pTTL / NEOGAP Therap - LARVOL DELTA

NEOGAP-CRC-01: A first-in-human phase I/IIa trial of personalised tumour trained lymphocytes (pTTL) in stage IV colorectal cancer (ESMO 2025) - P1/2 | "In Part II, patients receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine), followed by a single intravenous pTTL infusion (20 million–1 billion cells). Legal entity responsible for the study NEOGAP AB. Funding NEOGAP AB."

First-in-human • Metastases • P1/2 data • Colorectal Cancer • Oncology • Solid Tumor

A First-In-Human Trial of pTTL in Advanced Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=16 | Recruiting | Sponsor: Neogap Therapeutics AB | Trial completion date: Dec 2029 ➔ Jun 2032 | Trial primary completion date: Feb 2025 ➔ Dec 2027

IO biomarker • Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor

Neogap receives approval to administer full dose in cell therapy trial for colorectal cancer (Pharmafile) - "Neogap Therapeutics has received regulatory approval from the Swedish Medical Products Agency to administer the full dose of its investigational cell therapy to all patients in its ongoing phase 1 and 2 trial for advanced colorectal cancer. The approval allows for a revised study protocol that removes the initial dose-escalation step, allowing all participants to receive the full treatment dose from the outset. According to Neogap, the change is expected to streamline data collection on safety and preliminary efficacy and is consistent with emerging data from other cell therapy studies...The company has also been granted approval to extend the shelf life of both the lymph node-derived starting material and the final frozen product. This is expected to offer greater scheduling flexibility for patients undergoing concurrent treatments such as chemotherapy...Patient recruitment is ongoing at multiple sites across Sweden."

Regulatory • Trial status • Colorectal Cancer

Personal neoantigen-loaded microbeads train T cells to combat cancer (CIMT 2025) - "The long-term aim is to successfully treat patients with solid cancer with minimal side-effects by multiplying tumor-trained T lymphocytes, (pTTL)...Here we present the general therapy concepts and the resulting individual T cell phenotypic diversity by a combination of common and pioneering omics technologies. Consecutive samples were collected and analyzed during two weeks of EpiTCer® and RLN co-culture illustrating cellular and molecular dynamic mechanisms of bead-bound neoantigens on T cell adaptation to induce a lasting and robust anti-tumor activity."

Tumor-specific neoantigens • Colorectal Cancer • Oncology • Solid Tumor • CD4 • CD8

Personalized tumor-trained lymphocytes – a neoantigen targeted T cell therapy product for treatment of colorectal cancer (SITC 2024) - P1/2 | "Moreover, neoantigen-specificity is corroborated by the upregulation of T cell activation-induced marker coexpression of varying magnitude after stimulation with separate neoantigens on a subgroup of CD4+ and CD8+ T cells within pTTL.In the ongoing FIH trial, up to 16 patients with Stage IV CRC will be treated with a single-dose pTTL after chemotherapy-based preconditioning with cyclophosphamide and fludarabine. Biomarkers for pTTL persistence, pTTL characteristics, and response will be evaluated. Ethics Approval The study was approved by Swedish Ethical Review Authority, approval number 2022-01842-01."

IO biomarker • Tumor-specific neoantigens • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD40LG • CD8 • IFNG • IL2RA • LAMP1 • TNFA

A first in human phase I/IIa trial of personalized tumor-trained lymphocytes, pTTL, derived from regional lymph nodes for treatment of colorectal cancer (SITC 2023) - P1/2 | "pTTL is administered as a single-dose monotherapy after chemotherapy-based preconditioning with cyclophosphamide and fludarabine. Secondary outcomes include response, overall survival, and progression-free survival. Biomarkers for pTTL persistence, pTTL characteristics, and response will be evaluated."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD4 • CD8

A First-In-Human Trial of pTTL in Advanced Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=16 | Recruiting | Sponsor: Neogap Therapeutics AB

IO biomarker • Metastases • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor