Alimera Sciences Inc., of Atlanta, said it filed to effect a 1-for-15 reverse stock split. Shares will begin trading on a split-adjusted basis Nov. 15 under the existing symbol ALIM. The move is primarily intended to bring Alimera into compliance with the minimum bid price requirement for continued listing.
Bayer AG, of Berlin, and Dewpoint Therapeutics Inc., of Boston, said they signed a research, license and option agreement worth up to $100 million. The partnership will leverage Dewpoint's platform for biomolecular condensates and Bayer's small-molecule compound library to develop new treatments for cardiovascular and gynecological diseases. Bayer will gain the option to exclusively license a specified number of novel therapeutics derived from the research activities. The deal follows Bayer's participation in Dewpoint's January series A financing round through the Leaps by Bayer unit. (See BioWorld, Jan. 31, 2019.)
Biogen Inc., of Cambridge, Mass., and UPMC Health Plan said they entered a value-based agreement for multiple sclerosis (MS) drugs Tecfidera (dimethyl fumarate) and Avonex (interferon beta-1a), in which reimbursement provided by the drug manufacturer to UPMC Health Plan will be linked to MS patient-reported measures of disability progression in a real-world population. Previous value-based contracts for MS medications have connected payment to surrogate clinical indicators derived from claims and electronic health record data, such as MS-related emergency department visits, hospitalizations, medication adherence and relapse rates. However, a study conducted by the UPMC Center for Value-Based Pharmacy Initiatives, the UPMC Insurance Services Division's nonprofit research group, found that a panel of key MS stakeholders unanimously ranked "worsening physical disability" as one of the most meaningful MS outcomes.
Brainstorm Cell Therapeutics Inc., of New York, said it received a $495,330 grant from the National Multiple Sclerosis Society, through its Fast Forward program, to advance the company's phase II trial of repeated intrathecal administration of Nurown (autologous MSC-NTF cells) produced from autologous, bone marrow-derived mesenchymal stem cells, in participants with progressive multiple sclerosis.
Cellectis SA, of Paris, said a paper that describes proof of concept for rewiring the cell pathway to create highly intelligent T cells that can recognize cancerous tumors and cause a microsecretion of therapeutic proteins onto those tumors, which ultimately reshapes the tumor microenvironment and improves the T cells' ability to fight cancer, has been published in Nature Communications. By utilizing gene editing techniques to rewire the TCRα, CD25 and PD-1 genes, the study enabled CAR T cells to microsecrete the pro-inflammatory cytokine IL-12 in a tumor and time-dependent manner, paving the way for a next generation of tightly controlled, highly active and potentially safer CAR T-cell treatments.
Clovis Oncology Inc., of Boulder, Colo., said the Italian Medicines Agency has approved rucaparib for reimbursement in Italy, and the drug will soon be available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.
Cure Pharmaceutical Inc., of Oxnard, Calif., said it purchased a $200,000 convertible promissory note issued by Coeptis Pharmaceuticals Inc., of Pittsburgh, a biopharmaceutical company engaged in the acquisition, development and commercialization of branded 505(b)(2) pharmaceutical products. The purchase represents an initial step toward a potential acquisition of the company and the exclusive rights to Coeptis' approved drug, Consensi, the first fixed-dose combination drug for the treatment of co-morbid osteoarthritis and hypertension.
Fujifilm Corp., of Tokyo, said it will make a capital investment of about ¥13 billion (US$1.2 billion) in the gene therapy field to further expand the contract development and manufacturing business.
Integral Molecular Inc., of Philadelphia, said it has been awarded a contract from the National Institute of Allergy and Infectious Diseases, which will provide up to $5.5 million over the next five years to define antibody responses to pathogenic viruses, including Zika, Marburg and equine encephalitis, aiding the discovery of vaccines and therapeutics against those currently untreatable and often lethal viruses. The company's shotgun mutagenesis epitope mapping technology has been used to map more than 1,000 antibody binding sites to generate mechanistic insights and intellectual property, and is used throughout the vaccine industry.
Onxeo SA, of Paris, which is specializing in the development of drugs targeting tumor DNA damage response in oncology, in particular against rare or resistant cancers, said the results of preclinical studies comparing the efficacy and toxicity of two DNA repair inhibitors olaparib, a PARP inhibitor, and AsiDNA, the company's first-in-class DDR inhibitor have been published in Frontiers in Oncology. In vivo models showed that, while both DNA repair inhibitors were effective, only AsiDNA could delay resistance to carboplatin without increasing its toxicity.
