BioPharma, Pharma

BMS builds on BridgeBio alliance, inking deal for rights to KRAS cancer drug

Bristol Myer Squibb is getting rights to BBP-398, a contender in the chase for drugs that address difficult-to-target KRAS mutations. Meanwhile, BridgeBio Pharma receives some needed cash as it restructures in the wake of the Phase 3 failure of its lead program late last year.

 

Financial conditions are making it tough to raise capital from the public markets, so BridgeBio is turning to licensing deals as a way of bringing in funds. The company has agreed to out-license to Bristol Myers Squibb rights to a drug in development for tough-to-treat cancers in exchange for $90 million up front.

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The deal announced Thursday gives beleaguered BridgeBio some needed cash. The Palo Alto, California-based biotech has been laying off staff and restructuring its operations following the late 2021 Phase 3 failure of its lead drug candidate in a rare disease. In its report of first quarter financial results last week, BridgeBio told investors it would out-license some of its programs as a way of honing its focus on certain programs and conserving capital. The BridgeBio pipeline has more than 30 programs in various stages of development; the company identified six for which it is seeking partners.

For BMS, the deal gives it a contender in an increasingly competitive area of cancer drug research. The BridgeBio drug, BBP-398, is a small molecule designed to block SHP2, which is a protein in the RAS signaling pathway that can drive cancer growth. Overactivity of SHP2 contributes to many forms of cancer, and blocking the protein could offer yet another therapeutic option. BMS’s deal gives the pharmaceutical giant a shot at this approach, putting it in the competitive mix with clinical-stage candidates in development under Novartis, Sanofi-partnered Revolution Medicines, and Roche-partnered Relay Therapeutics among others.

According to the terms of the agreement with BMS, BridgeBio will continue to lead the ongoing Phase 1 development of BBP-398, both as a monotherapy and in combination with BMS checkpoint inhibitor Opdivo. BMS will pick up the drug’s development when it progresses to the next stage of clinical testing and through a potential regulatory submission and commercialization. BridgeBio stands to earn up to $815 million in milestone payments plus royalties from sales of an approved product. The California company could get higher royalties in the U.S. if it opts to fund part of the late-stage clinical development of the drug.

The agreement builds on an earlier partnership. Last July, BMS and BridgeBio announced they would collaborate in the development of BBP-398 in combination with Opdivo in patients with advanced solid tumors with mutations of the KRAS gene, part of the RAS family of genes. Both parties agreed to co-fund the clinical trials.

“We have seen the potential role SHP2 inhibition could play in unlocking possible combination therapies to treat patients suffering from a range of cancers. We are hopeful this collaboration with BridgeBio will help us maximize the possibilities SHP2 inhibition with BBP-398 will hold for patients,” Rupert Vessey, BMS’s executive vice president, research & early development, said in a prepared statement.

BridgeBio’s earlier deal with BMS was a non-exclusive one, and the company had earlier partners on BBP-398’s development. LianBio has rights to develop the drug in mainland China and other Asian markets. BridgeBio is also testing its experimental therapy in combination with Amgen’s Lumakras, which last year became the first drug approved to treat a KRAS mutation. The FDA regulatory nod for the Amgen drug covers non-small cell lung cancer characterized by a particular mutation called KRAS G12c.

In its first quarter financial results, BridgeBio reported a cash position of $633.5 million, which the company estimates will last into 2024.

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