Companies Turn to Advanced Therapies to Curb the Spread of Cancer

NEW YORK, Oct. 9, 2019 /PRNewswire/ -- In 2019, the American Cancer Society projected 1.76 million new cancer cases diagnosed and the number of deaths to stand at 606,880 in the U.S. Overall, the alarming projection has caused concern within the biotechnology marketspace. In response, biotechnology companies, specifically companies dabbling in the immunotherapy and oncology sector, are working to develop innovative treatments and therapies in order to effectively treat patients diagnosed with cancer. Mainly, most patients suffer from lung, breast, and prostate cancer, and in 2019, the National Cancer Institute expects 268,000 new breast cancer cases, 228,150 new lung cancer cases, as well as 174,650 new prostate cancer cases. Overall, several new cancer treatments such as immunomodulators, CAR-T cell therapy, and monoclonal antibodies are also becoming more abundant as biotechnology companies further develop and market these therapies. Compared to traditional treatments, these therapies are more technologically advanced, meaning they are more effective at suppressing or possibly even eliminating cancer. However, despite the progress in technology, the demand for cancer therapies isn't slowing down. Patients and medical institutes are constantly looking for more effective and efficient treatments in order to reduce the number of cases. And according to data compiled by Grand View Research, the global cancer immunotherapy market size is expected to reach USD 126.9 Billion by 2026 while exhibiting a CAGR of 9.6%. Additionally, the industry is expected to grow due to the increasing patient pools and higher mortality rates, while an increasing number of approvals for new immunotherapeutic drugs is also expected to propel the market. Oncology Pharma Inc. (OTC: ONPH), Kadmon Holdings, Inc. (NYSE: KDMN), Advaxis, Inc. (NASDAQ: ADXS), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), Geron Corporation (NASDAQ: GERN)

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 better protect 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. As well as 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."

Oncology Pharma Inc. (OTC: ONPH) announced yesterday that, "Stefan Gruenwald (MD, PhD), cofounder and president of Diagnomics Inc., has been elected to Oncology Pharma's supervisory board of directors. Dr. Stefan Gruenwald is a former VP of Research and Development at Becton Dickinson, a conglomerate with a current market capitalization of approximately $68 Billion. He is the co-founder and managing partner of Genautica, established in December of 2010. Genautica is a California LLC located in close proximity to the Biotech Hub of San Diego.

Dr. Stefan Gruenwald, through Genautica, has seed-funded Diagnomics, a biotech company employing a highly qualified team of scientists, including early pioneers in sequencing the human genome. Through its investment in Diagnomics, Genautica has also been a co-founder and early investment partner of the EONE-Diagnomics Genome Center (EDGC) in Korea, which went public in 2018 on KOSDAQ, the major Korean tech stock market for over 400 Million USD. Part of the IPO proceeds have been used to buy a female health clinic (10,000 patients), build an R&D center in Songdo, Korea, housing 14 biotech and pharmaceutical companies, acquiring one of the major diagnostics distribution companies and expanding the clinical genome center approach to various countries in Asia. EDGC has grown rapidly and annual revenues for 2019 are predicted to be around 50 million USD.

Chuck Wagner, President of Oncology Pharma Inc., commented: "Oncology Pharma conducted an exhaustive search to strengthen the board of directors' breadth of background and talent. I am delighted to have such an outstanding individual join the board to contribute to our mission, vision and goal of the company. Dr. Stefan Gruenwald is a pioneer with more than thirty years of experience in the biotechnology space and brings vast knowledge and experience in both the clinical, scientific and business fields to the company."

"I am very excited to join the Board of Directors of Oncology Pharma," said Dr. Gruenwald. "I've been involved in biotech for over a quarter of a century and I'm truly thrilled about this amazing opportunity to help this company to evolve into a world-wide leader in its space."

ABOUT ONCOLOGY PHARMA, INC: ONCOLOGY PHARMA, INC. (OTCPK: ONPH) (the "Company") is a pioneering oncology company dedicated to developing, manufacturing, and commercializing therapeutics. The Company has licensed Tulynode's patent pending Autologous Immuno-therapy for durable therapy response using an extracorporeal device. The Company is currently engaging in research and development of therapeutics for oncology, and prides itself for having a world-class Advisory Board that keeps the Company in the forefront of developing technologies in cancer research, biotechnology, and healthcare."

