Politics, Policy & Law
COVID-19 mAb developers with ties to China excluded from Warp Speed
NIH is testing mAbs from Vir and Brii, but the U.S. government won’t fund the products
NIH is testing mAbs from Vir Biotechnology and Brii Biosciences but the U.S. government won’t fund the products.
The Trump administration’s America First policies, especially its reluctance to support life sciences companies with ties to China, may be slowing the development of medicines that could treat or prevent COVID-19.
Two biotechs focused on infectious diseases, Vir Biotechnology Inc. (NASDAQ:VIR) and Brii Biosciences, have persuaded NIH that their mAbs may benefit patients hospitalized with COVID-19, but have had far less success in overcoming the U.S. government’s resistance to funding companies with links to China.
Vir has been largely frozen out of Operation Warp Speed because it is collaborating with WuXi Biologics Inc. (HKEX:2269), a multinational company based in Hong Kong.
Brii, a multinational company headquartered in Durham, N.C. and Beijing, has been excluded from Warp Speed, presumably because of its ties to China.
In contrast, COVID-19 mAb development by Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Eli Lilly and Co. (NYSE:LLY) has been propelled by cash infusions from Operation Warp Speed.
The initiative provided $450 million to Regeneron in July to fund manufacturing and advance procurement of its mAb cocktail.
Lilly has been awarded a contract for $375 million for 300,000 vials of bamlanivimab (LY-CoV555), the mAb it developed in partnership with AbCellera Biologics Inc. (NASDAQ:ABCL). The U.S. government has an option to purchase up to 650,000 additional doses through the end of June 2021 for up to an additional $812.5 million.
Lilly has rights to a second mAb from Chinese biotech Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877; Shanghai:688180), and early evidence suggests the two therapies are more effective when administered together. Lilly and Operation Warp Speed have not disclosed U.S. government funding for Lilly’s development of the Junshi mAb.
In addition to Warp Speed’s aversion to companies with ties to China, the U.S. government has sought to prevent the World Bank and other funding agencies from purchasing COVID-19 vaccines manufactured in China or Russia.
“There are several considerations that are carefully made when selecting entities to support the mission of OWS,” an HHS spokesperson told BioCentury in an emailed statement. “Location of manufacturing sites is just one consideration in the decision for U.S. government support. Other factors include timeline to potential Emergency Use Authorization (EUA), preclinical data supporting the safety and efficacy of the candidate therapeutic and the number of doses potentially available at the time of EUA. Companies are equitably weighted against these factors.”
Vir moved fast
Vir, one of the few infectious disease-focused biotechs launched in the pre-COVID era, was created to address challenges like SARS-CoV-2.
In January, within days of publication of the genome sequence of a novel coronavirus that was closely related to SARS, scientists at Humabs BioMed, a subsidiary of Vir, started scouring their collection of mAbs from SARS patients for potential COVID-19 therapies. “As soon as the sequence became available, we initiated the necessary experiments to utilize those data” for screening its mAb library to find an existing molecule with the right profile, Vir CSO Herbert “Skip” Virgin told BioCentury in January.
Based on its early start, as well as its history of collaborating with NIH’s National Institute of Allergy and Infectious Diseases (NIAID) on a successful Ebola mAb, Vir seemed like an obvious candidate for support from Operation Warp Speed.
NIAID director Anthony Fauci mentioned the Ebola collaboration in a conversation with BioCentury in January when he said the institute was planning to develop a similar COVID-19 therapy.
To accelerate development of a COVID-19 mAb, Vir looked for a partner that could quickly scale-up manufacturing to make it possible to start human testing as quickly as possible.
In February, Vir announced that it had formed a collaboration with WuXi Biologics.
Under the agreement, WuXi Biologics is responsible for cell line development, process and formulation development, and initial manufacturing for clinical development. The deal gave WuXi commercialization rights in greater China, while Vir retained rights to commercialize any approved products in all other markets worldwide.
WuXi committed to a far more aggressive timeline than other companies Vir approached, an individual familiar with the negotiations who was not authorized to speak to the press told BioCentury.
Whatever speed Vir gained by working with WuXi is unlikely to compensate for the cold shoulder the company has received from the U.S. government as a result of its connection to China.
Vir sought funding from BARDA and Warp Speed and would welcome the support in the future, George Scangos, the company’s president and CEO, told BioCentury. The lack of government support “has to do with the fact that WuXi is producing for us,” he said. “They are reluctant because of the connection to China.”
The only government support Vir’s mAb program has received is Warp Speed funding for the arm of the ACTIV-3 trial. The trial is being conducted and controlled by NIAID.
Vir “has gone ahead on our own, we’ve put our own money at risk,” Scangos added.
In addition to its collaboration with WuXi, Vir has a far more extensive partnership with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). In a deal announced in April, GSK invested $250 million in Vir and agreed to combine its functional genomics and vaccines expertise with Vir’s capabilities in CRISPR screening, artificial intelligence and epitope identification to discover new mAbs and vaccines for coronavirus infections, including but not limited to SARS-CoV-2.
GSK is accelerating the enrollment and completion of trials of Vir’s two COVID-19 mAbs, handling global regulatory filings, and providing some manufacturing capacity, Scangos told BioCentury. “In order to maximize speed, GSK has chipped in resources to help the program move faster in ways they weren’t obligated to do under the contract”
In a move that may have been intended to bolster the confidence of the U.S. government, in September Vir named Janet Napolitano, a former U.S. Secretary of Homeland Security, to its board of directors.
Brii CEO disappointed by ‘the new reality’
The ACTIV-3 substudy that is investigating the treatment of hospitalized COVID-19 patients with Brii’s mAb cocktail is being funded by NIAID. The funding is not part of Operation Warp Speed.
The lack of U.S. government support for his company’s R&D on COVID-19 mAbs has been “disappointing,” Zhi Hong, president and CEO of Brii, told BioCentury.
Brii was launched in 2018 with $260 million from Arch Venture Partners and a syndicate of Chinese investors and a mission to serve as a bridge between China and the U.S. by bringing drugs to treat infectious diseases to China and developing new infectious disease therapies for China and the world.
Arch co-founder and managing director Robert Nelsen serves on Brii’s board of directors, as does Vir’s Scangos. Arch also backed Vir and Nelsen serves on Vir’s board.
Brii’s Chinese roots “don’t help us in terms of getting funding to do R&D work [on COVID-19] like some other U.S. companies are able to get,” Hong said. He added that he hopes that “once we show some early data, for example, in ACTIV-3 or other trials that we're moving forward, those good data will speak for itself and then potentially help us to focus on addressing the patient need rather than bilateral issues.”
Hong said that Brii “is a multinational company, we're not just a Chinese company. Close to half of my team is in the U.S.” and much of the work on developing its mAbs has been conducted in the U.S.
Hong has a long history of working at the intersection of public health and infectious disease innovation. Before co-founding Brii, he was SVP and head of the Infectious Disease Therapy Area Unit at GSK for more than a decade, during which he prioritized making infectious disease therapies available to address global public health issues related to HIV and flu pandemics as well as antimicrobial resistance. He led GSK’s Institute for Infectious Diseases and Public Health in Beijing, which was formed in 2016 to provide patients access to affordable infectious disease treatments.
The need to factor geopolitics into the development of therapies intended to combat an infection that respects no boundaries has been a rude surprise, Hong told BioCentury. “Especially for somebody like me who has for decades devoted myself to public health, it was very disappointing to recognize the new reality.”