AIVITA Biomedical

What AIVITA Biomedical does

AIVITA Biomedical is a privately held biotechnology company founded in 2016 and headquartered in Irvine, California, that develops personalized autologous cell therapies using a proprietary platform built on stem cell growth and directed high-purity differentiation. The company's lead therapeutic programs are autologous dendritic cell vaccines targeting tumor-initiating cells via a pan-antigenic approach that addresses all neoantigens rather than a select few, designed to overcome cancer's tendency to mutate. Active programs include AV-GBM-1 (Phase 2 glioblastoma, 76% overall survival at 15 months vs 48% in control across 57 patients at 8 US sites), AVOVA-1 (Phase 2 ovarian, NCT02033616), and AV-MEL-1 (Phase 1B melanoma in combination with anti-PD1). The company also markets a multi-pathogen Vaccine Enabling Kit (AV-COVID-19) and pursues ophthalmology applications supported by CIRM and NIH R01 grants.

AIVITA operates a second commercial line in regenerative skincare built on its stem cell and secretome technology: the ROOT OF SKIN brand sold primarily through QVC Japan (with repeated consecutive sell-outs), the professional ROOT OF SKIN MD line distributed in Japan under import approval, and the PROVOQUE serum and eye complex, which was licensed worldwide to LevEllis in October 2024 while AIVITA retains active-ingredient manufacturing at its FDA-registered facility. The skincare business generates cash flow that supports the therapeutic pipeline. Three FDA IND clearances, a Japanese PMDA manufacturing quality and clinical safety consultation, and an FDA-registered manufacturing footprint constitute the regulatory scaffolding.

The company is pursuing partnership or investment to advance AV-GBM-1 into Phase 3, as signaled by presentations at Biotech Showcase, BIO CEO, Festival of Biologics, and World Vaccine Congress, the August 2022 SEC Form D exempt offering filed against a proposed $84,999,990 maximum, and the February 2024 appointment of former Biogen CEO Michel Vounatsos to the Board. Cumulative equity raised is approximately $44 million across a $2M Series A (2016, lead: California Technology Ventures), $15M Series B (2018, lead: SFC of South Korea), $25M Series B-2 (closed December 2020), and $6M exempt offering (August 2022), with an additional $1.7M CIRM grant for vision-loss research. The operating geography is the United States and Japan, with a 11–50 employee footprint.

Name

AIVITA Biomedical

Legal name

AiVita Biomedical, Inc.

Website

https://aivitabiomedical.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

AIVITA Biomedical is a private Irvine-based biotechnology company developing personalized autologous dendritic cell vaccines targeting tumor-initiating cells for glioblastoma, ovarian, and melanoma, alongside a commercial skincare line (ROOT OF SKIN, PROVOQUE) that funds its therapeutic pipeline.

Ownership category

akta.pro rank

Product category

Cancer Immunotherapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Dendritic Cell & Other APC-based Therapies (HLAAABAF)

akta.pro secondary industries

Therapeutic Vaccines (cancer, chronic infection immunotherapy) (HLAAAEAB), Cell Therapy Developers (Autologous) (HLAAABAA), Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies) (HLAAANAK)

Keywords

• Personalized cancer vaccines
• Autologous cell therapy
• Dendritic cell immunotherapy
• Regenerative skincare products
• Infectious disease vaccines

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Skincare Product Sales: Commercial skincare line including ROOT OF SKIN and PROVOQUE products sold through QVC Japan (home shopping), Guthy-Renker partnerships, and professional distribution in Japan. All proceeds from skincare sales support cancer treatment research.
2. Licensing Royalties: Licensing agreements for proprietary formulations and technology. LevEllis licensed skincare formulations in October 2024, with AIVITA continuing to manufacture active ingredients from its FDA-registered facility.
3. Therapeutic Development: Development and potential commercialization of personalized cancer immunotherapies and vaccines. The company is seeking partnership or investment for Phase 3 cancer immunotherapy and commercial vaccine kit.
4. Clinical Trial Services: Conducting Phase 2 clinical trials in glioblastoma, ovarian cancer, and melanoma with support from CIRM grants and NIH R01 grants for vision loss research.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels5 records

Core offering

AIVITA Biomedical develops personalized autologous cell therapy vaccines for cancer treatment (glioblastoma, ovarian, melanoma) and infectious disease prevention, using a proprietary platform of stem cell growth and directed high-purity differentiation to generate patient-specific dendritic cell vaccines. The company also manufactures and commercializes a line of regenerative skincare products (ROOT OF SKIN, ROOT OF SKIN MD, and PROVOQUE) derived from its stem cell technologies, with all skincare proceeds directed toward supporting its cancer treatment research programs.

Product overview

AIVITA Biomedical is a biotechnology company developing personalized vaccines for cancer treatment and infectious disease prevention. The company operates two main product lines: (1) Therapeutic programs including ROOT OF CANCER (AV-GBM-1 for glioblastoma), AVOVA-1 (ovarian cancer vaccine), AV-MEL-1 (melanoma vaccine), and the Vaccine Enabling Kit (AV-COVID-19) for infectious diseases — all utilizing an autologous dendritic cell platform that targets tumor-initiating cells with a pan-antigenic approach; and (2) Commercial skincare products including ROOT OF SKIN™ consumer line, ROOT OF SKIN™ MD professional line, and PROVOQUE™ (licensed to LevEllis), all derived from stem cell technologies. Revenue from skincare products supports the company's therapeutic pipeline.

