The BLUE KNIGHT Resident QuickFire Challenge: Accelerating Project NextGen has awarded a $1 million joint grant to Jurata Thin Film, Inc., a company aiming to revolutionize vaccine and biologic manufacturing, storage, distribution, and delivery using their proprietary thin film formulation, and CastleVax, Inc., a company commercializing the Newcastle Disease Virus (NDV) vaccine platform developed at The Icahn School of Medicine at Mount Sinai.
These funds will be used to further the development of a thermostabilized next-generation vaccine against SARS-CoV-2 that can be transported and stored without temperature control (refrigeration or freezing), then delivered without needles to induce mucosal immunity.
Project NextGen is a $5 billion initiative launched by the U.S. Department of Health and Human Services (HHS) in May 2023 and overseen by the Biomedical Advanced Research and Development Authority (BARDA) that aims to fund the development and testing of next-generation vaccines against SARS-CoV-2 that, among other things, confer mucosal immunity, offer broader and longer-lasting protection against variants, and “enable faster, cheaper, rapid, and more flexible production of vaccines and therapeutics”. Using Jurata’s thin film platform to stabilize CastleVax’s live-attenuated, next-generation NDV-vectored COVID-19 booster vaccine is expected to result in a shelf-stable, needle-free vaccine capable of inducing mucosal immunity and protecting against breakthrough infection and transmission of the virus.
Launched from Mount Sinai, CastleVax is a clinical-stage biotechnology company whose two lead candidates, an inactivated NDV and a live-attenuated NDV, both against SARS-CoV-2, have already generated clinical results both domestically and abroad. Their live-attenuated, next-generation COVID-19 booster vaccine will be used for the awarded studies, as it has been shown to elicit mucosal immunity in a Phase 1 clinical study in the United States. While CastleVax’s vaccine has shown compelling results in the clinic, it currently requires ultra-cold storage and administration via an intranasal spray device, making it logistically challenging to distribute and administer in low-resource regions, including low- and middle-income countries (LMICs).
Jurata specializes in stabilizing temperature-sensitive vaccines and biologics, completely removing the need for refrigeration and freezing from manufacturing of the finished product all the way through administration of the therapeutic to patients. Additionally, Jurata has evidence to suggest that their thin film technology could also change the route of administration of vaccines from intramuscular or intranasal to sublingual (under the tongue) or buccal (inside the cheek).
The awarded project aims to optimize Jurata’s formulation to stabilize CastleVax’s live-attenuated, next-generation COVID-19 booster vaccine and show in preclinical studies that the resulting thermostable vaccine elicits equivalent protection against SARS-CoV-2, compared to CastleVax’s original vaccine formulation.
“We are so excited about our partnership with Jurata Thin Film,” says CastleVax’s Chief Executive Officer, Dr. Michael Egan. He continued, “their thin film technology could make our live-attenuated, next-generation COVID-19 booster vaccine far more accessible to patients, no matter where they are in the world.” Jurata’s Chief Scientific Officer, Dr. Irnela Bajrovic, added, “the combination of our company’s technologies offers many advantages compared to current COVID-19 vaccines. We are honored to receive this award to pursue this work.”
An inactivated NDV-HXP-S COVID-19 vaccine elicits a higher proportion of neutralizing antibodies in humans than mRNA vaccination
SARS-CoV-2 vaccines have been essential in combating the ongoing COVID-19 pandemic, but room for improvement remains. Here, Carreño et al. analyzed immune responses in individuals vaccinated with a Newcastle disease virus-based SARS-CoV-2 vaccine, NDV-HXP-S. This vaccine can be produced in embryonated chicken eggs, similar to the majority of influenza vaccines, making it readily translatable. The authors found that vaccination with NDV-HXP-S elicited a higher proportion of neutralizing antibodies against SARS-CoV-2 than vaccination with the BNT162b2 mRNA vaccine. NDV-HXP-S vaccinees also had a response more focused on the receptor binding domain. Together, these data highlight the promise of NDV-HXP-S, which has moved into a Phase III trial in Thailand. Science Translational Medicine
Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomised, placebo-controlled, phase 1 trial
Production of affordable coronavirus disease 2019 (COVID-19) vaccines in low- and middle-income countries is needed. NDV-HXP-S is an inactivated egg-based recombinant Newcastle disease virus vaccine expressing the spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It’s being developed by public sector manufacturers in Thailand, Vietnam, and Brazil; herein are initial results from Thailand. Study shows preliminarily that the inactivated NDV-HXP-S vaccine candidate has an acceptable safety profile and is highly immunogenic. This vaccine can be produced at low cost in any facility designed for production of inactivated influenza virus vaccine; such facilities are present in a number of LMICs. eClinicalMedicine