Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours.
Sosei Group and Cancer Research UK announced that the first patient has been dosed in a Phase I/IIa clinical trial evaluating Sosei Heptares’ immunotherapy drug HTL0039732.
HTL0039732 works by blocking signalling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4).
In cancer, PGE2 acts in the tumour microenvironment to trigger cancer cells to evade the immune system. Targeting EP4 to block the effects of PGE2 increases the ability of the immune system to detect and control cancer cells.
Cancer Research UK’s Centre for Drug Development (CDD) is sponsoring, designing and conducting the Phase I/IIa trial with three main objectives: to define the toxicity, tolerability and pharmacokinetics of HTL0039732, to identify the recommended dose for Phase II studies, and to assess its antitumour activity as a monotherapy and in combination with the PD-L1 inhibitor atezolizumab.
Chief Investigator Dr Bristi Basu, University of Cambridge, and Co-Chief Investigator Dr Debashis Sarker, King’s College London, are leading the trial.
Dr Basu said: “By studying HTL0039732 alone and in combination with immunotherapy, we aim to understand more about how to optimise modulation of the immune system to fight cancers. We hope that this EP4-targeting approach will deliver a promising route to improving treatment options for patients with a broad range of cancers.”
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted HTL0039732 an Innovation Passport, the first step in its Innovative and Licensing Access Pathway (ILAP), which aims to improve patient access to new medicines by reducing the time to market.
Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World