Differentiator

Problem solved

Functional benefit

Brands

• ROOT OF SKIN: Stem-cell based rejuvenating skincare product line sold primarily through QVC Japan, including ROOT OF SKIN MD professional line and consumer products.
• PROVOQUE
• AV-GBM-1
• AVOVA-1
• AV-MEL-1
• AV-COVID-19

Products and services

• AV-GBM-1 (ROOT OF CANCER) Glioblastoma Immunotherapy
• AVOVA-1 Ovarian Cancer Immunotherapy
• AV-MEL-1 Melanoma Immunotherapy
• AV-COVID-19 Vaccine Enabling Kit
• ROOT OF SKIN Consumer Skincare Line
• ROOT OF SKIN MD Professional Skincare Line
• PROVOQUE Regenerative Skincare Serum

Quantifiable outcome

• 76% overall survival at 15 months in glioblastoma patients treated with AV-GBM-1 vs 48% in control arm
• +2 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core and minor.

• LevEllis, Inc.coreOEM/ Whitelabel/ Licensing Partner · 1 October 2024AIVITA Biomedical licensed novel skincare formulations to LevEllis, a global skincare retailer founded by Dr. Laura Ellis. The licensing agreement signed October 2024 grants exclusive worldwide rights to market and distribute PROVOQUE regenerative skincare serum formulations. AIVITA continues to manufacture the active ingredients from its FDA-registered facility in the USA. The product was validated by peer-reviewed study in the Journal of Drugs in Dermatology.
• TAE Life SciencescoreStrategic or Co-development Partner · 4 January 2023Strategic partnership announced January 2023 to advance development of target boron drugs for glioblastoma. TAE Life Sciences is developing next-generation boron neutron capture therapy (BNCT), and AIVITA brings its tumor-initiating cell targeting immunotherapy platform to the collaboration for potential combined treatment approaches.
• University of California, IrvinecoreStrategic or Co-development Partner · 1 July 2021Collaboration to validate 3D printed bioreactor for retinal organoid creation. Published in peer-reviewed manuscript 'Retinal organoids on-a-chip: a 3D printed microwell device for the consistent production of retinal organoids'. Part of ongoing CIRM and NIH R01 grant-funded research for vision loss treatment.
• Guthy-Renker (GRS, LLC)coreChannel Partner/ Reseller/ Distributor · 1 April 2019Partnership agreement to market ROOT OF SKIN product line. Guthy-Renker is a direct marketing company specializing in health and beauty products, providing expertise in direct-to-consumer sales for the skincare brand.
• Lacore LaboratoriesminorChannel Partner/ Reseller/ Distributor · 1 December 2017Asian distribution deal for skincare line allowing use of AIVITA's proprietary actives. Lacore Laboratories is a custom formulator and beauty product developer providing distribution access in Asian markets.

Scale indicators12 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Dendreon: Dendreon developed Provenge (sipuleucel-T), the first FDA-approved autologous dendritic cell therapy for prostate cancer. It is the most direct precedent for AIVITA's autologous dendritic cell vaccine approach and provides a benchmark for commercial-scale manufacturing and reimbursement of personalized cell therapies.
• Sotio Biotech: Sotio is developing autologous dendritic cell-based immunotherapies for prostate cancer and other solid tumors. Closely aligned with AIVITA's manufacturing approach and target indications, particularly in personalized cellular immunotherapy.
• Northwest Biotherapeutics: Northwest Biotherapeutics develops DCVax-L, an autologous dendritic cell vaccine for glioblastoma, the same indication as AIVITA's AV-GBM-1. Direct clinical competitor with overlapping patient population and similar personalized manufacturing model.
• Immunicum: Immunicum develops ilixadencel, an off-the-shelf dendritic cell-based immunotherapy for solid tumors. Comparable in target indications and mechanism, though using allogeneic rather than autologous cells; serves as a useful parallel for dendritic cell vaccine commercial strategy.

Broad incumbents

• Moderna: Moderna's individualized neoantigen cancer vaccine program (mRNA-4157) targets many of the same solid tumor indications as AIVITA's dendritic cell vaccines. While using mRNA rather than cells, it represents a competing modality for personalized cancer immunotherapy and has significant pharma partnerships.
• Iovance Biotherapeutics: Iovance is the leading commercial-stage autologous cell therapy company, with FDA-approved lifileucel (tumor-infiltrating lymphocytes) for melanoma. Comparable autologous cell therapy manufacturing infrastructure, regulatory pathway experience, and solid tumor focus, though using TILs rather than dendritic cells.
• BioNTech: BioNTech is developing individualized mRNA cancer vaccines (including BNT122 in partnership with Genentech) targeting neoantigens in solid tumors. Represents a major well-capitalized competitor in the personalized cancer vaccine space using a different but related modality.

Emerging players

• Adaptimmune: Adaptimmune develops engineered TCR-T cell therapies for solid tumors. While using a different cell engineering approach, it competes for the same solid tumor immunotherapy opportunity and represents an alternative autologous cell therapy modality for cancer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds6 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

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

Frequently asked questions about AIVITA Biomedical