Munich, Germany, May, 2023 – CatalYm today announced that the first results from its ongoing Phase 2a trial “GDFATHER-2” (GDF-15 Antibody-mediaTed Human Effector Cell Relocation Phase 2) will be featured in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023 in Chicago. The trial is evaluating CatalYm’s lead GDF-15 neutralizing antibody visugromab in combination with immune checkpoint inhibitor nivolumab in last-line, anti-PD-1/PD-L1 relapsed/refractory patients. Growth and differentiation factor 15 (GDF-15) is recognized as a negative regulator of antitumoral T cell activity preventing T cell recruitment to the tumor microenvironment as well as potently suppressing an adaptive immune response by additional mechanisms recently identified. The ASCO Annual Meeting will be held in Chicago, Illinois, from June 2 to 6, 2023.

Oral presentation details:

Presentation Title: Initial results from the phase 2a trial of visugromab (CTL-002) + nivolumab in advanced/metastatic anti-PD1/-L1 relapsed/refractory solid tumors (The GDFATHER-TRIAL)
Presenter: Dr. Ignacio Melero Bermejo, MD | Clinica Universidad de Navarra
Session: Developmental Therapeutics-Immunotherapy
Session Date and Time: Sunday, June 4, 2023, from 9:45 AM – 12:45 PM CDT
Location: In-Person | Arie Crown Theater | McCormick Place | Live Stream
Presentation Number: 2501

The full abstract details can be accessed via https://meetings.asco.org/abstracts-presentations/218293. The company will provide further information and a summary of the data following the oral presentation at ASCO.

ENDS

About the GDFATHER-2 Trials

The GDFATHER-2 trials (GDF-15 Antibody-mediaTed Human Effector cell Relocation Phase 2) (NCT04725474) are ongoing first-in-human Phase 2a cohorts investigating the effect of visugromab (CTL-002) as monotherapy and/or in combination with a PD-1 checkpoint inhibitor in patients with various advanced-stage, relapse/refractory solid tumors and the new biomarker-selected cohort. The study consists of two main segments (one tumor-specific, one biomarker-selected) with a total of five cohorts, enrolling > 200 patients in total to confirm a certain response rate within each tumor type/setting.

About Visugromab (CTL-002)

Visugromab is a humanized monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15 (GDF-15). GDF-15 is an essential player in feto-maternal tolerance, a powerful mechanism that cancer cells hijack to create an immunosuppressive environment to evade destruction. By neutralizing GDF-15, visugromab reverses the immunosuppressive effects that block an efficient anti-tumor immune response in the tumor microenvironment and the draining lymph nodes. Visugromab drives an activated and differentiated immune cell infiltration into the solid tumor as well as enables priming of T cells and enhances the tumor killing effects of T cells and NK cells. GDF-15 is currently investigated in an ongoing Phase 2 program that includes confirmatory studies in multiple sold tumor indications and the analysis of a predictive response biomarker to better identify the patients benefiting from this new class of immunotherapy.

About CatalYm

CatalYm is pioneering a novel immuno-oncology therapy, that safely overcomes GDF-15-mediated immunosuppression in the tumor microenvironment. Our lead product visugromab, a first-in-class GDF-15 neutralizing antibody, has demonstrated potent and durable anti-tumor efficacy with multiple, long-lasting objective responses in combination with anti-PD-1 treatment in phase 1/2 studies in advanced cancer patients. CatalYm is focused on maximizing visugromab’s potential as a new class of cancer immunotherapy with a clinically distinct profile in a range of solid tumor indications.

Contact

CatalYm GmbH
Dr. Phil L’Huillier, CEO
info@catalym.com

Media Inquiries
Trophic Communications
Dr. Stephanie May
Phone: +49 171 185 56 82
catalym@trophic.eu