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iStock, hurca Adaptimmune is rolling out its T cell therapy Tecelra for synovial sarcoma, recording $1.2 million in sales since its approval in August 2024. Nevertheless, it is pausing development of two oncology assets to save money. Despite the “increasing” momentum of its engineered T cell therapy Tecelra, Adaptimmune on Thursday expressed concern about its ability to continue as a business. “There is substantial doubt about our ability to continue,” the biotech wrote in a news release, adding that it will continue to “implement cost reduction measures.” In particular, Adaptimmune revealed on a Thursday investor call that it would pause work on two early-stage assets : the PRAME-targeting ADP-600 being developed for solid tumors and the anti-CD70 molecule ADP-520 for hematological malignancies. Both programs were undergoing IND-enabling studies. The company’s cash crunch comes as it works on launching Tecelra, the first FDA-approved engineered T cell therapy for solid tumors. The therapy won the FDA’s blessing in August 2024, allowing its use in patients with unresectable or metastatic synovial sarcoma. Adaptimmune has so far prepared 10 patients for treatment across 20 activated authorized treatment centers, according to its Thursday release. Adaptimmune is also currently exploring “all strategic options” for its business and all of its programs, for which it has enlisted TD Cowen’s help, CEO Adrian Rawcliffe said on the investor call. “This includes potential partnerships or collaborations, strategic combinations, various financial transactions and multiple pipeline monetization opportunities,” he added. Adaptimmune had just under $147 million in cash, cash equivalents and marketable securities at the end of 2024, according to its Q4 and full-year business update . The biotech expects to hit profitability in 2027, Rawcliffe said on the call. With two patients invoiced and no reimbursement denials to date, Tecelra has so far made $1.2 million for Adaptimmune. The company expects to have its full network of 30 treatment centers online by the end of 2025. “We feel very confident that the consensus analyst forecast of approximately $25 million of sales in 2025 is very achievable,” Rawcliffe said on the call. Meanwhile, Adaptimmune is also building toward its next potential launch, the TCR T cell therapy lete-cel, which in November 2024 cleared the mid-stage IGNYTE-ESO trial. In patients with advanced or metastatic synovial sarcoma or myxoid/round cell liposarcoma, lete-cel elicited a 42% response rate that lasted for a median of 12.2 months in the overall study population. Adaptimmune is working on filing a Biologics License Application for lete-cel later this year and expects the therapy to hit the market in 2027, Rawcliffe said on Thursday, forecasting peak sales of around $400 million. “We estimate that lete-cel will eventually make up over 60% of our combined sarcoma franchise revenue,” he added.

Visionary sector leaders Dan Menichella and Jo Brewer, PhD join as Non-Executive Directors Bringing strengths in strategy, immuno-oncology science execution from bench to approval, major partnerships and collaborations, and biotech scale up To support the acceleration of proof-of-concept cancer vaccine, ITOP1, into Phase I/IIa clinical development, to prevent the recurrence of oesophageal cancers OXFORD, England, March 20, 2025 /PRNewswire/ -- Infinitopes, a pioneering precision immuno-oncology company, today announced the appointments of Dan Menichella and Jo Brewer, PhD as Non-Executive Directors to its Board as the company prepares to transition into a clinical stage company with lead vaccine candidate, ITOP1, to treat patients with oesophageal cancer. Dan Menichella is a seasoned biotech executive, who brings extensive experience in vaccine development, strategic partnerships, and rapid corporate growth. As CEO and CBO of CureVac's U.S. subsidiary, he built out the Boston operation, delivered four deals in his first year – including a multi-product cancer vaccine collaboration with Eli Lilly worth up to $1.7 billion. He became CEO of CureVac AG in 2018. Before CureVac, Dan served as CBO at Bamboo Therapeutics, where he spearheaded the in-licensing of a Duchenne muscular dystrophy programme, unlocking the company's $43 million series A and subsequent $645 million buyout by Pfizer. He has significant fundraising experience and led many large transactions, including partnerships with Lilly, Biogen, and Takeda, and supported IPO's and successful exits. Dan's proven ability to forge high-value alliances and advance breakthrough therapeutics underscores his expertise in guiding life science ventures to success. Dan Menichella, incoming Non-Executive