CatalYm Appoints Drug Development Leader Roy Baynes to its Board of Directors and Strengthens Scientific Advisory Board with Three Accomplished Lung and Bladder Cancer Specialists

• Roy Baynes, a key architect for the Keytruda® program, joins Catalym’s Board of Directors to provide strategic guidance for the advanced clinical development of monoclonal antibody visugromab designed to neutralize the tumor-derived Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance
• Appointments to the Scientific Advisory Board include Dr. Petros Grivas, Dr. Roy S. Herbst, and Prof. Andrea Necchi, adding additional expertise in lung and bladder cancers as the company advances into Phase 2b clinical development

Munich, Germany, January 8, 2024 – CatalYm today announced the appointment of Dr. Roy Baynes as an independent member to its Board of Directors, as well as the appointment of Dr. Petros Grivas, Dr. Roy Herbst, and Prof. Andrea Necchi to the Scientific Advisory Board. With their combined industry insights, drug development expertise and scientific know-how, the new appointees will greatly support CatalYm with the late-stage clinical evaluation of the company’s lead candidate visugromab.

Visugromab is a monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15), a central mediator of immune resistance to cancer therapies. The candidate is currently being evaluated in an ongoing Phase 2 program (GDFATHER-2), from which positive interim data were recently presented at ESMO. The results highlighted that treatment with visugromab in combination with nivolumab achieves compelling anti-tumoral activity in rigorously defined anti-PD-(L)1 relapsed/refractory non-small cell lung cancer (NSCLC) and urothelial cancer (UC) patients while retaining an excellent safety and tolerability profile.

“Roy is a distinguished figure in oncology and pharmaceutical development. It is not an exaggeration that he has played an instrumental role in developing some of the most innovative cancer treatments, including Keytruda. We are thrilled to add his strategic and visionary perspective to our Board,” commented Phil L’Huillier, Managing Director and Chief Executive Officer at CatalYm. “With Petros, Roy and Andrea, we welcome three accomplished translational scientists with key knowledge and expertise in the treatment of lung and bladder cancer as clinical advisors. This collective infusion of expertise will significantly strengthen our company as we continue our GDFATHER-2 trial to maximize visugromab’s potential as a critical component for treatment success in a broad range of anti-cancer regimens and indications.”

“CatalYm’s novel approach is poised to enhance cancer treatment by counteracting immunotherapeutic drug resistance, a critical challenge in oncology,” said Dr. Roy Baynes, Independent Member of CatalYm’s Board of Directors. “The company has a unique understanding of GDF-15 and its role in cancer which has opened a differentiated strategy in immuno-oncology for the treatment of solid tumors. Visugromab has the potential to reach a broader patient population and to enhance therapeutic outcomes. This is the primary reason I am looking forward to working with the team.”

Dr. Roy Baynes is an established leader in global pharmaceutical development, known for leading the development strategy for numerous significant new medicines, including Keytruda®, which revolutionized cancer treatment globally. He currently serves as Executive Vice President and Chief Medical Officer at Eikon Therapeutics, heading the clinical R&D team. He also serves on the Board of Directors of Travere Therapeutics, Inc. and Natera, Inc. and is an Advisor to Nurix, Inc. and Decheng Capital. From 2013 until 2022, he worked at Merck as Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, where he was responsible for developing the entire clinical portfolio in the Merck Research Laboratories. Prior to this, Dr. Baynes held leading positions at Gilead, Inc. and Amgen, Inc. He was Professor of Medicine, Professor of Oncology and the Charles Martin Professor of Cancer Research at Wayne State University and the Barbara Ann Karmanos Cancer Center. Dr. Baynes holds a PhD from the University of Witwatersrand, where he also received his MMed (specialist registration), MB and BCh (Bachelor of Medicine and Surgery).

Dr. Petros Grivas is board-certified medical oncologist with vast experience and high expertise in genitourinary (GU) cancers. He has had a main role in several clinical trials leading to FDA approval of new drugs for urothelial cancer, including avelumab and Trodelvy®. Dr. Grivas is considered a key opinion, thought leader and international expert, giving lectures in several countries, educating oncologists and other healthcare providers, mentoring numerous trainees, leading large innovative clinical trials, reviewing grant proposals and manuscripts, and publishing novel and important research. He is dedicated to personalized and outstanding patient care, efficient clinical operations, and believes in optimal patient-physician relationship as well as community outreach. Dr. Grivas is the Clinical Director of the GU Cancers Program and Professor at the Dept. of Medicine, Division of Hematology Oncology, University of Washington and at the Clinical Research Division at Fred Hutchinson Cancer Center. He received his MD and PhD in Greece in 2005 and 2009, respectively. He completed his Internal Medicine Residency at the Hahnemann University Hospital/Drexel University College of Medicine (Philadelphia) in 2010, and a Hematology/Oncology Fellowship at the University of Michigan (Ann Arbor) in 2013. Dr. Grivas was Clinical Lecturer before he was recruited as Assistant Professor at the Cleveland Clinic (Cleveland).

Dr. Roy S. Herbst is widely recognized for his leadership and expertise in lung cancer treatment and research, particularly for the successful development of novel (immuno)therapies, including gefitinib, cetuximab, bevacizumab and axitinib. He and his Yale colleagues were among the first to describe the PD-1/PD-L1 adaptive immune response in early phase trials and to offer trials of PD-L1 inhibitors atezolizumab and pembrolizumab to lung cancer patients. He currently holds the positions of Ensign Professor of Medicine (Medical Oncology), Chief of Medical Oncology, Deputy Director, and Associate Director of Translational Research at the Yale Cancer Center. He previously served on the boards of the American Association for Cancer Research (AACR) and the International Association for the Study of Lung Cancer (IASLC), and has been involved with the National Cancer Institute’s Thoracic Malignancy Steering Committee since 2012. Before joining Yale, he was the Barnhart Distinguished Professor and Chief of the Section of Thoracic Medical Oncology at The University of Texas MD Anderson Cancer Center (UT-MDACC). Dr. Herbst holds a PhD from The Rockefeller University and a MS from Harvard University. He completed his fellowships at Brigham and Women’s Hospital and the Dana Farber Cancer Institute, and a residency at Brigham and Women’s Hospital. Dr. Herbst received his MD from Cornell University Medical College and earned a MS and BS degree from Yale University.

Professor Andrea Necchi is a medical oncologist specializing in the treatment of urological malignancies. In November 2020, he was appointed Associate Professor of Oncology at Vita-Salute San Raffaele University and Director of Genitourinary Medical Oncology at IRCCS San Raffaele Hospital and Scientific Institute in Milan, Italy. Prof. Necchi currently serves as a board member of the EAU Research Foundation and is an associate member of the ASCO-EAU penile cancer guidelines panel. His team pioneered the use of neoadjuvant immunotherapy in muscle-invasive bladder cancer with the PURE-01 trial. He is the principal investigator of our ongoing GDFATHER-2 trial and several other academic phase 1-2 trials of immuno-oncology combinations in urological malignancies. Prof. Necchi received his MD degree from the University of Milan.

ENDS

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.