Lilly drops another inherited gene therapy programme
Eli Lilly has removed a phase 1/2 trial of its GBA1 gene therapy in Gaucher disease type 1 from its pipeline, marking the second Prevail Therapeutics-derived asset the company has discontinued this year. Lilly acquired Prevail in a $1billion deal in late 2020, gaining two lead gene therapy programmes, it dropped the frontotemporal dementia candidate in February leaving the Gaucher programme as its best remaining shot a bringing a Prevail asset to market.
A Lilly spokesperson said the Gaucher disease type 1 programme did not meet their “high internal bar for success” and confirmed there was no safety signal behind the decision. The company will continue developing the same gene therapy for Parkinson’s disease through its ongoing Propel trial. The decision leaves Lilly with a narrowed gene therapy pipeline centred on the Parkinson’s programme and two hearing-loss assets acquired through its 2022 takeover of Akouos.
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Replimune receives FDA backing after two previous rejections
An FDA advisory committee has voted 10 to 3 in favour of the clinical benefit of Replimune’s oncolytic virus therapy RP1 in advanced melanoma, reversing the momentum on a candidate that had already been rejected by the agency twice. The vote assessed whether data from Replimune’s phase 1/2 Ignyte trial evaluating RP1 in combination with Bristol Myers Squibb’s Opdivo, were evaluable and clinically meaningful.
The positive vote represents a dramatic turnaround for the company, whose BLA has already received two Complete Response Letters from the FDA over concerns surrounding the single-arm design of the Ignyte stufy. Qhile FDA reviewers continued to question aspects of the trial design, advisory committee members concluded that the treatment demonstrated clinically meaningful benefit in a patient population with limited therapeutic options.
Read more via Biopharma Dive
Obsidian Therapeutics completes merge with Galera Therapeutics and secures $350million financing
Obsidian Therapeutics has completed its merger with Galera Therapeutics, alongside a previously announced $350million private placement financing. The oversubscribed placement drew a syndicate of new and existing investors including Redmile, RA Capital Management, RTW Investments, Novo Holdings and Wellington Management, among others.
The transaction represents one of the largest financings in the advanced therapies sector this year and reflects continued investor confidence in differentiated cell therapy technologies despite a challenging financing environment. The fresh capital is expected to support clinical advancement across Obsidian’s pipeline while strengthening its position as a next-generation engineered cell therapy developer.
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