These COVID-19 antibodies show “potent neutralizing effects”

September 8, 2020
Washington’s officially back to work. To kick off the short but sure-to-be-busy week, we take a closer look at Twist Bioscience’s antibody announcement as well as a recent meeting with South Africa’s biotech industry and regulators. Here are around 900 words, 4 and a…

Washington’s officially back to work. To kick off the short but sure-to-be-busy week, we take a closer look at Twist Bioscience’s antibody announcement as well as a recent meeting with South Africa’s biotech industry and regulators. Here are around 900 words, 4 and a half minutes.

These COVID-19 antibodies show “potent neutralizing effects”—and they’re made with synbio

Twist Biosciences Corporation’s therapeutic COVID-19 antibodies show “potent neutralizing effects,” according to new data released by the BIO member company. Here’s the scoop.

Twist Biosciences is a synthetic biology (synbio) and genomics company that has developed a “disruptive DNA synthesis platform” to manufacture DNA at the scale needed for drug R&D, biochemicals, agriculture, and more.

They’ve researched two promising therapeutic antibodies to treat COVID-19: Immunoglobulin G (IgG) antibodies, which target the SARS-CoV-2 spike protein, and substantially smaller single domain VHH “nanobodies,” which “can squeeze into spaces and bind or block to parts of molecules that would otherwise be inaccessible to human IgG antibodies,” making them good candidates to treat respiratory infections via an inhaler.

And these antibodies show potent neutralizing effects—“comparable to or better than those seen with antibody candidates derived from patients who had recovered from COVID-19,” according to the company.

Why use synbio? “The candidates were identified…in just six weeks by screening [Twist’s] proprietary synthetic antibody discovery libraries each containing more than 10 billion antibody sequences, and within months produced robust neutralization data in live virus cells.”

What’s next? The results “warrant advancement of several of these compounds into animal studies and potentially into human clinical trials,” said Dr. Richard Bowen of Colorado State University, where scientists independently verified the data. (The full data sets are available on the Twist website and will be submitted to a peer-reviewed journal.) 

Learn more about how the bioeconomy is engaging in the COVID-19 fight.

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How South Africa plans to drive access to new cures

BIO’s International Affairs Team sent us an update on a recent virtual meeting with AfricaBio, our sister association in South Africa, where they discussed how South African government and industry are driving access to new medicines and the importance of collaboration on COVID-19. 

One key challenge in South Africa: long delays in regulatory review. We heard insights from Dr. Boitumelo Semete, CEO of the South African Health Products Regulatory Authority (SAHPRA), a newly created entity to address this problem.

Dr. Semete is doing great work to reform the agency. She shared three key messages on what she sees as her role:

  • Supporting R&D as well as commercialization and access. As a regulator, she sees her role as enabling innovation as well as being efficient and responsive.
  • Supporting local innovation and local manufacturing.
  • Stimulating and catalyzing access to medicines, especially for emerging therapies, where SAHPRA must work with other regulators to enable adoption. 

Here’s how she plans to achieve these goals:

  • Collaboration. This includes work sharing as well as regional partnerships and looking at global trends.
  • Capacity building. SAHPRA must build internal capacities instead of relying solely on external consultants, by developing skill sets, training programs (like U.S. Trade and Development Agency reliance training), internal and external evaluator capacity, and nurturing the next generation of regulatory experts through internships and community service programs.
  • Digital transformation.
  • Improving stakeholder engagement. Right now, “the regulator is not accessible.”
This meeting was part of the BIO Africa annual conference, which this year brought together local and global industry and government officials to COVID-19. Panels and side meetings focused on preparing South Africa for uptake of COVID technologies by supporting local players that might be involved, like vaccine manufacturers. (BIO's Joe Damond talked about the COVID-19 pipeline.)

Global Blood Therapeutics (GBT) President and CEO Dr. Ted Love also participated in BIO Africa, and discussed his company’s treatment for sickle cell disease, which is prevalent among African patients. (Learn more in this episode of the I AM BIO Podcast.)

Joe’s World: COVID-19 is a reminder of how closely we’re all connected, and how health outcomes on one side of the world can have an impact on the other. As second and third waves of the pandemic are popping up in many countries, it’s clear we need to reach across borders in order to beat this virus. BIO looks forward to continuing to collaborate with our colleagues at AfricaBio and in the South African government, as well as with our international sister organizations around the world, to find treatments, vaccines, and diagnostics for this disease and others. – Joe Damond, BIO’s Executive Vice President for International Affairs


More Health Care News: 

STAT News: Operation Warp Speed promised to do the impossible. How far has it come?
“The vaccine makers are already producing doses, before they even know if the vaccines work. The idea is that if a vaccine is shown to be protective, use of it can start immediately. Moncef Slaoui, the scientific head of OWS, told STAT last week that the initiative has already started to stockpile upward of hundreds of thousands of doses.” 

The Wall Street Journal: COVID-19 vaccine developers prepare joint pledge on safety, standards
“A draft of the joint statement, still being finalized by companies including Pfizer Inc., Johnson & Johnson, and Moderna Inc. and reviewed by The Wall Street Journal, commits to making the safety and well-being of vaccinated people the companies’ priority. The vaccine makers would also pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in the manufacturing processes.”

BIO Beltway Report

President Trump’s Tuesday: Heading to Jupiter, FL, where he’s expected to give remarks on environmental issues. Then, to Winston-Salem, NC, for a campaign event.

What’s Happening on Capitol Hill: Officially back to work, with government funding and the next round of coronavirus aid at the top of the list, per POLITICO PRO. Tomorrow, September 9, Senate HELP will hold a full committee hearing, Vaccines: Saving Lives, Ensuring Confidence, and Protecting Public Health.

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