Imugene Ltd CEO Leslie Chong talked with Kerry Stevenson at Proactive about the FDA's fast-track designation for its immunotherapy candidate, Azercell. The therapy, an allogeneic off-the-shelf CAR-T treatment, has shown promising results in patients with diffuse large B-cell lymphoma (DLBCL), a highly aggressive form of blood cancer.
Chong highlighted that four out of seven patients treated with Azercell achieved complete response, meaning their cancer was no longer detectable. The longest response duration has now exceeded 11 months. “The FDA has recognised the importance of a product like this and has given us fast-track designation,” Chong stated.
The FDA's fast-track status allows Imugene to expedite regulatory discussions and move towards potential commercialization more efficiently. The company sees this as a critical milestone, with Chong emphasising that the priority now is gathering sufficient data to advance towards registration studies.
With an estimated 80,000 new DLBCL cases diagnosed annually in the US, Azercell could address a significant unmet need, especially for patients who have exhausted other treatment options.
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