Palm Beach, FL – December 1, 2022 – FinancialNewsMedia.com News Commentary – Pancreatic cancer accounts for over 3% of all types of cancers in US. A lethal type of cancer, pancreatic cancer starts in the pancreas of the human body when abnormal cells in the pancreas grow and divide out of control and form a tumor. The presence of tumors prevents the normal functioning of the pancreas. The occurrence and mortality rate of pancreatic cancer is more in men than in women. Pancreatic cancer starts when the cells start growing abnormally and results in symptoms such as abdominal pain, weight loss, diarrhea, jaundice, blood clot, etc. The biggest risk factor, which leads to pancreatic cancer, is smoking. Other risk factors include pancreatitis, obesity, family history of pancreatic cancer, and older age. Treatment for pancreatic cancer depends on the stage and location of the cancer as well as on overall health and personal preferences. A report from Fortune Business Insights said that The global pancreatic cancer treatment market size is expected to rise substantially owing to increasing consumption of cigarettes and rising incidents of cancer across the globe. The report continued: “Rising rates in tobacco consumption, increasing cigarette smokers are likely to enhance the growth of pancreatic cancer market. Additionally, rising prevalence of cancer, increase in intake of alcohol, growing obesity rates, and growing awareness pertaining to various treatment options available are anticipating the market growth at a global level… High adoption of tobacco products is likely to increase the risk factor of contracting this disease. In addition to this, there is spike in adoption of tobacco mostly among youths across the globe… Increasing addiction of smoking among the people including youth is expected to drive the growth of the market in the forthcoming years.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Arcus Biosciences, Inc. (NYSE: RCUS), AstraZeneca PLC (NASDAQ: AZN), Bristol Myers Squibb (NYSE: BMY), AbbVie (NYSE: ABBV).
Fortune Business Insights concluded: “North America is projected to dominate the global pancreatic cancer treatment market over the forecast period, followed by Europe. The dominance of this region is mainly attributed to the improved healthcare infrastructure, high adoption of pancreatic treatment procedures, and the presence of large patient population. In addition, increasing incidence of pancreatic cancer is increasing the demand for treatment options. On the other hand, Asia Pacific is expected to witness the fastest growth during the forecast period. Presence of well-established hospitals and critical care centers, expanded interest for developing novel treatment options as well as large population suffering from pancreatic cancer drive the growth of the market in Asia Pacific region. Latin America and Middle East America are also expected to have a substantial growth in the pancreatic cancer treatment market.”
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech® Receives FDA Fast Track Designation for the Treatment of Advanced/Metastatic Pancreatic Cancer – FDA Fast Track designation granted after presentation at the SITC 37th Annual Meeting demonstrating 69% objective response rate – Oncolytics Biotech® today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep’s second FDA Fast Track designation.
“Receiving this Fast Track designation is an important accomplishment that speaks to the impressive response rate and the durability of the response in our PDAC study, and it also reflects the pressing need to improve upon the standard of care in this indication,” stated Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. “We expect the opportunity for more frequent communication about our data with FDA provided by this designation will be invaluable as we work to align with the Agency on the best design for a registrational PDAC study. With our core programs in breast and pancreatic cancer both nearing pivotal trials, and eligible for the Fast Track program’s numerous benefits, we believe we are at a crucial point in Oncolytics’ evolution and are excited for what’s ahead.”
In November 2022, at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, Oncolytics reported interim clinical data showing a 69% objective response rate (ORR) including a complete response (n=13) in a cohort of first-line advanced/metastatic PDAC patients treated with the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in the Company’s phase 1/2 GOBLET study. This ORR is nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer.
Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need. For conditions where an available treatment exists, a therapy must show some advantage over the available treatment, such as superior effectiveness, to be granted a Fast Track designation. A clinical program that receives Fast Track designation may benefit from more frequent meetings and communications with the FDA to discuss development plans and ensure the collection of appropriate data needed to support approval. In addition, clinical programs with Fast Track designation may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met. CONTINUED… Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/
Other recent developments in the biotech industry of note include:
Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, recently reported financial results for the third quarter ended September 30, 2022 and provided a pipeline update on its six clinical-stage molecules – targeting TIGIT, the adenosine axis (CD73 and A2a/A2b), HIF-2a and PD-1 – across multiple common cancers. As part of its pipeline update, the company is announcing a strategic protocol amendment to the ARC-10 registrational Phase 3 study following proactive discussions with the U.S. Food and Drug Administration (FDA). The new, amended ARC-10 study design will compare domvanalimab and zimberelimab to pembrolizumab, a global standard-of-care (SOC) in PD-L1-high NSCLC, the target indication for ARC-10; the study will no longer include a chemotherapy arm.
“Arcus continues to execute on its strategy to be a leader in the TIGIT field and to advance our clinical pipeline, including our adenosine pathway modulators etrumadenant and quemliclustat,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “The optimization of our Phase 3 ARC-10 study design and the initiation of the fourth Phase 3 registrational study for domvanalimab position Arcus to leverage the full potential of domvanalimab. We continue to have strong conviction that domvanalimab plus zimberelimab has the potential to be a best-in-class anti-TIGIT / anti-PD-(L)1 regimen and to create a new standard-of-care in multiple settings. With $1.2 billion and a deep pipeline of six, soon to be eight, clinical-stage molecules, we are poised to be a leader in the development of innovative therapies for cancer patients in need.”
AstraZeneca PLC (NASDAQ: AZN) recently announced that it will present new data advancing its ambition to redefine care at the 2022 San Antonio Breast Cancer Symposium (SABCS), December 6-10, 2022.
Twelve AstraZeneca medicines and potential new medicines will be featured in 55 presentations, including five oral presentations, showcasing the Company’s growing leadership across different subtypes and stages of breast cancer.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Our data at SABCS are strong validation of our clinical strategy to provide next-generation treatment solutions for patients with nearly all major types of breast cancer. We are excited to share results from the pivotal CAPItello-291 trial, which will support the opportunity of our novel AKT inhibitor capivasertib for patients with HR-positive disease. We also look forward to presenting defining data from the SERENA-2 Phase II trial that will demonstrate the potential of our next-generation SERD camizestrant to improve upon currently available endocrine therapies for patients with ER-driven disease.”
Envisagenics, an Artificial Intelligence (“AI”)-driven biotechnology company that delivers therapies for RNA splicing diseases, recently announced a research collaboration agreement with Bristol Myers Squibb (NYSE: BMY). The multi-year collaboration will leverage Envisagenics’ SpliceCore® AI platform to identify alternative splicing derived targets for therapeutic development to expand Bristol Myers Squibb’s vast oncology pipeline. Envisagenics will receive an upfront payment and milestone payments based on development, regulatory, and commercial achievements.
Envisagenics, an AI-driven biotech that focuses on RNA splicing diseases, announced a research collaboration with BMS.
SpliceCore, a cloud-based, AI-powered platform, can identify disease-specific splicing-derived targets by using RNA-sequencing data. Envisagenics will integrate data from thousands of patients to identify mRNAs encoding for tumor-specific cell surface antigens, thereby fostering the discovery of novel targets to enable development of therapeutics.
AbbVie (NYSE: ABBV) recently announced the European Commission (EC) approved SKYRIZI® (risankizumab, 600 mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn’s disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.
“There are still many patients suffering from debilitating symptoms associated with Crohn’s disease, such as abdominal pain and stool frequency, which is why we’ve embraced the challenge of serving these patients in need,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “The approval of SKYRIZI in the European Union is a significant milestone in our pursuit to expand our IBD portfolio.”
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