Faron provides update on pipeline progress ahead of R&D Day

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today provides an update on the progress of its two clinical stage programmes, Clevegen and Traumakine, ahead of the Company’s virtual R&D Day.

Clevegen

Clevegen is Faron’s wholly-owned novel precision cancer immunotherapy, targeting Clever-1 positive tumour associated macrophages (TAMs) in selected metastatic or inoperable solid tumours, currently under development in the ongoing phase I/II MATINS clinical trial.  Faron today announces that:

• The World Health Organization (WHO) has approved bexmarilimab as the International Nonproprietary Name (INN) for Clevegen.
• An additional cohort has been added to Part II of the ongoing MATINS trial, exploring the potential of bexmarilimab in patients with anaplastic thyroid cancer, currently without effective treatment. This follows announcement by the Company on 30 March 2020 of the cancer types to be included in Part II of the trial.
• Clinical expansion plans for bexmarilimab will include the investigation of alternative dosing cycles, as pharmacodynamics markers may indicate a need for shorter frequencies, as well as further studies in additional clinical settings.
• Clinical studies are being planned to investigate bexmarilimab in combination with standard of care (SOC) as a first-line therapy in selected advanced solid tumours, and as a standalone neoadjuvant therapy for patients with early stage colon cancer. The Company currently expects patient recruitment for a small number of cohorts to complete around late Q3 with discussions with the FDA to follow in Q4.

Traumakine

Traumakine, Faron’s investigational intravenous (IV) interferon (IFN) beta-1a, is currently under development for the treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and is being used in two global, adaptive trials investigating potential COVID-19 treatments – REMAP-CAP, the Randomized, Embedded, Multifactorial Adaptive Platform rial for Community-Acquired Pneumonia, and the WHO Solidarity trial.   

Today the Company announces that a third trial will investigate the potential of  Faron’s IV IFN beta-1a to treat COVID-19. HIBISCUS (Human Interferon Beta In Severe CoronavirUS), will be 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). The phase II/III pivotal, randomized, placebo controlled study aims to recruit 350 patients with 1:1 randomization who will be followed for ventilation free dats (VFD) and mortality over the 28 day period post first dosing. No corticosteroid use will be accepted in the study which is expected to enroll patients over 6-8 months throughout the US with many significant hospitals participating. Commencement of the trial remains subject to finalisation of funding arrangements and regulatory approval. Further announcements will be made in due course.

Dr. Markku Jalkanen, Faron's CEO, said: “We are pleased today to be reporting the continued progress of our two development programmes. Confirming the generic name, bexmarilimab, for our lead immunotherapy is an important milestone for this programme which is rapidly advancing and has shown exciting clinical activity. The positive data seen so far for bexmarilimab gives us the confidence to pursue ambitious future clinical expansion plans for this potential therapy.

“The scientific community is currently focused on discovering new therapeutics to treat COVID-19 and we are very pleased to be supporting these efforts, now with three trials investigating the potential of Traumakine in severely ill patients.  We continue to believe in the potential of Traumakine as a future treatment for ARDS and one that could have significant impact on the intensive-care burden from COVID-19. We look forward to providing updates on both development programmes as they progress.”

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