On November 21, 2018 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-888 for the treatment of Pancreatic Cancer. OBI-888 is a first in class monoclonal antibody cancer immunotherapy targeting Globo H, a glycolipid antigen (Press release, OBI Pharma, NOV 21, 2018, View Source [SID1234531559]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A Phase 1 study of OBI-888 has commenced enrollment at the University of Texas M.D. Anderson Cancer Center in patients with locally advanced or metastatic solid tumors, potentially including Pancreatic, Breast, Gastric, Esophageal, Colorectal and Lung Cancers.

Amy Huang, General Manager of OBI Pharma, noted, "The orphan drug designation for OBI-888 by the FDA is encouraging and is a significant step in the development of this novel monoclonal antibody drug candidate targeting Globo H. In addition to targeting other solid tumors, OBI-888 will be evaluated for the treatment of pancreatic cancer, a disease with very limited treatment options. OBI will continue our utmost efforts to develop innovative therapies for people living with cancer."

About Pancreatic Cancer

Pancreatic Cancer originates in the exocrine or endocrine pancreatic cells and is thought to be caused by poor diet, smoking, and genetic factors. Pancreatic Cancer is a deadly disease that currently affects 69,839 people in the US and has a survival rate of only 8.5% at five years. In addition, treatment options are limited to surgical resection for patients with early stages of the disease and these patients may only have a five-year survival rate of up to 34.3%. As Pancreatic Cancer is asymptomatic in early stages, a majority of patients are undiagnosed or misdiagnosed until advanced stages of the disease. Surgery is no longer effective at this stage of the disease, leaving a large population with limited treatment options.

About Orphan Drug Designation (ODD)

The orphan drug designation provides OBI Pharma with potential benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees, and tax credits for qualified clinical trials. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for rare diseases or conditions that affect fewer than 200,000 people in the U.S.

About OBI-888

OBI-888 is a novel first-in-class monoclonal antibody, which selectively targets Globo H, an antigen expressed in up to 15 epithelial cancers. This Globo H targeting antibody has been shown to induce tumor-killing via antibody dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated phagocytosis (ADCP) and complement dependent cytotoxicity (CDC).

OBI-888 is also anti-immunosuppressive and anti-angiogenic. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, colon, lung, and breast), OBI-888 has demonstrated tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-888 was well-tolerated, and no adverse effect was found in all the doses tested.

OBI Pharma owns global rights to OBI-888.

On November 21, 2018 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies with the goal of activating a patient’s immune system against cancer through T-cell activation, reported the pricing of an underwritten public offering consisting of 8,000,000 shares of Common Stock together with Warrants to purchase 4,000,000 shares of Common Stock at a combined price to the public of $1.50 (Press release, Heat Biologics, NOV 21, 2018, View Source [SID1234531543]). The gross proceeds to the Company from this offering are expected to be approximately $12,000,000 before deducting underwriting discounts, commissions and other offering expenses. The Warrants will have an exercise price of $1.65, will be exercisable upon issuance and will expire five years from the date of issuance. Heat Biologics, Inc. has granted the underwriter a 45-day option to purchase additional shares of Common Stock and/or additional Warrants to cover over-allotments, if any. The offering is expected to close on November 26, 2018, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

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

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-221201) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the y prospectus supplement and accompanying prospectus may be obtained, when available, 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]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Heat Biologics, Inc. has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Heat Biologics, Inc. and such offering.

This press release shall not constitute an offer to sell or the 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 21, 2018 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that management will present a company update at the 30th Annual Piper Jaffray Healthcare Conference (Press release, Bicycle Therapeutics, NOV 21, 2018, View Source [SID1234531544]). The presentation will take place at 8:10 a.m. ET on Tuesday, November 27, 2018.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On November 21, 2018 PellePharm, a late clinical-stage biopharmaceutical company committed to targeting rare dermatologic conditions at their source, reported that Sanuj K. Ravindran, M.D., chief executive officer and president, will present at the Piper Jaffray Healthcare Conference on Tuesday, November 27, at 12:30 p.m. EST in New York (Press release, PellePharm, NOV 21, 2018, View Source [SID1234531545]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation can be accessed on the company’s website at www.pellepharm.com. A replay of the webcast will be archived on the PellePharm website for at least two weeks following the presentation.

On November 21, 2018 The Board of Directors of Alliance HealthCare Services, Inc. ("Alliance") reported the promotion of Rhonda Longmore-Grund, currently the organization’s Interim CEO, Executive Vice President and Chief Financial Officer, to the role of Chief Executive Officer, effective immediately (Press release, Alliance HealthCare Services, NOV 21, 2018, View Source [SID1234531546]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ms. Longmore-Grund joined Alliance in 2016 as Executive Vice President and Chief Financial Officer, bringing significant international and capital market experience and having led organizations through strategic expansion and growth. Prior to joining Alliance, she held several CFO roles including Senior Vice President and Chief Financial Officer for Printronix, a global provider of industrial print technology solutions serving Fortune 500 customers around the world. She has also served on the executive teams of Ingram Micro, Inc., Exult, Inc., Velocium (now owned by Northrop Grumman) and Digital Equipment Corporation (DEC). Ms. Longmore-Grund holds a Masters of Arts in Law and Diplomacy and International Business from The Fletcher School of Law and Diplomacy at Tufts University.

At Alliance, Ms. Longmore-Grund has been instrumental in several key strategic initiatives for the organization, including two ownership transitions, privatization and refinancing, earning her and the Alliance team an excellent reputation in the financial community. Ms. Longmore-Grund has also served a pivotal role in the organization’s acquisitions, strategic planning, and culture and engagement initiatives. Most recently, Ms. Longmore-Grund recruited Ms. Prudence Kuai as Chief Information Officer to Alliance, a former WellPoint, Arcadian and Florida Blue executive team member who brings significant payer and information systems expertise to the Alliance senior team.

"We were fortunate to have several very strong internal and external candidates for the CEO role at Alliance," said Paul Viviano, Board Member and search committee chair. "In the end, it was Rhonda’s unique blend of values-based and collaborative leadership, proven record of success both in finance and more generally, and her earned reputation as a trusted and effective leader both within the Alliance team and in the healthcare marketplace that make her the right choice for leading Alliance’s continued success as a national leader in outsourced medical services."

Alliance partners with health systems, hospitals and physician groups to provide radiology, cancer care and pain management services across the United States. The company has become one of the nation’s leading healthcare organizations, with more than 1,100 customers and a patient average satisfaction score of 97%.

In fall of 2017, the organization became wholly owned by Tahoe Investment Group. Says Board Member Charles Feng, "On behalf of Chairman Huang, the Tahoe team and our Board, we are thrilled to have Rhonda in the CEO role. Our growth plan depends on our team’s ability to succeed in a shifting healthcare marketplace, and we look forward to their continued progress on behalf of our patients and partners under Rhonda’s leadership."

The company plans to immediately begin a search for the Chief Financial Officer role