CastleVax, Inc.

NEW YORK, NY, USA I July 30, 2024 I CastleVax, a clinical stage mucosal vaccine platform company, has received an additional Project NextGen award valued at approximately $34 million to support the continued development of the company’s next-generation, mucosal vaccine to protect against symptomatic COVID-19 infection. The project award was made through the Biomedical Advanced Research and Development Authority’s (BARDA’s) Rapid Response Partnership Vehicle (RRPV) to support CastleVax in planning for and preparing the mucosal vaccine candidate CVAX-01 for Phase 2b clinical efficacy testing. The RRPV is a Consortium funded by BARDA, part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). Under the award, CastleVax, in collaboration with BARDA’s Clinical Studies Network, will conduct a Phase 2b efficacy study enrolling 10,000 trial participants; half will receive a single intranasal dose of CastleVax’s next-generation NDV-HXP-S vaccine (CVAX-01), and half will receive a single intramuscular dose of a currently licensed COVID-19 vaccine. All study participants will be actively monitored post-vaccination for the occurrence of SARS-CoV-2 breakthrough infection. Based upon pre-clinical and Phase 1 clinical data, it is expected that participants receiving CastleVax’s next-generation, nasally delivered, CVAX-01 COVID-19 vaccine will demonstrate reduced numbers of SARS-CoV-2 breakthrough infections relative to individuals who received the standard systemic vaccine. “CastleVax is grateful to continue our clinical development efforts under BARDA’s Project NextGen of our innovative, next-generation, mucosal COVID-19 vaccine to protect against breakthrough infection and transmission,” said Michael Egan, PhD, CastleVax’s Chief Executive Officer and Chief Scientific Officer. The NDV-vectored vaccine platform was developed by Icahn School of Medicine at Mount Sinai scientists Peter Palese, PhD, Horace W. Goldsmith Professor and Chair Emeritus of Microbiology; Adolfo García-Sastre, PhD, Director of the Global Health and Emerging Pathogens Institute, and the Irene and Dr. Arthur M. Fishberg Professor of Microbiology and Medicine (Infectious Diseases); Florian Krammer, PhD, Professor in Vaccinology; and Weina Sun, PhD, Assistant Professor of Microbiology, and was licensed by Mount Sinai to CastleVax Inc. Mount Sinai has a financial interest in this technology and in CastleVax. Drs. Palese, García-Sastre, Krammer, and Sun also have a financial interest in this technology and in CastleVax pursuant to the Mount Sinai Intellectual Property Policy. Mount Sinai is represented on the CastleVax Board of Directors by Dr. Erik Lium; Mr. Matthew Rosamond, Chief Financial Officer, Icahn Mount Sinai; and Mr. Stephen Harvey, MBA, Chief Financial Officer, Mount Sinai Health System. This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number 75A50123D00005. About CVAX-01 : The next-generation, live, attenuated, NDV-vectored COVID-19 vaccine (CVAX-01) expresses a stabilized SARS-CoV-2 spike protein, utilizing HexaPro technology developed in the laboratory of Dr. Jason McLellan at The University of Texas at Austin and licensed to CastleVax. The CVAX-01 vaccine has an attractive safety profile and low reactogenicity in humans as documented in several completed and on-going phase 1, 2 and 3 clinical trials (NCT04871737, NCT05205746, NCT05710783 and NCT05181709). In addition, the live version and an inactivated version of this same vaccine delivered by intramuscular administration has completed two Phase 3 immunobridging studies and has received Emergency Use Authorization in Mexico and Thailand, respectively. About CastleVax : In August of 2022, the Mount Sinai Health System launched CastleVax, Inc., a clinical-stage vaccine research and development company devoted to the commercial development of the NDV vaccine platform technology with an initial focus on respiratory viruses. For more information on CastleVax and the NDV vaccine platform, visit https://www.castlevax.com . SOURCE: CastleVax

