CellVax Therapeutics Inc.

What CellVax Therapeutics Inc. does

CellVax Therapeutics, Inc. is a privately held, clinical-stage biotechnology company founded in 2020 and headquartered in Miami, Florida, with technology roots in Brazil dating to 2001. The company is developing a proprietary personalized tumor cell-based cancer immunotherapy platform branded Vax-P, which converts a patient's own solid tumor cells into Tumor Presenting Cells (TPCs) by stimulating de novo expression of MHC Class II molecules on the tumor cell surface through ex vivo cultivation with cytokines; these modified cells are irradiated and delivered as an intradermal injection intended to activate both CD4+ helper T cells and CD8+ cytotoxic T cells for a multi-neoantigen immune response.

Its lead product FK-PC101 is an autologous cellular immunotherapy for prostate cancer patients at high risk of recurrence after radical prostatectomy, targeting the roughly 30% of post-prostatectomy patients who recur and seek to avoid or delay salvage radiotherapy and androgen deprivation therapy. A Phase II adaptive design trial (CELLVX-230, NCT06636682) is enrolling up to 230 participants across 21 US clinical sites through a partnership with the Society of Urologic Oncology Clinical Trials Consortium, with first patients dosed at Carolina Urologic Research Center (Myrtle Beach, SC) and Central Ohio Urology Group. The company reported Phase II data from Brazil showing recurrence reduced from 36.8% (control) to 11.8% (treated) at four years (p=0.0453) and an 8.5% mortality reduction. A second pipeline asset, FK-GI101, is being advanced toward clinical development in gastrointestinal cancers through a cGMP manufacturing partnership with Cellipont Bioservices. CellVax holds patents granted in 14 countries including the US (US9320785B2).

The business model is clinical-stage and pre-revenue, with future revenue expected to come from commercialization of an approved autologous cell therapy biologic, likely priced as a specialty oncology product. Manufacturing is outsourced to CDMOs Theragent (Arcadia, CA) for FK-PC101 and Cellipont Bioservices for FK-GI101; clinical distribution runs through the SUO-CTC investigator network. The company has raised approximately $7.3M cumulatively across four exempt offerings from 2020 to 2024 and operates with 1-10 employees.

Name

CellVax Therapeutics Inc.

Legal name

CellVax Therapeutics, Inc.

Website

https://cellvx.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Product category

Personalized Cancer Immunotherapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Developers (Autologous) (HLAAABAA)

akta.pro secondary industries

Dendritic Cell & Other APC-based Therapies (HLAAABAF), Therapeutic Vaccines (cancer, chronic infection immunotherapy) (HLAAAEAB)

Keywords

• Personalized cancer immunotherapy
• Autologous cell therapy
• Tumor presenting cells
• Prostate cancer vaccine
• Solid tumor treatment

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Pre-revenue Clinical Stage: CellVax is a privately held clinical-stage company in the research and development phase. No commercial revenue has been generated as the company is conducting Phase II clinical trials for its lead product FK-PC101.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

CellVax is a clinical-stage biopharmaceutical company developing personalized autologous cancer immunotherapies using a proprietary Tumor Presenting Cells (TPC) platform. The technology modifies patient tumor cells ex vivo to express MHC Class II molecules, activating both CD4+ helper T cells and CD8+ cytotoxic T cells to produce a multi-neoantigen immune response against solid tumors. Its lead product FK-PC101 is in Phase II clinical trials for high-risk prostate cancer patients post-prostatectomy, and FK-GI101 is being advanced toward clinical trials for gastrointestinal cancers.

Product overview

CellVax Therapeutics has developed a proprietary personalized tumor cell-based cancer immunotherapy platform called Vax-P (Tumor Presenting Cells). The platform uses the patient's own cancer cells to create Tumor Presenting Cells (TPCs) that activate both CD8+ cytotoxic T cells and CD4+ helper T cells, generating a multi-neoantigen immune response. Lead product FK-PC101 is in Phase II clinical trials in the US for prostate cancer patients at high risk of recurrence after prostatectomy. Second product FK-GI101 is advancing toward clinical development for gastrointestinal cancers.

Differentiator

Problem solved

Functional benefit

Products and services

• FK-PC101 FK-PC101 is a novel personalized autologous cancer immunotherapy for prostate cancer patients at high risk of recurrence after radical prostatectomy. The therapy consists of the patient's own tumor cells modified ex vivo to express MHC Class II molecules, creating Tumor Presenting Cells (TPCs) that activate both CD8+ cytotoxic T cells and CD4+ helper T cells. In the Brazilian Phase II study, recurrence was reduced from 36.8% (control) to 11.8% (treated) at four years post-prostatectomy (p=0.0453), with an 8.5% mortality reduction.
• FK-GI101 FK-GI101 is a personalized immunotherapy for gastrointestinal cancers (including gastric, intestinal, and colon cancers), based on the same proprietary Tumor Presenting Cells (TPC) platform technology used in FK-PC101. It is being advanced toward clinical trials through a cGMP manufacturing partnership with Cellipont Bioservices announced on 2025-07-31.

