Glycostem Therapeutics

What Glycostem Therapeutics does

Glycostem Therapeutics B.V. is a clinical-stage Dutch biotechnology company founded in 2007 and headquartered at Pivot Science Park in Oss, Netherlands. The company develops off-the-shelf allogeneic Natural Killer (NK) cell immunotherapies derived from umbilical cord blood CD34+ hematopoietic stem and progenitor cells, targeting hematological malignancies (initially Acute Myeloid Leukemia and Multiple Myeloma) and expanding into solid tumors and B-cell-driven autoimmune diseases. Its lead investigational product, oNKord® (international nonproprietary name: inaleucel), is in a pivotal Phase I/IIa WiNK trial across 8 clinical sites in 5 European countries, with reported Phase I outcomes of 80% one-year survival versus 35% expected in elderly AML patients and median survival of 22 months, with no cytokine release syndrome or graft-versus-host disease observed.

Glycostem's core technology is the proprietary uNiK™ production platform — a closed, feeder cell-free system operating in a class C cleanroom that uses a synthetic culture medium and a patented combination of growth factors to expand and differentiate NK cells at clinical scale. Confirmed in Phase I to produce 100 billion NK cells per cord blood unit (enabling up to 20 patient doses of oNKord® or more than 100 patient doses of viveNK™), with at least three years of cryopreserved shelf life. The second-generation viveNK™ platform adds CAR engineering (including CD19 CAR-NK for B-cell malignancies and autoimmune indications) and TCR-NK products, co-developed with Zelluna Immunotherapy for solid tumors. The platform is protected by nine patent families and has received EMA and FDA Orphan Drug Designations for AML (2014 and 2016 respectively) and FDA Orphan Drug Designation for Multiple Myeloma (2020).

The business model combines clinical-stage development with regional licensing and commercialization partnerships. Glycostem manufactures in-house at its GMP-licensed facility in Oss and supplies clinical trial sites directly in Europe. Future commercial revenues are structured through two exclusive partnerships: medac GmbH for the EU, UK and additional European countries (agreement signed August 2022) and inno.N for Korea and Japan (September 2019), both covering AML and Multiple Myeloma indications. The company has historically been funded by a mix of venture equity (Lupus Ventures, E&F Healthcare Holdings totaling approximately €17M across 2017 and 2019) and non-dilutive sources (RVO Innovation Credit €5M, Eurostars €3.6M, Marie Curie MATURE-NK €3.51M). Pricing is not publicly disclosed; the company states its cost structure aims to be a fraction of autologous CAR-T-cell products.

Name

Glycostem Therapeutics

Legal name

Glycostem Therapeutics B.V.

Website

https://glycostem.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

Glycostem Therapeutics is a clinical-stage Dutch biotech developing off-the-shelf allogeneic Natural Killer (NK) cell immunotherapies from umbilical cord blood CD34+ stem cells for hematological malignancies and solid tumors, with lead candidate oNKord® in a pivotal Phase I/IIa AML trial.

Ownership category

akta.pro rank

Product category

Cellular Immunotherapy / NK Cell Therapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB)

akta.pro secondary industries

NK Cell Therapies (HLAAABAD), Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC), Cell Processing & Ancillary Materials (media, cytokines, beads, vectors, disposables) (HLAAABAH), Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL)

Keywords

• Allogeneic NK cell therapy
• Cellular immunotherapy
• Cord blood stem cells
• CAR-NK oncology
• Off-the-shelf cancer treatment

Headquarters

HQ city

Oss

HQ country

Netherlands

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Product Revenue - oNKord®: Glycostem manufactures and supplies oNKord® to clinical trial sites across Europe and receives manufacturing revenue as part of future revenues from commercialization agreements. Revenue from product sales expected upon regulatory approval.
2. Milestone Payments: Under the medac license agreement, Glycostem receives undisclosed upfront payment and is eligible for additional payments upon achievement of development and sales milestones.
3. Regional Commercialization Fees (inno.N): Exclusive commercialization agreement for oNKord® in Korea and Japan with inno.N involves down payments and milestone payments.
4. Government Innovation Credit: €5 million loan awarded by RVO's Innovation Credit for co-funding pivotal clinical trials. This represents non-dilutive funding.
5. Equity Investment: Glycostem has raised equity from LUPUS Ventures (€3M in 2017, €5M in 2019), E&F Healthcare Holdings (€9M in 2019), and received Eurostars grant funding (€3.6M for MODIFY-NK project).

