Addex Therapeutics Ltd., of Geneva, said its American depositary shares, representing its ordinary shares, are now listed for trading on Nasdaq under the symbol ADXN.
Allergy Therapeutics plc, of Worthing, U.K., said preclinical results of its peanut allergy vaccine candidate have been published in The Journal of Allergy and Clinical Immunology. The study used a peanut allergy mouse model to demonstrate that the virus-like particle (VLP) platform used in the vaccine candidate could offer an effective way to treat peanut allergies and prevent anaphylaxis. It provides the proof of concept for the generation of sustained immunity and protection through vaccination. The vaccine candidate uses a formulation incorporating VLP-based technology, which enhances the body’s immune response by making the peanut allergen resemble an invading virus. The engineered, plant-based cucumber mosaic virus used in the vaccine is not able to replicate or to infect humans and so provides a platform to induce protective antibodies in a way more akin to traditional vaccination rather than current allergen-specific immunotherapy approaches such as desensitization via transdermal patches or oral administration.
Chimerix Inc., of Durham, N.C., said data in support of brincidofovir (BCV) as a potential treatment for smallpox were highlighted at the American Society for Microbiology Biothreats meeting in Arlington, Va. Independent experiments were performed in two lethal animal models of smallpox. In those studies, either rabbits or mice were inoculated with rabbitpox or ectromelia virus, respectively, to determine the survival benefit of BCV in animals acutely infected with those orthopoxviruses. The animal models are being studied in connection with the FDA Animal Rule. In both studies, animals that received BCV, regardless of time post-infection, demonstrated a statistically significant survival advantage relative to placebo.
Conatus Pharmaceuticals Inc. and Histogen Inc., both located in San Diego, said they entered a definitive agreement, with Histogen merging with a wholly owned subsidiary of Conatus in an all-stock transaction. The combined company, which will focus on advancing technology for dermatological and orthopedic indications, will operate under the Histogen name, and its shares are expected to trade on Nasdaq under a new ticker symbol that is still to be determined. Histogen’s lead product candidate, HST-001, or hair-stimulating complex, is a minimally invasive treatment to promote new hair growth in patients with male pattern hair loss. In addition, the company is developing HST-002, a human-derived collagen and extracellular matrix dermal filler, and HST-003, an extracellular matrix scaffold for the treatment of articular cartilage defects.
Cytodyn Inc., of Vancouver, Wash., said it is exploring its CCR5 antagonist, leronlimab, as a potential treatment for patients infected with the 2019 novel coronavirus (2019-nCoV) because of its potential to "synergize" with retroviral therapies under investigation as a potential treatment for the virus. Leronlimab is currently under development in two other indications, HIV infection and metastatic triple-negative breast cancer.
Cyxone AB, of Stockholm, said an order for more rabeximod substance will be placed earlier than expected with the primary objective of providing optimal conditions for conducting a rheumatoid arthritis phase IIb trial. The decision follows the initiation of preparatory work for substance capsulation that began earlier this year and is part of the clinical program. As a result, the first patient is expected to enter the study in the first quarter of 2021.
Decibel Therapeutics Inc., of Boston, disclosed a new strategic research focus on regenerative medicine approaches for the inner ear. The company also made public a collaboration and option agreement that gives Decibel exclusive access to novel compounds targeting proteins in a critical regenerative pathway. Decibel signed an exclusive worldwide option agreement with Rockefeller University, which has discovered a series of small-molecule LATS kinase inhibitors targeting the Hippo signaling pathway.
Hepion Pharmaceuticals Inc., of Edison, N.J., disclosed positive findings from an expanded study with human precision cut liver slices. In that specialized experimental model using human liver tissue, Hepion's drug candidate, CRV-431, prevented experimentally induced liver fibrosis to a greater extent than four other leading drug candidates in nonalcoholic steatohepatitis: obeticholic acid (Ocaliva, Intercept Pharmaceuticals Inc.), elafibranor, in the works by Genfit SA, of Lille, France; resmetirom, from Conshohocken, Pa.-based Madrigal Pharmaceuticals Inc.; and arachidyl amido cholanoic acid, from Tel Aviv, Israel-based Galmed Pharmaceuticals Ltd.
Hoth Therapeutics Inc., of New York, after further evaluation under its commercial evaluation sublicense and option agreement with the University of Maryland, Baltimore (UMB) and Isoprene Pharmaceuticals Inc., of Baltimore, will exercise its option for full licensing rights to develop and commercialize therapeutic compounds for the treatment of dermatological conditions in humans. The licensing agreement stems from results reported by UMB relating to the effect retinoic acid metabolism blocking agents offer in treating cancer and dermatology-related issues. Hoth has begun its preclinical study program and anticipates sharing those results upon completion of the study.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said it further engaged Locust Walk as strategic advisor to lead out-licensing negotiations for rights to phase III-ready oral rinse brilacidin for oral mucositis.
Johnson & Johnson, of New Brunswick, N.J., said it is mobilizing resources at Janssen Pharmaceutical Cos. to launch a multipronged response to the novel coronavirus (2019-nCoV) outbreak. The company has begun efforts to develop a vaccine candidate against 2019-nCoV and broadly collaborate with others to screen a library of antiviral therapies. The work will leverage Janssen's Advac and PER.C6 technologies.
Merck & Co. Inc., of Kenilworth, N.J., said preliminary results of a new study by the Economist Intelligence Unit on lung cancer show a fragmented policy approach across Europe. "National Lung Cancer Clinical Guidelines should include time frames for fast-tracking people suspected of having lung cancer for diagnostic testing and provide a rapid referral for secondary or tertiary treatment for those diagnosed with lung cancer," the company said.
