MSK and Atara snag an FDA 'breakthrough' tag for T cell project

Memorial Sloan Kettering Cancer Center picked up the FDA's coveted breakthrough-therapy designation for a promising T cell therapy, working with partner Atara Biotherapeutics ($ATRA) to get it on the market for patients with complications tied to bone marrow transplants.

The treatment, dubbed EBV-CTL, uses off-the-shelf cytotoxic T lymphocytes to attack cancer cells associated with Epstein-Barr virus (EBV), which often crop up in patients who have just received new bone marrow. MSK developed the therapy by harvesting healthy T cells from third-party donors and exposing them to certain antigens, creating souped-up cells that can home in on EBV-expressing tumors and kill them. The center is currently running a Phase II trial with the therapy.

The breakthrough tag guarantees MSK and Atara greater access to FDA experts during the development process and a speedy review if and when they submit the treatment. And it brings the partners "one step closer to our ultimate goal of making EBV-CTL available to all patients with EBV-LPD, a serious and life threatening condition with limited treatment options," MSK Pediatrics Chairman Richard O'Reilly said in a statement.

Atara got involved in the program in September, signing a deal in which it traded an undisclosed amount of cash and stock to MSK in exchange for exclusive options on three T cell projects. Beyond MSK's work in EBV, the biotech has optioned a Phase II cytomegalovirus program and a Phase I effort targeting Wilms tumor 1.

The deal closely followed Atara's $55 million IPO, executed in October, and expanded the biotech's pipeline beyond its core competency of molecularly targeted treatments. Outside of its MSK-partnered projects, Atara is working on the Phase II PINTA 745, a peptide-antibody combo that inhibits myostatin in order to fight protein energy wasting; STM 434, a Phase I oncology therapy that inhibits activin to kill off ovarian cancer and other solid tumors; and NINA 842, a preclinical myostatin-targeting antibody designed to combat cancer-related weight loss.

For MSK, the agreement is one of its many industry tie-ups, headlined by a novel deal with Juno Therapeutics ($JUNO) in which the center is eligible for escalating payments as the high-profile biotech's share price moves upward.

- read the statement

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