Biotechnological Breakthroughs Help Revamp the Fight Against Cancer News Commentary

NEW YORK, Jan. 9, 2020 /PRNewswire/ -- Biotechnology plays an important role throughout various sectors by improving industry standards, services, and developing new products. While agriculture, material science and environmental science are major areas of research, the largest impacts are made in the medical field. As major players in the research and development of pharmaceuticals, the role of biotech firms in the healthcare field is undisputable. From genetic analysis to the development of new drugs and treatments for the both common and rare conditions, many biotech businesses are seeing themselves transform into pharmaceutical and biopharmaceutical companies. Some of the noteworthy processes within the industry include microbiology, genetic engineering and biochemistry, among many others. And while there are many various types of medical conditions, the market is seeing a large spur of demand for therapeutic and diagnostic solutions such as red biotechnology, recombinant technology, and DNA sequencing. Additionally, the rising occurrence of persistent conditions such as diabetes and cancer globally is expected to further increase the need for new and innovative biotechnology products. And, according to Polaris Market Research, the global biotechnology market size was valued at USD 390.1 Billion in 2017 and is projected to register a CAGR of 7.7% during the forecast period of 2019 – 2026. Todos Medical Ltd. (OTC: TOMDF), Agenus Inc. (NASDAQ: AGEN), Leap Therapeutics, Inc. (NASDAQ: LPTX), Trillium Therapeutics Inc. (NASDAQ: TRIL), Verastem, Inc. (NASDAQ: VSTM)

Overall, the cancer treatment market is one of the biggest segments of the biotechnology industry. According to the National Cancer Institute, it was estimated that 1.73 million in the U.S. were affected by cancer in 2018. Additionally, the report also suggested that 609,640 people passed away due to cancer. The increase in competition and continuous technological advancements has so far led to improvements in the product portfolio of biotech firms in the field. Therefore, product approvals and product development are one of the key developmental strategies adopted by the market players in the global cancer therapeutics market. More specifically, by cancer type, the market is segmented into Blood Cancer, Breast Cancer, Prostate Cancer, Gastrointestinal Cancer and numerous other cancer types. 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. (OTCQB: TOMDF) announced breaking news today that, "it has entered into an exclusive option agreement to acquire Provista Diagnostics, Inc., an in vitro diagnostics company with a CLIA/CAP certified lab in Alpharetta, Georgia, developing and commercializing the proprietary Videssa® blood test for breast cancer. Videssa has been clinically validated for the early and accurate detection of breast cancer based on data from over one thousand patient samples.

'The Videssa technology platform and the menu of cancer and autoantibodies tests from Provista Diagnostics represent a robust , reliable, cost- effective and clinically useful line of products for the early and accurate detection of breast cancer,' said Dr. Jorge Leon, Senior Medical Advisor of Todos. 'Once confirmed through a clinical utility study to support reimbursement in breast cancer and bench marking, this pipeline of tests can play a real role in the management of cancer patients worldwide.'

Concurrent with this announcement, the Company announced that it has appointed Gerald Commissiong, a US-based executive, as Chief Executive Officer, and that it has appointed Daniel Hirsch, an Israeli-based executive of American descent, as Chief Financial Officer. Mr. Commissiong and Mr. Hirsch have been tasked with effectuating the relocation of Todos from Israel to the US so that the Company can focus its development and commercialization efforts of its proprietary Total Biochemical Infrared Analysis (TBIA) cancer diagnostic platform in the United States. Todos' former CEO, Dr. Herman Weiss, will remain with the Company as Chairman of the Board.

'We are excited to be joining forces with Todos Medical and leveraging the combined knowledge and capabilities of our respective technologies to advance the early detection of breast cancer and other women' cancers. Provista's expertise in conducting rigorous prospective clinical trials; clinical validation and the publication of results in peer reviewed journals; as well as our commercial expertise from piloting commercial efforts with approx. 150 providers, gives us a distinct advantage as we position ourselves as the leaders in the space. I look forward to continuing to work with Todo Medical's leadership to develop best in class diagnostics' said Uriel E. Kusiatin, CEO, Provista Diagnostics.

