Biopharmaceutical company Verastem Inc. (VSTM:NASDAQ), which is focused on developing and commercializing medicines to treat patients with solid tumor cancers, today announced that "the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of its investigational RAF/MEK inhibitor VS-6766, 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."
The National Ovarian Cancer Coalition's CEO Melissa Aucoin commented, "Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with current therapies...A Breakthrough Therapy designation in this disease is a significant step forward for the women who often, at a relatively young age, start a lengthy battle with this highly recurrent and impactful disease."
Verastem Oncology indicated that it is evaluating the efficacy and safety of VS-6766 in combination with defactinib in its ongoing Phase 1/2 FRAME trial. The firm stated that early positive results from the study demonstrated "a 70% overall response rate (ORR) in patients with KRAS Mutant Tumors, 44% ORR in KRAS Wild-Type Tumors and 52% ORR."
Verastem Oncology's CEO Brian Stuglik remarked, "Breakthrough Therapy designation will facilitate our efforts to verify the robust and durable response and compelling safety profile of VS-6766 with defactinib that we have seen in patients with LGSOC and potentially bring a new therapy to these patients as quickly as possible...The majority of LGSOC is RAS pathway-driven, and we are committed to exploring the potential for VS-6766 as a backbone therapy across RAS pathway-driven solid tumors."
The firm explained that the FDA's Breakthrough Therapy designation facilitates expedited development and approval for medicines targeted to treat serious or life-threatening medical conditions.
The company advised that it is also presently studying VS-6766 in a Phase 2 registration-directed trial. The RAMP 201 study is investigating both the use of VS-6766 on a stand-alone basis and in conjunction with defactinib in treating patients with recurrent LGSOC.
Verastem noted that "LGSOC is a recurrent, chemotherapy-resistant cancer with a high mortality rate." The condition represents 6-8% of all ovarian cancers and affects 80,000 women globally.
Verastem Oncology is a biopharmaceutical company headquartered in Needham, Mass., that is engaged in developing and commercializing medicines that can produce improve outcomes for cancer patients. The firm's pipeline is centered upon novel small molecule drugs that inhibit critical signaling pathways in cancer. The leading candidates in its pipeline are VS-6766, an RAF/MEK inhibitor and defactinib, a focal adhesion kinase (FAK) inhibitor.
Verastem started off the day with a market cap of around $548.4 million with approximately 171.9 million shares outstanding and a short interest of about 3.1%. VSTM shares opened about 3% higher today at $3.28 (+$0.09, +2.82%) over Friday's $3.19 closing price and reached a new 52-week high this morning of $4.08. The stock has traded today between $3.26 and $4.08 per share and is currently trading at $4.00 (+$0.81, +25.24%).[NLINSERT]
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