Abbvie Inc., of North Chicago, said the EMA’s Committee for Medicinal Products for Human Use granted a positive opinion for anti-TNF-alpha drug Humira (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS) in adolescents, 12 and older, with an inadequate response to conventional systemic therapy. Humira was approved by the European Commission for adults with moderate to severe HS, an inflammatory skin disease, in July.
Acticor Biotech SAS, of Paris, and Mediolanum Farmaceutici SpA, of Milan, Italy, said they entered a research collaboration for Acticor’s ACT-017, a humanized antibody fragment. Under the terms, Mediolanum will co-finance research and development of ACT-017, currently in preclinical development as a potential next-generation antithrombotic treatment for acute ischemic stroke. Acticor received an undisclosed nonrefundable lump sum payment for the preclinical development of ACT-017 and is eligible for additional payments to launch clinical development phases I and II. Mediolanum will co-own the results of the collaboration and will acquire marketing rights over two main European countries. Specific terms were not disclosed.
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said pursuant to a global alliance inked in January 2014, Paris-based Sanofi SA’s Genzyme unit elected to opt in to co-develop and co-commercialize fitusiran, an RNAi therapeutic for the treatment of hemophilia and rare bleeding disorders (RBD), in the U.S., Canada and Western Europe. That expanded right is in addition to Sanofi’s previously exercised opt-in decision to develop and commercialize fitusiran in their rest of world territories. The decision was based on recent promising interim clinical results from a phase I study of fitusiran presented in late July and additional data that will be presented at the American Society of Hematology meeting in San Diego in December. Under the terms, certain development and sales and marketing costs for fitusiran will be shared 50/50 between Sanofi Genzyme and Alnylam. In addition, Sanofi Genzyme will be required to make payments totaling up to $75 million upon the achievement of development and regulatory milestones for fitusiran. Upon the initiation of the first global phase III trial for fitusiran, expected to start next year, Alnylam will earn a milestone payment of $25 million. Sanofi Genzyme also will be required to pay tiered double-digit royalties up to 20 percent on annual fitusiran net sales in its territory. The companies will share profits equally in the co-commercialization territory, where Alnylam expects to book product sales. (See BioWorld Today, Jan. 14, 2014.)
Amgen Inc., of Thousand Oaks, Calif., said the European Commission granted marketing authorization for Parsabiv (etelcalcetide), an intravenously administered calcimimetic agent, for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis. Approval was based on three phase III trials, all of which met their primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study with cinacalcet.
Ampliphi Biosciences Corp., of San Diego, said it settled its pending lawsuit with NRM VII Holdings I LLC relating to a complaint filed by NRM against the company and its board following the automatic conversion of NRM’s series B convertible preferred stock into common shares of Ampliphi stock in April. Under the terms of the settlement, NRM agreed to dismiss with prejudice the lawsuit, and Ampliphi’s insurance carrier will make a cash payment of $2 million to NRM.
Anavex Life Sciences Corp., of New York, presented preclinical data at the Society for Neuroscience meeting in San Diego, showing ANAVEX 1066, its mixed sigma-1/sigma2 receptor ligand, demonstrated efficacy in neuropathic pain and visceral pain in rat models. In the chronic constriction injury model of neuropathic pain, a single oral administration of ANAVEX 1066 dose-dependently restored the nociceptive threshold in the affected paw to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant for two hours. In a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent directly into the colon, and a single oral administration of ANAVEX 1066 returned the nociceptive threshold to control levels in a dose-dependent manner. Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit with ANAVEX 1066 and a favorable safety profile in a battery of behavioral measures.
Armo Biosciences Inc., of Redwood City, Calif., said the FDA granted the company’s lead immuno-oncology drug AM0010 (pegylated interleukin-10) orphan designation for pancreatic cancer. The agency also granted fast track designation for AM0010 in combination with FOLFOX as a second-line therapy in patients with advanced metastatic pancreatic cancer. The drug is in phase I testing in patients with advanced solid malignancies, as a single agent, in combination with standard-of-care chemotherapy or in combination with anti-PD-1 antibodies. Armo plans to initiate a pivotal phase III trial by the end of 2016, using AM0010 in combination with FOLFOX as a second-line therapy in patients with advanced metastatic pancreatic cancer.
Aslan Pharmaceuticals Pte Ltd., of Singapore, and JHL Biotech Inc., of Taiwan, said they signed a manufacturing services partnership under which JHL will provide process development services to Aslan for the continued development of its ASLAN004 program. Under the terms, Aslan will work with JHL to perform process development and manufacturing of ASLAN004, a fully human monoclonal antibody that blocks the signaling of the IL-4 and IL-13 receptors, for the manufacture of ASLAN004 for clinical trials. Terms were not disclosed.
Celldex Therapeutics Inc., of Hampton, N.J., presented preclinical data at the Society for Immunotherapy of Cancer meeting in National Harbor, Md., showing that CDX-1140, a fully human antibody targeted to CD40, demonstrated potent agonist activity to CD40, a key activator of the immune response. Findings showed that CDX-1140 binds with CD40 with high affinity and specificity and does not block CD40 ligand binding. It also demonstrated direct antitumor activity in immune-deficient mice challenged with human lymphomas. Pharmacological activity was observed in vivo, with minimal toxicity. Celldex is working on IND-enabling studies to support phase I dose-escalation trials.
