Better and safer T-cell treatments for solid tumors and blood cancers
CEO: Usman “Oz” Azam
Clinical focus: T-cell immunotherapies for cancer
The scoop: Armed with $135 million in series A funding and T-cell technology licensed from the University of Pennsylvania, Tmunity is working on T-cell treatments that could be transformative and curative, including T-cell receptor therapies, CAR-T or other T-cell enhancing approaches. While its R&D bread and butter is oncology, it’s also interested in other areas, including HIV.
What makes Tmunity fierce: Tmunity closed a colossal $100 million round in January, supplementing it with another $35 million raised in April. It was the “unprecedented” expertise of the founders and management, as well as the company’s exclusive T-cell R&D and licensing pact with the University of Pennsylvania, that drew such strong backing from big-name investors, says CEO Usman “Oz” Azam.
“The scientific cofounders have collectively manufactured and developed more cell therapy products than any other group on the planet—Carl June, Bruce Levine, Yangbing Zhao, Anne Chew and Jim Riley from Penn,” Azam said. This Penn team, led by June, developed Tisagenlecleucel, a CAR-T therapy licensed to Novartis and eventually approved and marketed as Kymriah. Azam’s own credentials aren’t too shabby either—he previously led the Cell & Gene Therapies unit at Novartis, helping Kymriah “get across the finish line” in 2016 and 2017.
Tmunity’s deep coffers give it the runway to pursue multiple approaches, a strategy that’s especially important in cancer, Azam said. He pointed to the difficulty researchers have had in translating the success of Kymriah and Yescarta—the first FDA-approved CAR-T therapies—in blood cancers to solid tumors.
“We are prepared to take the appropriate scientific risk. … We have a vision that in order to cure cancer, we’re going to have to take multiple shots on goal. No one modality alone is going to win,” Azam said.
Tmunity has two programs in the clinic, a CAR-T treatment for prostate cancer and a CRISPR-edited T-cell receptor (TCR) therapy aimed at treating myeloma, melanoma and sarcoma.
“We are hoping to be the first U.S. company that can demonstrate that we can treat patients safely with a T-cell receptor product that has a CRISPR modification to it,” Azam said.
And that’s not all Tmunity has in the works. With five more CAR-T programs and two more TCR programs in preclinical development, the biotech aims to roll out a minimum of two IND programs per year, tackling a variety of tumor types, including acute myeloid leukemia, ovarian cancer and pancreatic cancer, Azam said.
While its clinical programs are now conducted through Penn, Tmunity does have its own manufacturing facility outside the university in Philadelphia.
“We are focusing on early-process science and development [at that site],” Azam said. But as programs mature, the company plans to make it a multifunctional facility; Azam hopes the site will be handling human cellular material by the fall.
Meanwhile, Tmunity is already thinking about manufacturing and pricing. CAR-T therapies are bespoke treatments made of a patient’s own T cells, and as such can’t be mass-produced. That's one reason why Kymriah and Yescarta have sticker prices of $475,000 and $373,000 respectively—prices that have raised a lot of questions about healthcare costs, given the raft of other cell therapies working their way toward the market.
It’s important for Tmunity to figure out how it will first manufacture a product stable that meets Good Manufacturing Practice (GMP) requirements, and then go on to produce those treatments at scale cost-effectively, so that patients can afford them, Azam said.
The company is growing fast. Since launch, Tmunity has built out its management team, most recently recruiting Christina Coughlin from Immunocore. Like others on the team, she previously worked with June; earlier in her career, she served as a physician-scientist at Penn and the Children's Hospital of Philadelphia. The company also aims to grow from 25 employees to about 45 by the end of the year.
“We’re trying to get to the clinic as fast as possible and address unmet need,” Azam previously told FierceBiotech. “The initial CAR-T therapies have done an amazing job getting through to patients. So many more patients are going to benefit from the type of work we and other companies are doing.”
Investors: Be The Match BioTherapies, Gilead Sciences, Kleiner Perkins, Lilly Asia Ventures, Parker Institute for Cancer Immunotherapy, Ping An Ventures, University of Pennsylvania