Abcellera Biologics Inc., of Vancouver, British Columbia, plans to apply its monoclonal antibody screening platform in a collaboration with Pfizer Inc., of New York, to discover function-modulating antibodies against undisclosed membrane protein targets. Abcellera is set to receive an undisclosed, up-front payment and research support and is eligible for up to approximately $90 million in milestone payments as well as tiered mid-to-low single-digit royalty payments based on development and commercialization of antibodies generated during the collaboration. Additional terms were not disclosed.

Adocia SAS, of Lyon, France, said it launched two new projects using its Biochaperone technology: the combination of insulin lispro with pramlintide (Smylin, Astrazeneca plc) and the combination of insulin lispro with GLP-1 receptor agonist exenatide (Byetta, Astrazeneca plc). Adocia plans to advance one of those compounds to the clinic in the fourth quarter of this year.

Alexion Pharmaceuticals Inc., of New Haven, Conn., filed its Form 10-Q for the quarter ending Sept. 30, 2016, with the SEC. The company delayed the filing while conducting an internal investigation of allegations by a former employee concerning certain sales practices related to Soliris (eculizumab). The company concluded that its previously issued financial results do not require restatement, adding that no instances of improper revenue recognition associated with pull-in sales were identified, all Soliris orders were valid and placed by customers to fulfill actual needs and no instances were identified where Soliris was sold to build stock of unwanted product. However, Alexion identified material weakness in its internal controls over financial reporting as of Dec. 31, 2015, and subsequent quarters. In particular, the investigation concluded that certain revenue pulled from the first quarter of 2016 into the fourth quarter of 2015, representing less than 1 percent of 2015 revenue, involved inappropriate business conduct, including violations of company policies and procedures. Alexion said it initiated remedial actions to strengthen internal controls, including expanded training programs and new processes related to financial reporting, controls and compliance. This month, the company plans to file an amended Form 10-K for the fiscal year ending Dec. 31, 2015, to reflect that its disclosure controls and procedures were not effective as of that date and that a material weakness occurred. Alexion said 2016 revenues are expected to fall within the previously guided range of $3.05 billion to $3.10 billion. (See BioWorld Today, Oct. 28, 2016.)

Ambrx Inc., of San Diego, and Mabspace Biosciences Co. Ltd., of Suzhou, China, said they agreed to collaborate on discovery and development of multiple antibody-drug conjugates (ADCs) in China and around the world for oncology. Mabspace will employ its immune tolerance breaking technology to generate and identify humanized antibodies suitable for ADC development, and Ambrx will employ its Eucode-based site-specific conjugation technology to develop lead ADC molecules. The parties will jointly develop and share the cost and rights of the resulting ADC products.

Amunix Operating Inc., of Mountain View, Calif., said Biogen Inc., of Cambridge, Mass., exercised its option to enter an exclusive, worldwide license agreement to develop and commercialize a recombinant factor IX product candidate that incorporates Amunix's XTEN technology to provide extended half-life. The agreement is part of Biogen's hemophilia business, which is expected to launch as Bioverativ on Feb. 1, as an independent, public company. Under the terms, Amunix will get a $1.25 million up-front payment and will be eligible to receive up to $17.25 million in clinical and commercial milestone payments, plus royalties on commercial sales from products incorporating Amunix's technology.

Auspherix Ltd., of Stevenage, U.K., said preliminary data suggested that its organogold small molecules, which previously demonstrated potent and broad-spectrum activity against gram-positive and gram-negative bacteria, showed a low propensity for the emergence of resistance. The company is on track to advance a development candidate from one of three lead series into human studies by early 2019, with an initial focus on treating complicated urinary tract infections.

Boehringer Ingelheim Pharmaceuticals Inc., a unit of Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said the FDA approved supplemental new drug applications for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) to include data from the EMPA-REG OUTCOME trial. The study concluded that empagliflozin reduced the risk for cardiovascular death compared with placebo when added to standard-of-care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. The medications are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. (See BioWorld Today, June 27, 2016.)

