On August 12th, Bayer and biotech company Kumquat Biosciences announced the achievement of a global exclusive licensing and collaboration agreement, aiming to jointly develop and commercialize Kumquat's KRAS G12D inhibitor, bringing new therapeutic hope to patients with pancreatic cancer, colorectal cancer, and lung cancer.
KRAS gene mutation is a key factor driving tumor growth, and approximately 25% of all cancers have KRAS mutations. Among them, KRAS G12D mutation is particularly common in specific cancer types, such as pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer. Pancreatic ductal adenocarcinoma, as the most common type of pancreatic cancer, is difficult to treat, with the five-year survival rate of patients being less than 10%.
Currently, the marketed KRAS inhibitors mainly target the relatively rare G12C mutation. In the race for drug development targeting G12D mutation, several companies have candidate drugs entering the clinical testing stage, and the KRAS G12D inhibitor from this collaboration is expected to meet the long-term unmet needs in this field.
According to the agreement, Kumquat will be responsible for initiating and completing the Phase Ia study, while Bayer will be responsible for completing subsequent development and commercialization activities.
Kumquat will receive up to 1.3 billion US dollars (equivalent to approximately 9.3 billion yuan), including upfront payments, clinical and commercial milestone payments, and tiered patent royalties based on net sales. In addition, Kumquat also retains the exclusive right to negotiate for participating in profit sharing in the United States.
Kumquat Biosciences is a clinical-stage biotechnology company founded by pioneers in the KRAS pathway. Since its establishment in 2019, it has received support from a number of well-known investment funds, including OrbiMed, Sequoia China, and Roche Venture Fund. Previously, Kumquat has reached lucrative cooperation agreements with Eli Lilly and Takeda respectively. The cooperation amount with Eli Lilly in 2021 was as high as 2.07 billion US dollars, while the cooperation amount with Takeda in 2024 reached 1.33 billion US dollars.
The collaboration between Bayer and Kumquat this time is not only an important layout for both parties in the field of precision oncology but also brings new hope to patients with KRAS G12D mutation-related cancers.
Moreover, in the vast battlefield of cancer treatment, Bayer is accelerating its pace, and its cancer drug pipeline covers multiple tumor types.
In the field of prostate cancer, darolutamide is Bayer's ace. Its Phase III clinical ARASENS study is a global multicenter, randomized, double-blind, placebo-controlled study, which is used to compare the efficacy and safety of darolutamide + docetaxel (DOC) + ADT versus placebo + docetaxel + ADT in the treatment of mHSPC patients. The current data are encouraging. The combined therapy is superior to traditional therapy in terms of radiographic progression-free survival and overall survival, which means it may change the treatment mode of mHSPC.
In the field of non-small cell lung cancer, Sevabertinib is emerging. It is an oral, reversible small-molecule tyrosine kinase inhibitor (TKI) that can precisely target multiple HER2 mutations. The US FDA granted the breakthrough therapy designation to this product in 2024, and this variety was declared for marketing in China in July this year.
In the field of colorectal cancer, regorafenib is a solid strength of Bayer, used for the treatment of refractory metastatic colorectal cancer (mCRC). A number of clinical studies are continuously carried out, aiming to further clarify its efficacy and safety in mCRC patients, so as to optimize the treatment plan and bring more survival hope to patients.
References:
1. Yaozhi Data
2. https://mp.weixin.qq.com/s/PK9KIhxaFdI7haqRiPY3tQ
3. https://mp.weixin.qq.com/s/P5pD7KErByySgJ7TmECIOA
4. https://mp.weixin.qq.com/s/w1xM1rY71NiQ7t_yRFZ8sw
