Astrazeneca plc, of London, and its R&D arm, Medimmune, and Moderna Therapeutics Inc., of Cambridge, Mass., are collaborating to discover, co-develop and co-commercialize messenger RNA (mRNA) therapeutic candidates for the treatment of a range of cancers. The collaboration is in addition to the agreement announced by the companies in 2013 to develop mRNA therapeutics for the treatment of cardiovascular, metabolic and renal diseases as well as selected targets in oncology. Under the terms of the new agreement, they will collaborate on two specific immuno-oncology programs, based on promising preclinical data, including pharmacology in tumor models. Moderna will fund and be responsible for discovery and preclinical development of product candidates, with the aim of delivering one investigational new drug application-ready molecule for each of the two programs. Moderna's efforts will be led by its oncology-focused venture, Onkaido. Astrazeneca will be responsible for early clinical development, led by Medimmune, and Moderna and Astrazeneca will share the costs of late-stage clinical development. The two companies will co-commercialize resulting products in the U.S. under a 50:50 profit sharing arrangement. Separately, Moderna announced that Kenilworth, N.J.-based Merck & Co. Inc. has licensed a vaccine program against an undisclosed viral target, including mRNA 1566 and a set of related novel vaccine candidates, as part of the ongoing collaboration between the companies to discover and develop vaccines and passive immunity treatments against viral diseases using modified messenger RNA (mRNA). As part of the initial three-year research agreement announced in January 2015, Merck made an up-front cash payment of $50 million and a $50 million equity investment to use granted licenses to commercialize five product candidates.

Astrazeneca plc, of London, and Incyte Corp., of Wilmington, Del., are collaborating to evaluate the efficacy and safety of Incyte's Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in combination with Astrazeneca's epidermal growth factor receptor (EGFR) inhibitor, Tagrisso (osimertinib). The combination will be assessed as a second-line treatment for patients with EGFR mutation-positive non-small-cell lung cancer who have been treated with a first-generation EGFR tyrosine kinase inhibitor and subsequently developed the T790M resistance mutation. Under terms of the agreement, a phase I/II study will be conducted by Incyte. This deal builds on an existing collaboration between the two companies, announced in May 2014, to explore Astrazeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab, in combination with Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor, epacadostat (INCB24360).

Caladrius Biosciences Inc., of Basking Ridge, N.J., said it inked an agreement with venture capital firm SPS Cardio LLC to out-license patent and commercialization rights to CD34 ischemic repair technology, which is Caladrius' CD34 cell therapy or CLBS10, for acute myocardial infarction (AMI) and chronic heart failure (CHF) outside the U.S. in select territories. SPS is funding further development in specific countries, and plans to hold a phase II proof-of-concept trial in India evaluating CD34 to prevent adverse events in those with heart failure. Under the terms, SPS gains exclusive license in AMI and CHF in India and other territories outside the U.S., including certain Asia Pacific and Latin American countries. The U.S., Europe, Japan, China and South Korea are all excluded. Caladrius holds the rights to access and use any clinical and nonclinical data generated in India. Financial terms were not disclosed.

Cure Duchenne Ventures LLC said it is investing in Bamboo Therapeutics Inc., of Chapel Hill, N.C., an early stage biotech that is developing gene therapies for orphan diseases, coming from research by Jude Samulski and Xiao Xiao at the University of North Carolina. The gene therapy uses an rAAV technology platform and aims to deliver a mini-dystrophin gene sequence to treat those with Duchenne muscular dystropy. Jak Knowles, managing director of Cure Duchenne, will join Bamboo's board. Financial terms were not disclosed.

Cytokinetics Inc., of South San Francisco, said it recently presented data from EMPOWER, a phase III trial of dexpramipexole in those with amyotrophic lateral sclerosis (ALS), at the sixth annual California ALS Research Summit in La Jolla, Calif. The objective of EMPOWER, one of the largest clinical trials held to study ALS, was to investigate the natural history of slow vital capacity (SVC) decline to find what demographic variables effect decline in SVC and determine how changes in SVC can predict other clinically meaningful events in the disease.

