CastleVax
CastleVax is a clinical-stage biotechnology company developing a Newcastle Disease Virus-based mucosal vaccine platform, with lead candidate CVAX-01 — an intranasal COVID-19 vaccine — licensed from Mount Sinai and funded primarily by BARDA for global government and LMIC distribution.
- Company typePrivate
- Founded2022
- HeadquartersNew York, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What CastleVax does
CastleVax Inc. is a clinical-stage vaccine research and development company headquartered in New York City, founded in August 2022 as a spin-out from the Mount Sinai Health System. The company's core technology is a Newcastle Disease Virus (NDV)-based vaccine platform — a live, attenuated avian paramyxovirus engineered to express stabilized antigenic proteins — which is licensed exclusively from the Icahn School of Medicine at Mount Sinai and uses HexaPro spike protein technology (six proline substitutions) licensed from UT Austin. CastleVax's lead product is CVAX-01, an intranasal NDV-vectored COVID-19 vaccine candidate designed to induce both systemic and mucosal immunity, including secretory IgA at the respiratory portal of entry. The company also has licensed products distributed internationally (Patria in Mexico via Avimex with Emergency Use Authorization; HXP-GPOVac in Thailand via GPO with full regulatory approval) and a pipeline targeting RSV, HMPV, norovirus, and additional pandemic pathogens.
CastleVax operates a licensing and government-procurement business model rather than direct commercialization. Revenue streams are structured around licensing its platform technology to regional vaccine manufacturers (GPO Thailand, IVAC Vietnam, Avimex Mexico, Instituto Butantan Brazil) for local production using egg-based manufacturing infrastructure, supplemented by government grants and contracts — most notably a BARDA Project NextGen award valued at up to $338 million to advance CVAX-01 through Phase 2b clinical efficacy testing in 10,000 participants. The company serves governments and public health authorities (its primary customer segment) seeking vaccine supply security and pandemic preparedness, as well as high-risk individuals (65+ and immunocompromised) in need of mucosal immunity. Distribution occurs exclusively through technology transfer and licensing channels rather than direct sales.
The company is led by CEO/CSO Michael A. Egan, Ph.D. (25+ years of vaccine R&D experience from Gates MRI, Takeda, Profectus, and Wyeth) and co-founded by globally recognized Mount Sinai scientists Peter Palese, Adolfo García-Sastre, Florian Krammer, and Weina Sun. Board representation includes Mount Sinai Health System executives (Erik Lium as Board Chair; Stephen Harvey as CFO of MSHS; Matt Rosamond as CFO of Icahn School of Medicine). H.C. Wainwright & Co. serves as financial and capital markets advisor. With 1-10 employees, CastleVax remains a capital-efficient, science-driven organization whose valuation thesis depends on Phase 2b/3 clinical success and ultimate regulatory approval of its intranasal vaccine platform.
CastleVax firmographics
Firmographics- Name
- CastleVax
- Legal name
- CastleVax Inc.
- Website
- https://castlevax.com
- Company type
- Private
- Founded year
- 2022
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- CastleVax is a clinical-stage biotechnology company developing a Newcastle Disease Virus-based mucosal vaccine platform, with lead candidate CVAX-01 — an intranasal COVID-19 vaccine — licensed from Mount Sinai and funded primarily by BARDA for global government and LMIC distribution.
- Ownership category
- akta.pro rank
CastleVax industry classification
Industry- Product category
- Biotechnology
- NAICS
- Pharmaceutical Preparation Manufacturing (325412)
- SIC
- Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Vaccine Technology Platforms (mRNA, viral vector, protein subunit, inactivated/live-attenuated, VLP, DNA) (HLAAAEAD)
- akta.pro secondary industries
- Prophylactic Human Vaccines (routine, pediatric, adult) (HLAAAEAA), Vaccine Fill-Finish, Packaging & Cold-Chain Formulation (vial/syringe, lyophilization, thermostable) (HLAAAEAJ)
Keywords
Where CastleVax is headquartered
LocationHeadquarters
- HQ city
- New York
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
CastleVax business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Others
Revenue model
- Vaccine Development and Licensing: CastleVax is a clinical-stage vaccine platform company focused on developing and commercializing the NDV-based vaccine platform technology. Revenue will come from licensing the platform technology to manufacturers, government procurement contracts, and potential product sales upon regulatory approval.
