K36 Therapeutics

What K36 Therapeutics does

K36 Therapeutics is a clinical-stage biopharmaceutical company founded in 2021 and headquartered in Cambridge, Massachusetts, that is developing first-in-class small molecule inhibitors targeting the NSD2 (MMSET/WHSC1) histone methyltransferase for the treatment of hematologic and solid tumor malignancies. The company's pipeline is built around two programs: KTX-1001 (Gintemetostat), an oral, highly selective NSD2 inhibitor in-licensed from Novartis and being advanced for relapsed/refractory multiple myeloma in patients harboring the t(4;14) chromosomal translocation (a high-risk subtype present in approximately 20% of multiple myeloma patients); and KTX-2001, a selective oral NSD2 inhibitor being developed for metastatic castration-resistant prostate cancer (mCRPC) both as monotherapy and in combination with Bayer's darolutamide. Both programs are in Phase 1 clinical trials, with KTX-1001 (K36-MMSET-001) enrolling patients in the United States, Canada, France, and Spain, and KTX-2001 (STRIKE-001) actively enrolling in the United States with an expected enrollment of approximately 140 patients.

The company's go-to-market approach is oriented around clinical proof-of-concept rather than product commercialization. K36 is a pre-revenue entity that funds operations through venture capital, having raised approximately $100M across a $30M Series A (December 2021, led by F-Prime Capital and Atlas Venture) and a $70M Series B (June 2023, with participation from Bristol-Myers Squibb, Nextech Invest, and existing investors). Future revenue is expected to come from licensing or royalty arrangements with larger pharmaceutical partners, or potential independent commercialization after regulatory approval. The company pursues a biomarker-driven patient selection strategy, leveraging NSD2 overexpression and t(4;14) translocation as stratification markers to enable precision medicine positioning. Leadership is led by CEO Terry Connolly, PhD, with a recently appointed CMO (Shinta Cheng, MD, PhD) supporting the dual-program clinical portfolio.

Name

K36 Therapeutics

Legal name

K36 Therapeutics

Website

https://k36tx.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

K36 Therapeutics is a clinical-stage biopharmaceutical company developing first-in-class oral small molecule NSD2 (MMSET) inhibitors for hematologic and solid tumor malignancies. Its lead programs — KTX-1001 (Gintemetostat) for t(4;14) multiple myeloma and KTX-2001 for metastatic castration-resistant prostate cancer — are in Phase 1 trials.

Ownership category

akta.pro rank

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 Development and Commercialization: K36 Therapeutics is a clinical-stage biopharmaceutical company developing first-in-class NSD2 inhibitors for the treatment of cancer. As a pre-revenue entity, the company has no approved products and generates no product revenue. It funds operations through venture capital financing (Series A and Series B). The company aims to advance its clinical pipeline through proof-of-concept, with the intention of eventually commercializing its therapies independently or through strategic partnerships with larger pharmaceutical companies.

Distribution channels2 records

Marketing channels5 records

Core offering

K36 Therapeutics is a clinical-stage biopharmaceutical company developing first-in-class, oral small molecule inhibitors of the NSD2 (MMSET/WHSC1) histone methyltransferase. Its lead asset, gintemetostat (KTX-1001), is in Phase 1 trials for relapsed/refractory multiple myeloma with the t(4;14) translocation, while KTX-2001 is in Phase 1 trials for metastatic castration-resistant prostate cancer (mCRPC). The company's pipeline targets epigenetic drivers of cancer through biomarker-stratified patient selection.

Product overview

K36 Therapeutics is developing a pipeline of selective NSD2 inhibitors targeting epigenetic drivers of cancer. The company's lead product is Gintemetostat (KTX-1001), a first-in-class oral inhibitor for multiple myeloma targeting the t(4;14) translocation, currently in Phase 1 clinical trials with expansion cohorts evaluating combinations with carfilzomib, mezigdomide, and pomalidomide. The second product, KTX-2001, is a selective NSD2 inhibitor for metastatic castration-resistant prostate cancer, also in Phase 1 development as monotherapy and in combination with darolutamide. Both products represent first-in-class epigenetic therapies targeting the NSD2 histone methyltransferase.

