On September 20, 2019 Taiho Pharmaceutical Co., Ltd. reported that an antitumor agent "ABRAXANE I.V. Infusion 100 mg" (paclitaxel protein-bound particles for injectable suspension (albumin-bound); [nab-paclitaxel]), launched in Japan in September 2010, received additional approval for weekly administration*1 in combination with atezolizumab (genetic recombinant) in patients with breast cancer from Japan’s Ministry of Health, Labour and Welfare (Press release, Taiho, SEP 20, 2019, View Source [SID1234539665]).

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!

ABRAXANE was approved in Japan to treat patients with breast cancer in July 2010, gastric cancer and non-small cell lung cancer in February 2013 and unresectable pancreatic cancer in December 2014. The additional dosage and administration in the breast cancer indication was approved on the basis of a global phase III clinical study (IMpassion130 study) conducted by Chugai Pharmaceutical Co., Ltd. and is in addition to the already approved course of administration every three weeks*2.

The IMpassion130 study is a Phase III, multicentre, double-blind, randomized, placebo-controlled, global clinical study evaluating the efficacy, safety, and pharmacokinetics of atezolizumab in combination with ABRAXANE compared with ABRAXANE plus placebo in patients with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic breast cancer. One of the primary endpoints of this study is progression-free survival (PFS) in the intent-to-treat (ITT) and PD-L1 positive population, statistically significant extension of PFS was shown.*3

About ABRAXANE
ABRAXANE, is albumin-bound nanoparticles of paclitaxel that can be reconstituted with saline solution. It was developed by Abraxis BioScience, LLC and is marketed worldwide by Celgene Corporation, the parent company of Abraxis BioScience, LLC. Taiho Pharmaceutical has the development and marketing rights in Japan. ABRAXANE was initially approved in January 2005 by the U.S. FDA for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. As of January 2019, it has been approved in 74 countries worldwide, including the U.S. and Europe.

About Triple-Negative Breast Cancer
In Japan, 86,500 women (2018 predicted value) are estimated to be afflicted with breast cancer each year, and 14,800 women in Japan (2018 predicted value) die as a result of the disease.*4 Triple-negative breast cancer is defined by the lack of expression of female hormone receptors (estrogen and progesterone receptors) and the overexpression of the HER2 protein and amplification of the HER2 gene, which are involved in cancer cell proliferation. Triple-negative breast cancer accounts for 15% of all breast cancer cases and generally progresses quickly and carries a poor prognosis.

Product Information
Product Name
ABRAXANE I.V. Infusion 100 mg (paclitaxel injection [suspension with albumin])

Indication
Breast cancer, gastric cancer, non-small cell lung cancer and unresectable pancreatic cancer

Dosage and Administration (Newly approved dosage and administration is underlined.)
Either method A or method E*5 should be used for breast cancer; either method A or method D should be used for gastric cancer; method B should be used for non-small cell lung cancer; and method C used for unresectable pancreatic cancer.

Method A: In usual cases, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 260 mg/m2 (body surface area), followed by a treatment-free interval for at least 20 days.

The treatment cycle above is to be repeated.

Dosage should be reduced based on the patient’s condition.

Method B: In usual cases, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 100 mg/m2 (body surface area), followed by a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks, repeating this cycle subsequently. Dosage should be reduced based on the patient’s condition.

Method C: In usual cases, in combination with gemcitabine, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 125 mg/m2 (body surface area), followed by a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks followed by a one-week rest. The treatment cycle above is to be repeated. Dosage should be reduced based on the patient’s condition.

Method D: In usual cases, paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 100 mg/m2 (body surface area), followed by a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks followed by a one-week rest. The treatment cycle above is to be repeated. Dosage should be reduced based on the patient’s condition.

Method E: In usual cases, in combination with atezolizumab (genetic recombinant), paclitaxel is to be intravenously administered to an adult patient for 30 minutes once a day at 100 mg/m2 (body surface area), followed by a treatment-free interval for at least 6 days. The administration is once a week for 3 consecutive weeks followed by a one-week rest. The treatment cycle above is to be repeated. Dosage should be reduced based on the patient’s condition.

*1. Administration once per week is continued for a period of 3 weeks after which there is a treatment-free interval of 1 week, which constitutes a single course. This course may be repeated.

*2. There is a treatment-free interval of at least 20 days after each administration, which constitutes a single course. This course may be repeated.

*3: Source: Schmid P, Adams S, Rugo HS, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med 2018;379:2108-21

*4. "Latest Cancer Statistics," a cancer information service of the National Cancer Center Japan

View Source

*5. A usage and dosage limited to "PD-L1-positive, hormone receptor-negative and HER2-negative inoperable or metastatic breast cancer" which is the indication for atezolizumab

On September 20, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will present at the Ladenburg Thalmann Healthcare Conference, being held at the Sofitel, in New York City (Press release, TG Therapeutics, SEP 20, 2019, View Source [SID1234539666]). The presentation is scheduled to take place on Tuesday, September 24, 2019 at 11:00 AM ET.

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 this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

On September 20, 2019 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, principally through out-licensing arrangements, reported that it has entered into a securities purchase agreement with institutional investors in the United States to purchase approximately $5.0 million of its common shares in a registered direct offering and warrants to purchase common shares in a concurrent private placement (Press release, AEterna Zentaris, SEP 20, 2019, View Source [SID1234539667]). The combined purchase price for one common share and one warrant will be $1.50.

