Acucela Inc., of Seattle, disclosed the publication of an article concerning the company’s drug candidate, emixustat hydrochloride (emixustat), in Drug Discovery Today, exploring the cellular and metabolic stressors associated with degenerative retinal diseases and the potential role of visual cycle modulation with emixustat in the treatment of the diseases. The accumulation of toxic visual cycle byproducts and retinal hypoxia are stressors associated with retinal diseases such Stargardt disease and diabetic retinopathy, respectively.
Alzecure Pharma AB, of Stockholm, exclusively in-licensed a project in the clinical phase targeting neuropathic pain from Acturum Life AB, of Vasteras, Sweden. The project is in the clinical development phase, and Alzecure's aim is to develop a new topical local treatment for neuropathic pain. The mechanism of action is via VR1 receptors, which have a key role in pain signaling, the company said. The agreement with Acturum covers all indications for the global market, and no milestone payments are due before phase II studies begin.
Bicycle Therapeutics plc, of London, disclosed a second collaboration with Cancer Research UK, an independent funder of cancer research, in which the agency will fund and sponsor development of BT-7401, a multivalent Bicycle CD137 agonist, through a phase IIa study. The company said it believes the drug has the potential to open up new treatment options for the large numbers of patients who stop responding to checkpoint inhibitors. BT-7401 could offer improved antitumor activity with fewer side effects compared with antibody-based approaches, which so far have been limited by toxicity, Bicycle said.
Bone Biologics Inc., of Burlington, Mass., said it completed a preclinical study showing its rhNELL-1 growth factor effectively promotes bone formation in a phylogenetically advanced spine model. In addition, rhNELL-1 was shown to be well-tolerated, and there were no findings of inflammation.
Bristol-Myers Squibb Co., of New York, finished its divestment of its oral solid, biologics and sterile product manufacturing and packaging facility in Anagni, Italy, to Catalent Inc., of Somerset, N.J. The divestiture is part of a strategy to simplify and realign its business portfolio to address changes in its business and the future requirements of its evolving pipeline, BMS said. The Anagni facility manufactures and packages cardiovascular, cancer, metabolic and anti-inflammatory medicines as well as nonpenicillin-based antibiotics, antivirals and analgesics as injectables and biologics.
CARB-X in Boston, a global nonprofit partnership led by Boston University, said scientists developing promising new antibiotics in India, Ireland, France, Switzerland, the U.S. and U.K. are to share up to $17.6 million to speed treatments for the world’s deadliest superbugs. A year since launching, the international partnership made public its second round of antibiotic research and development funding. The seven projects supported include five potential new class antibiotics for gram-negative bacteria, a potential new treatment for drug-resistant gonorrhea, a new molecule targeting a superbug causing serious infections in cystic fibrosis patients, and a phase I trial with a new oral broad-spectrum antibiotic.
Cellectis SA, of Paris, disclosed the publication in Nature Reviews Drug Discovery that reviews the opportunities and challenges presented by universal allogeneic CAR T-cell therapies. Cellectis was the first company to develop and test an allogeneic CAR T-cell therapy in patients, the company noted. One of the major challenges in the allogeneic approach involves mitigating the risk of graft-vs.-host-disease, and the review examines aspects of the challenge, weighing the pros and cons associated with various methods and outlining the gene-editing work that Cellectis has done in the area.
Curis Inc., of Lexington, Mass., signed an option and license agreement to acquire exclusive, worldwide rights from Immunext Inc., of Lebanon, N.H., to develop and commercialize anti-V-domain Ig suppressor of T-cell activation (VISTA) antibodies for the treatment of cancer, including Immunext's lead compound, CI-8993 (formerly JNJ-61610588). VISTA is a negative checkpoint regulator that plays a key role in the immune suppression induced by cancer, the company said. Recent studies also suggest VISTA is strongly up-regulated in response to treatment with other cancer immunotherapy agents.
