Regeneron again backs ISA Pharma’s HPV program in $30M funding round

Regeneron again backs ISA Pharma’s HPV program in $30M funding round

Regeneron is once again backing ISA Pharmaceuticals’ efforts to move a human papillomavirus treatment towards the market in a €26 million ($30 million) funding round.

The Dutch biotech will use the funding to bankroll the advancement of three late-stage clinical trials for a human papillomavirus type 16 (HPV16) treatment called ISA101b in partnership with Regeneron. This strain of HPV is responsible for more than 50% of human cervical cancers and more than 85% of HPV-positive head and neck cancers, according to a statement.

ISA Pharma raised the funds from new investor Invest-NL and existing backers like Regeneron to bring the immunotherapy toward market approval.

The company has completed a phase 2 trial of the treatment in vulvar intra-epithelial neoplasia, a type of cancer affecting the vulva, and also successfully completed a phase 1/2 trial in cervical cancer.

With today’s funding round, Regeneron further committed itself to ISA Pharma’s lead candidate after first linking arms in December 2017. ISA101b is being studied in a phase 2 clinical trial for first- and second-line HPV16-positive head-and-neck cancer in combination with Regeneron and Sanofi’s PD-1 inhibitor Libtayo. Last June, the companies said the same combination would be studied in a phase 2 trial of patients with cervical cancer.

ISA Pharma is one of multiple companies testing treatments in combination with Libtayo. Inovio is looking at a DNA medicine in combination with the drug for patients with the brain cancer glioblastoma and BioNTech is working on a mid-stage study of an mRNA cancer immunotherapy with Libtayo in advanced melanoma patients.

ISA101b is also being tested in a phase 2 trial of patients who’ve had no prior treatment for intermediate-risk head-and-neck cancer associated with HPV-16. That trial is investigating the treatment alongside Merck’s Keytruda in combination with chemotherapy cisplatin and radiotherapy. ISA Pharma dosed the first patient in January and expects to complete enrollment in late 2022.

Tuesday’s funding will also support ISA Pharma’s pipeline of preclinical candidates. The biotech has three products that are expected to enter phase 1 this year or in 2022.

This includes an immunotherapy intended to prevent COVID-19 hospital and ICU admissions by preventing progressive pneumonia and other complications. The immunotherapy, dubbed ISA106, is meant to elicit a T-cell immune response against SARS-CoV-2, the virus that causes the respiratory disease. ISA Pharma said in March that preclinical work had been completed and a phase 1 dose finding study was expected to begin in “the next few months.”

Other preclinical candidates include the cancer drug ISA103 and ISA104, for hepatitis B virus.

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