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 22, 2019 Elpiscience BioPharma and Bio-Techne Corporation reported that the companies have entered into a strategic collaboration for the development of anti-cancer therapeutics (Press release, Elpiscience, APR 22, 2019, View Source;id=1313 [SID1234536921]). Under the terms of the agreement, Elpiscience will have access to multiple antibodies from Bio-Techne’s antibody library for use in preclinical, clinical and commercial pharmaceutical development.

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As a biotech company committed to leading the innovation and development of the next generation of cancer immunotherapy, Elpiscience, in collaboration with Bio-Techne, a global leader in life sciences and molecular diagnostics, will expand mutual capabilities in the field of cancer immunotherapy. This strategic collaboration also aims to accelerate the development of new biologics to address unmet medical needs in Oncology.

Dr. Darren Ji, CEO of Elpiscience, said: "We are very happy to enter into a strategic collaboration with Bio-Techne in therapeutic antibody research and development. This collaboration will leverage the strengths of both companies in the field of anti-cancer therapeutics and speed up the development of new cancer immunotherapies in order to bring more efficient treatment to cancer patients worldwide."

David Eansor, President of Bio-Techne’s Protein Sciences Segment commented "We are extremely excited to partner with Elpiscience in the development of novel cancer immunotherapies. It is our goal to increase our partnerships with therapeutics developers to unleash the potential of our vast library of high-quality antibodies towards the development of next generation immunotherapies."

On April 22, 2019 Molecular Templates, Inc., (Nasdaq: MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for MT-5111, an ETB targeting HER2 (Press release, Molecular Templates, APR 22, 2019, View Source [SID1234535314]). MTEM expects to start dosing in a Phase I study in relapsed/refractory patients with HER2-positive solid tumors in 3Q19.

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This Phase I study is an open-label, dose escalation and expansion study of MT-5111 given as monotherapy in subjects with HER2-positive solid tumors. The primary objective of the trial is to evaluate the safety and tolerability of MT-5111 and determine the recommended Phase II dose in subjects with advanced HER2-positive solid tumors.

"We are excited to be advancing MT-5111, which utilizes our proprietary de-immunized toxin scaffold, into the clinic for the treatment of patients with HER2-positive cancers. HER2 is a well validated target that is central to disease and when existing HER2-targeting therapies fail, the target persists, suggesting that a HER2-targeted therapy with a new mechanism of action has good potential to provide benefit to patients," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "We have seen promising responses to our lead pipeline candidate MT-3724 in DLBCL and we are excited to further leverage the novel mechanism of action of our ETB platform with MT-5111. We look forward to providing an update on the Phase I study by year-end 2019."

About MT-5111
MT-5111 is an ETB consisting of a single chain variable fragment (scFv) with affinity for HER2, fused to the enzymatically active de-immunized Shiga-like toxin-A subunit (SLTA). MT-5111 specifically binds and kills HER2 expressing cells in a manner consistent with SLTA mediated cellular cytotoxicity. MT-5111 has been specifically designed to avoid competition with and to overcome the primary mechanisms of tumor resistance to current HER2 targeted therapies. To accomplish this, first, MT-5111 binds a HER2 domain that is distinct from the trastuzumab and pertuzumab binding sites, which results in MT-5111 HER2-mediated binding and cell kill even in the presence of these monoclonal antibodies. As such, MT-5111 may have the potential to be combined with other HER2 targeted therapies. Second, SLTA is a large molecule protein and is not a substrate of drug efflux transporters such as MDR1 which has been demonstrated to be one of the primary mechanisms of resistance to the antibody drug conjugate, T-DM1. Third, MT-5111 mediated ribosomal inhibition and cell death take place intracellularly so changes in the tumor microenvironment which inhibit immune-mediated mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC) are not expected to inhibit MT-5111 activity. Finally, mutations to the HER2 kinase domain that can induce constitutive downstream signaling to drive tumor proliferation are not expected to interfere with MT-5111 activity, given that its mechanism of action is not dependent upon kinase domain binding and MT-5111 works directly on ribosomes to mediate ribosomal inhibition and cell death. Based on these mechanisms, MT-5111 represents a novel HER2 targeted therapy which could provide benefit in subjects with HER2-positive cancers and potentially overcome mechanisms of tumor resistance to existing HER2 targeted therapies.

On April 22, 2019 GlycoMimetics, Inc. (NASDAQ: GLYC) reported the publication of a paper in Nature Cell Biology that describes how tumor cells engage specific stromal components, most notably E-selectin, for propagation and outgrowth (Press release, GlycoMimetics, APR 22, 2019, View Source [SID1234535315]).1 The paper provides further scientific support for the clinical trial in breast cancer patients with bone metastasis that was recently announced by GlycoMimetics.

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Specifically, Esposito et. al. identify an E-selectin ligand expressed on tumor cells that is necessary for inducing mesenchymal-epithelial transition (MET) and that drives metastatic progression within the bone marrow microenvironment. Of note, in preclinical animal models of human breast cancer, inhibition of E-selectin with GlycoMimetics’ compound uproleselan (GMI-1271) prevented bone metastases progression and significantly attenuated bone metastases-associated bone degradation, resulting in a significant survival advantage in treated tumor-bearing mice. Previously published work also demonstrates a complimentary role for CXCR4. Together these observations support the testing of GMI-1359, GlycoMimetics’ dual-function antagonist, which targets both mechanisms.

"The scientific rationale for potential uses of GMI-1359 in oncology indications continues to build," said John L. Magnani, PhD, Chief Scientific Officer of GlycoMimetics. "This most recent paper contributes additional understanding to the critical role of E-selectin and to the potential uses of compounds that target this mechanism in cancer, in particular in cancers that metastasize to bone."

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers.