Bayer has teamed up with Kumquat Biosciences for a juicy opportunity, committing up to $1.3 billion for the global license to a KRAS G12D inhibitor that is on the cusp of the clinic.
Kumquat, which also has alliances with Eli Lilly and Takeda, is advancing multiple programs targeting the KRAS pathway. KRAS is a frequently mutated oncogene, but the lack of well-defined binding pockets rendered the proteins undruggable for years. With Amgen and Mirati Therapeutics showing KRAS G12C can be drugged, interest in hitting other KRAS variants has increased in recent years.
KRAS G12D, a mutation found in about 38% of pancreatic cancer patients, is at the center of the next wave of programs. Kumquat received FDA clearance to study its drug candidate in humans last month.
The timing of the IND clearance puts Kumquat behind the front-runners. Revolution Medicines is leading the way, with the biotech considering taking zoldonrasib into a pivotal trial next year. The pivotal trial plan is built on early-phase data in patients with pancreatic or non-small cell lung cancer (NSCLC). KRAS G12D mutations are found in about 4% of NSCLC patients.
Bristol Myers Squibb, which acquired a KRAS G12D inhibitor in its Mirati buyout, exited the race earlier this year because of formulation challenges, but a host of other companies is still chasing Revolution. Bayer joins a pack that features clinical-phase KRAS G12D inhibitors, degraders and TCR-engineered T cells from companies including Astellas, AstraZeneca, Eli Lilly and Roche.
Kumquat will run the phase 1a trial of its Bayer-partnered prospect. Beyond that, Bayer will handle R&D and commercialization. The deal gives Kumquat an exclusive option to negotiate for profit-loss sharing in the U.S.
Bayer will slot the candidate into an oncology pipeline that is led by prostate cancer asset darolutamide and NSCLC program sevabertinib, both of which are in phase 3 development. The company said its deal with Kumquat complements its existing precision oncology portfolio.