Debiopharm International SA, part of Debiopharm Group, of Lausanne, Switzerland, and Arbor Pharmaceuticals LLC, of Atlanta, said they have cemented an agreement to commercialize and promote Debiopharm's triptorelin 22.5 mg in the U.S. for central precocious puberty (CPP). Under terms of the deal, Arbor gains exclusive U.S. commercial rights for triptorelin 22.5 mg, an agonist analogue of the natural gonadotropin-releasing hormone. Following approval, triptorelin 22.5 mg will be available mainly to pediatricians and pediatric endocrinologists. No financial terms were disclosed.

Diffusion Pharmaceuticals LLC, of Charlottesville, Va., said it completed its merger with Restorgenex Corp., of Buffalo Grove, Ill. The new company will be called Diffusion Pharmaceuticals Inc. Diffusion plans to continue development of trans sodium crocetinate (TSC), which showed positive results in a phase II study in glioblastoma multiforme (GBM). The lead drug candidate was designated an orphan drug by the FDA to treat GBM, and the company plans to initiate a phase III trial in newly diagnosed GBM sometime this year. No financial terms were disclosed.

Emergent Biosolutions Inc., of Gaithersburg, Md., received a favorable private letter ruling from the IRS related to the planned spin-off of its biosciences business. Subject to its terms, the ruling confirms that certain aspects of the planned transaction, including those related to the qualification of the business as an active trade or business, will not preclude the spin-off from qualifying as tax-free to Emergent and its stockholders.

Epivax Inc., of Providence, R.I., announced the company's participation in a new, biosimilars venture, Aceno Biotherapeutics. Aceno will use advanced computational tools to actively develop a portfolio of biobetters that will be immune-engineered by Epivax. Aceno's approach combines Epivax' immunoinformatics design toolbox, its immune-modulating sequences (Tregitopes) and an advanced in silico molecular modeling platform to accelerate the process of optimizing biobetters.

Evofem Inc., of San Diego, met with representatives of the FDA in a pre-investigational new drug application meeting for its lead product, Amphora to be evaluated for the prevention of recurrence of bacterial vaginosis (BV). As a result of this meeting, Evofem will be developing a formal research protocol to begin clinical studies.

Exelixis Inc., of South San Francisco, submitted a marketing authorization application (MAA) to the EMA for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. The EMA's Committee for Medicinal Products for Human Use previously granted accelerated assessment to cabozantinib for advanced RCC. The MAA is based on results of METEOR, a phase III pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis announced top-line results from METEOR demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, cabozantinib was associated with a 42 percent reduction in the rate of disease progression or death. Cabozantinib is currently marketed in capsule form under the brand name Cometriq in the U.S. for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC.

Filament Biosolutions Inc., of New York, inked a broad partnership with Ajinomoto North America Inc., a subsidiary of Ajinomoto Co. Inc., of Tokyo, to develop and commercialize a portfolio of medical foods. Through the partnership, Filament has received financing from Ajinomoto, and will work closely with Ajinomoto's scientists and food technologists to assist in product development, as well as to identify future opportunities for additional medical food products. Filament has introduced two medical food product candidates into its portfolio, FB-2710 and FB-3100. Both candidates will incorporate Ajinomoto amino acids that will be formulated to address specific underlying nutritional deficiencies, resulting from a disease, in patients that are under the supervision of a physician. Financial terms were not revealed.

F-star Biotechnology Inc., of Cambridge, U.K., entered a collaboration and license agreement with Abbvie Inc., of North Chicago, to research and develop bispecific antibodies in immuno-oncology. Financial terms were not disclosed. F-star's Modular Antibody Technology platform introduces an antigen binding site into the constant region of an antibody to create a so-called Fcab (an Fc-domain with antigen binding activity). In a combinatorial plug & play process, an Fcab can then be used to make many different bispecific antibodies using variable regions binding to second targets. F-star and Abbvie will create Fcabs against two immuno-oncology targets and generate several mAb2 drug development candidates from these Fcabs.