- Government Contracts and Grants: CastleVax receives significant funding from government sources including BARDA Project NextGen awards (up to $338 million) and state-level biodefense funds for advancing clinical development of COVID-19 and future pandemic vaccines.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels3 records
CastleVax product offering
Product offeringCore offering
CastleVax is a clinical-stage vaccine platform company that develops and licenses mucosal (intranasal) vaccines built on the Newcastle Disease Virus (NDV) vector platform expressing stabilized antigens such as HexaPro spike protein. Its lead candidate CVAX-01 targets COVID-19 and is in Phase 2 clinical testing, while the broader NDV platform supports a pipeline of respiratory and pandemic-preparedness vaccines licensed to international manufacturers in Thailand, Vietnam, Brazil, and Mexico.
Product overview
CastleVax is a clinical-stage vaccine company with a platform-plus-products architecture. The core technology is the Newcastle Disease Virus (NDV) vaccine platform, which produces live attenuated mucosal vaccines. The primary product is CVAX-01, a next-generation intranasal COVID-19 vaccine, alongside NDV-HXP-S (an alternative COVID-19 formulation). The company also has licensed products (Patria in Mexico, HXP-GPOVac in Thailand) and a robust pipeline including bivalent RSV+HMPV and Norovirus mucosal vaccines, plus a broader pandemic preparedness program targeting multiple viral pathogens.
Differentiator
Problem solved
Functional benefit
Brands
- CVAX-01: Next-generation intranasal COVID-19 vaccine candidate using Newcastle Disease Virus (NDV) vector technology with HexaPro spike protein.
- NDV-HXP-S
Products and services
- CVAX-01 Next-generation, live, attenuated, Newcastle Disease Virus (NDV)-vectored intranasal COVID-19 vaccine candidate expressing a stabilized SARS-CoV-2 spike protein using HexaPro technology. Designed to elicit mucosal immunity and protect against SARS-CoV-2 breakthrough infection and transmission. Currently in Phase 2 clinical testing.
- NDV-HXP-S COVID-19 booster vaccine utilizing Newcastle Disease Virus vector technology expressing stabilized SARS-CoV-2 spike protein with HexaPro technology. Available as live attenuated (intranasal/intramuscular) and inactivated (intramuscular) formulations. Demonstrated safety profile and low reactogenicity in multiple Phase 1, 2, and 3 clinical trials.
- NDV Vaccine Platform Live, attenuated Newcastle Disease Virus (NDV)-based vaccine platform for developing mucosal vaccines. Enables rapid development of safe and highly immunogenic viral vectors using efficient mucosal delivery, with no pre-existing immunity in humans, flexible genome capacity up to 5kb, and bilipid membrane for foreign antigen incorporation. Supports monovalent, bivalent, or multivalent formulations. Licensed from Mount Sinai on an exclusive basis.
- Patria (AVX/COVID-12) NDV-based COVID-19 vaccine developed by Laboratorio Avimex under license from CastleVax. Received Emergency Use Authorization in Mexico from COFEPRIS. Phase 3 results demonstrated effectiveness as a booster vaccine generating neutralizing antibodies comparable to WHO-approved vaccine comparator.
- HXP-GPOVac NDV-HXP-S COVID-19 vaccine produced by Thailand's Government Pharmaceutical Organization (GPO). Inactivated formulation produced using egg-based technology. Received conditional approval for emergency use in Thailand as a booster for adults 18 years and older, marking the first domestically produced COVID-19 vaccine in Thailand.
