Immunocore has enrolled the first participant in a dose-finding trial of its lead program IMCgp100 in the treatment of uveal melanoma. And, with the company aiming to identify the optimal dose in the next 6 to 8 months, it is now positioned to advance into a pivotal Phase II trial in the orphan indication by the end of the year.
|Immunocore Chief Medical Officer Christina Coughlin|
The trials now underway and looming into view represent an important test for Immunocore, which has landed big deals on the strength of the potential of its bispecific biologic approach that uses a T cell receptor as the targeting system instead of an antibody domain. Having landed collaborations with AstraZeneca ($AZN), Eli Lilly ($LLY), Genentech and GlaxoSmithKline ($GSK), Immunocore pulled in $320 million (€283 million) in private investment last year, giving it the financial clout to move its lead candidate toward approval unpartnered.
In dosing the first patient in the Phase I study, Oxford, U.K.-based Immunocore has taken a small step toward that goal. The trial will prepare Immuncore for the upcoming pivotal Phase II trial. "We are attempting to … increase the dose that we're able to give by moving the dose escalation beyond the first few weeks of treatment, where we see some of the toxicity that is associated with these T cell-based approaches," Immunocore Chief Medical Officer Christina Coughlin told FierceBiotech. The aim is to identify the optimal dose within eight months and then quickly start the pivotal study.
Beyond that, IMCgp100 could advance quickly toward the market. In September, EMA accepted the drug into its adaptive pathways pilot program, potentially offering it as a shortcut to use in the real world. "Depending on the strategy for registration … it could potentially get started later this year, actually quite late this year, or early next year. And that could potentially lead to being on the market at some point very late in 2018 or early in 2019, if successful," Coughlin said.
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