Anocca has Dosed First Patients with Precision TCR-T Cell Therapy Targeting Mutant KRAS in Pancreatic Cancer

SÖDERTÄLJE, Sweden--(BUSINESS WIRE)--Anocca AB (‘Anocca’ or the ‘Company’), a clinical-stage biotechnology company developing advanced T-cell immunotherapies, today announced the successful dosing of the first patients across multiple clinical sites with ANOC-001, a novel T cell receptor-modified T cell therapy (TCR-T)[1] targeting KRAS G12V mutations in an aggressive form of pancreatic cancer.

ANOC-001 is the first product to enter Anocca’s VIDAR-1 clinical programme, which focuses on pancreatic ductal adenocarcinoma (PDAC). The therapy is designed for patients whose tumours carry a specific mutation in the KRAS gene. The product candidate has been discovered, developed and manufactured by Anocca at its in-house facilities in Sweden. ANOC-001 is the first non-viral gene-edited T cell therapy to be evaluated in Europe, with the deployment of this technology enabling scalable product development and future commercialisation.

Pancreatic cancer remains one of the deadliest cancer types, with a five-year survival rate below 10% (1). Despite recent advances there are currently no definitive treatments for patients with progressed disease (2). KRAS mutations are one of the most common cancer mutations and are implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. VIDAR-1 addresses this unmet need by engineering the immune system’s T-cells to recognise and attack cancer cells carrying the KRAS mutation.

Reagan Jarvis, co-founder and Chief Executive Officer of Anocca, said: “The dosing of patients marks an important milestone for Anocca, and demonstrates our ability to develop, manufacture and clinically deploy precision TCR-T cell therapy products. The novel ANOC-001 clinical candidate was developed with Anocca’s proprietary analytical platform that maps targets and identifies, characterises and engineers T-cell receptors. We are grateful to our team, investors and partners whose efforts and participation made this milestone possible.”

Hugh Salter, Chief Scientific Officer, added: “The VIDAR-1 clinical programme is designed to evaluate multiple TCR-T product candidates targeting distinct KRAS mutations and HLA combinations [2]. ANOC-001 is the first product in this series and additional products targeting different forms of mutant KRAS will be introduced into the uniquely designed clinical programme. By using non-viral gene editing technology, we are able to scale delivery of highly precise therapies to broader patient populations. We would like to thank our clinical collaborators for their support as well as the study participants and their families.”

Recruitment and manufacture are ongoing for Phase I of the multi-centre VIDAR-1 trial, which is being conducted at eight leading university hospitals across Sweden, Denmark, Germany, and The Netherlands.

ENDS

About Anocca

Anocca is a fully integrated clinical-stage biopharmaceutical company that develops libraries of T-cell receptor-modified T cell therapies (TCR-T) to redefine the treatment of solid tumours and other difficult to treat diseases, including infectious and autoimmune diseases. The company has built a unique discovery engine that uses programmable human cells to recreate and manipulate T cell immunity. These proprietary technologies enable scaling of TCR-T cell therapy development, allowing the systematic generation of libraries of products that represent personalised treatments for the broad patient populations. Anocca currently has the broadest pipeline of TCR-T oncology cell therapy treatments.

Anocca operates an advanced research and development infrastructure, underpinned by a custom software ecosystem, AnoccaOS, and an in-house cGMP manufacturing and process development facility. Anocca’s TCR-T cell therapies are novel discoveries from its platform and manufactured using non-viral gene editing technology at Anocca’s facilities in Södertälje, Sweden. 130+ staff from 40+ nations work at Anocca.

About the VIDAR-1 clinical programme

VIDAR-1 is designed as a multi-product umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product in a set of phase I/II studies. Phase I is currently conducted at eight sites in four countries with additional countries and sites in phase II. Patients will be eligible to enrol if they have an HLA (i.e., genetic marker), and KRAS mutation, matching an available product.

More information about the clinical trial can be found at the EU’s clinical trials website.

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

[1] TCR-T: T cell receptor-modified T cell therapy, a form of targeted cell therapy, that harnesses T cells’ natural targeting capability to identify and eradicate tumour cells.
[2] HLA (Human Leukocyte Antigen): HLA molecules are the part of a person’s genetic profile that determines how the immune system presents disease targets to T cells.