What Cugene does

Cugene, Inc. is a Boston-based clinical-stage biotechnology company founded in 2016, headquartered at 130 Turner Street, Suite 702, Waltham, MA. The company develops precision immunotherapies for cancer and autoimmune diseases using a biologics-based platform that combines engineered cytokines, bispecific antibodies, and a proprietary masking technology for tissue- or cell-selective targeting.

Cugene's pipeline is anchored by three technology platforms. CUG252 is a precision-engineered Treg-selective, long-acting IL-2 mutein designed to restore regulatory T cell functionality and suppress autoantibody production in autoimmune and inflammatory diseases, with an ongoing Phase 1b trial in Systemic Lupus Erythematosus (SLE) following FDA-cleared Phase 1a in healthy volunteers. In oncology, TILKine™ and VitoKine™ are TIL-targeting bispecific technologies engineered to selectively engage tumor-infiltrating lymphocytes, simultaneously blocking immune checkpoints and activating effector T cells through cis-signaling, with VitoKine additionally differentiated by a proprietary masking domain enabling tumor-specific activation. VitoKine-2 is a next-generation tumor-activable IL-2 therapeutic designed for monthly high-dose administration with an enlarged therapeutic window.

The business model is anchored on licensing and collaboration. In May 2022, Cugene entered into an exclusive worldwide license option agreement with AbbVie for CUG252 and other novel IL-2 muteins for autoimmune and inflammatory diseases, positioning the company to capture milestone and royalty economics while a major pharmaceutical partner handles global development and commercialization. The company is pre-revenue, with no disclosed product sales; revenue, if any, would flow from licensing milestones. The company markets through scientific conference presentations, peer-reviewed publications, and partnership announcements targeting investors and pharmaceutical partners rather than direct clinical end-users.

Name

Cugene

Legal name

Cugene, Inc.

Website

https://cugene.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

Cugene is a Boston-based clinical-stage biotechnology company developing precision immunotherapies — including Treg-selective IL-2 and TIL-targeting bispecifics — for cancer and autoimmune diseases, with CUG252 in Phase 1b trials and a worldwide license option held by AbbVie.

Ownership category

akta.pro rank

Product category

Clinical-stage Biopharmaceuticals (Precision Immunotherapy)

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

Engineered Protein Therapeutics (de novo/AI-designed proteins, novel scaffolds) (HLAAAAAJ)

akta.pro secondary industries

Recombinant Protein Therapeutics (enzymes, hormones, growth factors) (HLAAAAAB), Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB)

Keywords

• Clinical-stage biotechnology
• Precision immunotherapy development
• Autoimmune disease therapeutics
• Oncology biologics
• Engineered cytokine therapy

Headquarters

HQ city

Waltham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Licensing and Collaboration Agreements: Pre-revenue clinical stage company generating income through exclusive licensing agreements with pharmaceutical partners. AbbVie collaboration provides potential milestone and royalty payments for CUG252 and other IL-2 muteins.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

Cugene is a Boston-based clinical-stage biotechnology company developing a pipeline of precision immunotherapies for cancer and autoimmune diseases. Its portfolio centers on biologics-based therapeutics including CUG252 (a Treg-selective long-acting IL-2 mutein for autoimmune/inflammatory diseases), TILKine and VitoKine (TIL-targeting bispecific technologies for solid tumors), and VitoKine-2 (an advanced tumor-activable IL-2). These candidates are integrated with a proprietary masking technology that enables tissue- or cell-selective targeting to minimize systemic toxicity.

Product overview

Cugene is a clinical-stage biotechnology company developing a pipeline of precision immunotherapies for cancer and autoimmune diseases. The company's product portfolio centers on its technology platform utilizing biologics-based therapeutics, including: CUG252 (a Treg-selective long-acting IL-2 for autoimmune diseases), TILKine™ and VitoKine™ (bispecific TIL-targeting technologies for oncology), and VitoKine-2 (an advanced tumor-activable IL-2 therapeutic). These products are integrated with proprietary masking technology and precision immuno-engineering to achieve tissue or cell-selective targeting with reduced systemic toxicity.

