On September 6, 2018 Gibson Oncology, LLC ("Gibson"), a privately held clinical stage company, reported that it acquired three (3) clinical non-camptothecin Topoisomerase I drugs from Linus Oncology (Press release, Gibson Oncology, SEP 6, 2018, View Source [SID1234532070]). These novel anti-cancer drugs have been tested in over 70 patients by the National Cancer Institute (NCI) and have been shown to be both safe and effective in phase I clinical trials. There are multiple United States and international patents on these agents.

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!

The compounds acquired are indenoisoquinolines ("indenos"), a novel class of drugs which were invented and developed by Purdue University and the NCI to minimize the diarrhea and neutropenia associated with the administration of traditional camptothecin agents such as irinotecan and topotecan. The multiple phase I trials have shown effectiveness in end-stage cancer patients with solid tumors who had failed administration of up to nine (9) drugs given previously. Simultaneously, these new drugs dramatically reduce the incidence of grade 3 and 4 neutropenia and diarrhea.

In addition, Gibson strengthened its Indeno product platform through obtaining an exclusive, worldwide development and commercialization license from Purdue University for the recently discovered pro-drugs for this novel class of compounds.

With pre-clinical studies already performed which demonstrate both the effectiveness of indenos after the development of irinotecan resistance as well as synergy between PARP inhibitors and the indenos, Gibson intends to approach the FDA about phase II studies. Several academic organizations, both in the United States and in Europe, have approached Gibson about helping conduct these studies.

"We are excited to advance these novel, potent, and well-tolerated small molecule topoisomerase I inhibitor drugs in advanced stage and/or resistant cancers as a single agent or in combination with immune-oncology and targeted therapies for improved patient outcomes," stated Randall Riggs, CEO of Gibson Oncology, LLC.

On September 6, 2018 Gibson Oncology, LLC ("Gibson"), a privately held clinical stage company, reported that it acquired three (3) clinical non-camptothecin Topoisomerase I drugs from Linus Oncology (Press release, Gibson Oncology, SEP 6, 2018, View Source [SID1234532059]). These novel anti-cancer drugs have been tested in over 70 patients by the National Cancer Institute (NCI) and have been shown to be both safe and effective in phase I clinical trials. There are multiple United States and international patents on these agents.

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!

The compounds acquired are indenoisoquinolines ("indenos"), a novel class of drugs which were invented and developed by Purdue University and the NCI to minimize the diarrhea and neutropenia associated with the administration of traditional camptothecin agents such as irinotecan and topotecan. The multiple phase I trials have shown effectiveness in end-stage cancer patients with solid tumors who had failed administration of up to nine (9) drugs given previously. Simultaneously, these new drugs dramatically reduce the incidence of grade 3 and 4 neutropenia and diarrhea.

In addition, Gibson strengthened its Indeno product platform through obtaining an exclusive, worldwide development and commercialization license from Purdue University for the recently discovered pro-drugs for this novel class of compounds.

With pre-clinical studies already performed which demonstrate both the effectiveness of indenos after the development of irinotecan resistance as well as synergy between PARP inhibitors and the indenos, Gibson intends to approach the FDA about phase II studies. Several academic organizations, both in the United States and in Europe, have approached Gibson about helping conduct these studies.

"We are excited to advance these novel, potent, and well-tolerated small molecule topoisomerase I inhibitor drugs in advanced stage and/or resistant cancers as a single agent or in combination with immune-oncology and targeted therapies for improved patient outcomes," stated Randall Riggs, CEO of Gibson Oncology, LLC.

On September 6, 2018 Advaxis, Inc. (Nasdaq: ADXS) ("Advaxis" or the "Company") reported that it intends to offer and sell in an underwritten public offering shares of its common stock, with each share of common stock to be sold together in a fixed combination with a warrant to purchase common stock (Press release, Advaxis, SEP 6, 2018, View Source [SID1234530400]). The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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!

Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. are acting as joint book-running managers for the offering.

