Ponsegromab

GDF15 might sound familiar. It’s a protein that Amgen, Merck and Eli Lilly built analogs for in attempts to make new weight loss drugs. But those drugs largely failed — and Amgen, the last standing of the three — quietly pulled the plug on its GDF15 program in January . But GDF15 is not dead. The science behind the weight loss drugs goes back to the observation that some cancer patients have high levels of GDF15 and lose a lot of weight, so cancer researchers have been making antibodies that inhibit the protein instead of mimicking it. German biotech CatalYm, named for “Catalyzing antibodies,” is running a mid-stage program for a GDF15 antibody, visugromab, in solid tumors. It’s now raised €50 million (roughly $49 million USD) in a Series C to “be more aggressive with the Phase II,” CEO Phil L’Huiller told Endpoints News . New investors Brandon Capital and Jeito Capital are leading the round, followed by existing investors Forbion, Novartis’ venture arm, Vesalius Biocapital III, Bayern Kapital, BioGeneration Ventures and Coparion. In addition, Brandon’s Jonathan Tobin and Jeito’s Andreas Wallnöfer are joining CatalYm’s board. According to Wallnöfer, CatalYm marks Jeito’s first investment in Germany. At ESMO earlier this year, CatalYm read out the full data from an 18-person Phase I study on visugromab in combination with Opdivo in patients who were heavily pretreated and progressed on previous PD-1 therapy — patients who’ve exhausted all their options. In that study, three patients had a partial response, one of whom had a durable response for over a year. Three additional patients also had stable disease on the treatment, and one of those patients saw their cancer stop progressing on treatment for over a year as well. Wallnöfer highlighted the potential for visugromab as a combination therapy for solid tumor patients, noting that the drug had a durable effect as the last line of treatment on top of its “benign” safety profile — no dose-limiting toxicities or grade 4 or 5 adverse events were observed in the Phase I study. In March, CatalYm began a Phase II study on visugromab. Taking the two higher doses from the first study (10 and 20 mg/kg), the new program plans to enroll around 160 patients. It’s also expanded to the US — a decision that came after the Phase I readout, L’Huiller said, noting that CatalYm met a clinician at MD Anderson who showed interest in opening a study site for visugromab. That Phase II study and another biomarker study are slated for initial readouts in the first half of next year, L’Huiller said. The Series C comes at a time when the public market is ice cold. “In terms of the financing, it started out fairly challenging because of the global situation and the IPO window being closed,” L’Huiller said. “That influenced the way we looked at financing. We said, ‘let’s stay and do another private round rather than a crossover or an IPO round.’” In November, just one biotech, Acrivon Therapeutics , made the private-to-public jump, while others pulled away from plans. Pfizer also has a GDF15-targeted antibody for cancer, known as ponsegromab, for which it recently started a Phase II trial . But Pfizer’s drug is for a different purpose — stemming weight and muscle loss in cancer patients.

The assay uses the sandwich test format for the detection of GDF-15 in human serum Roche branch offices in Basel. (Credit: F. Hoffmann-La Roche Ltd) Roche has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. Elecsys GDF-15 is an in vitro diagnostic immunoassay designated for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumours to be treated with Pfizer’s investigational drug PF-06946860. Cachexia is a metabolic disorder and comorbidity, which occurs with various chronic diseases such as cancer, heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease (CKD). According to the company, cachexia affects over 30 million people across the globe and is a highly prevalent complication of cancer that is said to affect between 50 to 80% of all cancer patients. Elecsys GDF-15 is a quantitative serologic and two-incubation step electrochemiluminescence immunoassay (ECLIA), which uses the sandwich test format to detect GDF-15 in human serum. The GDF-15 assay, which is designed for use on cobas e immunoassay analysers, has a CE mark approval in various applications including risk prediction of major bleeding events of atrial fibrillation patients and risk stratification of patients with an acute coronary syndrome or chronic heart failure. Roche Diagnostics CEO Thomas Schinecker said: “We are pleased to partner with Pfizer to address this unmet medical need in oncology through strong companion diagnostics. “The FDA BDD grant for the Elecsys GDF-15 assay shows the importance of these strong partnerships. The ability to detect elevated GDF-15 in patients who are experiencing weight loss may provide a precision-medicine approach to identifying patients likely to respond to a GDF-15 therapeutic treatment.” In December 2020, Roche expanded its Covid-19 test portfolio with the introduction of Elecsys SARS-CoV-2 antigen test in the CE mark accepting markets. The test is developed for the in vitro qualitative detection of the nucleocapsid antigen of SARS‑CoV‑2.