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!

Under the terms of the securities purchase agreement, Aeterna has agreed to sell 3,325,000 shares of its common shares. In a concurrent private placement, Aeterna has agreed to issue warrants to purchase up to an aggregate of 3,325,000 common shares. The warrants will be exercisable for a period of 5 years commencing six months from the date of issuance and have an exercise price of $1.65 per share.

The Company expects gross proceeds from the registered direct offering and concurrent private placement to be approximately $5.0 million before deducting placement agent’s fees and expenses. The registered direct offering and concurrent private placement is expected to close on or about September 24, 2019, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as sole placement agent in connection with the offering.

The common shares described above are being offered by Aeterna Zentaris pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232935) previously filed and declared effective by the Securities and Exchange Commission (SEC). The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities law.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the common shares in connection with the offering. A prospectus supplement relating to the shares of common shares will be filed by Aeterna with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

On September 20, 2019 An Upstate Medical University professor is the lead investigator on a recently awarded National Institutes of Health grant to study how manipulating a gene could help people better tolerate and recover from chemotherapy (Press release, SUNY Upstate, SEP 20, 2019, View Source [SID1234551515]).

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!

William Kerr, PhD, is a professor of microbiology and immunology, biochemistry and molecular biology as well as pediatrics at Upstate. Kerr has spent much of his career studying the SHIP1 enzyme, which can affect how an immune cell detects and kills cancer cells. He is a co-founder of Alterna Therapeutics, a private biotechnology company. Kerr, Alterna Therapeutics and a Syracuse University professor are the recent beneficiaries of the one-year $225,000 NIH grant.

Kerr said research supported by the grant will be conducted at Upstate and at the Central New York Biotech Accelerator.

"This NIH grant at Upstate advances and showcases SUNY’s enduring commitment to medical discovery and innovation," said SUNY Chancellor Kristina Johnson. "This research has the potential to impact millions of people whose lives are upended by the devastating effects of chemotherapy. I applaud Dr. Kerr for his leadership on this work that may one day result in better therapeutics for people diagnosed with cancer."

The project is described this way: "While chemotherapy remains a mainstay in the treatment of cancer, some types of chemotherapy deplete bone marrow stem cells that are responsible for daily production of blood cells. The severely debilitating side effects of chemotherapy on daily blood cell production frequently result in hospitalization and treatment delays, and may compel dose reductions that compromise drug efficacy, with potentially fatal consequences. This project will develop a novel technology to significantly improve blood cell recovery following chemotherapy, thus reducing healthcare costs for cancer patients and saving lives."

Kerr’s initial study of this topic involved modulating the activity of the SHIP1 enzyme to enhance blood cell recovery after radiation exposure. Papers describing these findings have been cited in ongoing research more than 100 times and featured by the editors at the journal Science, he said. In 2015, Kerr received an investment from SUNY’s Technology Accelerator Fund (TAF) to systematically test more than 100 SHIP1 inhibitors to find the best candidates for a therapeutic product. TAF targets critical research and development milestones – such as feasibility studies, prototyping and testing – which demonstrate that an idea or innovation has commercial potential. Since its launch in 2011, TAF has invested over $2.6 million to successfully advance the commercial readiness of 49 SUNY-developed innovations.

This new study will apply modulating the activity of the SHIP1 enzyme but after chemotherapy rather than radiation, Kerr said.

"We’re very interested in exploring the potential to expand stem cell production to help promote recovery of blood cell populations," said Alterna Therapeutics co-founder and CEO Chris Meldrum. He noted that Kerr’s breakthrough could be especially helpful to patients who undergo chemotherapy or other treatments that severely deplete or suppress production of blood cells by the bone marrow. Some of those treatments cause severe deficiencies in neutrophil and platelet counts, which can make a patient very sick requiring hospitalization. That in turn can slow down or halt their treatments, which puts the patient at a higher risk for the cancer to return. The discovery from Dr. Kerr’s lab additionally has the potential to be a treatment used in improving blood cell recovery following bone marrow transplant procedures.

"It’s taken us about a year to get some of these grants and now that we have the first one we’ll be applying for others," Kerr said, noting this is a "phase one grant" to test the initial science and could lead to Phase 2 funding from the NIH for further clinical development and testing.

"I’m excited. This bodes well that the review committees of the NIH see research conducted by Alterna Therapeutics as valuable and thus something that the NIH should support because it could lead to next generation cancer therapies."

On September 20, 2019 IGM Biosciences, Inc. (Nasdaq: IGMS) reported the closing of its initial public offering of 12,578,125 shares of its common stock at a price to the public of $16.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 1,640,625 additional shares (Press release, IGM Biosciences, SEP 20, 2019, View Source [SID1234539668]). The shares began trading on The Nasdaq Global Select Market on September 18, 2019 under the symbol "IGMS." IGM received gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, of approximately $201.3 million.

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!

Jefferies, Piper Jaffray, Stifel and Guggenheim Securities acted as joint book-running managers for the offering.

A registration statement relating to the offering was declared effective by the United States Securities and Exchange Commission on September 17, 2019. The offering was made only by means of a prospectus. A copy of the final prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Piper Jaffray & Co, Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected].

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