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Biotechs Partner on HPV Cancer Immunotherapies

Drug vials

(angelsalamag054, Pixabay)

18 December 2017. Biotechnology companies in the U.S. and the Netherlands are collaborating on treatments for cancers caused by a type of human papillomavirus, or HPV. Regeneron Pharmaceuticals Inc. in Tarrytown, New York and ISA Pharmaceuticals B.V. in Leiden are planning clinical trials to test a combination of their respective therapies that harness the immune system as treatments for cervical and head-and-neck cancer.

The partnership will test ISA Pharmaceuticals’ experimental therapy code-named ISA101 in combination with cemiplimab made by Regeneron. ISA develops synthetic peptides, chains of amino acids smaller than proteins, but larger than natural peptides, which the company says are better candidates for treatments invoking the immune system. ISA101 contains 13 of these longer synthetic peptides derived from cancer-causing proteins produced by the HPV16 virus.

HPV infections are the most common viral infections of the reproductive tract, and are often sexually transmitted. In most cases, infections clear up quickly, with little, if any, intervention. Infections from HPV16, however, can lead to precancerous lesions and eventually cervical cancer, as well as head and neck cancer. The companies cite data showing that more than half of cervical as well as head and neck cancers are traced to HPV16.

ISA Pharmaceuticals says ISA101 can fill the gap between a preventive vaccine for HPV-associated cancer and a treatment for the disease. The therapy has been tested in early- and intermediate-stage trials as a preventive vaccine. The new agreement with Regeneron aims to extend its use to treatment of an existing cancer.

Regeneron designs biologic therapies from genetically-engineered mice producing antibodies that respond as a human to a specific pathogen, while not affecting the rest of the animal. The mouse antibody is then extracted and recombined with human genetic characteristics for testing as a therapy candidate.

The antibody therapy in this case is cemiplimab, developed in partnership with drug maker Sanofi, now in early- to late-stage clinical studies as a treatment for a number of solid tumor cancers both on its own and in combination with other drugs. Cemiplimab blocks the programmed cell death protein 1, or PD-1, which acts as a checkpoint preventing the immune system from acting against cancer cells.

The deal gives Regeneron an option for a worldwide exclusive license to ISA101, with ISA Pharmaceuticals receiving an initial payment, plus an equity investment from Regeneron. ISA and Regeneron will share the costs of clinical trials as well as exchange supplies of their respective drugs for those studies. If Regeneron exercises its option to license ISA101, ISA will be eligible for milestone payments and royalties on sales. Further financial details, including dollar amounts, were not disclosed.

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