Biotechs Strive to Provide Patients With More Affordable Treatment Options

NEW YORK, April 11, 2019 /PRNewswire/ -- The American Cancer Society estimated that in 1991, cancer deaths peaked at 215 deaths per 100,000 persons. As of 2014, the rate dropped significantly to just 161 deaths per 100,000 persons, representing a 25% decline. The decline translates to more than 2.1 million fewer deaths over the span of the past two decades, as cancer deaths have steadily dropped due to new, innovative technology that detects cancer early on, or with treatments that specifically target cancerous cells. As technology continues to develop and advance, it is expected that the number of deaths to gradually decline. However, despite cancer-related deaths decreasing, the number of cancer cases is still growing each year as ,pre patients are being diagnosed with cancer due to environmental and hereditary factors. These factors can lead to common forms of cancer such as lung, colorectal, breast, and prostate. Chemotherapy is widely used to treat patients suffering from cancer in earlier stages, however, further into the process, patients can select therapy options which include targeted therapy drugs and immunological therapy drugs. Now, biotechnology companies are rapidly accelerating their pipelines in order to develop advanced treatments and therapies to help effectively treat cancer or ultimately even eradicate the disease. Biotechnology companies are also heavily investing in conducting clinical trials and studies in order to develop effective drugs. According to data compiled by Allied Market Research, the global oncology/cancer drug market was valued at USD 97.40 Billion in 2017. By 2025, the market is projected to reach USD 176.50 Billion while also registering a CAGR of 7.6% from 2018 to 2025., Inc. (OTC: SNET), Atossa Genetics Inc. (NASDAQ: ATOS), Agenus Inc. (NASDAQ: AGEN), Sunesis Pharmaceuticals, Inc.  (NASDAQ: SNSS), OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED)

Cancer is a disease which involves the abnormal growth of cells that results in the formation of a tumor. The abnormal cells have a tendency to spread to other local tissues and may also spread to different parts of the body through the blood and the lymphatic system. Previously, detecting cancer early on was challenging, but the advancement of early screening technology has allowed patients to receive therapy before their cancer worsens. Targeted therapy is also becoming a popular treatment among patients because it specifically targets cancerous cells without damaging blood cells. Now, there is also a growing demand for personalized medicine, which is expected to create new opportunities within the market. Personalized medicine tailors treatment towards the patient's characteristics such as his or her molecular structure and genetic profile. However, the biggest hindrance is the cost of some of these therapies. For an average patient, it is difficult to obtain the monetary funds necessary to pay for effective treatments. For instance, the U.S. Food and Drug Administration approved tisagenlecleucel to treat patients with acute lymphoblastic leukemia, a drug which genetically re-engineers the patient's own T-cells to attack the leukemic cells. This was the first cell-based gene therapy approved in the U.S. and is priced at USD 475,000 for a course of treatment. Biotechnology companies are now tasked with developing effective treatments but also at an affordable cost. "Ultimately, I want to access the best available therapies for the people I treat: the ones most likely to bring meaningful improvements in their quality and length of life, and the ones that reduce the toxicity associated with treatment," said Ajay Aggarwal, Oncologist at Guy's and St Thomas' NHS Trust in London, "Any new cancer therapy, drug or not, should undergo robust evaluation for outcomes that truly matter to individuals. As it is, limited finances are too often being directed from evidence-based therapies to those that promise false hope.", Inc. (OTC: SNET) earlier last week 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:] 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:] 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, 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. 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. is currently engaging in research and development of therapeutics for oncology. 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."

