Adaptimmune gets boost from FDA as T-cell cancer drug wins inside track

Adaptimmune has been struggling as of late, losing its R&D chief during a CEO transition as its share price $ADAP steadily drifted down to alarming lows. But the struggling biotech got a much-needed boost today from the FDA, which put one of its top cancer drugs on the inside track reserved for drugs that qualify as a Regenerative Medicine Advanced Therapy.
RMAT — which extends to cell therapies — hasn’t received nearly as much attention as the FDA’s much cooler sounding breakthrough therapy designation, but it comes with much the same open-door invitation from the agency, an opportunity to discuss fast-tracking surrogate endpoints, and a chance to shoot ahead in gaining a marketing decision.

And Adaptimmune — now helmed by Adrian Rawcliffe, who stepped up to replace founding CEO James Noble — needs to prove itself. Shares are down 91% from last fall’s spike.
The RMAT designation goes to ADP-A2M4, one of the biotech’s top in-house TCR programs after they handed the lead — NY-ESO — to their partners at GlaxoSmithKline. They won the designation off of some very early-stage data in synovial sarcoma, where execs believe they can show clear headway in developing a T cell therapy for solid tumors. In this case, the drug targets MAGE-A4, a common antigen.

The biotech has only put out data on 14 patients, but there’s some promise there, with a 50% partial tumor response (confirmed as well as unconfirmed, it should be noted) in 7 of the patients. It’s now in Phase II, with a PD-1 combo approach being assembled on a parallel track, and Adaptimmune is promising to have this on the market as a groundbreaking new therapeutic approach in 2022.

Adaptimmune has won some cautious support from analysts on the data updates, with some concerns about this new drug’s ability to transcend various tumors apart from sarcoma. And the biotech has quite a mountain to climb. Its stock bumped up slightly Tuesday morning, with a 5% jump.

Struggling Adaptimmune gets a boost from the FDA as T-cell cancer drug wins an inside track at the agency