Galecto Refocuses on Oncology, Liver Disease; Acquires AML Asset from Bridge Medicines

Galecto, Inc., a clinical-stage biotechnology company, has announced a strategic shift to concentrate on cancer and liver disease, capitalizing on its clinical-stage asset GB1211, which has exhibited promising outcomes in studies related to non-small cell lung cancer (NSCLC) and decompensated cirrhosis. The company has also expanded its pipeline through the acquisition of global rights to BRM-1420, a novel dual inhibitor targeting ENL-YEATS and FLT3, from Bridge Medicines. This asset shows potential for treating multiple genetic subsets of acute myeloid leukemia (AML).

Dr. Hans Schambye, CEO of Galecto, emphasized that the strategic review concluded the company's best route to create value and impact patient lives would be to focus on GB1211 and acquire complementary assets like BRM-1420. This new addition is anticipated to significantly advance Galecto's mission to develop breakthrough treatments for oncology and liver diseases. The potential of BRM-1420 lies in its ability to target challenging genetic subsets of AML and its demonstrated synergistic effects when combined with standard-of-care therapies and menin inhibitors.

Miles Gerson, Head of Takeda Ventures, highlighted that AML remains the most common acute leukemia in adults, with current treatments falling short. He expressed optimism about the continued development of BRM-1420 under Galecto’s leadership, given Bridge Medicines' noteworthy progress in this new class of drugs.

In exchange for the acquisition, Galecto issued 62,594 shares of common stock and 160.562 shares of newly-issued Series A preferred stock, convertible into 160,562 shares of common stock, to Bridge Medicines. This represented a significant stake in Galecto's common stock pending stockholder approval.

Matthew Kronmiller, CEO of Bridge Medicines, will join Galecto's management team as the Executive Vice President of Strategy and Chief Business Officer. The acquisition was approved by the Boards of Directors of both companies, with financial advising from Leerink Partners for Galecto and Lazard for Bridge Medicines. Legal counsel for the transaction was provided by Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo, P.C. for Galecto, and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP for Bridge Medicines.

BRM-1420 is recognized for its potent and selective inhibition of ENL-YEATS and FLT3 in multiple genetic subsets of AML. It disrupts critical oncogenic pathways and has shown significant activity in preclinical models, including cell lines with common AML mutations such as MLL-r and NPM1c. The drug has exhibited superior efficacy compared to FLT3 and menin inhibitors and has inhibited cell proliferation in AML patient samples with various genotypes. These genotypes account for over 30% of the AML patient population, representing a substantial unmet medical need. Preclinical data suggest BRM-1420 could work synergistically with existing treatments like azacitidine, venetoclax, and cytarabine, as well as with therapies currently under development.

Galecto intends to file an Investigational New Drug (IND) application for BRM-1420 in the US around late 2025 or early 2026, with plans to initiate clinical studies in AML patients subsequently. The exclusive global rights to the program were licensed to Galecto through Bridge Medicines from The Rockefeller University, following pioneering discoveries in collaboration with the Tri-Institutional Therapeutics Discovery Institute (Tri-I TDI).

Galecto continues to develop GB1211, an oral galectin-3 inhibitor, for treating oncology and severe liver cirrhosis. Currently, GB1211 is undergoing a Phase 2 trial at Providence Portland Medical Center in combination with pembrolizumab for melanoma and head and neck squamous cell carcinoma. The trial aims to evaluate the safety and efficacy of GB1211 in conjunction with pembrolizumab. Additionally, Galecto completed a Phase 1b/2a trial of GB1211 in combination with atezolizumab for first-line NSCLC, where some patients showed partial responses according to RECIST criteria.

As part of its strategic review, Galecto decided to halt further development of its LOXL-2 inhibitor candidate, GB2064. The company's pipeline focuses on first-in-class small molecule drugs targeting cancer and fibrosis signaling pathways, continuing their commitment to novel treatments for cancer and liver diseases.