CytoImmune Therapeutics

What CytoImmune Therapeutics does

CytoImmune Therapeutics is a privately held, clinical-stage biotechnology company founded in 2017 by Michael Caligiuri, M.D. and Jianhua Yu, Ph.D., developing off-the-shelf allogeneic CAR-NK (chimeric antigen receptor natural killer) cell therapies for cancer. The company's portfolio is built on two proprietary platforms — TRACK-NK (Tumor-Reactive and Anti-PD-L1 Co-stimulated Killer Cells, with triple cytokine induction and optional anti-PD-L1 combination) and Coalescent (triple-edit NK cells expressing a CAR plus secretory soluble IL-15 and a BiKE bispecific killer engager). Lead clinical assets include CYTO-102 (TRACK-NK for NSCLC), CYTO-201 (FLT3 CAR-NK for AML), CYTO NK-203 (PSCA CAR-NK for pancreatic cancer) and a GPRC5D/BCMA CAR-NK for multiple myeloma.

The company's core technology uses umbilical cord blood-derived NK cells engineered via retroviral transduction — a deliberate choice that avoids the chromosomal abnormality risk of gene-editing approaches used by competitors. Only an estimated 2 of 10 umbilical cords yield NK cells suitable for expansion; a proprietary bioassay selects viable cords, and K562 feeder cells expressing membrane-bound IL-21 and 4-1BB ligand drive 1,500-2,000-fold expansion. From a single cord the company can dose 10-20+ patients without inducing immune cell exhaustion. The product has been engineered to function as off-the-shelf therapy with no HLA matching required, controlled expansion to mitigate cytokine release syndrome and ICANS risk, and cryopreservation with 90% post-thaw viability.

CytoImmune is pre-revenue. Its go-to-market is structured for clinical trials via partnerships with research hospitals (City of Hope is the foundational partner and Phase 1 trial site for CYTO-102) and ultimately for outpatient hospital administration post-approval. The company operates a 37,000 sq ft in-house cGMP manufacturing facility in Toa Baja, Puerto Rico, capable of 4,000 doses/year with Phase II expansion planned to 40,000 doses/year, and benefits from approximately $15M in Puerto Rico tax credits in 2021 projected at ~$20M annually. Expected future revenue is structured as licensing/royalties on commercialization of cell therapy products. Headcount is 51-100 with approximately 40+ in Puerto Rico manufacturing; corporate headquarters is in Duarte, California, with a regional subsidiary in Melbourne, Australia.

Name

CytoImmune Therapeutics

Legal name

CytoImmune Therapeutics, Inc.

Website

https://cytoimmune.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

CytoImmune Therapeutics is a privately held clinical-stage biotechnology company developing off-the-shelf allogeneic CAR-NK cell therapies built on its TRACK-NK and Coalescent platforms for solid tumors and hematologic malignancies, manufactured at its Puerto Rico cGMP facility and licensed from City of Hope.

Ownership category

akta.pro rank

Product category

CAR-NK Cell Therapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

NK Cell Therapies (HLAAABAD)

akta.pro secondary industry

Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC)

Keywords

• CAR-NK cell therapy
• Allogeneic immunotherapy
• Cancer cell therapy
• Natural killer cells
• Umbilical cord blood

Headquarters

HQ city

Monrovia

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Cell Therapy Commercialization: Pre-revenue clinical stage company developing NK cell immunotherapy products for cancer treatment. Revenue expected from commercialization of CAR-NK cell therapies for solid tumors and hematologic malignancies.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

CytoImmune Therapeutics is a clinical-stage biotechnology company developing off-the-shelf, allogeneic CAR-NK cell therapies manufactured from umbilical cord blood for solid tumors and hematologic malignancies. Its pipeline candidates include CYTO-102 (NSCLC), CYTO-201 (AML), CYTO NK-203 (pancreatic cancer), and a GPRC5D/BCMA BiKE-secreting CAR-NK for multiple myeloma, all engineered through the proprietary TRACK-NK and Coalescent platforms. The company runs its own 37,000 ft2 cGMP clinical manufacturing facility in Puerto Rico.

Product overview

CytoImmune Therapeutics is a clinical-stage biotechnology company developing a portfolio of engineered NK (natural killer) cell-based cancer therapies. The company's product portfolio centers on two proprietary platforms: TRACK-NK (Tumor-Reactive and Anti-PD-L1 Co-stimulated Killer Cells) and Coalescent. Key products include CYTO-102 (TRACK-NK for NSCLC), CYTO-201 (FLT3 CAR-NK for AML), CYTO NK-203 (PSCA CAR-NK for pancreatic cancer), and GPRC5D BiKE secreting BCMA CAR-NK for multiple myeloma. These off-the-shelf allogeneic therapies are manufactured from umbilical cord blood and engineered to express CARs, secrete IL-15 for sustained activity, and optionally secrete bispecific killer engagers (BiKEs). The company operates its own GMP manufacturing facility in Puerto Rico.

