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Galecto will focus on cancer and liver disease, leveraging existing clinical stage asset GB1211Bolsters pipeline by obtaining global rights to BRM-1420, a novel dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of acute myeloid leukemia (AML)BRM-1420 has the potential for enhanced clinical effectiveness compared to FLT3 inhibitors alone and has shown synergistic effects with SOC in preclinical models BOSTON, Oct. 07, 2024 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, today announced that, following an intensive strategic review process, Galecto has determined to focus on cancer and liver disease, leveraging its existing clinical stage asset GB1211, which has shown positive results in non-small cell lung cancer (NSCLC) and decompensated cirrhosis clinical studies. Galecto further announced that it has bolstered its pipeline with the acquisition of the global rights to BRM-1420, a novel, first-in-class asset developed by Bridge Medicines, a company co-founded by Takeda. “Our strategic review process concluded that our best opportunity for building value and changing the lives for patients with severe diseases was to focus on our existing clinical stage compound GB1211 and increase our chance for success by acquiring complementary assets. The addition of BRM-1420 represents a significant advancement in our mission to develop and deliver breakthrough treatments for oncology and liver conditions,” said Dr. Hans Schambye, CEO of Galecto. “We are particularly optimistic about BRM-1420's potential to address challenging genetic subsets of AML and its observed synergistic effects with standard-of-care therapies and menin inhibitors.” “AML is the most common acute leukemia in adults, yet despite available treatments, patient prognosis remains poor with significant unmet needs,” said Miles Gerson, Head of Takeda Ventures and Takeda’s Representative to Bridge Medicines. “Bridge Medicines has made considerable progress in recent years developing this new class of drugs and Galecto’s team is well positioned to continue advancing BRM-1420.” As consideration for the acquisition of the global rights of BRM-1420, Galecto issued 62,594 shares of common stock to Bridge Medicines, representing 4.99% of the outstanding shares of Galecto’s common stock as of the date of the asset purchase, and 160.562 shares of a newly-issued Series A preferred stock convertible into 160,562 shares of common stock, or approximately 12.8% of Galecto’s common stock, upon receipt of stockholder approval. Matthew Kronmiller, Bridge Medicine’s Chief Executive Officer, will be joining Galecto’s management team as the Executive Vice President of Strategy and Chief Business Officer. The transaction was approved by the Boards of Directors of both companies. Leerink Partners served as the exclusive financial advisor to Galecto and Lazard served as exclusive financial advisor to Bridge Medicines. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to Galecto. Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP is serving as legal counsel to Bridge Medicines. About BRM-1420BRM-1420 is a potent and selective ENL-YEATS and FLT3 inhibitor of multiple genetic subsets of AML. It disrupts key oncogenic pathways by inhibiting these domains, showing potent activity in MLLr and NPM1c cell lines. Promising preclinical and in vivo results highlight its efficacy in inhibiting leukemia cell growth and extending survival in AML models. In animal models, BRM-1420 exhibited superior efficacy to both FLT3 and menin inhibitors and was shown to inhibit cell proliferation in primary AML patient samples across multiple genotypes, including MLL-r, NPM1m, cKIT+, FLT3+, TET2+, and TP53+. These mutations are often seen in AML and, in total, could account for greater than 30% of the AML patient population. Many of these mutations have proven difficult to treat with currently available regimens and therefore represent a significant unmet medical need. The Company believes, based on preclinical data, that BRM-1420 could be additive or synergistic when used in combination with the current standard of care (azacitidine, venetoclax, cytarabine, gilteritinib), as well as current therapies under development, such as menin inhibitors. Galecto plans to file an IND for BRM-1420 in the US in late 2025 or early 2026 and initiate clinical studies in patients with AML thereafter. Exclusive global rights to the program were assigned by Bridge Medicines to Galecto through a license with The Rockefeller University. The pioneering discoveries were a result of collaboration between the Rockefeller University and the Tri-Institutional Therapeutics Discovery Institute (Tri-I TDI), followed by licensing by Bridge Medicines. About Galecto’s PipelineGalecto continues to develop GB1211, its first-in-class, oral small