Palm Beach, FL –October 27, 2020 – Every year, the number of cancer-related deaths caused due to gastric cancer has been reaching to more than 800,000, as per the records of the World Health Organization. In the recent past, the number of people diagnosed with gastric cancer was approximately in thousands, according to the American Cancer Society. Thus, growing incidence of gastric cancer across the world is foreseen to push the global market for the next few years. Age, diet, and stomach disease can affect the risk of developing stomach cancer. Symptoms of stomach cancer include indigestion and stomach discomfort or pain. This type of cancer is difficult to diagnose because most people typically do not show signs in the earlier stages. Since stomach cancer usually does not cause any early symptoms, it often goes undiagnosed until after it spreads to other parts of the body. According to the National Cancer Institute, 1.8% of the deaths caused by cancer is due to stomach cancer. A report from Datamintelligence.com said that: “The Global Stomach Cancer Treatment Market is expected to grow at a CAGR of 5.2% during the forecasting period (2020-2027). The report added that the stomach cancer treatment market growth is driven by several factors, such as increasing cases of stomach cancer and increasing the approval of new drugs. Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Selecta Biosciences, Inc. (NASDAQ: SELB), Axovant Gene Therapies Ltd. (NASDAQ: AXGT), Cardiff Oncology, Inc. (NASDAQ: CRDF), Pfizer Inc. (NYSE:PFE).
A report from Grand View Research said: “The global stomach cancer treatment market is expected to witness significant growth over the forecast period… The factors that propel the growth of the global market include innovations in treatment, a growing number of cancer treatment centers, increasing research and development activities, and combination therapies. In addition, the growing prevalence of lymphoma, adenocarcinoma, gastrointestinal stromal tumors, carcinoid tumors, etc. are also driving the growth of the global market. In the case of geographical region, Asia-Pacific followed by Latin America is the most important market for stomach cancer treatment due to the large patient pool in case of stomach cancer. Whereas, gastric cancer treatment market in regions such as North America and Africa are projected to witness slow growth owing to the low occurrence rate of stomach cancer.”
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech® Collaborates with Roche and AIO to Initiate a Phase 1/2 Gastrointestinal Cancer Trial Combining Pelareorep with Roche’s Anti-PD-L1 Checkpoint Inhibitor – Oncolytics Biotech® today announced a new multi-indication gastrointestinal (GI) cancer study to be managed by AIO, a leading academic cooperative medical oncology group based in Germany. The phase 1/2 trial, known as GOBLET, will investigate the use of pelareorep, in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®), in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers.
“We are very excited for the opportunity to treat patients with pelareorep, which has the potential to address significant unmet needs across multiple challenging indications with poor prognoses in the GI cancer space,” said Dirk Arnold M.D., Ph.D., Director of the Asklepios Tumorzentrum Hamburg, and principal investigator of the newly announced trial. “Despite the great commercial success of checkpoint inhibitors, as many as four in five patients do not respond to these therapies in most GI malignancies, often due to an immunosuppressive tumor microenvironment (TME). We believe that pelareorep treatment may substantially increase the proportion of patients who are eligible for, and respond to, checkpoint inhibitor therapy. Prior clinical data in breast, hematological, and also some early data in gastrointestinal cancers have shown that systemic pelareorep administration reverses immunosuppressive TMEs by increasing tumor immune cell infiltration and PD-L1 expression.”
Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, added, “In this trial, we aim to demonstrate that the great potential shown by pelareorep in our lead breast cancer program can be extended to other advanced malignancies for which new treatments are needed. Pelareorep’s potential in GI cancers is supported by the encouraging early clinical data we previously reported in pancreatic and colorectal cancer, which showed that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study), and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). We hope the GOBLET study, in addition to providing positive safety and efficacy data, will also support our previously identified predictive blood-based biomarkers CEACAM6 and T cell clonality. This will allow us to select the most appropriate patients for future registration studies, thereby increasing their likelihood of success.”