Differentiator

Problem solved

Functional benefit

Products and services

• CYTO-102 (TRACK-NK) Allogeneic CAR-NK cell therapy engineered to secrete high levels of soluble IL-15 and react to PD-L1-positive tumors; developed as monotherapy and in combination with atezolizumab for non-small cell lung cancer (NSCLC).
• CYTO-201 (FLT3 CAR-NK) Allogeneic FLT3-directed CAR-NK cell therapy co-expressing soluble IL-15; developed for acute myeloid leukemia (AML).
• CYTO NK-203 (PSCA CAR-NK) Off-the-shelf allogeneic CAR-NK cell therapy derived from umbilical cord blood expressing a CAR against prostate stem cell antigen (PSCA) with soluble IL-15; developed for pancreatic cancer.
• GPRC5D BiKE Secreting BCMA CAR-NK Allogeneic CAR-NK cell therapy secreting a bispecific killer engager (BiKE) that targets GPRC5D and BCMA, for the treatment of multiple myeloma.

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Two partnerships are on record, tiered core.

• Matica BiotechnologycoreStrategic or Co-development Partner · 10 October 2024Strategic partnership for viral vector and cell therapy production. Matica Biotechnology partnered with CytoImmune Therapeutics for viral vector manufacturing and cell therapy production to advance CytoImmune's cell therapy programs.
• City of Hope National Medical CentercoreStrategic or Co-development PartnerFoundational research and clinical trial partnership. City of Hope licensed patent applications to CytoImmune and conducts clinical trials including Phase 1 trial of CYTO-102 in NSCLC. Collaboration based on technologies developed by founders Michael Caligiuri and Jianhua Yu.

Scale indicators3 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• Fate Therapeutics: Fate Therapeutics is a leading iPSC-derived NK and T-cell therapy company pursuing off-the-shelf cell therapies for cancer, representing the most advanced direct competitor in engineered NK space and an analogous manufacturing-and-platform capital-light thesis.
• Century Therapeutics: Century Therapeutics develops iPSC-derived allogeneic cell therapies (including NK and T-cell programs) for cancer, overlapping the broader allogeneic engineered NK cell therapy category and competing for similar hematologic malignancy indications.
• Allogene Therapeutics: Allogene is a clinical-stage leader in allogeneic CAR-T cell therapies (with parallel NK interests), sharing the off-the-shelf, "healthy-donor-derived" cell therapy positioning and competing for capital, partnerships, and oncology indications.
• Caribou Biosciences: Caribou develops allogeneic CAR-NK and CAR-T cell therapies using CRISPR-based gene editing for oncology, sharing the allogeneic, off-the-shelf cell therapy positioning and competing for similar hematology and solid tumor indications.
• Nkarta Inc. Nkarta is a clinical-stage biotech developing allogeneic CAR-NK cell therapies for hematologic malignancies and solid tumors, built on a similar cord-blood-derived NK engineering platform and directly competing for the same off-the-shelf CAR-NK opportunity as CytoImmune.

Broad incumbents

• Atara Biotherapeutics: Atara is a more mature allogeneic T-cell therapy company whose allogeneic platform parallels CytoImmune's NK approach; CEO Vidal's CMC background at Atara directly connects the two companies and represents a relevant comparable for commercial-scale allogeneic manufacturing.
• Cellectis (Allogene legacy): Cellectis is a foundational allogeneic CAR-T platform company using gene editing, conceptually adjacent to CytoImmune's allogeneic NK platform and a relevant broad comparable in off-the-shelf engineered cell therapy.

Emerging players

• Shoreline Biosciences: Shoreline Biosciences is an early-stage developer of iPSC-derived NK cell therapies with strategic partnerships, pursuing similar off-the-shelf NK oncology applications as CytoImmune but at an earlier stage.

Others

• Matica Biotechnology: Matica Biotechnology is a viral vector and cell therapy CDMO with a strategic partnership with CytoImmune for production; while not a direct competitor, it is a comparable cell-therapy manufacturing platform relevant to CytoImmune's outsourced capacity strategy.
• City of Hope / COH Ventures (research partner): City of Hope is the academic medical center from which CytoImmune licensed its core NK platform IP and conducts CytoImmune's lead Phase 1 clinical trials, making it both a research/clinical partner and a key ecosystem reference for NK cell therapy development.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cytoimmune-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

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

M&A

Investments1 record

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

Frequently asked questions about CytoImmune Therapeutics