• HTL0039732 (also known as NXE0039732) is Nxera’s novel oral EP4 antagonist with the potential to treat a wide range of cancers in combination with other immunotherapies
• Cancer Research UK’s Centre for Drug Development is sponsoring and managing the ongoing Phase 1/2a clinical trial of HTL0039732

Tokyo, Japan and Cambridge and London, UK, 13 September 2024 – Nxera Pharma (TSE: 4565, “Nxera”) and Cancer Research UK announce an upcoming presentation on the ongoing Phase 1/2a clinical trial (NCT05944237) of Nxera’s immunotherapy drug HTL0039732 (also known as NXE0039732) at the European Society for Medical Oncology Congress (ESMO) 2024, taking place on 13–17 September in Barcelona, Spain.

The trial’s co-chief investigator, Dr. Debashis Sarker from Guy's and St Thomas’ NHS Foundation Trust, will present a “Trial in Progress1” poster at ESMO 2024 on Saturday 14 September (presentation 679TiP, available on the ESMO website here).

The first-in-human trial is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of HTL0039732 as a monotherapy and in combination with the checkpoint inhibitor atezolizumab, in patients with advanced solid tumors.

HTL0039732 is an oral small molecule drug candidate that was rationally designed using Nxera’s NxWave™ platform and evaluated through rigorous translational and preclinical studies. HTL0039732 works by blocking signaling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4). PGE2 acts in the tumor 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 and makes HTL0039732 a potential candidate to treat patients with cancers that generally do not respond well to current immunotherapies.

Cancer Research UK’s Centre for Drug Development is sponsoring and managing the trial, which is led by chief investigator Dr Bristi Basu, University of Cambridge, and Dr Sarker. The first patient was dosed in August 2023 and the trial is currently open for recruitment at Addenbrooke’s Hospital in Cambridge, Guy’s Hospital in London, and the Christie Hospital in Manchester.

Dr. Debashis Sarker says: “We are excited to present this ‘Trials in Progress’ poster at ESMO, outlining the scientific rationale and design of the clinical trial of HTL0039732, given alone and in combination with immunotherapy for patients with advanced solid cancers. HTL0039732 targets an important protein within the tumor immune microenvironment called EP4, triggering cancer cells to evade the immune system. Targeting EP4 potentially increases the ability of the immune system to detect and control cancer cells. Enrolment to the trial began in the UK in August 2023 and is ongoing across multiple cancer types.

“We are hopeful that this trial will identify a novel way to target the immune system and improve treatment options for patients with a range of different solid cancers.”

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About Nxera PharmaNxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.

In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery “NxWaveTM” platform to provide a sustainable source of best- or first-in-class candidates.

Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565).

For more information, please visit www.nxera.lifeLinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma

About Cancer Research UK’s Centre for Drug DevelopmentCancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. Six of these new agents have made it to market, including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase 3 trials. Thirteen agents remain in active development with the potential to reach the market.  It currently has a portfolio of 16 projects in preclinical development, Phase 1 or early Phase 2 clinical trials.  www.cruk.org.uk/cdd 

Enquiries:

For Nxera – Media and Investor RelationsKentaro Tahara, VP Investor Relations and Corporate StrategyShinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life

For Nxera – MEDiSTRAVA (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | Nxera@medistrava.com

For Cancer Research UKTim Bodicoat, Content Managertim.bodicoat@cancer.org.uk

Nxera Pharma Forward-Looking StatementsThis press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

1 A “Trial in Progress” presentation describes the rationale behind and design of a clinical trial. No data will be presented.