The company announced promising new data from its 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. In this trial, bexmarilimab is being investigated as a potential monotherapy in patients with solid tumours who have exhausted all treatment options.
Across the 141 evaluable patients, median progression-free survival (PFS) was 59 days (95% confidence interval, 57 – 60) and median overall survival was 129 days (95% confidence interval – a measure of the likelihood of repeated experiments producing results in the expected range, which in this case is 115 – 178).
In relation to the RECIST (Response Evaluation Criteria in Solid Tumours) 1.1 criteria, the disease control rate (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, overall survival and the PFS were improved, Faron said. This improved survival in responding patients was not associated with the duration of previous therapy. The six-month survival rate was 100% for disease control rate (DCR) patients compared to 31.1 % for non-DCR patients.
The 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, Faron’s statement revealed.
The 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.
“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,” said Markku Jalkanen, Faron’s chief executive officer.
“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,” Dr Jalkanen added.
“The company intends to present more of the data at an upcoming scientific conference, but these initial findings should help it refine its plans for which direction/indication(s) to pursue. We find these described effects – even when using bexmarilimab as a last-line treatment where the patients had exhausted all other options – intriguing and look forward to hearing the company’s plans in due course,” said Peel Hunt, Faron’s broker.
Shares in Faron were up 2.9% at 355p in late morning trading.
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