Philogen announces publication of PET clinical data with proprietary ultra-high affinity FAP-targeting small molecule ligand (OncoFAP)

Philogenannounces publication of PET clinical data with proprietary ultra-high affinity FAP-targeting small molecule ligand (OncoFAP)

Translational studies performed at the European Institute for Molecular Imaging and the Department of Nuclear Medicine (University and University Hospital of Münster)show rapid and selective tumor uptake of OncoFAP with unprecedented selectivity against healthy organs in cancer patients

Philogen, in collaboration with Senn Chemicals, has already produced the equivalent of 1 million GMP doses of clinical-grade OncoFAP-DOTAGA

Siena, Italy, January7^th, 2022 - Philogen S.p.A., a clinical-stage biotechnology company focused on antibody and small molecule-based targeted therapeutics, announces that its wholly-owned Swiss subsidiary, Philochem AG, has co-authored a new translational study on ⁶⁸Ga-OncoFAP, a best-in-class FAP-targeting small molecule for applications in cancer and inflammation.

The paper, entitled "Translational imaging of the fibroblast activation protein (FAP) using the new ligand "[68Ga]Ga-OncoFAP-DOTAGA", was published in the peer-reviewed journal European Journal of Nuclear Medicine and Molecular Imaging and reports the novel pre-clinical and clinical findings obtained with ⁶⁸Ga-OncoFAP.

The data confirmed the rapid and selective accumulation of ⁶⁸Ga-OncoFAP in solid tumor lesions in disease models and in patient cases. Additionally, ⁶⁸Ga-OncoFAP showed excellent selectivity against healthy organs, including kidneys, at early time points (i.e., already one hour after systemic administration) and an impressive tumor-targeting performance in mice and in patients with different stages of disease (i.e., from localized to disseminated disease).

Dario Neri, Chief Executive Officer of Philogen commented: "We are delighted with the translational results presented in our recent paper which showed OncoFAP's strong selectivity against healthy organs in cancer patients. In order to pave the way towards a broader adoption of this technology, we have established a network of Nuclear Medicine centers across various continents to support our future clinical studies. The equivalent of 1,000,000 GMP-grade doses of OncoFAP-DOTAGA has already been produced in collaboration with Senn Chemicals."

The results presented in this article stem from a collaboration between the European Institute for Molecular Imagingand the Department of Nuclear Medicine at the University and University Hospital of Münster and the scientists at Philochem AG.

OncoFAP has been manufactured in GMP conditions at Senn Chemicals AG, a CDMO in peptide synthesis and small molecules with expertise in small scale GMP production.

Fibroblast Activation Protein (FAP) has recently emerged as a tumor-associated antigen with abundant and selective expression in the majority of human solid malignancies. The discovery of OncoFAP, together with its preclinical characterization, has been recently reported in Proc Natl Acad Sci USA in April 2021.

Philochem's OncoFAP-derivates are the small organic ligands with the highest affinity to the FAP antigen reported to date.

OncoFAP is currently being studied as modular component for the generation of therapeutic products enabling the targeted delivery of a potent beta-emitter (lutetium-177), of fluorescein-specific CAR T-cells, and of highly cytotoxic auristatin derivatives.

The article can be accessed from the European Journal of Nuclear Medicine and Molecular Imaging website under the following link.

About Philogen

Philogen is a Swiss-Italian clinical-stage biotechnology company listed on the Italian Stock Exchange. It is engaged in the discovery and development of novel pharmaceutical and biopharmaceutical products. Philogen's strategy is to deliver bioactive agents, for example cytokines or drugs, to the site of disease using antibodies and other ligands that specifically and efficiently target stromal antigens. This technology has generated a strong proprietary pipeline of clinical-stage products and preclinical compounds in an array of disease indications. Philogen is headquartered in Siena, Italy, and has research activities at its subsidiary company Philochem near Zurich, Switzerland. Philogen has signed agreements with several major pharmaceutical companies. For more information, please visit www.philogen.comand www.philochem.com.

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