invIOs presents promising new clinical data in solid tumors from autologous cell therapy APN401 at AACR Annual Meeting 2023

invIOs presents promising new clinical data in solid tumors from autologous cell therapy APN401 at AACR Annual Meeting 2023

• APN401 induced prolonged stable disease in two heavily pre-treated patients, using invIOs’s proprietary rapid cell-processing platform technology to manufacture Cbl-b silenced PBMCs and deliver treatment in under 24 hours
• Data underscores potential of invIOs’s pioneering approach targeting the master immune checkpoint Cbl-b
• Phase 1b clinical study demonstrated feasibility of integrating into daily clinical practice

Vienna, Austria, 18 April 2023: invIOs GmbH (“invIOs”), a privately held biotechnology company developing novel therapies for cancer, today announced data from a poster showing two patient case studies from a clinical trial of its lead candidate cell therapy APN401 during the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida.

The poster, “APN401, a novel cancer therapy using Cbl-b silenced autologous PBMCs, induced stable disease in two patients with advanced solid tumors”, highlights two cases of heavily pre-treated patients, one diagnosed with metastatic appendix carcinoma and one diagnosed with squamous cell carcinoma of the head and neck. Both patients were part of invIOs’s recently completed Phase 1b trial and achieved stable disease for up to 6 months during treatment with APN401.

Dr Romana Gugenberger, CMSO of invIOs, said:

“We believe that our approach based on silencing the master immune system checkpoint Cbl-b could have a significant impact on the development of effective cell therapy treatments for solid tumors, and make these cancers vulnerable to anti‑tumor immune responses. These two case studies from our successfully completed clinical trial demonstrate APN401’s potential in patients with advanced metastatic disease whose cancer had progressed despite numerous previous treatments. In addition, the study confirmed that invIOs’s cell therapy platform represents a feasible approach for rapid local manufacturing of a Cbl-b silenced cell therapy, enabling out‑patient treatment with vein-to-vein times of less than 24 hours. The promising results of this study open the door to continuing further development of the APN401 program in earlier lines of treatment, including as a combination therapy.”

The patient with metastatic appendix carcinoma was treated with 12 treatment cycles over the course of 44 weeks and presented with stable disease for 27 weeks, while the patient with metastatic head and neck cancer received six treatment cycles over 20 weeks and was progression-free for 22 weeks, suggesting immunological anti-tumor activity. This is further supported by analysis of both patients’ Cbl-b silenced PBMCs (peripheral blood mononuclear cells), which showed increased cytotoxic capacity and increased potency. Furthermore, analysis of the patients’ T cells before each infusion cycle showed an increase in T cell clonality during the treatment period. In both cases, the treatment was well tolerated.

Professor Thorsten Füreder, program director for respiratory tract cancers and cancer of unknown primary at the Department of Medicine I, Medical University of Vienna, chair of the university’s immune-oncology tumor board, and an investigator on the study, said:

“From a clinical perspective, the therapy of heavily pre-treated recurrent/metastatic HNSCC patients remains a challenge, since the majority of patients show progressive disease and can expect progression-free survival of approximately just 2 months. In this context, disease stabilization for almost 5.5 months in a recurrent/metastatic HNSCC patient treated with APN401 is an encouraging signal and clinically relevant. Larger trials beyond the case series are now needed to derive a definitive conclusion regarding the clinical activity of this novel approach.”

About APN401 and invIOs’s proprietary cell therapy platform

APN401 leverages invIOs’s proprietary cell therapy platform, which enables rapid treatment of patients with personalized cell therapies, and holds the promise to be effective against even solid tumors. The technology has the potential to be used with a range of approaches such as siRNA or mRNA, or combinations of modalities to target expression of multiple genes and create next-generation cancer immunotherapies.

APN401 is designed to supercharge immune cells to fight tumors by overriding multiple immune checkpoints via silencing Cbl-b (Casitas B-lineage lymphoma b), which is regarded as a master checkpoint of the immune system. Cbl-b deficiency can make cells resistant to the inhibitory signals from both CTLA-4 and PD-L1/PD-1 checkpoints, which are used by many solid tumors for immune evasion. APN401 uses small interfering RNA (siRNA) to silence Cbl-b in the patients’ PBMCs. Typical vein-to-vein time for each treatment cycle with APN401 is 24 hours, with cell processing taking just six hours using invIOs’s proprietary closed, modular, automated and highly scalable system.

About invIOs

invIOs is a privately held biotech company based in Vienna, Austria, focusing on the discovery and development of innovative cancer immunotherapies.

invIOs’s proprietary cell therapy platform for intracellular modification of gene expression enables rapid treatment of patients in an out-patient setting through the creation of personalized cell therapies using a patient’s fresh immune cells. Once clinically validated, this novel concept may allow access to and treatment for indications not previously addressable by immunotherapy.

APN401 is the first candidate treatment from invIOs’s cell therapy platform. It is a first‑in‑class out-patient approach to strengthen immune reactivity by targeting the intracellular master checkpoint inhibitor Cbl-b. A second Phase 1b clinical trial in patients with advanced solid tumors has recently been completed.

INV441, the second candidate from invIOs’s platform, is a tumor-specific cell therapy that targets Cbl-b to activate local tumor infiltrating lymphocytes (TILs). It is in pre-clinical evaluation for the treatment of patients with glioblastoma.

INV501 is a novel small molecule candidate designed to address a new, undisclosed immune-oncology target to activate strong anti-tumor immune responses. The program is currently in pre-clinical testing.

For further information, please visit www.invios.com and connect with us on LinkedIn.

Contacts

invIOs
Peter Morley
Head of Communications
T +43 1 8656577 121
Email: investors@invios.com

MC Services AG
Raimund Gabriel, Dr. Regina Lutz, Laurie Doyle
T +49 89 210 228 0
Email: invios@mc-services.eu