Centivax Antibody Effective in Reducing COVID-19 Lung Damage, Virus Levels and Symptoms as Both Therapeutic and Preventative in Healthy and Immunocompromised Hamsters; Confirmed by Multiple National Laboratories

“Hamsters, like humans, can become infected and fall ill after exposure to SARS-CoV-2, the virus that causes COVID-19. This is why hamsters are considered the gold standard to evaluate the effectiveness of therapeutics to treat and prevent the novel coronavirus in humans,” explains Dr. Sawsan Youssef, Chief Science Officer of Distributed Bio and Centivax.

“This is a watershed moment for a COVID-19 therapy,” says Dr. Jacob Glanville, Founder, CEO, and President of Centivax and Distributed Bio. “These two world-class laboratories came to the same robust conclusion: that we had generated neutralizing antibodies that successfully protected hamsters from the novel coronavirus. Independent validation of this kind is a cornerstone of good medical science. We move forward now with confidence into rapid clinical development of our human therapy.”

Therapeutic Applications

Dr. Alex Bukreyev’s laboratory led the protective hamster model research at UTMB/GNL, where hamsters already infected with COVID-19 were administered the Centivax lead antibody. “We tested the Centivax lead antibody in the hamster model of COVID-19 and observed a significant reduction of the viral load in the lungs and reduced pathology,” stated Dr. Bukreyev.

“These positive antiviral results in the hamsters provide support for the use of our Centivax antibody in a hospital setting as a rapid treatment for severe, moderate, and mild COVID-19 patients,” says Dr. Jacob Glanville.

Preventative Applications

The positive preventative results indicate that the Centivax antibody could be used as a prophylactic to protect vulnerable populations such as the elderly, the immunocompromised, and frontline care workers from the symptoms of COVID-19. Dr. Jay Hooper’s laboratory led the prophylactic model research at USAMRIID, where hamsters were first administered the Centivax antibody and then exposed to the novel coronavirus. “Two monoclonal antibodies that showed promise in our neutralization assay were tested in two Syrian hamster models of COVID-19 — both antibodies showed evidence of protective efficacy,” Dr. Hooper remarked. His laboratory confirmed that the Centivax lead antibodies provided protection in both healthy as well as immunocompromised hamsters. A similar effect in humans could protect high-risk and immunosuppressed populations from COVID-19.

Coronavirus Neutralization

These results expand on previous findings by five independent laboratories across 3 nations that the Centivax antibodies were able to potently neutralize the novel coronavirus SARS-CoV-2. In addition to previous reports of neutralization of the virus by USAMRIID, UTMB/GNL, and Dr. Peter S. Kim’s lab at Stanford University, two additional partners confirmed potent neutralization: Dr. Nigel Temperton’s laboratory, Viral Pseudotype Unit at the University of Kent in the United Kingdom, and Sino Biological in China. “The Viral Pseudotype Unit evaluated a panel of Centivax/Distributed Bio antibodies for their ability to neutralize SARS-CoV-2 Spike-pseudotyped HIV vectors. Many were found to be potent neutralizers in our sensitive assay,” stated Dr. Temperton. “We evaluated a panel of 50 antibodies from Centivax/Distributed Bio: we identified multiple potent neutralizers in our assay,” added Dr. Zie Zhang, President of Sino Biological.

“Best-in-Class” Therapeutic Optimization

“While neutralization of the coronavirus is necessary, there are many other factors that influence the performance of a therapeutic antibody,” explains Sarah Ives, Director of Contract Research at Distributed Bio. “By leveraging the advanced bioengineering capabilities at Distributed Bio, we have enhanced the potency, thermostability, safety, half-life, and manufacturability of the Centivax lead candidates.” Centivax was able to successfully engineer these potent therapeutic antibodies in less than 9 weeks by implementing Distributed Bio’s breakthrough computationally optimized antibody engineering technologies: Tumbler to adapt antibodies previously proven to neutralize SARS-CoV-1 from 2002 to target the related but novel SARS-CoV-2, and SuperHuman 2.0 to discover new antibodies de novo. For both technologies, the discovery process included optimization engineering for affinity, thermostability, humanness, specificity, safety, half-life, non-immunogenicity, and manufacturability. “Such optimizations have very practical consequences, as they enable Centivax antibodies to have outstanding safety profiles, be manufactured more easily and less expensively, be more shelf-stable, and possibly be delivered more conveniently, such as though subcutaneous injection outside a hospital environment,” explains Dr. David Gangemi, Director of Virology at Centivax. “The objective is to deliver a best-in-class therapeutic with an optimized therapeutic profile,” concludes Dr. Glanville, “to make a medicine I would give to my own family.”

