Cullinan Therapeutics

Name

Cullinan Therapeutics

Legal name

Cullinan Therapeutics, Inc.

Website

https://cullinanoncology.com

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

101–250 employees

Short description

Cullinan Therapeutics is a clinical-stage biopharmaceutical company developing bispecific T cell engagers (CD19xCD3, BCMAxCD3, FLT3xCD3) and the partnered EGFR inhibitor zipalertinib for autoimmune diseases and oncology. Pre-commercial, with PDUFA set for February 2027.

Ownership category

akta.pro rank

Product category

Clinical-Stage Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412)

SIC

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

akta.pro primary industry

Bispecific & Multispecific Antibodies (HLAAAAAF)

Keywords

• Clinical-stage biopharmaceuticals
• T cell engager therapies
• Bispecific antibody pipeline
• Autoimmune disease therapeutics
• Oncology drug development

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: As a clinical-stage biopharmaceutical company, Cullinan Therapeutics currently has no revenue. Future revenue will come from commercialization of approved drug products including zipalertinib (NSCLC), CLN-978 (autoimmune), velinotamig (autoimmune), and CLN-049 (AML). The company is not yet profitable and relies on equity financing and potential licensing/partnership deals.
2. Licensing and Partnership Revenue: Partnership with Taiho Oncology/Taiho Pharmaceutical for zipalertinib development and commercialization. Taiho is responsible for completing the rolling NDA submission and will lead commercialization efforts in certain geographies, with Cullinan receiving potential milestone payments and royalties.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Cullinan Therapeutics is a clinical-stage biopharmaceutical company developing T cell engager bispecific antibodies (CLN-978, velinotamig, CLN-049) and the EGFR inhibitor zipalertinib for autoimmune diseases and cancer. Its pipeline targets high-unmet-need indications including SLE, RA, lupus nephritis, EGFR exon 20 insertion NSCLC, and AML/MDS, with commercialization led through a partnership with Taiho Oncology for its lead oncology asset.

Product overview

Cullinan Therapeutics is a clinical-stage biopharmaceutical company developing targeted therapies in oncology and autoimmune diseases. The company's pipeline centers on T cell engager bispecific antibody programs: CLN-978 (CD19xCD3) and velinotamig (BCMAxCD3) target B cell-driven autoimmune diseases including SLE, RA, and lupus nephritis, while CLN-049 (FLT3xCD3) addresses acute myeloid leukemia. In oncology, zipalertinib (EGFR inhibitor, partnered with Taiho Oncology) is under FDA review for EGFR exon 20 insertion mutation NSCLC with PDUFA date February 27, 2027.

Differentiator

Problem solved

Functional benefit

Products and services

• CLN-978
• Velinotamig
• Zipalertinib
• CLN-049

Quantifiable outcome

• 35% confirmed objective response rate in 176 NSCLC patients with EGFR exon 20 insertions
• +5 more outcomes

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Taiho Oncology / Taiho PharmaceuticalcoreStrategic or Co-development Partner · 1 November 2025Cullinan Therapeutics partnered with Taiho Oncology and Taiho Pharmaceutical for the development and commercialization of zipalertinib, an oral EGFR tyrosine kinase inhibitor for EGFR exon 20 insertion mutation NSCLC. Taiho is responsible for completing the rolling NDA submission and will lead commercialization efforts in certain geographies, with Cullinan receiving potential milestone payments and royalties. The NDA is supported by Phase 2b REZILIENT1 trial data showing 35% confirmed ORR in 176 patients. PDUFA date is February 27, 2027.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Amgen: Amgen is a global biopharmaceutical leader and pioneer of BiTE (bispecific T-cell engager) technology with Blincyto (CD19xCD3) approved in B-cell ALL. Directly comparable to Cullinan's TCE platform approach in both oncology and autoimmune applications, but at much larger scale.
• Roche: Roche markets multiple T-cell engaging bispecific antibodies including mosunetuzumab (CD20xCD3) and glofitamab (CD20xCD3), and has deep autoimmune commercial infrastructure. Comparable as a broad incumbent in the bispecific T-cell engager space with overlapping oncology and autoimmune ambitions.
• AbbVie: AbbVie co-developed epcoritamab (CD20xCD3, approved as Epkinly) with Genmab and has a significant autoimmune franchise. Relevant peer given bispecific TCE development and overlapping B-cell target approach for autoimmune indications like SLE and RA.
• Regeneron Pharmaceuticals: Regeneron is developing odronextamab (CD20xCD3) and has an established bispecific antibody platform through its Regeneron Bispecifics technology. Comparable as a TCE developer with strong oncology and autoimmune ambitions and significantly greater resources.
• Johnson & Johnson (Janssen): Janssen developed teclistamab (BCMAxCD3) and talquetamab (GPRC5DxCD3), and markets amivantamab (EGFRxMET) for EGFR exon 20 NSCLC directly competing with zipalertinib. Highly comparable across both Cullinan's TCE and EGFR exon 20 oncology programs.
• AstraZeneca: AstraZeneca acquired Gracell Biotechnologies and is developing T-cell engager and cell therapy programs in autoimmune and oncology. Direct peer in TCE platform development with overlapping autoimmune ambitions and significantly greater resources.

Direct peers

• MacroGenics: MacroGenics is a clinical-stage biotech developing multiple DART-format bispecific T-cell engagers including flotetuzumab (CD123xCD3) and enoblituzumab. Directly comparable as a clinical-stage peer focused on bispecific antibody platforms for oncology.

Emerging players

• Cabaletta Bio: Cabaletta Bio is developing CD19 CAR-T cell therapies for autoimmune diseases including SLE and lupus nephritis. Comparable as a peer pursuing deep B-cell depletion in autoimmune indications, though using cell therapy rather than bispecific TCE approach.
• Kyverna Therapeutics: Kyverna Therapeutics is developing CD19 CAR-T therapies for autoimmune diseases including SLE, myositis, and MS. Emerging peer in the autoimmune B-cell depletion space with similar patient populations to Cullinan's CLN-978 and velinotamig programs.
• Cartesian Therapeutics: Cartesian Therapeutics is developing engineered cell therapies and RNA-based immunotherapies for autoimmune diseases and oncology. Adjacent peer pursuing innovative immune-modulating approaches for autoimmune indications overlapping with Cullinan's TCE strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/CullinanTx

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds5 records

Investors24 records

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 Cullinan Therapeutics