FinancialBuzz.com News Commentary

NEW YORK, April 17, 2019 /PRNewswire/ --Cancer is among one of the leading causes of death in the world since many countries are burdened by the lack of access to adequate healthcare, which results in the high number of deaths. In 2018, the World Cancer Research Fund (WCRF) estimated that there were 18 million new cancer cases worldwide. Among the 18 million, 9.5 million were men and 8.5 million were women, while the most commonly diagnosed cancers were lung, breast, and colorectal. The three top diagnosed cancers accounted for over a third of global cases. Most cases of cancers are caused primarily by risk factors which include poor diet, nutrition, and physical condition. However, in some instances, cancer can be caused by hereditary factors such as genetics or even environmental impacts. The WCRF even said that around 40% of cases could have been prevented in 2018 if patients had a more well-rounded diet. Now, due to the increasing rate of cases, biotechnology and pharmaceutical companies are challenged with developing new therapies and treatments to aid patients suffering from cancer. Within the cancer marketspace, some companies are developing and manufacturing treatments designed to suppress the side effects. Others are aiming to neutralize the cancerous cells and prevent spreading, while yet others are ultimately looking for a cure for cancer. Regardless of the segment companies are involved within, collectively, they are bolstering the overall cancer therapy market. And according to data compiled by Mordor Intelligence, the global cancer therapy market was valued at USD 136.25 Billion in 2018. By 2024, the market is expected to reach USD 220.70 Billion, exhibiting a CAGR of 8.37%. SourcingLink.net, Inc. (OTC: SNET), CEL-SCI Corporation (NYSE: CVM), Curis, Inc.  (NASDAQ: CRIS), Geron Corporation (NASDAQ: GERN), NewLink Genetics Corporation (NASDAQ: NLNK)

In the U.S., it is estimated that approximately 45 million Americans lack access to health insurance and millions more are uninsured. Pharmaceutical companies have taken the initiative and launched Patient Assistance Programs (PAPs) in order to treat individuals who do not have health insurance. Normally, these programs are free or offer low-cost prescription drugs in order to treat patients who suffer from serious illnesses. Furthermore, governments across the world are also launching initiatives in order to raise awareness of cancer. When combined, the rising number of cases, stronger R&D, increasing PAPs, and government initiatives are all collectively accelerating the cancer marketplace. Moving forward, pharmaceutical and biotechnology companies are expected to develop new treatments and therapies to effectively treat cancer. Treatments such as chemotherapy, immunotherapy, and radiotherapy are the most common forms of therapies. However, researchers and scientists have recently developed new methods of treatments such as targeted therapy and personalized medicine. "We still look at a microscope, we still look at what organ the cancer started in. But increasingly we're looking at the molecular signature. It's not just the genomics, and it's not just the genes. It's also the cellular environment around that cancer. We're now targeting our therapies to the mutations that are found in that particular cancer," said Richard Wender, Chief Cancer Control Officer at the American Cancer Society, in an interview with Singularity. "Our traditional ways of learning about cancer were by finding a particular cancer type and conducting a long clinical trial that took a number of years enrolling patients from around the country. That is not how we're going to learn to treat individual patients in the future."

SourcingLink.net, Inc. (OTC: SNET) earlier this month announced that, "it entered into an exclusive, worldwide licensing agreement with NanoSmart Pharmaceuticals, Inc (NanoSmart) for the right to use NanoSmart's Anti-Nuclear Antibody (ANA)-targeted drug delivery technologies to develop and commercialize chemotherapy drug formulations for veterinary oncology.

The National Cancer Institute estimated that as many as 12 million pets are diagnosed with cancer each year. The pet cancer therapeutics market, according to Global Insights [source: https://gminsights.wordpress.com/tag/pet-cancer-therapeutics-market-size/] is projected to exceed a revenue of $300 million by 2024, with a compound annual growth rate of 10% over 2017-2024.  In addition, the Comparative Oncology Program of the National Cancer Institute is designed to "gain a better understanding of the biology of cancer and improve the assessment of novel treatments for humans by treating pet animals with naturally-occurring cancers." [source: NCI Center for Cancer Research: https://ccr.cancer.gov/research]

SourcingLink.net stated, 'We are pleased to have licensed the application of NanoSmart's tumor-targeting technologies to improve the safety and quality of treatments for animals suffering from cancer and other diseases. This is a significant extension of our oncology product portfolio into animal health care to address the growing need for improved pet cancer therapies that can improve outcomes and extend lifespan.'

The license includes broad access to NanoSmart's proprietary drug delivery approaches, including ANA-targeted nanoparticles, for the purpose of developing veterinary oncology drug products. Under the terms of the agreement, NanoSmart will receive restricted common shares of SNET stock, an upfront fee, an annual maintenance fee, and a high single-digit royalty on net sales of formulations that incorporate NanoSmart's intellectual property. Dr. James Smith, President of NanoSmart, stated, 'This additional license agreement demonstrates the value and broad-applicability of our drug delivery platform technologies. The development of products for this market will also support SNET's and NanoSmart's mutual goal to provide new and affordable therapeutic options to those suffering from this devastating disease. We look forward to supporting the SNET team to develop and commercialize these novel products.'

About SourcingLink.net: SourcingLink.net, Inc. ("SNET") is a pioneering oncology company dedicated to developing, manufacturing and commercialization of therapeutics. SNET licensed Tulynode's patent pending Autologous Immuno-therapy for durable therapy response using an extracorporeal device.  SourcingLink.net prides itself for having a world-class Advisory Board that keeps the Company leadership in the forefront of developing technologies in cancer research, biotechnology and healthcare. SourcingLink.net is currently engaging in research and development of therapeutics for oncology. SourcingLink.net is committed to its core corporate mission and values of highest U.S. Pharma Code of Conduct standards of behavior for being in compliance with the laws, regulations, company directives and guidance."