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Glycostem Therapeutics is a clinical-stage biotechnology company developing off-the-shelf, allogeneic Natural Killer (NK) cell immunotherapies derived from umbilical cord blood CD34+ hematopoietic stem cells. Its lead investigational product oNKord® (INN: inaleucel) targets acute myeloid leukemia (AML) and multiple myeloma (MM), while the second-generation viveNK™ platform delivers CAR-engineered and TCR-NK products for hematologic malignancies and solid tumors, all manufactured via the proprietary uNiK™ closed production process.

Product overview

Glycostem Therapeutics is a clinical-stage company developing a pipeline of cellular immunotherapy products based on stem cell-derived Natural Killer (NK) cells for cancer treatment. The company offers three main products: oNKord® (first-generation off-the-shelf allogeneic NK cells for AML and MM), viveNK™ (second-generation CAR-engineered NK cells for B cell malignancies and solid tumors), supported by the uNiK™ closed production platform. The company holds GMP manufacturing license and operates pivotal clinical trials in Europe.

Differentiator

Problem solved

Functional benefit

Brands

• oNKord®: First-generation off-the-shelf allogeneic NK cell immunotherapy product derived from umbilical cord blood CD34+ stem cells, for treatment of AML and multiple myeloma.
• viveNK™
• uNiK™

Products and services

• oNKord® (inaleucel / GTA002) Off-the-shelf, allogeneic Natural Killer (NK) cellular immunotherapy product derived from umbilical cord blood (UCB) CD34+ stem cells. Indicated for hematologic malignancies including acute myeloid leukemia (AML) and multiple myeloma (MM). Currently in Phase I/IIa clinical trials (WiNK trial). Does not cause Cytokine Release Syndrome (CRS) or Graft-versus-Host Disease (GvHD). Cryopreserved with at least 3 years shelf life.
• viveNK™ CAR-NK Platform Chimeric Antigen Receptor (CAR)-engineered NK cell therapy platform. Second-generation products include CD19 CAR-NK for B cell malignancies and TCR-NK products (GTA201) for solid tumors, designed to enhance tumor targeting and prolong persistence compared to CAR-T treatments. Also explored for B-cell-driven autoimmune indications such as systemic lupus erythematosus (SLE).
• uNiK™ Production Platform Closed production process platform for clinical-scale and clinical-grade NK cell production from umbilical cord blood. Uses automated CliniMACS Prodigy closed-system manufacturing in a class C clean room. Capable of producing oNKord® for up to 20 patients and viveNK™ for more than 100 patients from one cord blood unit.

Quantifiable outcome

• 80% one-year survival rate vs 35% expected in untreated AML patient population (Phase I trial, n=10)
• +5 more outcomes

Named customers3 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

Feature6 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• medac GmbHcoreChannel Partner/ Reseller/ Distributor · 1 August 2022License, manufacturing, supply and commercialization agreement for Glycostem's lead product oNKord® in the EU, UK and further European countries for AML and MM patients. Glycostem receives undisclosed upfront payment and manufacturing revenue plus milestone payments upon achievement of development and sales milestones.
• Pieris PharmaceuticalsminorStrategic or Co-development Partner · 12 March 2021Material Transfer Agreement to study potential of Pieris' Anticalin technology to enhance activity of oNKord® and CAR-NK products for solid tumor targeting. Parties also exploring unique NK-based CAR treatments using viveNK™ and Pieris' Anticalin platform.
• Ghent University (UGent)coreTechnology or Integration · 17 December 2020License agreement for innovative NK cell production technology. The technology increases CD16 receptor expression, enhancing NK cell activity and antibody binding properties. Also has significant positive impact on production time — potentially halving differentiation time of NK cells — without negative effect on potency.
• AutolomousminorImplementation/ SI/ Consulting Partner · 3 June 2020Implementation of AutoloMATE platform to digitize manufacturing and release of Glycostem's NK cell therapies. First application of the AutoloMATE platform to an allogeneic process, using distributed ledger technologies, IoT and AI to drive efficiency in manufacturing data capture and release.
• Zelluna ImmunotherapycoreStrategic or Co-development Partner · 19 November 2019Development, license and supply agreement for allogeneic TCR-guided NK cell therapies (TCR-NK) for treatment of solid cancers. Zelluna provides TCR targeting mechanism; Glycostem manufactures clinical grade NK cells. Industry's first commercial development partnership of TCR-NK cells for treating cancer.
• Dr. Rizwan Romee (Harvard/Dana-Farber)minorOthers · 12 September 2019US-based advisor to Glycostem's Advisory Board. Dr. Romee is Associate Professor at Harvard Medical School/Dana Farber Cancer Institute and brings expertise in NK cell-based studies in hematologic malignancies and combination therapies. Expected to support US market commercialization discussions and FDA guidance for oNKord®.
• inno.NcoreChannel Partner/ Reseller/ Distributor · 11 September 2019Two agreements with Korean pharmaceutical company inno.N: (1) exclusive commercialization agreement for oNKord® for Korea and Japan against down and milestone payments; (2) co-development agreement for a CAR-NK product (target not disclosed) with global commercialization rights held by inno.N.
• Phio PharmaceuticalsminorStrategic or Co-development Partner · 28 March 2019Research collaboration exploring synergies between Phio's self-delivering RNAi technology (sd-rxRNA®) and Glycostem's NK cell generation technology (oNKord®) to develop next-generation cellular immunotherapies for cancer with enhanced efficacy and/or safety.
• Marie Curie MATURE-NK ProgrammecoreStrategic or Co-development Partner · 1 December 2018Glycostem is commercial partner in the EU Horizon 2020 funded Marie Curie MATURE-NK programme (€3.51M grant, 4-year duration). Consortium with 12 European academic institutions and companies (Innate Pharma, Miltenyi, Fraunhofer IZI) led by Prof Ulrike Köhl to develop novel methods to manufacture tumour reactive NK cells and educate PhD candidates.
• Eurostars MODIFY-NK ConsortiumcoreStrategic or Co-development Partner · 16 May 2018Eurostars-funded project (€3,626,860 total award) for 'A novel modified NK cell immunotherapy for treatment of solid tumours'. Consortium includes Glycostem, YUMAB GmbH (Germany), Explicyte (France), and OZ Biosciences SAS (France). CAR-NK product will be validated in preclinical solid tumour model and ready for clinical studies within 24 months.