The GOBLET study will make use of a new master clinical supply agreement between Oncolytics and Roche. Per the agreement, Roche will supply atezolizumab for use in Oncolytics’ clinical development plan. Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, said, “The GOBLET study represents an exciting opportunity to further expand the commercial opportunity of pelareorep beyond our primary focus of breast cancer. We are especially grateful for Roche’s support of this study, which we view as an encouraging sign for pelareorep, the study design, and our strategy to develop pelareorep-based therapies in collaboration with industry leaders. We are hopeful that the continued execution of this strategy could result in the rapid development and approval of pelareorep-based therapies for use in metastatic breast cancer and other indications.” Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/
Other recent developments in the biotech industry include:
Selecta Biosciences, Inc. (NASDAQ: SELB) and Asklepios BioPharmaceutical, Inc. (AskBio), recently announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to MMA-101 for the treatment of isolated methylmalonic acidemia (MMA) due to methylmalonyl-CoA mutase (MMUT) gene mutations. The FDA grants Rare Pediatric Disease Designation to incentivize development of new treatments for serious and life-threatening diseases that primarily affect children ages 18 years or younger with fewer than 200,000 people affected in the U.S. The Rare Pediatric Disease designation program allows for a Sponsor who receives an approval for a product to potentially qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.
“This Rare Pediatric Disease designation from the FDA highlights the significant unmet medical need that Selecta and AskBio are seeking to address with MMA-101 for this rare metabolic disorder,” said Carsten Brunn, Ph.D., chief executive officer of Selecta Biosciences. “When used with AAV gene therapy vectors, Selecta’s ImmTOR aims to inhibit the immune response to the AAV vector, potentially allowing re-dosing of gene therapies. Ongoing clinical programs will focus on evaluating product candidate performance in patients who may have been underdosed or those who may lose transgene expression over time. We’re honored to receive this recognition and look forward to advancing this program in hopes of helping young patients affected by MMA and their families.”
Axovant Gene Therapies Ltd. (NASDAQ: AXGT) recently announced that it has received Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for AXO-AAV-GM2, a one-time gene therapy delivered directly to the central nervous system that is in development for GM2 gangliosidosis, also known as Tay-Sachs and Sandhoff disease. In addition to the Rare Pediatric Disease designation, AXO-AAV-GM2 has Orphan Drug Designation (ODD) and is the first gene therapy that has been administered to children with Tay-Sachs disease.
“We are thrilled to bring AXO-AAV-GM2 one step closer to patients in need through this Rare Pediatric Disease designation. AXO-AAV-GM2 has the potential to be the first treatment approved for Tay-Sachs and Sandhoff disease, rare and fatal pediatric diseases with no current treatment options,” said Sean O’Bryan, Senior Vice President, Regulatory Affairs & Quality.
Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, recently announced that new data and analyses related to its ongoing Phase 2 trial of onvansertib in metastatic castration-resistant prostate cancer (mCRPC) patients were featured in an electronic poster at the 27th Annual Prostate Cancer Foundation Scientific Retreat. The poster includes efficacy data demonstrating success in achieving the primary endpoint of disease control in patients showing initial resistance to Zytiga®(abiraterone); safety across three different dose and dosing schedules, as well as the potential clinical benefit for patients with the basal molecular tumor subtype.
“There is a pressing unmet need for therapies that can address resistance to abiraterone and other androgen receptor signaling inhibitors (ARSi), in mCRPC,” said David Einstein, M.D., attending physician at Beth Israel Deaconess Medical Center and principal investigator of the onvansertib Phase 2 trial. “Data presented at the PCF retreat demonstrate the potential of onvansertib to address this need, as we are seeing clinically meaningful rates of disease control, some quite durable, in patients with known mechanisms of ARSi resistance.”
Pfizer Inc. (NYSE:PFE) recently announced the full analysis from one of its Phase 3 studies (NCT03760146), which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older not previously vaccinated against pneumococcal disease. The data from this pivotal trial were presented as part of IDWeek’s virtual 2020 medical congress, along with data from a Phase 2 proof-of-concept study in infants given a four-dose pediatric series.
Earlier this month, Pfizer submitted the 20vPnC biologics license application for adults 18 years of age or older to the U.S. Food and Drug Administration, and is awaiting acceptance of the application for review. Pfizer anticipates submitting the 20vPnC marketing authorization application for adults to the European Medicines Agency in Q1 2021.
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