CatalYm raises $150m for GDF-15-targeting immune modulator

German cancer biotechnology company CatalYm has successfully raised $150 million in a Series D funding round, leveraging the recent positive data surrounding its lead monoclonal antibody, visugromab. The company's research and development focus is on drugs that target growth differentiation factor-15 (GDF-15), a critical regulator of immune resistance in cancer treatments. CatalYm had earlier made headlines this year with follow-up data showcasing visugromab's efficacy in heavily pretreated cancer patients.

The newly acquired funding, spearheaded by Canaan Partners and Bioqube Ventures, will be channeled towards CatalYm's upcoming Phase IIb trial. This trial will explore visugromab in specific checkpoint-naïve front-line and second-line treatment scenarios. To date, visugromab has been tested in combination with Bristol Myers Squibb’s (BMS) anti-PD-1 drug, Opdivo (nivolumab), targeting patients with non-squamous non-small cell lung cancer (NSCLC), hepatocellular carcinoma, and urothelial carcinoma. CatalYm presented these findings from the ongoing GDFATHER Phase I/IIa trial at the American Society of Clinical Oncology (ASCO) meeting in Chicago on June 2.

In diverse tumor types, patients treated with visugromab exhibited an objective response rate of 16.7%. For NSCLC, the average duration of response exceeded 15 months, while for urothelial cancer, it surpassed 14 months. Remarkably, 77% of patients' responses were still ongoing at the time of assessment. These results are especially significant considering that the 90 patients involved had previously undergone extensive treatment and had not responded to prior anti-PD-1 therapies.

Anti-PD-1 checkpoint inhibitors, including BMS' Opdivo, enhance the immune system's capability to combat cancer by obstructing the PD-1 receptor on T-cells. This receptor usually serves to regulate immune responses. However, cancer cells can manipulate this pathway to evade immune attacks. Elevated levels of GDF-15 in cancers can neutralize the efficacy of anti-PD-1 drugs by fostering an immunosuppressive tumor environment that impedes T-cell activation and recruitment, a challenge that visugromab is designed to overcome.

Checkpoint inhibitors have generated substantial revenue in recent years. For instance, MSD’s PD-1 checkpoint inhibitor, Keytruda (pembrolizumab), emerged as the highest-grossing drug worldwide last year, with earnings of $25 billion. BMS’ Opdivo brought in $9 billion during the same period. A significant factor contributing to these high sales figures is the ability of such drugs to be combined with other anti-cancer treatments.

In the announcement related to the funding, CatalYm’s CEO, Phil L’Huillier, commented: “We continue to demonstrate visugromab’s potential to induce cancer remission depth and durability across multiple solid tumor indications, emphasising the substantial role that visugromab could play in a novel anti-cancer therapy regimen.”

This infusion of capital positions CatalYm to advance its promising oncology pipeline, particularly focusing on the further development and clinical testing of visugromab. The company's strategy aligns with the broader trend in oncology research, which increasingly looks to combination therapies to enhance treatment efficacy and patient outcomes. CatalYm’s approach of targeting GDF-15 could offer a novel pathway to overcoming some of the resistance mechanisms that undermine current cancer immunotherapies.