4 September 2024

Accession Therapeutics submits CTA to the UK MHRA to start Phase 1 first-in-human clinical trial with lead TROCEPT anti-cancer immunotherapy

Milestone reached in under three years from company inception

Oxford, UK, September 4 2024 – Accession Therapeutics Limited, which is developing novel, first-in-class immunotherapies targeted at tumour sites and administered systemically to provide a step-change in cancer treatment has filed a Clinical Trial Application (CTA) with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This is the first clinical trial showcasing the company’s TROCEPT-01 lead program and will enrol patients with a variety of solid tumour carcinomas including non-small cell lung, bladder, pancreatic, head and neck, cholangiocarcinoma and endometrial cancers. Accession Therapeutics announced a £25m raise earlier this year to fund generation of the first clinical data for TROCEPT-01, and to advance its second programme to clinical trial readiness.

Lead product TROCEPT-01 encodes a clinically validated immune checkpoint inhibitor transgene as the payload. Once cancer cells are infected, they will start producing and secreting the drug payload. The program has the potential to expand the indications in which checkpoint inhibitors could be successful and increase clinical response rates through high tumour-localised production of the drug.

TROCEPT-01 is the first program to come from Accession Therapeutics’ TROCEPT platform. The Phase 1 study will provide clinical validation of the platform and provide the rationale for subsequent programs. These programs will contain the same backbone but differ in the transgene payloads, which may include different modalities and mechanisms of action.

Bent Jakobsen, PhD FMedSci, CEO of Accession Therapeutics, said, ‘We’re delighted that in under 3 years we have taken a program from research to the clinic, a milestone which is testament to the strength and expertise of the Accession team. We hope that clinical data will enable us to show that TROCEPT-01 can be given systemically, while only replicating and producing the drug in cancer cells, which has enormous potential to provide a step-change in treatment for many solid tumour types. We have created a highly versatile platform with multiple opportunities to generate value.’

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