SM-88 Overview

TYME SM-88_Image

 

What is SM-88

SM-88 (racemetyrosine) is an orally administered cancer metabolism-based therapy that is chemically altered to be non-functional for fundamental tumor cell processes, including protein synthesis. Scientific literature has broadly published that normal healthy cells do not regularly take up certain non-essential amino acids, specifically tyrosine, while a wide range of cancer cells upregulate methods to consume these metabolites. We believe that, when taken up by a cancer cell, our proprietary modified dysfunctional tyrosine interrupts protein synthesis, reduces key cellular defenses, and ultimately leads to an oxidative stress-related apoptosis or cell death. We also believe this selective cancer uptake of nonessential amino acids is supported by the current safety profile showing minimal observed drug-related serious adverse events (each, an “SAE”) in approximately 180 cancer patients treated with SM-88 to date, which includes patients of the Compassionate Use Program (discussed below) for whom we have safety results, but limited information regarding efficacy.

SM-88 is currently administered with the conditioning agents Methoxsalen, Phenytoin and Sirolimus (“MPS”). The conditioning agents are administered at doses between 5% and 25% of their U.S. Food and Drug Administration (“FDA”) approved doses in non-cancer indications. We believe, based on scientific literature of their respective biologic functions, the physiologic, but sub-therapeutic doses of these agents may augment either the uptake of SM-88 or destabilize cancer cells.

We are currently evaluating SM-88 in a pivotal trial and an adaptive randomized Phase 2/3 clinical trial (Precision Promise) for patients with second-line pancreatic cancer. Patients are also being enrolled Phase 2 study (HoPES) in high-risk sarcomas. Additionally, the company expects to initiate the Phase 2 study (OASIS) evaluating SM-88 in breast cancer (HR+/HER2-).

Additionally, we are developing an injectable formulation of SM-88 (SM-88i) for the treatment of multiple oncology indications. SM-88i is currently in preclinical development.

We believe we can become a leader in developing and delivering CMBTs with our platform technology for the following reasons:
  • Members of our management team have extensive experience in the development of novel cancer therapies.
  • Oral SM-88 has demonstrated meaningful clinical benefit and well tolerated safety profile, in metastatic cancer patients across 15 different types of solid tumors and hematologic cancers.
  • To date, SM-88 has shown a favorable safety profile and we believe the unique mechanism of action increases prospects for evaluation of the potential of SM-88 as a preferred therapy in combination with existing treatment modalities.
  • We currently retain all commercial rights for SM-88 and new pipeline candidates through a strong and growing patent estate of nearly 200 pending patent applications granted and/or pending globally which broadly covering compositions, methods, manufacturing and use of the Company's pipeline to 2032, and beyond.
  • We have a technology base and patent portfolio supporting SM-88 and have filed patents applications for additional drug candidates to provide a pipeline of oncology drug development programs based on our CMBT technology platform.

TYME has established preclinical research collaborations with academic institutions, as well as internal preclinical initiatives, to broaden the detailed understanding of the mechanisms associated with SM-88. The overall goals of these efforts are to potentially identify patient or disease biomarkers that could be applied to patient selection in clinical trials, as well as identify potential combinations with other anti-cancer mechanisms that could aid future clinical development. We currently have a research collaboration with Mayo Clinic and NYU Langone Health and could establish additional collaborations in the future.