ISA Pharmaceuticals HPV Program Backed by Regeneron

In a €26 million ($30 million) fundraising round, Regeneron supports ISA Pharmaceuticals attempts to bring a human papillomavirus therapy to market. In collaboration with Regeneron, the Dutch biotech will utilize the funds to advance three late-stage clinical trials for ISA101b, a human papillomavirus type 16 (HPV16) treatment.

According to a statement, this strain of HPV is responsible for more than 50% of human cervical cancers and more than 85% of HPV-positive head and neck malignancies. To push the immunotherapy closer to market approval, ISA Pharmaceuticals received funding from new investor Invest-NL and current sponsors such as Regeneron.

Regeneron has increased its commitment to ISA Pharma’s leading candidate with today’s funding round, after first linking arms in December 2017. In phase 2 clinical trial, ISA101b is being tested in conjunction with Regeneron and Sanofi’s PD-1 inhibitor Libtayo for first- and second-line HPV16-positive head-and-neck cancer. In addition, the companies announced in June that the same combination would be tested in a phase 2 trial of cervical cancer patients.

Multiple firms are testing medicines in combination with Libtayo, including ISA Pharma. BioNTech is working on mid-stage research of mRNA cancer immunotherapy with Libtayo in advanced melanoma patients. Inovio is looking at a DNA medication combined with the treatment for patients with brain cancer glioblastoma.ISA101b is also being investigated in a phase 2 trial in patients with intermediate-risk head-and-neck cancer linked to HPV-16 who have received no prior therapy. In that experiment, the medication is being tested alongside Merck’s Keytruda combined with cisplatin chemotherapy and radiotherapy. The first patient was dosed in January, and ISA Pharmaceuticals plans to finish enrollment in late 2022.