Visugromab

MUNICH & SAN FRANCISCO--( BUSINESS WIRE )-- CatalYm today announced the appointment of Scott Clarke as Chief Executive Officer. Mr. Clarke brings over two decades of executive leadership experience in driving company growth, developing products, and shaping and executing transactions in the biopharmaceutical industry. He takes the helm as CatalYm enters a new stage of corporate and clinical development, including the initiation of a broad Phase 2b program for its lead candidate, visugromab, in non-squamous non-small-cell lung cancer and additional tumor indications. Based in the US, he will oversee both EU and US operations. “Scott Clarke is a fantastic addition to CatalYm’s leadership team. The company is in a strong position following its oversubscribed $150 million Series D financing and its recent publication in Nature of positive visugromab data. These events provide significant momentum for Scott’s start as CEO,” said Jon Edwards, Interim Chair of CatalYm’s Board of Directors . “We are confident that his experience in oncology and partnering will be a substantial asset as we initiate CatalYm’s broad Phase 2b program with visugromab in hard-to-treat, metastatic solid tumor indications.” “I am impressed by CatalYm’s compelling clinical data demonstrating that visugromab is uniquely positioned as a novel cancer treatment capable of reversing key resistance mechanisms and reinstating an efficient anti-tumor response,” said Scott Clarke, Chief Executive Officer at CatalYm . “I am very excited to join the CatalYm team at such a pivotal stage. I am committed to realizing visugromab’s potential to deliver unprecedented cancer remission depth and durability for patients with very limited therapeutic options.” Scott Clarke joins CatalYm from Ambagon Therapeutics, where he oversaw the company’s $85 million Series A financing and the evolution of its discovery pipeline of molecular glues. Previously, he served as CEO at Tizona Therapeutics, overseeing significant transactions and the development of its first-in-class anti-CD39 antibody for advanced cancers. Earlier in his career, he led oncology partnering at Roche, and was responsible for product development at BioMarin, contributing to multiple approved medicines. Mr. Clarke earned a Bachelor of Science in Chemical Engineering at the University of California, Berkeley, a Master of Science in Biotechnology at Northwestern University, and an MBA at London Business School. About CatalYm CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and other indications. In its first-in-human Phase 1/2a study, visugromab demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was recently published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies. Founded in 2016 and based in Munich, Germany and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Bioqube Ventures, Forbion, Omega Funds, Gilde Healthcare, Jeito Capital, Novartis Venture Fund, Vesalius, Brandon Capital, Bayern Kapital, BioGeneration Ventures, and Coparion.

MUNICH--( BUSINESS WIRE )-- CatalYm today announced that data of the first-in-human Phase 1/2a study of its lead drug candidate visugromab were published in Nature. The paper titled “Neutralizing GDF-15 can overcome anti-PD-(L)1 resistance in solid tumors” emphasizes the significant potential of visugromab to induce unprecedented cancer remission depth and durability across multiple solid tumor indications as well as in combination with nivolumab in late- to last-line solid tumors. Visugromab is a humanized, monoclonal antibody that counteracts GDF-15, a critical immunosuppressant used by tumor cells to survive. The publication provides a mature data set of the GDFATHER Phase 1/2a trial ( NCT04725474 ), demonstrating that the company’s anti-GDF-15 antibody visugromab in combination with the PD-1-inhibitor nivolumab delivers deep and durable responses in by strict RECIST 1.1 criteria anti-PD-(L)1 relapsed/refractory solid tumor patients. Building on interim data presented at ASCO earlier this year, the additional findings extend the durability profile of the anti-tumor responses seen in these late- to last-line metastatic non-small cell lung cancer (NSCLC), urothelial cancer (UCC) and hepatocellular cancer (HCC) patients. The publication further provides a wealth of translational research data that demonstrate the detailed proof-of-mechanism (POM) for visugromab, which induces T-cell influx, T-cell proliferation, and Interferon-γ signature induction in the tumor microenvironment both in monotherapy and in combination with nivolumab. Furthermore, pan-cancer