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Regeneron Gains Cancer, Infectious Disease Immunotherapies

Regeneron lab

Regeneron lab (Regeneron Pharmaceuticals, Instagram)

23 Nov. 2021. A biotechnology company is licensing five of its vaccines for cancer and infectious diseases to Regeneron Pharmaceuticals in a deal valued at nearly $1 billion. In the agreement Regeneron is also taking an equity stake in Nykode Therapeutics AS, known until today as Vaccibody, based in Oslo, Norway.

Nykode Therapeutics discovers and develops vaccines that generate an immune response to treat or protect against specific diseases. The company’s technology connects antigens provoking immune responses to antigen presenting cells that direct antigens to white blood cells in the immune system to attack disease-causing cells. Nykode says it uses a modular approach to designing its vaccines, with separate components for targeting and binding to an invading pathogen or cancer cell, as well as an antigen to invoke an immune response.

Genes coding for each vaccine component are linked and encoded into a fusion protein that express properties of its components. The company says its vaccines can mix and match different targeting and antigen components to address a range of diseases. The targeting unit in the vaccine, says Nykode, identifies and delivers vaccines to specific antigen presenting cells, which determine the actions taken by the vaccine to provoke an immune response.

Nykode’s lead program, code-named VB10.16, is an immunotherapy designed to treat human papilloma virus or HPV 16, a high-risk cancer-causing strain of the virus, now in a mid-stage clinical trial. The company also licensed its technology to biopharmaceutical company Genentech, a division of global drug maker Roche, to develop neoantigen cancer vaccines. Neoantigens are unique sets of mutations expressed in cancer patients’ tumors, which offer targets for individualized cancer treatments.

In addition, Nykode is developing two Covid-19 vaccines designed as boosters generating T-cell responses protecting against disease from a range of SARS-CoV-2 variants. Those vaccines are in an early-stage clinical trial.

Combine antibodies into modular vaccine design

Regeneron, in Tarrytown, New York, develops synthetic antibodies that stimulate the immune system to prevent or treat infectious diseases. The company’s VelocImmune technology produces these human antibodies with genetically engineered mice. The engineered mice become living production lines, says the company, producing antibodies that respond as a human to a specific pathogen, while not affecting the rest of the animal. Regeneron developed and produces one of the first antibody therapies for Covid-19, a combination of two synthetic antibodies, casirivimab and imdevimab, given as a single infusion for neutralizing the SARS-CoV-2 virus responsible for Covid-19 infections.

Under their agreement, Regeneron receives a license for five new Nykode vaccine programs, three cancer immunotherapies and two for infectious diseases, although further details on specific diseases are not disclosed. The companies will collaborate on combining Nykode’s modular vaccine design with Regeneron’s synthetic antibody technology. Nykode is responsible for discovery and preclinical work of its vaccine components, and early-stage clinical trials in each of these programs. Regeneron is responsible for discovery and preclinical work on its synthetic antibodies for the joint products, as well as all mid- and late-stage clinical trials and commercialization.

“Regeneron has generated unique know how in selecting and validating immunogenic antigens from extensive analysis of patient material,” says Nykode’s chief strategist Agnete Fredriksen in a company statement. “These can now be incorporated into our vaccine platform to deliver the antigens directly to antigen presenting cells and optimize the likelihood of inducing strong and broad clinically relevant immune responses.”

Regeneron is providing an initial payment of $30 million and taking a $20 million equity stake in Nykode Therapeutics. Nykode is also eligible for another $875 million in development and commercialization milestone payments, as well as royalty on product sales. In addition, Regeneron is covering costs of further research, as well as clinical, regulatory, manufacturing, and commercialization work.

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