Anocca AB

SÖDERTÄLJE, Sweden I November 26, 2024 I Anocca AB, a leading T-cell receptor-engineered T-cell (TCR-T) cellular therapeutics company, announces the submission of its first Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a Phase I/II multi-asset umbrella trial, VIDAR-1. The VIDAR-1 programme will begin with ANOC-001, which targets mutant KRAS G12V, in patients with advanced pancreatic cancer. Subject to approval of the CTA, Anocca aims to initiate the study in Q2, 2025. ANOC-001 is the lead product from Anocca’s robust preclinical pipeline of TCR-T cell therapies. Reagan Jarvis, co-founder and Chief Executive Officer, commented, “This is an important milestone for Anocca, affirming the value of our unique cell biology R&D engine. Our approach integrates the systematic generation of validated TCR-T target maps from tumour-selective genetic sequences and supports the delivery of libraries of potent and highly specific therapeutic TCRs to leverage the diverse cancer target space. With our in-house cGMP facilities and gene-edited autologous TCR-T manufacturing capability we can efficiently and cost effectively develop new investigational products at scale. Our ambition is to grow our pipeline rapidly across the immense untapped target space for TCR-T cell therapies in solid tumours.” Hugh Salter, Chief Scientific Officer at Anocca, elaborated, “KRAS is an immensely important target in many cancer types, but has to date been challenging to address. KRAS mutations are a hallmark of PDAC, which is among the most difficult to treat cancers, and we believe TCR-T cell therapies and, in particular, our VIDAR-1 assets can be effective in addressing this target and providing a new solution in an indication with high unmet medical need.” About the VIDAR-1 clinical programme VIDAR-1 is designed as a multi-asset umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product, where each product is specific for a different combination of HLA and mutation, in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. Subject to approval of the CTA, the company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enroll if they have a HLA and KRAS mutation matching an available product. About KRAS and PDAC Mutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect ~90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2). References 1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol . 10(1):10–27. doi: 10.14740/wjon1166 2 . Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24 . doi: 10.1038/s41575-023-00840-w About Anocca Anocca is a fully integrated biopharmaceutical company that develops libraries of T-cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autoimmune diseases. Its unique discovery engine uses programmable human cells to recreate and manipulate T cell immunity. This proprietary technology scales TCR-T cell therapy development, allowing the systematic generation of personalised treatments for the broadest patient populations. Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem, AnoccaOS, and in-house cGMP manufacturing and process development facilities. All Anocca’s therapeutic TCRs are novel discoveries from its platform and manufactured using non-viral gene editing technology at Anocca’s facilities in Sweden. SOURCE: Anocca

SÖDERTÄLJE, Sweden, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Anocca AB, a leading T cell receptor-engineered T cell (TCR-T) cellular therapeutics company, announces it will present its novel platform approach to therapeutic TCR discovery and preclinical data for its lead TCR-T cell therapy product at the European Society of Medical Oncology (ESMO) Congress 2024. Category: Investigational ImmunologyPoster title: Preclinical development of TCR-modified T-cell therapies against mutated KRAS Date and time: 9am-5pm local time on Saturday 14 SeptemberLocation: Hall 6, Fira Barcelona Gran Via, Barcelona, SpainLink: https://tinyurl.com/4n67775y The poster introduces Anocca’s programmable cellular technology platform that systematically recreates human T-cell biology to map T-cell targets and build TCR libraries for the generation of validated therapeutic TCRs, and describes the preclinical development of its lead therapeutic TCR-T product targeting KRAS-G12V that is being progressed into planned clinical trials. KRAS is the most frequently mutated oncogene and associated with highly fatal cancers of the pancreas, lung and colon. Due to its intrinsic properties, effective targeting strategies have historically been elusive, presenting significant unmet need. Hugh Salter, Chief Scientific Officer at Anocca, and presenter of the poster, added, "We are excited to present our technology platform and the details of our lead TCR-T product at ESMO. Our research demonstrates that TCR-T cell therapies offer a precise route, via autologous modification of patient CD8 cells, to directly address foundational driver events in solid tumours.” Members of the company’s management team, including CSO Hugh Salter, CMO Zahid Bashir, Clinical Science Lead Rehab Alnabhan, and Director of Clinical Operations Sheila Forsman, will be available for meetings at ESMO. About AnoccaAnocca is a fully integrated biopharmaceutical company developing libraries of T cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autoimmune diseases. Its proprietary technologies have been designed to vastly expand TCR-T cell therapy development, allowing the systematic generation of treatments for the broadest patient populations that equip the immune system against the most difficult to treat solid tumours. Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem and in-house clinical manufacturing and process development facilities. Its unique discovery platform uses programmable human cells to recreate and manipulate T cell immunity. Follow Anocca on LinkedIn and visit our website Media Inquiries Anocca ABwww.anocca.com/contact Scius Communications (for Anocca AB)Katja StoutTel: +44 7789 435 990katja@sciuscommunications.com Daniel GoochTel: +44 7747 875 479daniel@sciuscommunications.com

