It’s been a rapid year of change for Coimmune Inc., which was incorporated only 12 months ago and now has FDA approval of an IND clearing the way for a phase IIb trial using CMN-001 to treat advanced metastatic renal cell carcinoma (mRCC).
Durham, S.C.-based Coimmune’s dendritic cell-based immunotherapy is tailored to each patient’s medical indication. It is designed to capture both mutated and variant antigens unique to each tumor. CMN-001 is a big part of the company’s past, as the drug is the former AGS-003 from Argos Therapeutics Inc., which a year ago was sinking into chapter 11 until SCM Life Science Co. Ltd. and Genexine Inc., both Korean companies, bought Argos’ assets, including intellectual property, for $11.1 million and christened the new company Coimmune.
At the time, Coimmune’s CEO, Charles Nicolette, was Argos’ chief scientific officer. He felt Argos’ assets held more promise than they’d been allowed to attain, so he reached out to investors to see who would be willing to fund the company going forward. The SCM-Genexine deal to hold Argos together would work best, he told BioWorld, if the people who had done all the work were kept on the payroll. It paid off as the company had little turnover, he added. Coimmune was off to a running start with everyone who knew everything.
“I was able to keep together 14 employees, including myself; we’ve all worked together for 16 years, we’re the founding workforce,” Nicolette said.
Nicolette said he believes in controlling growth and having institutional memory intact. The just-approved IND is a case in point. Its rapid creation wouldn’t have happened, he said, if long-term employees hadn’t been around to put it together.
“Some of the data was more than a decade old and people remembered it,” Nicolette said. “Without that memory, you have a situation where anything you didn’t publish was forgotten forever.”
Primarily poor risk mRCC patients will be recruited for the interventional trial, dendritic cell immune therapy plus standard treatment of advanced renal cell carcinoma. CMN-001 will be used in combination with nivolumab plus ipilimumab as first-line therapy and in combination with lenvatinib plus everolimus as second-line therapy post first-line failure. The primary outcome measure is overall survival.
The study’s design comes from a retrospective analysis of a previous trial of CMN-001. Researchers found a synergy with CMN-0001 and one of the approved treatments among the more than 90 randomized subjects.
Another entry on the busy calendar at Coimmune: The company filed a patent application on the new mechanism of action for the combination therapy in January.
The phase IIb’s principal investigator is Christopher Wood, professor and vice chairman in the department of urology at Houston’s MD Anderson Cancer Center.
All Nicolette wants from the phase IIb is to reproduce the sportive clinical signal the company found in its previous study. It’s the same with the other asset in Coimmune’s pipeline, an off-the-shelf CAR T therapy Coimmune is developing to treat acute lymphoblastic leukemia in pediatric and adult patients, a study that is being conducted in Italy. In January, Coimmune merged with Formula Pharmaceuticals Inc. and swiftly followed up with a $6 million investment to fund its upcoming phase I in lymphoblastic leukemia. The acquisition sprang from a lesson learned from the recent past.
“Don’t be a one-hit wonder,” Nicolette said. “That was the genesis of us seeking the merger with Formula, to get the asset in play. We’re only looking for things with a clinical legacy.”
Nicolette described both programs as “de-risked” because Coimmune only wants to reproduce results it has seen in previous clinical trials. He expects data at the end of 2022 and, depending on how the data fall, then it may be time to increase the company’s brisk pace by putting itself up as a potential acquisition or enter the market with an IPO.
“I’m hopeful that some sort of acquisition would be possible if data are positive,” he said. “In both trials, we feel that positive data would substantially indicate that a pivotal study for registration would be successful.”