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Generate:Biomedicines

A clinical-stage biotechnology company developing protein therapeutics designed using generative artificial intelligence and high-throughput experimental validation. Generate:Biomedicines’ most advanced program is a long-acting anti-TSLP monoclonal antibody in Phase III for severe asthma, positioning the company at the intersection of AI-enabled design and late-stage immunology development.

Company Overview

Generate:Biomedicines applies generative AI models to design novel proteins with predefined functional properties. Its strategy is to pair computational design with rapid laboratory build-test cycles, with the aim of improving affinity, specificity, developability and dosing profiles before clinical entry.

The company is advancing wholly owned programs while also leveraging its platform in multi-target collaborations with large pharmaceutical partners.

Headquarters and Global Presence

Generate:Biomedicines is headquartered in Somerville, Massachusetts.

Clinical development is conducted through global trial networks, reflecting the company’s progression into late-stage international studies.

Founding and History

Generate:Biomedicines was founded within Flagship Pioneering and launched in 2020.

The company has raised multiple private financings to support platform build-out and pipeline expansion, including a $273 million Series C announced in September 2023. Over time, it has transitioned from platform validation to clinical-stage execution.

Therapy Areas and Focus

Generate:Biomedicines develops protein-based therapeutics across:

Immunology and inflammation, including severe asthma and chronic obstructive pulmonary disease
Oncology, including antibody and cell therapy concepts
Infectious disease and pathogen-directed biologics

Immunology currently represents the most advanced clinical focus.

Technology Platforms and Modalities

The company describes its core capability as generative biology: the design of novel proteins using proprietary AI models trained on biological sequence and structural data, combined with high-throughput experimental validation.

Disclosed modalities include:

Monoclonal antibodies, including long-acting designs
Antibody concepts linked to conjugate safety enablement, such as free-payload binding antibodies
Cell therapy programs, including preclinical CAR T candidates

The platform supports both internal programs and external collaborations.

Key Personnel

Mike Nally, Chief Executive Officer
Aarif Khakoo, MD, MBA, Chief Scientific Officer
Laurie Lee, MD, Chief Medical Officer, Immunology & Inflammation

Strategic Partnerships

Generate:Biomedicines uses partnerships to expand target coverage and share development risk.

Selected collaborations include:

Amgen, under a multi-target, multi-modality research collaboration first announced in January 2022 and subsequently expanded
Novartis, under a multi-target collaboration announced in September 2024
MD Anderson Cancer Center, under a co-development and commercialization collaboration in oncology
Roswell Park Comprehensive Cancer Center, in a 50/50 collaboration for a preclinical CAR T program targeting MUC16

FAQ Section

Generate:Biomedicines designs protein therapeutics using generative AI models coupled with high-throughput experimental validation. The objective is to optimize key drug properties during the design phase rather than relying solely on downstream screening and iteration.

The company’s disclosed focus spans immunology and inflammation, oncology and infectious disease. Severe asthma is currently the most advanced indication.

Key disclosed programs include:

GB-0895, an anti-TSLP monoclonal antibody in Phase III for severe asthma and in Phase I for COPD

Earlier-stage assets include:

GB-4362, a monoclonal antibody designed to bind free MMAE to mitigate systemic exposure from MMAE-based ADCs
GB-5267, an IL-18–armored CAR T targeting MUC16 for metastatic ovarian cancer, currently in preclinical development

Recent updates have included initiation of global Phase III trials for GB-0895 in severe asthma and executive leadership expansion with the appointment of a Chief Scientific Officer. The company has also disclosed first-in-human results from additional AI-designed antibody programs.

Phase I data have been described as supporting tolerability and pharmacodynamic effects consistent with TSLP blockade. The candidate is designed for extended half-life, enabling dosing intervals of up to six months in Phase III studies.

Near-term milestones center on Phase III execution for GB-0895, including enrollment progress and eventual top-line readouts. Additional IND filings and first-in-human studies are expected as earlier programs mature.

The company focuses specifically on de novo and optimization-driven protein design rather than small molecules. Differentiation is expected to be demonstrated through clinical validation, repeatability across targets and modalities, and the ability to generate candidates with differentiated dosing and safety profiles.

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