Contrafect Corp., of Yonkers, N.Y., said it entered a three-year collaboration with Rockefeller University to identify new lysine therapeutic candidates targeting gram-negative bacteria. The agreement renews and expands the existing collaboration between two and will focus on gram-negative pathogens such as Pseudomonas aeruginosa, Escherichia coli and Klebsiella, including antibiotic-resistant strains.
Erytech Pharma SA, of Lyon, France, withdrew its MAA for Graspa for the treatment of acute lymphoblastic leukemia (ALL) but will resubmit in mid-2017. The company determined that the time allowed in the CHMP procedure was not sufficient to provide the additional data requested in the CHMP’s day 180 list of outstanding issues (LOI). The company intends to resubmit an MAA around mid-2017. Erytech received the day 180 LOI in September 2016 and has been in discussion with the rapporteur/co-rapporteur and the CHMP to provide the requested additional data regarding the comparability between the old and new form of asparaginase encapsulated in Graspa and the development of a new immunogenicity assay, as well as the pharmacodynamics effects of eryaspase. Generation of the additional data will require more time than allowed in the CHMP’s approval procedures.
Heat Biologics Inc., of Durham, N.C., presented preclinical data at the Society for Immunotherapy of Cancer meeting in National Harbor, Md., from its Compact platform, a single product that combines its Impact therapeutic vaccine with an immune co-stimulatory molecule. Researchers assessed Compact/OX40L in a third colorectal cancer mouse model, showing it amplified antigen-specific CD8-positive T cells and memory precursor effector cells. It also blocked tumor growth and increased tumor rejection and animal survival, generating better results than an OX40 antibody, without the broad systemic inflammation seen with OX40 antibody therapy. Further data showed Compact/OX40L, teamed with PD-1 or PD-L1-blocking antibodies, produced greater antitumor immunity than either compound alone.
Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved the use of Stelara (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease who have not had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha antagonist or have medical contraindications to such therapies. Stelara, which is designed to target interleukin (IL)-12 and IL-23 cytokines, gained U.S. approval in that indication in September.
Lannett Co. Inc., of Philadelphia, said it received FDA approval for its ANDA for memantine hydrochloride tablets USP 5 mg and 10 mg, as a therapeutic equivalent to reference drug Namenda (Forest Laboratories LLC) for the treatment of moderate to severe dementia.
Nanobiotix SA, of Paris, presented preclinical data demonstrating that its radioenhancer nanoparticle, NBTXR3, actively stimulates the host immune system to attack tumor cells. Those data from the ongoing NBTXR3 immuno-oncology program were presented at the Society for Immunotherapy of Cancer meeting in National Harbor, Md. Results showed that radiotherapy with NBTXR3 elicits a marked enhancement of immunogenic cell death compared to radiotherapy alone across different cancer cell lines, in radioresistant or radiosensitive models. Data from a second experiment in which two tumors were implanted on both sides of mice – with one tumor subsequently treated – showed that both tumors demonstrated volume shrinkage, with the use of NBTXR3 in combination with radiotherapy resulting in a control on the untreated tumor and a statistically significant increase of overall survival.
The Supreme Court of Denmark upheld the Eastern High Court’s decision in a case charging Neurosearch AS, of Hellerup, with market manipulation in violation of the Danish Securities Trading Act and the Market Abuse Regulation. The company has been fined DKK5 million (US$720,356). The charges were related to Neurosearch’s release of top-line phase III data on Huntexil. Trading was suspended Monday on Nasdaq Copenhagen market, prior to the announcement of the verdict.
Novo Nordisk AS, of Bagsværd, Denmark, said it has extended the Changing Diabetes in Children program by four years. The effort provides access to diabetes treatment and insulin to children with type 1 diabetes in developing countries. The expansion adds Cambodia, Ivory Coast, Myanmar, Senegal and Sudan. The company said that by 2020 more than 20,000 children will have benefitted, according to its estimations. The program began in 2009.
Novartis AG, of Basel, Switzerland, said the FDA granted priority review to the PKC412 (midostaurin) new drug application for the treatment of acute myeloid leukemia (AML) in newly diagnosed adults with a FLT3 mutation, as well as for the treatment of advanced systemic mastocytosis. The premarket approval application for the PKC412 FLT3 companion diagnostic, developed in collaboration with Invivoscribe Technologies Inc., also was accepted for review by the FDA. Outside the U.S., the marketing authorization application for PKC412 (midostaurin) in those indications has already been accepted by the EMA.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., said positive data of its phosphatidylserine (PS)-targeting antibodies from multiple preclinical research were presented to the Society for Immunotherapy of Cancer 2016 Annual Meeting, held recently in National Harbor, Md. The data showed that PS-targeting antibodies similar to bavituximab synergized with checkpoint inhibitors and radiation improving anti-tumor activity in animal melanoma models. The company conducted the research in collaboration with Memorial Sloan Kettering Cancer Center.
Pfizer Inc., of New York, said it entered a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), under which the firm will collaborate with NCI’s Center for Cancer Research to arrange and conduct preclinical and clinical trials to evaluate three investigational immunotherapy agents. Those include Pfizer’s immunotherapy agonistic monoclonal antibodies targeting OX40 (CD134), (also known as PF-04518600); and utomilumab, targeting 4-1BB (CD137), (also known as PF-05082566); as well as avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody (also known as PF-06834635 and MSB0010718C), which is being developed through an alliance between Merck KGaA, of Darmstadt, Germany, and Pfizer. Under terms of the CRADA, the three investigational immunotherapies will be studied alone, in various combinations with each other and in combination with standard therapies such as chemotherapy, radiation and targeted therapies across a range of cancers.