Leap Therapeutics

What Leap Therapeutics does

Leap Therapeutics is a clinical-stage biopharmaceutical company founded in 2011 and headquartered in Cambridge, Massachusetts, focused on developing targeted and immuno-oncology monoclonal antibody therapeutics for cancer. The company's pipeline is built around three core candidates: sirexatamab (DKN-01), an anti-DKK1 antibody currently in Phase 2 development; FL-301, an anti-Claudin18.2 antibody; and FL-501, an anti-GDF-15 antibody in preclinical stages. Each candidate targets a distinct biological mechanism implicated in tumor immune evasion and growth, with biomarker-driven patient selection strategies (e.g., DKK1-high expression) intended to enable precision-medicine positioning across multiple tumor types including colorectal, gastric, endometrial, prostate, and lung cancers. In May 2026, the FDA granted Fast Track designation to sirexatamab for DKK1-high metastatic colorectal cancer, an important regulatory milestone.

Name

Leap Therapeutics

Legal name

Leap Therapeutics, Inc.

Website

https://leaptx.com

Company type

Public

Founded year

2011

Operating status

Ipo

Headcount range

1–10 employees

Short description

Leap Therapeutics is a pre-revenue clinical-stage biopharmaceutical company developing monoclonal antibody therapies targeting DKK1, GDF-15, and Claudin18.2 for biomarker-defined cancer indications. Founded in 2011 in Cambridge, MA, the company advances immuno-oncology treatments across multiple tumor types.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

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

akta.pro primary industry

Oncology & Hematology Pharmaceuticals (HLAIAAAC)

akta.pro secondary industries

Drug Discovery (Target ID/Validation & Hit Discovery) (HLAIALAA), Predictive Biomarkers for Therapy Selection (response/non-response stratification) (HLAAAMAE)

Keywords

• Cancer immunotherapy
• Monoclonal antibody therapeutics
• Oncology drug development
• Biomarker targeted therapy
• Clinical stage biopharmaceuticals

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

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

Revenue model

1. Drug Development & Commercialization: Pre-revenue clinical-stage biopharmaceutical company. Revenue will be generated from drug commercialization upon regulatory approval. Pipeline includes sirexatamab (DKN-01) in Phase 2 across multiple oncology indications, FL-301 in development, and FL-501 in preclinical stage.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels2 records

Core offering

Leap Therapeutics is a clinical-stage biopharmaceutical company developing targeted and immuno-oncology therapeutics, including three humanized monoclonal antibody drug candidates: sirexatamab (DKN-01, anti-DKK1), FL-301 (anti-Claudin18.2), and FL-501 (anti-GDF-15). The company uses biomarker-based patient selection (DKK1 expression via RNAscope) to identify cancer patients most likely to respond across multiple oncology indications including gastric, colorectal, endometrial, prostate, lung, and pancreatic cancers.

Product overview

Leap Therapeutics is a clinical-stage oncology drug development company focused on targeted and immuno-oncology therapeutics. The company's pipeline consists of three main drug candidates: Sirexatamab (DKN-01), an anti-DKK1 antibody in Phase 2 development across multiple cancer indications including gastric, colorectal, endometrial, prostate, and lung cancers; FL-301, an anti-Claudin18.2 antibody in development for gastric and pancreatic cancer; and FL-501, an anti-GDF-15 antibody in preclinical development. The company employs a biomarker-focused strategy, using DKK1 expression determined via RNAscope assay to select patients most likely to respond to therapy.

Differentiator

Problem solved

Functional benefit

Products and services

• Sirexatamab (DKN-01) A humanized monoclonal antibody that binds and removes free DKK1 from the tumor microenvironment. It reduces cell proliferation via CKAP4/PI3K/Akt downregulation, suppresses MDSC cells, reduces angiogenesis, and activates NK cells. In combination with anti-PD1 therapy it upregulates PD-L1 and enhances CD8 T cell adaptive immunity. Patients are selected using DKK1 expression determined via RNAscope in situ hybridization with H-Score measurement.
• FL-301 A humanized monoclonal antibody targeting Claudin18.2, being developed for patients with gastric and pancreatic cancer.
• FL-501 A humanized monoclonal antibody designed to neutralize GDF-15 and prevent binding to its receptor GFRAL. Engineered for higher target affinity and longer plasma half-life compared to competing therapies. In preclinical cachexia models it increased body weight and restored muscle mass and may reverse immunosuppression in cancers where elevated GDF-15 correlates with poor survival.

Quantifiable outcome

• Single agent and combination activity demonstrated in three different tumor types; well tolerated as monotherapy and in combination with chemotherapy or checkpoint inhibitors
• +2 more outcomes

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• NGM Biopharmaceuticals: Clinical-stage biopharma that has also developed anti-GDF-15 antibodies for cancer cachexia and metabolic disease. Most direct comparable given shared anti-GDF-15 mechanism and similar development stage.
• AVEO Oncology: Clinical-stage oncology company developing targeted therapeutics including biomarker-driven approaches in GI cancers (gastric, colorectal), with similar pipeline stage and indication focus to Leap's sirexatamab.
• Arcus Biosciences: Clinical-stage immuno-oncology company developing antibodies and small molecules for tumor microenvironment modulation. Comparable pipeline depth and combination-therapy strategy targeting similar mechanisms.
• Compugen: Clinical-stage immuno-oncology company using computational discovery to identify novel targets, including undisclosed antibodies in oncology. Similar reliance on novel target biology and biomarker-driven patient selection.
• Cullinan Oncology: Clinical-stage oncology company with multiple targeted programs across solid tumors, including biomarker-selected approaches. Similar small-team, multi-asset clinical-stage model.

Emerging players

• Jounce Therapeutics: Clinical-stage immuno-oncology company developing antibodies targeting the tumor microenvironment, including combinations with checkpoint inhibitors. Overlaps with Leap's mechanism involving MDSC suppression and immune activation.
• Surface Oncology: Clinical-stage immuno-oncology company focused on the tumor microenvironment and immunosuppressive cell populations. Comparable mechanism space to sirexatamab's MDSC-targeting activity.
• Werewolf Therapeutics: Clinical-stage oncology company developing novel immunotherapies with INDUKINE conditional activation platform. Comparable clinical-stage oncology profile and focus on targeted immune modulation.
• Mersana Therapeutics: Clinical-stage oncology company developing antibody-drug conjugates and targeted therapies for cancer, including GI indications. Similar clinical-stage profile and oncology platform focus.

Broad incumbents

• BeiGene: Global oncology company with commercial-stage immune checkpoint inhibitors (tislelizumab) and a broad pipeline across gastric, lung, and other tumor types Leap also targets. Existing Leap investor and indirect benchmark for indication priorities.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/cypherpunktech

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds23 records

Investors11 records

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

M&A2 records

Investments1 record

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

Frequently asked questions about Leap Therapeutics