Aduro Biotech Inc., of Berkeley, Calif., said preclinical data showing that its personalized live attenuated double-deleted Listeria platform (pLADD) induced broad innate immune responses involving cytokines, chemokines, natural killer and gamma delta T cells, as well as antigen-specific adaptive T-cell responses, will be presented at the Society for Immunotherapy of Cancer meeting in National Harbor, Md. The combination of pLADD with an anti-PD-1 led to a sustained immune response and significant prolongation of survival in the models, the company said.
Alexion Pharmaceuticals Inc., of New Haven, Conn., said it would file its third-quarter 10-Q form late, as its board audit and finance committee investigates allegations made by a former employee with respect to the company's sales practices of Soliris (eculizumab). The committee is investigating whether company personnel engaged in sales practices that were inconsistent with company policies and procedures.
Aptinyx Inc., of Evanston, Ill., won $2.85 million in research grants, comprising three SBIR grants. The funds will support studies conducted by Aptinyx researchers and collaborators to evaluate compounds for neuropathic pain and age-related cognitive decline. Aptinyx is currently conducting a phase I study of its lead candidate, NYX-2925, a small-molecule modulator of the NMDA receptor, in healthy volunteers and has selected the indication of neuropathic pain associated with diabetic peripheral neuropathy for future development.
Bristol-Myers Squibb Co., of New York, licensed exclusive worldwide rights for the development and commercialization of Osaka, Japan'-based Nitto Denko Corp.'s investigational siRNA molecules targeting heat-shock protein 47 (Hsp47) in vitamin A-containing formulations, including Nitto's lead asset, ND-L02-s0201, currently in phase Ib testing for the treatment of advanced liver fibrosis. The agreement also grants BMS the option to receive exclusive licenses for Hsp47 siRNAs in vitamin A-containing formulations for the treatment of lung fibrosis and other organ fibrosis. Under terms of the agreement, BMS will make an up-front payment of $100 million to Nitto. Nitto is also eligible to receive clinical and regulatory milestone payments, royalties, sales-based milestone payments as well as option exercise payments for lung and other organ fibrosis. In separate news, BMS said it entered a five-year research collaboration with the Johns Hopkins University to identify mechanisms of response and resistance in patients whose cancer is being treated with checkpoint inhibitor-based immunotherapies, including Opdivo (nivolumab) monotherapy or Opdivo in combination with Yervoy (ipilimumab) or other investigational immunotherapies. The agreement will involve an interdisciplinary research program that will study patient tumor samples in four primary research areas: characterization of tumor antigens and tumor antigen-specific T cells; multifaceted profiling of the tumor microenvironment; assessment of microbiome components that modulate systemic antitumor immunity; and elucidation of tumor and immunometabolism factors that modify responsiveness to immunotherapy.
Cell Medica Ltd., of London, said it expanded its partnership with Baylor College of Medicine to develop an off-the-shelf allogeneic cell therapy, taking advantage of invariant natural killer T (NKT) cells. The partnership will develop off-the-shelf therapies based on CAR-modified NKT cells generated in large volumes from healthy donors. The work will be conducted under an exclusive license and co-development agreement between Cell Medica and Baylor, signed in June. Baylor will perform the research required to develop off-the-shelf NKT cell therapies with funding and strategic input from Cell Medica. The company will have an exclusive option to develop all products and technologies arising from that effort.
Cymabay Therapeutics Inc., of Newark, Calif., said the FDA granted orphan drug designation for MBX-8025 to treat patients with primary biliary cholangitis (PBC). The compound is a selective PPAR-delta agonist being evaluated in high unmet need and orphan diseases. The FDA also granted orphan drug designation for MBX-8025 to treat patients with homozygous familial hypercholesterolemia and hyperlipoproteinemia types I or V (Fredrickson classification).
