GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, announced that GenFleet has entered into a discovery and development collaboration with Verastem Oncology (Nasdaq: VSTM) to advance three novel oncology discovery programs primarily in RAS pathway-driven cancers. The risk-sharing structure of the collaboration provides Verastem Oncology a milestone-based option to license up to three compounds. The licenses would give Verastem Oncology development and commercialization rights outside of China while GenFleet would retain rights inside of China.
The terms of the agreement include combined upfront, research support and option payments to GenFleet of $11.5 million for the first program, with potential total deal size across all programs up to $625.5 million excluding royalties. The collaboration provides Verastem Oncology with the exclusive rights to in-license each of the compounds after successful completion of pre-determined milestones. Further development and regulatory milestones and potential royalty payments across all three programs are included in the collaboration agreement should Verastem Oncology exercises its in-license options.
Center for Drug Evaluation of China's National Medical Products Administration has granted Breakthrough Therapy Designation for GFH925 monotherapy treating advanced NSCLC and CRC patients harboring KRASG12C mutation. GenFleet’s proven expertise can be quickly applied to the development of other programs primarily targeting the RAS pathway beyond KRASG12C. In this synergistic collaboration, GenFleet will partner its accomplished capabilities in developing leading-edge therapies with both companies’ strengths in R&D, clinical research and regulatory affairs to advance the co-development of three novel oncology programs primarily targeting the RAS pathway.
"We are pleased to reach an agreement with Verastem to develop multiple products based on GenFleet's proprietary discovery platform and our extensive experience in developing RAS inhibitors. Both companies have already achieved significant clinical breakthroughs in RAS pathway-driven cancers, and we look forward to a synergistic collaboration between GenFleet's proven R&D capabilities and Verastem Oncology's clinical and regulatory expertise. This discovery partnership will also enhance GenFleet's global footprint in delivering potentially life-saving therapies to cancer patients,” said Qiang Lu, Ph.D., Chairman of GenFleet.
Verastem Oncology is well positioned to focus on the development of RAS pathway- driven cancer therapeutics and the avutometinib (RAF/MEK clamp) & defactinib (FAK inhibitor) combination therapy has been granted with FDA’s Breakthrough Therapy Designation for treating recurrent low-grade serous ovarian cancer regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy. Verastem is also conducting trials of avutometinib in combination with KRASG12C and EGFR inhibitors, and its expertise in global clinical development and regulatory affairs will promote comprehensive collaboration with GenFleet.
“We are pleased to partner with GenFleet on this important discovery and development collaboration with the aim of bringing needed therapies to patients with RAS pathway-driven cancers where there is high unmet need,” said Dan Paterson, Chief Executive Officer of Verastem Oncology.“This synergistic collaboration enables Verastem to augment its research and development pipeline aligned with its strategy and expertise in RAS pathway-driven cancers and potential combinations with our lead compound avutometinib.”
About RAS Proteins
RAS proteins, in active GTP-bound or inactive GDP-bound form, are binary molecular switches controlling cellular responses in signaling pathways including RAS-RAF-MEK-ERK、PI3K/AKT/mTOR. Three RAS genes encode for protein isoforms, namely Kirsten RAS (KRAS), Harvey RAS (HRAS) and Neuroblastoma RAS (NRAS), and KRAS is the most frequently mutated oncogene in humans.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a development-stage biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition and focal adhesion kinase (FAK) inhibition.