Differentiator

Problem solved

Functional benefit

Products and services

• CUG252 A precision engineered Treg-selective, long-acting IL-2 mutein that abolishes binding to effector cells and retains full agonist activity on IL-2α. It restores full Treg functionality, suppresses autoantibody production, and restores immune homeostasis for treating autoimmune and inflammatory diseases including Systemic Lupus Erythematosus (SLE).
• TILKine A TIL-targeting bispecific technology engineered to selectively engage tumor-reactive tumor-infiltrating lymphocytes (TILs) in the tumor environment. Through cis-signaling, it simultaneously blocks a key immune checkpoint and activates effector T cells, driving a potent and localized anti-tumor response. Aiming for first-line monotherapy for solid tumors.
• VitoKine A TIL-targeting bispecific technology uniquely differentiated by a proprietary masking domain that enables tumor-specific TIL activation, minimizing systemic immune activation. Together with TILKine, these technologies reinvigorate exhausted T cells and expand tumor-killing effector T cells for precise and profound tumor eradication.
• VitoKine-2 A precision-engineered tumor-activable IL-2 therapeutic designed to target tumor-infiltrating lymphocytes (TIL) in the tumor microenvironment. Uses unique masking technology to remain inert until activated, minimizing peripheral T cell activation and reducing systemic toxicities. Designed for monthly high-dose administration with an enlarged therapeutic window for both IO-responsive and unresponsive patients.

Quantifiable outcome

• Complete tumor regressions observed in multiple cold and hot mouse models with efficacy superior to ICIs
• +2 more outcomes

Segments2 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.

• AbbViecoreStrategic or Co-development Partner · 16 May 2022AbbVie and Cugene entered into an exclusive worldwide license option agreement for CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins for the potential treatment of autoimmune and inflammatory diseases. This collaboration positions Cugene's pipeline for global development and potential commercialization through a major pharmaceutical partner.

Scale indicators2 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Roche: Roche has multiple engineered IL-2 and IL-15 programs (including collaborations with Squarex and others) targeting Treg expansion for autoimmune disease, and is the dominant broad incumbent in oncology biologics — a relevant comparable for both halves of Cugene's pipeline.
• Sanofi: Sanofi is a global immunology leader (Dupixent franchise) actively pursuing Treg-focused and engineered cytokine programs for autoimmune indications, and a major oncology biologics player — overlapping with Cugene on both autoimmune and oncology axes.
• Eli Lilly: Lilly acquired Dice Therapeutics and is partnered with Nektar on rezpegaldesleukin (Treg-selective IL-2), placing it as a large-cap incumbent competitor in the same autoimmune IL-2 space as CUG252, with materially greater development and commercial resources.

Direct peers

• Nektar Therapeutics: Nektar developed NKTR-358 (now rezpegaldesleukin, partnered with Eli Lilly), a Treg-selective IL-2 for autoimmune diseases — directly comparable to Cugene's CUG252 in mechanism, target selectivity approach, and indication strategy.
• AnaptysBio: AnaptysBio is a clinical-stage biotech with proprietary antibody discovery and engineering platforms producing both wholly-owned and partnered antibodies for inflammation and immuno-oncology — comparable to Cugene in its biologics-platform-plus-pipeline model and therapeutic area focus.
• Compass Therapeutics: Compass develops bispecific antibodies for oncology, with candidates designed to engage tumor-reactive immune cells — directly comparable to Cugene's TILKine/VitoKine bispecific strategy targeting tumor-infiltrating lymphocytes.
• CytomX Therapeutics: CytomX's Probody platform uses masking technology to render antibody therapeutics inert until activated in the tumor microenvironment — the same underlying conditional-activation thesis Cugene applies with VitoKine, applied to bispecific antibodies and cytokines.
• Xilio Therapeutics: Xilio develops tumor-activated immunotherapies, including masked IL-2 and IL-12 molecules (XTX101, XTX301), using a masking domain to limit systemic activity — closely paralleling Cugene's VitoKine platform and tumor-selective cytokine thesis.
• Werewolf Therapeutics: Werewolf's PREDATOR platform engineers tumor-conditional IL-2 and IL-12 cytokines designed to be inert systemically and activated in the tumor microenvironment — conceptually analogous to Cugene's VitoKine masking approach.

Others

• AbbVie: AbbVie is Cugene's exclusive worldwide license option partner for CUG252 and other IL-2 muteins — a large-cap pharma incumbent in immunology and oncology and a critical strategic counterparty rather than a direct competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cugene

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Cugene