Manhattan BioSolutions Announces Positive Preclinical Data Validating its Novel Synthetic Microbial Therapeutic Platform

New York City, New York Feb 23, 2021 (  – Manhattan BioSolutions, Inc, an emerging biotechnology company focused on the discovery of immunoregulatory therapies for the treatment of metastatic cancers, today announced positive preclinical data from its in vivo efficacy study in a mouse model of bladder cancer. These data validate the key advantages of the Synthetic Microbial Immune Stimulator (sMIST) platform and support the further development of live, non-pathogenic mycobacteria for the treatment of bladder cancer, as well as the potential expansion of its sMIST candidates into other indications. “The successful completion of the proof-of-concept study is an early, yet significant milestone in the development of our lead candidate, a novel agent that has the potential to impact muscle-invasive, advanced and/or metastatic bladder cancer, a lethal disease with poor survival outcomes”, said Dr. Boris Shor, CEO of Manhattan BioSolutions.

Lead sMIST candidates are based on live Mycobacterium Bovis BCG genetically engineered to target mutant forms of an oncogenic receptor frequently mutated and overexpressed in most subtypes of bladder cancer and other neoplasms. sMIST therapy is designed to induce both innate and tumor-specific cellular immune responses with the potential for significant synergy with immune checkpoint inhibitors.

The proof-of-concept in vivo efficacy study compared the antitumor activity of sMIST candidates to benchmark unmodified BCG bacteria using a syngeneic mouse model of bladder cancer. Data from this study demonstrate the ability of sMIST immunotherapy to inhibit tumor growth and induce sustained tumor regressions. Remarkably, the survival analysis showed that a much shorter time was needed to achieve complete tumor regressions in the sMIST arms versus unmodified BCG control. The subcutaneous injections with sMIST offer distinct advantages over other types of administration routes typically used for microbial therapeutics, including intravesical, systemic, or intratumoral applications.

Dr. Jessica Seeliger, scientific advisor to Manhattan Biosolutions and Associate Professor of Pharmacological Sciences at Stony Brook University, stated, “These data from preclinical studies of sMIST immunotherapy are very encouraging and provide support to further advance the lead candidates into preclinical development. The discovery and validation of genetically engineered BCG candidates with exciting anti-tumor activity may have a potent impact on the future of microbe-based drugs”.

“Much of the broad spectrum protective effects of unmodified BCG vaccine are attributed to trained immunity, the epigenetic and metabolic reprogramming of myeloid cells. We are pleased to see the discovery of synthetic live medicines with the potential to induce both innate and cancer-specific adaptive immune mechanisms”, stated Dr. Yossef Av-Gay, scientific co-founder of Manhattan Biosolutions and a Professor of Microbiology and Immunology at the University of British Columbia.

About Manhattan BioSolutions

Manhattan BioSolutions, Inc is a privately held biotechnology company focused on the development of immunotherapies that target microbial recognition and inflammatory signaling pathways for the treatment of metastatic cancers. Manhattan BioSolutions leverages two therapeutic modalities for drug discovery: synthetic microbes — genetically engineered living drugs and monoclonal antibodies against innate immune sensors that recognize pathogens or endogenous “danger signals” released as a result of tissue injury or inflammation. The company has established partnerships with the Stony Brook University, The University at Buffalo, INSERM, EVQLV Inc, and has been awarded grants by the National Institutes of Health (NIH) and the National Science Foundation (NSF).

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Contact for investor inquiries:
Jordana Lovett, PhD
Director of Investor Relations
(857) 600-1021