Pictured: White House/iStock, Danny Kronstrom Pharmaceutical companies have come under fire from the White House for the second time in as many weeks. The Biden administration announced Thursday “dozens” of drugmakers will be required to pay inflation rebates back to the Centers for Medicare and Medicaid Services due to “price gouging.” Under the Inflation Reduction Act (IRA), CMS has come up with a list of 48 Medicare Part B drugs that raised their prices faster than inflation and “may be subject to inflation rebates in the first quarter of 2024,” according to the agency’s announcement. The White House contends that the IRA will save some seniors who take the 48 Medicare Part B drugs from their yet undisclosed list “as much as $2,786 per average dose.” CMS said in its press release that it will issue invoices for the rebates to the drug companies involved starting in 2025, including years 2022, 2023 and 2024. The White House’s press release specifically called out Signifor, an endocrine disorder drug developed by Novartis, for raising prices faster than inflation every quarter since the IRA passed into law in August 2022. “Some Medicare beneficiaries who take Signifor could save $311 per monthly dose starting January because of the law,” according to the Biden administration. Last week, the White House announced its intention to invoke “march-in rights” to take back patents of expensive medications whose research relied on federal funds. While use of march-in rights is not likely to be widespread, Department of Health and Human Services Secretary Xavier Becerra said in a statement that it is a “powerful tool” to help “ensure that the benefits of the American taxpayer’s investment in research and development are reasonably accessible to the public.” HHS on Thursday also announced that the Administration for Strategic Preparedness and Response (ASPR) is making fair pricing a standard part of contract negotiations for medical products. In September 2023, ASPR finalized a Project NextGen contract—a government initiative to advance new vaccines and therapeutics faster and at lower cost—which was signed by Regeneron, agreeing that if pharma’s COVID-19 treatment is commercialized, its list price in the U.S. will be equal to or less than retail price in comparable global markets. Similar language has also been added to agreements with a handful of other vaccine developers like CastleVax, Codagenix and Gritstone Bio, the first three vaccines selected for development under Project NextGen, the Biden administration said. Pharma companies have been fighting the IRA’s Drug Price Negotiation Program in court, with lawsuits claiming the Medicare negotiations are unconstitutional. They say it will force companies to sell at lower-than-market value and threaten R&D in the future for new and innovative medicines. However, as of October 2023, all 10 of the pharma companies whose products were selected in the first round of Medicare price negotiations begrudgingly agreed to participate in the talks under the IRA. A recent report found that if the Medicare price negotiation program had been in effect in 2021, out of pocket costs for Part D participants would have dropped 23% for patients on the 10 costliest drugs at the time. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

The U.S. government announced Friday the selection of three next generation COVID-19 vaccine candidates, awarding millions of dollars to support mid-stage clinical trials of the shots as part of the Project NextGen initiative.Launched in May by the Department of Health and Human Services, Project NextGen is designed to advance new COVID therapies and serve as a successor of sorts to Operation Warp Speed, which helped bring the first coronavirus vaccines to market.All told, the federal government is doling out $500 million in new awards, on top on a $1.4 billion in contracts that HHS announced in August.Through Project NextGen, we are combining research and development expertise at HHS with the lessons learned throughout the pandemic to protect our nation from COVID-19, said HHS Secretary Xavier Becerra, in a Friday statement.Under the new awards, CastleVax received $8.5 million for developing its vector-based intranasal vaccine, Codagenix got $10 million for a live attenuated nasal vaccine and Gritstone Bio won $10 million for its self-amplifying mRNA-based vaccine. (Gritstone disclosed the funding last month.)The Biomedical Advanced Research and Development Authority is awarding the rest of the $481 million to companies supplying laboratories, tools for preparedness against COVID outbreaks, genome sequencing and cold-chain sample management. Some of the other companies receiving the funding include Vir Biotechnology, Luminary Labs and ModeX Therapeutics.The investment comes as demand for the current vaccines has waned. Pfizer and Moderna, whose shots dominate the U.S market, have reported declining sales this year. They are currently rolling out recently approved versions updated to target newer circulating strains. But distribution is no longer being centrally managed by the federal government, and uptake has been complicated by patchy availability.Both companies are now working to develop combination influenza and COVID vaccines. Moderna announced earlier this month positive results for its candidate from an early-stage study, and is targeting an approval in 2025.A combination shot could make vaccination against the two recurring pathogens more convenient and, over time, Moderna expects the COVID vaccine market to resemble that for flu. '