The Silicon Review
Headquartered in Rehovot, Israel, Todos Medical Ltd. (OTCQB: TOMDF) is engineering life-saving diagnostic solutions for the early detection of a variety of cancers. The company’s state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer’s influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos’ two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Now, the company is in the process of acquiring U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista’s proprietary commercial-stage Videssa® breast cancer blood test.
But that’s not all; Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer’s disease. Its Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer’s disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain. In July 2020, Todos completed the acquisition of Breakthrough Diagnostics, Inc., the owner of the LymPro Test intellectual property, from Amarantus Bioscience Holdings, Inc. (OTC: AMBS), its joint venture.
Additionally, the company’s experience in developing and commercializing first-of-their-kind diagnostic tests has laid the groundwork for Todos to apply its capabilities to evaluate and deliver superior COVID-19 testing products to reach significant lab throughput capacities. In a brief interview, Gerald Commissiong, President and CEO, talked to us about the company’s many innovations and future projects. Here are the excerpts from the interview:
Q. What makes your screening unique?
Within the early detection/screening universe for breast cancer, Todos is the only spectroscopy-based assay that is mechanism agnostic, solely looking for differences in immune profiling between disease and healthy-normal, based upon algorithms developed using AI.
There are a few blood-based approaches to Alzheimer’s, most of these approaches center on identifying canonical Alzheimer’s markers – Amyloid or Tau. The rationale for these tests is that they serve as a proxy for brain concentration Amyloid and Tau-based imaging. Given the failure of these two mechanisms to demonstrate improvement across hundreds of clinical trials, we believe that looking upstream from Amyloid and Tau is where both true diagnostic and therapeutic avenues exist. LymPro captures both Amyloid and Tau-based information by proxy.
We believe Total Biochemical Infrared Analysis (TBIA) could be commercialized within a year based on the data already gathered in Singapore and our recent partnership with Pathnova to help drive the program forward to commercialization in Singapore. We have gathered data from several hundred subjects to date, including over 200 in Singapore, and are currently adding to that database by recruiting study participants in Europe. We believe that the data gathered thus far is sufficient to allow for a commercialization in Europe and Singapore, and potentially in other south east Asian jurisdictions as well. The algorithm optimization is the final key to driving commercialization.
Q. How was it working through the pandemic? How challenging was it for you?
We have been working hard to implement measures to help increase COVID-19 response by developing a range of testing capabilities, mobile testing labs, nutraceuticals to stop replication of coronaviruses, and other initiatives.
Q. Could you tell us more on what Todos Medical is currently working on?
We have taken on the significant task of commercializing a new lab testing business with uncertain international supply chains and stiff competition, and have been able to carve out a niche of providing labs with timely comprehensive lab-based COVID testing solutions that can scale to meet the requirements of local, state and federal contracting demands. Our focus on automation has created a commercial infrastructure able to deploy integrated solutions for labs looking to scale lab services for their core clients, and we believe the growing need for regional lab solutions in the United States will only make Todos’ turnkey solutions that much more attractive to existing and prospective clients.
Given Todos’ position of enabling labs to cost-effectively scale capacity in order to meet these new requirements for optimal reimbursement, we are now able to focus our new client acquisition strategy on those clients with strong demand from pre-existing and emerging relationships for COVID testing. We believe this will allow us to springboard our offering beyond PCR COVID-19 testing into new areas of molecular testing that are enabled by the automation Todos provides, and we intend to stay on the cutting edge of actionable tests with strong clinical utility that will enable physicians to provide improved patient outcomes with a lower overall cost of care.
Additionally, the Company is preparing to expand its offering into genomic sequencing in order to position its clients as Center of Excellence in COVID testing, able to quickly reflex test confirmed PCR positive patients for variant determination. This capability will become increasingly important, especially as new variants emerge and as infected vaccinated individuals continue to spread the virus leading to evolutionary pressures to produce variants that will overcome current traditional receptor binding domain (RBD) antibodies.
Further, Todos has made significant investments in helping to develop a novel mobile biosafety level 3 molecular laboratory infrastructure capable of doing high-capacity (2,000+ tests/day) housed in a 20-foot container, able to be deployed globally. We intend to focus on initially deploying in the New York City area before scaling deployment to other areas. This will allow for six hours or less turnaround times that will be suitable to cater to sporting events, theater shows, international travel, nightlife, as well as several other industries where impulse decision making is critical for business.
Also, we expect to soon be reaching critical, clinical development milestones surrounding our lab-based 3CL protease test, as well as milestones surrounding the development of the related point-of-care or at-home diagnostic test. Concurrently, we are beginning to get commercial traction with the launch of our dietary supplement Tollovid™ that received a certificate of free sale from the US FDA in the third quarter of 2020, as well as more concentrated version named Tollovir™, which Todos is advancing together with NLC Pharma through a more traditional regulatory pathway in Israel and eventually worldwide.
Gerald Commissiong, President and CEO
Serving as President and CEO of Todos Medical, Commissiong is also the interim-CEO of Breakthrough Diagnostics, Inc., Todos’ joint venture with Amarantus. Further, Commissiong has been responsible for Amarantus’ strategic transactions, licensing, research collaborations, mergers & acquisitions in therapeutics and diagnostics, as well as fund raising, having raised over of $50 million since inception. Prior to co-founding Amarantus, Commissiong played professional football for the Calgary Stampeders of the Canadian Football League. Commissiong received a B.Sc. in Management Science and Engineering with a focus on Financial Decisions from Stanford University.