VIENNA, Austria I December 16, 2021 I invIOs (innovative Immuno-Oncology) GmbH, a privately held biotechnology company developing novel therapies for cancer, is pleased to announce it will commence operations on 1 January 2022.

invIOs, a fully owned subsidiary of APEIRON Biologics AG has been assigned APEIRON’s innovative cancer immunotherapy activities and all related clinical and preclinical R&D projects.

invIOs’ CEO Peter Llewellyn-Davies and his management team have taken this step to realize the full potential of its cutting-edge development projects and to create an early clinical-stage focused entity to allow investors to benefit from significant upside potential, especially specialized international biotech investors.

The proprietary cell therapy technology platform for the modulation of intracellular Immuno-Oncology targets enables rapid treatment of patients using their own cells with short out-of-body time in an out-patient setting. The groundbreaking concept allows access to indications that have previously not been addressable by earlier cell therapy approaches.

The first clinically validated target is the immune master-checkpoint Cbl-b; the clinical-stage lead candidate APN401 will show results in the near term on safety with data from an ongoing Phase 1b trial to be finalized in Q2 2022. A discovery pipeline with two additional promising candidates could give rise to new effective therapies for cancer patients, namely INV441 aiming to activate TILs (tumor-infiltrating lymphocytes) in solid tumors and INV501, an oral small molecule for tumor specific immune activation.

Peter Llewellyn-Davies, CEO of invIOs, comments: “Our passion is to develop life-saving therapies for patients suffering from cancer where there currently exist only limited treatment options. invIOs’ highly experienced team has a proven track-record of taking drugs to market with a core competency in immuno-oncology. The new company is geared towards enabling innovation and growth and will facilitate access to funding from specialized investors and partners. invIOs’ novel approach represents an investment opportunity with significant upside potential and important benefits for healthcare professionals and patients.”

invIOs is headquartered in Vienna, Austria and will streamline the development of novel therapies in immuno-oncology backed by the acumen of the existing team. Accordingly, all current APEIRON employees are assigned to invIOs.

About invIOs GmbH

invIOs is a privately held biotech company based in Vienna, Austria, focused on the discovery and development of innovative cancer immunotherapies. The proprietary cell therapy technology platform for the silencing of intracellular IO targets, enables rapid treatment of patients using their own cells, by employing short out-of-body times in an out-patient setting. The novel concept allows access to and treatment for indications that had not previously been addressable by cell therapy.

APN401 is the first clinically validated candidate based on the cell therapy platform. The clinical program is a first-in-class ambulatory autologous transient cell therapy to strengthen immune reactivity via an intracellular master checkpoint inhibitor, Cbl-b. It is currently being evaluated in a Phase 1b clinical trial in patients with advanced-stage solid tumors.

The second candidate of the platform is INV441, an early-stage cell therapy approach aiming to activate tumor-associated immune cells.

Thirdly, the orally administered small molecule candidate INV501 is being developed to target tumor-specific immune activation via this different entry-point.

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About APEIRON Biologics AG

APEIRON Biologics is a privately held biotech company based in Vienna, Austria. APEIRON received EU marketing approval for APN311 (dinutuximab beta, Qarziba®) in 2017 for the treatment of pediatric neuroblastoma patients and out-licensed global, exclusive rights for this product to EUSA Pharma Ltd.

The Company is also developing a promising drug for COVID-19: APN01 (rhsACE2, alunacedase alfa), a soluble recombinant version ACE2, which is regarded to be the cell receptor allowing SARS-CoV-2 to enter the body. APN01 has shown potential clinical benefits for COVID-19 and has completed a double blind, placebo-controlled Phase 2 trial in Europe and Russia. An inhalative drug delivery of APN01 is currently being evaluated in a clinical phase 1 study.