On November 26, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the first patient was treated in a phase 2 study combining pelareorep with Merck’s Keytruda to treat advanced pancreatic adenocarcinoma (Press release, Oncolytics Biotech, NOV 26, 2018, View Source [SID1234531633]). The primary objective of the study is to determine the overall response rate (ORR) by iRECIST criteria. Secondary objectives include safety of the combination, immune response as determined by analysis of pre- and post-treatment biopsies and blood-based immune markers, determination of progression-free survival (PFS) by iRECIST criteria; and one-year, two-year and median overall survival (OS).

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"We are very excited to start enrollment in this combination study which expands upon our findings from an earlier Keytruda study in advanced pancreatic cancer," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "REO 024, our previous phase 1b study with Keytruda, showed objective response, long-term stabilization of disease and promotion of an inflamed phenotype in second line pancreatic cancer patients. This new phase two study should corroborate anti-tumor activity and potentially confirm predictive biomarkers laying the groundwork towards our goal of becoming a standardized backbone for checkpoint inhibitors."

This study is a phase 2, single arm, open-label study enrolling up to 30 patients with advanced pancreatic adenocarcinoma who experienced disease progression or did not tolerate first-line therapy. The principal investigator is Dr. Devalingham Mahalingam, of Northwestern University. The first 16 patients will be enrolled in stage one, and up to 14 additional patients will be enrolled in stage two if pre-specified criteria are met. The pre-defined criteria state that, for the primary objective, three or more responses out of 16 are needed in stage one to continue the trial to the full 30 patients.

For more information about the study, including a comprehensive list of inclusion and exclusion criteria, please visit: www.clinicaltrials.gov (identifier: NCT03723915).

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On November 26, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the BMO Prescriptions for Success Healthcare Conference on Wednesday, December 12th, at The Mandarin Oriental, New York (Press release, Johnson & Johnson, NOV 26, 2018, View Source [SID1234531631]). Ciro Römer, Company Group Chairman for the Johnson & Johnson Medical Devices Companies North America region will represent the Company in a session scheduled at 10:00 a.m. (Eastern).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast replay will be available approximately two hours after the live webcast.

On November 26, 2018 Heat Biologics, Inc. (”Heat”) (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported the closing of its previously announced underwritten public offering of 8,000,000 shares of its common stock together with warrants to purchase 4,000,000 shares of its common stock at a combined price to the public of $1.50 (Press release, Heat Biologics, NOV 26, 2018, View Source [SID1234531630]). The warrants have an exercise price of $1.65, are exercisable upon issuance and expire five years from the date of issuance. In addition, the underwriter exercised the over-allotment option to purchase an additional 1,200,000 shares of common stock and warrants to purchase 600,000 shares of common stock. Gross proceeds to Heat from this offering are approximately $13,800,000 before deducting underwriting discounts and commissions and other estimated offering expenses payable by Heat.

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A.G.P./Alliance Global Partners acted as the sole book-running manager for the offering.

CIM Securities, LLC acted as a financial advisor to Heat Biologics in connection with the offering.

The securities described above were offered by Heat Biologics, Inc. pursuant to a registration statement on Form S-3 (No. 333-221201) previously filed with the U.S. Securities and Exchange Commission ("SEC") and declared effective on November 13, 2017. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 26, 2018 Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, is reported that its Board of Directors appointed Samson Tom, PhD, MBA to serve as President and Chief Executive Officer, effective November 26, 2018 (Press release, Osiris Therapeutics, NOV 26, 2018, View Source [SID1234531628]). Dr. Tom was at Osiris from 2003 to 2011, where he held several leadership positions spanning multiple functional areas including Quality, Operations, Clinical Development, and Product Development. Subsequently, he served as Group Director, Biosurgery Research & Development at Ethicon, Inc. (a Johnson & Johnson company). Prior to rejoining Osiris, he served as Vice President, Research & Development for Surgical Orthobiologics at Bioventus, LLC. Dr. Tom brings a strong combination of scientific and commercial experience in the regenerative medicine space. He earned a BA in Biology and Chemistry from Cornell University, a MS and PhD in Biochemistry from the University of Rochester School of Medicine and Dentistry, and a MBA in General Management from the Johns Hopkins University Carey Business School.

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"Returning to Osiris definitely feels like coming home," said Dr. Tom. "Developing and launching novel solutions to address unmet needs for patients and the medical community have always been at the core of Osiris. I am truly energized to continue this legacy and look forward to working with the entire team during the next phase in the evolution of this innovative company.""I am pleased to welcome Dr. Tom back to Osiris as President and CEO," said Peter Friedli, Chairman of the Board. "At this important juncture for the company, Dr. Tom is a great fit due to his familiarity with our technologies and our culture of innovation. I look forward to working with him to achieve greater operational efficiency and future growth."Jason Keefer, who previously served as Interim President and Chief Executive Officer, will transition to lead the commercial functions of the organization and serve on the management team as Chief Commercial Officer.

On November 26, 2018 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of bone marrow transplant to more patients, reported that it will host a live webcast of an investor and analyst event at 8:30 p.m. PST (11:30 p.m. EST) on Sunday, December 2, 2018, during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Magenta Therapeutics, NOV 26, 2018, View Source [SID1234531627]).

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To access the webcast, please visit the "Events & Presentations" page within the Investors & Media section of the Magenta Therapeutics website at View Source Replays of the webcast will be available on the Magenta Therapeutics website for 90 days following the event.