The Company intends to use the net proceeds of the offering to fund its continued research and development initiatives in connection with expanding its product pipeline and for other general corporate purposes, including, but not limited to (i) progression of ADXS-HOT into clinical research in both monotherapy and combination therapy; (ii) investment in ongoing clinical research in ADXS-PSA and ADXS-NEO, both in monotherapy and combination therapy; and (iii) investment in ongoing clinical research with axalimogene filolisbac in head and neck cancer and other HPV associated cancers, including any wind down costs associated with ongoing trials.

The securities described above will be offered by the Company pursuant to a "shelf" registration statement (File No. 333-226988) previously filed with the Securities and Exchange Commission (the "SEC") on August 23, 2018 and declared effective by the SEC on August 30, 2018.

The offering may be made only by means of a prospectus supplement and the accompanying prospectus. Before investing in the offering, you should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Advaxis has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the Company and the offering. A preliminary prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website at View Source, copies of which can be obtained, when available, from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by email at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at 212-667-8055, or by email at [email protected].

This press release shall 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 6, 2018 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, reported the pricing of its underwritten public offering of $150,000,000 of American Depositary Shares ("ADSs") representing ordinary shares of the Company (Press release, Zai Laboratory, SEP 6, 2018, View Source;p=RssLanding&cat=news&id=2366260 [SID1234530327]).

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!

Zai Lab sold 7,500,000 ADSs at a price of US$20.00 per ADS. Each ADS represents one ordinary share of Zai Lab. The gross proceeds to Zai Lab from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $150,000,000. In addition, Zai Lab has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 ADSs at the public offering price, less underwriting discounts and commissions. The offering is expected to close on September 10, 2018, subject to customary closing conditions.

J.P. Morgan, Citigroup, Jefferies and Leerink Partners are acting as joint book-running managers for the offering.

A registration statement on Form F-1 relating to the securities sold in this offering has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. Copies of the registration statement related to this offering can be accessed through the SEC’s website at www.sec.gov.

This offering is being made only by means of a prospectus. A final prospectus, when available, may be obtained from: (i) J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-866-803-9204 or email: [email protected], (ii) Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or telephone: 1-800-831-9146 (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 1-877-821-7388, or by email at [email protected] or (iv) Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: 1-800-808-7525 ex. 6132 or email: [email protected].

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

On September 6, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application for its lead product candidate, RP1, for patients with solid tumors (Press release, Replimune, SEP 6, 2018, View Source [SID1234529738]). The Company intends to open its ongoing Phase 1/2 clinical trial in the U.S. and begin enrolling patients in the fourth quarter of 2018. The clinical trial is currently ongoing in the U.K., as previously announced.

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!

In part one of the Phase 1/2 clinical trial, Replimune is assessing the safety and tolerability of RP1 administered alone in patients with advanced solid tumors. Following this dose escalation phase, further patients will receive RP1 in combination with nivolumab anti-PD1 therapy. In part two of the Phase 1/2 clinical trial, expected to initiate in the first half of 2019, Replimune intends to study the safety and efficacy of RP1 in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancers, and non-melanoma skin cancers. For each of the tumor types other than melanoma, patients will be naïve to immune checkpoint blockade, whereas in melanoma, patients both previously treated and previously untreated with immune checkpoint blockade will be enrolled. This clinical trial is a collaboration with Bristol Myers Squibb, which is providing nivolumab for use in the study.

RP1 is Replimune’s first Immulytic product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency. This is intended to result in highly immunogenic cell death and robust activation of a systemic anti-tumor immune response.

About Oncolytic Immunotherapy
Oncolytic immunotherapy is an emerging class of cancer therapy which exploits the ability of viruses to selectively replicate in and kill tumors, while at the same time inducing a potent, patient-specific, anti-tumor immune response. Oncolytic viruses have the ability to induce a robust immune response against a patient’s particular complement of tumor antigens, including neo-antigens, in situ in the patient in an off-the-shelf format. While clinically active alone, oncolytic immunotherapy may have synergy with certain other treatments and, in particular, with immune checkpoint blockade therapies.