molecule, galectin-3 inhibitor for the treatment of oncology and severe liver cirrhosis. GB1211 is currently being studied in an investigator-initiated Phase 2 trial at Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI). GB1211 is being administered in combination with the standard therapeutic dose of pembrolizumab (Keytruda®) in patients with unresectable or metastatic melanoma or recurrent or metastatic HNSCC progressing during or after platinum-containing chemotherapy. This trial is designed to evaluate the safety and efficacy of GB1211 in combination with pembrolizumab and determine whether the addition of GB1211 increases the response rate of pembrolizumab in metastatic melanoma and HNSCC patients. This trial was initiated and enrolled its first patient in the second quarter of 2024. In addition, during the second half of 2023, Galecto concluded its Phase 1b/2a trial examining GB1211 in combination with atezolizumab, a PD-L1 checkpoint inhibitor, for the treatment of first-line non-small cell lung cancer (NSCLC). Four patients in this trial showed a partial response according to RECIST criteria (version 1.1), and two of these four patients continue to receive treatment in the extension phase of the trial. As part of the strategic alternative review process, Galecto has determined not to further advance GB2064, its LOXL-2 inhibitor candidate, at this time. About GalectoGalecto is a clinical-stage biopharmaceutical company committed to realizing the promise of novel treatments for cancer and liver diseases. The Company’s pipeline consists of first-in-class small molecule drug candidates that target cancer and fibrosis signaling pathways, including (i) an orally active galectin-3 inhibitor (GB1211) for the treatment of liver cirrhosis; (ii) an orally active galectin-3 inhibitor (GB1211) in combination with a checkpoint inhibitor for various oncology indications; and (iii) a preclinical dual inhibitor of ENL-YEATS and FLT3 (BRM-1420) for multiple genetic subsets of AML. Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com. Forward-Looking StatementsCertain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Galecto’s preclinical and clinical development plans for BRM-1420; BRM-1420's potential to address challenging genetic subsets of AML and its observed synergistic effects with standard-of-care therapies and menin inhibitors; that BRM-1420 has the potential to transform the treatment of AML; that the MLL-r, NPM1m, cKIT+, FLT3+, TET2+, and TP53+ mutations could account for greater than 30% of the AML patient population; and that BRM-1420 could be additive or synergistic when used in combination with current standard of care as well as current therapies under development. Such forward-looking statements include statements about Galecto’s focus and plans for preclinical and clinical development of its product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto’s product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto’s Annual Report on Form 10-K, as filed with the SEC on March 8, 2024. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law. For more information, contact: Investors/USMedia/EUAshley R. Robinsonarr@lifesciadvisors.comSandya von der Weidsvonderweid@lifesciadvisors.com+1 617 430 7577+41 78 680 0538

May 01, 2024 -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, today announced that the first patient has been enrolled in an investigator-initiated Phase 2 trial to evaluate GB1211, Galecto’s first-in-class, oral small molecule galectin-3 inhibitor candidate, at the Earle A. Chiles Research Institute (EACRI), a division of Providence Cancer Institute in Portland, Oregon, USA. Under the direction of Providence investigators Dr. Brendan Curti and Dr. William Redmond, the study aims to evaluate the safety and efficacy of GB1211 at a dose of 100mg twice daily in combination with pembrolizumab for the treatment of metastatic malignant melanoma (MM) and head and neck squamous cell carcinoma (HNSCC). Drs. Curti and Redmond received an R01 Research Project Grant award from the National Cancer Institute, National Institutes of Health, for their investigator-initiated Phase 2 trial. Galecto has committed to supply GB1211 for the trial. Galectin-3 is overexpressed in many cancers, including melanoma and HNSCC. Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness and metastatic potential. Furthermore, increased levels of galectin-3 in the tumor microenvironment can cause checkpoint inhibitor resistance by blocking the binding of the checkpoint inhibitor antibodies, pembrolizumab and atezolizumab (Tecentriq®), to their respective targets. Preclinical data has shown that GB1211 has the ability to reduce galectin-3 associated interference with immune checkpoint inhibition (ICI), thus alleviating galectin-3-specific ICI resistance. In the fourth quarter of 2023, Galecto reported topline results from its Phase 1b/2a GALLANT-1 clinical trial evaluating GB1211 twice daily in combination with atezolizumab for the first-line treatment of non-small cell lung cancer (NSCLC). Galecto reported that investigator-assessed objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received the recommended Phase 2 dose level of GB1211 100 mg for at least three weeks. Historically, response rates of only 22–38% have been observed with atezolizumab monotherapy in the first-line treatment of advanced NSCLC, suggesting a potential benefit of adding GB1211 to ICI. Dr. Brendan Curti, Medical Director, Providence Melanoma Program, and EACRI Member and Robert W. Franz Endowed Chair for Clinical Research, said, “Our ability to perform bench-bedside research is a great strength of the Providence Cancer Institute. The insights from Dr. Redmond’s lab about how to use galectin inhibitors to alter the tumor microenvironment and promote anti-tumor activity, as well as our initial observations in patients, provide a robust rationale for our phase II clinical trial in patients with melanoma and HNSCC.” Dr. William Redmond, Member and Director, EACRI Immune Monitoring Lab, and co-principal investigator for the trial, stated, “We have published a significant amount of data on the important role of galectin-3 in creating immune suppression within the tumor microenvironment. We are excited to start this study in melanoma and HNSCC patients to potentially counteract ICI resistance and increase the efficacy of ICI by combining GB1211 and pembrolizumab.” “We are excited that the Providence Cancer Institute and Drs. William Redmond and Brendan Curti have initiated this trial. Dr. Redmond is a world-leading expert on the role of galectin-3 in cancer and ICI resistance and has demonstrated how galectin inhibition can be used to enhance tumor treatment,” stated Dr. Hans Schambye, CEO of Galecto. “Following the encouraging topline results from the GALLANT-1 trial that we reported in the fourth quarter of 2023, we look forward to exploring potential synergies with another leading ICI, pembrolizumab. This new trial marks a significant stride towards exploring GB1211's potential to enhance the effectiveness of ICI in various cancer indications.” The randomized, double-blind placebo-controlled, investigator-initiated Phase 2 trial will evaluate whether the addition of GB1211 increases the response rate of pembrolizumab in metastatic melanoma and HNSCC patients. The study will employ a fixed dose of GB1211 in conjunction with the standard therapeutic dose of pembrolizumab in patients with unresectable or metastatic MM or recurrent or metastatic HNSCC progressing during or after platinum-containing chemotherapy. In addition to monitoring for toxicity and clinical response, biospecimens will be obtained to assess immunologic measures relevant to galectin biology and T-cell checkpoint inhibition. Tumor volume will be assessed by immune response RECIST criteria (iRECIST criteria 1.1). It is anticipated that early data from this trial could be available as early as 2025. Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness, and metastatic potential. In the tumor tissue, galectin-3 supports the creation of fibrosis, tumor proliferation, metastasis, and immune avoidance. Preclinical data announced at the 2022 ASCO Annual Meeting furthermore suggest that galectin-3 can enhance PD-1 and PD-L1 binding and avert the interference of anti-PD-1/anti-PD-L1 therapies by blocking the binding of the antibodies to their respective targets. GB1211 is specifically designed to counter these anti-checkpoint inhibitor effects of galectin-3. GB1211 demonstrated an anti-cancer effect and antifibrotic activity in multiple preclinical models and has successfully completed a Phase 1 trial in 78 healthy volunteers. In the Phase 1 trial, GB1211 was well-tolerated and exhibited dose-dependent pharmacokinetics. Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has multiple Phase 2 clinical opportunities in fibrosis and cancer, including (i) an orally active LOXL2 inhibitor (GB2064) for the treatment of myelofibrosis; (ii) an orally active galectin-3 inhibitor (GB1211) for the treatment of liver cirrhosis; and (iii) an orally active galectin-3 inhibitor (GB1211) in combination with a checkpoint inhibitor for various oncology indications. Providence Cancer Institute of Oregon, a part of Providence St. Joseph Health, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. Providence Cancer Institute is home to the Earle A. Chiles Research Institute, a world-class research facility located within the Robert W. Franz Cancer Center in Portland, Oregon, and is a recognized leader in the field of cancer immunotherapy since 1993. Learn more at www.providence.org/ORcancer. 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