CEL-SCI Corporation (NYSE: CVM) believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. CEL-SCI Corporation recently announced that the Independent Data Monitoring Committee (IDMC) for the Company's pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. The IDMC made the following recommendation: The IDMC recommendation is to continue the trial until the appropriate number of events have occurred. IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time. CEL-SCI's Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to receiving the Standard of Care (SOC), which involves surgery, radiation and/or concurrent radiochemotherapy. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby it is better able to mount an attack on the tumor. The aim of treatment with Multikine is to increase the body's immune system against the tumor prior to SOC.

Curis, Inc.  (NASDAQ: CRIS) is a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, including fimepinostat, which is being investigated in clinical studies in patients with DLBCL and solid tumors. Curis, Inc. recently announced that the first mesothelioma patient has been enrolled and dosed in the Phase I study of CA-170. CA-170 is an orally available, dual inhibitor of VISTA and PDL1, which the company believes could provide benefit in tumors with high levels of VISTA expression. Over 90% of mesothelioma cells express VISTA. The company had previously announced its expectation to begin enrollment of mesothelioma patients in a dedicated cohort within the existing Phase 1 study. VISTA (V-domain Ig-containing Suppressor of T cell Activation) is an independent, inhibitory T cell checkpoint protein that is expressed on both immune cells and tumor cells. VISTA has been identified as a potential resistance mechanism to treatment with anti-PD1 antibodies in melanoma and anti-CTLA4 antibodies in prostate cancer. Recent literature indicates that high levels of VISTAexpression have been found on various tumors, including mesothelioma, ovarian cancer, endometrial cancer, triple negative breast cancer, gastric cancer, and non-small cell lung cancer. "We are pleased to announce that the CA-170 study has begun dosing patients ahead of schedule," said James Dentzer, President & Chief Executive Officer of Curis. "On last quarter's earnings call, we outlined the reorganization of company resources to strengthen focus on clinical execution. Today's announcement is a result of those efforts. We re-iterate our confidence in our expectation to report initial efficacy data in this study in the second half of 2019."

Geron Corporation (NASDAQ: GERN) is a clinical stage biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. Geron Corporation recently announced the results from IMbark, a Phase 2 clinical trial of imetelstat treatment in Intermediate-2 or High-risk myelofibrosis (MF) patients who are relapsed or refractory to a Janus Kinase (JAK) inhibitor, were presented at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, California. The oral presentation was made on December 3, 2018 by John Mascarenhas, M.D., Associate Professor of Medicine in the Myeloproliferative Disorders Program of the Tisch Cancer Institute, Division of Hematology/Oncology at the Icahn School of Medicine at Mount Sinai, and an IMbark clinical investigator. For the 9.4 mg/kg dosing arm (n=59), the spleen response rate was 10% (6/59) and the symptom response rate was 32% (19/59). In addition, improvement in bone marrow fibrosis was observed in 25% (15/59) of patients. The new data presented at ASH indicate that median overall survival (OS) for the 9.4 mg/kg dosing arm was 29.9 months, which suggests a meaningful survival outcome with imetelstat treatment in this poor-prognosis patient population, all of whom met rigorous criteria for having failed or not responded to JAK inhibitor treatment prior to enrollment in the trial. Other observational studies of similar patient populations published in medical literature have reported median OS ranged from approximately 12-14 months. "The IMbark results suggest a meaningful survival outcome in this poor-prognosis, relapsed/refractory MF patient population where there are currently no approved treatments," said John A. Scarlett, M.D., Geron's President and Chief Executive Officer. "We plan to explore potential late-stage development opportunities for imetelstat in MF through discussions with experts in MF and regulatory authorities and expect to provide a decision regarding future development of imetelstat in this patient population by the end of the third quarter of 2019."  

NewLink Genetics Corporation (NASDAQ: NLNK) is a clinical stage biopharmaceutical company focusing on developing novel oncology product candidates to improve the lives of patients with cancer. NewLink Genetics Corporation recently announced results from a Phase 2 study of NLG207, a nanoparticle formulation of the topoisomerase 1 inhibitor camptothecin, conducted in conjunction with The GOG Foundation, Inc. (GOG-3008), in patients with refractory ovarian cancer. The data were presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2019 in Atlanta, Georgia. NLG207 is a potentially best-in-class topoisomerase 1 inhibitor with demonstrated antitumor activity in recurrent ovarian cancer, including cancer resistant to platinum therapy.  The combination therapy of NLG207 plus weekly paclitaxel was well tolerated in heavily pretreated patients with most adverse events consistent with those observed for paclitaxel as a single agent. Prior single agent activity observed in both preclinical and clinical studies, along with Phase 2 results in combination with paclitaxel reported here, support further investigation of NLG207 as a single agent and in combination treatment regimens for patients with recurrent ovarian, fallopian tube or primary peritoneal cancers, particularly those which are platinum resistant. "We were excited by the single agent activity of NLG207 observed in prior trials and are encouraged by the Phase 2 data presented today at AACR that support the potential for this drug candidate to improve upon current therapies in ovarian cancer, particularly given its favorable safety profile," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer of NewLink Genetics.  "We wish to thank the patients, their families, and the investigators who participated in this trial as we continue our efforts to better the lives of individuals suffering from cancer."

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