Kadmon Holdings, Inc. (NYSE: KDMN) presented earlier last year preclinical data on KD033, its anti-PD-L1/IL-15 fusion protein in development for oncology indications, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place November 7-11, 2018, in Washington, D.C. KD033 is a novel immunotherapy designed to stimulate an immune response directed to the tumor microenvironment. Recombinant IL-15 alone, which stimulates cancer-fighting immune effector cells, is not well tolerated when administered systemically. Kadmon has developed a novel approach to overcome this challenge by fusing IL-15 to an anti-PD-L1 antibody to direct IL-15 activity specifically to the tumor microenvironment, promoting efficacy and inducing durable responses while potentially increasing tolerability. "Although immunotherapy has been game-changing for the treatment of cancer, many tumors learn to evade current therapies, limiting efficacy and durability of response. New approaches are needed to address relapsed or refractory patients as well as non-responders," said Harlan W. Waksal, M.D., President and CEO at Kadmon. "By directing a potent cancer-fighting response to the tumor site, KD033 has potential to safely overcome resistance and induce long-lasting responses for patients. We look forward to continuing our research on KD033 and initiating our first-in-patient studies in the second half of 2019."

Advaxis, Inc. (NASDAQ: ADXS) a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announced recently updated data from the Phase 1/2 KEYNOTE-046 study in metastatic, castration-resistant prostate cancer (mCRPC). This trial is being conducted in conjunction with Merck (known as MSD outside the U.S. and Canada) and is evaluating ADXS-PSA, one of Advaxis' Listeria monocytogenes (Lm)-based immunotherapies, alone and in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. Findings will be highlighted in a poster discussion entitled "Effects of ADXS-PSA with or without Pembrolizumab on Survival and Antigen Spreading in Metastatic, Castration-Resistant Prostate Cancer Patients" at the American Association for Cancer Research (AACR) Annual Meeting underway in Atlanta. The poster discussion will be held today from 1:00-5:00 p.m. ET and will be led by lead author Mark N. Stein M.D., FACS, Associate Professor of Medical Oncology at Columbia University Medical Center. "We are very excited to report the updated ADXS-PSA data today at the AACR meeting," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "These data show the clinical potential of ADXS-PSA both alone and in combination with KEYTRUDA®. It is meaningful that the combination has been well-tolerated in the study population because dose-related toxicities can present challenges for cancer patients, and an additive therapy with a favorable safety and tolerability profile may offer an attractive option for clinicians if developed further in this indication." He concluded, "Based on the prolonged survival data and strong safety profile to date, we believe that continued clinical development of ADXS-PSA in combination with KEYTRUDA® is warranted and represents a potentially significant opportunity for Advaxis."

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a clinical-stage biopharmaceutical company focused on novel cancer immunotherapeutics for a broad range of cancer indications. SELLAS Life Sciences Group, Inc. recently announced the dosing of the first patient in its Phase 1/2 open-label study of GPS in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in patients with selected WT1-positive advanced cancers, including both solid tumors and hematologic malignances. "This is an important milestone as this study allows us to potentially enhance our safety and activity profile of GPS in combination with anti-PD-1 therapies, particularly in combination with KEYTRUDA® in multiple malignances, following intriguing initial combination clinical data with OPDIVO®," said Angelos M. Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS. "We are confident this study will build on our body of clinical evidence in support of the use of GPS in combination with PD-1 inhibitors to benefit cancer patients with limited treatment options. We believe that our innovative WT1 immunotherapeutic, GPS, in combination with anti-PD-1 immunotherapy agents, may provide therapeutic benefit for patients with WT1 expression. These beliefs are shared by the renowned U.S. oncologists who are undertaking this work. We look forward to studying this combination in patients with a wide range of cancers and expect to provide the first clinical data from this study in the first quarter of 2020."

Geron Corporation (NASDAQ: GERN) is a late-stage clinical 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 opening of patient screening and enrollment for the Phase 3 portion of IMerge to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS). IMerge is a two-part Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with lower risk MDS who are relapsed after or refractory to erythroid stimulating agents (ESAs). The Phase 3 portion is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of red blood cell transfusion independence (TI). The trial is planned to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia. The primary efficacy endpoint is 8-week TI rate, which is defined as the proportion of patients achieving transfusion independence during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of transfusion independence lasting at least 24 weeks, or 24-week TI rate, durability of transfusion independence and the amount and relative change in transfusions. "The start of the Phase 3 portion of IMerge is a significant milestone for Geron and imetelstat," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "We are hopeful that the Phase 3 will confirm the encouraging results from the Phase 2 portion, and that imetelstat could become a much-needed treatment alternative for patients with lower risk MDS."

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