Pharmaceutical company Bayer teams up with Kumquat for potential billion-dollar-plus collaboration focused on addressing the KRAS cancer variant in tumor therapy.

In a significant move, Bayer has partnered with Kumquat Biosciences to develop a potential treatment for pancreatic, colorectal, and lung cancer. This collaboration aims to bolster Bayer's early precision oncology portfolio, as the pharmaceutical giant joins a growing number of drug developers seeking to treat forms of cancer by inhibiting variants of KRAS.

Kumquat Biosciences, led by CEO Yi Liu, is developing a KRAS G12D inhibitor. Under their global exclusive license agreement, Bayer will pay Kumquat up to $1.3 billion. This includes an undisclosed upfront payment, payments tied to achieving clinical and commercial milestones, and additional tiered royalties on net sales.

The partnership provides Kumquat with the financial resources to accelerate its broader clinical pipeline for long-term value and position Kumquat to deliver life-changing medicines and achieve sustained growth in the coming years. The collaboration validates the strength of Kumquat's platform and the potential of their KRAS G12D candidate to address long-standing unmet needs in oncology.

Meanwhile, Astellas Pharma is developing two Phase I protein degraders targeting solid tumors, ASP3082 and ASP4396. ASP3082 is in a Phase I trial (NCT05382559), while ASP4396 is in a Phase I study (NCT06364696).

Other drug developers are also actively working on KRAS G12D inhibitors. Mirati Therapeutics, a developer of a KRAS G12D inhibitor, was acquired by Bristol Myers Squibb (BMS) for up to $5.8 billion. AstraZeneca is studying AZD0022, an oral small molecule selective inhibitor, in a Phase I/II trial (NCT06599502) alone and in combination with Eli Lilly's Erbitux (cetuximab). They are also developing NT-112, a TGFBR2 KO armored T cell receptor T cell therapy, in a Phase I trial (NCT06218914) being studied alone and in combination with AZD0240.

Eli Lilly is studying LY3962673, a KRAS inhibitor highly selective against HRAS, NRAS, KRAS-wildtype, and other non-G12D KRAS mutations, in the Phase I MOONRAY-01 trial (NCT06586515). Roche is conducting a Phase I trial (NCT06619587) for GDC-7035, also known as RG6620, a KRAS G12D inhibitor.

KRAS mutations occur in nearly 25% of human cancers, with G12D being the most prevalent oncogenic KRAS variant that lacks effective treatment options. KRAS G12D mutations were found most frequently in 37% of pancreatic ductal adenocarcinoma (PDAC), 13% of colorectal cancer, and four percent of non-small cell lung cancers (NSCLCs). PDAC is the most common type of pancreatic cancer, accounting for 85% of cases, and remains one of the most difficult tumors to treat.

Amgen brought the first KRAS-targeting drug to market in 2021. The collaboration between Bayer and Kumquat Biosciences could generate up to $1.3 billion-plus for Kumquat, as they launch and complete a Phase Ia study of the KRAS G12D inhibitor, with Bayer agreeing to complete development and commercial activities related to the candidate. Kumquat retains an exclusive option to negotiate with Bayer to share profits and losses in the U.S.

This partnership underscores the growing interest in KRAS inhibitors as potential treatments for various types of cancer, particularly those with high incidences such as PDAC, colorectal cancer, and NSCLCs. As research continues, we can expect to see more developments in this field, offering hope for patients and their families.