immunogenomic analyses demonstrate the impact of GDF-15 on the tumor microenvironment and its immune cell landscape. The full publication can be accessed and downloaded via the following link . “The publication of our data in Nature confirms the high significance and novelty the scientific community has ascribed to GDF-15 as an immuno-oncology target, as well as the potential of visugromab to transform the cancer immunotherapy treatment landscape,” said Eugen Leo MD PhD MBA, Chief Medical Officer at CatalYm . “We observed both robust proof-of-mechanism and clinical proof-of-concept in this first-in-human trial for visugromab, with more than half of our responders achieving deeper RECIST 1.1 responses than seen with their initial checkpoint inhibitor treatment. Notably, we see a growing number of lasting complete responses in late- to last-line patients who had no further therapeutic alternatives anymore. This is a significant outcome not seen with other exploratory I/O treatments in this setting. We are now rapidly advancing visugromab into earlier lines of treatment, with several trials planned for 2025 in high unmet medical need solid tumor indications.” Summary of Key Clinical Results from the ongoing GDFATHER Phase 1/2a trial ( GDF -15 A ntibody-media T ed H uman E ffector T Cell R elocation Phase 1/2a Trial): The matured results from the Phase 2a indication-specific cohorts for NSCLC, UC, and all HCC so far treated show the following Objective Response Rates (ORR) based on strict RECIST 1.1 criteria: non-squamous NSCLC: ORR of 19.0% (4/21), with 2 partial responses (PR) and 2 complete responses (CR) UC: ORR of 18.5% (5/27), with 4 PR and 1 CR HCC: interim ORR of 20.0% (4/20), with 3 PR and 1 CR The current mean duration of response (DoR) for UC and NSCLC surpassed 15 and 16 months with 7/9 responses ongoing. More than half of all responders in the NSCLC and UC cohorts of the trial experienced a response depth on study treatment as per RECIST 1.1 criteria that had not been reached on their prior anti-PD1/PD-L1 treatment that was mostly administered as first-line treatment and in combination with chemotherapy. Among the NSCLC and UC responders, 3 out of 4 complete responders had not achieved a complete response on any prior line of systemic treatment, including their initial anti-PD1/PD-L1 therapy. Additionally, biomarker analyses revealed promising potential for patient stratification, with elevated levels of serum GDF-15 correlating with reduced immune cell infiltration in tumors. The combination of visugromab with nivolumab was overall well-tolerated, with a safety profile comparable to nivolumab treatment alone. In a subgroup of patients that had combined manifest cachexia, a similar effect on weight gain was observed as demonstrated for another GDF-15 inhibitor in a recent cachexia trial. Cachexia, a syndrome characterized by severe weight loss and muscle wasting is driven by elevated GDF-15 levels in certain cancer types. By neutralizing GDF-15, visugromab can help mitigate these effects, potentially improving the quality of life for patients undergoing intensive cancer treatments. Based on these encouraging data, CatalYm is currently preparing for a broad Phase 2b program in earlier treatment settings for non-squamous NSCLC and additional tumor indications. These developments highlight the company’s commitment to tackling cancer resistance and improving treatment outcomes for patients across multiple tumor types. About Visugromab (CTL-002) Visugromab is a monoclonal antibody that neutralizes the tumor-derived Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant fostering immunotherapy resistance. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by reenabling immune cell activation, proliferation and Interferon-γ signature induction. Visugromab has demonstrated a good safety profile and potent and durable anti-tumor efficacy in combination with anti-PD-1 treatment in advanced cancer patients. The antibody will now be investigated in Phase 2b studies in multiple solid tumor indications. About CatalYm CatalYm has identified GDF-15 as a key cancer therapy resistance mechanism and is developing it as safe and efficacious immune therapy for solid tumors. GDF-15 is an immunosuppressant that is hijacked by cancer cells to evade immune system attack. Visugromab, CatalYm’s lead antibody, has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. CatalYm is now advancing to Phase 2b studies to confirm visugromab as a new class of cancer immunotherapy in a broad range of anti-cancer regimens.