A New Jersey-based microcap biotech company called Tyme Technologies (NASDAQ:TYME) is collaborating with investigators from Massachusetts General Hospital and Weill Cornell Medical Center to launch the proof-of-concept RESPOnD trial to test TYME-19, an oral synthetic bile acid that demonstrates broad spectrum antiviral activity as well as efficacy against SARS-CoV-2, the virus behind COVID-19, in preclinical research.
TrialSite breaks down this recent news about Tyme Technologies (the Company).
What has been the Company’s primary focus?
The Company has been developing cancer metabolist-based therapies (CMBT’s) and, based on that research, were able to uncover a new approach to treating COVID-19 using a metabolic agent called TYME-19. The Company positions itself as a leader in the development of bile acids as potential therapies for cancer, COVID-19 and other diseases.
The Relevance to COVID-19 and Viruses
Viruses hijack a cell’s ability to make proteins and lipids and divert these processes to make viral proteins and lipids in order to reproduce. Viruses accomplish this by inducing stress in the endoplasmic reticulum (ER), where cells process proteins, which enables the virus to remodel protein and lipid synthesis. In preclinical testing, TYME-19 has been shown to counteract these effects, preventing viral replication, by reducing ER stress. In addition, TYME-19 is believed to physically degrade viruses by solubilizing the protective lipid layer and other structural components, which prevent a virus from binding to and infecting a cell.
What is TYME-19?
TYME-19 is a synthetic bile acid, a family of metabolic agents that the Company uses in its anticancer product, TYME-18. The company declared that its expertise in metabolic therapies led it to expeditiously identify TYPE-19 as a potent, well characterized antiviral bile acid. They have subsequently performed preclinical experiments establishing effectiveness against COVID-19. Bile acids are primarily used for liver disease. But they represent a family of critical cellular regulators across cardiovascular, neurologic, and metabolic systems with some exhibiting antiviral properties. Hence the investigational claims here.
Dr. John Rothman, Executive Vice President Product Development at TYME, reports a confluence of three elements, including 1) recent research findings that bile acids occur naturally as part of the response to viral infection; 2) demonstrated tolerability of the agent; and 3) multiple antiviral mechanisms of the investigational product.
What has the Company done in Preclinical research?
The Company has commenced preclinical testing and found that TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity to the treated cells. Previous research revealed that select bile acids, such as TYME-19, have had broad antiviral activity. Part of a family of metabolic agents called bile acids that have formerly been associated with liver disease are becoming recognized for their potential utility to treat multiple diseases. As it turns out, bile acids are important regulators for many cellular functions throughout the central nervous, cardiovascular and metabolic systems.
What’s with the MGH & Weill Cornell Partnership?
The Company partnered with both 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.
The Proof-of-Concept Clinical Trial
The Company and the two academic medical centers seek to evaluate TYME-19 versus placebo in newly diagnosed, symptomatic patients with defined high-risk factors. The trial will measure specific indicators of safety and efficacy, including time to resolution of symptoms, changes in viral load, rate of hospitalization and others. Positive results from the proof-of-concept could lead to a development program in which TYPE-19 is studied as a potential new oral treatment for patients with COVID-19 before they require hospitalization, and/or as prophylaxis for high-risk individuals and front-line workers.
Principal investigator POV
Curtis L Cetrulo, Jr., MD of Massachusetts General Hospital and Harvard Medical School acknowledged the enormous unmet need for therapies that can be used prior to a COVID-19 patient going to the hospital. He commented, “We are encouraged with this news approach to fight COVID-19, especially one in a class of therapies that has a well understood safety profile and considerable research behind it. We are also hopeful that TYME-19’s potential broad antiviral properties could help us prepare for future outbreaks.”
Founded in 2011, TYME is an emerging biotechnology company developing Cancer Metabolism-Based Therapies (CMBTs™) that are intended to be effective across a broad range of solid tumors and hematologic cancers, while also maintaining patients’ quality of life through relatively low toxicity profiles. Unlike targeted therapies that attempt to regulate specific pathways within cancer, TYME’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic requirements to cause cancer cell death. Our first-in-class CMBT compounds include SM-88 and TYME-18. These compounds are structurally and mechanistically different, and we believe they offer 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, this pipeline offers hope to patients for a new future in long-term management of advanced cancers.
The company has raised approximately $20 million. Founded by Steve Hoffman, the company is a small cap, publicly traded company.