Safety and Clinical Development

Going forward, the best antibodies are being progressed for safety assessment with Charles River Laboratories. “We are encouraged by the neutralizing effect seen thus far,” said Birgit Girshick, Corporate Executive Vice President at Charles River. “As a strategic partner of Distributed Bio, we’re proud to support this innovative program and are excited by the potential it holds.” Centivax aims to complete pre-clinical development and initiate a clinical study for COVID-19 patients by the end of summer, and remains open to any collaborative opportunities to further accelerate rapid global access to the medicine to follow. “This will likely be the fastest I’ve ever taken a therapeutic antibody into the clinic,” explains Dr. Sawsan Youssef, “but the world needs this therapy now.”

For more information on preclinical discovery and development, please see our prior press release on in-vitro neutralization and a piece from the magazine Our World. Centivax would like to thank the community effort of over 1,200 people across 44 nations who donated to help enable the discovery and characterization of these antibodies.

[The information contained in this press release does not necessarily reflect the position or policy of the Government and no official endorsement should be inferred.]

About Centivax

Centivax is a therapeutics company founded to treat, cure and eradicate complex pathogens of the 21st century. This goal is executed by combining computationally guided therapeutic engineering to efficiently make break-through medicines, with a unique business strategy to make sure that we have the freedom to pursue medicines that matter and sell those medicines at a price that the world can afford. Centivax technologies were made possible by the emerging field of computational immunology and developed by pioneers of that field over a decade. From our unique vantage point as the creators of these technologies, we were able to see that the true consequence of computational immunoengineering went far beyond disrupting the biologics discovery services market, and had broken open pathways to victory against many of the major outstanding druggability challenges in our generation of medicine. Central to Centivax’s DNA is a commitment to making all of our medicines available at close to cost in the developing world and to run a lean business that keeps our medicines affordable. We focus on common-sense rapid product creation as a means of ensuring a sustainable R&D budget while reducing our reliance on external funding and ensuring that our incentives are always aligned with making medicines that matter. In 2019, Centivax’s universal vaccine technology was awarded a Gates Foundation Grand Challenge “End the Pandemic Threat” award and was featured in the Netflix documentary series Pandemic: How to Prevent an Outbreak.

Contact:

Press & Communications: info@centivax.com

Therapeutics & Diagnostics: partner@centivax.com

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About Distributed Bio

Distributed Bio is a biologics discovery contract research organization and a field leader in computational immunoengineering of biomedicines. Our mission is to create breakthrough technologies to drug previously challenging targets (GPCRs, ion channels, pMHC complexes, condition-specific binders, anti-idiotypes, and broadly neutralizing viral epitopes), engineering IgGs, CAR-Ts, VHHs, bi-specifics and other biologic modalities to suit any therapeutic area. Distributed Bio’s SuperHuman 2.0 computationally optimized antibody library contains more than 76 billion unique fully human and computationally diversified antibodies, enabling rapid recovery of high affinity, therapeutic-quality antibodies against novel therapeutic targets like SARS-CoV-2. SuperHuman2.0 has been licensed by numerous pharmaceutical companies and can be accessed through Distributed Bio discovery services to generate antibodies against any target. In addition, the Distributed Bio Tumbler platform is another industry standard antibody optimization technology, licensed by multiple pharmaceutical partners to optimize the developability and potency of biologic medicines. Distributed Bio has been profitable since day one in 2012 with no venture capital investment.

Contact:

Press & Communications: info@distributedbio.com

Antibody Discovery & Optimization: bd@distributedbio.com

distributedbio.com | info@distributedbio.com | Twitter: @distributedbio

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