Verastem的KRAS G12D候选药VS-7375早期数据积极但同步宣布2.5亿美元增发，盘中已涨约16%

Dive Brief:
- Verastem Oncology shares rose 18% Wednesday after the company released highly anticipated early data suggesting its experimental cancer drug could help certain patients with three different types of tumors.
- The drug, VS-7375, targets the most prevalent of the “KRAS” mutations that drive cancer, one known as G12D. The medicine is designed to bind to both the “on” and “off” states of the mutation, which may allow it to hold back tumor growth more completely than rival treatments that only target one or the other, Verastem said.
- The small study included patients with metastatic pancreatic ductal adenocarcinoma, metastatic colorectal cancer and advanced non-small cell lung cancer. Based on the results, the company plans to kick off a trio of late-stage trials before the end of June.
Dive Insight:
Verastem’s data give the company an early boost as it vies for attention in one of the hottest areas of cancer research. Revolution Medicines led the way in August, winning Food and Drug Administration approval for Rasonque, which had shown groundbreaking results in pancreatic cancer and is widely expected to generate billions of dollars in sales.
Research released earlier this year showed that Rasonque could almost double survival for pancreatic patients with G12 mutations. But the door may have cracked open for rivals a bit this month, when the FDA released documents suggesting the drug’s effects were varied among the different types of G12 mutations and more modest for G12D, Verastem’s target.
In Verastem’s Phase 1/2 study, researchers looked at how well VS-7375 could reduce signs of cancer in patients, a measure called an “objective response rate.” They found response rates ranging from 36% to 50% in the pancreatic patients, depending on how many lines of treatment they had already undergone. The figure was 33% for the colorectal cancer patients and 43% for those with non-small cell lung cancer.
Those results came close to or exceeded the expectations of Wall Street analysts for each of the indications. The data show “a competitive profile,” RBC Capital Markets analyst Leonid Timashev wrote in a note to clients.
Verastem also chose Wednesday to announce a $250 million stock offering and a transition plan for a new CEO. In all, Verastem is having a “transformative day,” Timashev wrote.
Still, Verastem’s research is in early stages, and its drug needs to succeed in larger pivotal trials. The company said it has already reached alignment with the FDA on a Phase 3 trial in pancreatic cancer that will study VS-7375 as a first-line treatment and begin by the end of the year. It expects to enroll the first patients in colorectal and lung cancer Phase 3 trials in the first half of next year.
Verastem will have plenty of competition. Revolution is also developing a drug, zoldonrasib, specifically designed to target G12D and is working on medicines tailored to other mutations. And KRAS has drawn interest from a range of developers: from major players like Eli Lilly and Roche to smaller companies like Tango Therapeutics, Erasca and BridgeBio Oncology Therapeutics.
Like many pharmaceutical companies in recent years, Verastem looked to China to help build its pipeline by collaborating with GenFleet Therapeutics. GenFleet is developing the drug in China and began its registrational trial late last year.