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]).

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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.

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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.

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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]).

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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 20, 2018 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, VBL Therapeutics, NOV 20, 2018, View Source [SID1234531467]).

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"We continue the development of our novel anticancer drug VB-111, as we enroll and treat patients in the ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer while exploring the opportunity to develop it in other indications," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We are excited about the potential of our MOSPD2-targeting platform and are advancing two parallel programs exploring MOSPD2 as a therapeutic target in both oncology and inflammatory disease."

"VBL is well capitalized with more than $53 million in cash and equivalents at September 30, 2018. We believe this will be sufficient to support our Phase 3 clinical trial for VB-111 for ovarian cancer, and advance our pipeline, including the VB-600 platform targeting MOSPD2, for at least the next three years," concluded Dr. Harats.

Third Quarter and Recent Corporate Highlights:

Continued to treat patients in the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer.
° OVAL is evaluating VB-111 in combination with chemotherapy, without any change from the regimen which demonstrated overall survival (OS) benefit in the Phase 2 study for ovarian cancer.
° An efficacy interim readout is expected to occur in the fourth quarter of 2019.
° Data on the immune mechanism of VB-111 in platinum resistant ovarian cancer will be presented in March 2019 at the 50th Annual Meeting conference of the Society of Gynecologic Oncology (SGO) in Hawaii.
Presented new analysis from the Phase 3 GLOBE study of VB-111 in patients with recurrent glioblastoma at the 2018 Society for Neuro-Oncology (SNO) annual meeting.
VBL is developing two independent platforms of proprietary monoclonal antibodies targeting MOSPD2; one for inflammatory indications using classical antibodies, and a second, separate platform for oncology indications, based on bi-specific antibodies.
Presented new data on the Company’s MOSPD2 oncology program:
° In July 2018, a paper published in the International Journal of Cancer featured VBL data showing that MOSPD2 can play a major role in breast cancer cell migration and metastasis, and that targeting MOSPD2 may be a viable therapeutic strategy to prevent the spreading of breast cancer cells.
° Previously, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 annual meeting, the Company presented a late-breaking study demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding to MOSPD2.
Presented new data on the Company’s MOSPD2 inflammatory disease program:
° At the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), VBL presented data demonstrating that MOSPD2 is essential for the disease development and progression in the experimental autoimmune encephalomyelitis (EAE) model for multiple sclerosis. VBL’s proprietary monoclonal antibodies were successfully used both to prevent development, as well as to treat EAE once symptoms had appeared.
Published positive new data on Lecinoxoid drug candidates for the treatment of renal fibrosis in Basic and Clinical Pharmacology and Toxicology.
° The paper published in Basic and Clinical Pharmacology and Toxicology describes the role of the Company’s lecinoxoid drug candidates, VB-201 and VB-703, in slowing the decline of kidney function in renal fibrosis.
° Recently granted US patent provides patent protection for lecinoxoids treatment of liver and renal fibrosis until at least November 2035 and supports potential partnering opportunities.
Continued to strengthen the Company’s intellectual property portfolio – European Patent Office issued Patent No. 2908865, extending exclusive protection for VB-111 until October 2033, before any further potential extension. Similar VB-111 composition-of-matter patents have also been granted in the US, Japan, China and additional countries.
Strengthened the Board of Directors with the appointment of Dr. Shmuel ("Muli") Ben Zvi, a well-known pharmaceutical executive in Israel and former senior manager at Teva Pharmaceuticals Industries Ltd.
Third quarter Ended September 30, 2018 Financial Results:

Revenues: Revenues related to the Company’s collaboration in Japan amounted to $0.1 million in the third quarter ended September 30, 2018.
Cash Position: Cash, cash equivalents and short-term bank deposits at September 30, 2018, were $53.7 million and working capital was $50.1 million. The Company estimates that, based on current projections, the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements for more than 3 years and is expected to be sufficient to support the Company’s Phase 3 clinical trial for VB-111 for ovarian cancer, and to advance its pipeline, including the VB-600 platform targeting MOSPD2 during this period.
R&D Expenses: Research and development expenses for the quarter ended September 30, 2018, were approximately $4.1 million, compared to approximately $4.8 million in the comparable period in 2017.
G&A Expenses: General and administrative expenses for the quarter ended September 30, 2018 were $1.4 million, compared to $1.7 million for the comparable period in 2017.
Comprehensive Loss: The Company reported a comprehensive loss for third quarter ended September 30, 2018 of $5.4 million, or ($0.15) per share, compared to a net loss of $6.5 million, or ($0.24) per share in third quarter ended September 30, 2017.
For further details on VBL’s financials, including the results for the nine month period ended September 30 2018, refer to Form 6-K filed with the S.E.C.

Conference Call:
Tuesday, November 20th @ 8:30am Eastern Time
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International: 323-994-2082
Conference ID: 4933637
Webcast: View Source