Project Grant R43AI165352
- This Project Grant award of $161,500.00 from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research Federal Grant Program (CFDA 93.855) aims to develop a stable mRNA prophylactic vaccine against the SARS-CoV-2 Omicron variant. The awardee, The Methodist Hospital Research Institute, will apply its "RNA-Plex" technology, which uses a polymer-based carrier to stabilize mRNA molecules and enhance their translation in cells, to...
- This National Science Foundation (NSF) Small Business Technology Transfer (STTR) Phase I grant, awarded under the NSF Technology, Innovation, and Partnerships (CFDA 47.084) program, provides $274,991 to Duravax Inc. to develop thermostable formulations of mRNA vaccines and therapeutics. The project aims to overcome the cold-chain limitations of current mRNA products by demonstrating the feasibility of storing mRNA APIs and mRNA-lipid nanoparticles at room temperature for extended periods. If...
- This Project Grant award from the National Science Foundation (NSF) Technology, Innovation, and Partnerships (TIP) program (CFDA 47.084) provides $305,000.00 in funding to Immuno Nano Med, Inc. to demonstrate the feasibility of producing a novel room-temperature-stable, dry-powder inhalable influenza vaccine. The goal is to develop an innovative, next-generation influenza vaccine technology that can promote public health by eliminating the pain points of current flu vaccines, such as the need...
- This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), with a CFDA number of 93.855, provides $314,347 in funding to Gateway Bio Inc. for the period from September 23, 2025 to August 31, 2026. The project aims to develop a new lipid nanoparticle (LNP) delivery system for mRNA payloads that uses a proprietary polyethylene glycol (PEG) alternative called POEGMA. This novel LNP is intended to address concerns around PEG-related allergies and reduced...
- This Cooperative Agreement award, valued at $1,673,641.00, was provided by the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855). The goal is to evaluate a novel mRNA-based SARS-CoV-2 vaccine candidate that incorporates a multi-organ protection (MOP) sequence and an mRNA-encoded molecular adjuvant (IL-12p70) to enhance immune responses, particularly in older individuals. The project involves a two-stage clinical...
- This $249,999 National Science Foundation project grant supports the development of a bioengineered nanobarrier spray to protect against SARS-CoV-2 and other viral infections of the nasopharynx. Funded under the NSF Engineering program (CFDA 47.041), the two-year award to the University of Southern California will support computational modeling of nanobarrier delivery via nasal applicator as well as efficacy testing in a coronavirus mouse model. Specifically, the university researchers will...
- This federal Project Grant award of $867,563 from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), aims to develop a pioneering class of nanobodies engineered from llama immune systems to provide comprehensive protection against all betacoronaviruses, including SARS-CoV-1, MERS-CoV, and SARS-CoV-2. The key products and services to be delivered include: Identifying and characterizing a diverse repertoire...
- The National Science Foundation (NSF) awarded a $997,689 Cooperative Agreement under its NSF Technology, Innovation, and Partnerships (CFDA 47.084) program to Omnicyte LLC, a minority-owned small business in Branford, CT. The funding supports the design and production of a next-generation COVID-19 vaccine that addresses weaknesses of current vaccines, such as reduced booster effectiveness, short-lived efficacy, and side effects. The project aims to develop a vaccine candidate with improved...
- The National Institute of Allergy and Infectious Diseases (NIAID) awarded a $676,666 Project Grant under the Allergy and Infectious Diseases Research program (CFDA 93.855) to The General Hospital Corporation, doing business as Massachusetts General Hospital (MGH), for the project "Spatial and Temporal Adjuvant Delivery for Skin mRNA Vaccination". The goal of this project is to determine whether intranasal or intradermal delivery of a newly developed adjuvant can expand the breadth...
- This $304,742 Project Grant awarded by the National Science Foundation (NSF) under the Technology, Innovation, and Partnerships (CFDA 47.084) program supports the development of a novel low-cost intradermal delivery platform for nucleic acid vaccines. The project aims to create a handheld pen device that can deliver electrical pulses through microelectrodes to create temporary pores in skin cells, allowing direct vaccine delivery to immune cells without the need for lipid nanoparticles (LNPs) or...
