Biomunex Pharmaceuticals SAS

T-cell engagers are a class of immunotherapies that direct T cells to recognise and eliminate cancer cells. Credit: skynesher via Getty Images. US-based Normunity has raised $75m in a Series B funding round to support the clinical development of its lead programme, NRM-823, a potential first-in-class T-cell engager (TCE) targeting solid tumours. NRM-823 is an engineered antibody that redirects T cells to attack cancer cells by binding to a highly specific tumour-associated target. Normunity said that this novel target is expressed across multiple types of solid tumours, making it a promising candidate for addressing cancers that are often challenging to treat. The company plans to initiate a Phase I clinical trial for NRM-823 in the second half of 2025. The Series B round was co-led by Samsara BioCapital and Enavate Sciences, with participation from Pfizer Ventures, Regeneron Ventures, Sanofi Ventures, Taiho Ventures, and others. This latest round follows Normunity’s $65m Series A round in 2022, bringing the company’s total funding to $140m. The financing will also enable the expansion of Normunity’s pipeline, which focuses on novel targets implicated in tumour-specific immune suppression. TCEs are a class of immunotherapies that direct T cells to recognise and eliminate cancer cells. Recent developments in this field suggest significant potential for transforming cancer treatment, particularly for solid tumours, which have historically been less responsive to traditional immunotherapies. “The T-cell engager space has seen multiple recent successes in solid tumours, and we believe this modality is poised to transform the treatment of numerous cancers in the coming years,” said Sara Nayeem, executive vice president of investments at Enavate Sciences. “We are excited to support the development of NRM-823, which has demonstrated compelling preclinical efficacy and safety.” Normunity’s progress aligns with broader trends in the TCE landscape. For example, Ipsen committed up to $610m last month to license a bispecific TCE from Biomunex Pharmaceuticals, which targets mucosal-associated invariant T cells (MAITs). This approach seeks to address safety challenges associated with traditional bispecifics by selectively engaging a cytotoxic T-cell subset. Similarly, Candid Therapeutics entered the TCE market in September 2024 with $370m in funding. While initially focusing on autoimmune diseases, the company plans to expand its pipeline to include cancer therapies, highlighting the versatility of this technology. Normunity’s trajectory is further supported by its collaboration with Alloy Therapeutics to develop precision immuno-oncology programs. Announced in November 2022, this partnership leverages Alloy’s antibody discovery capabilities to advance Normunity’s portfolio of therapies targeting immune suppression in tumours.

Ipsen has announced that it will be gaining exclusive global rights to Biomunex Pharmaceuticals’ pre-clinical T cell engager (TCE) in a deal worth up to $610m, marking an expansion to the company’s immuno-oncology pipeline. BMX-502 is a bispecific antibody that engages and activates a subset of cytotoxic T cells called MAIT cells and targets the GPC3 tumour antigen to kill cancer cells. GPC3 is highly expressed across several cancer types, including melanoma and hepatocellular carcinoma, while MAIT cells are present throughout the body, particularly in mucosal and barrier tissues. MAIT engagers have the potential to provide a “more robust therapeutic window” compared to classical pan-TCEs in specific tumour types and are expected to overcome limitations associated with the therapies, such as cytokine release syndrome, according to Ipsen. Following Biomunex’s completion of the Investigational New Drug (IND)-enabling package for BMX-502, Ipsen will assume responsibility for phase 1 preparation activities, including submission of the IND application, and all subsequent clinical-development and global commercialisation. In exchange, Biomunex will be eligible for up to $610m, including an undisclosed upfront fee, development, regulatory and commercial milestones, in addition to tiered global royalties on sales. Mary Jane Hinrichs, senior vice president and head of early development at Ipsen, said: “This new MAIT-engager programme will complement our existing TCE portfolio as we harness the next-generation of TCEs to overcome treatment challenges, including dose-limiting toxicity, to bring transformational new medicines to people living with solid tumours around the world.” Also commenting on the agreement, Pierre-Emmanuel Gerard, founder, president and chief executive officer of Biomunex, said: “We are convinced that our MAIT engagers will represent a new step forward in the development of disruptive immuno-therapies for the treatment of cancer. We look forward to initiating and supporting the development of BMX-502 alongside Ipsen.” The deal comes six months after Ipsen expanded its ongoing oncology research partnership with Marengo Therapeutics to include Marengo’s TCE platform. The new agreement, worth up to $1.2bn, centres around Marengo’s TriSTAR platform, which offers the potential to produce candidates able to overcome the effects of poor T cell quality and T cell exhaustion that may limit the activity of traditional TCEs targeting difficult-to-treat ‘cold’ tumours.

BMX-502 is designed to engage and activate mucosal-associated invariant T cells to target and destroy malignant cells. Credit: Pickadook/Shutterstock. Ipsen has entered an exclusive worldwide licensing agreement with Biomunex Pharmaceuticals for BMX-502, a first-in-class bispecific antibody designed to engage and activate mucosal-associated invariant T cells (MAIT cells) to target and destroy malignant cells. The agreement grants Ipsen exclusive worldwide rights for the development, manufacturing and commercialisation of BMX-502. Biomunex is set to finalise the investigational new drug (IND)-enabling package. Ipsen will take over the responsibility for preparation activities related to the Phase I trial, including the IND application submission, and all clinical development and commercialisation efforts. Biomunex could receive up to $610m, including upfront and milestone payments, as well as tiered global royalties on sales. Ipsen early development senior vice-president and head Mary Jane Hinrichs stated: “As we continue to grow Ipsen’s pipeline using a science-first approach to partnering across the ecosystem, we believe BMX-502 is a strong addition with first-in-class potential in solid tumours. “This new MAIT-engager programme will complement our existing TCE portfolio as we harness the next generation of T cell engagers to overcome treatment challenges, including dose-limiting toxicity, to bring transformational new medicines to people living with solid tumours around the world.” BMX-502, which leverages Biomunex’s BiXAb technology, specifically targets the glypican-3 (GPC3) tumour antigen, a clinically validated target expressed in high levels in several cancer types. It will treat tumours by activating MAIT cells, which are abundant in mucosal and barrier tissues. Biomunex CEO, founder and president Dr Pierre-Emmanuel Gerard stated: “This agreement with such an innovative oncology company as Ipsen is proof of the relevance of the MAIT-engager approach of Biomunex, the first company worldwide to have identified the high therapeutic potential of MAIT cells in cancer treatment. “It also represents the demonstration of the added value of our best-in-class BiXAb platform to rapidly generate innovative and promising bispecific antibodies. We are convinced that our MAIT engagers will represent a new step forward in the development of disruptive immuno-therapies for the treatment of cancer.” In October 2024, Ipsen’s elafibranor (Iqirvo) received approval from the UK Medicines and Healthcare Products Regulatory Agency for the treatment of primary biliary cholangitis in adults.