In preclinical studies, IPH45 effectively hinders the growth of tumours expressing Nectin-4, both in laboratory settings and in vivo. Credit: Gorodenkoff via Shutterstock.

Innate Pharma has announced positive preclinical data of its antibody-drug conjugate (ADC) candidate IPH45, as it plans to advance the candidate towards clinical trials. 

The data was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California, from 5 to 10 April.  

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In preclinical studies, IPH45 effectively hinders the growth of tumours expressing Nectin-4, both in laboratory settings and in vivo, even in cases resistant to Padcev (enfortumab vedotin), a drug used to treat advanced bladder cancer jointly developed by Astellas and Seagen. IPH45 has demonstrated greater efficacy than Padcev in various models of urothelial carcinoma, regardless of Nectin-4 levels. 

Innate Pharma now plans to advance IPH45 towards clinical trials, with an investigational new drug (IND) application planned for later this year. 

ADCs are a form of targeted cancer therapy where an antibody is linked to a potent drug, allowing precise delivery of medication directly to cancer cells and reducing damage to surrounding healthy tissue.

According to GlobalData, the lead ADCs are Roche’s Kadcyla (trastuzumab emtansine) and Polivy (polatuzumab vedotin), which are currently approved in multiple regions, including the US and the EU, for select cancers. Roche’s two drugs generated $2.1bn and $877m in sales in 2023 respectively, as per the company’s financials. 

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In the announcement accompanying the data, Innate Pharma’s chief scientific officer Eric Vivier said: “These promising results underscore the potential of IPH45 to provide new solutions for patients in a variety of Nectin-4 expressing cancers, beyond Nectin-4high expressing bladder. Based on these encouraging data, we are eagerly advancing IPH45 towards clinical trials.” 

Innate Pharma was involved in an investigation with the US Food and Drug Administration (FDA) last year, following the death of a patient in a clinical trial of IPH4102 (lacutamab), the biotech’s humanised cytotoxicity-inducing cancer antibody. In October 2023, the FDA put a clinical hold and paused the recruitment for all -IPH4102 trials, including the Phase II TELLOMAK study (NCT03902184) and the Phase Ib peripheral T cell lymphoma (PTCL) study (NCT05321147).

However, the FDA lifted the partial clinical hold in January 2024 after determining that the death was caused by aggressive disease progression.