With $100 million in series A money from what CEO Usman Azam called "global, visionary investors," Tmunity Therapeutics Inc. will target solid tumors as well as hematological cancers with T-cell therapies, he told BioWorld.

"We know there's a much higher bar and a tougher bar to clear when it comes to solid-tumor thinking," he said, but technology from the University of Pennsylvania just might do the job. "We just started on that journey," he said.

Philadelphia-based Tmunity was founded on a collaboration and license agreement with Penn, and has "built out the distinct modules that are needed for success in this space, we believe," Azam said, pointing to "the ability to integrate [platforms] and move things rapidly into the clinic" as "the great skillset that the U of Penn team has."

At the start of 2016, the company garnered $10 million in an equity financing from Penn Medicine, the academic medical center of Penn, and Lilly Asia Ventures.

Early clinical work already is underway with a prostate cancer candidate as well as one potentially for myeloma and melanoma. The latter program, expected to start enrolling soon, represents the first CRISPR-edited T-cell receptor (TCR) bid in the U.S., though companies in China have been in CRISPR trials. "We hope at the right scientific forums we're able to talk more about the data as they emerge," Azam said. "We have a lot of work to do."

Backers in the series A include Ping An Ventures; the Parker Institute for Cancer Immunotherapy; and Be The Match Biotherapies, which provides cell therapy supply chain delivery for autologous or allogeneic therapies, partners with organizations pursuing cellular therapies in every stage of development, and grew out of the 30-year-old National Marrow Donor Program/Be The Match.

Also on the roster is Foster City, Calif.-based Gilead Sciences Inc., which is "obviously very committed to the space now," Azam said, a reference to Gilead's $11.9 billion acquisition of Kite Pharma Inc., of Los Angeles, last year. Gilead bought Kite, which works on chimeric antigen receptor (CAR) T cells and TCR drugs, for $180 per share in cash, a 29.5 percent premium to the previous trading close and a 50 percent premium to the company's 30-day volume-weighted average price. (See BioWorld, Aug. 29, 2017.)

Along with the two trials ongoing, Tmunity has five more CAR T programs at the preclinical stage and two more TCR prospects, with more IND filings planned for this year. Tmunity deploys "a number of platforms," Azam said. "It's not one specific, unique tool that we use," and the integrative approach developed by Penn means not only an ability to make drug candidates in an academic setting but also to scale up to GMP standards in the company's own manufacturing plant. Such "learnings together make us feel confident we have the ability to create lots of these products," he said.

Talks are ongoing with other would-be collaborators. "The main partnering activity that hopefully you're going to see from us is going to be around the manufacturing-site enablement," Azam said. "We have a lot of inbound interest," as suitors appreciate the prospect of working with the likes of scientific founder Bruce Levine, who "probably has manufactured more cellular products than anybody else that I know of. There's a lot of room for good, win-win situations there."

Levine has overseen the production, testing and release of 2,600 such products administered to more than 1,000 patients in trials since 1996.

'Small' team due to expand

Some have also approached Tmunity about working with new targets. "I think we're going to be quite busy in the deal space, but we've got a great pipeline emerging," Azam said. "We want to build out our company and get our products into the clinic as fast as possible. That's really going to be the focus," with everything else, including business development, secondary.

Azam worked for 10 years with Basel, Switzerland-based Novartis AG, where he became acquainted with the Penn team. When he was asked to join Tmunity, it was "a dream come true for me," he said. Last year, Novartis won approval for the CAR T-cell immunotherapy Kymriah (tisagenlecleucel, previously CTL-019) to treat patients up to age 25 with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Another star in the space in 2017 was Gilead's – previously Kite's – Yescarta (axicabtagene ciloleucel, previously KTE-C19), cleared by the FDA to treat adults with relapsed or refractory large B-cell lymphoma (BCL) after two or more lines of systemic therapy, including diffuse large BCL (DLBCL), primary mediastinal large BCL, high-grade BCL and DLBCL arising from follicular lymphoma. (See BioWorld, Aug. 31, 2017, and Oct. 20, 2017.)

Other Tmunity scientific founders include Carl June, who maintains a research lab that studies various mechanisms of lymphocyte activation that relate to immune tolerance and adoptive immunotherapy for cancer and chronic infection. In 2011, his research team published findings detailing a new therapy in which patients with refractory and relapsed chronic lymphocytic leukemia were treated with genetically engineered versions of their own T cells, a therapy that has since been used with promising results to treat children with refractory ALL. June has published more than 350 papers.

Azam described the current staff number as small. "We are looking forward to expanding our team but we're not discussing numbers of employees right now," he said, also declining to say how much the company can accomplish with the funds available, but said Tmunity officials "have what we need" to build significantly on what's been done so far.