Microcures Inc., of New York, said that following the successful completion of an initial pilot animal study, it has initiated a second, larger preclinical burn study of its lead product candidate, siFi2, in collaboration with the U.S. Army Institute of Surgical Research. 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. It's intended as a supplement to current standard of care.
Mogrify Ltd., of Cambridge, U.K., said it has secured $1.1 million of additional funding to support assessment of its regenerative cartilage therapy, for the treatment of cartilage defects, osteoarthritis and other musculoskeletal conditions, before entering clinical trials. The grant, from NHS England-funded SBRI Healthcare, will help the company advance cell conversions through preclinical safety and efficacy studies in vivo, it said.
Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said it recently received necessary information regarding the formatting and content of upcoming regulatory filings for fexapotide triflutate, its candidate for the treatment of prostate enlargement in men. Filings seeking approvals in the U.S. and in Europe are now targeted for the first half of 2020 in both jurisdictions, it said.
Oncology Pharma Inc., of San Francisco, said it has "completed its relationship" with Tulynode Biosciences Inc., of San Diego, and will be focusing on cancer drugs instead of medical devices. The company is now focusing its efforts on obtaining funding for Kalos Therapeutics Inc., Nanosmart Pharmaceuticals Inc., Diagnomics Inc. and Ribera Solutions Inc.
Onxeo SA, of Paris, said it entered a clinical research agreement with European cancer center Gustave Roussy to conduct the Revocan phase Ib/II study designed to evaluate the effect of Asidna, the firm’s DNA damage repair inhibitor, on the acquired resistance to PARP inhibitor niraparib in its approved indication for second-line maintenance treatment of relapsed ovarian cancer.
Otonomy Inc., of San Diego, said an experimental AAV-based gene therapy it’s developing with Applied Genetic Technologies Corp., of Alachua, Fla., for the treatment of GJB2 deficiency for congenital hearing loss showed encouraging preclinical results "that demonstrate our ability to express a gene of interest in the target cells relevant" to the indication. Additional preclinical results regarding the company's OTO-510 program highlight the therapeutic potential of a class of cisplatin-binding molecules for protection against cisplatin-induced hearing loss and the higher potency of those agents versus. molecules in clinical development, the company said. The updates were presented at the Association for Research in Otolaryngology 43rd Annual MidWinter Meeting in San Jose, Calif.
Sorrento Therapeutics Inc., of San Diego, and Celularity Inc., of Warren N.J., created a clinical and manufacturing collaboration to treat and prevent the Wuhan coronavirus, 2019-nCoV, by expanding the use of Celularity’s CYNK-001, an allogeneic, off-the-shelf, placental-derived natural killer cell therapy. Sorrento will use its existing cGMP cell therapy manufacturing facilities in San Diego to supplement Celularity's new cGMP facility in Florham Park, N.J. Sorrento owns 25% of Celularity. No financial details were disclosed.
Spinalcyte LLC changed its name to Fibrogenesis. The Houston-based regenerative medicine company is developing human dermal fibroblasts for use in spinal replacement procedures and for other degenerative disc disease treatments. The name change, company officials said, was made to reflect the broad clinical applications of fibroblasts that it offers.
Spring Bank Pharmaceuticals Inc., of Hopkinton, Mass., discontinued all its hepatitis B drug development, including inarigivir soproxil, which was in the phase IIb Catalyst study for treating chronic hepatitis B virus (HBV). The decision follows a series of serious adverse events, including a patient death, in the trial in December. The Catalyst study was part of a collaboration with Foster City, Calif.-based Gilead Sciences Inc., which concurrently stopped dosing the final cohort of patients in its phase II trial examining inarigivir 400 mg, co-administered with Vemlidy (tenofovir alafenamide), to treat naive chronic HBV patients. Spring Bank will not invest further resources toward its chimeric oligonucleotide antisense program for HBV and has begun discussions with external parties to license the program.
New preclinical data from Syros Pharmaceuticals Inc., of Cambridge Mass, show that inhibiting cyclin-dependent kinase 7 (CDK7) results in different transcriptional effects than inhibiting cyclin-dependent kinase 12 (CDK12), pointing to therapeutic opportunities for treating difficult-to-treat cancers. Syros studied the transcriptional effects of selective CDK7 and CDK12 inhibition in an ovarian cancer cell line, marking what the company labeled as the first reported direct comparison of the two approaches. CDK7 and CDK12 are CDK family members that have emerged as drug targets in cancer because of their roles in transcription. The findings showed that CDK7 and CDK12 inhibition had distinct effects despite decreasing expression of many of the same genes, such as CDK7 decreasing the expression of more genes, and that CDK12 inhibition decreased expression of genes with longer transcripts. Syros’ oral CDK7 inhibitor, SY-5609, is in a phase I trial in patients with advanced breast, colorectal, lung or ovarian cancers, or with solid tumors of any histology that harbor Rb pathway alterations.
Veloxis Pharmaceuticals A/S, of Copenhagen, has, upon request from Asahi Kasei Pharma Denmark A/S, requested Nasdaq Copenhagen A/S to remove Veloxis' shares from trading and official listing at Nasdaq Copenhagen. Nasdaq Copenhagen has accepted the request. Asahi Kasei Group, of Tokyo, disclosed plans to acquire Veloxis late last year.
Wuxi Biologics, of Hong Kong, created an R&D team of more than 100 people to develop and manufacture multiple neutralizing antibodies to treat the Wuhan coronavirus, 2019-nCoV. The first batch of antibody is expected to be produced in two months, ready for preclinical toxicology studies and initial human clinical studies. Large-scale manufacturing could follow the studies at the company's four GMP facilities with single batch bioreactor capacity ranging from 2,000 liters to 12,000 liters. A single batch at that scale combined is expected to treat up to 80,000 patients.