CellVax Therapeutics Inc.
Privately held clinical-stage company developing a personalized autologous tumor cell–based immunotherapy platform. Lead program is an individualized, ex vivo–modified autologous tumor-cell vaccine intended to induce MHC class II expression on patient tumor cells to generate multi-neoantigen CD4+ and CD8+ T cell responses. The company has completed Phase I/II trials in Brazil and initiated an adaptive Phase II study in the U.S.; it has pursued IND regulatory interactions and established CDMO partnerships for cGMP manufacture and tech transfer.
Industries
Nr. of Employees
small (1-50)
CellVax Therapeutics Inc.
Patents
Products
FK-PC101
Personalized autologous tumor-cell vaccine prepared from a patient's own tumor cells that have been modified ex vivo to express MHC class II, irradiated to prevent replication, and administered intradermally to elicit CD4+ and CD8+ T cell responses.
therapeutic vaccine for prostate cancer
A personalized immunotherapy vaccine developed by CellVax Therapeutics, designed to treat prostate cancer by modifying tumor cells to activate the immune system. The vaccine is made by fragmenting a tumor sample, cultivating and modifying tumor cells, exposing them to radiation, and incorporating them into the vaccine formulation.
FK-GI101
Personalized immunotherapy for gastrointestinal (GI) cancers developed by CellVax Therapeutics.
FK-PC101
Personalized autologous tumor-cell vaccine prepared from a patient's own tumor cells that have been modified ex vivo to express MHC class II, irradiated to prevent replication, and administered intradermally to elicit CD4+ and CD8+ T cell responses.
therapeutic vaccine for prostate cancer
A personalized immunotherapy vaccine developed by CellVax Therapeutics, designed to treat prostate cancer by modifying tumor cells to activate the immune system. The vaccine is made by fragmenting a tumor sample, cultivating and modifying tumor cells, exposing them to radiation, and incorporating them into the vaccine formulation.
FK-GI101
Personalized immunotherapy for gastrointestinal (GI) cancers developed by CellVax Therapeutics.
Services
Outsourced end-to-end cGMP manufacturing, release, disposition and analytical method tech transfer through CDMO partnerships to produce individualized autologous cell doses for clinical trials.
Outsourced end-to-end cGMP manufacturing, release, disposition and analytical method tech transfer through CDMO partnerships to produce individualized autologous cell doses for clinical trials.
Expertise Areas
- Personalized cancer immunotherapy
- Autologous cell therapy development
- Clinical trial design and execution (adaptive trials)
- cGMP cell therapy manufacturing and tech transfer
Key Technologies
- Ex vivo tumor cell modification
- MHC class II induction on tumor cells
- Autologous tumor-cell vaccine formulation
- Cell irradiation for replication inactivation
News & Updates
First autologous vaccine batch produced at a CDMO facility to dose the first patient in the randomized Phase 2 clinical trial.
IND application submitted to the FDA for the individualized cell-based immunotherapy with CDMO support for process optimization and assay development.
FDA clearance of IND to start adaptive Phase II study (CELLVX-230) in men with high-risk prostate cancer post-radical prostatectomy; multicenter randomized trial with primary endpoint disease-free survival.
Peer-indexed article reporting reduced recurrence rates in treated patients versus control at 4 years post-radical prostatectomy.
Multiple media articles and TV interviews describing clinical testing in the U.S., regulatory milestones, and preliminary clinical outcomes.
Patents granted covering composition, methods of preparation and use (example: US patent issued in 2016).
First autologous vaccine batch produced at a CDMO facility to dose the first patient in the randomized Phase 2 clinical trial.
IND application submitted to the FDA for the individualized cell-based immunotherapy with CDMO support for process optimization and assay development.
FDA clearance of IND to start adaptive Phase II study (CELLVX-230) in men with high-risk prostate cancer post-radical prostatectomy; multicenter randomized trial with primary endpoint disease-free survival.
Peer-indexed article reporting reduced recurrence rates in treated patients versus control at 4 years post-radical prostatectomy.
Multiple media articles and TV interviews describing clinical testing in the U.S., regulatory milestones, and preliminary clinical outcomes.
Patents granted covering composition, methods of preparation and use (example: US patent issued in 2016).