SAN FRANCISCO—Nearly a year after Tmunity Therapeutics raised $100 million to develop better and safer T cell treatments, the company is getting ready to present data, unveil new targets and boost its headcount in 2019.
Tmunity has a pair of clinical-stage assets: a CAR-T treatment for castration-resistant prostate cancer and a CRISPR-edited T cell receptor therapy for melanoma, myeloma and synovial sarcoma. In 2019, the Philadelphia-based biotech hopes to share human data about the former program at the American Society of Clinical Oncology meeting and the latter at the American Society of Hematology meeting, CEO Usman “Oz” Azam said at the J.P. Morgan Healthcare Conference.
Also in 2019, the company will start executing its “aggressive” plan to file two new INDs per year. Azam kept mum on the details but did say both targets are in solid tumors, with the first IND to come in the first half of the year and the second to follow by the end of 2019.
Born out of an extensive collaboration and licensing agreement with the University of Pennsylvania, Tmunity boasts a star-studded list of scientific co-founders—including Carl June—and, at launch, had been conducting its early phase 1 work and some manufacturing at the university’s facilities. At the time, the company was working on getting its own GMP facility up and running, and since then it's started growing cells at that site.
It will be ready for multicenter phase 2 clinical trials by 2020, Azam said. And in anticipation of that, Tmunity is planning to nearly double in size. Over the past six months or so, the company has grown from 25 to 34 employees, and wants to hit 65 by the end of the year.
“We’ve hired out our full management team and great people in our R&D organization,” Azam said. With phase 2 in the offing, he will look to build Tmunity’s manufacturing team, “mainly around process science development and vector knowhow.” The company will also build its clinical and regulatory staff, as well as its market access, pricing and commercialization teams.
“We would love to be a fully vertically integrated commercial entity as well, but that will really be predicated on success in the clinic right? So we want to lay the foundations of great people who can take us there,” Azam said.
It’s no secret that Azam wants Tmunity to “be the Genentech of the cell and gene industry.” But there’s more—"As important for me is I want Tmunity to be seen as the center of gravity for cell therapies, that we are the dominant player when it comes to really integrating the disparate components that everybody is trying to fix.”
Pricing and access are a part of that: “These products are still incredibly difficult to manufacture, very costly and I think companies like ours have a responsibility to address that,” Azam said. “We don’t want to break the healthcare budget of the world even though we are trying to create curative programs, so that’s something I think you’re going to see a transformation in that happening."