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 20, 2018 Array BioPharma Inc. (Nasdaq: ARRY) reported that its Chief Executive Officer, Ron Squarer, will speak at the 30th Annual Piper Jaffray Healthcare Conference in New York (Press release, Array BioPharma, NOV 20, 2018, View Source [SID1234531485]). The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

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Event:

30th Annual Piper Jaffray Healthcare Conference

Presenter:

Ron Squarer, Chief Executive Officer, Array BioPharma

Date:

Tuesday, November 27, 2018

Time:

9:00 a.m. Eastern Time

Webcast:

View Source;tp_key=8e5fb74efb

On November 20, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported that it will participate in a fireside chat at the Evercore ISI HealthconX Conference in Boston, MA on Tuesday, November 27 (Press release, Aeglea BioTherapeutics, NOV 20, 2018, http://ir.aegleabio.com/news-releases/news-release-details/aeglea-biotherapeutics-present-evercore-isi-healthconx [SID1234531501]).

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Presentation Details
Date: Tuesday, November 27, 2018
Time: 2:45 p.m. ET
Location: The Boston Harbor Hotel, Boston, MA
Room: South Atlantic Room (2nd floor)
Webcast: View Source

To access the live and archived audio webcast of the fireside chat, visit the Presentations & Events section of the Aeglea BioTherapeutics investor relations website. Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary. Replays of the webcast will be available for 30 days thereafter.

On November 20, 2018 Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics, will participate in a fireside chat at the Evercore ISI HealthCONx Conference on Tuesday, November 27, 2018, at 10:15 a.m. EST at the Boston Harbor Hotel (Press release, Heron Therapeutics, NOV 20, 2018, https://herontherapeutics.gcs-web.com/news-releases/news-release-details/heron-therapeutics-present-evercore-isi-healthconx-conference [SID1234531522]).

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A live webcast of the event will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the event will be archived on the site for 60 days.

On November 19, 2018, MabVax Therapeutics Holdings, Inc. ("MabVax" or the "Company") entered into an Equity Purchase Agreement with Triton Funds LP, an institutional investor ("Triton"), pursuant to which Triton will, subject to the terms of the Equity Purchase Agreement, purchase up to $1 million of the Company’s to be designated 0% Series P Convertible Preferred Stock (such stock, the "Series P Preferred") (Filing, 8-K, MabVax, NOV 20, 2018, View Source [SID1234531563]). Pursuant to the terms of the Equity Purchase Agreement, the Company has the right, but not the obligation, to direct Triton to purchase a number of shares of Series P Preferred (the "Put Shares") at a price per share equal to the stated value of $100.00 per share. The Put Shares are convertible into common stock at the conversion rate of $100 divided by an amount equal to 75% times the volume-weighted average price of the Company’s common stock measured for the five-business day period ending on the business day prior to the Company receiving a conversion notice (the "Conversation Rate"). The Company may direct Triton to purchase Put Shares at any time on or after the date of effectiveness of a registration statement registering the shares of common stock issuable upon conversion of the Put Shares, subject to a maximum of $300,000 for the initial purchase and terms providing the Company may not direct Triton to purchase Put Shares during the 30 day period immediately following delivery of the initial purchase notice. The Equity Purchase Agreement will terminate on the earlier of (i) the date on which Triton has purchased Put Shares with an aggregate purchase price of $1.0 million or (ii) 90 days after the effectiveness of a registration statement registering the shares of common stock underlying the Put Shares.

On November 19, 2018 and in connection with the Equity Purchase Agreement, the Company also entered into a Registration Rights Agreement with Triton pursuant to which the Company agreed to file a registration statement registering for resale the Commitment Shares (defined below) and the shares of common stock issuable upon conversion of the Put Shares. The Company intends on filing a registration statement on Form S-1 in connection with its obligations pursuant to the Registration Rights Agreement.

On November 19, 2018 and in connection with the Equity Purchase Agreement, the Company entered into a Share Donation Agreement pursuant to which the Company agreed to issue 175,000 shares of common stock (the "Commitment Shares") to Triton Funds LLC, manager of Triton, as an inducement to and upon Triton’s execution of the Equity Purchase Agreement.

The Equity Purchase Agreement, Registration Rights Agreement and Share Donation Agreement contain representations, warranties and other provisions customary for transactions of this nature.

In connection with the Equity Purchase Agreement and the issuance of the Put Shares, the Company agreed to file, prior to the issuance of any Put Shares, a Certificate of Designations for the Series P Preferred in the form attached to the Equity Purchase Agreement (the "Series P Certificate of Designations"). Each share of Series P Preferred will be convertible into shares of common stock at the Conversion Rate. This Conversion Rate will be subject to adjustment in the event of stock splits, stock dividends, combination of shares and similar recapitalization transactions. The Company is prohibited from effecting the conversion of shares of the Series P Preferred to the extent that, as a result of such conversion, the holder would beneficially own more than 4.99%, in the aggregate, of the issued and outstanding shares of the Company’s common stock calculated immediately after giving effect to the issuance of shares of common stock upon the conversion of the Series P Preferred (the "Beneficial Ownership Limitation"). The Beneficial Ownership Limitation may be increased by the holder up to, but not exceeding, 9.99%. Each share of Series P Preferred entitles the holder to vote on all matters voted on by holders of common stock. With respect to any such vote, each share of Series P Preferred entitles the holder to cast a number of votes equal to the number of shares of common stock such shares of Series P Preferred Stock are convertible into at such time, but not in excess of the Beneficial Ownership Limitation.

The issuances pursuant to the Equity Purchase Agreement and the Share Donation Agreement are exempt from registration requirements pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) the Securities Act of 1933, as amended (the "Securities Act") and Regulation D under the Securities Act.

The foregoing descriptions of the Equity Purchase Agreement, Series P Certificate of Designations, Registration Rights Agreement and Share Donation Agreement are subject to and qualified in their entirety by the Equity Purchase Agreement, Form of Series P Certificate of Designations, Registration Rights Agreement and Share Donation Agreement attached as Exhibits 10.1, 10.2, and 10.3, respectively.

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