The latest news from pharma companies on vaccine and antibody development for the novel coronavirus, including from Sanofi and Regeneron Pharmaceuticals.

Sanofi Joins with HHS for Coronavirus Vaccine Development

Sanofi Pasteur, the vaccines global business unit of Sanofi, is partnering with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response of the US Department of Health and Human Services, to develop a coronavirus (COVID-19) vaccine.

Sanofi says it will apply previous development work applied to a SARS (severe acute respiratory syndrome) vaccine. COVID-19 belongs to a family of coronaviruses that can cause respiratory disease. In late 2002, the SARS coronavirus emerged and then largely disappeared by 2004. Sanofi says it plans to further investigate an advanced preclinical SARS vaccine candidate that could protect against COVID-19.

Sanofi says it will use its recombinant DNA platform to produce a 2019 novel coronavirus vaccine candidate.  It says that the recombinant technology produces an exact genetic match to proteins found on the surface of the virus. The DNA sequence encoding this antigen will be combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product, and used to rapidly produce large quantities of the coronavirus antigen, which will be formulated to stimulate the immune system to protect against the virus.

In December 2019, Sanofi entered into an agreement with BARDA to establish production facilities in the US for an adjuvanted recombinant vaccine for use in the event of an influenza pandemic and based on the same technology platform that will be used for the COVID-19 program.

Source: Sanofi

Regeneron, HHS Expand Agreement for Coronavirus Antibody Development

Regeneron Pharmaceuticals has announced an expanded agreement with the US Department of Health and Human Services (HHS) to develop new treatments for the novel coronavirus, 2019-nCoV.

Regeneron has a number of active collaborations with HHS’s Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR), including a collaboration to advance Regeneron’s investigational Ebola treatment, REGN-EB3, which demonstrated positive clinical data in 2019.

The HHS and Regeneron Other Transaction Agreement (OTA) was originally established in 2017 and is focused on discovery, research, development and manufacturing of a portfolio of antibodies targeting up to 10 pathogens that pose significant risk to public health, now including the Influenza virus and 2019-nCoV. Overall, the OTA provides a funding and collaboration vehicle for HHS to promote innovation in technology for advanced research and development.

The company’s collaboration with the HHS effort uses Regeneron’s proprietary VelociSuite technologies, including its VelocImmune platform, which uses a genetically engineered mouse with a humanized immune system with all or parts of a virus of interest, to facilitate identification, preclinical validation, and development of promising antibody candidates.

Source: Regeneron Pharmaceuticals

Vir Biotechnology Identifies Two Antibodies for Coronavirus Neutralization

Vir Biotechnology, a clinical-stage immunology company focused on immune approaches to treating and preventing infectious diseases, has identified two monoclonal antibodies that bind to SARS-CoV-2 (previously known as “2019-nCoV”), which were originally found because they bind and neutralize the original SARS-CoV. The antibodies target the SARS-CoV-2 spike protein in the region that the virus uses to enter cells through the cellular receptor ACE2. Infection with SARS-CoV-2 causes the newly named disease, coronavirus (COVID-19).

The company says it is moving ahead with research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.

To that end, the company is exploring collaborations with a number of other companies and government agencies, which includes specific efforts at accessing manufacturing capacity globally. Vir is investigating other approaches to identify additional potential therapies for SARS-CoV-2. In addition to testing these two antibodies, the company is also exploring the isolation of new antibodies specific for this virus using its antibody technology platform. These efforts may allow additional approaches to address the outbreak.

It identified these antibodies from an existing library of 20 fully human antibodies that bind and neutralize related coronaviruses, such as SARS-CoV and coronaviruses that infect animals. This library was built through a method using successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases, including those caused by rapidly evolving and/or previously untreatable pathogens.

Source: Vir Biotechnology

Codagenix, Serum Institute of India To Co-Develop Coronavirus Vaccine

Codagenix, a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies, is collaborating with the Serum Institute of India (SII) to co-develop a live-attenuated vaccine against the emergent coronavirus. The SII says it expects to be ready with a vaccine by early 2022.

There are currently no licensed vaccines or therapeutics for coronavirus, now referred to as COVID-19. A live-attenuated vaccine has multiple advantages, including mounting an immune response to multiple antigens of the virus and the ability to scale for mass production. The cost of the project is up to RS 3,000 crore ($418 million), for which SII says it will secure external funding via various global partners. SII expects the vaccine candidate to progress to the human trial phase within the next six months, as of February 19, 2020.

Codagenix uses viral deoptimization to synthesize live-attenuated vaccines. Codagenix’s technology allows for the generation of multiple vaccine candidates against emerging viruses, starting with the digital sequence of the viral genome. Codagenix has already designed multiple coronavirus vaccine candidate genomes using its proprietary deoptimization technology. The vaccine viruses will then be grown and tested in vivo by contracted laboratories suitable for containment prior to testing in clinical trials. 

Source: Codagenix, Serum Institute of India