UPDATED: After crossing t's, dotting i's, Immunocore nails down breakthrough therapy designation for lead TCR therapy
Days after tapping a new commercial head, Immunocore has scored a breakthrough therapy designation for its lead T cell receptor program, which it plans on punting to regulators for a speedy consideration in unresectable or metastatic uveal carcinoma later this year.
CEO Bahija Jallal has already nailed down $175 million to back a potential launch for tebentafusp, and earlier this week she tapped AstraZeneca vet Ralph Torbay to lead the charge. The company will approach regulators in Q3, it announced on Friday.
Regulators based the BTD on a Phase III survival data readout back in November — the first positive late-stage survival data for a TCR, according to Immunocore. Researchers gathered 378 patients for the study, pitting tebentafusp (IMCgp100) against investigators’ choice where there is no specifically approved therapy.
At the first planned interim readout for the intent-to-treat, all-comers group in uveal melanoma for tebentafusp (IMCgp100), Immunocore noted an impressive hazard ratio of 0.51 against the physicians’ choice standard of care.
“Although not yet mature, the Kaplan-Meier estimates suggest a 1-year OS rate of approximately 73% vs 58%, respectively,” the company said.
The results preceded a Phase II readout at ESMO, which turned up a mere 5% objective response rate — the primary endpoint — but showed a reduction in target lesions in 44% of patients. Immunocore researchers noted early on that the TCR approach doesn’t do much in the way of triggering objective response rates. So instead, they’re going for the gold standard on overall survival.
With a median follow-up of 19.6 months in the Phase II trial, the median OS was 16.8 months, Immunocore announced at ESMO. Researchers further pointed out that the 12-month OS rate of 62% in patients overall was increased to 86% in patients achieving target lesion reduction.
“For any biotech company that starts with a new platform, the key milestone is to prove that it works in the clinic. This is transformational for the company,” Jallal told Endpoints in November after announcing the Phase III data. “It just puts us on the map.”
Six weeks later, Jallal reeled in a $75 million C round and added $100 million in debt to back tebentafusp’s potential launch. On Feb. 4, the company priced an upsized IPO at $26 a share, netting about $258.3 million.
Immunocore burst onto the scene in 2015 with a $320 million launch round, breaking a record for UK biotechs. The original team under CEO Eliot Forster exited the company amid some turbulence, and former chief commercial officer Andrew Hotchkiss stepped up as interim chief in 2018. About a year later, Jallal announced she was taking the helm.
Jallal said she felt like a “kid in a candy store,” with Immunocore’s broad platform designed to target cancer, infectious diseases and autoimmune conditions.
Immunocore’s pipeline also includes a handful of Phase I programs for hepatitis B, synovial sarcoma and other solid tumors.