Aeolus Pharmaceuticals Inc., of Mission Viejo, Calif., said it obtained a worldwide, exclusive license to develop a series of compounds from National Jewish Health in Denver. The compounds, for which the firm has filed a provisional patent application in the U.S., have demonstrated antimicrobial and anti-inflammatory action. They have been shown to be effective at killing multiple drug-resistant clinical strains of Pseudomonas aeruginosa isolated from cystic fibrosis patients and improving bacterial clearance and diminishing lung inflammation in a cystic fibrosis mouse model of Pseudomonas aeruginosa lung infection, Aeolus said, adding that the compounds might have applications in both biodefense and medical indications.
Cardio3 Biosciences SA, of Mont-Saint-Guibert, Belgium, said it intends to change its corporate name to Celyad and will seek shareholder approval at the annual meeting of shareholders scheduled for May 5. Once approved the company's ticker symbol will change from CARD to CYAD.
Celprogen Inc., of Torrance, Calif., said it developed a pharmacological inhibitor, CEP1430, a synthetic molecule capable of inhibiting the growth and proliferation of the human pancreatic tumor. The molecule can be administered both intravenously and intraperitoneally and has been developed by the firm using cancer stem cell drug discovery high-throughput screening technology. Preclinical results so far have shown CEP1430 is efficacious against pancreatic cancer stem cells and circulating tumor cells without adverse effects at doses tested and reduced the tumor volume in the treated group by 80 percent to 90 percent in comparison to control.
Coherus Biosciences Inc., of Redwood City, Calif., and Baxter International Inc., of Deerfield, Ill., said they amended certain financial terms of their potential $246 million collaboration inked in August 2013 to develop and commercialize CHS-0214, a biosimilar of Enbrel (etanercept, Amgen Inc.), for Europe, Canada, Brazil and certain other markets. Under terms of the amended agreement, certain existing milestones and funding obligations have been revised, and the collaboration has been expanded to include select pre-commercialization activities. In aggregate, the revised milestone payments may exceed the previous Baxter funding obligations by about $12 million. Additionally, Baxter has agreed to purchase Coherus common stock in a private placement transaction. All other contractual provisions remain materially unchanged. (See BioWorld Today, Sept. 4, 2013.)
Inmed Pharmaceuticals Inc., of Vancouver, British Columbia, said it was awarded a grant from Mitacs, a Canadian nonprofit organization aimed at accelerating innovative projects through strategic academic and industry collaboration, to further develop the firm's nanoparticle-based delivery system for lead candidate CTI-085, in development for glaucoma. Initial formulation, in vivo and in vivo testing is under way, and the grant is partially funding ongoing work on the delivery system. It is the second grant awarded to Inmed from Mitacs. (See BioWorld Today, April 13, 2015.)
Intellect Neurosciences Inc., of Englewood Cliffs, N.J., said its securities were approved to trade on the OTCQB marketplace under the ticker ILNS.
Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, and Bristol-Myers Squibb Co., of New York, said they selected a development candidate for neuropathic pain as part of their neuroscience drug discovery and development alliance and are proceeding with plans to progress the candidate through investigational new drug application-enabling studies. BMS has the first option under the alliance to obtain exclusive clinical development and commercialization rights upon the initiation of phase I studies, subject to the payment of milestones and royalties to Lexicon. The two companies have been working together in neuroscience since 2003. (See BioWorld Today, Dec. 19, 2003.)
Motif Bio plc, of London, said the FDA has agreed to their proposed phase III development program for its lead product candidate, iclaprim. The program is designed to obtain marketing approval for an intravenous formulation of iclaprim in the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital-acquired bacterial pneumonia (HABP) caused by gram positive pathogens, including resistant strains such as methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae. The company said the FDA confirmed that two ABSSSI trials or one ABSSSI trial plus one HABP trial meeting their pre-specified primary endpoints are required for approval of iclaprim.
Repros Therapeutics Inc., of The Woodlands, Texas, said the FDA assigned a PDUFA goal date of Nov. 30, for review of the new drug application for its enclomiphene citrate product candidate, formerly known as Androxal. In addition, the FDA has informed the company that it is currently planning to hold an advisory committee meeting on the application during the review process.
Sellas Life Sciences Group, of Zug, Switzerland, said it has signed an exclusive global collaboration and license agreement with Trojantec Ltd., a U.K.-based discovery research and development company affiliated with Imperial College London, U.K., for the development, marketing and commercialization of the TR-1 cancer therapeutic technology and drug. TR-1 is the first clinical drug candidate that "replaces" dysfunctional p53/p21 suppressor proteins, in contrast to other p53-targeting small-molecule drugs in clinical development that only inhibit MDM2. A planned phase I study will demonstrate the first systemic administration of a cell-penetrating peptide delivering another therapeutic peptide, p21, to the nucleus of cells and will further establish the potential of this new class of medicines for a wide range of therapeutic areas.