Catabasis Pharmaceuticals Inc., of Cambridge, Mass., said preclinical data on CAT-5571, its activator of autophagy designed to treat cystic fibrosis (CF), were published in the Journal of Medicinal Chemistry. The data suggested that CAT-5571, in combination with standard-of-care therapy, increased the cell surface expression and function of the CF transmembrane conductance regulator (CFTR) in bronchial epithelial cells isolated from multiple CF patients with the F508del mutation. In late 2017 or early 2018, Catabasis expects to initiate a phase I trial of CAT-5571, which comprises cysteamine covalently conjugated to docosahexaenoic acid using the company's SMART linker drug discovery platform, for the potential treatment of CF.

Cymabay Therapeutics Inc., of Newark, Calif., said it has concluded its scientific advice discussions with the EMA on the phase III development program for arhalofenate for gout. Similar to what the company agreed with the FDA last year, the European program will include two pivotal studies of arhalofenate in combination with febuxostat (40 mg) in patients with chronic gout and a third study in combination with febuxostat (80 mg) in subjects with tophaceous gout, a more advanced form of the disease. The trials will asses serum uric acid lowering responder rates for patients achieving the targets of <6 and <5 mg/dL for chronic and tophaceous gout, respectively.

Dynavax Technologies Corp., of Berkeley, Calif., said it is restructuring operations to prioritize its clinical and preclinical immuno-oncology portfolio. Its lead candidate, SD-101, a cancer immunotherapeutic, is being studied in several phase I/II studies evaluating its potential against multiple solid tumors and hematologic malignancies. SD-101, an intratumoral TLR9 agonist, has shown encouraging early clinical data in metastatic melanoma. Meanwhile, the company suspended manufacturing for Heplisav-B and reduced its global workforce by 38 percent. It will incur restructuring costs, currently estimated to be $3 million, primarily in the first quarter of 2017. The company estimates that its cash, cash equivalents and marketable securities were about $81.4 million as of Dec. 31. Going forward, it expects Heplisav-B costs prior to any FDA decision to be less than $1 million per month, and all other operating costs to be less than $60 million per year to support continued development of its oncology program. Dynavax said it continues to believe that Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]), is an approvable product and plans to submit its response to the FDA's outstanding questions shortly. (See BioWorld Today, Nov. 15, 2016.)

Eisai Inc., a unit of Eisai Co. Ltd., of Tokyo, said it reached an agreement with Arena Pharmaceuticals Inc., of San Diego, to revise its marketing and supply agreement for the chronic weight management treatment, Belviq/Belviq XR (lorcaserin hydrochloride), by acquiring full rights to develop and market the drug. Eisai gained sole responsibility for global development and regulatory submissions as well as global marketing for lorcaserin. Arena remains eligible to earn $26 million in potential and regulatory milestones, including $25 million upon global net sales reaching $250 million in any 12-month period and $1 million for approval in Brazil. Other unearned purchase price adjustments and clinical and commercial milestones were eliminated, and a planned technology transfer will enable Eisai to participate in the manufacture of lorcaserin. Eisai will also assume Arena's exclusive distribution agreements with third parties to develop and market lorcaserin in South Korea, Taiwan and Israel and will serve as exclusive supplier. In separate news, its Eisai GmbH unit reported that the German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report recognizing an additional benefit generated by the administration of Kisplyx (lenvatinib) in combination with everolimus for the treatment of advanced renal cell carcinoma vs. the established comparator therapy. The final decision to implement the report's recommendation lies with the German Federal Joint Committee and is expected for March 2017. (See BioWorld Today, Nov. 11, 2013.)

Fibrocell Science Inc., of Exton, Pa., said the FDA granted fast track status to FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin disease for which no FDA-approved therapies exist. The candidate previously received FDA orphan status for the treatment of dystrophic epidermolysis bullosa, which includes RDEB, and a rare pediatric disease designation by the FDA for treatment of RDEB. Fibrocell is developing FCX-007 in collaboration with Intrexon Corp., of Germantown, Md.

