Arch Biopartners Inc., of Toronto, said the European Commission designated AB569 as an orphan medicinal product for the treatment of patients with cystic fibrosis (CF). AB569, which comprises sodium nitrite ethylenediaminetetraacetic acid, was developed to treat antibiotic-resistant bacterial infections, which is a significant problem in the lungs of most adult CF patients.

Biogen Inc., of Cambridge, Mass., said aducanumab, its investigational treatment for Alzheimer's disease was accepted into the EMA's PRIME (PRIority MEdicines) program, which aims to bring treatments to patients faster. Acceptance was based on results from the phase Ib trial testing the human recombinant monoclonal antibody in patients with prodomal or mild Alzheimer's. Through PRIME, Biogen will have access to enhanced support from the EMA, including its advice at key development milestones and the potential for accelerated assessment of a marketing authorization application. Aducanumab is in two phase III studies, ENGAGE and EMERGE, in people with early Alzheimer's disease. (See BioWorld Today, March 8, 2016.)

Bonesupport AB, of Lund, Sweden, said a paper published in Nature Scientific Reports covers a preclinical study, which demonstrated that Cerament loaded with a combination of recombinant human bone morphogenic protein 2 (rhBMP-2) plus zoledronic acid (ZA) in very low doses was able to quantitatively and qualitatively generate a higher amount of mineralized bone volume. The study also showed in vivo that the mineralized volume was significantly higher when Cerament was combined with rhBMP-2 and ZA (21.4±5.5mm³) as compared to Cerament in combination with just rhBMP-2 (10.9±2.1mm³).

Braeburn Pharmaceuticals Inc., of Princeton, N.J., said it plans to make Probuphine available to health care providers and patients this month, following FDA approval on May 26. The product is the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Patients can only receive the treatment from certified health care providers who have been specially trained to insert the implants just under the skin of the inside of the upper arm through an in-office procedure.

Chemconnection, of Oss, the Netherlands, is reporting the successful GMP production of Cripec docetaxel for its customer Cristal Therapeutics BV, of Maastricht, the Netherlands, a privately-held life sciences company developing nanomedicines against cancer and other diseases.

Chemocentryx Inc., of Mountain View, Calif., said it received priority medicines, or PRIME, designation from the EMA for its complement 5a receptor inhibitor, CCX168, in the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 was previously granted orphan drug status in Europe in granulomatosis with polyangiitis and microscopic polyangiitis, two primary forms of AAV. Chemocentryx signed a deal last month with Vifor Pharma Ltd., of Glattbrugg, Switzerland, for ex-U.S. commercial rights to CCX168 in orphan and rare renal diseases. (See BioWorld Today, May 11, 2016.)

Chugai Pharmaceutical Co. Ltd., of Tokyo, said it granted Roche AG, of Basel, Switzerland, an exclusive license to develop and market of SA237 globally outside Japan, South Korea and Taiwan. The humanized monoclonal antibody is designed to target the IL-6 receptor, using Chugai's antibody-recycling technology. Chugai will continue to manage product manufacturing and supply of SA237. The company is conducting two multinational, pivotal phase III studies of the candidate in patients with neuromyelitis optica, an autoimmune disease of the central nervous system characterized by inflammation of the optic nerve and spinal cord. Terms called for Chugai to receive an undisclosed up-front fee, milestone payments and product royalties.

Galena Biopharma Inc., of San Ramon, Calif., said the FDA designated Neuvax (nelipepimut-S), combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), for fast track development to treat patients with early stage, node-positive breast cancer with low to intermediate HER2 expression, or HER2 1+ or 2+, following standard of care. Galena's fully enrolled global phase III Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with Neuvax Treatment, or PRESENT, trial is evaluating Neuvax plus GM-CSF vs. placebo plus GM-CSF to prevent cancer recurrence. On Wednesday, the company's shares (NASDAQ:GALE) gained 35 cents, or 19.3 percent, in heavy trading to close at $2.16.

