A startup developing a drug for severe oral mucositis in patients receiving treatment for head and neck cancer has closed a new round of venture capital financing.
Galera Therapeutics, based in Malvern, Pennsylvania, said Wednesday that it had raised $150 million in a joint, oversubscribed Series C funding round and royalty purchase agreement. Clarus led the round, while other new investors include Adage Capital Management, HBM Healthcare Investments, Nan Fung Life Sciences, RA Capital, Rock Springs Capital and Tekla Capital Management. Existing investors participating included Correlation Ventures, New Enterprise Associates, Novartis Venture Fund, Novo Ventures and Sofinnova Ventures. The total investment includes a $70 million equity raise and an $80 million royalty financing payable from future sales.
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The company plans to use the funding to advance clinical development of its lead drug candidate, GC4419, and to fund a registrational Phase III trial in patients with severe oral mucositis.
According to the Oral Cancer Foundation, oral mucositis is probably the most common and debilitating complication of chemotherapy and radiation therapy, potentially leading to increased risk of infections due to open sources in mucous membranes, along with inability to eat due to nutritional problems and pain. According to Galera, Grade 3 or 4 SOM occurs in about 70 percent of patients receiving chemoradiotherapy.
The company noted that in a Phase IIb study, GC4419 showed reductions in the incidence and duration of SOM from radiation therapy among patients with locally advanced head and neck cancer. The drug has received Breakthrough and Fast Track designations from the Food and Drug Administration.
“This significant raise further validates the dramatic and meaingful results of our randomized Phase IIb clinical trial and the potential and the potential of GC4419 to revolutionize radiotherapy,” Galera CEO Mel Sorensen said in a statement. He added that the company plans to also study the drug in radiation-induced esophagitis and an undisclosed cancer-related indication.
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The company presented data from the Phase IIb study in June at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology annual meeting in Vienna. Data from the double-blind, placebo-controlled study of 223 patients receiving GC4419 at 30mg or 90mg showed that in the 90mg cohort, there was a statistically significant, 92 percent reduction in median duration of SOM, from 19 days to 1.5 days, which was the study’s primary endpoint.
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