Genvec Inc., of Gaithersburg, Md., reported that it was notified by partner Novartis AG that enrollment would be paused in a clinical trial of CGF166 to conduct a safety review of patient data, based on the recommendation of the trial's data safety monitoring board. Further details were not released. According to clinical trials.gov, the phase I study is intended evaluate CGF166 delivered through IL-infusion to improve hearing and vestibular function. CGF166 is a recombinant adenovirus 5 (Ad5) vector containing a cDNA encoding the human atonal transcription factor. The company's stock (NASDAQ:GNVC) fell 58.7 percent to close at 72 cents.

Hemoshear Therapeutic LLC, Charlottesville, Va., is initiating the next stage of a multi-year collaboration with Pfizer Inc., of New York. Hemoshear will leverage its discovery platform, Reveal-Tx, with the aim of developing a predictive model for preclinical drug-induced vascular injury (DIVI). Financial terms were not disclosed.

Juno Therapeutics Inc., of Seattle, has acquired Abvitro Inc., of Boston, giving Juno a single cell sequencing platform that will augment Juno's capabilities to create best-in-class engineered T cells against a broad array of cancer targets. Juno intends to relocate the Abvitro scientists to Seattle and incorporate this platform into its therapeutic discovery process. Financial terms were not revealed.

Lycera Corp., of New York, entered a license agreement with Celgene Corp., of Ann Arbor, Mich., in which Lycera granted to Celgene an exclusive license for Lycera's portfolio of ex vivo RORgamma agonist compounds. Lycera received a $17.5 million up-front cash payment and has the potential to receive an additional near-term milestone payment of $5 million.

Mimedx Group Inc., of Marietta, Ga., signed a deal to acquire Stability Inc., a provider of human tissue products to surgeons, facilities and distributors for an undisclosed sum.

Numedii Inc., of Palo Alto, Calif., formed a discovery collaboration with Astellas Pharma Inc., of Tokyo, to identify new indications for a number of undisclosed Astellas compounds using Numedii's predictive big data intelligence technology. Financial terms of the agreement were not disclosed.

Neuralstem Inc., of Germantown, Md., said research published in Stem Cells Translational Medicine showed that HK532-IGF-1 cells, the company's line of cortical neural stem cells engineered to express insulin-like growth factor-1, differentiated into a subtype of neurons (GABAergic) that are dysregulated in Alzheimer's disease and produced increased vascular endothelial growth factors in vitro. The cells also were found to increase neuroprotection, while not affecting normal cellular function. In a mouse model of Alzheimer's disease, the cells survived transplantation into the peri-hippocampus and exhibited long-term persistence in targeted brain areas. Researchers concluded that HK532-IGF-1 cells should be further studied as a possible disease-modifying Alzheimer's intervention.

Oxis International Inc., of Paris, said it reached an agreement to restructure unregistered debt and equity securities that will eliminate more than 12 million warrants, $14.8 million of notes and all series H and I preferred shares. The company said the move is intended to put it in sound financial shape to continue its phase I/II FDA trial of OXS-1550 in non-Hodgkin lymphoma and leukemia and is a step in getting the company's stock approved for a listing on Nasdaq.

Pfizer Inc., of New York, said it expanded its R&D investment strategy to include early stage companies by providing them with both equity and access to resources for research in promising areas aligned with Pfizer's core interests. The first four investments are: Bioatla LLC, of San Diego, which is developing conditionally active biologics; Nextcure Inc., of Germantown, Md., which is developing immuno-oncology drugs; Cortexyme Inc., of Stanford, Calif., which is working on treatments for neurodegenerative disease; and 4D Molecular Therapeutics Inc., of Emeryville, Calif., which is developing its Therapeutic Vector Evolution platform.

