On August 28, 2023 Verastem Oncology (Nasdaq: VSTM) (the "Company"), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that the Company has entered into a discovery and development collaboration with GenFleet Therapeutics ("GenFleet") to advance three oncology discovery programs targeting RAS pathway-driven cancers (Press release, Verastem, AUG 28, 2023, https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-enters-discovery-and-development-collaboration [SID1234634719]).
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The collaboration, which builds on the strengths of both Companies in oncology small molecule drug development, enables Verastem Oncology to partner its clinical development and regulatory expertise with GenFleet’s accomplished discovery capabilities. This includes Verastem Oncology’s experience and established network of collaborators, including scientific and clinical experts in RAS biology and RAS pathway-dependent cancers and GenFleet’s accomplishments with its KRAS G12C inhibitor program. The risk-sharing structure of the collaboration is designed to allow Verastem Oncology the flexibility of 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 development and commercialization rights inside of China.
"With the aim of bringing needed therapies to patients where there is high unmet medical need, we are looking forward to working with GenFleet on this important discovery and development collaboration," said Dan Paterson, President and Chief Executive Officer of Verastem Oncology. "This synergistic collaboration augments our research and development pipeline in alignment with our strategy and expertise in RAS pathway-driven cancers. It also may enable new combinations with our lead assets avutometinib and defactinib."
"We are pleased to reach an agreement with Verastem Oncology 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.
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 three programs up to $625.5 million excluding royalties if Verastem Oncology exercises its in-license options. The collaboration provides Verastem Oncology with exclusive rights to obtain a license to each of the compounds after successful completion of pre-determined milestones in Phase 1 trials.
About Avutometinib (VS-6766)
Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. Avutometinib is currently in late-stage development.
In contrast to other MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.
Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS pathway-driven tumors as part of its (Raf And Mek Program). RAMP 201 is a registration-directed trial of avutometinib alone and in combination with defactinib in patients with recurrent LGSOC. Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively. Supported by the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, the Company is conducting RAMP 205, a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.