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Groundbreaking Clinical Trials Accelerating New Treatment Options for Pancreatic Cancer

Palm Beach, FL – February 2, 2022 – News Commentary – In the battle against pancreatic cancer, new and innovative clinical trials have become extremely critical. These trials offer patients early access to cutting-edge treatments that can lead to progress in research and hopeful for better outcomes.  Every treatment available today was originally researched, developed and approved through a clinical trial – a research study that investigates new treatments or combinations of existing treatments to determine if they are beneficial to people living with pancreatic cancer.  Pancreatic cancer is increasingly becoming a major concern globally, constantly driving the need for treatment innovations and drug development efforts. The unmet needs related to the disease is attracting many multinational companies to invest in the industry. These factors combined with rising healthcare expenditure worldwide will augment the market growth. A report from Global Market Insight said that Pancreatic Cancer Treatment Market size is expected to generate substantial revenue during 2021 to 2027.  The report continued: “Pancreatic cancer is considered one of the most aggressive forms of cancer that originates in the pancreatic tissues and can rapidly spread to the nearby organs. Unhealthy lifestyle choices such as smoking, alcohol and tobacco consumption as well as lifestyle associated diseases such as obesity and diabetes are among the key causes of pancreatic cancer. The American Cancer Society estimates that more than 60,000 Americans will be diagnosed with pancreatic cancer in 2021. Similar trends are being witnessed in many other parts of the world which will certainly bolster industry trends.”   Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Bristol Myers Squibb (NYSE: BMY), Seagen Inc. (NASDAQ: SGEN), Exact Sciences Corp. (NASDAQ: EXAS), Kura Oncology, Inc. (NASDAQ: KURA).


Global Market Insight added: “Chemotherapy, immunotherapy, targeted therapy, and hormone therapy, among others, are the different types of pancreatic cancer treatment options. Among these, the targeted therapy segment is likely to capture a fair share of the market by 2027. Targeted therapy targets the cancer’s specific proteins, genes, or the tissues which contribute to the growth of the cancer. The treatment blocks the growth and spread of cancer cells while limiting damage to the healthy ones. Targeted therapy will observe increased demand for pancreatic cancer treatment in the coming years.”


Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech® Provides Positive Safety Update on the Pancreatic Cancer Cohort of its Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial Oncolytics Biotech® ) today announced the successful completion of the three-patient safety run-in for the pancreatic cancer cohort of the phase 1/2 GOBLET study following evaluation by the study’s Data Safety Monitoring Board (DSMB). The DSMB noted no safety concerns in these patients and recommended the study proceed as planned. The safety run-in for the trial’s third-line metastatic colorectal cancer cohort remains ongoing.


The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.


“This positive safety evaluation adds to a robust body of evidence demonstrating the favorable safety profile of pelareorep-checkpoint inhibitor combinations across multiple indications,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. “It also represents an important step in the development of these combinations for the treatment of pancreatic cancer and builds on prior clinical proof-of-concept data in this indication. These data highlight the potential of pelareorep to benefit patients with pancreatic and other gastrointestinal cancers by reversing immunosuppressive tumor microenvironments that limit the effectiveness of checkpoint inhibitors. We believe adding pelareorep to treatment regimens will improve clinical response rates in these patients, and we look forward to evaluating this hypothesis through successfully advancing the GOBLET study.”


The GOBLET study’s pancreatic cancer cohort extends previously reported clinical data demonstrating the synergy and anti-cancer activity of pelareorep combined with checkpoint inhibition in pancreatic cancer patients who progressed after first-line treatment (link to PR, link to poster). It also builds on prior early clinical data that showed a greater than 80% increase in median progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression who received pelareorep in combination with chemotherapy (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, GOBLET also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may increase the likelihood of success of future registrational studies by allowing selection of the most appropriate patients.   CONTINUED Read this full press release and more news for ONCY at:    


Other recent developments in the biotech industry of note include:


Seagen Inc. (NASDAQ: SGEN) recently announced data from a phase 1 clinical trial combining SEA-CD40 with chemotherapy and an anti-PD-1 in patients with metastatic PDAC at the ASCO GI annual meeting taking place in San Francisco, January 20 – 22, 2022. SEA-CD40 is a novel, investigational, nonfucosylated monoclonal receptor-agonistic antibody directed to CD40, which is expressed on antigen-presenting cells. In preclinical models, the combination of SEA-CD40 and chemotherapy resulted in antitumor activity which is further enhanced with anti-PD-1 treatment.


In the ongoing phase 1 trial, SEA-CD40 was combined with chemotherapy [gemcitabine and nab-paclitaxel (GnP)], and an anti-PD-1 (pembrolizumab), in 61 patients with untreated metastatic PDAC. Of these, 40 patients received 10 mcg/kg and 21 patients received 30 mcg/kg of SEA-CD40. Key endpoints include confirmed objective response rate (cORR) per RECIST v1.1 by investigator, progression-free survival (PFS) and overall survival (OS)…


…”Preliminary activity is encouraging based on historical chemotherapy outcomes. Further survival follow up is required to inform our next steps in pancreatic cancer,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We are continuing to advance the ongoing phase 2 trial of SEA-CD40 in melanoma and in non-small cell lung cancer.”


Exact Sciences Corp. (NASDAQ: EXAS) recently announced performance data for a second-generation Cologuard (multi-target stool DNA) test showing overall sensitivity of 95.2% for colorectal cancer (CRC) at specificity of 92.4% for negative samples confirmed by colonoscopy. Subgroup analyses showed 83.3% sensitivity for high-grade dysplasia, the most dangerous precancerous lesions, and 57.2% for all advanced precancerous lesions. These data will be presented January 22 at ASCO GI in a poster titled, “Second-generation Multi-target Stool DNA Panel Reliably Detects Colorectal Cancer and Advanced Precancerous Lesions.”


Cologuard is the first and only FDA-approved, non-invasive stool DNA test used to screen average-risk people for CRC. Exact Sciences is developing a second-generation Cologuard to improve the specificity and precancer sensitivity of the test, decreasing the false positive rate and increasing the detection rate of precancerous lesions. The study shows the potential of a highly discriminate panel of methylated DNA markers and fecal hemoglobin to accomplish both in a real-world setting. If approved, the second-generation Cologuard test could help increase screening rates while sending fewer people to follow-up colonoscopies unnecessarily and identifying more advanced precancers before they progress to cancer, helping prevent the disease.


Bristol Myers Squibb (NYSE: BMY) recently announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).


“This positive CHMP opinion is an important milestone that recognizes Breyanzi as a differentiated cell therapy with the potential to address unmet needs for patients in the European Union with aggressive lymphomas who have limited treatment options,” said Anne Kerber, senior vice president, Cellular Therapy Development, Bristol Myers Squibb. “We look forward to the European Commission’s decision as we continue to accelerate our research in cell therapy to develop new treatment options for patients living with difficult-to-treat blood cancers.”


Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, recently announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). The partial clinical hold was lifted following agreement with the FDA on the Company’s mitigation strategy for differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.


“I am very proud of our team for working diligently with the FDA and site investigators to resolve the partial clinical hold in such a timely manner,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Activities to resume patient screening are underway, and we look forward to expediting enrollment of patients in the Phase 1b study and determining the recommended Phase 2 dose for KO-539 in the coming months. Meanwhile, we continue to be encouraged by the safety, tolerability and clinical activity observed among currently enrolled patients and look forward to sharing a comprehensive update on the Phase 1 study at a future medical meeting.”


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