First Patient Dosed in Nxera–Cancer Research UK Phase 2a Trial For Advanced Solid Tumours

Nxera Pharma Co., Ltd.,  and Cancer Research UK today announced that the first patient has been dosed in a Phase 2a clinical trial (NCT05944237) evaluating Nxera’s investigational immunotherapy HTL0039732 (NXE0039732) for advanced solid tumours.

Dr Matt Barnes, Chief Scientific Officer and President of Nxera Pharma UK, said, “We are proud to reach this important milestone in the development of HTL0039732 and to continue our productive collaboration with Cancer Research UK. The initiation of the Phase 2a trial marks a significant step forward in our efforts to bring this promising drug to patients with difficult-to-treat cancers. The encouraging data from the Phase 1 study provide a strong foundation for continued clinical investigation, and we look forward to sharing further updates as the trial progresses.”

The advancement to Phase 2a follows the successful completion of the Phase 1 study, which identified a safe and well-tolerated dose of HTL0039732 in combination with the checkpoint inhibitor atezolizumab. Results showed strong engagement of the intended target EP4, without significantly engaging EP2, and encouraging early efficacy, including two confirmed partial responses in distinct tumor types. Phase 1 data will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 in October.

Dr Bristi Basu, Chief Investigator, University of Cambridge, said, “It is exciting to move to the next phase of assessing this new inhibitor of an important receptor EP4, which is implicated in suppression of the antitumor immune response. We hope that by combining it with immunotherapy, we will build on some of the promising early data we have seen in patients treated in the Phase 1 trial.”

HTL0039732 is an oral small molecule and novel EP4 antagonist designed to block prostaglandin E2 (PGE2) signalling through the EP4 receptor. PGE2 is known to help cancer cells evade immune system detection in the tumor microenvironment. By inhibiting EP4, HTL0039732 may enhance immune system recognition of cancer cells, potentially benefitting patients with tumors resistant to current immunotherapies.

Dr Lars Erwig, Director of the Centre for Drug Development, Cancer Research UK, said, “The dosing of the first patient in the Phase 2a trial of HTL0039732 is a significant step forward in the Centre for Drug Development’s collaboration with Nxera Pharma, which exemplifies the power of partnership in accelerating the development of groundbreaking therapies. The need for novel immunotherapies is more pressing than ever, as many cancers continue to evade current treatments. We look forward to continuing this journey and bringing hope to patients and their families.”

The Phase 2a trial is sponsored and managed by Cancer Research UK’s Centre for Drug Development, with Dr Bristi Basu (University of Cambridge) as Chief Investigator and Dr Debashis Sarker (King’s College London) as Co-Chief Investigator. The trial is being conducted across multiple sites in the Experimental Cancer Medicine Centre (ECMC) network, led by Addenbrooke’s Hospital in Cambridge, and will enroll patients across four cohorts: microsatellite stable colorectal cancer (MSS CRC), gastric/gastroesophageal junction adenocarcinoma, clear cell renal cell carcinoma, and metastatic castration-resistant prostate cancer. Nxera Pharma holds a license to the trial results to continue clinical development and commercialisation of HTL0039732.