invIOs GmbH (“invIOs”), a privately held biotechnology company developing novel therapies for cancer, today announces that it has started patient recruitment for a Phase 1b trial of its novel autologous cell therapy, APN401, in patients with solid tumors, and has successfully secured grant funding. The PALINDROM study aims to determine the optimal dosage of APN401 in a multi-site setting for a subsequent Phase 2 study.
PALINDROM is a multi-center trial taking place in Austria with two GMP-compliant manufacturing sites in Vienna and Linz. The trial will evaluate two dosage levels of APN401 infusions in up to 12 patients across four clinics, focusing on the treatment’s tolerability, safety and clinical activity in patients with advanced and metastatic solid tumors for whom established standard therapies have either become ineffective or are not suitable.
As part of the Austrian Life Sciences Programme 2023 initiative, the Austrian Research Promotion Agency (FFG) has awarded invIOs funding to support the PALINDROM study. The study, which will be carried out 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 started, and invIOs aims to complete enrollment by the end of the year.
“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,” said Peter Llewellyn-Davies, CEO of invIOs. “The Austrian Life Sciences Programme is a massive boost for the wider Austrian biotech industry and in particular for invIOs, as we continue to make strong progress across our three EPiC-based programs.”
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 endpoint of the PALINDROM study is to define and confirm the safety profile of APN401. Secondary endpoints will include measures of immunological and anti-tumor activity, including overall response rate (ORR) and progression-free survival (PFS), as well as analysis of 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 of APN401, including in earlier lines of treatment and potentially as a combination therapy.
APN401 is an innovative approach that leverages invIOs’s proprietary EPiC cell therapy platform to transfect autologous peripheral blood mononuclear cells (PBMCs) with siRNA to silence Cbl-b, which belongs to a class of proteins found in immune cells that are known to play a key role in inhibiting immune responses against cancer. By transiently blocking Cbl-b it is possible to overcome the immunosuppressive tumor microenvironment (TME) and enhance killing of tumor cells and also to induce prolonged anti-tumor immune cell memory.
As an individualized treatment, APN401 educates and empowers the patient’s own most recent immune cells to detect and attack tumor cells. Previous pilot trials have shown the potential clinical benefits of the treatment including rapid cell manufacturing, short vein-to-vein time, tumor-agnostic applicability and very good tolerability.
invIOs earlier this year announced promising clinical data from a Phase 1 study suggesting clinical activity of APN401 in two heavily pre-treated patients, one with metastatic appendix carcinoma and one with squamous cell carcinoma of the head and neck, who achieved stable disease for up to six months during treatment. The study further demonstrated that the EPiC platform represents a feasible approach for rapid local manufacturing of a Cbl-b silenced cell therapy, enabling out-patient treatment of patients with advanced solid tumors with vein-to-vein times of less than 24 hours.
In addition to the funding for the PALINDROM study, invIOs also recently secured a grant from the FFG to progress a novel CAR-T cell therapy approach leveraging the EPiC platform against aggressive lung tumors in a joint project with the Medical University of Innsbruck. The INV451 project is invIOs’s third program from the EPiC platform. The project aims to refine and enhance the efficacy of CAR-T cell therapies against solid tumors by discovering additional insights into the mechanisms that tumors use to escape detection and evade destruction by the immune system, and hence to identify druggable factors that can overcome resistance to treatment.
invIOs is a privately held biotech company based in Vienna, Austria, focusing on the discovery and development of novel therapies for cancer. The invIOs team leverages deep expertise in immune system activation to develop individualized and targeted approaches against solid tumors. invIOs is advancing a pipeline of three programs encompassing small molecule and cell therapy approaches.
EPiC, invIOs’s proprietary cell therapy platform, enables rapid treatment of patients in an out-patient setting. EPiC is a technology platform that allows the creation of personalized cell therapies based on localized processing of a patient’s fresh immune cells. The first asset from the EPiC platform, APN401, is in Phase 1 clinical trials against various solid tumors. The second asset, INV441, is being developed against glioblastoma and is in preclinical evaluation. The third EPiC program, INV451, is a novel CAR-T cell approach against lung cancer being developed with the Medical University of Innsbruck.
INV501 is a novel small molecule candidate that can selectively enhance anti-tumor immune responses. It induces T cell activation, proliferation, and tumor-reactive cytotoxicity. An orally available compound with good bioavailability, INV501 is currently in preclinical testing in several solid tumor models and has demonstrated preclinical proof of concept with strong data in multiple solid tumor indications.
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