Evotec AG, of Hamburg, Germany, entered a strategic partnership with the University of Oxford, Oxford University Innovation Ltd. (OUI), the university's research commercialization company, and Oxford Sciences Innovation, aimed at accelerating the translation of basic biomedical research from Oxford into new therapeutics. Projects will be sourced exclusively from Oxford University researchers via OUI across any therapeutic area and for any therapeutic modality and will be aided by a drug discovery expert in residence seconded by Evotec to that initiative, designated LAB282 supported by a fund of £13 million (US$16.3 million), and embedded in the university.
Galectin Therapeutics Inc., of Norcross, Ga., said it plans to identify a strategic partnership for galectin-3 inhibitor GR-MD-02 for the treatment of serious skin diseases, including moderate to severe plaque psoriasis and severe atopic dermatitis. It has complete data on the therapy given to five patients with moderate to severe plaque psoriasis for up to 24 weeks with 8-mg/kg doses of GR-MD-02 delivered every other week. All five patients had significant clinical improvement as measured by the PASI (Psoriasis Area and Severity Index).
Genmab A/S, of Copenhagen, said the EMA's Committee for Medicinal Products for Human Use issued a positive opinion recommending the use of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for the treatment of adults with relapsed chronic lymphocytic leukemia. The marketing authorization application was submitted in March by partner Novartis AG, of Basel, Switzerland.
IBM Watson Health and the Broad Institute of MIT and Harvard University announced a research initiative aimed at discovering the basis of cancer drug resistance. The five-year, $50 million project will study thousands of drug-resistant tumors and draw on Watson's computational and machine learning methods to help researchers understand how cancers become resistant to therapies. The anonymized data will be made available to the scientific community to catalyze research worldwide. The Broad Institute will generate tumor genome sequence data from patients who initially respond to treatment but who then become drug-resistant. Broad will use new genome-editing methods to conduct large-scale cancer drug resistance studies to help identify tumors' specific vulnerabilities. IBM scientists will use Watson to analyze those data and identify genomic patterns that may help researchers and clinicians predict drug sensitivity and resistance.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., and its collaborators published results in Nature Partner Journals Vaccines demonstrating that its Zika DNA vaccine (GLS-5700) protected animals from infection, brain damage and death. In the study, 100 percent of GLS-5700-vaccinated animals were protected from Zika infection after exposure to the virus. In addition, vaccinated mice were protected from degeneration in the cerebral cortex and hippocampal areas of the brain, while unvaccinated mice showed significant degeneration of the brain after Zika infection. The Zika vaccine was developed in a collaboration among Inovio, the Wistar Institute and Geneone Life Science Inc., of Seoul, South Korea, and is currently in two human studies, with data from a phase I trial expected by year-end. (See BioWorld Today, Jan. 25, 2016.)
Medicinova Inc., of La Jolla, Calif., said the EMA's Committee for Orphan Medicinal Products issued a positive opinion recommending orphan medicinal product designation for MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis.
Novavax Inc., of Gaithersburg, Md., is cutting its workforce by 30 percent as part of a restructuring intended to decrease the company's cash burn and support its development priorities through 2017. As a result, the company estimates a reduction in cash burn of $70 million to $100 million in 2017 relative to 2016. Its main goals include continuance of a phase III trial of its respiratory syncytial virus (RSV) vaccine to prevent RSV in infants via maternal immunization and the initiation of a phase II study of the vaccine, both with and without adjuvants, in older adults. The company also hopes to begin a phase I trial of its Zika virus envelope dimer nanoparticle vaccine candidate in 2017. Novavax reported a net loss of $66.3 million for the third quarter of 2016, compared to a net loss of $33.1 million for the third quarter of 2015. As of Sept. 30, the company had $300.3 million in cash and cash equivalents and marketable securities, compared to $230.7 million as of Dec. 31, 2015. Shares of Novavax (NASDAQ:NVAX) fell 30 cents, or 17.7 percent to close Thursday at $1.40.