- Bivalent RSV+HMPV Vaccine Mucosal vaccine candidate targeting Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV) in development as part of CastleVax's pipeline of respiratory virus mucosal vaccines.
- Mucosal Norovirus Vaccine Mucosal vaccine candidate targeting Norovirus in development as part of CastleVax's pipeline of mucosal vaccines for respiratory and enteric pathogens.
- Pandemic Preparedness Pipeline NDV platform engineered to express antigens from emerging and endemic viruses including SARS-CoV-2, RSV, HMPV, CMV, HBV, HCV, Arenaviruses (Lassa), Filoviruses (Ebola), Nipah Virus, Hendra Virus, Chikungunya, Rift Valley Fever, Hantavirus, and Highly Pathogenic Avian Influenza for pandemic preparedness.
Quantifiable outcome
- In Phase 1/2 studies, NDV-HXP-S performed as well as Pfizer/BioNtech vaccine and outperformed AstraZeneca vaccine in immunogenicity
- +3 more outcomes
Companies that use CastleVax
Customer profileNamed customers4 records
Segments3 records
Ideal customer profiles3 records
CastleVax technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
CastleVax partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and major.
- AptarGroup, Inc.coreAptarGroup provides nasal vaccine delivery solutions (LuerVax® and Spray Divider™) utilized in CastleVax's Phase II clinical trial of CVAX-01. Their regulatory and technical expertise supports next-generation nasal vaccine delivery development.
- Icahn School of Medicine at Mount SinaicoreMount Sinai developed the NDV-vectored vaccine platform technology through scientists Peter Palese, Adolfo García-Sastre, Florian Krammer, and Weina Sun. Licensed exclusively to CastleVax for commercial development. Mount Sinai holds a financial interest in CastleVax and is represented on the Board of Directors.
- The University of Texas at Austin (UT Austin)coreUT Austin developed the HexaPro spike protein technology (6 proline stabilizing mutations) used in CastleVax's vaccines. Licensed on a non-exclusive basis to CastleVax. The same team previously developed spike proteins used in several approved COVID-19 vaccines globally.
- Laboratorio Avimex (Mexico)majorAvimex licensed CastleVax's NDV-based vaccine technology to develop Patria® (AVX/COVID-12) COVID-19 vaccine. Completed Phase 3 clinical trials showing effectiveness as a booster comparable to WHO-approved vaccine. Received Emergency Use Authorization in Mexico. Project financed by Conacyt (Mexican National Council of Science and Technology).
- Government Pharmaceutical Organization (GPO) ThailandmajorGPO licensed the NDV-HXP-S vaccine technology for domestic production in Thailand. Completed Phase 3 clinical evaluation with 4,000 volunteers. Received conditional approval for emergency use - the first domestically produced COVID-19 vaccine in Thailand. Manufacturing capacity of 5-10 million doses annually.
- Institute of Vaccines and Medical Biologicals (IVAC) VietnammajorIVAC licensed the NDV-HXP-S vaccine (COVIVAC) for production in Vietnam. Phase 2 results showed higher concentration of neutralizing antibodies compared to AstraZeneca vaccine. Phase 3 clinical trials in planning.
- PATHmajorPATH served as connector, facilitator, and technical advisor for the international NDV-HXP-S vaccine consortium. With funding from CEPI, PATH supported consortium efforts aligned with advancing immunization equity. Supported vaccine development in Thailand, Vietnam, and Brazil.
Scale indicators7 records
Recent moves7 records
Expansion highlights5 records
CastleVax competitors and assessment
Company assessmentOthers
- Intravacc: Vaccine contract development and manufacturing organization with mucosal vaccine expertise and government/biodefense relationships analogous to CastleVax's BARDA-funded development model.
Direct peers
- CyanVac: Clinical-stage vaccine developer using bovine and avian paramyxovirus vectors (closely related to NDV) for intranasal mucosal vaccines, including RSV and COVID-19 candidates. Directly comparable platform approach and mucosal delivery focus targeting respiratory pathogens.