Five Prime Therapeutics Inc., of South San Francisco, said Bristol-Myers Squibb Co. (BMS), of New York, exercised its option to extend the research term of its collaboration to discover, develop and commercialize immuno-oncology therapies directed toward targets in three undisclosed immune checkpoint pathways. BMS, which has advanced the first antibody from the collaboration to investigational new drug-enabling studies, will provide additional funding for a 12-month extension of the research term, to March 2018. (See BioWorld Today, Nov. 25, 2014.)

Genvec Inc., of Gaithersburg, Md., entered an exclusive option agreement with Washington University in St. Louis to license intellectual property and technology related to gene editing and pulmonary endothelial cell targeting. If the option is exercised, the license will allow broad utilization of technology developed by David Curiel, a professor of radiation oncology, and Jeffrey Arbeit, a professor of surgery, at Washington University School of Medicine. Genvec plans to initially focus on research utilizing the technology to develop treatments for hemophilia. Financial terms were not disclosed.

Iljin SNT Co. Ltd., of Seoul, South Korea, completed its acquisition of 1.33 million units of Vancouver, British Columbia-based Aurinia Pharmaceuticals Inc. at $2.25 per unit. Each unit comprises one common share in the capital of Aurinia and one half of one common share purchase warrant.

Imperial Innovations Group plc, of London, changed its name to Touchstone Innovations plc. The group invests in opportunities from the University of Oxford, the University of Cambridge and University College London as well as Imperial College London.

Iterum Therapeutics Ltd., of Dublin, said its first product candidate, sulopenem, an oral penem antibiotic, is under development for the treatment of multidrug-resistant infections. The candidate was licensed from New York-based Pfizer Inc. in late 2015. Under Iterum's agreement with the company, Pfizer received an initial equity interest and an up-front cash payment. It is also eligible to receive additional equity, development and commercial event-driven cash milestone payments and royalties based upon global net sales of any potential sulopenem products.

Kalobios Pharmaceuticals Inc., of Brisbane, Calif., reported guidance from a recent meeting with the FDA to discuss development plans for antiparasitic compound benznidazole for the treatment of Chagas disease, a neglected tropical disease. The FDA confirmed the company's proposed 505(b)(2) approach to demonstrate safety and efficacy using some data drawn from previously conducted studies and, if approved as a treatment for Chagas, benznidazole is expected to be eligible for a priority review voucher.

M2gen, of Tampa, Fla., said Merck & Co. Inc., of Kenilworth, N.J., joined its Oncology Research Information Exchange Network Avatar research program. Launched in April of 2016, the program fosters collaboration among stakeholders in cancer research, including patients, with the shared goal of discovering and developing therapies and ultimately matching patients to the best treatment options.

Melinta Therapeutics Inc., of New Haven, Conn., said the FDA accepted the company's NDAs for intravenous and oral Baxdela (delafloxacin) for filing and granted priority review status to both. Baxdela is a fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus. Melinta submitted NDAs for Baxdela in October for the treatment of patients with acute bacterial skin and skin structure infections.

Merus NV, of Utrecht, the Netherlands, and the Institute for Research in Biomedicine Barcelona, a research center devoted to understanding fundamental questions about human health and disease, entered a research collaboration to jointly develop agents that target the tumor microenvironment. The research collaboration will combine Merus' Biclonics technology platform for the discovery and development of therapeutic bispecific antibodies and the institute's cell and animal models to evaluate therapeutic targeting of stromal cells that support tumor growth and metastasis, the company said.

Neovacs SA, of Paris, disclosed a collaboration with the Sunnybrook Research Institute for preclinical development of Neovacs' VEGF Kinoid, specifically to obtain the proof of concept for the treatment of colorectal and ovarian cancers. The Neovacs technology presents a new therapeutic opportunity for those types of cancers where the VEGF-A (vascular endothelial growth factor-A) protein plays an important role in the vascularization of the tumor, the company said. Based on active immunotherapy, the approach aims to enhance the immune system of the patient by enabling it to produce self-polyclonal antibodies, which will selectively target and neutralize the cytokine VEGF-A.

