Safer Treatments Gain Market Traction as Cancer Occurence Continues to Grow

Safer Treatments Gain Market Traction as Cancer Occurence Continues to Grow

PR Newswire

NEW YORK, January 30, 2019

NEW YORK, January 30, 2019 /PRNewswire/ -- News Commentary 

Cancer is among the leading causes of death around the globe. In 2018 alone, there were 9.6 million deaths worldwide that resulted from cancer, led by lung, bowel, stomach, and liver-related cases, according to the Cancer Research UK. However, technology is continually evolving in order to effectively detect and combat cancerous cells. Immuno-oncology or cancer immunotherapy is becoming a more common method as it boosts the body's natural defenses in order to fight off cancer rather than attack the body as chemotherapy. According to data compiled by Zion Market Research, the global immuno-oncology therapy market is expected to generate revenues of approximately USD 97.34 Billion by 2022. Additionally, it is set to grow at a CAGR of 14.6% throughout the forecast period from 2017 to 2022. The market growth is accelerated as cancer-related cases continue to increase year over year. Governments and medical institutions, as well as companies, are taking initiatives in order to properly treat cancer by investing into research and development as well as promoting innovation and advancements in technology., Inc. (OTC: SNET), Oragenics, Inc. (NYSE: OGEN), OncoSec Medical Incorporated (NASDAQ: ONCS), Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS), Rexahn Pharmaceuticals Inc. (NYSE: RNN)

There is an ongoing shift from traditional chemotherapies to immunotherapies, which also has an impact on the market by further propelling its growth. In addition to early detection and treatment of cancer, the immuno-oncology industry is also developing post-treatment therapies to prevent patients from recurrence. There has also been an introduction of immunomodulatory drugs such as thalidomide, lenalidomide, and pomalidomide, which were among the best treatment options in the past few years. There has also been an influx of newer drug classes like antibodies and HDAC inhibitors which are designed to target specific cancers. "Faced with growing clinical workloads and decreasing margins, oncologists are under a growing amount of pressure at work," said Joe DePinto, President of Cardinal Health Specialty Solutions. "But, as our research shows, many oncologists are meeting their challenges head-on by proactively investing in tools, technology and additional clinical support staff. And today they are feeling more confident in their ability to adapt to changing trends, such as value-based care.", Inc. (OTC: SNET) announced yesterday that it, "is pleased to announce that it is excited about integrating liquid biopsy in its R&D program, including clinical trials, and for monitoring the therapy of its "patent pending" autologous immune-therapy approach. SNET believes that liquid biopsy is a "game changer"; it is simple, non-invasive, it has minimal complications, it is more economical compared to a solid (surgical) tissue biopsy and moreover, a liquid biopsy is potentially a powerful "tool" that can be used for detecting and analyzing circulating tumor cells, circulating tumor DNA and exosomes.

Forward-looking Statements: This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements, which contain words such as "expect", "believe" or "plan", by their nature address matters that are, to different degrees, uncertain. These uncertainties may cause actual future events to be materially different than those expressed in our forward-looking statements. We do not undertake to update our forward-looking statements."

Oragenics, Inc. (NYSE: OGEN) is focused on becoming a leader in novel antibiotics against infectious disease and on developing effective treatments for oral mucositis. Oragenics, Inc. recently announced that it has received clearance to enroll patients residing in Germany from the Paul Erlich Institute and patients residing in the United Kingdom from the Medicines and Healthcare products Regulatory Agency (MHRA), into its Phase 2 clinical trial of AG013, a live biotherapeutic product for the potential prevention and treatment of OM. The ongoing Phase 2 trial is a double-blind, placebo-controlled, two-arm, multi-center trial, in which approximately 200 patients will be randomized in a 1:1 ratio to receive either AG013 or placebo. The purpose of the study (NCT03234465) is to evaluate the safety, tolerability and efficacy of topically administered AG013 compared to placebo for reducing the incidence and severity of OM in patients undergoing traditional chemoradiation for the treatment of head and neck cancer. Key measures include duration, time to development, and overall incidence of OM (using a World Health Organization scale) during the active treatment phase, which begins from the start of chemoradiation therapy and ends two weeks following its completion. "We are pleased with the receipt of regulatory Health Authority approvals in Germany and the United Kingdom. These approvals provide us with the opportunity to expand the number of clinical trial sites from which we can draw patients to participate in our clinical trial of AG013," stated Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics, Inc. Dr. Joslyn continued "The approvals of Germany and the United Kingdom, further enhance our ability to complete the clinical study in 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 announced that it has established a collaboration with the GOG Foundation, Inc., to conduct a registration-enabled study of TAVO™ (tavokinogene telseplasmid) in women with recurrent/persistent cervical cancer (OMS-150). In June, 2018, KEYTRUDA® (pembrolizumab) received accelerated approval from the FDA for the treatment of advanced cervical cancer with disease progression during or after chemotherapy based on data from a single-arm 98 patient study that showed a 14% overall response rate (ORR). Previous data in other advanced solid tumors demonstrate that TAVO combined with KEYTRUDA can induce objective responses in patients who do not respond to anti-PD-1 antibody monotherapy. "KEYTRUDA is only the second drug in 30 years to be approved for the treatment of cervical cancer and, though it represents significant progress, the number of patients who can benefit is limited. Our goal is to improve upon the 14% KEYTRUDA response rate with the addition of TAVO," said Daniel J. O'Connor, President and Chief Executive Officer of OncoSec. "We believe that TAVO, our proprietary intratumoral plasmid-based IL-12, is an excellent complement for expanding the clinical benefit of anti-PD-1 therapies, especially for those patients that are resistant to anti-PD-1 therapies. Given that KEYTRUDA is already approved and reimbursed for this indication, this study fits perfectly with our strategy of identifying opportunities to conduct small, relatively low-cost single-arm clinical studies that have the potential to offer a rapid path to drug approval and commercialization."

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."

Rexahn Pharmaceuticals Inc. (NYSE: RNN) is a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat. Rexahn Pharmaceuticals, Inc. recently presented updated, preliminary data from the ongoing Phase 2a clinical trial of RX-3117 in combination with ABRAXANE®(paclitaxel protein-bound particles for injectable suspension) in first-line metastatic pancreatic cancer patients at the 2019 ASCO Gastrointestinal Cancers (ASCO GI) Symposium on January 18, 2019. The multicenter, single-arm, open-label study is designed to evaluate RX-3117 in combination with ABRAXANE in first-line metastatic pancreatic cancer patients.  The Phase 2a trial is expected to enroll 40 evaluable patients. As of January 9, 2019, 36 patients were enrolled into the study, and 24 patients had at least one scan on treatment and were included in the evaluation of overall response. One patient (1/24, 4.2%) had a complete response (CR) after 6 cycles of treatment and eight patients (8/24, 33.3%) had a partial response (PR). A further 13 patients had stable disease (13/24, 54.2%). The overall response rate (ORR) was 38%, and the disease stabilization rate at eight weeks was 92%. The combination of RX-3117 and ABRAXANE appears to be safe and well-tolerated. The most common related adverse events were nausea, diarrhea, fatigue, alopecia, decreased appetite, rash, vomiting, and anemia. "We continue to be encouraged by the preliminary data from this study," said Ely Benaim, M.D., Chief Medical Officer of Rexahn. "Because most patients are still being treated in the study, it is too early to estimate progression free survival, but we expect to complete enrollment and report additional efficacy data later this year."

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