ERS Genomics Ltd., of Dublin, signed an agreement with New England Biolabs Inc. (NEB), of Ipswich, Mass., (NEB), granting NEB rights to sell CRISPR/Cas9 tools and reagents. NEB offers recombinant and native enzymes for genomic research, and continues to expand its product offerings into new areas of research, including genome editing, the company said. As a provider of CRISPR/Cas9 reagents and tools, NEB’s license from ERS expands the company’s rights to use and sell those technologies.
Evotec SE, of Hamburg, Germany, received a $6 million payment from Bristol-Myers Squibb Co. (BMS), of New York, following the decision to expand their collaboration to include additional cell lines in their induced pluripotent stem cells deal. Evotec and Celgene Corp., now part of BMS, started the collaboration in December 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases. The deal has already been expanded with additional cell lines several times.
While no financial details have been disclosed, Galecto Inc., of Copenhagen, and Pharmakea Inc., of San Diego, will merge under the name Galecto. The companies specialize in fibrosis and cancer, including an inhaled galectin-3 modulator in a phase IIb trial for treating idiopathic pulmonary fibrosis. Pharmakea develops small molecules targeting LOXL2, an enzyme involved in the formation of the extracellular matrix during the fibrotic process.
Two years ago, Genoway SA, of Lyon, France, acquired exclusive worldwide rights to Kenilworth, N.J.-based Merck & Co. Inc.’s CRISPR/Cas9 portfolio, which are applications involving rodent cells or animals. Now Merck entered an additional license giving Genoway nonexclusive rights to commercialize the development and use of all other animal cell models for its customers' internal research uses and commercial exploitation.
Gracell Biotechnologies Co. Ltd., of Suzhou, China, initiated a study of GC-027 for treating relapsed or refractory T-cell malignancies. Cells for the treatment are made of T cells from healthy donors, then are genetically edited and inserted with chimeric antigen receptor ex vivo, which can bind to and eliminate target T malignant cells. Gracell is currently in a phase I trial for GC-007F, a cell gene therapy for treating relapsed/refractory B-cell acute lymphoblastic leukemia.
The Institute for Clinical and Economic Review (ICER) plans to review the comparative clinical effectiveness and value treatments for Lentiglobin, from Bluebird Bio Inc., of Cambridge, Mass., and Reblozyl (luspatercept-aamt), from Celgene Corp., of Summit, N.J., and Acceleron Pharma Inc., of Cambridge, Mass., to treat beta-thalassemia. While Lentiglobin is an investigational gene therapy marketed in Europe as Zynteglo, the FDA decision on its U.S. approval is expected by late 2020. Luspatercept-aamt was approved by the FDA in November. Comments on the ICER scoping document can be submitted by email to firstname.lastname@example.org and must be received by 5 pm Eastern on Jan. 27.
Shares of Inventiva SA, of Daix, France, have been admitted to the Deferred Settlement Service on the Long Only segment, following an annual review by Euronext Paris. Admission allows holders of French securities accounts to purchase Inventiva shares. The admission is designed to boost the company stock’s liquidity by widening its investor base. Inventiva is developing oral small-molecule therapies for treating fibrosis, lysosomal storage disorders and oncology.
In the first global clinical collaboration between the two companies, Inxmed Co. Ltd., of Shanghai, and MSD, a subsidiary of Kenilworth, N.J.-based Merck & Co. Inc., will evaluate IN-10018, a selective ATP-competitive, focal adhesion kinase inhibitor, in combination with pembrolizumab, MSD's anti-PD-1 therapy, for pancreatic cancer patients. Inxmed is the study sponsor and MSD will provide pembrolizumab for the study.
Microcures Inc., of New York, was awarded a Phase II Small Business Innovation Research grant from the NIH. The two-year, $1.5 million award will support ongoing development of the company’s lead product candidate, siFi2. Topical siFi2, a small interfering RNA therapeutic, is designed to treat burn wounds by silencing the activity of Fidgetin-like 2, a fundamental MRP, in wounded tissue. SiFi2 is a supplement to current standard of care.