Regenerx Biopharmaceuticals Inc., of Rockville, Md., said data published in Life Science Alliance demonstrate how thymosin beta 4 (Tβ4) promotes the body's ability to clean out damaged cells in order to regenerate newer, healthier cells (autophagy) and repair damage in chronic granulomatous disease (CGD). Researchers showed in vitro that certain proteins underexpressed in CGD patients were normalized by Tβ4 and promoted autophagy and up-regulation of genes involved in mucosal barrier protection. In an in vivo study, inflammation and granuloma formation were reduced and survival increased in mice with colitis and aspergillosis upon treatment with Tβ4.
Rubius Therapeutics Inc., of Cambridge, Mass., reported in its third-quarter earnings that it has manufactured RTX-134, a drug from its Red Cell Therapeutics platform in development for phenylketonuria for its phase Ib trial, and is actively recruiting patients. The firm said it expects results during the first quarter of 2020, a delay from its prior guidance of data by year-end, noted J.P. Morgan analyst Jessica Fye. "This pushes out a milestone with potential to be derisking for both '134 as a product and the broader RED platform and removes the key catalyst for the stock this year," she wrote in a research note. "While only a slight delay, we do not see this helping the market's already mixed sentiment on the stock." Shares of Rubius (NASDAQ:RUBY) fell 20% or $1.96, to close Thursday at $7.88.
Sarepta Therapeutics Inc., of Cambridge, Mass., and Stridebio Inc., of Research Triangle Park, N.C., signed a collaboration and license agreement to develop in vivo AAV-based therapies for up to eight central nervous system and neuromuscular targets. Pursuant to the agreement, Sarepta is granted an exclusive license on selected targets to leverage Stridebio's structure-driven capsid technology, intended to enhance specific tropism to tissues of interest and evade neutralizing antibodies. The parties also plan to focus on strategies intended to address redosing challenges in patients who have received AAV-delivered gene therapy. Stridebio will conduct all IND-enabling research, development and manufacturing for the first four targets, which are MECP2 (Rett syndrome), SCN1A (Dravet syndrome), UBE3A (Angelman syndrome) and NPC1 (Niemann-Pick). Sarepta will have an exclusive option to four additional targets based on Stridebio's capsid technology. Stridebio will receive a $48 million up-front payment in the form of cash and Sarepta stock, in addition to significant future development, regulatory and commercial milestones for the four programs, along with royalties on worldwide net sales of any commercial products developed through the collaboration. Sarepta has also obtained an exclusive option to expand the collaboration to include up to an additional four targets, with an up-front payment of up to $42.5 million along with future downstream milestone payments, while Stridebio has an option to obtain co-development and co-commercial rights to one of the collaboration targets.
Sienna Biopharmaceuticals Inc., of Westlake Village, Calif., said Nasdaq's hearing panel granted the company's request for continued listing under certain conditions. On or before Dec. 5, the company must update the panel regarding the results of the bankruptcy auction and provide a timeline. On or before Dec. 13, in the event the auction process results in an asset sale, the company must have completed the asset sale transaction or update the panel on alternative plans.
Skyhawk Therapeutics Inc., of Waltham, Mass., said it entered a second global collaboration with an affiliation of Summit, N.J.-based Celgene Corp., following their 2018 collaboration. The new deal focuses on targets relevant to the field of autoimmune disorders, oncology and immuno-oncology and allows the parties to systematically interrogate a range of targets that have been clinically validated or are highly associated with the genetic basis of disease but have been considered undruggable using conventional small-molecule therapies. Under the terms, Skyhawk gets an $80 million up-front payment and is eligible for potential milestone payments and royalties. In exchange, Celgene gains options to exclusively license worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following Celgene's exercise of its option, Celgene will be responsible for further development and commercialization. (See BioWorld, June 27, 2018.)
Vaccinex Inc., of Rochester, N.Y., received notice of a $750,000 grant from the Alzheimer's Association under the 2020 Part the Cloud program to evaluate its lead candidate, pepinemab (VX-15), in Alzheimer's disease. The 60-subject, randomized, placebo-controlled, multicenter study is expected to start enrolling in the second quarter of next year. Top-line data are expected in late 2021 or early 2022.
Viome Inc., of Seattle, disclosed a partnership with Glaxosmithkline plc, of London, to increase understanding of chronic diseases and a potential role for vaccines. The long-term goal is to help prevent some chronic diseases and reduce the number of relapses. Terms were not disclosed.