DOUBLE-ENCAPSULATED MRNA VACCINE FOR COVID-19 - PROJECT SUMMARY COVID-19, THE MULTIORGAN DISEASE CAUSED BY THE NOVEL CORONAVIRUS SARS-COV-2, HAS BECOME THE MOST IMPACTFUL HEALTHCARE, SOCIAL, AND ECONOMIC CRISIS OF OUR LIFETIME. SARS-COV-2 IS GENETICALLY RELATED TO THE PREVIOUS TWO CORONAVIRUSES THAT CAUSED HUMAN OUTBREAKS IN THE 21ST CENTURY, SARS-COV AND MERS-COV. EVEN THOUGH COVID-19 MORTALITY IS LOWER THAN THE OTHER TWO CORONAVIRUS DISEASES, THE PANDEMIC HAS IMPACTED, BY MID-APRIL 2022, >500 MILLION PEOPLE WORLDWIDE, AND CAUSED >6 MILLION DEATHS. HAD THE COVID-19 MORTALITY BEEN CLOSER TO THOSE OF SARS AND MERS, THE IMPACT OF THE CURRENT PANDEMIC WOULD BE INCOMPARABLY MORE CATASTROPHIC. THE NEED FOR COLD STORAGE, THE REQUIREMENT FOR BOOSTERS, AND THE POTENTIAL FOR ADVERSE ALLERGIC REACTIONS, ARE MAJOR DRAWBACKS OF CURRENT COVID-19 VACCINES. TO ADDRESS THESE SHORTCOMINGS, WE PROPOSE TO GENERATE A COVID-19 MRNA VACCINE THAT IS STABLE AT ROOM TEMPERATURE, REQUIRES ONLY ONE INJECTION, THUS BEING MORE PRACTICAL TO DEPLOY NATIONALLY AND GLOBALLY DURING VACCINATION CAMPAIGNS, AND IS LESS PRONE TO CAUSE HYPERSENSITIVITY REACTIONS. WE PLAN TO CONDUCT THIS PROOF-OF- CONCEPT STUDY OVER A 24-MONTH PERIOD WITH A MULTIDISCIPLINARY TEAM OF ENGINEERS, MOLECULAR VIROLOGISTS, AND IMMUNOLOGISTS. OUR OVERARCHING GOAL IS TO DOUBLE NANOENCAPSULATE THE MRNA MOLECULE THAT ENCODES THE CORONAVIRUS SPIKE PROTEIN IN PHOSPHOLIPID NANOSOMES AND THEN INTO BIODEGRADABLE POLYMER NANOSPHERES TO SUSTAIN MRNA RELEASE. WE WILL CHARACTERIZE THE ANTIGENICITY AND INTEGRITY OF THE NANOENCAPSULATED MRNA BEFORE AND AFTER NANOENCAPSULATION AND COATING AND DETERMINE THE BEST PROCESS CONDITIONS THAT ENSURE STABILITY AT ROOM TEMPERATURE AFTER LYOPHILIZATION. WE WILL ALSO EVALUATE THE SAFETY, PHARMACOKINETICS, AND IMMUNOGENICITY OF THE NANOENCAPSULATED ANTIGEN AND PERFORM CHALLENGE STUDIES IN TWO ANIMAL MODELS, IN ANTICIPATION OF SUBSEQUENT CLINICAL STUDIES. BASED ON THESE STUDIES, WE WILL SELECT THE BEST NANOFORMULATION FOR SCALE-UP, MORE DETAILED CHARACTERIZATION, ESTABLISH POTENCY AND RELEASE SPECIFICATIONS, AND REGULATORY STUDIES IN PHASE II.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | $0 | 7/7/25 | ||
| Not listed | $300.0k | 3/8/24 | ||
| Not listed | $0 | 3/7/24 | ||
| Not listed | $300.0k | 3/3/23 | ||
| Not listed | $300.0k | 3/3/23 |