Geovax Labs Inc., of Atlanta, said testing of its Ebola vaccine in non-human primates showed complete protection against a lethal Ebola virus challenge. The vaccine was administered as a single inoculation (prime) or as two inoculations at four-week interval (prime-boost) to groups of four rhesus macaques each. A control group received the company's modified vaccinia Ankara, or MVA, vector without Ebola virus protein inserts. Four weeks after inoculation, animals in all three groups were exposed to a lethal dose of Ebola virus. Three of the four unvaccinated animals died within 12 days while all of the vaccinated animals survived. The vaccine is based on the company's MVA virus-like particle platform, which previously demonstrated safety in four trials of its HIV vaccine candidates.

Incyte Corp., of Wilmington, Del., and the Moffitt Cancer Center in Tampa, Fla., established a research support and collaboration agreement in which Incyte will provide undisclosed funding to conduct three Moffitt blood cancer research programs over a three-year period. The programs will focus on specific cancers, including myeloproliferative neoplasms, mantle cell lymphoma, diffuse large B-cell lymphoma and chronic myelomonocytic leukemia, with the goal of improving the understanding of the basic cancer biology and interrogating certain therapeutic hypotheses involving Incyte's small-molecule therapeutics, both as single agents and in combination.

Merus NV, of Utrecht, the Netherlands, signed a commercial multi-product license agreement for nonexclusive use of the Glymaxx antibody-dependent cell-mediated cytotoxicity (ADCC) enhancement technology developed by Probiogen AG, of Berlin. Merus will use the technology in its Biclonics pipeline of bispecific cancer antibodies, including MCLA-158, the first Glymaxx-modified ADCC-enhanced bispecific antibody that will be advanced under the commercial license. MCLA-158 is in development to treat colorectal cancer and other types of solid tumors. Financial terms were not disclosed.

Nanobio Corp., of Ann Arbor, Mich., is presenting preclinical data at the GTCbio 14th Vaccines Research & Development Conference in San Diego, demonstrating that its intramuscular nanoemulsion (NE) vaccination elicited robust antibody responses in mice. Data also confirmed that the NE is compatible with other intramuscular vaccine adjuvants, with combination studies showing significant synergy, particularly with respect to cell-mediated immunity. Nanobio is developing its NE adjuvant for use in intramuscular vaccines for pandemic influenza and other diseases. The primary research presented was conducted under a five-year contract from the National Institute of Allergy and Infectious Diseases.

Nektar Therapeutics Inc., of San Francisco, inked an agreement giving Daiichi Sankyo Europe, a unit of Daiichi Sankyo Co. Ltd., of Tokyo, exclusive rights to market Onzeald (etirinotecan pegol, formerly NKTR-102), in Europe, Switzerland and Turkey in return for an up-front payment of $20 million and $60 million in milestone payments linked to the achievement of European regulatory milestones and European sales of Onzeald. Nektar also is entitled to double-digit royalties on net product sales in Europe. Nektar retained rights to the candidate in the U.S. and the rest of the world. Although the phase III BEACON study of Onzeald in patients with advanced breast cancer missed its primary endpoint and failed to achieve statistical significance on the primary and secondary endpoints, Nektar plans to submit a marketing authorization application (MAA) to the EMA this month for conditional approval of the candidate to treat patients with advanced breast cancer and brain metastases. The Committee for Medicinal Products for Human Use previously granted accelerated assessment for the filing. Nektar retained responsibility for sponsoring and funding the confirmatory trial to support the MAA filing and the right to use the data for a potential U.S. new drug application for Onzeald. (See BioWorld Today, March 19, 2015.)

Oncovista Innovative Therapies Inc., of San Antonio, is "dormant," the company said on Wednesday. On April 29, both William Brock and Alexander Ruckdaschal submitted their resignation from the company's board. Consequently, the license rights of L-nucleoside conjugate OVI-117 will return to the licensor, San Antonio-based Lipitek International Inc. OVI-117 was the lead from a series of conjugates of L-nucleosides with cytotoxic drugs, which included OVI-110 and OVI-151 for the potential treatment of cancer, including solid tumors, according to Thomson Reuters Cortellis Clinical Trials Intelligence. In September 2015, the program was in phase I development for colon cancer.