Mina Therapeutics Inc., of London, and Astrazeneca plc, of Cambridge, U.K., will collaborate to evaluate small activating RNA (saRNA) molecules in metabolic diseases. Upon completion of the studies, Astrazeneca will have the option to negotiate a license agreement to further develop saRNA molecules that activate an undisclosed gene target identified by Astrazeneca. No further details about the collaboration have been disclosed.
Mundipharma Pte. Ltd., of Singapore, said it has sealed an exclusive sales agreement with Biosolution Co. Ltd., a Korea-based leader in cell-based biotechnology, to market and distribute in South Korea its fourth-generation autologous chondrocyte implantation product, Cartilife, an autologous cartilage-derived chondrocyte cell therapy for the treatment of cartilage defects. It's the second deal between Mundipharma and Biosolution, following an exclusive sales agreement for the allogeneic keratinocyte cell therapy product, Keraheal-allo, which was announced in May 2016.
Nuvo Pharmaceuticals Inc., of Mississauga, Ontario, will repay a bridge loan to Deerfield Management Co. LP that it had taken to support its acquisition of Aralez Pharmaceuticals Canada and certain rights to Vimovo (naproxen/esomeprazole magnesium). With the repayment complete, Nuvo will receive the full $7.5 million annual minimum royalty payment due from the 2019 sales of Vimovo in the U.S. The company has received $5.6 million to date.
Pear Therapeutics Inc., of Boston and San Francisco, said it entered agreements with multiple organizations intended to add to its portfolio of prescription digital therapeutics. The announced deals include an acquisition from Firsthand Technology Inc., of Seattle, for treatments for acute and chronic pain, the licensing of content for a clinical-stage digital therapeutic for irritable bowel syndrome from the Karolinska Institute in Sweden, and the licensing of a clinical-stage digital therapeutic for the treatment of migraine headaches from Cincinnati Children’s Hospital Medical Center. Pear also licensed machine learning-based voice digital biomarkers from Winterlight Labs Inc. and announced a collaboration with Neurolex Laboratories Inc. to collect structured voice data in patients with depression, as well as healthy volunteers.
Phoremost Ltd., of Cambridge, U.K.., said it entered a multiproject drug discovery collaboration with Boehringer Ingelheim GmbH, of Ingelheim, Germany. Phoremost will receive an up-front payment and research funding of undisclosed values together with downstream success-based milestones. The company will deploy its phenotypic screening platform, Siteseeker, toward disease relevant pathways nominated by BI. Further financial terms are not disclosed.
Principia Biopharma Inc., of South San Francisco, said it will expand its development of rilzabrutinib, an oral, reversible covalent BTK inhibitor formerly known as PRN-1008, into IgG4-related disease.
Protagonist Therapeutics Inc., of Newark, Calif., said an oral, gut-restricted IL-23 receptor antagonist peptide has been nominated as a second-generation development candidate under its worldwide license and research collaboration agreement with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson. The pair are working on PTG-200 (JNJ-67864238) and second-generation peptides for indications including inflammatory bowel disease. Protagonist said PTG-200 remains on track to deliver phase II results in Crohn's disease in 2021.
Sanofi SA, of Paris, and Sebia SA, of Lisses, France, entered an agreement to develop an in vitro diagnostic test designed to mitigate the potential interference caused by isatuximab in immunofixation electrophoresis (IFE) tests. New multiple myeloma therapies that use biologics, specifically monoclonal antibodies, are known to interfere with the patient’s monoclonal protein in IFE tests, which can mislead health care professionals in interpreting the patient’s response to therapy. Isatuximab is a monoclonal antibody that targets a specific epitope of CD38 capable of triggering multiple mechanisms of action that are believed to promote programmed tumor cell death and immunomodulatory activity. Under the terms of the agreement, Sebia will develop the test and act as worldwide supplier, aiming to seek a CE mark for the test this summer. Financial terms were not disclosed.
Synaffix BV, of Amsterdam, said that Shanghai Miracogen Inc., a Chinese biotech company with a clinical-stage pipeline of antibody-drug conjugates (ADC), has expanded its existing collaboration by taking a license to develop and commercialize a second candidate. Miracogen has been granted nonexclusive rights to Synaffix’s Glycoconnect and Hydraspace ADC technologies for use in the candidate. Synaffix is eligible to receive up-front, milestone and royalty payments of undisclosed value tied to the new program.
