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Biotech Firms Strive to Combat the Growing Burden of Diseases With Innovative Technologies News Commentary

NEW YORK, April 4, 2019 The global burden of diseases continues to grow each year, despite various ongoing medical advancements. In 2017, the Institute for Health Metrics and Evaluation (IHME) said in a report that a total of 359 diseases and injuries were added to the fatal and non-fatal list of conditions since 1950. According to data by the Global Burden of Diseases, the most common causes of fatalities resulted from heart conditions, stroke, respiratory infections, lung diseases, Alzheimer's, diabetes, and kidney diseases. While some of these cases are difficult to prevent, most medical conditions can be treated in order to suppress the growth of maladies, or potentially eliminate it. For instance, patients suffering from cancer can undergo chemotherapy in order to prolong life expectancy or reduce symptoms. On the other hand, radiotherapy is used to control or kill malignant cells, ultimately curing the patient of cancer if the treatment is successful. Chemotherapy and radiotherapy are the most common forms of cancer treatment, however, biotechnology and pharmaceutical companies are developing innovative and advanced treatments in order to treat patients more effectively. Yet, at the same time, more diseases are being discovered, prompting healthcare companies to continually develop new treatments. As such, the growing number of diseases worldwide will continue to expand the biotechnology market as more countries demand effective and efficient treatment solutions. According to data compiled by Variant Market Research, the global biotechnology market is projected to reach USD 726.8 Billion by 2025, witnessing a CAGR of 8.1% from 2017 to 2025., Inc. (OTC: SNET), ArQule, Inc. (NASDAQ: ARQL), Sorrento Therapeutics, Inc (NASDAQ: SRNE), Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS), OncoSec Medical Incorporated (NASDAQ: ONCS)

Solutions such as red biotechnology, recombinant technology, and DNA sequencing are some of the main factors fanning the demand for the market. Moreover, the growing prevalence of diseases such as cancer, hepatitis B, and other orphan disorders are also expected to influence the growth of the biotechnology market. Currently, segments such as cell-based assays, PCR technology, chromatography, nanobiotechnology, tissue engineering and regeneration are among the largest biotechnology applications. "Biotechnology is technology based on biology, which is one of the fundamentals of pharmacology – where new medicines are discovered through biotechnology," said AIMST University Faculty of Applied Sciences dean Professor Manickam Ravichandrand, "It is essential for predicting and curing new diseases that could plague mankind," he said, adding that stem cell and gene therapy are going to be the important methods of treatment, particularly in the field of medicine in the near future, according to The Star., Inc. (OTC: SNET) yesterday 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."

ArQule, Inc. (NASDAQ: ARQL) is a biopharmaceutical company engaged in the research and development of targeted therapeutics to treat cancers and rare diseases. ArQule, Inc.'s partner, Basilea Pharmaceutica Ltd. recently announced that it entered into a collaboration with Roche (SIX: RO, ROG) to explore a combination of derazantinib (BAL087) and Roche's PD-L1-blocking immune-checkpoint inhibitor, atezolizumab (Tecentriq®), in patients with urothelial cancer. Basilea expects to start a biomarker-driven multi-cohort phase 1/2 study in mid-2019. The planned study will assess the safety, tolerability and efficacy of the derazantinib-atezolizumab combination in patients with advanced urothelial cancer and confirmed FGFR genomic aberrations. Basilea will be the sponsor of the study, and Roche will provide clinical supply of atezolizumab. Peter Lawrence, President and Chief Operating Officer of ArQule, said, "This new combination trial with Tecentriq represents an important step in the development of derazantinib (BAL087, formerly ARQ087) and has the potential to expand meaningfully its therapeutic utility. We look forward to further progress and updates from Basilea."

Sorrento Therapeutics, Inc (NASDAQ: SRNE) is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento Therapeutics, Inc. and Yuhan Corporation recently announced that ImmuneOncia, a joint venture formed in September 2016, has completed the Phase 1 study of IMC-001 (also known as STI-3031), a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. This Phase 1 dose-escalation study, approved by the South Korean Ministry of Food and Drug Safety (MFDS) in February of 2018, enrolled subjects with locally-advanced or metastatic solid tumors at Seoul National University Hospital (SNUH) and Samsung Medical Center (SMC). The Recommended Phase 2 Dose (RP2D) was determined to be successful with no observations of dose-limiting toxicities. More results of this study will be disseminated at upcoming conferences. IMC-001 is a fully human anti-PD-L1 monoclonal antibody immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, suppressing the inhibitory signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting natural killer (NK) cells and other effector cells against the tumor and potentially further strengthening the anti-tumor effect of the antibody. The clinical-grade material of IMC-001 was manufactured by Sorrento in its San Diego-based GMP antibody production facility. "Based on the results of the Phase 1 trial of IMC-001, we are planning on conducting a Phase 2 trial to evaluate its efficacy in rare cancers in the second half of this year," stated Yun Jeong Song, Chief Executive Officer of ImmuneOncia. "Moreover, we greatly appreciate those who supported us and for their contributions as the company successfully completed a Phase 1 trial of IMC-001. In collaboration with various institutions, we will continue our research and development of IMC-001 as well as the additional checkpoint immune-oncology molecules in our pipeline."

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. "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."

OncoSec Medical Incorporated (NASDAQ: ONCS) is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec Medical Incorporated recently presented pre-clinical data highlighting its novel anti-tumor product candidate, SPARK™, and its improved electroporation generator, "APOLLO™," during a poster presentation at the 2019 American Association for Cancer Research (AACR) Annual Meeting in Atlanta, Georgia. The poster, entitled, "Intratumoral electroporation of plasmid IL-12 and CXCL9 with membrane-bound anti-CD3 elicits robust anti-tumor immunity," provides new preclinical data demonstrating robust anti-tumor responses driven by significant enhancements made to OncoSec's proprietary cancer immunotherapy platform. "The data presented at AACR highlight OncoSec's potentially game-changing approach to drug development.  With this data, we show the ability to not only identify the right genes to have anti-cancer effect, but, importantly, that we can deliver those genes directly into tumor cells. We are able to do this with any gene that is identified as having an anti-cancer effect, without having to expose the patient to a systemic therapy, in an expeditious and cost-effective manner. In doing so, these cells convert immunologically cold tumors into inflamed immunogenic lesions, which is fundamental to generating objective responses in both treated and untreated distant tumors," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec. "Many immunotherapies are stalled for serious toxicity issues associated with treatment, including cytokine release syndrome.  In contrast, our clinical studies, in more than 180 patients with several different tumor types, have demonstrated that TAVO has broad clinical activity without the toxicity commonly associated with IL-12.  The foundation of our DNA-based immunotherapy relies on electroporation, which bypasses the pitfalls associated with viral vectors or systemic cytokines."

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Last Updated: 05-Apr-2019