ANOC-001 / Anocca - LARVOL DELTA

Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC (clinicaltrials.gov) - P1/2 | N=96 | Recruiting | Sponsor: Anocca AB

New P1/2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma • Solid Tumor

Anocca Raises $46M to Advance Clinical Trial Targeting Pancreatic Cancer (Contract Pharma) - "Mellby Gård led the financing with strong support from AMF, Ramsbury, and existing shareholders, alongside new investors."

Financing • Pancreatic Cancer

Anocca Announces Authorisation of Clinical Trial Application to Start First In-Human Trial in Advanced Pancreatic Cancer (GlobeNewswire) - "Anocca AB... announces the authorisation of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state. VIDAR-1 is a Phase I/II multi-product umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer. VIDAR-1 will test multiple products starting with the company’s lead product ANOC-001 that targets mutant KRAS G12V....Phase I of the multi-centre trial will start in leading university hospitals in four northern European countries: Sweden, Denmark, Germany and The Netherlands. Anocca aims to initiate the study in Q2, 2025."

Trial status • Pancreatic Cancer

Anocca Announces Submission of Clinical Trial Application for Multi-asset Trial VIDAR-1 in Advanced Pancreatic Cancer (GlobeNewswire) - "Anocca AB...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."

New P1/2 trial • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Preclinical development of TCR-modified T cell therapies against mutated KRAS (ESMO 2024) - "We describe the preclinical development of a therapeutic TCR and corresponding IMP-ready TCR-T product for KRAS G12V in HLA-A*11:01 restriction. Using a cell-based approach, valid epitopes in mutant KRAS/HLA combinations were assessed using mass spectrometry... This TCR-T is being progressed into planned clinical trials. Additional TCRs for additional mutKRAS/HLA combinations are in development."

Preclinical • Oncology • Solid Tumor • CD8 • KRAS

Anocca Presents Data at ESMO Congress on Preclinical Development of its TCR-T Cell Therapies for Cancer (GlobeNewswire) - "Anocca AB...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....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."

Preclinical • Oncology

Development of a clinical candidate TCR for mutant KRAS using a high-precision cell-based platform (SITC 2023) - "Herein, we describe use of the platform to perform target quantification and to generate a clinical candidate TCR recognizing the 10mer peptide derived from the KRAS G12V mutant form presented in HLA-A*11:01...Primary CD8 cells were transduced by insertional gene editing, generating a TCR-product with high levels of surface TCR and potent cytotoxic action. Conclusions The TCR-T product is now being advanced to clinical trial and is designed to be the first entry in a broader program covering multiple HLA restrictions and mutant KRAS epitopes."

Clinical • Oncology • Solid Tumor • CD8 • KRAS