Faron Pharmaceuticals (LON:FARN) has reported “continued progress” for two of its clinical stage programmes, Clevegen and Traumakine, ahead of a virtual R&D day on Tuesday.
For Clevegen, a precision cancer immunotherapy targeting Clever-1 positive tumour-associated macrophages in selected metastatic or inoperable solid tumours, Faron said the World Health Organisation (WHO) has approved bexmarilimab as the International Nonproprietary Name (INN) for the treatment. INNs are designed to make communication about pharmaceutical drugs more precise and avoid prescribing errors.
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Faron also said an additional cohort has been added to Part II of the ongoing MATINS trial which is exploring the potential of bexmarilimab (Clevegen) in patients with anaplastic thyroid cancer.
The company also said clinical expansion plans for Clevegen will include an investigation into 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 also being planned to investigate the treatment in combination with standard of care (SOC) as a first-line therapy in advanced solid tumours, and as a standalone neoadjuvant therapy for patients with early stage colon cancer. The company expects patient recruitment for a small number of cohorts to complete in the third quarter with discussions with the US Food and Drug Administration (FDA) to follow in the fourth quarter.
Meanwhile, the firm announced that its Trumakine product, which is designed to help treat Acute Respiratory Distress Syndrome (ARDS) and is being used in two global, adaptive trials investigating potential coronavirus (COVID-19) treatments, will now be subject to a third trial to investigate whether the company’s IV IFN beta-1a can treat coronavirus.
The HIBISCUS ( Human Interferon Beta In Severe CoronavirUS) trial will focus on intensive care patients with ARDS caused by viral infection such as coronavirus and influenza. The phase II/III pivotal, randomised, placebo controlled study aims to recruit 350 patients over six to eight months throughout the US with “many significant hospitals participating”.
Faron said the commencement of the trial remains subject to finalisation of funding and regulatory approval and announcements would be made in due course.
"We are pleased today to be reporting the continued progress of our two development programmes. Confirming the generic name, bexmarilimab, for our lead immunotherapy [Clevegen] 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”, Faron chief executive Markku Jalkanen said in the statement.
"The scientific community is currently focused on discovering new therapeutics to treat [coronavirus] 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", he added.
Faron’s shares climbed 4.5% to 350p in early trading on Tuesday.