Pharma Focus Europe

Invios Commences Additional Clinical Trial for APN401, an Innovative Cell Therapy for Solid Tumors, and Secures Substantial Research Grant From Austria

Tuesday, September 05, 2023

invIOs GmbH, a privately owned biotechnology firm dedicated to pioneering cancer therapies, has initiated the recruitment of patients for a Phase 1b clinical trial of its innovative autologous cell therapy, APN401. This trial aims to enroll patients with solid tumors and has also successfully secured grant funding. The PALINDROM study's primary goal is to establish the optimal dosage of APN401 for subsequent Phase 2 research.

The PALINDROM trial is a multicenter endeavor taking place in Austria, with two Good Manufacturing Practice (GMP)-compliant manufacturing facilities located in Vienna and Linz. It will assess two different dosage levels of APN401 infusions in up to 12 patients across four medical facilities, focusing on the therapy's tolerability, safety, and clinical efficacy in patients with advanced and metastatic solid tumors who have exhausted conventional treatment options.

The Austrian Research Promotion Agency (FFG) has awarded invIOs funding as part of the Austrian Life Sciences Programme 2023 initiative to support the PALINDROM study. This study, conducted under the EU's new Clinical Trial Regulation, has received regulatory approval from the Austrian Agency for Health and Food Safety (AGES). Patient recruitment has already begun, and invIOs aims to complete enrollment by year-end.

Peter Llewellyn-Davies, CEO of invIOs, expressed his satisfaction with the Austrian government's support, stating, "I am delighted that the Austrian government is supporting our latest clinical trial using the EPiC cell therapy platform to develop an innovative and potentially game-changing approach to treating solid tumors."

Dr. Romana Gugenberger, Chief Medical and Scientific Officer of invIOs, added, "We have already demonstrated the safety and technical feasibility of our EPiC cell therapy platform technology that underpins APN401 in first-in-human clinical trials. This new study aims to show that EPiC can be effective when multiple manufacturing and treatment sites are involved. We look forward to taking this novel, easy-to-administer treatment option to the next phase of development."

The primary objective of the PALINDROM study is to define and confirm the safety profile of APN401. Secondary goals include assessing immunological and anti-tumor activity, including overall response rate (ORR) and progression-free survival (PFS), as well as analyzing relevant biomarkers. By establishing the maximum tolerated dose (MTD) and/or maximum manufacturable dose (MMD) of APN401, PALINDROM is expected to pave the way for a larger Phase 2 study, potentially including earlier lines of treatment and combination therapies.

APN401 represents a groundbreaking approach that utilizes invIOs's proprietary EPiC cell therapy platform to modify autologous peripheral blood mononuclear cells (PBMCs) with siRNA to suppress Cbl-b, a protein known to inhibit immune responses against cancer. By temporarily blocking Cbl-b, it becomes possible to overcome the immunosuppressive tumor microenvironment (TME), enhance tumor cell destruction, and induce lasting anti-tumor immune memory.

As a personalized treatment, APN401 harnesses the patient's own immune cells to target and eliminate tumor cells. Previous pilot trials have demonstrated the therapy's potential clinical benefits, including rapid cell manufacturing, short treatment times, applicability across various tumor types, and excellent tolerability.

Earlier this year, invIOs announced promising clinical data from a Phase 1 study, indicating clinical activity of APN401 in two heavily treated patients with metastatic appendix carcinoma and squamous cell carcinoma of the head and neck, both of whom achieved stable disease for up to six months during treatment. The study further highlighted the EPiC platform's capability for rapid local manufacturing of a Cbl-b silenced cell therapy, allowing outpatient treatment of patients with advanced solid tumors within a vein-to-vein time frame of less than 24 hours.

In addition to the funding received for the PALINDROM study, invIOs also secured a grant from the FFG for advancing a novel CAR-T cell therapy approach that utilizes the EPiC platform against aggressive lung tumors. This joint project with the Medical University of Innsbruck, known as the INV451 project, represents invIOs's third program stemming from the EPiC platform. The project aims to enhance the efficacy of CAR-T cell therapies against solid tumors by gaining deeper insights into the mechanisms tumors use to evade detection and destruction by the immune system, ultimately identifying druggable factors to overcome treatment resistance.

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