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Cancer and vaccine developments at Milton Park
Published on 9 February 2024
Recent advancements driven by Adaptimmune, Exscientia and Emergex Vaccines highlight developments in both cancer treatments and vaccinations, offering a glimpse into the progressive direction of ongoing clinical research taking place at Milton Park.
Adaptimmune announces U.S. FDA acceptance of Biologics License Application (BLA)
Milton Park-based Adaptimmune Therapeutics plc, a company redefining the treatment of solid tumour cancers with cell therapy, announced that the U.S. FDA has accepted for priority review its BLA for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma.
If approved, afami-cel will be the first engineered T-cell therapy for solid tumours and the first effective treatment option for synovial sarcoma in more than a decade. The application has a Prescription Drug User Fee Act (PDUFA) target action date of August 4, 2024.
Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer, commented: “The FDA’s acceptance of the BLA submission brings us one step closer to redefining treatment for people with synovial sarcoma. Our franchise has great potential and, if approved, we have the capabilities and the capital to launch afami-cel – the first engineered T-cell therapy on the market for a solid tumour cancer.”
Projections have predicted US sales of up to $400 million for the company, with funding of over $300m secured into early 2026.
Emergex gears up for Phase I-II clinical trial
Park-based Emergex Vaccines, a clinical stage biotechnology company, is addressing major global infectious diseases through the development of fully synthetic T cell-priming immune set-point candidates.
Philippines FDA authorisation to initiate a Phase I-II clinical trial of CoronaTcP has been achieved and is set to begin in the second quarter of 2024, aiming to target Betacoronaviruses, including SARS-CoV-1 and emerging variants.
Professor Thomas Rademacher, Co-Founder and Chief Executive Officer at Emergex, said: “We thank the Philippines FDA for rapidly approving this trial after a successful Phase I clinical trial in Switzerland. Coronaviruses are susceptible to high mutation rates, and cellular immunity is critical for long-lasting protection.
“We look forward to evaluating our T cell-based approach, which has the potential to improve any previous immune status. Emergex is rapidly moving forward with plans for the trial, and we expect to start enrolling volunteers in Q2 2024.”
Exscientia receives $2.3m grant
AI-driven precision medicine company, Exscientia, has announced a $2.3m grant from Open Philanthropy. Exscientia occupies a purpose-built lab building on the Park and aims to harness the activation of the host interferon response as a therapeutic approach for pandemic influenza, with the grant provided in the context of the Pandemic Antiviral Discovery initiative.
Professor Ian Goodfellow, Vice President of Antivirals for Exscientia commented: We are thrilled that these expert institutions are supporting Exscientia’s capabilities to develop innovative solutions to address significant unsolved health issues, expressed through this grant.
“If we manage to ‘turn on’ the interferon response, in a highly controlled manner using small molecule therapeutics, we may be able to transform the way influenza can be treated and prevented in the future – an essential requirement of effective pandemic preparedness.”
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