Obsidian Therapeutics has raised $160.5m in a Series C financing round, with plans for the funds to be injected into the biotech’s tumour-infiltrating lymphocyte (TIL) cell therapy programme.
Obsidian, already backed by Bristol Myers Squibb (BMS), added Novo Nordisk Foundation’s investment arm Novo Holdings to its arsenal of investors in this latest round. US investment firm Wellington Management led the oversubscribed Series C. The US biotech previously raised $115m in a Series B round in 2021.
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Obsidian’s lead asset is OBX-115, which is part of its TIL programme. OBX-115 is a TIL cell therapy – which expands and enhances the patient’s own immune cells extracted from around and within the tumour itself. Unlike the emerging chimeric antigen receptor (CAR) T cell therapies, TILs already have multiple tumour target recognition.
The T cell immunotherapy is in a Phase I clinical trial for the treatment of melanoma and a Phase I/II clinical trial for the treatment of non-small cell lung cancer (NSCLC).
In the melanoma trial (NCT05470283), which is being sponsored by the MD Anderson Cancer Centre, OBX-115 is being administered in combination with the diuretic acetazolamide. Data from the study will inform dose levels for a Phase II trial. The company reported an objective response rate of 50% and a complete response rate of 33% in topline data released in December 2023.
The NSCLC trial (NCT06060613) is investigating OBX-115 as a monotherapy, with endpoints assessing the drug’s safety and efficacy in treating advanced solid tumours.
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By GlobalDataObsidian said the Series C proceeds will go towards clinical trial activities and manufacturing scale-up with a view to conducting pivotal trials.
Obsidian has engineered OXB-115 such that it produces the membrane-bound interleukin 15 (IL-15). Interleukin-2 (IL-2) co-administration is usually needed with traditional TIL cell therapies to act as an immunostimulatory agent. Obsidian states that the membrane-bound IL-15 could widen patient access by reducing potential toxicities associated with high-dose IL-2.
Vertex and BMS have seen the potential in Obsidian’s platform, both signing multi-year partnerships with the biotech to discover and develop new cell therapies.
Last month, Iovance Biotherapeutics’ Amtagvi (lifileucel) became the first TIL cell therapy to get regulatory backing in the US, winning a US Food and Drug Administration (FDA) accelerated approval. Obsidian’s OBX-115 will face competition from Iovance, with Amtagvi indicated for the treatment of metastatic or unresectable melanoma.
Iovance has priced its immunotherapy at $515,000 in a market where there are currently no other FDA-approved cell therapies for the treatment of solid tumours. Amtagvi is forecast to generate sales of $846m by 2029, according to GlobalData’s Pharma Intelligence Centre.
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Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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