Two big-name biopharmas—Takeda Pharmaceutical and Alnylam Pharmaceuticals—today separately entered the scramble to develop new treatments for SARS-CoV-2 infection, the virus identified as the cause of the global COVID-19 outbreak—adding to the 35 coronavirus treatments in development that were identified by GEN this week.
Takeda said it has begun development of TAK-888, an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) designed to treat high-risk individuals with COVID-19.
Takeda’s H-IGs are plasma derived-therapies that have previously shown effectiveness in treating of severe acute viral respiratory infections. Such therapies are designed to concentrate pathogen-specific antibodies from plasma collected from recovered patients or vaccinated donors in the future. By transferring the antibodies to a new patient, Takeda reasons, a person’s immune system can better respond to the infection and increase their chance of recovery.
“We have identified relevant assets and capabilities across the company and are hopeful that we can expand the treatment options for patients with COVID-19 and the providers caring for them,” Rajeev Venkayya, MD, president of Takeda’s Vaccine Business Unit and co-lead of the company’s COVID-19 response team, said in a statement. “As a company dedicated to the health and well-being of people around the world, we will do all that we can to address the novel coronavirus threat.”
To that end, Takeda said, it has begun talks with health and regulatory agencies and healthcare partners in the U.S., Asia, and Europe to quickly advance its research into TAK-888. Those talks will include how to access plasma from people who have successfully recovered from COVID-19, or who have been vaccinated once a vaccine is developed, since these donors would have developed antibodies to the virus that could potentially prevent illness in COVID-19 patients, or at least mitigate its severity.
Takeda said it will initially produce the therapy in a segregated area within its manufacturing facility in Georgia, since the plasma needed for TAK-888 is unlikely to come from current plasma donors.
The development and production of TAK-888 should not negatively impact Takeda’s ability to produce its other plasma-derived therapies, the company added.
Takeda added that it is also studying whether any of its currently marketed and pipeline products may be effective treatments for infected patients, while an internal working group of in-house experts in public health, vaccines, plasma-derived therapies, and R&D will continue to apply the company’s 75+ years of experience in developing plasma-derived products, and global collaboration partners, to further address COVID-19.
“These efforts are at an early stage but being given a high priority within the company,” Takeda stated.
Alnylam, Vir pursue siRNA approach
Also today, Alnylam joined Vir Biotechnology in saying they will expand a 2 1/2-year-old small interfering RNA (siRNA) collaboration to include developing and commercializing one or more siRNAs to treat SARS-CoV-2 and potentially other coronaviruses as well.
The SARS-CoV-2 partnership is the second launched in as many weeks by Vir, a San Francisco developer of infectious disease treatments. On February 25, Vir joined WuXi Biologics in announcing a development and manufacturing collaboration to advance and produce human monoclonal antibodies as potential treatments for COVID-19.
Under Vir’s expanded collaboration with Alnylam—whose value was not disclosed—the companies plan to develop siRNAs identified by Alnylam that target highly conserved regions of coronavirus RNAs. Alnylam has designed and synthesized over 350 siRNAs targeting all available SARS-CoV and SARS-CoV-2 genomes, which will be screened in in vitro potency assays, the companies said.
Potent siRNA lead candidates will be further evaluated by scientists at Vir for in vitro and in vivo antiviral activity, leading to the selection of a development candidate.
Vir has agreed to lead all development and commercialization of any selected development candidates. Upon clinical proof of concept, Alnylam will have the option to share equally in the profits and losses associated with the development and commercialization of the coronavirus program—or to receive development and commercialization milestones and royalties of unspecified amounts on net sales of products resulting from the collaboration in amounts agreed upon for the coronavirus program.
The SARS-CoV-2 treatment would be the sixth siRNA for infectious disease to be developed by Vir and Alnylam. The companies launched their partnership in October 2017, initially agreeing to develop up to five novel siRNAs to treat infectious diseases, starting with ALN-HBV02 (VIR-2218), a treatment for chronic hepatitis B virus infection.
In November 2019, the companies announced initial positive Phase I/II data for ALN-HBV02—namely “substantial” multi-log decreases in HBsAg and favorable tolerability with no subjects or patients showing clinically significant elevations in liver alanine transaminase levels—representing the first human proof of concept for Alnylam’s Enhanced Stabilization Chemistry Plus (ESC+) GalNAc conjugate delivery technology.
The original Vir-Alnylam collaboration also called for developing RNAi products for up to four additional infectious disease targets of Vir’s choosing. Vir said it retains the option to further develop any resulting product candidates.