Organogenesis Inc., of Canton, Mass., said its FDA-approved bioengineered living cell therapy, Apligraf, became the first wound-healing therapy to show significant change in the genomic profile of a treated nonhealing wound. An analysis from a multidisciplinary research team found that the application of Apligraf in conjunction with compression therapy altered specific molecular and cellular responses in the wound environment when applied to a chronic venous leg ulcer, converting the chronic wound profile to resemble an acute, healing wound profile. The findings were published in Science Translational Medicine.

Paxvax Inc., of Redwood City, Calif., disclosed a partnership with the NIH and the U.S. Department of Defense on its chikungunya vaccine program. According to the terms of the collaboration, Paxvax has in-licensed the NIH virus-like particle vaccine technology for chikungunya with plans to bring the vaccine through full commercialization. The NIH has already completed a phase I trial and is currently assessing the vaccine in a phase II trial. In addition to conducting its own trials, Paxvax will work with the Walter Reed Army Institute of Research to conduct an additional trial to assess the potential advantages of an alum adjuvant in the vaccine formulation.

Pixarbio Corp., of Cambridge, Mass., sold to Henry Sargent all of the membership interests in Buddhi Mat LLC, the company's wholly owned subsidiary. Sargent agreed, as part of the transaction, to assume all of the debts of Buddhi as of Friday, Dec. 30, 2016, and to indemnify Pixarbio with respect to any, and all, debts, liabilities and/or obligations of Buddhi as of the closing. Terms were not disclosed.

Prometic Life Sciences Inc., of Laval, Quebec, amended its licensing agreement with Hematech Biotherapeutics Inc., of Taipei, Taiwan, in May 2012, and has reacquired the rights initially granted to Hematech to a 50 percent share of the worldwide profits related to plasminogen congenital deficiency sales. The parties had originally entered two separate agreements: the licensing agreement and a further agreement that provided Hematech with the manufacturing rights to supply Prometic with additional plasma-derived biopharmaceuticals on a contract manufacturing basis. Since 2012, Prometic has secured manufacturing capacity.

Promis Neurosciences Inc., of Toronto, said PMN 310, a monoclonal antibody, has been designated its first lead product for development in Alzheimer's disease (AD). The company said it has demonstrated that its candidates display the optimal target profile of selectively binding prion-like forms of amyloid beta in AD and inhibiting both their propagation and neurotoxicity in laboratory tests in vitro.

Redhill Biopharma Ltd., of Tel-Aviv, Israel, signed a collaboration agreement with the Department of Molecular Biology and Genetics of Denmark-based Aarhus University for the evaluation of Redhill's phase II-stage oncology drug candidate, Mesupron (upamostat), described as an orally administered protease inhibitor with several potential mechanisms of action to inhibit tumor invasion and metastasis. Terms were not disclosed.

Rondinx Inc., of Tel-Aviv, Israel, unveiled its approach to discovering how changes in the human microbiome affect health and disease. The firm's cloud-based technology platform is designed to profile and predict microbial growth dynamics from single metagenomic samples. The scientific foundation was established at the Weizmann Institute of Science and exclusively licensed to Rondinx.

Soligenix Inc., of Princeton, N.J., received positive scientific advice from the EMA for the development of SGX942 (dusquetide) to treat oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. The advice indicates that a single, double-blind, placebo-controlled, multinational, phase III pivotal study (IDR-OM-02), if successful, in conjunction with the phase II dose-ranging study, IDR-OM-01, will be sufficient to support a marketing authorization application. Dusquetide (the active ingredient in SGX942) is an innate defense regulator. It modulates the body's reaction to both injury and infection toward an anti-inflammatory and an anti-infective response. In a phase II study in 111 patients with oral mucositis due to chemoradiation therapy for head and neck cancer, SGX942 decreased the duration of severe oral mucositis by 50 percent overall compared to the placebo group, from 18 days to nine days.

