Ganfeborole

MENLO PARK, Calif.--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company advancing novel small molecule therapeutics through its boron chemistry platform, today announced a collaboration agreement with the global biopharma company GSK to develop new therapies for tuberculosis (TB). As part of this effort, the Gates Foundation will provide a third year of funding to support AN2’s work within the collaboration. TB continues to pose a major global health challenge, affecting more than a quarter of the world’s population and causing over 1.25 million deaths annually.1 “Our boron chemistry platform offers a differentiated and proven approach to small molecule drug discovery, paving the way for potential breakthroughs in addressing high unmet needs in infectious diseases and other therapeutic areas,” said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. “Boron chemistry has enabled the design of compounds that target novel mechanisms, such as LeuRS, not achieved by traditional carbon-based chemistry approaches. We believe it has the potential to deliver impactful therapeutics in infectious diseases like nontuberculous mycobacterial (NTM) lung disease and TB and for other therapeutic areas including critical solid-tumor oncology targets such as PI3Kα and ENPP1 and other high priority targets.” LeuRS is the same validated target underlying epetraborole (in development for NTM lung disease), ganfeborole (in development for TB), and tavaborole, an FDA-approved antifungal. Easom continued: “This collaboration builds on years of partnership between the team now at AN2 and GSK, underpinned by a shared commitment to exploring the potential of boron-based therapeutics. We are hopeful that this approach may contribute to addressing the significant unmet needs of TB patients in the future. Our team brings extensive experience applying boron chemistry to drug discovery and working alongside GSK’s Global Health research and development team, we look forward to advancing a program that could help address this urgent global health challenge.” Thomas Breuer, Chief Global Health Officer, GSK said: "Getting ahead of tuberculosis, the world’s deadliest infectious disease, requires bold science and strong partnerships. Through this collaboration with AN2 Therapeutics, supported by the Gates Foundation, we are proud to be advancing innovative approaches in the hopes of developing new TB treatments for those who need it most in lower income countries.” About AN2 Therapeutics AN2 Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform. AN2 has a pipeline of boron-based compounds in development for Chagas disease, melioidosis, and NTM lung disease caused by M. abscessus, along with programs focused on targets in oncology and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical medical needs and improve health outcomes. For more information, please visit our website at www.an2therapeutics.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding AN2 Therapeutics’ collaboration with GSK, the potential of AN2’s boron chemistry platform, the development of LeuRS-targeting therapeutics, and the ability of such programs to address tuberculosis or other areas of unmet medical need. Forward-looking statements are based on AN2’s current expectations and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, the ability to successfully initiate and complete preclinical and clinical studies, obtain regulatory approvals, and commercialize any resulting products; the timing and success of collaborations; and other risks described in AN2’s filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in AN2’s most recent quarterly report on Form 10-Q and other filings. AN2 undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. 1 https://www.cdc.gov/global-hiv-tb/media/pdfs/2025/03/2025_DGHT-TB-Overview-Factsheet.pdf

Hopes for GSK3528869 appeared to be dashed in December when GSK terminated a phase 1/2 chronic hepatitis B study.\n GSK is prioritizing development of its hepatitis B treatment bepirovirsen as the pharma ends work on another potential functional cure for the infectious disease.On a media call Wednesday morning to discuss her company\'s fourth-quarter and full-year earnings, CEO Emma Walmsley said that when it came to the British pharma’s infectious disease pipeline, “we\'re prioritizing development of bepirovirsen, our potential functional cure for hepatitis B.”The pharma licensed the antisense oligonucleotide from Ionis Pharmaceuticals for $25 million upfront in 2019 and is currently aiming for an approval decision by regulators for chronic hepatitis B next year. The reemphasis on bepirovirsen came as GSK disclosed this morning that it has discontinued work on GSK3528869. The company had been holding out hopes that the candidate could be another functional cure for the infection—meaning it reduces hepatitis B virus DNA and viral proteins to undetectable levels. This stands in contrast to currently available oral antiviral therapies, which only suppress the virus.But those hopes for GSK3528869 appeared to be dashed in December when GSK terminated a phase 1/2 chronic hepatitis B study after the therapeutic vaccine regimen failed to meet the efficacy endpoint. The study tested different dose levels and sequences—and included placebo—but the idea was to prime the immune system with a viral vector encoding hepatitis B protein antigens, boost the immune system with a different vaccine and administer adjuvants to enhance the response.At the time, the pharma still had another study of GSK3528869 listed as active on the federal trial database. That study was evaluating the effect of giving vaccines to prime and boost the immune system—and adjuvants to enhance the response—after patients have received GSK’s bepirovirsen. But GSK confirmed in its earnings documents (PDF) today that it won’t be taking GSK3528869 forward.GSK isn’t the only pharma to have struggled with hepatitis B candidates in the clinic. Roche axed phase 1 and 2 trials in a recent pipeline cull, while Altimmune dropped a drug candidate after phase 2 data disappointed, and Ascletis Pharma stopped a hepatitis B program after the asset flopped in another indication.While bepirovirsen is taking priority, GSK still has a number of other assets in clinical development for chronic hepatitis B, including the hepatitis B virus-targeted siRNA GSK5637608, the PAPD5/PAPD7 inhibitor GSK3965193 and the TLR8 agonist GSK5251738. GSK also disclosed this morning that it had removed a capsid protein inhibitor for HIV called VH4004280 from its phase 2 pipeline. The company still has another HIV capsid protein inhibitor in multiple clinical trials in the form of VH3739937.The final drug to be pulled is the phase 1-stage GSK2556286, which is designed to inhibit the intracellular growth of Mycobacterium tuberculosis. The pharma has other tuberculosis candidates in the clinic in the form of the leucyl t-RNA synthetase inhibitor ganfeborole, the ethionamide booster alpibectir and the serine beta lactamase inhibitor sanfetrinem cilexetil. When it came to M&A, Walmsley told journalists on the media call that the company “continues to add new opportunities through targeted business development.” She pointed to the acquisition of Boston-based cancer-focused biotech IDRx last month as “a good example of what we want to do here.”