On April 23, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that four abstracts have been accepted for presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 31 to June 4, 2019 at the McCormick Place Convention Center in Chicago, Illinois (Press release, Athenex, APR 23, 2019, View Source;p=RssLanding&cat=news&id=2395278 [SID1234535344]).

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"We are very pleased with the abstracts that have been accepted for presentation at ASCO (Free ASCO Whitepaper) this year," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "We look forward to sharing additional information on our lead, pivotal stage Oraxol (Oral paclitaxel and HM30181A) program as well as preliminary results from our Oratecan (Oral irinotecan and HM30181A) Phase I study and preclinical proof of concept data for our new arginine deprivation therapy platform, Pegtomarginase. We believe these will demonstrate the broad applicability of the Orascovery technology for a wide range of commonly used chemotherapy agents and the depth of our oncology-focused pipeline."

Presentation details:

Title: (Abstract TPS1116) KX-ORAX-001: An open label, randomized, multicenter, Phase III registrational study to determine the safety, tolerability, and tumor response of Oraxol (HM30181A + oral paclitaxel) and its comparability to IV paclitaxel in patients with metastatic breast cancer (MBC).
Poster Session: Breast Cancer—Metastatic
Session Date, Time, Location: Sunday June 2, 2019, 8:00 AM-11:00 AM Central Daylight Time, Hall A

Title: (Abstract 1084) Oral paclitaxel in the treatment of metastatic breast cancer (MBC) patients.
Poster Session: Breast Cancer—Metastatic
Session Date, Time, Location: Sunday June 2, 2019, 8:00 AM-11:00 AM Central Daylight Time, Hall A

Title: (Abstract 3032) A Phase 1 study of the oral administration of irinotecan in combination with the potent P-glycoprotein (P-gp) inhibitor HM30181A.
Poster Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)
Session Date, Time, Location: Saturday June 1, 2019, 8:00 AM-11:00 AM Central Daylight Time, Hall A

Title: (Abstract 3090) Design, engineering, and characterization of a novel long-acting (Pegylated) single isomer human arginase for arginine depriving anti-cancer treatment.
Poster Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)
Session Date, Time, Location: Saturday June 1, 2019, 8:00 AM-11:00 AM Central Daylight Time, Hall A

The abstract titles are currently available on the ASCO (Free ASCO Whitepaper) iPlanner website, with the full abstracts scheduled to be published on May 15, 2019.

Athenex has received approval of the International Nonproprietary Name (INN) "encequidar" for its novel P-gp pump inhibitor molecule, HM30181A. The Company may use the nomenclature "encequidar" in future communications.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On April 23, 2020 Cytura Therapeutics reported the successful closure of a Seed financing round (Press release, Cytura Therapeutics, APR 23, 2019, View Source [SID1234572898]). The funding is provided by a syndicate led by Thuja Capital Healthcare (Seed) Fund II and includes BOM Brabant Ventures, the Centre for Drug Design and Discovery (CD3) – KU Leuven and the Gemma Frisius Fund. Cytura Therapeutics will use the new funding to advance its first proprietary small molecule program and to further expand their pipeline of new disruptive drugs, targeting genomic instability.

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The company will be based at the Pivot Park Life Science Campus in Oss and collaborate with the Amsterdam UMC and the Centre for Drug Design and Discovery (CD3) of the KU Leuven. Genomic instability is a major problem in cancer progression and therapy resistance. By targeting genome instability this approach could be applied both as a stand-alone as in combinations therapy. On the latter, there is a large group of patients who will at first respond to the applied therapy and later on become resistant during treatment.

"One of the biggest issues in cancer treatment is that the disease has the ability to change its nature over time caused by the increasing genomic instability. Cytura’s R&D efforts are focused on the development of small molecules that will slow down or stop this genomic instability. I am committed to find this medicine which could lead to real advancements in the fight against cancer."

On April 23, 2019 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it has entered into definitive agreements with institutional investors to purchase an aggregate of 9,375,000 units at a public offering price of $1.60 per unit in a registered direct offering (Press release, Moleculin, APR 23, 2019, View Source [SID1234535328]). Each unit is comprised of one share of common stock and 0.5 of a warrant to purchase one share of common stock.

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Each warrant will have an exercise price of $1.75 per share and is exercisable immediately. The warrants will expire five years from the date of issuance. The shares of common stock and the accompanying warrants included in the units can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about April 25, 2019, subject to customary closing conditions.

The gross proceeds of the offering are expected to be approximately $15.0 million, prior to deducting the placement agent fees and other estimated offering expenses.

Oppenheimer & Co. Inc. is acting as the sole placement agent for the offering. Roth Capital Partners, LLC and Maxim Group LLC are acting as financial advisors to the Company.

The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities described above are being offered pursuant to a prospectus supplement and an accompanying prospectus forming part of a shelf registration statement on Form S-3 (No. 333-219434) previously filed with and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, 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 the solicitation of an offer to buy any of the securities described herein, 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 April 23, 2019 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of glioblastoma (Press release, MediciNova, APR 23, 2019, View Source;p=RssLanding&cat=news&id=2395443 [SID1234535345]).

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Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than December 2037. The allowed claims cover a method of treating a patient diagnosed with glioblastoma or recurrent glioblastoma using MN-166 (ibudilast) as part of a combination therapy. The allowed claims cover the use of MN-166 (ibudilast) with several types of combination therapies including laquinimod in addition to radiation therapy, electric field therapy, and various therapeutic agents such as temozolomide.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to receive notice that this new patent will be granted. We believe it could substantially increase the potential value of MN-166 as we recently initiated enrollment in a clinical trial of MN-166 in combination with temozolomide for the treatment of recurrent glioblastoma."

About Glioblastoma

According to the American Association of Neurological Surgeons, glioblastoma (GBM) is a devastating brain cancer that typically results in death in the first 15 months after diagnosis. GBM develops from glial cells (astrocytes and oligodendrocytes) and rapidly grows and commonly spreads into nearby brain tissue. GBM is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that GBM represents 15% of all brain tumors and 56% of all gliomas and has the highest number of cases of all malignant tumors, with approximately 12,000 new cases diagnosed each year. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with GBM. Median survival is 14.6 months and two-year survival is 30%. Approximately 5% of GBM patients survive longer than 36 months.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glial cells, which play a major role in certain neurological conditions. MN-166 (ibudilast)’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, which provide the rationale for treatment of progressive multiple sclerosis (MS) and other neurological diseases such as amyotrophic lateral sclerosis (ALS), glioblastoma (GBM) and substance abuse/addiction. MediciNova is developing MN-166 for progressive MS and other neurological conditions such as ALS, glioblastoma, substance abuse/addiction and chemotherapy-induced neuropathy. MediciNova has a portfolio of patents which covers the use of MN-166 (ibudilast) to treat various diseases including progressive MS, ALS, and drug addiction.

On April 23, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of uro-oncology, reported that it has entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest (Press release, UroGen Pharma, APR 23, 2019, View Source [SID1234535329]). UroGen and Janssen will each conduct certain activities under the terms of the agreement.

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"We are excited to enter into this agreement with Janssen, an industry leader with a history of developing transformative therapies," said Liz Barrett, President and Chief Executive Officer of UroGen. "We maintain a strong commitment to bringing innovative treatments to patients in areas of unmet need."