On February 5, 2019 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at the upcoming Immuno-Oncology 360° Conference in New York on Thursday, February 7, 2019 at 3:50 PM, EST (Press release, Personalis, FEB 5, 2019, View Source [SID1234534800]).

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The presentation, entitled "A Universal Cancer Immunogenomics Solution for Biomarker Discovery," will discuss the current challenges facing investigators in immuno-oncology translational research and explore how the Personalis Platform overcomes the limitations associated with conventional NGS approaches that are used in translational research and the clinical development of new oncology therapeutics. The presentation will also introduce Personalis’ new ImmunoID NeXT Platform.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Kedar Hastak, PhD, Field Applications Scientist for Personalis.

On February 5, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or "the Company") reported that its novel Phase 1/2 combination trial of Actimab-A and venetoclax has been initiated (Press release, Actinium Pharmaceuticals, FEB 5, 2019, View Source [SID1234533070]). Gary Schiller, MD, Professor, Hematology-Oncology and Director, Hematologic Malignancy/Stem Cell Transplant Program at the UCLA Medical Center will serve as Principal Investigator for this study. The Phase 1/2 combination trial will enroll patients with relapsed or refractory AML or Acute Myeloid Leukemia that have been previously treated with venetoclax and patients that have never received venetoclax.

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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

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Venetoclax is a BCL-2 or B-Cell Lymphoma 2 inhibitor that is jointly developed and marketed by AbbVie and Genentech. BCL-2 is one of several proteins encoded by the BCL2 gene family, which regulates apoptosis or programmed cell death. MCL-1 is another protein encoded by the BCL2 gene family that is also overexpressed in cancers, including relapsed or refractory AML, that prevents apoptosis and promotes resistance to venetoclax, which does not bind to MCL-1. It has been demonstrated that MCL-1 levels can be depleted with radiation, but only external radiation was used in these studies. Actinium believes that the targeted radiation from Actimab-A can more effectively deplete MCL-1 levels thereby removing the AML cells’ resistance mechanism and rendering them more susceptible to venetoclax. In preclinical studies, Actinium demonstrated this synergistic effect when combining Actimab-A with venetoclax that led to increased cancer cell death, the results of which were highlighted in a webinar hosted by Actinium that can be accessed here.

Dr. Dale Ludwig, Actinium’s Chief Scientific Officer said, "The ability to deplete MCL-1, a known resistance mechanism to venetoclax, by selectively targeting AML cells that express CD33 with Actimab-A and hitting them with potent alpha radiation from Actinium-225 is very compelling. I am excited to see this study enter the clinic as I believe Actimab-A’s targeted radiation will prove to be synergistic with venetoclax as we have shown in our preclinical work. With our powerful Antibody Warhead Enabling technology platform we are excited to deploy targeted radiation as a weapon against cancer cells by exploiting their susceptibility to radiation and leveraging potential synergies with other therapeutic modalities."

Dr. Mark Berger, Chief Medical Officer of Actinium said’ "Despite advancements and recent approvals of AML therapies including venetoclax, there is a real need to improve their incremental benefits and produce more durable responses as well as curative outcomes for patients with relapsed and refractory disease. We are excited about this trial as our recent phase 2 study with Actimab-A demonstrated an ability to produce complete responses in difficult to treat AML patients. We attribute this efficacy to ARCs being agnostic to cytogenetic factors, the ubiquitous expression of CD33 in AML and potency of the Actinium-225 warhead. We are hopeful that the combination of Actimab-A and venetoclax will in the clinic will validate our preclinical studies showing synergy and result in improved patient outcomes."

On February 5, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary technology and products to kill tumors and increase immune cell recognition of solid tumor cancers, reported that Lewis H. Bender, President and CEO, will participate in the "Reshaping Tumor Microenvironments via Immunotherapies" panel at the 2019 BIO CEO & Investor Conference (Press release, Intensity Therapeutics, FEB 5, 2019, View Source [SID1234533088]). The panel will examine the next wave of innovation in immunotherapies, leveraging knowledge of how tumor microenvironments develop to create treatments able to demonstrate more durable effects on shrinking tumors across wider ranges of patients. The panel will be held on Monday, February 11, 2019 at 9:00 a.m. ET in New York, NY.

