Updated results from IMV Inc.’s ongoing phase II trial of DPX-Survivac to treat advanced recurrent ovarian cancer show the company’s lead candidate was active and well-tolerated in patients. Having hit its primary objectives, IMV will meet with the FDA to work out a pivotal phase IIb trial design in ovarian cancer that could support an accelerated pathway.
In the Feb. 25 conference call to investors, IMV’s chief medical officer, Joanne Schindler, gave a hint of what could be on the table at the FDA meeting as she mentioned the tough lives these patients live.
“Unfortunately, they've gone through a lot at this point in time,” she said. And “we know that they would really prefer to be off of chemo and to have other options. So we believe there's a path there. And we know that FDA would accept that based upon where our competitors are going as well that they can take that path forward. So it's something we will consider as we look forward to our next step.”
The response rate will be a clinical component in the FDA meeting and IMV CEO and director, Frederic Ors, said on the call that he believes IMV can meet the response rate numbers the FDA would want for a monotherapy treatment.
“When we had the meeting with the FDA on the back of treatment arm one results, it's a question we had to them,” he said. “And the answer back was that any new treatment that … has more than 20% response rate with long duration or at least more than six-month duration and brings something new to the table of treatment would have the potential to be approved. And so that's the answer that we got. And based on the safety profile, the long duration of responses and the activity we are seeing here, we believe we have a solid case to go back to them, show them the data and discuss a potential design.”
BTIG analysts found the study’s 21% monotherapy objective response rate in patients with at least three prior lines “encouraging, although historical treatment rates in late line patients are generally approximate due to small trials of very heterogeneous patients.”
The patients were indeed heavily pretreated, Schindler said, and have limited options beyond single-agent chemotherapy.
Findings from the phase II Decide1 study also showed 79% of patients achieved disease control, while 53% had tumor shrinkage of target lesions and durable clinical benefits lasting six months or longer were seen in 37% of the patients.
Investors, however, digested the data and pulled back, plunging the stock (NASDAQ:IMV) 39.96% on Tuesday to close at $2.87 per share. The lowest per share price for IMV in the past 12 months was $2.31 on Nov. 18.
There is also competition. Interim data from a phase II study from Aim Immunotech Inc., of Ocala, Fla., of advanced recurrent ovarian cancer using Ampligen (rintatolimod) plus cisplatin and Keytruda (pembrolizumab) at the University of Pittsburgh Medical Center are expected this year. Enrollment has commenced and several patients have begun treatment, with up to 45 patients to be enrolled. Ampligen is also being used as a monotherapy to treat pancreatic cancer patients in an early access program in the Netherlands at Erasmus Medical Center.
Aim is also re-examining Ampligen’s antiviral properties to determine if it could become a vaccine to protect against the Wuhan coronavirus (COVID-19). The company said it obtained genomic RNA sequences of the new virus and compared them to the SARS virus' RNA sequences. The RNA sequences of the SARS virus in key areas of viral replication are almost identical for the Wuhan coronavirus, the company said, adding that, in NIH studies of SARS-infected mice, Ampligen conferred “significant antiviral/survival effect.”
IMV also is testing DPX-Survivac in other tumor types, with two actively accruing phase II studies in combination with Merck Co. Inc.’s Keytruda, an investigator-sponsored study in recurrent/refractory diffuse large B-cell lymphoma and a basket study across five solid tumor indications. Updated data are expected from both studies in the first half of this year.