Pipeline

Graph Pipeline

 

Expanding Innovative Pipeline of Cancer Metabolism-Based Compounds (CMBTsTM)

TYME has multiple cancer metabolism-based assets and other formulations for SM-88 in development, including injectable, intranasal, and transdermal, which are in pre-clinical stages.

Our first-in-class Cancer Metabolism-Based Therapies (CMBTs) compounds include SM-88 and TYME-18. These compounds are structurally and mechanistically different, but each offers the potential for better and safer medicines. Early clinical results demonstrated by SM-88 in multiple advanced cancers, including pancreatic, prostate, sarcomas and breast, reinforce the potential of our emerging CMBT pipeline. Moreover, we believe this pipeline offers hope to patients for a new future in long-term management of advanced cancers, as well as commercial promise for TYME.

Our lead clinical CMBT compound, SM-88, is an oral investigational modified proprietary tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. To date, clinical trial data have shown that SM-88 has achieved confirmed tumor responses across 15 different cancers, both solid and liquid tumors, including pancreatic, lung, breast, prostate, sarcoma and lymphoma cancers with minimal serious Grade 3 or higher adverse events, which we believe is rare for investigational compounds. Our lead compound SM-88 is now in a pivotal trial and an adaptive randomized Phase II/III clinical trial with registration intent for patients with second- and third-line pancreatic cancer. Patients are also being enrolled in a Phase II study evaluating SM-88 in high-risk sarcomas, and we presented final SM-88 Phase II clinical data at European Society for Medical Oncology’s ESMO 2019 conference showing encouraging clinical benefit in patients with bio-marker recurrent prostate cancer.

We are making noteworthy progress across multiple areas of drug development. The major objective of our clinical-trial programs is to broaden our knowledge of the full potential of SM-88, and to evaluate and advance the promising potential of other innovative, proprietary new CMBT compounds. Our clinical-trial programs produced impressive results in fiscal 2020. Data from these studies were highlighted at multiple major international medical meetings by clinical investigators representing leading cancer research centers of excellence.

TYME recently announced a potential new approach to treating COVID-19 using a metabolic agent, TYME-19. TYME-19 is a synthetic bile acid, a family of metabolic agents that the Company also uses in its anticancer product, TYME-18. Because of its expertise in metabolic therapies, the Company was able to quickly identify TYME-19 as a potent, well characterized antiviral bile acid and has performed preclinical experiments establishing effectiveness against COVID-19. Bile acids have primarily been used for liver disease; however, they represent a family of critical cellular regulators across cardiovascular, neurologic, and metabolic systems, with some also having antiviral properties.

TYME has partnered with physicians from Massachusetts General Hospital and the Weill Cornell Medical Center to design a trial for recently diagnosed, symptomatic patients. The proof-of-concept trial is expected to start as soon as customary trial site approvals are completed.

TYME has an expanding patent portfolio broadly covering compositions, methods, manufacturing and use of its pipeline to 2032, and beyond. To date, TYME has 194 issued patents and patent applications worldwide, including 10 issued patents and an additional 12 patent applications in the United States. We will continue to make appropriate investments in our CMBT pipeline that have the potential to yield clinical results of the kind presented throughout fiscal 2020. We are encouraged by what we accomplished and are very excited about the opportunities that lie ahead.

MOA Backgrounder

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