Director at Infinitopes, added: "I am honoured to join Infinitopes' Board of Directors at this exciting time for the company, as we begin the Phase I/IIa clinical trial in oesophageal cancer. Infinitopes is a highly innovative company with a strong commitment to cancer research. Its approach holds the promise to revolutionise cancer treatments for patients, and I am excited and committed to support Jonathan and the team as they embark on this groundbreaking path." Jo Brewer, PhD, is a recognised industry leader in cancer immunotherapy and cell therapies, with over 20 years of experience bringing cutting-edge treatments from discovery to the clinic. Currently serving as CSO at Adaptimmune, she has been instrumental in developing autologous and allogeneic T-cell therapies, leading to Tecelra®, the first engineered TCR-T cell therapy for solid tumours to reach the market. As a founding scientist at Adaptimmune, Jo played a critical role in the development of multiple immunotherapies, including lete-cel for sarcoma and uza-cel, now partnered with Galapagos. She has built and led multiple research teams at Adaptimmune and played a significant role in the upscaling from a small biotech to 500+ employees, driving innovation across discovery and translational science. Jo Brewer, PhD, incoming Non-Executive Director at Infinitopes, remarked: "Infinitopes, with its pioneering approach to precision cancer vaccines, driven by its innovative AI/ML-powered Immunomics™ platform, has the potential to revolutionise how we target and treat cancers. The precision and speed that its world-leading clinicians and scientists are advancing its novel immunotherapies is truly impressive, and I look forward to joining the Board at such a critical time of clinical development, to contribute my expertise to bringing these transformative treatments to patients." Jonathan Kwok, Chief Executive Officer & Co-Founder at Infinitopes, said : "I'm delighted to welcome Dan and Jo to our Board at a pivotal time, as we prepare to begin our first clinical trial for ITOP1, our proof-of-concept cancer vaccine candidate, initially targeting oesophageal cancers. Their leadership and deep expertise in immuno-oncology and biotech growth is invaluable as we advance our AI/ML-driven antigen discovery platform and push the boundaries of what is possible in cancer vaccine development. Their decision to join Infinitopes reflects the strength of our technologies, our ambitious mission, and the future potential impact for patients worldwide." In April 2024 Infinitopes announced its oversubscribed £12.8 million seed financing to advance its AI/ML Precision Immunomics™ bespoke antigen discovery platform. This proprietary technology enables the safe and highly accurate design of 'best-in-class' therapeutics for multiple cancer indications. Guided by an exceptional leadership team and distinguished Scientific Advisory Board (SAB) of world-class clinicians, scientists, and regulatory experts, Infinitopes is poised to initiate its vaccine candidate, ITOP1, in a highly anticipated double-blind, randomised, placebo-controlled Phase I/IIa clinical trial. This trial is aimed at treating patients with oesophageal cancer and is expected to begin at four UK NHS university cancer centres in the first half of 2025. About Infinitopes Infinitopes Ltd is a soon to be clinical stage, integrated cancer biotechnology company supported by Cancer Research UK (CRUK) and the University of Oxford. The Company combines two world leading platforms, in precision target discovery and in high efficiency, vector delivery systems, to develop immunologically durable vaccines against multiple solid tumour indications. The lead vaccine candidate is expected to begin Phase I/IIa trials in H1' 25. Infinitopes has gathered together in-house talent across antigen discovery, immunology, vaccinology, oncology, biomanufacturing, clinical trials and regulation, winning an 'Innovative Licensing and Access Pathway' (ILAP) innovation passport from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in 2022. Infinitopes has also won two prestigious, maximum size, nondilutive awards from Innovate UK, a Cancer Therapeutics Award (in 2022) and a Future Economy Investor Partnership (in 2023). Since incorporation, the Infinitopes team has raised nearly $20m from sector expert investors including Cancer Research Horizons, Cancer Research Institute, Kindred Capital, Manta Ray Ventures, Martlet, Meltwind, Octopus Ventures, Saras Capital, Wilbe and the Fundación CRIS Contra el Cáncer, funding its rapid growth from three academic co-founders to 28 full time equivalents. It is now the largest tenant of Oxford University's BioEscalator innovation accelerator. 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