Medicines of the revolution could be on the cusp of a breakthrough.
The company hopes to soon publish results from a Phase 3 trial of its experimental drug that could become the first treatment targeting pancreatic cancer, the deadliest of major cancers. Only 13% of people with pancreatic cancer live five years after being diagnosed, a figure that has not changed much even though the outlook for other cancers improves thanks to new drugs such as immunotherapy. The possibility of a new treatment has boosted RevMed's stock by nearly 185% over the past year and made it a prime acquisition target.
“This is incredibly important,” said Leonid Timashev, an analyst at RBC Capital Markets. “We've had doctors describe this as potentially the biggest breakthrough ever made in pancreatic cancer.”
RevMed came into the spotlight this week when former senator Ben Sasse told the New York Times that he is taking the company's drug, daraxonrasib. Sasse announced late last year that he was diagnosed with stage 4 pancreatic cancer and given three to four months to live.
Senator Ben Sasse (R-NE) speaks during Attorney General nominee Merrick Garland's confirmation hearing before the Senate Judiciary Committee, Washington, DC, February 22, 2021.
To Drago | Swimming pool | Reuters
Sasse told the Times that his tumors have shrunk by 76% since he started treatment, but called it a “nasty drug” that causes “crazy” side effects like a rash. Sasse's bloody and peeling face led the interviewer to tell Sasse that he looks “terrible.”
RevMed's daily pill broadly targets RAS mutations, which drive tumor growth and are found in approximately 90% of pancreatic cancer cases. Timashev describes RevMed's drug as hitting the heart of what makes cancer go away.
That's both a benefit and a disadvantage. RAS proteins are found throughout the body, especially in the skin. RevMed's drug does not distinguish between the mutated version and the normal version, leading to unpleasant side effects like those Sasse experienced.
RevMed in a statement said that most cases of rash have been low grade and no patients stopped treatment because of it. The company added that reports of bleeding skin rashes have been anecdotally described by clinical trial investigators and are considered rare.
At first, RevMed wasn't sure people would be able to tolerate daraxonrasib because it was so active against all different forms of RAS, said CEO Mark Goldsmith. The company started with a “very, very low dose” and gradually increased it.
“We worry about every escalation,” he said. “Every time the team said we were about to increase the dose, a group of us seniors sitting in a conference room would just hold our heads in our hands thinking, 'Is this it? Can we go higher?'”
The company's scientists predicted that at 80 milligrams, tumors would begin to shrink, Goldsmith said.
“They had done the science to predict that, and that's exactly what happened,” he said. “We saw the first patient's tumor shrink and we said, 'Wow, our team is pretty good. They know how to predict these things.'”
But showing that the drug can shrink tumors probably won't be enough to win approval from the U.S. Food and Drug Administration. Goldsmith said the agency has been clear privately and publicly that RevMed needs to show that daraxonrasib can keep people alive longer, which is known in the medical community as an overall survival benefit.
The magnitude of that benefit could have significant implications for how widely the drug will be used and how the company's stock will react to its late-stage data. RevMed expects to share data this quarter from a Phase 3 trial studying its pill versus chemotherapy in people whose cancer has spread and who have already tried another treatment.
Analysts at RBC Capital Markets laid out their base case in a note to clients on Friday, predicting the stock will rise 25% to 40% if RevMed's drug shows an overall survival benefit of more than 13 months and cuts the risk of death in half compared to chemotherapy. For the drug to fail the Phase 3 trial would be an “incredible disappointment,” Timashev said, an outcome he considers unlikely. In his opinion, a more likely risk is that the drug will not provide as much benefit as investors expect.
Part of the recent rise in RevMed stock comes from speculation that the company will be acquired, with Merck reportedly looking to reach a deal early this year.
Goldsmith said RevMed doesn't pay much attention to “external noise” and is focused on building the company.
“We know that pharmaceutical companies are very interested in what we do,” he said. “Either they're trying to copy it or they're trying to get it. And those kinds of things will happen around us. Sometimes there will be rumors. What can we say? We're not really focused on how to put the company in the hands of others. Are we focused on how to make the biggest difference?”