Novo Nordisk A/S, of Bagsvaerd, Denmark, said it submitted a type II variation application to the EMA seeking to include data from the two SWITCH phase IIIb trials in the label for Tresiba (insulin degludec), a once-daily basal insulin that provides a duration of action beyond 42 hours. Data from the SWITCH trials included results showing that patients treated with Tresiba vs. insulin glargine U100 had fewer episodes of overall symptomatic blood glucose confirmed hypoglycemia and fewer episodes of nocturnal blood glucose confirmed symptomatic hypoglycemia, while demonstrating noninferiority in terms of HbA1c reduction. Tresiba gained FDA approval last year.
Perrigo Co. plc, of Dublin, said as part of its ongoing business portfolio review, it will look at strategic alternatives for the rights to the royalty stream from sales of multiple sclerosis drug Tysabri (natalizumab), which is sold by Cambridge, Mass.-based Biogen Inc. Perrigo acquired rights to the Tysabri royalty stream in 2013 when it acquired Elan Corp. plc. (See BioWorld Today, July 30, 2013.)
Pfizer Inc., of New York, said the European Commission approved Ibrance (palbociclib) for the treatment of women with HR-positive/HER2-negative locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor. The approval also covers the use of Ibrance in combination with fulvestrant in women who have received prior endocrine therapy. Approval was based on the positive PALOMA trials. (See BioWorld Today, April 16, 2015.)
Redhill Biopharma Ltd., of Tel Aviv, Israel, said it concluded a type B meeting with the FDA on its chemistry, manufacturing and controls aspect of the RBH-105 phase III program. Subject to final minutes of the meeting, the FDA accepted the firm's manufacturing plan for an NDA to be submitted for the fixed-dose, oral combination therapy for the eradication of H. pylori infection, subject to positive results from the planned confirmatory phase III study.
Seattle Genetics Inc., of Bothell, Wash., said the FDA granted breakthrough therapy designation to Adcetris (brentuximab vedotin) for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large-cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma, accounting for more than 75 percent of the disease, the company said.
Selecta Biosciences Inc., of Watertown, Mass., said it is getting worldwide rights to intellectual property, data and materials generated through a discovery collaboration initiated and funded by Paris-based Sanofi SA for the development of candidates to treat peanut allergy and celiac disease. Selecta said the move followed Sanofi's strategic review of its R&D portfolio, which resulted in a decision to exit the collaboration. The transition of the discovery programs is not expected to have a material impact on Selecta's cash runway. The company ended the third quarter with about $79.9 million in cash. Selecta and Sanofi inked the potential $900 million deal in 2012 to discover targeted, antigen-specific immunotherapies for food allergies, with Sanofi initially working on a food allergy candidate and last year exercising the option for the celiac disease candidate. Shares of Selecta (NASDAQ:SELB) closed Thursday at $20.68, up $1.59. (See BioWorld Today, Nov. 29, 2012, and May 14, 2015.)
Sosei Group Corp., of Tokyo, said subsidiaries Heptares Therapeutics and Jitsubo Co. Ltd. entered a collaboration to develop peptide candidates designed to target a G protein-coupled receptors (GPCRs) implicated in severe gastrointestinal disorders. Jitsubo will apply its Peptune and Molecular Hiving peptide engineering technologies and medicinal chemistry capabilities to a GPCR target selected by both units, while Heptares will use its Star platform. Heptares will be responsible for development and commercialization of any candidates that emerge from the collaboration, and will make payments to Jitsubo on achievement of agreed milestones, plus royalties on future sales of any resulting products. No further details were disclosed.
Therapix Biosciences Ltd., of Tel Aviv, Israel, said it signed a nonbinding memorandum of understanding for a cooperation with Rafa Laboratories Ltd., of Jerusalem, to conduct a proof-of-concept clinical trial of a cannabinoid-based candidate to treat various medical indications characterized by lower abdominal pain. Therapix plans to make use of its licensed entourage technology for the purpose of integrating a palmitoylethanolamide with an FDA-approved cannabinoid drug.