Differentiator

Problem solved

Functional benefit

Products and services

• Gintemetostat (KTX-1001) A first-in-class, oral, highly selective small molecule inhibitor of NSD2 (MMSET) developed for the treatment of multiple myeloma patients harboring the t(4;14) chromosomal translocation. It targets the epigenetic driver of the disease to reduce H3K36me2 levels, restore gene expression to normal levels, slow tumor progression, and is being evaluated as monotherapy and in combination with carfilzomib, mezigdomide, and pomalidomide in the K36-MMSET-001 Phase 1 trial. The product is in clinical development for patients who have received 1-3 prior lines of therapy.
• KTX-2001 A selective, oral NSD2 inhibitor in clinical development for metastatic castration-resistant prostate cancer (mCRPC). It reduces H3K36me2 levels, suppresses oncogenic transcriptional programs, inhibits tumor cell proliferation, and is being evaluated as both monotherapy and in combination with the androgen receptor pathway inhibitor darolutamide in the STRIKE-001 Phase 1 trial, which is designed to enroll approximately 140 patients.

Quantifiable outcome

• Phase 1 clinical data for KTX-1001 demonstrated pharmacodynamic target engagement (H3K36me2 suppression in patient samples), emerging signs of clinical activity in heavily pretreated relapsed/refractory multiple myeloma patients, and a manageable safety profile.
• +2 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• BayercoreStrategic or Co-development Partner · 7 August 2025K36 Therapeutics entered into a clinical trial collaboration with Bayer for the supply of darolutamide. Bayer provides darolutamide for use in combination with KTX-2001 in the STRIKE-001 Phase 1 clinical trial for metastatic castration-resistant prostate cancer (mCRPC). This collaboration leverages Bayer's marketed androgen receptor inhibitor alongside K36's NSD2 inhibitor.
• NovartiscoreOEM/ Whitelabel/ Licensing Partner · 9 December 2021K36 Therapeutics in-licensed KTX-1001 (a small-molecule treatment targeting MMSET/NSD2 for multiple myeloma) from Novartis. This in-licensing agreement provided K36 with the foundational compound for its lead clinical program, which was subsequently advanced through IND submission and Phase 1 clinical trials.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Bayer: Prostate cancer incumbent (Nubeqa/darolutamide) and K36's clinical trial collaborator for darolutamide supply. Strategic partner in mCRPC development.
• Bristol-Myers Squibb: Multiple myeloma market leader (Pomalyst, Empliciti, CELMoDs) and a strategic investor in K36's Series B. Competes in the same MM treatment landscape and validates K36's commercial opportunity.
• Janssen Pharmaceuticals (Johnson & Johnson): Multiple myeloma leader (Darzalex, Carvykti) and major prostate cancer franchise. Dominant incumbent in both lead indications K36 is pursuing.

Emerging players

• Arcellx: Clinical-stage cell therapy company developing CAR-T treatments for multiple myeloma. Competes in the same MM patient population K36 is targeting, though via a different modality.
• Monte Rosa Therapeutics: Clinical-stage biotech developing molecular glue degraders for cancer and other diseases. Comparable stage and oncology focus, with adjacent targeted-protein-degradation approach.

Direct peers

• Syndax Pharmaceuticals: Clinical-stage oncology company developing epigenetic-targeted small molecules (e.g., HDAC and EZH2 inhibitors). Closest analog to K36 in stage, modality (small molecule), and chromatin/epigenetic oncology focus.
• Foghorn Therapeutics: Clinical-stage biotech developing small molecule inhibitors of chromatin remodeling proteins for cancer. Highly comparable to K36's epigenetic cancer strategy and stage.
• Prelude Therapeutics: Clinical-stage precision oncology company developing small molecule inhibitors of PRMT5 and other epigenetic targets. Comparable in modality, stage, and oncology focus.
• Constellation Pharmaceuticals: Epigenetic-focused oncology company (acquired by MorphoSys) that developed EZH2 and other chromatin-targeted inhibitors. Direct historical comparator in the same therapeutic class.
• Epizyme: Epigenetic oncology company (now part of Ipsen) that developed EZH2 inhibitor tazemetostat. Historical direct peer in the targeted epigenetic oncology space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/k36-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds2 records

Investors5 records

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M&A

Investments

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

Frequently asked questions about K36 Therapeutics