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On February 5, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Status for its drug candidate WP1066 for the treatment of glioblastoma, the most aggressive form of brain tumor (Press release, Moleculin, FEB 5, 2019, View Source [SID1234533053]).

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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

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"We continue to be encouraged by the progress of the physician-led clinical trial of WP1066," commented Walter Klemp, Moleculin’s Chairman and CEO, "and, now having the FDA grant Orphan Drug status for WP1066 positions us well for potential marketing of this drug. We believe that WP1066 represents a new class of drugs which we call ‘Immune/Transduction Modulators’ because it has demonstrated the ability in preclinical testing in animals to both stimulate a natural immune response to tumors and directly attack tumor cells by inhibiting multiple key oncogenic transcription factors, including STAT3, HIF1-α and c-Myc."

Dr. Sandra Silberman, Chief Medical Officer for New Projects at Moleculin added: "The development of WP1066 is gaining momentum. In addition to the glioblastoma trial at MD Anderson, we have had interest from additional investigators, including Emory University and Mayo Clinic for conducting clinical trials for the treatment of pediatric brain tumors, as well as others interested in treating a range of highly resistant tumors including AML and pancreatic cancer. Because we’ve seen strong anti-tumor activity in a wide range of animal models, we believe this represents an important new approach to treating many types of cancer."

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

On February 5, 2019 OPKO Health, Inc. ("OPKO Health" or the "Company") (NASDAQ: OPK) reported the pricing of its offering of $200 million aggregate principal amount of Convertible Senior Notes due 2025 (the "Notes") (Press release, Opko Health, FEB 5, 2019, View Source [SID1234533071]). The Notes will be general senior unsecured obligations of the Company, will pay interest semiannually in arrears at a rate of 4.50% per annum, and will mature on February 15, 2025, unless earlier repurchased, redeemed or converted. The Notes will be convertible into, at the Company’s election, cash, shares of the Company’s common stock, or a combination of cash and common stock, as further described in the prospectus supplement. The conversion rate for the Notes will initially be 236.7424 shares of common stock per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $4.22 per share of common stock, and is subject to adjustment under the terms of the Notes. The Company has granted the underwriter an option to purchase up to an additional $30 million aggregate principal amount of the Notes to cover over-allotments, if any. The sale of the Notes is expected to close on February 7, 2019.

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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

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The Company may not redeem the Notes prior to February 15, 2022, but may redeem the Notes, at its option, on or after February 15, 2022 if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price for the Notes for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption. The redemption price will equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

The Company intends to use the net proceeds received from the offering of the Notes to fund research and development to further develop and commercialize its portfolio of proprietary pharmaceutical and diagnostic products and for working capital, capital expenditures, acquisitions and other general corporate purposes, which will include the repayment or repurchase of indebtedness or debt securities outstanding from time to time, including $28.8 million principal amount and accrued but unpaid interest currently outstanding under the Company’s line of credit with an affiliate of the Company’s Chairman and Chief Executive Officer.

In connection with the Company’s offering of the Notes, the Company has entered into a share lending agreement with an affiliate of Jefferies LLC (the "Share Borrower"), under which it will lend to the Share Borrower a total of up to 30 million shares of the Company’s common stock. The borrowed shares will be newly-issued shares issued in connection with the offering of the Notes and will be cancelled or held as treasury shares upon the expiration or early termination of the share lending agreement.

Purchasers of the Notes may separately sell up to 30 million shares of the Company’s common stock that they may borrow through the Share Borrower. The Company expects that the selling stockholders will use the short position created by such sales to establish their initial hedge with respect to their investments in the Notes. The Company will not receive any proceeds from the sale of the borrowed shares.

Jefferies LLC is acting the sole book-running manager for the offering.

The offering of the Notes and the offering of the Company’s common stock is being made by means of separate prospectus supplements to the prospectus forming a part of the Company’s effective shelf registration statement filed with the Securities and Exchange Commission (the "SEC") on January 28, 2019 and other related documents. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplements may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY, 10022, by email at [email protected] or by phone at +1 877 821 7388. Before you invest, you should read the prospectus supplements and accompanying base prospectus along with other documents that the Company has filed with the SEC for more complete information about the Company and these offerings.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, the Notes, the Company’s common stock or any other securities, nor will there be any sale of convertible notes, the Company’s common stock or any other securities in any state or other 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 other jurisdiction.