Oncternal Therapeutics Inc. and Tokalas Inc. completed a merger to create a new San Diego-based clinical-stage oncology company. The transaction was approved by both companies' shareholders in a transaction of undisclosed value and results in the combination of all assets, R&D programs and operations under the Oncternal name. As a combined company, Oncternal will hold exclusive worldwide development and commercialization rights to two clinical-stage oncology candidates. Cirmtuzumab is a first-in-class anti-ROR1 monoclonal antibody, currently in a phase I trial for patients with relapsed or refractory chronic lymphocytic leukemia. TK216 is a first-in-class small-molecule ets-family transcription factor inhibitor, about to enter phase I testing for patients with Ewing sarcoma.

Proqr Therapeutics NV, of Leiden, the Netherlands, said QR-110 has received orphan drug status from both the FDA and the EMA for the treatment of Leber's congenital amaurosis Type 10 (LCA10), the most common cause of genetic blindness in childhood. The candidate is a first-in-class oligonucleotide, designed to address the underlying cause of LCA10 due to the p.Cys998X mutation.

Q Biomed Inc., of New York, said it has entered a definitive agreement to exclusively license an FDA-approved drug for the treatment of pain associated with metastatic bone cancer from a private U.S. company focused on the development of generic pharmaceuticals. Neither the drug nor the company were named. The parties hope to close the deal by the end of June. The company has also been conducting due diligence on several potential assets for other indications with the goal of expanding its pipeline. In addition, Q Biomed said that Mannin Research Inc., its technology partner company, has initiated preclinical lead candidate optimization for its drug development program, MAN-01 for treatment of primary open angle glaucoma.

Regen Biopharma Inc., of San Diego, said that it has been approved by OTC Markets Group Inc. to uplist its common and series A preferred shares to the OTCQB Venture Marketplace, where they now trade under the symbol RGBP.

Regenerx Biopharmaceuticals Inc., of Rockville, Md., and Hong Kong-based Lee's Pharmaceutical Holdings Ltd. said that they're accelerating the development of RGN-259 in China after a regulatory rules change allowing for drugs manufactured outside China to be used in phase I and phase II trials. "We welcome this regulatory change in China, which could be of significant benefit to Lee's Pharm and Regenerx, as China may eventually become one of the biggest markets in the world for RGN-259," said J.J. Finkelstein, Regenerx's president and CEO. RGN-259 is a T-beta-4-based ophthalmic drug candidate is being developed for dry eye syndrome and for the treatment of neurotrophic keratopathy.

Retrotope Inc., of Los Altos, Calif., gained FDA orphan status for its stabilized fatty acid drug, RT001, for the treatment of Friedreich's ataxia (FA). The designation follows the recent announcement that RT001 was well tolerated with no serious adverse events or dose limiting toxicities in the first cohort of its phase I/II trial in FA patients. RT001 is a chemically stabilized form of a natural fatty acid that confers resistance to lipid peroxidation in mitochondrial and cellular membranes via a novel mechanism.

Txcell SA, of Valbonne, France, said it inked an R&D collaboration with the Lübeck Institute of Experimental Dermatology (LIED), part of the University of Lübeck in Germany, covering the development of a CAR-Treg-based cellular immunotherapy for bullous pemphigoid, a rare, potentially fatal autoimmune disease characterized by tense inflammatory skin blisters. Txcell and LIED will conduct nonclinical pharmacology studies with CAR-Treg cells to prepare for a first-in-human trial. Financial terms were not disclosed, but Txcell retains all rights to existing and future programs developed under the agreement.

Viamet Pharmaceuticals Inc., of Research Triangle Park, N.C., said the FDA granted fast track designation for VT-1129, an orally available inhibitor of fungal CYP51, for the treatment of cryptococcal meningitis. The product previously received orphan and qualified infectious disease product designations from the FDA. Viamet is conducting a phase I trial of VT-1129 in healthy volunteers.

Xenetic Biosciences Inc., of Lexington, Mass., said that its board has approved a proportional 1-for-33 reduction and reverse stock split of its issued and outstanding common stock (OTCQB:XBIO) in preparation for its planned uplisting to the Nasdaq Capital Market. "We expect the Nasdaq listing will enable us to attract a broader range of investors and to increase share liquidity, critical elements that we expect will propel the company forward as we advance to our next stage of growth," said Xenetic's CEO Scott Maguire.