- Codagenix: Clinical-stage vaccine company using live-attenuated viral vector platforms (including intranasal formulations) to develop vaccines against influenza, RSV, and other respiratory viruses. Shares CastleVax's live-attenuated intranasal mucosal vaccine thesis.
- Meissa Vaccines: Clinical-stage biotech developing intranasal live-attenuated vaccines for RSV and other respiratory viruses, with similar small team, mucosal immunity focus, and clinical-stage profile comparable to CastleVax.
- FluGen: Developer of M2SR intranasal influenza vaccine, sharing CastleVax's intranasal respiratory vaccine positioning and clinical-stage development profile.
Emerging players
- Vaxxinity: Clinical-stage biotech developing vaccines for infectious diseases and chronic conditions. CastleVax's Director of Clinical Operations previously led vaccine trials at Vaxxinity, reflecting overlapping talent pool and clinical operations approach.
Broad incumbents
- Bharat Biotech: Large global vaccine manufacturer with multiple platform technologies (including intranasal and viral vector vaccines) serving LMIC markets, comparable to CastleVax's licensed manufacturing partners in India-adjacent emerging markets.
- Novavax: Established commercial-stage vaccine developer with COVID-19 and influenza candidates using protein subunit and matrix-M adjuvant platforms. Competes with CastleVax for the same next-generation COVID-19 booster market.
- Moderna: Dominant mRNA COVID-19 vaccine manufacturer and BARDA Project NextGen recipient, representing the entrenched standard-of-care comparator against which CastleVax's CVAX-01 is being tested.
- BioNTech: mRNA vaccine leader with Pfizer-partnered COVID-19 vaccine that serves as the primary comparator and standard-of-care threat to CastleVax's intranasal COVID-19 booster strategy.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
CastleVax social profiles
Digital presenceCastleVax compliance and trust
Trust signalCompliance3 records
CastleVax financial estimates
Financial estimateRevenue estimate
Valuation estimate
CastleVax leadership team
Management profileNumber of profiles
Profiles11 records
CastleVax funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
CastleVax M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about CastleVax
What does CastleVax do?
CastleVax is a clinical-stage vaccine platform company that develops and licenses mucosal (intranasal) vaccines built on the Newcastle Disease Virus (NDV) vector platform expressing stabilized antigens such as HexaPro spike protein. Its lead candidate CVAX-01 targets COVID-19 and is in Phase 2 clinical testing, while the broader NDV platform supports a pipeline of respiratory and pandemic-preparedness vaccines licensed to international manufacturers in Thailand, Vietnam, Brazil, and Mexico.
Is CastleVax a public or private company?
CastleVax is a private company. It is classified as corporate owned and is currently operating.
When was CastleVax founded?
CastleVax was founded in 2022. It employs 1 to 10 people.
Where is CastleVax based?
CastleVax is headquartered in New York, United States, in the North America region.
How does CastleVax make money?
Two revenue lines are on record. Vaccine Development and Licensing is the primary driver. The others are government Contracts and Grants.
Who are CastleVax's main competitors?
Intravacc is listed as an others. Direct peers are CyanVac, Codagenix, Meissa Vaccines and FluGen. Vaxxinity is listed as an emerging player. Broad incumbents are Bharat Biotech, Novavax, Moderna and BioNTech.
Does CastleVax have an API?
No public API is recorded for CastleVax.
What industry is CastleVax in?
CastleVax's product category is Biotechnology. Its primary akta.pro industry code is HLAAAEAD, Vaccine Technology Platforms (mRNA, viral vector, protein subunit, inactivated/live-attenuated, VLP, DNA), with a secondary code of HLAAAEAA, Prophylactic Human Vaccines (routine, pediatric, adult). Its NAICS code is 325412 and its SIC code is 2834.