Visugromab

CatalYm’s series D haul is close to triple its series C total in late 2022, when the biotech raised about $49 million. On the heels of early-stage data for monoclonal antibody visugromab showing “impressive and lasting responses” among patients with difficult to treat cancers, CatalYm has secured a $150 million series D.  The German biotech plans to use the funds to develop and expand phase 2b trials into select checkpoint naïve front-line and second-line treatment settings, the company said in a Tuesday release. “We continue to demonstrate visugromab’s potential to induce cancer remission depth and durability across multiple solid tumor indications emphasizing the substantial role visugromab could play in a novel anti-cancer therapy regimen,” CatalYm Managing Director and CEO Phil L’Huillier, Ph.D., said in the release. “We are building significant momentum for CatalYm’s development strategy and look forward to the support of these high-profile new and existing international investors.” Those investors include newcomers Canaan Partners and Bioqube Ventures, who led the round, along with Forbion Growth, Omega Funds and Gilde Healthcare. Existing investors Jeito Capital, Brandon Capital Partners, Novartis Venture Fund and Vesalius also threw some cash into the mix. CatalYm’s series D haul is close to triple their series C total in late 2022, when the biotech raised about $49 million. Visugromab targets growth differentiation factor 15, an immunosuppressant which is normally used by fetal cells to prevent the mother’s immune system from attacking them. In cancer, GDF-15 is hijacked by tumor cells to protect them from the patient’s immune system, causing immunotherapies like anti-PD-1 therapy to fail. At the American Society of Clinical Oncology this year, CatalYm presented data from the GDFATHER trial, which is testing visugromab in combination with Bristol Myers Squibb's anti-PD-1 drug Opdivo in patients with non-squamous non-small cell lung cancer (NSCLC), urothelial cancer and hepatocellular cancer. These patients were heavily pretreated and had shown resistance to anti-PD-1 therapy in the past. Each patient group had around 20 patients, with 90 total patients. Across all tumor types, patients who received visugromab showed an objective response rate of 16.7%, including four patients whose tumors disappeared. The average duration of response surpassed 15 months for NSCLC, and 77% of the patients’ responses are still ongoing. “We were initially drawn to the exciting biology around GDF-15 and found CatalYm to be at the forefront of the field,” Jon Edwards, Ph.D., managing partner at Bioqube Ventures, said in a statement. “We believe this approach has the potential to significantly increase durability and deepen responses, unlocking the full potential of I/O treatments. We are excited to support this fantastic team, and syndicate, in running robust clinical studies in a variety of promising indications.”

MUNICH--( BUSINESS WIRE )-- CatalYm today announced the completion of a $150 million Series D financing. The oversubscribed round was led by new investors, Canaan Partners and Bioqube Ventures, and joined by Forbion's Growth Opportunities Fund (“Forbion Growth”), Omega Funds and Gilde Healthcare. Existing investors Jeito Capital, Brandon Capital Partners, Novartis Venture Fund and Vesalius Biocapital III also participated in the round. The proceeds will fund the expansion of the company’s broad Phase 2b development of visugromab into randomized Phase 2b studies in select checkpoint naïve frontline and second-line treatment settings. Visugromab has already demonstrated outstanding anti-tumor activity in combination with checkpoint inhibitor treatment. Visugromab is a humanized monoclonal antibody engineered to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15), which acts as a key regulator of immune resistance to cancer therapies. CatalYm recently reported impressive follow-up results from its ongoing “GDFATHER” Phase 1/2a trial ( GDF -15 A ntibody-media T ed H uman E ffector Cell R elocation Phase 1/2a) ( NCT04725474 ) in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 in Chicago. The data showed that treatment with visugromab combined with the anti-PD-1 antibody, nivolumab achieves deep and durable anti-tumoral activity, including several complete responses in anti-PD-1/PD-L1 relapsed/refractory patients with non-small cell lung cancer (NSCLC), urothelial cancer (UC) or hepatocellular carcinoma (HCC). “This substantial raise and strong syndicate recognize our achievements as a company and emphasize the excellent results of visugromab and our broad Phase 2b clinical program. We continue to demonstrate visugromab’s potential to induce cancer remission depth and durability across multiple solid tumor indications emphasizing the substantial role visugromab could play in a novel anti-cancer therapy regimen,” said Phil L’Huillier, Managing Director and Chief Executive Officer at CatalYm . “We are building significant momentum for CatalYm’s development strategy and look forward to the support of these high-profile new and existing international investors, who share our vision of breaking immunosuppressive barriers to improve therapeutic outcomes.” In conjunction with the close of the financing, Colleen Cuffaro, Partner at Canaan, Jon Edwards, Managing Partner at Bioqube Ventures and Otello Stampacchia, Managing Director and Founder at Omega Funds, will join the CatalYm Board of Directors . Stefan Luzi, Partner at Gilde Healthcare will join as Board Observer. “The recent data presented at ASCO highlight visugromab’s highly differentiated therapeutic profile and validate the ability of Phil and his team to expeditiously execute on the company’s clinical plan,” commented Colleen Cuffaro, Partner at Canaan Partners . “As the company advances into expanded Phase 2b development, we are excited to provide our strategic guidance on the company’s trajectory toward changing the current treatment regimens for hard-to-treat solid tumor indications.” Jon Edwards, Managing Partner at Bioqube Ventures added: “We were initially drawn to the exciting biology around GDF-15 and found CatalYm to be at the forefront of the field. We believe this approach has the potential to significantly increase durability and deepen responses, unlocking the full potential of I/O treatments. We are excited to support this fantastic team, and syndicate, in running robust clinical studies in a variety of promising indications.” Founded in 2016 with support from Forbion Ventures Fund III and BGV, CatalYm is a leader in the development of a new class of cancer treatments aiming to prevent or reverse cancer resistance to checkpoint inhibition, chemotherapy and other targeted treatments. The approach neutralizes GDF-15, a critical immunosuppressant used by tumor cells to survive. With its broad Phase 2b development plan, the company targets high-need solid tumor indications including NSCLC, UC, HCC and bladder cancer where existing and acquired resistance are a major problem. CatalYm is now in preparations to launch further randomized, controlled studies in several major cancer indications in combination with checkpoint inhibitors and standard-of-care in first- and second-line treatment in the first half of 2025. 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, an immunosuppressant important for feto-maternal tolerance, 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. 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 and tumor infiltration. 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 is currently being investigated in ongoing Phase 2a studies in multiple solid tumor indications.