COVID-19 Update: Biden blasts testing shortfall; Biogen to manufacture Vir’s mAbs; Gates funding Inovio’s device; Cruz wants reciprocal approvals

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Joe Biden Thursday blasted the Trump administration for the slow rollout of COVID-19 tests and Tony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, acknowledged that the response has been “a failing.”

Total U.S. COVID-19 testing capacity increased incrementally Thursday to about 20,000 tests per day, according to a tally from the American Enterprise Institute. Trump administration officials have said they cannot provide estimates of testing capacity.

Former Vice President Biden called on the White House to provide daily reports on the numbers of tests conducted by the CDC, state and local health authorities, and private laboratories.

In a speech, Biden said the Trump “administration’s failure on testing is colossal, and it’s a failure of planning, leadership and execution.”

In testimony to the House Oversight and Investigations Committee, Fauci said “the system is not really geared to what we need right now.”

Implicitly contradicting recent statements from President Donald Trump and HHS Secretary Alex Azar who have said that tests are widely available, Fauci added that the lack of tests “is a failing; let’s admit it.” He said that “the idea of anybody getting it easily the way people in other countries are doing it, we are not set up for that. Do I think we should be? Yes. But we are not.”

Biogen, Vir in COVID-19 mAbs deal

Vir Biotechnology Inc. (NASDAQ:VIR) Thursday announced a partnership with Biogen Inc. (NASDAQ:BIIB) for the development and clinical manufacturing of human mAbs for the potential treatment of COVID-19.

Under a letter of intent signed by the two companies, Biogen would be responsible for cell line development, process development and clinical manufacturing activities to develop antibodies discovered by Vir. Financial terms were not disclosed.

Vir CEO George Scangos is the former CEO of Biogen and chair of a BIO committee that is coordinating the biotech industry’s COVID-19 responses.

Vir has reported that it has identified mAbs that bind to SARS-CoV-2, the virus that causes COVID-19. The mAbs were isolated from individuals who had survived infection with the related SARS coronavirus.

Vir’s technology stems from its 2017 acquisition of Humabs BioMed S.A., which is located in Bellinzona, Switzerland.

Vir has also announced a collaboration with WuXi Biologics Inc. (HKEX:2269). Under the deal, WuXi Biologics will develop and manufacture mAbs discovered by Vir to treat and/or protect against COVID-19. WuXi Biologics will be responsible for cell-line development, process and formulation development, and initial manufacturing for clinical development. The deal gives WuXi Biologics commercialization rights in Greater China.

Vir gained $3.83 (11%) to $37.60 on a day when the Dow Jones Industrial, NASDAQ Composite, Standard & Poor’s 500 and key biotech indexes fell 9-11%. Biogen fell $25.37 to $268.88.

Gates funding for Inovio

Inovio Pharmaceuticals Inc. (NASDAQ:INO) said Thursday it has received a $5 million grant from the Bill & Melinda Gates Foundation to accelerate the testing and scale-up of Cellectra, a device for the intradermal delivery of its COVID-19 DNA vaccine, INO-4800 (see “Plotting a Scientific Path to Counter COVID-19”).

The portable handheld device allows for stockpiling without maintenance in a pandemic scenario, Inovio said.

Inovio has already received a grant of up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop INO-4800; the company expects to start a U.S. Phase I trial of the vaccine in April.

The Gates Foundation is also partnering with the Wellcome Trust and Mastercard to invest up to $125 million to fund a COVID-19 Therapeutics Accelerator (see “Trio Commit $125M to COVID-19 Therapies”).

Inovio added $1.13 (14%) to $9.50 Thursday.

Reciprocal approval bill

Sens. Ted Cruz (R-Texas) and Mike Lee (R-Utah) have tweaked reciprocal international drug and device approval legislation for the COVID-19 outbreak.

Cruz and Lee Wednesday released a draft of the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULTS) for Coronavirus Patients Act of 2020 and said they intend to introduce it soon.

The bill would require FDA, within 30 days of a request from a manufacturer, to approve any drug or device that had been approved in any of a number of foreign countries to treat or prevent the “coronavirus or another disease of epidemic potential.” Reciprocal approval would apply to Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the European Union, or a country in the European Economic Area.

FDA could reject a request for reciprocal approval if it determined that a drug or device wasn’t safe or effective, and it could require postmarketing studies of drugs approved through the reciprocal process.

Congress, however, would have the power to override a decision by FDA to decline to grant reciprocal marketing approval.

Cruz and Lee did not provide any evidence that relevant products have been or are likely to be approved outside the U.S. prior to FDA approval.

Similar legislation introduced by Cruz, Lee and Sen. Ron Johnson (R-Wis.) in July 2019 that was not limited to drugs and devices for pandemics has not attracted support in the Senate.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus. Click here to sign up for our daily email.

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