our focus on Clever-1 and the potential of bexmarilimab, either alone or in combination with standard of care, to treat blood cancers," said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. "High Clever-1 expression is associated with poor survival in certain blood cancer patients and bexmarilimab provides a novel treatment approach for these patients, downregulating Clever-1 expression and igniting an effective immune response. We look forward to the imminent start of our hematology cancer clinical trial program to further explore these promising findings."

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6069

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 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

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

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 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 humanized 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 tumors, 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 hospitalized 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.

 

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.

 

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.
 
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NRAGPURPAUPPGCP
Date   Source Headline
2nd Mar 20181:25 pmRNSHolding(s) in Company
1st Mar 201812:42 pmRNSHoldings in Company
1st Mar 201812:41 pmRNSHoldings in Company
26th Feb 20181:37 pmRNSIssue of Equity
21st Feb 20183:31 pmRNSResults of Placing & Issue of Equity
21st Feb 20187:00 amRNSFaron hosts R&D Day today in London
16th Feb 20187:00 amRNSProposed Placing to raise up to £15m
5th Feb 20187:00 amRNSSecond Traumakine manufacturing site established
1st Feb 20187:00 amRNSFaron Announces Clevegen Grant of European Patent
29th Jan 20187:00 amRNSFDA grants Fast Track Designation for Traumakine®
24th Jan 20187:00 amRNSFDA approval of Faron's Traumakine® IND
19th Dec 20177:00 amRNSINFORAAA trial receives recommendation from IDMC
14th Dec 20177:00 amRNSFaron announces R&D Day in February 2018
11th Dec 20177:32 amRNSRecruitment completed in Traumakine INTEREST Trial
6th Dec 20176:06 pmRNSHolding(s) in Company
1st Dec 20172:55 pmRNSHoldings in Company
1st Dec 20177:01 amRNSAppointment of Chief Commercial Officer
24th Nov 201710:23 amRNSHolding(s) in Company
21st Nov 20177:00 amRNSGrant of options
20th Nov 20177:00 amRNSChange of Adviser
16th Oct 20179:00 amRNSHolding(s) in Company
13th Oct 20179:00 amRNSDirector/PDMR Shareholding
11th Oct 20172:00 pmRNSIssue of Equity & PDMR Shareholding
9th Oct 20174:30 pmRNSResult of Placing & Subscription & Issue of Equity
5th Oct 20177:00 amRNSProposed Placing and Subscription
2nd Oct 20177:00 amRNSTraumakine Receives PIM Designation from MHRA
11th Sep 20173:19 pmRNSDirectors Dealings
6th Sep 20177:00 amRNSInterim Results
4th Sep 20177:00 amRNSFDA advises Faron to proceed directly to BLA
4th Aug 20177:00 amRNSUpdate on INTEREST Phase III Study from IDMC
28th Jul 20179:34 amRNSHolding(s) in Company
10th Jul 20174:51 pmRNSHolding(s) in Company
10th Jul 20177:00 amRNSNotice of Results
16th Jun 20172:43 pmRNSDirector/PDMR Shareholding
1st Jun 20177:00 amRNSExercise of Warrants and Options
30th May 20172:06 pmRNSHoldings in Company
22nd May 201711:31 amRNSDirector/PDMR Shareholding
22nd May 20177:00 amRNSDirector/PDMR Shareholding
18th May 20179:20 amRNSDirector/PDMR Shareholding
16th May 201712:00 pmRNSResult of AGM
8th May 20174:40 pmRNSSecond Price Monitoring Extn
8th May 20174:35 pmRNSPrice Monitoring Extension
8th May 20177:00 amRNSUpdate on INTEREST Phase III Study from IDMC
27th Apr 20175:57 pmRNSExercise of Warrants
26th Apr 201712:32 pmRNSDirector's dealings
21st Apr 20175:56 pmRNSDirector/PDMR Shareholding
19th Apr 20177:00 amRNSNotice of Annual General Meeting
19th Apr 20177:00 amRNSProposed Board Changes
18th Apr 20174:17 pmRNSPurchase of Shares
18th Apr 20177:00 amRNSCollaboration with Birmingham University

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