Zealand Pharma A/S ("Zealand") reports that Boehringer Ingelheim has announced the initiation of two Phase 1 trials, the first with a glucagon/GLP-1 agonist that has the potential for once-weekly administration for the treatment of obesity and/or type 2 diabetes and the second with a novel differentiated long-acting amylin analog for the treatment of obesity and/or diabetes.
Organovo Holdings, Inc announced it has awarded the 2017 ExVive 3D Tissue Application Award to researchers at Amgen, Inc and Medikine, Inc. The program is designed to explore new applications using Organovo’s ExVive Liver and Kidney Tissues in collaboration with biopharmaceutical partners. The Company had many applicants for its awards, with the winners submitting the two most creative and novel proposals with the aim of bridging preclinical and clinical research. The projects will be performed by Organovo and include comprehensive studies and data analysis.
Iovance Biotherapeutics, Inc a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology,announced that the first patient was dosed in its C-145-04 Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma.
Anthera Pharmaceuticals announced that the RESULT Phase 3 clinical study of Sollpura for exocrine pancreatic insufficiency due to cystic fibrosis has been approved by the European Cystic Fibrosis Society Clinical Trial Network (ECFS CTN) Executive Committee.
Applied Genetic Technologies Corporation a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, announced that it has filed an Investigational New Drug application (IND) with the U.S. Food and Drug Administration to conduct a Phase 1/2 clinical trial of the company's gene therapy product candidate for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene.
RedHill Biopharma Ltd a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported, following a second pre-planned meeting to assess the safety and efficacy data from its ongoing first Phase III study with RHB-104 for Crohn’s disease (the MAP US study) by an independent Data and Safety Monitoring Board (DSMB), that it has received a unanimous positive recommendation from the DSMB to continue the study as planned.
AXIM Biotechnologies, Inc a world leader in cannabinoid research and development, today announced that it has entered into a Clinical Study Agreement (CSA) with the University of British Columbia in Canada to begin a clinical trial with its CanChew Plus® cannabidiol (CBD) chewing gum product to treat drug-induced psychosis in adult patients.
Titan Pharmaceuticals, Inc. a specialty pharmaceutical company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura™ long-term, continuous drug delivery technology, announced today that it has entered into a venture loan and security agreement with Horizon Technology Finance Corporation, which provides Titan with up to USD10 million of available borrowing capacity.
A first tranche of USD7 million was funded upon execution of the loan agreement. A second tranche of USD3 million will be available to Titan, at its option, through March 31, 2018, subject to the satisfaction of certain revenue and product development milestones, and other borrowing conditions.
The loan agreement has a term of 46 months, with interest only payments through December 31, 2018, followed by equal monthly installments of principal and accrued interest for 30 months thereafter. The initial interest rate is 9.63%, which is based on a floating rate equal to the sum of the one month LIBOR (floor of 1.10%) plus 8.4%. Each loan tranche is also subject to a 5.0% final payment when the principal is paid in full. The loan is senior debt and is secured by all of Titan's assets, with the exception of its intellectual property.
"We believe this transaction balances our capital needs and opportunity to grow the company, and our commitment to minimizing dilution for shareholders to the extent possible," commented Titan President and CEO Sunil Bhonsle. "We were impressed with Horizon's ability to tailor a financing structure that matched Titan's objectives. We expect that our existing cash on hand, combined with the net proceeds from the first tranche of this loan, will be sufficient to fund planned operations into early 2019."
Gerald A. Michaud, President of Horizon, stated, "We are pleased to provide this debt financing to Titan. The company's proprietary long-term drug delivery platform, ProNeura, represents a new standard of chronic disease management utilizing subdermal implants. We look forward to working with Titan as its lead product, Probuphine®, advances in the marketplace and the company continues to develop a growing pipeline of new treatments for select therapeutic markets."
In connection with this transaction, Titan issued to Horizon warrants to purchase an aggregate of 280,612 shares of Titan's common stock. The per share exercise price of these warrants is the lower of USD1.96 or the price per share of any securities that may be issued by the company in an equity financing during the next 18 months. The company also issued the lender a warrant that will only become exercisable upon the funding of the second tranche of the loan, with number of shares and exercise price to be calculated at such time. The company has agreed to file a registration statement with the Securities and Exchange Commission (SEC) within the next 90 days covering the resale of the shares underlying the lender warrants.
Verona Pharma plc a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces today that the first patients have been dosed in a Phase 2b clinical trial evaluating RPL554 as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”). Verona Pharma expects to report top-line data from this trial in the second half of 2018.
Axsome Therapeutics, Inc a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, announced positive topline clinical trial results from a Phase 1 pharmacokinetic study of AXS-06, a novel, oral, non-opioid, fixed-dose combination of meloxicam and esomeprazole being developed for the treatment of osteoarthritis and rheumatoid arthritis. Axsome has received, from the U.S. Food and Drug Administration (FDA), Pre-Investigational New Drug Application (Pre-IND) written guidance on a proposed clinical developmental plan for AXS-06. Based on this guidance, Axsome believes that AXS-06 is Phase 3-ready. AXS-06 is now Axsome’s third product candidate in clinical development and its second differentiated oral, non-opioid product candidate for the management of chronic pain.
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