Quantifiable outcome

• Recurrence rate reduction from 36.8% (control) to 11.8% (treated) at 4 years post-prostatectomy
• +2 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core.

• Cellipont BioservicescoreImplementation/ SI/ Consulting Partner · 31 July 2025Cellipont Bioservices provides cGMP manufacturing services for CellVax's FK-GI101 personalized immunotherapy for gastrointestinal cancers. The expanded partnership aims to advance the therapy into clinical trials for GI cancers including gastric, intestinal, and colon cancers.
• Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC)coreStrategic or Co-development Partner · 1 October 2024SUO-CTC is a clinical research investigator network with 650+ members from 300+ clinical sites in the US and Canada. The consortium supports CellVax's Phase II clinical trial (CELLVX-230) for FK-PC101, with Dr. Scott Eggener from University of Chicago serving as Principal Investigator.
• TheragentcoreImplementation/ SI/ Consulting Partner · 1 November 2022Theragent is a comprehensive Contract Development and Manufacturing Organization (CDMO) providing end-to-end manufacturing, release, and disposition of clinical material for CellVax's FK-PC101 from its CGMP cell therapy manufacturing facility in Arcadia, CA. Theragent provided process optimization, assay development, and regulatory affairs support for the IND submission. Manufacturing partnership began November 2022.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Dendreon (Sanpower Group): Dendreon developed Provenge (sipuleucel-T), the first FDA-approved autologous cellular immunotherapy for prostate cancer. CellVax's FK-PC101 targets the same post-prostatectomy patient population using a different autologous cell-engineering approach, making Dendreon the most directly comparable commercial-stage peer.
• Northwest Biotherapeutics: Northwest Biotherapeutics develops DCVax, an autologous dendritic cell-based cancer vaccine platform. It is a direct peer in the personalized dendritic / antigen-presenting cell therapy space and shares the same core challenge of scaling autologous manufacturing commercially.
• Iovance Biotherapeutics: Iovance commercializes Amtagvi (lifileucel), the first FDA-approved TIL (tumor-infiltrating lymphocyte) therapy for solid tumors. It is a relevant peer as another autologous cell therapy developer targeting solid tumors with a personalized ex vivo cell engineering platform.
• Gritstone bio: Gritstone develops personalized neoantigen cancer vaccines using a different delivery modality (viral vector plus mRNA) but with the same core thesis of multi-neoantigen immune activation. It is a directly comparable emerging player in personalized cancer immunotherapy.
• Adaptimmune Therapeutics: Adaptimmune develops engineered TCR cell therapies for solid tumors. While mechanistically different (TCR-engineered T cells vs. modified tumor cells), it is a directly comparable clinical-stage cell therapy peer targeting the same solid tumor opportunity.

Broad incumbents

• BioNTech: BioNTech is a leading cancer immunotherapy company developing individualized mRNA cancer vaccines (e.g., autogene cevumeran with Roche). It represents a broader, well-capitalized incumbent pursuing personalized cancer vaccines with a different (mRNA) delivery platform.
• Moderna: Moderna develops mRNA-based personalized cancer vaccines (mRNA-4157/V940 with Merck) for melanoma and other solid tumors. It is a broad incumbent in personalized cancer immunotherapy with substantially greater capital and manufacturing scale than CellVax.
• Bristol-Myers Squibb: Bristol-Myers Squibb markets checkpoint inhibitors (Opdivo, Yervoy) and is a broad incumbent in oncology immunotherapy. Any CellVax regimen positioning in prostate cancer will be benchmarked against BMS's checkpoint inhibitor data and combinations.
• Merck & Co. Merck's Keytruda dominates the immuno-oncology landscape and is being tested in prostate cancer combinations. As the largest IO incumbent, Merck sets the competitive standard that any novel autologous immunotherapy like FK-PC101 will need to beat or combine with.

Emerging players

• PDS Biotech: PDS Biotech is a clinical-stage immunotherapy company developing Versamune-based cancer vaccines that activate both CD4+ and CD8+ T cells. Its mechanism overlaps conceptually with CellVax's dual-arm immune activation thesis, making it a relevant emerging peer.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds4 records

Investors

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CellVax Therapeutics Inc.