In addition, the Company announced that it has entered into a letter of intent (LOI) with Orot+,(the operational division of ) its existing distribution partner in Europe for its TBIA-based TM-B1 and TM-B2 breast cancer tests, to expand that partnership to include all cancer indications in all jurisdictions outside the US ('Ex-US TBIA Cancer Partnership').

'I am excited about the opportunity to lead the effort to refocus Todos' efforts on the US market,' said Gerald Commissiong, Chief Executive Officer of Todos. 'The TBIA platform developed in Israel has resulted in a CE Mark for breast cancer tests in Europe, where Orot+ is currently enrolling patients in a commercial validation study to support the commercial launch of the TM-B1 and TM-B2 blood tests later this year. With the pending Ex-US TBIA Cancer Partnership for all traditional marketing, and the pending acquisition of Provista that will give Todos ownership of a CLIA/CAP certified lab and Videssa that has already been validated and commercialized in the United States, we believe that we are positioning Todos to become the premier breast cancer blood testing company, with the potential to expand that leadership position to all cancers.'

About Videssa® Breast: Videssa Breast is the only simple blood test to provide early and accurate detection of active breast cancer. In those women who present with suspicious mammography results, the decision whether to order additional imaging or biopsy can be difficult. With a simple blood draw, Videssa Breast can help guide further diagnostic procedures or provide assurance that the patient does not have breast cancer. When used in combination with imaging, Videssa Breast offers the healthcare provider additional data leading to increased confidence and clarity when clinical assessment is challenging.

About Provista Diagnostics: Provista Diagnostics is a privately held molecular diagnostics company focused on developing and commercializing a new generation of proprietary blood-based proteomic diagnostic, prognostic and monitoring tests designed to address the unmet needs in women's cancer, such as breast and gynecologic cancers. Provista Diagnostics' state-of-the-art, high-complexity clinical laboratory is accredited by the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA). Additional information about Provista Diagnostics is available at Information about Provista Diagnostics' clinical trials is available at

About Todos Medical Ltd: Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also has initiated the development of blood tests for neurodegenerative disorders such as Alzheimer's disease through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. Todos has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancer's influence on the immune system, which triggers biochemical changes in peripheral blood mononuclear cells and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The company's two cancer screening tests, TM-B1 and TM-B2, have received the CE mark. Breakthrough Diagnostics is developing the LymPro Test®, a blood test for diagnosing Alzheimer's disease."

Agenus Inc. (NASDAQ: AGEN) announced on January 8th, 2020, the dosing of the first patient with AGEN1223. AGEN1223 is a novel bi-specific antibody discovered by Agenus and designed to deplete regulatory T cells in the tumor microenvironment. The first patient was infused in December 2019 and the trial is underway with a plan to initiate combinations with balstilimab, Agenus' investigational PD-1 inhibitor, in 2020. Dr. Anthony El-Khoueiry of the USC Norris Comprehensive Cancer Center and Keck School of Medicine was the clinical investigator dosing this first patient. Dr. El-Khoueiry is the phase I program director and a recognized expert in early drug development and translational medicine with a focus in hepatobiliary (liver, gall bladder, and bile duct) and pancreatic cancers. "AGEN1223 is a novel bispecific antibody designed to selectively deplete specific immune-suppressive cells called regulatory T cells. The ability to deplete these cells in the tumor microenvironment may be an important treatment advantage for patients with cancer," said Dr. Anna Wijatyk, Head of Clinical Development at Agenus. "AGEN1223 is designed to eliminate the escape pathways that tumors use to continue to grow beyond multiple lines of therapy, including anti-PD-1 therapy. We believe that AGEN1223, due to its design to both selectively deplete intratumoral Tregs while sparing peripheral Tregs and to activate effector immune cells, represents an important novel therapy and promising combination agent for patients with aggressive tumors."

Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, announced earlier last year, an investigator-initiated study led by David R. Wise, M.D., Ph.D. of the Perlmutter Cancer Center at NYU Langone Health to study DKN-01, as a monotherapy and in combination with docetaxel in patients with advanced prostate cancer. This clinical trial is specifically targeting a biomarker-selected patient population in metastatic castrationresistant prostate cancer (mCRPC) with elevated Dickkopf-1 (DKK1) levels. "DKK1 can promote prostate cancer growth through suppressing the anti-tumor immune response. We have discovered that DKK1 is upregulated in the substantial portion of advanced prostate cancers that lack expression of androgen receptor," commented Dr. Wise. "Patients with this type of prostate cancer have a very poor prognosis and may benefit from this new immunotherapy strategy targeting DKK1 therapy with DKN-01." "An important part of our DKN-01 development strategy is to target biomarker-selected patient populations," said Cynthia Sirard, M.D., Vice President, Clinical Development of Leap Therapeutics. "In our esophagogastric cancer study, we have identified DKK1 levels measured by RNAScope as a potential predictor of response to DKN-01-based therapy. We are looking forward to treating mCRPC patients with elevated DKK1 levels in this study, building on our and Dr. Wise's work."

Trillium Therapeutics Inc. (NASDAQ: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, provided on January 7th, 2020, an update on its TTI-621 and TTI-622 clinical programs. "We have now completed the initial dose finding and signal seeking parts of our phase 1 study of intravenous TTI-621 at doses up to 0.5 mg/kg," said Dr. Jan Skvarka, President and Chief Executive Officer of Trillium. "The program continues to demonstrate clear single agent activity across a range of hematologic malignancies, as well as a strong tolerability profile. We believe that TTI-621, even at these low initial doses, is the only anti-CD47 agent that has shown meaningful single agent activity, including complete responses. Our immediate priority is to complete the ongoing monotherapy dose escalation under revised DLT criteria for thrombocytopenia. We are currently dosing at 1.0 mg/kg, or 5 times the dose level at which we observed initial single agent activity. Once we have defined the maximum tolerated dose (MTD), we intend to move TTI-621 into combinations with other agents in larger indications with high unmet need, namely acute myeloid leukemia (AML)/myelodysplastic syndromes (MDS), peripheral T-cell lymphoma (PTCL) and other oncology indications. We currently expect that we will identify the MTD and initiate one or more combination studies later this year." "We are equally excited about the dose escalation progress with our IgG4-based agent, TTI-622," said Dr. Yaping Shou, Trillium's Chief Medical Officer. "We believe that the clean binding profile on red blood cells provides TTI-622 with the opportunity to potentially achieve best-in-class status among IgG4-based anti-CD47 molecules."

Verastem, Inc. (NASDAQ: VSTM), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, announced on January 8th, 2020, a global licensing agreement with Chugai Pharmaceutical Co., Ltd., (Chugai) whereby Verastem Oncology is obtaining worldwide development and commercialization rights to the RAF/MEK inhibitor CH5126766 (CKI27) from Chugai currently under development for the treatment of KRAS mutant solid tumors. The Company will host an investor call to discuss the opportunity and a development update today (details below). CH5126766 in combination with Verastem Oncology's focal adhesion kinase (FAK) inhibitor, defactinib, is currently the subject of a clinical study (Phase I followed by expansion cohorts) with the expansion cohorts now ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).1 This clinical study of the defactinib/CH5126766 combination is supported by the single-agent Phase 2 studies of defactinib in KRAS mutant NSCLC2 and CH5126766 in KRAS mutant NSCLC and LGSOC.3 "Based on the single-agent defactinib results in KRAS mutant NSCLC, we conducted an internal pre-clinical effort to identify drug classes that were synergistic with defactinib and saw the highest level of synergy in combination with MEK inhibitors and, specifically, with CH5126766," said Dan Paterson, President and Chief Operating Officer of Verastem Oncology. "The exciting early clinical results led to our decision to enter into a partnership with Chugai for CH5126766 and accelerate the combination development program for patients with KRAS mutant cancers, which are highly aggressive and recurrent. We plan to initiate discussions with regulatory authorities about our development plans and to define the registration path early this year."

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