So Long, Farewell: Head of Novartis AG's Shuttered CAR-T Unit to Helm Biotech Upstart Tmunity

So Long, Farewell: Head of Novartis AG' Shuttered CAR-T Unit to Helm Biotech Upstart Tmunity December 7, 2016
By Alex Keown, BioSpace.com Breaking News Staff

PHILADELPHIA – Usman Azam, the former head of Novartis ’ Cell and Gene Therapy Unit, has resurfaced with a new role – president and chief executive officer of Tmunity Therapeutics.

Azam, along with hundreds of staffers, were let go by Novartis earlier this year when that company dissolved its Cell and Gene Therapy Unit. Now Azam will help Tmunity develop treatments that “unleash the immunological potential of T cells” on a variety of diseases.

Tmunity is developing novel T Cell Receptor (TCR) engineered T cells, regulatory T cells (Treg), and universal engineered T cell platforms that exhibit best-in-class control over T cell activation and direction in vivo. Tmunity Therapeutics launched earlier this year with $10 Million in equity financing from Penn Medicine, the academic medical center of the University of Pennsylvania (Penn), and Lilly Asia Ventures.

In a statement, Azam said he has worked with the development of novel drugs and biologics for 20 years but had never been more excited about the “potential we have at Tmunity to make a significant contribution to the treatment of cancer, HIV, and autoimmune disease by delivering the promise of T cell medicine.”

Azam said the company is creating business model that integrates research, transitional medicine, manufacturing science, clinical development and customer centric approaches to “foster further successful commercial adoption of cell and gene therapies.”

Tmunity will enter a field of companies well-ahead in CAR-T development, including Azam’s former employer, Novartis. Earlier this month, Novartis announced its experimental CAR-T therapy CLT019 sent 82 percent of patients’ blood cancer into remission, according to interim data presented at the American Society of Hematology. That data puts Novartis in line to hit its 2017 goal to regulatory approval for its pediatric leukemia CAR-T therapy, CTL019. The global Phase II study found that 82 percent of pediatric patients, 41 out of 50, achieved complete remission or complete remission with incomplete blood count recovery at three months following infusion of CTL019. For all patients with complete remission, no minimal residual disease was detected, Novartis said.

Other companies making waves in the CAR-T field include, Kite Pharma and its lead CAR T- product candidate, KTE-C19, for DLBCL. Kite aims to file for an approval of its lead CAR-T therapy by the end of the year.

While those are CAR-T successes, there have been some setbacks in the field, particularly with Juno Therapeutics . That company halted placed its Phase II clinical Rocket trial of JCAR015 on hold for the second time following the announcement that two patients died. Those deaths marked the fourth and fifth deaths associated with this trial. In July, the company announced three patients in the Rocket trial died.

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