On January 6, 2021 Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported the appointment of industry veteran Frank Neumann, M.D., Ph.D., as Chief Medical Officer to oversee the Company’s clinical and regulatory strategy and Medical Affairs team (Press release, Verastem, JAN 6, 2021, View Source [SID1234573569]).
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"Frank brings deep expertise across the full spectrum of clinical and regulatory activities in all stages of Oncology drug development," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "His strong industry experience and commitment to urgently addressing the high unmet needs of patients will be critical to delivering novel treatments and establishing the backbone of RAS targeted therapy as we move forward with our registration-directed trials of VS-6766 and defactinib."
"I am thrilled to be joining Verastem at this time given the encouraging results to date of VS-6766 and defactinib for patients with difficult-to-treat KRAS mutant tumors and the possibility to address limitations seen with other therapeutic approaches," said Dr. Neumann. "The broad potential of these development programs and the opportunity to further establish Verastem’s scientific and medical leadership is truly energizing."
Dr. Neumann joins Verastem from bluebird bio where he served as VP, Head of Oncology Clinical Research, Clinical Research Development. In this role, he was responsible for planning and execution of oncology research asset strategies from pre-clinical to Investigational New Drug Application (IND) submissions, across both solid tumor and hematological indications. He has also held various leadership roles at Takeda Pharmaceuticals, including global clinical lead for ICLUSIG (ponatinib) and medical team lead for NINLARO (ixazomib). He served as clinical development head for all of Takeda’s cell therapy approaches globally from POC to Phase 1 and was also responsible for various U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) interactions for Takeda’s programs.
Earlier in his career, Dr. Neumann was a member of the oncology medical teams at AstraZeneca and Sanofi-Aventis and was a research scholar at the University of Texas MD Anderson Cancer Center. Dr. Neumann received his medical degree from the Heinrich-Heine University in Duesseldorf, Germany and his Ph.D. from the Rheinische-Friedrich-Wilhelm University in Bonn, Germany. He is Board-Certified in Hematology/Oncology, Internal Medicine, and Palliative Care Medicine and is currently an assistant professor at the Heinrich Heine University in Düsseldorf, Germany.
About VS-6766
VS-6766 is an oral small molecule inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.
About Defactinib
Defactinib (VS-6063) is an oral small molecule inhibitor of the FAK and PYK2 signaling pathways that is currently being evaluated as a potential combination therapy for various solid tumors. Verastem has received Orphan Drug Designation for defactinib in ovarian cancer in the U.S., EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions have described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.1,2
About the VS-6766/Defactinib Combination
RAS mutant tumors are present in about 30% of all human cancers, have historically presented a difficult treatment challenge and are often associated with significantly worse prognosis.3 Challenges associated with identifying new treatment options for these types of cancers include resistance to single agents,3 identifying tolerable combination regimens with MEK inhibitors and new RAS inhibitors in development addressing only a minority of all RAS mutated cancers.
The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mutant tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with recurrent low-grade serous ovarian cancer (LGSOC), KRAS mutant NSCLC and colorectal cancer. Updated data from this study presented at the 2nd Annual RAS-Targeted Drug Development Summit in September 2020 demonstrated a 56% overall response rate and long duration of therapy among patients with KRAS-G12 mutant LGSOC.4 Based on an observation of higher response rates seen in NSCLC patients with KRAS-G12V mutations in the study, Verastem is also exploring the role of VS-6766 and defactinib in KRAS-G12V mutant NSCLC. The FRAME study was expanded in August 2020 to include new cohorts in pancreatic cancer, KRAS mutant endometrial cancer and KRAS-G12V mutant NSCLC.