Tot Biopharma Co. Ltd., of Suzhou, China, and Lee's Pharmaceutical Holdings Ltd., of Hong Kong, said Lee's, through its wholly owned subsidiary Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd., acquired the exclusive license of TAB014, a monoclonal antibody developed and manufactured by Tot in China. TAB014 can be used to treat wet age-related macular degeneration and other eye diseases. Lee's will get exclusive rights to carry out the clinical and commercial development of TAB014 in China (including mainland China, Hong Kong and Macau), and make the up-front payment, milestone payment and after-launch sales commission to Tot. Lee's will also pay the costs incurred during the processes of clinical development, regulatory submission and product commercialization in the licensed territory. An IND application of TAB014 has been submitted to CFDA.

Trethera Corp., of Santa Monica, Calif., and Nanotherapeutics Inc., of Alachua, Fla., signed an exclusive worldwide agreement whereby Nanotherapeutics granted Trethera an exclusive license for the global development, manufacturing and marketing of Triapine (3-AP) and all formulations, for the treatment of hematological malignancies. Triapine is a clinical-stage, small-molecule inhibitor of ribonucleotide reductase, a key enzyme in the de novo pathway of nucleotide biosynthesis. Trethera has advanced preclinical development of small-molecule inhibitors of deoxycytidine kinase (dCK), the rate-limiting enzyme in the salvage pathway of nucleotide biosynthesis. Results of its preclinical studies indicate robust and durable antileukemic activity of its dCK inhibitors when combined with inhibitors of RNR, and those combinations have demonstrated superior activity over single-agent treatments. Trethera plans to start a phase I trial in the second half of 2017.

Ultragenyx Pharmaceutical Inc., of Novato, Calif., and Kyowa Kirin International plc, of London, a wholly owned subsidiary of Kyowa Hakko Kirin Co. Ltd., said the EMA accepted for review the marketing authorization application for KRN23 to treat X-linked hypophosphatemia (XLH). Ultragenyx and Kyowa Hakko Kirin entered a collaboration and license agreement in August 2013 to develop and commercialize KRN23, a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Hakko Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23). It is being developed to treat XLH and tumor-induced osteomalacia, diseases characterized by excess activity of FGF23. A phase III program studying KRN23 in adults and phase II and phase III studies in pediatric patients with XLH are ongoing.

XTL Biopharmaceuticals Ltd., of Raanana, Israel, said it will pursue Sjögren's syndrome as the second indication for its lead drug candidate, hCDR1, also known as edratide. Currently in development for the treatment of systemic lupus erythematosus (SLE), hCDR1 has been tested in more than 400 patients and is set to enter a global phase II trial for SLE. hCDR1 has a favorable safety profile, is well-tolerated by patients and has demonstrated efficacy in at least one clinically meaningful endpoint, the company said.

Zymeworks Inc., of Vancouver, British Columbia, achieved a research milestone in a second immune-modulating bispecific antibody in its collaboration with Eli Lilly and Co., of Indianapolis, using Zymeworks' Azymetric platform. Zymeworks will receive an undisclosed milestone payment from Lilly. Zymeworks granted Lilly a worldwide, royalty-bearing license to research, develop and commercialize certain bispecific therapeutic candidates toward Lilly's therapeutic targets. For that program, Zymeworks is eligible to receive further milestone payments as well as tiered royalties on product sales. The Azymetric platform consists of a library of amino acid substitutions that enable the transformation of monospecific antibodies into bispecific antibodies, which gives them the ability to simultaneously bind two non-overlapping epitopes, or antigens. Azymetric bispecific technology enables the development of biotherapeutics with dual-targeting of receptors/ligands and simultaneous blockade of multiple signaling pathways, increasing tumor-specific targeting and efficacy while reducing toxicities and the potential for drug-resistance. (See BioWorld Today, Oct. 24, 2014.)