Algernon Pharmaceuticals Inc., of Vancouver, British Columbia, said NP-120 (ifenprodil), which the company is advancing to treat idiopathic pulmonary fibrosis, showed superiority over gefapixant, a phase III candidate from Kenilworth, N.J.-based Merck & Co. Inc., in an in vivo cough study using the guinea pig citric acid challenge model. At clinically relevant doses, ifenprodil (1.5 mg/kg) showed a reduction of 42% in mean cough frequency vs. untreated control (p <0.01), while gefapixant (3.5 mg/kg) showed a 20% reduction in mean cough frequency vs. untreated control (p <0.05). Ifenprodil (59.8 seconds) and gefapixant (49.7 seconds) both showed a non-statistically significant delay in the onset of first cough when compared to control (34.2 seconds).
Bayer AG, of Leverkusen, Germany, said it formed a three-year collaboration with Children's Hospital of Philadelphia (CHOP) to discover and develop small molecules leading to a potentially first-in-class oral non-replacement therapy to treat hemophilia A and B. The partnership is expected to leverage CHOP's expertise in hemophilia and coagulation and Bayer's research capabilities. Bayer expects to invest $5 million in joint research over the life of the agreement with the option to extend the collaboration by mutual agreement. Bayer secured an option for an exclusive license to the collaboration results.
Cerecor Inc., of Rockville, Md., said it inked a definitive agreement to acquire Aevi Genomic Medicine Inc. (formerly Medgenics, Inc.), of Wayne, Pa., in an all-stock transaction valued at approximately $16.1 million at closing, plus contingent value rights (CVRs) for up to $6.5 million in clinical and regulatory-based milestone payments. Pricing of Aevi shares (NASDAQ:GNMX) will be based on the number of shares outstanding immediately prior to closing, including shares to be issued to Children’s Hospital of Philadelphia Foundation at the conversion of an outstanding secured promissory note and to Astrazeneca plc, of Cambridge, U.K., in connection with the exercise of Aevi’s license option for MEDI-2338. The CVRs would entitle Aevi shareholders to an additional $2 million in cash or stock upon enrollment of a phase II study related to tumor necrosis factor 14 ligand inhibitor AEVI-002, mTORC1/2 inhibitor AEVI-006 (OSI-027) or anti-IL-18 monoclonal antibody AEVI-007 (MEDI-2338) within 24 months and an additional $4.5 million in cash or stock upon FDA approval within 60 months of an NDA for AEVI-007 or AEVI-006. Structured as a merger, the transaction is expected to be tax-deferred to Aevi stockholders, with Cerecor retaining its public reporting and current listing (NASDAQ:CERC). The deal is expected to close during the first quarter of 2020, subject to effectiveness of a Cerecor registration statement, Aevi shareholder approval and other customary conditions. On Thursday, GNMX shares closed even at 14 cents while CERC shares fell 33 cents to close at $3.37.
Cynata Therapeutics Ltd., of Melbourne, Australia, said it received positive efficacy data from preclinical studies of its Cymerus mesenchymal stem cells (MSCs). In a model of severe pneumonia-induced sepsis, the MSC treatment increased blood oxygen levels and lung compliance and decreased alveolar neutrophil infiltration, barrier permeability and inflammation, with each benefit statistically significant in comparison to placebo control. Positive trends also were seen in a preclinical model of mild pneumonia-induced sepsis. In addition, the MSCs were shown to enhance phagocytosis, both directly and indirectly.
Fibriant BV, of Leiden, the Netherlands, expanded its recombinant fibrinogen license agreement with Bioceros BV, of Utrecht, the Netherlands, for CHOBC expression technology to also include development and manufacturing of recombinant human (pro)thrombin. Fibriant’s platform produces recombinant fibrinogen variants. Expanding the license enables Fibriant to develop fully recombinant fibrin-based topical products based on different fibrinogen variants, with applications in hemostasis, regenerative medicine and host-defense.
Genmab A/S, of Copenhagen, hit a $100 million sales volume milestone in its Darzalex (daratumumab) collaboration with Janssen Biotech Inc., triggered by $2.5 billion calendar year sales. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize Darzalex, a CD38-targeting monoclonal antibody for treating multiple myeloma. The EU recently approved its use in combination with lenalidomide and dexamethasone in adults with newly diagnosed disease who are ineligible for autologous stem cell transplant.
Idorsia Ltd., of Allschwil, Switzerland, and Tokyo’s Mochida Pharmaceutical Co. Ltd. entered a license agreement for supplying, co-developing and co-marketing daridorexant, a dual orexin receptor antagonist, in Japan. Idorsia receives an initial ¥1 billion (US$9.12 million) and is entitled to three additional development and regulatory milestones. Idorsia also is entitled to sales milestones and tiered royalty payments based on net sales. Costs associated with the co-development are shared. Idorsia is responsible for the design and conduct of additional preclinical and clinical studies, and for health authority registration, with oversight from a joint development committee. Should Idorsia wish to out-license daridorexant for use in any field other than insomnia and related disorders to a third party in Japan, Mochida will be offered the right of first refusal.
Medusa Merger Corp., an indirect, wholly owned subsidiary of Basel, Switzerland-based Novartis AG, began its tender offer to purchase all outstanding shares of common stock of The Medicines Co. for $85 per share. The offer expires at midnight ET, at the end of the day on Jan. 3.
Osivax SAS, of Lyon, France, and the NIH’s National Institute of Allergy and Infectious Diseases will develop Osivax’s lead universal flu vaccine candidate, OVX-836, which is in a phase I trial. Osivax will use the institute’s preclinical services for immunological assessments. Tests will include flow cytometry analyses to refine cellular immune response evaluation, which will further characterize the CD4, CD8 and polyfunctionality of T-cell immune responses.
Siga Technologies Inc., of New York, said the Canadian Department of National Defence (CDND) issued an advanced contract award notice (ACAN), indicating that the CDND intends to purchase up to 15,325 courses of oral antipoxviral drug Tpoxx (tecovirimat) over four years as specified in the ACAN, with an initial purchase of 2,500 courses. The ACAN is required to remain open for at least 15 days, during which time a potential alternative supplier may submit a competing statement of capabilities. The contract would represent the first international order for Tpoxx. As Siga previously announced, the CDND intends to award a contract to support regulatory approval for Tpoxx by Heath Canada. Siga is currently targeting a Canadian regulatory filing in the second half of 2020, with approval anticipated in 2021.
Vedanta Biosciences Inc., of Cambridge, Mass., was awarded a second research grant, worth $5.8 million, from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a nonprofit partnership for accelerating early development in antibacterial R&D to treat drug-resistant bacteria. Vedanta is eligible for $3.5 million in further funding upon completion of specific milestones. The funding is for developing VE-707, a human microbiome-derived discovery program designed to restore a healthy microbiota as well as to prevent infection and colonization recurrence of several multidrug-resistant organisms.
Zionexa U.S. Corp., of New York, and Petnet Solutions Inc., part of Siemens Healthineers AG, of Erlangen, entered an exclusive agreement for the manufacturing and distribution of Zionexa’s new positron emission tomography diagnostic drug, fluoroestradiol, which is pending approval by the FDA. Zionexa will produce and distribute the drug in the U.S. and ensure patients with metastatic breast cancer have access. Terms were not disclosed.