Araim Pharmaceuticals Inc., of Tarrytown, N.Y., said the European Commission has granted orphan medicinal product designation in the EU for their lead product candidate, innate repair receptor activator ARA 290, for prevention of graft loss in pancreatic islet transplantation.
Aveo Oncology Inc., of Cambridge, Mass., said its development partner, Eusa Pharma Ltd., of Hemel Hempstead, U.K., has submitted its responses to the EMA Day 120 list of questions issued by the Committee for Medicinal Products for Human Use as part of the centralized review process of the marketing authorization application for tivozanib for the first-line treatment of advanced renal cell carcinoma. The next step in the filing process, the EMA Day 180 list of outstanding issues, is expected in the first quarter next year.
Biocorrx Inc., of Anaheim, Calif., said it selected Covance Inc. as the contract research organization for nonclinical studies of its injectable naltrexone formulation, BICX101, being developed by its pharmaceuticals subsidiary. Covance is scheduled to initiate its first-study on Dec. 22 and expects completion within four to five weeks. The company is planning the request for a pre-IND meeting with the FDA and anticipates a meeting date in Q1 2017.
C3 Jian Inc., of Los Angeles, changed its name to C3J Therapeutics Inc., saying the name better reflects its focus on developing therapeutics to reengineer the human microbiome. A phase II trial of lead candidate C16G2 in the prevention of dental caries is currently underway.
Cascadian Therapeutics Inc., of Seattle, said it received board approval for a reverse stock split of the company's outstanding common shares at a ratio of 1-for-6, and a reduction in the number of authorized shares of common stock from 200 million to 66.7 million shares.
Cellectar Biosciences Inc., of Madison, Wis., said it selected Hamilton, Ontario-based Centre for Probe Development and Commercialization, a GMP manufacturing organization specializing in radiopharmaceuticals, as a supplier of their lead phospholipid drug conjugate (PDC), CLR 131 under development for a range of hematologic malignancies. It is currently being evaluated in a phase I trial in patients with relapsed or refractory multiple myeloma and plans are in process to initiate a phase II study to assess efficacy in a range of B-cell malignancies in the first quarter of next year. CLR 131 utilizes the company's PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells.
Chugai Pharmaceutical Co. Ltd., of Tokyo, and Berlin-Chemie Menarini, of Florence, Italy, a company of the Menarini Group, have entered into a global license agreement for PA799, class I PI3K inhibitor. Chugai has conducted a phase I study on the inhibitor for solid tumors in Europe. Chugai will grant Menarini Group an exclusive license for the manufacturing, development and marketing of PA799 worldwide and will receive an upfront, milestone and royalty payments.
Curis Inc., of Lexington, Mass., said the EMA Committee for Medicinal Products for Human Use has granted full approval to Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC inappropriate for surgery or radiotherapy. Erivedge is also approved in the U.S. for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. Erivedge was developed and is marketed by Roche AG and Genentech, of South San Francisco, a member of the Roche Group, under a collaboration agreement.
Epizyme Inc., of Cambridge, Mass., said tazemetostat has been given fast track designation by the FDA as a treatment for those with diffuse large B-cell lymphoma, or DLBCL, with EZH2 activating mutations. The company also said it is focusing its phase II trial on adults with genetically defined solid tumors on those cancers marked by loss of INI1. Epizyme is expanding enrollment in the epithelioid sarcoma cohort of the study after seeing early activity in that segment, with the aim of adding 30 participants. The company said this is the largest clinical trial to date in that rare cancer.
Galapagos NV, of Mechelen, Belgium, reported that it will be included in the Stoxx Europe 600 Index, effective Dec. 19. Stoxx Ltd. is a global index provider and offers a global, comprehensive index family of more than 7,500 rules-based indices.
Immage Biotherapeutic Corp., of Philadelphia, has completed animal trials in which it harnesses the power of the immune system to target a specific protein, MAGE A, in an effort to find a better cure for triple negative breast cancer. During animal trials, the company tested the same four goals set with in vitro studies. The research indicated that their vector expressed the protein and that the protein got an immune response. Immage also determined through animal trials that the company had created the right immune cells to kill the targeted cancer cells in vitro. Immage plans to file an IND application for a phase I trial in late 2017.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., said it applied to the British Columbia Securities Commission and Ontario Securities Commission for a decision that it is no longer a reporting issuer for the purposes of British Columbia and Ontario securities law. The company's predecessor, Genetronics Biomedical Corp., was delisted from the Toronto Stock Exchange in 2003. The application will not affect Inovio's listing on Nasdaq. A successful outcome of the application will mean that Inovio will not have to file financial statements or other disclosures with Canadian securities regulatory authorities.
Intellipharmaceutics International Inc., of Toronto, said it filed a new drug application with the FDA for marketing authority for Rexista abuse-deterrent oxycodone hydrochloride extended-release tablets in these dosages: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg. The abuse-deterrent opioid is intended to manage pain that is severe enough for daily, round-the-clock, long-term treatment, and which has no adequate alternative treatment options. The company was previously granted a waiver by the FDA of the $1,187,100 application fee.
Janssen Research & Development LLC, part of Johnson & Johnson, of New Brunswick, N.J., has submitted an anticipated marketing authorization application to the EMA seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. The filing for the fully human anti-IL-23 monoclonal antibody, discovered by Janssen using Morphosys AG's HuCAL antibody library technology, follows the recent submission of a BLA in the U.S. that triggered an undisclosed milestone payment to Martinsried, Germany-based Morphosys. (See BioWorld Today, Nov. 18, 2016.)
Macrocure Ltd., of Petach Tikva, Israel, has delayed the scheduled date for its previously announced special meeting of shareholders to Dec. 19, 2016. The company's prospective merger with Leap Therapeutics Inc., of Cambridge, Mass., will be presented for approval. Pursuant to the prospective merger, Macrocure will become a wholly owned subsidiary of Leap, and Leap will become a public company. Macrocure delayed the meeting date in order to provide more time for its shareholders to review proxy materials and to vote via the mail-in proxy. (See BioWorld Today, Aug. 30, 2016.)
Merck & Co. Inc., of Kenilworth, N.J., said the FDA accepted for review the sBLA for Keytruda (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. The FDA granted priority review with a PDUFA of March 8, 2017. The sBLA review will be based on tumor response rate and durability of response. The application, which is seeking approval for Keytruda at a fixed dose of 200 mg every three weeks, is based on data from five uncontrolled, open-label, multi-cohort, multi-site phase I/II trials investigating the activity of Keytruda in MSI-H cancer.
Moberg Pharma AB, of Stockholm, has entered an agreement with Strides Pharma Inc., part of Strides Shasun Ltd., of Bangalore, India, to divest the brand Pediacare for $5 million plus the inventory value at closing allowing the firm to focus on its core business. The divested brand originated from an acquisition in July 2016 where the primary purpose was to acquire New Skin, an asset in specialty skin care. The divestment results in no capital gain or loss. Additionally, Moberg Pharma has obtained a waiver from its bondholders to increase flexibility in acquisition financing. The waiver provides better possibility to optimize financing of acquisitions of profitable assets.
Monosol Rx, of Warren, N.J., has filed an NDA with the FDA for Tadalafil Pharmfilm for the treatment of erectile dysfunction. Tadalafil is a PDE5 inhibitor currently marketed in pill form for the treatment of erectile dysfunction and benign prostatic hyperplasia under the brand name Cialis, and for treatment of pulmonary arterial hypertension under the brand name Adcirca. Tadalafil Pharmfilm will be offered in single pack doses and is expected to have several Orange Book listed patents upon approval.
Shares of Phaserx Inc. (NASDAQ Capital Market:PZRX) climbed $1.69, or 149.6 percent, to $2.82 on Monday as the Seattle-based company gained FDA orphan drug status for its lead candidate, PRX-OTC, an experimental treatment for the rare liver disorder ornithine transcarbamylase deficiency. The company is preparing to file an investigational new drug application for PRX-OTC by the end of 2017 and to initiate clinical trial in 2018, said President and CEO Robert Overell.
Pixarbio Corp., a Cambridge, Mass.-based company developing a system for the sustained therapeutic release of non-opiate drugs for pain, up-listed from the OTC Pink Sheets to the OTCQX Market. Its shares will continue to be traded under the symbol PXRB.
Redhill Biopharma Ltd., of Tel-Aviv, Israel, presented a poster related to Yeliva (ABC294640), the company's first-in-class, orally administered sphingosine kinase-2 (SK2) selective inhibitor, at the 2016 EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium in Munich. The poster described results from non-clinical studies conducted by Apogee Biotechnology Corp., of Hummelstown, Pa., demonstrating the potential antitumor and anti-inflammatory effects of Yeliva in combination with radiation.
Relypsa Inc., a Redwood City, Calif.-based subsidiary of Galenica Group, gained FDA approval for a supplemental new drug application that sought to remove a black box warning regarding the separation of its hyperkalemia treatment, Veltassa (patiromer), and other oral medications. The updated label recommends patients take Veltassa at least three hours before or three hours after other oral medications. In addition, data from the company's Veltassa drug-drug interaction program has been added to the clinical pharmacology section of the drug's label. (See BioWorld Today, Oct. 23, 2015.)
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, reported that the European Commission has granted conditional marketing authorization for Ninlaro (ixazomib) when provided in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy. The decision follows a positive opinion granted by the EMA's Committee for Medicinal Products in September. Takeda also gained a positive listing recommendation for its Crohn's disease medicine Entyvio (vedolizumab) from the Canadian Drug Expert Committee of the Common Drug Review. The recommendation conveys the group's support for Canada's publicly-funded drug insurance plans to cover Entyvio for people with Crohn's disease, when it is prescribed by their doctor.
Topivert Pharma Ltd., of London, gained FDA approval for an investigational new drug application for the evaluation of TOP1630 ophthalmic solution as a treatment of patients with dry eye syndrome. The company said that it is on schedule to start a phase I/IIa proof-of-concept study in the U.S. in January 2017 to assess the candidate's safety and efficacy in patients with dry eye.