Innovative Diagnostic Methods Remains Vital in the Fight Against Cancer

NEW YORK, April 9, 2021 /PRNewswire/ -- The cancer treatment market is one of the biggest segments of the biotechnology industry. According to the National Cancer Institute, roughly 1.8 million people were diagnosed with cancer in the United States in 2020. Overall, lung and bronchus cancer is the second most common cancer diagnosis with an estimated 228,820 new cases. Prostate cancer is the leading cancer diagnosis among men and the third most common diagnosis overall with 191,930 expected cases. However, the increase in competition and continuous technological advancements has led to improvements in the product portfolios of biotech firms in the field. Therefore, product approvals and product development are one of the key developmental strategies adopted by market players in the global cancer therapeutics market. And, according to a report by Mordor Intelligence, the breast cancer segment is projected to account for the largest market size over the forecast period of 2020–2025. As per estimates provided by the Breast Cancer Organization in 2018, it is estimated that over 2,66,120 new cases of invasive breast cancer are expected to be diagnosed in women in the United States, along with 63,960 new cases of non-invasive (in situ) breast cancer. Todos Medical Ltd. TOMDF, Agenus Inc. AGEN, Leap Therapeutics, Inc. LPTX, Trillium Therapeutics Inc. TRIL, Verastem, Inc. VSTM

New technologies and innovation will play a major role in drug and therapeutic developments in

the comping years. New startups which use Artificial Intelligence for drug discovery platforms and other technologies are also becoming more prevalent. For example, Forbes reported that Valo Health, which is developing a drug discovery platform powered by both artificial intelligence and large patient datasets, announced back in January that it's working on multiple targets that are implicated in different cancers.

Todos Medical Ltd. TOMDF announced yesterday breaking news that, it has received a notice of allowance ('Letter of Intent to Grant a Patent') from the European Patent Office covering the use of the Company's proprietary Total Biochemical Infrared Analysis ('TBIA') method that uses blood (plasma and/or peripheral blood mononuclear cells 'PBMCs') to distinguish between patients with benign tumors vs. malignant tumors vs. no tumors (healthy controls).

The patent application specifically covers methods for capturing consistent data from infrared spectroscopy readers, as well as the application of various artificial intelligence algorithm development methods to the data. The ability of TBIA to make a diagnosis of cancer has first been applied to the detection of breast and colon cancers, where Todos has received CE Marks in Europe paving the way for commercialization initially focused on TMB-2 (dense breast / inconclusive mammogram secondary screening) and TMB-1 (general breast cancer screening) cancer detection tests.

"As we continue to expand our patent position in the blood-based spectroscopy cancer detection market, we are extremely pleased with the progress being made by our development partners in Singapore and Israel who have been steadily advancing our TBIA platform for commercialization outside the US," said Gerald E. Commissiong, President & CEO of Todos Medical. "TBIA represents a potentially game-changing approach to cancer detection because we will be able to run different artificial intelligence-developed algorithms for multiple cancer types on the same blood sample. While the focus is initially on improving the diagnosis of breast cancer and colon cancer using this method, the potential applies to all cancers. Our vision is to develop a single, simple and cost-effective blood test that can identify any cancer at its earliest stages of formation, and then use emerging methods such as liquid biopsy to monitor patient responses to treatment. Because TBIA is so simple and cost effective to use, we believe that this technology will compete extremely well with liquid biopsy for the cancer screening market. We are positioning for TBIA to become a routine screening test done for cancer in a variety of patient screening settings worldwide."

In August 2020, the Company entered into a strategic partnership with Singapore-based Pathnova Laboratories, a spinout of Temasek Life Sciences Laboratory, to optimize TBIA's artificial intelligence cancer detection engine and commercialize TBIA in Singapore. In September 2020, the Company expanded its partnership with Israel-based Care GB by forming a joint venture called BioImagery Ltd. (the "Joint Venture") to support the commercialization of the cancer portion of Todos' TBIA immune profiling platform in Israel, Europe and Africa. The management teams at BioImagery and Pathnova have been working closely together to optimize the TBIA cancer detection ahead of commercial launch in those jurisdictions."

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Agenus Inc. AGEN reported earlier year that it has entered into a clinical collaboration with Nelum Corp. to evaluate the safety and efficacy of zalifrelimab, Agenus' anti-CTLA-4 antibody, in combination with NLM-001, Nelum's small molecule hedgehog inhibitor, and chemotherapy for first-line advanced pancreatic cancer. "This collaboration with Nelum is an exciting next step in our partnership strategy to broaden combinations and indications with our late-stage checkpoint antibodies," said Julie DeSander, Vice President of Business Development and Alliance Management. "Zalifrelimab, our first generation anti-CTLA-4 antibody, shows promising results alone and in combination with balstilimab, our anti-PD-1 antibody, and offers the potential to expand therapeutic benefit in novel combinations."

Leap Therapeutics, Inc. LPTX announced last week the completion of enrollment for the first-line patient cohort in the DisTinGuish study, a clinical trial evaluating Leap's anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.'s anti-PD-1 antibody, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ). "The completion of enrollment for the first-line patients in the DisTinGuish study is an important milestone for the DKN-01 and tislelizumab combination development program," said Cynthia Sirard, M.D., Chief Medical Officer of Leap Therapeutics. "In collaboration with our partner, BeiGene, we are committed to realizing the potential of DKN-01 as part of a new combination therapy with tislelizumab aimed at treating gastric and gastroesophageal junction cancer patients, where a high global unmet medical need remains."

Trillium Therapeutics Inc. TRIL, a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, recently presented at the American Society of Hematology (ASH) Annual Meeting, taking place virtually from December 5-8, 2020, and provides guidance for 2021. "Our presentations at ASH, as of a data cutoff of November 3, build upon our last corporate update from September 8," said Jan Skvarka, President and CEO of Trillium Therapeutics. "We presented data where TTI-622 continued to demonstrate a strong safety profile, as well as further dose-dependent improvements in receptor occupancy and PK data. We completed a safety evaluation of the 12 mg/kg dose level, with results indicating no observed dose-limiting toxicity or other major safety concerns, and we escalated dosing to 18 mg/kg. As of the November 3 cutoff, one patient at the 12 mg/kg dose level achieved a stable disease assessment and continued on therapy. TTI-621 continued dosing at 2 mg/kg. We are looking forward to further progress in 2021, moving to combination studies in heme malignancies and solid tumors, and building on a foundation of demonstrated monotherapy activity of our molecules."

Verastem, Inc. VSTM reported back in December that the initiation of a Phase 2 registration-directed clinical trial of VS-6766, its RAF/MEK inhibitor, alone and in combination with defactinib, its FAK inhibitor, in patients with KRAS mutant non-small cell lung cancer (NSCLC)."Currently available options for patients with KRAS mutant NSCLC are associated with minimal efficacy, as well as resistance and toxicity issues. Our study will further elucidate the impact of VS-6766, alone or in combination with defactinib, in overcoming these challenges to improve outcomes," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "Our VS-6766 and defactinib NSCLC development program's specific focus on G12V mutations is unique and represents a potentially significant step forward in understanding how we can deliver a better treatment option for these patients."

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