CatalYm Secures $150M to Boost GDF-15 Inhibitor Post-ASCO Success

CatalYm recently garnered attention at the American Society of Clinical Oncology (ASCO) meeting with its promising early response data for an anti-GDF-15 antibody in heavily pretreated patients with late-stage solid tumors. The biotech firm now aims to advance visugromab into first-line treatment settings, thanks to a new $150 million funding round aimed at developing this potentially first-in-class immuno-oncology (IO) therapy.

Currently, CatalYm is evaluating visugromab in patients with hepatocellular carcinoma (HCC), urothelial cancer (UC), and non-small-cell lung cancer (NSCLC). These patients are also receiving the PD-1 inhibitor Opdivo (nivolumab) in the Phase I/IIa GDFATHER trial. At ASCO, the company reported that about 20% of the patients across different cohorts responded positively to the treatment. Specifically, four out of 21 NSCLC patients (19%), five out of 26 UC patients (19.2%), and four out of 20 HCC patients (20%) showed favorable responses. For last-line, late-stage patients, the typical response rate with standard-of-care treatments ranges between 8% and 12%.

CEO Phil L’Huillier mentioned that visugromab appears to lead to more durable responses compared to the two-to-four months seen with chemotherapy in a similar patient population. Many of the responders are still undergoing treatment, with some patients continuing their therapy for up to 18 months. The official duration of response is yet to be determined for any of the three cohorts. The antibody's level and duration of response, along with its safety profile, present "compelling clinical data" for these patients who have no other alternatives, L’Huillier added.

CatalYm’s recent series D funding round was led by new investors Canaan Partners and Bioqube Ventures. They were joined by Forbion’s Growth Opportunities Fund, Omega Funds, and Gilde Healthcare. Existing investors, including Jeito Capital, Brandon Capital Partners, Novartis Venture Fund, and Vesalius, also participated. L’Huillier noted that the significant interest from investors is particularly noteworthy given the current environment where venture capital is not as readily available as in previous years. The novel approach of neutralizing GDF-15 to treat cancer was particularly appealing to investors.

CatalYm was co-founded in 2016 by Jörg Wischhusen, a professor at the University of Würzburg in Germany, who discovered the role of GDF-15 in foetomaternal tolerance and how cancer hijacks this mechanism within the tumor microenvironment to evade immune detection. By neutralizing GDF-15, CatalYm aims to expose the tumor to the immune system. Company scientists have also elucidated the cellular mechanisms by which the protein protects cancer cells. GDF-15 reduces immune cell infiltration, inhibits antigen-presenting cell activation, and interferes with T-cell priming. Additionally, GDF-15 can influence metabolic functions, causing symptoms like vomiting and nausea when it signals through a receptor in the brainstem.

Neutralizing GDF-15 not only addresses cancer through immune mechanisms but also alleviates sickness often associated with chemotherapy, radiotherapy, and antibody-drug conjugates. In patients with high GDF-15 serum levels, visugromab has even resulted in improved body condition and weight gain, which L’Huillier described as a significant differentiator.

CatalYm plans to test visugromab in frontline and second-line settings — specifically, checkpoint-naïve and checkpoint-refractory NSCLC patients — in randomized controlled studies. These trials are scheduled to begin next year, with results expected in early 2027. The recent financing is projected to support the company until the end of 2027, as CatalYm aims to achieve first-in-class status with visugromab.

Other companies are also exploring GDF-15 targeting agents. Pfizer's anti-GDF-15 antibody, ponsegromab, is in Phase II trials for cancer-related cachexia and heart failure. NGM Biopharmaceuticals is planning a Phase II trial of NGM120, an antibody that inhibits GDF-15 signaling, to treat hyperemesis gravidarum, a condition causing severe vomiting and weight loss in pregnant women.

L’Huillier emphasized that CatalYm is at the forefront of addressing the local immunosuppressive effects of GDF-15, and more companies are now entering the field based on encouraging results from CatalYm, Pfizer, and others.