Scale indicators12 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Nkarta Therapeutics: Nkarta is a clinical-stage biotech developing allogeneic, off-the-shelf CAR-NK cell therapies for cancer using a similar core thesis to Glycostem's viveNK platform — both target hematologic malignancies with engineered NK cells designed for scalable, donor-derived manufacturing.
• Fate Therapeutics: Fate is a leader in iPSC-derived NK cell therapies (e.g., FT516, FT538) for cancer, sharing Glycostem's off-the-shelf NK cell premise and competing directly in hematologic malignancy indications including AML and B-cell lymphomas.
• Century Therapeutics: Century develops iPSC-derived allogeneic cell therapies including CAR-NK and CAR-T candidates, pursuing hematologic cancers with an off-the-shelf, multiplexed-engineering approach directly comparable to Glycostem's uNiK/viveNK platforms.
• Innate Pharma: Innate Pharma is a French clinical-stage biotech focused on NK cell engagers and antibody-based immuno-oncology, and is also a partner in Glycostem's Marie Curie MATURE-NK consortium — directly comparable on NK-cell biology and hematologic cancer indications.
• ImmunityBio: ImmunityBio develops NK cell therapies including haNK (high-affinity NK) and t-haNK candidates for solid and hematologic tumors, directly competing in the off-the-shelf NK oncology space with multiple clinical-stage assets.
• Zelluna Immunotherapy: Zelluna is a Norwegian biotech developing allogeneic TCR-NK therapies for solid tumors and is Glycostem's named co-development partner; both companies share TCR-guided NK cell manufacturing for cancer indications.

Emerging players

• Shoreline Biosciences: Shoreline is developing iPSC-derived NK cell and macrophage therapies for cancer, pursuing a similar scalable allogeneic NK manufacturing model and partnering with large pharma (Bayer, Gilead) — an emerging competitive threat to Glycostem's platform thesis.
• Acepodia: Acepodia develops off-the-shelf NK cell therapies using antibody-cell conjugation (ACC) technology for solid and hematologic tumors, pursuing an alternative NK engineering approach that overlaps with Glycostem's viveNK CAR-NK ambitions.
• GT Biopharma: GT Biopharma develops tri-specific NK cell engagers (GTB-3550) for hematologic malignancies, sharing Glycostem's NK-based hematologic cancer focus via a different (engager-based rather than cell-therapy) modality.

Broad incumbents

• Miltenyi Biotec: Miltenyi is a global life-science tools and cell therapy manufacturing leader whose CliniMACS Prodigy system is used by Glycostem for CD34+ selection; it also has internal cell therapy programs and competes broadly in the cell therapy infrastructure space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/glycostem-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Glycostem Therapeutics