Biotech Brief: Demand is Growing for Safer, More-Efficacious Drugs When Treating Pancreatic Cancer

PALM BEACH, Florida, Jan. 27, 2020 /PRNewswire/ -- In the pancreatic cancer, the search is on for safer more efficacious drugs. As per the American's Cancer Society Cancer Facts and Figures report, by the end of the year 2019, over 56,700 Americans will be diagnosed with pancreatic cancer. A recent research article says that the pancreatic cancer diagnosis rate has observed a 2% increase from the last year. Often times, the pancreatic cancer diagnosis is difficult owing to no standard, cost-effective diagnostics tool. This results in the delayed screening of pancreatic cancer, which eliminates surgical removal of the tumor as a viable option. By the time, the pancreatic cancer is diagnosed, it has had spread all over in the body. s per the estimates presented by Cancer.net, if the pancreatic cancer is detected at early stages the possible chances of 5-year survival rate is 34%. The sad part is that only 10% of the patients are diagnosed at stage I. The moment, pancreatic cancer spreads to surrounding parts of the body, the 5-year survival rate reduces to 12%. Whereas, in the case of the tumor spreading to distant parts of the body, the rate swoops down to 3%. Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), NanoViricides, Inc. (NYSE: NNVC), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Bristol-Myers Squibb Company (NYSE: BMY), GlaxoSmithKline plc (NYSE: GSK).

The advancement in the medical sectors has helped the metastatic pancreatic cancer patient pool to find an effective cure in the form of various therapies that promise to kill the tumor from its root. Pancreatic therapies that can successfully target cancer depending upon the reason behind the origin of the tumor will surely expand the Metastatic pancreatic cancer market size. he progress in the medical sector, the development of innovative diagnostics tools, rising metastatic pancreatic cancer prevalence, increasing awareness among people and upcoming pipeline therapies is hopeful and expected to advance the metastatic pancreatic cancer market forward.

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech^® Announces Statistically Significant Data Demonstrating the Potential of CEACAM6 as a Prognostic Biomarker for Pelareorep in the Treatment of Pancreatic Adenocarcinoma Oncolytics Biotech^® currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that a poster presentation highlighting statistically significant data demonstrating that CEACAM6 is a potential biomarker for pelareorep in the treatment of pancreatic cancer. The presentation was delivered at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO in San Francisco.

"We have potentially identified a second biomarker for pelareorep," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These results suggest that CEACAM6 levels can predict long term benefit in pancreatic cancer. We are working with potential industry partners and academic collaborators to verify this important finding not only in pancreatic cancer but potentially in other GI indications where this biomarker is linked to clinical outcomes"

The poster, CEACAM6 is a candidate biomarker for Reolysin^® (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), highlights data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer. ata in the presentation associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep-treated patients with pancreatic cancer, with PFS increasing by more than 80%, from 5.72 months to 10.32 months (p=0.05). 

"I'm extremely happy to see additional data come from this important study run by the Ohio State University Comprehensive Cancer Center," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. This statistically significant result suggests CEACAM6 may become an additional prognostic biomarker for pelareorep and could provide considerable clinical value as we investigate its potential in pancreatic and other GI cancers."

CEACAM6 is differentially expressed in pancreatic adenocarcinoma cells. High levels of CEACAM6 have previously been demonstrated to block viral trafficking in virally infected cells, thereby decreasing viral replication. Study investigators speculated that altered CEACAM6 levels may be predictive for pelareorep sensitivity and may serve as a biomarker. ead this full press release and more news for ONCY at: ttps://www.financialnewsmedia.com/news-oncy/ 

Other recent developments in the biotech industry include:NanoViricides, Inc. (NYSE: NNVC) recently announced that it has successfully completed genetic toxicology testing required to support the IND application for NV-HHV-101 moving towards human clinical trials. NV-HHV-101 was found to be safe in terms of potential genotoxicity in the suite of tests that were performed by an independent laboratory. The drug did not induce mutations in bacteria and did not cause chromosomal damage in human cells.

The US FDA and other international regulatory authorities require these genetic toxicological studies to support the Investigational New Drug (IND) Applications for entering human clinical trials.

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced the Coalition for Epidemic Preparedness Innovations (CEPI) has awarded Inovio a grant of up to $9 million to develop a vaccine against the recently emerged strain of coronavirus (2019-nCoV). This initial CEPI funding will support Inovio's preclinical and clinical development through Phase 1 human testing of INO-4800, its new coronavirus vaccine matched to the outbreak strain. CEPI previously awarded Inovio a grant of up to $56 million for the development of vaccines against Lassa fever and Middle East Respiratory Syndrome (MERS), also caused by a coronavirus.

Bristol-Myers Squibb Company (NYSE: BMY) recently announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo(nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The FDA has granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 15, 2020.

"The FDA's acceptance of our application for Opdivo plus Yervoyrepresents an important milestone for patients with lung cancer in the United States, where, despite recent treatment advances, lung cancer remains the cause of more than 150,000 deaths each year," said Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb.

GlaxoSmithKline plc (NYSE: GSK) recently announced the US Food and Drug Administration (FDA) granted a priority review for the company's Biologics License Application (BLA) seeking approval of belantamab mafodotin (GSK2857916) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

The BLA is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study, recently published in The Lancet Oncology, which enrolled heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care.

In 2017, belantamab mafodotin was granted Breakthrough Therapy designation by the FDA, which is intended to facilitate the development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.

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