Atossa Genetics Inc. (NASDAQ: ATOS) is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. Atossa Genetics Inc. recently announced that the FDA had issued a "Safe to Proceed" letter under their "expanded access" program permitting the use of Atossa's oral Endoxifen as a post-mastectomy treatment in a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient. This patient completed a 3-week course of Atossa's oral Endoxifen prior to her surgery under an FDA-approved expanded access program. The tumor activity from the initial biopsy was compared to the tumor activity at surgery, finding that the cancer cell biological activity was reduced by two measures: the Ki-67 activity decreased by 50%, and the estrogen receptor content decreased by over 20%. There were no safety or tolerability issues, including vasomotor symptoms such as hot flashes and night sweats. The latter symptoms are often a tolerability challenge for patients on tamoxifen. "We are extremely pleased that this patient not only benefitted from Endoxifen prior to her surgery, but that the FDA agrees that continued Endoxifen therapy is appropriate for this pre-menopausal patient," commented Dr. Steven C. Quay, President and CEO of Atossa. "This positive progress supports our expansion of oral Endoxifen clinical trials. After surgery is completed, the current standard of care in the USA to prevent a recurrence and/or a new cancer is for patients to undergo ovarian ablation (chemical treatment to induce menopause) and take aromatase inhibitors (AI) for 5 to 10 years.  Alternatively, tamoxifen therapy can be used for 5-10 years for those patients who do not want to take AIs, or for whom these medications are contraindicated. This patient, like many others, was not a good candidate for tamoxifen therapy due to low liver enzyme (CYP2D6) activity which means her liver would not adequately metabolize tamoxifen. Unlike tamoxifen, oral Endoxifen does not require liver metabolism so it may be a better treatment approach."

Agenus Inc. (NASDAQ: AGEN) is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. Agenus Inc. recently announced that the first patient was dosed in the clinical trial of its next-generation anti-CTLA-4 antibody (AGEN1181). AGEN1181, a novel 'Fc engineered' antibody with potential for enhanced anti-tumor functions, is specifically designed to boost cancer killing immune cells and deplete cells that block the activity of these cancer killing cells. The first patient in the trial was dosed by Dr. Steven J. O'Day, M.D., Executive Director of the John Wayne Cancer Institute & Cancer Clinic, and a pioneer in delivering immune therapies to patients with cancer.  Dr. O'Day's pivotal work has led to the approvals of commercial antibodies targeting CTLA-4 and PD-1.  "AGEN1181 represents an important next-generation breakthrough with its potential for enhanced immune activation and tumor fighting abilities," said Dr. O'Day. "The pre-clinical data so far suggest that AGEN1181 may bring superior benefit compared to first generation anti-CTLA-4 antibodies and may be an optimal partner for combinations. I am thrilled to be working with this compound."

Sunesis Pharmaceuticals, Inc.  (NASDAQ: SNSS) is a biopharmaceutical company developing new therapeutics for the treatment of hematologic and solid cancers. Sunesis Pharmaceuticals, Inc. recently announced that the Company has opened the 100 mg cohort in the Phase 1b/2 trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies. Preliminary safety, pharmacokinetic, and pharmacodynamic data from the now completed 50 mg cohort of the study were recently presented at the 60thAmerican Society of Hematology (ASH) Annual Meeting in December 2018. Vecabrutinib (SNS-062) is a selective, oral, reversible, non-covalent inhibitor of Bruton's tyrosine kinase (BTK). BTK is a validated target for the treatment of B-cell malignancies driven by B-cell receptor signaling. "We are excited to study the 100 mg dose level as we continue the dose escalation portion of this study," said Dayton Misfeldt, Sunesis interim Chief Executive Officer. "Thus far, we have seen an encouraging safety profile, evidence of pharmacodynamic activity in CLL and other B cell cancer patients both with and without BTK C481 mutations, and some improvements in clinical symptoms. We anticipate that the target dose level for vecabrutinib will likely be between 100 mg and 300 mg BID and look forward to providing a clinical update on potentially active dose levels at a major medical meeting in the second quarter of 2019."

OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED) is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics. OncoMed Pharmaceuticals, Inc. recently announced initial results from the Phase 1a dose escalation portion of a Phase 1a/b trial of etigilimab, the company's anti-TIGIT antibody. TIGIT (T-cell immunoreceptor with Ig and ITIM domains) is a next generation checkpoint receptor shown to block T-cell activation and the body's natural anti-cancer immune response. OncoMed's anti-TIGIT checkpoint inhibitor candidate is an IgG1 monoclonal antibody which binds to the human TIGIT receptor on T-cells with a goal of improving the activation and effectiveness of T-cell and NK cell tumor-killing activity. The data were presented today at the Society for Immunotherapy of Cancer meeting taking place in Washington, D.C. "These data indicate that etigilimab was well-tolerated by patients and showed modulation of specific subsets of peripheral T cells," said John Lewicki, Ph.D., President and Chief Executive Officer of OncoMed. "The decrease in peripheral Tregs and observations of stable disease in certain patients are consistent with the expected mechanisms of our IgG1 anti-TIGIT antibody."

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