/ Press release May 31, 2024 SÖDERTÄLJE, SWEDEN, 31 May 2024 – Anocca AB, a leading T cell receptor-engineered T cell (TCR-T) cellular therapeutics company, announces the appointment of Christiane Hanke-Harloff to its Board of Directors. With a distinguished career spanning the biotechnology, pharmaceutical, and CDMO sectors, Christiane Hanke-Harloff brings a wealth of expertise and strategic insights. Christiane is currently a Board member of InnoCore Pharmaceuticals BV and Ascenion GmbH, former Board member of Recipharm AB and also serves as an advisor for lifescience sector investors and biotech firms. Previously held executive roles at Gilead Sciences, Gedeon Richter and other biotech companies, where she was responsible for organisational strategy and the expansion of international business units. She earned her PhD in molecular biology from the Max Planck Institute of Biochemistry in Martinsried, Germany. "We’re pleased to welcome Christiane Hanke-Harloff to Anocca's board. Her extensive experience and deep understanding of the industry and CDMO landscape will be invaluable as we navigate our clinical development and manufacturing expansion," said Hans Stråberg, Anocca’s Chairman of the Board. "Christiane's appointment comes at a pivotal time for Anocca," noted Reagan Jarvis, Co-founder and CEO of Anocca. "Her industry experience will play a valuable supportive role as we progress our TCR-T cell therapies into clinical development for hard-to-treat cancers.” Christiane Hanke-Harloff stated, "Anocca's innovative approach and comprehensive capabilities spanning research to manufacturing position it as a leader in TCR-T cell therapy. I am excited to collaborate with the team as we advance these groundbreaking therapies into clinical development." Anocca has been making significant developments in advancing precision TCR-T cell therapies aimed at transforming patient outcomes in hard-to-treat solid tumor indications. With recent achievements including the licensing agreement for use of EmendoBio’s novel gene editing technology, and by securing GMP license for the largest cell-therapy manufacturing facility in the Nordics, the company is accelerating its journey from discovery to clinical development. Anocca is a fully integrated biopharmaceutical company developing libraries of T cell receptor-engineered T cell (TCR-T) therapies to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autommune diseases. Its proprietary technologies have been designed to vastly expand TCR-T cell therapy development, allowing the systematic generation of treatments for the broadest patient populations that equip the immune system against the most difficult to treat solid tumours. Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem and in-house clinical manufacturing and process development facilities. Its unique discovery platform uses programmable human cells to recreate and manipulate T cell immunity. Follow Anocca on LinkedIn and visit our new website Anocca AB Jacob Michlewicz, CFO media@anocca.com Scius Communications (for Anocca AB) Katja Stout Tel: +44 7789 435 990 katja@sciuscommunications.com Daniel Gooch Tel: +44 7747 875 479 daniel@sciuscommunications.com