Sellas Life Sciences Group, of Zug, Switzerland, said the FDA granted orphan status to its WT1 cancer vaccine for the treatment of patients with acute myeloid leukemia (AML). Sellas plans to start a pivotal phase III trial in AML early this year.

Sorrento Therapeutics Inc., of San Diego, said it formed an exclusive partnership with Karolinska Institutet in Stockholm to perform immuno-oncology research and develop new natural killer (NK) cell-based therapies. Under the agreement, Sorrento will sponsor preclinical and clinical R&D programs focused on NK biology as well as adoptive NK cell therapies and, in return, obtain full rights to the resulting discoveries and developments. The research will be performed at Karolinska, but there will also be an active research exchange with Sorrento R&D in San Diego. A joint steering committee with members from both will guide the program activities. Financial terms were not disclosed.

Sucampo Pharmaceuticals Inc., of Rockville, Md., said it inked an option and collaboration agreement under which Cancer Prevention Pharmaceuticals Inc. (CPP), of Tucson, Ariz., has granted Sucampo the sole option to acquire an exclusive license to commercialize CPP-1X/sulindac combination product in North America. The compound is currently in a phase III trial for the treatment of familial adenomatous polyposis. Under the terms, Sucampo will invest $5 million in CPP in the form of a convertible note, with a planned additional $5 million equity investment in CPP's next qualified financing, which will be either an IPO or a private financing as defined by the agreement. In addition, Sucampo will pay CPP an option fee of up to $7.5 million, payable in two tranches. CPP will complete the ongoing phase III trial under the oversight of a joint steering committee, and, upon exercise of its exclusive option, Sucampo would acquire an exclusive license to the product and would be obligated to pay CPP up to an aggregate of $190 million in license fees and milestone payments upon the achievement of specified clinical development and sales milestones. Under the license terms, Sucampo and CPP would share equally in profits from the sale of approved products.

Synpromics Ltd., of Edinburgh, Scotland, and the Cell Therapy Catapult, a U.K.-based organization seeking to accelerate the growth of the U.K. cell and gene therapy industry, launched a collaboration to remove what they said was a major barrier to the development of that industry by reducing the cost and increasing the scale and efficiency of viral vector manufacturing. The collaboration will use Synpromics' synthetic promoter design technology, and Cell Therapy Catapult's manufacturing platform to create stable producer cell lines for the high titre and large scale manufacture of viral vectors. The work will be part funded by a £2 million (US$2.9 million) grant from Innovate UK, the U.K.'s innovation agency. The project will run for three years, and will be focused on developing prototype cell lines to deliver industry relevant viral vectors, including retrovirus, and adeno associated virus. Synpromics will be responsible for the expression platform development with the Cell Therapy Catapult responsible for process industrialization and control.

Tetragenetics Inc., of Arlington, Mass., received a grant of about $1.5 million from the National Institute of General Medical Sciences. The grant, to be awarded over two years, will help establish a public-private partnership between Tetragenetics and the Tetrahymena Stock Center at Cornell University to provide recombinant protein expression services to the not-for-profit research community. It will also support work that will expand the capabilities of Tetragenetics' Tetraexpress protein production platform, the company said.

Tiziana Life Sciences plc, of London, said it plans to develop foralumab, a fully human anti-CD3 antibody in two indications: graft vs host disease and ulcerative colitis. In addition, the company will add two new professors to its scientific advisory board, Kevan Herold of Yale University and Howard Weiner, of Harvard University.

Valneva SE, of Lyon, France, reported that Taiwan-based Adimmune Corp. has secured marketing approval from the Taiwanese Food & Drug Administration for Valneva's Japanese encephalitis vaccine . The product is expected to be marketed in Taiwan under the trade name Jeval. The approval follows the agreement signed in 2014 between Valneva and Adimmune granting Adimmune the right to commercialize Jeval in Taiwan, including the right to locally fill and pack it. Adimmune intends to establish a local fill-and-finish of the vaccine within the next two years, according to a statement.