Syntrix Pharmaceuticals Inc., of Auburn, Wash., said researchers at the Fred Hutchinson Cancer Research Center and the NIH independently showed SX-682 eradicates pivotal immunosuppressive cell barriers in solid tumors to enhance checkpoint inhibition in non-small-cell lung cancer and natural killer cell-based immunotherapy in head and neck squamous cell carcinoma, respectively.
Tyme Technologies Inc., of New York, and Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., said they formed a U.S. collaboration focused on the co-promotion of Tyme’s lead cancer metabolism-based therapy, oral SM-88, in advanced cancers. In clinical trials, oral SM-88 has demonstrated complete or partial responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung and blood cancers with minimal serious grade 3 or higher adverse events. Under the terms, Tyme will receive a $20 million up-front cash payment for 10 million restricted shares of its common stock at $2 per share. In addition, Tyme will receive a $20 million milestone payment upon the successful completion of the first to occur of the following three events: achievement of the primary endpoint of overall survival in its TYME-88-Panc pivotal trial; achievement of the primary endpoint of overall survival in the PanCAN Precision Promise SM-88 registration arm; or FDA approval of SM-88 in any cancer. The payment would be split into a $10 million milestone cash payment and a $10 million investment in Tyme at a 15% premium to the then-prevailing market price. Eagle’s shares will be restricted from sale until the earlier of three months following the milestone event or the three-year anniversary of the agreement. Under the co-promotion deal, Eagle will undertake 25% of the promotional sales effort for SM-88 in the U.S. oncology market and receive 15% of the net U.S. revenues of SM-88. Tyme will be responsible for clinical development, regulatory approval, commercial strategy, marketing, reimbursement and manufacturing of SM-88. There is also the potential to evaluate oral SM-88 in combination therapy or as a monotherapy through leveraging Eagle’s oncology pipeline and expertise in oncology settings, which may include trials in breast or lung cancers and other tumor types.
Velabs Therapeutics GmbH, of Heidelberg, Germany, said it entered an exclusive license agreement with Alytas Therapeutics GmbH, of Jena, Germany, for the development and commercialization of Alytas’ antibodies in the field of senescence, related degenerative processes and pathologies. Velabs, a startup of the European Molecular Biology Laboratory, has recently started developing antibody-based senolytics, a class of drugs designed to prevent cell and tissue degeneration that can occur during the aging process by eliminating so-called senescent cells. Alytas specializes in the research of fat metabolism in connection with obesity. In a previous strategic partnership, the two firms co-developed different sets of preclinical antibodies for an immune-based obesity treatment. The current license will allow Velabs to exclusively develop those antibodies against senescence-related degenerative processes. Financial terms were not disclosed.
Vivus Inc., of Campbell, Calif., said publication of a new study in the Journal of General Internal Medicine from the Toolbox trial, a real-world study in urban-safety-net primary care clinics offering a “toolbox” of cost-effective weight management tools, found that a higher proportion of subjects who initially selected Qsymia (phentermine and topiramate extended-release capsules) from the toolbox or added it to their weight management plans during the study period achieved at least a 5% weight loss compared with subjects who never used Qsymia.
Zenith Epigenetics Ltd., of Calgary, Alberta, said it received a $5 million milestone payment from Newsoara Biopharma Co. Ltd., of Shanghai, related to a licensing agreement for Zenith’s lead compound, ZEN-3694, in China, Hong Kong, Taiwan and Macau. ZEN-3694 is being developed for epigenetic combination therapies in oncology for multiple indications. The milestone was linked to completion of Zenith’s phase II prostate cancer study.
Zyus Life Sciences Inc., of Saskatoon, Saskatchewan, a company focused on developing and commercializing cannabinoid-based formulations, signed an agreement with the University of Saskatchewan to partner on a preclinical study to determine the impact of cannabis derivatives on mental health conditions.