Aditxt Therapeutics Inc., of Mountain View, Calif., is preparing to test its nucleic acid-based Apoptotic DNA Immunotherapy (ADi) in patients with psoriasis. The company signed an agreement with a regulatory consultant based in Munich, Germany, to help Aditxt submit its IND in Germany with a plan to start the clinical trial program in the fourth quarter of 2021.
Arch Biopartners Inc., of Toronto, licensed new patent claims for AB-569, a topical wound application designed to prevent, treat and heal burn/blast wound infections, from the University of Cincinnati. The license builds on the company's existing license for AB-569. Financial terms of the deal weren't disclosed.
Betterlife Pharma Inc., of Vancouver, British Columbia, entered a research agreement with the University of California, San Diego for Adam Halberstadt's lab to perform preclinical behavioral pharmacology studies on TD-0148A, a second-generation lysergic acid diethylamide derivative.
Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, plans to test Scenesse (afamelanotide) in patients with xeroderma pigmentosum (XP) variant and XP complementation group C. Scenesse promotes DNA repair through several mechanisms, including nucleotide excision repair.
Exacis Biotherapeutics Inc., of Cambridge, Mass., has been able to use mRNA-based cell-reprogramming and gene-editing technologies to produce its ExaNK engineered NK cell therapy candidates. The reprogramming uses undisclosed stealthing targets to produce rejection-resistant cells. Exacis is using the technology to produce ExaCAR-NK cells that are targeted to a tumor with a chimeric antigen receptor, as well as non-CAR-bearing ExaNK cells designed to improve the effect of monoclonal antibodies. Exacis plans to present the progress at a conference later this year and has filed a patent application for the work.
Glaxosmithkline plc, of London, terminated Moncef Slaoui as chair of the board of Galvani Bioelectronics, which is majority owned by GSK. The termination follows allegations of sexual harassment and inappropriate conduct by Slaoui against an employee of GSK when Slaoui was an employee of GSK. Christopher Corsico, senior vice president of development at GSK and a current member of the Galvani's board, has been appointed as the new chair of the board. Amy Altshul, senior vice president of legal, R&D and global commercial franchises at GSK, has been appointed to Galvani's board.
Hutchison China Meditech Ltd., of Hong Kong, plans to sell its indirect interest in its over-the-counter drug joint venture, Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Co. Ltd., to GL Mountrose Investment Two Ltd. for approximately $169 million. The transaction is expected to close in mid-2021.
Intensity Therapeutics Inc., of Westport, Conn., with the Ottawa Hospital and the Ontario Institute for Cancer Research, will conduct a randomized phase III study evaluating clinical and biological effects of intratumoral INT-230-6 vs. no treatment in early breast cancer. The study is for evaluating change in pathological complete response compared to standard of care. The primary endpoint is the proportion of patients achieving a complete cell cycle arrest, defined as a reduction in the proportion of cells staining positive for Ki67, a cancer cell proliferation marker. Ottawa Hospital will conduct enrollment and treatment plus evaluate clinical responses, The institute will analyze immune responses and conduct biomarker analyses. Intensity will fund the trial and provide INT230-6, which is composed of cisplatin and vinblastine, and a penetration enhancer molecule.
Fresh preclinical data from Interna Technologies BV, of Utrecht, the Netherlands, showed its lead candidate, INT-1B3, merits further development for treating cancer, the company said. INT-1B3 is a mimic of tumor suppressing miRNA-193a-3p. Data from extended RNA-sequencing and transcriptome-wide analysis after transfection of the miR-193a-3p mimic (1B3) in human tumor cell lines revealed insights into underlying molecular pathways of 1B3’s tumor suppressor functions, the company said. Differentially expressed genes mapped by Ingenuity Pathway Analysis strongly indicated up-regulation of the tumor suppressive PTEN pathway as well as down-regulation of many oncogenic growth factor signaling pathways. The analysis pointed to an extensive link of 1B3 with cancer, based on predicted negative effects on tumor cell survival, proliferation and migration as well as induction of cell death in tumor cells. These data strongly suggest that 1B3 is a tumor suppressor agent targeting various key hallmark pathways across cancer types, the company added.
Positive data from a non-IND study by Kaleido Biosciences Inc., of Lexington, Mass., show a reduction in health care use and recovery time for those with mild to moderate COVID-19 plus one or more co-morbidity. Oral KB-109, from Kaleido’s Microbiome Metabolic Therapy platform, met its primary endpoint by demonstrating an overall favorable safety and tolerability profile with no unexpected treatment-related adverse events. The number of hospitalizations, emergency room visits and urgent care visits was reduced by about 62%.
Krystal Biotech Inc., of Pittsburgh, launched Jeune Inc., a gene-based aesthetic skin conditions company formed to advance aesthetic medicines. Jeune has an exclusive license to a portfolio of candidates derived from Krystal’s technology platform that are designed to directly address biological changes in the skin associated with intrinsic and extrinsic aging. The lead candidate, KB-301, is designed to deliver the human COL3A1 gene to increase production of normal type III collagen at the site of administration.
Neurobo Pharmaceuticals Inc., of Boston, said it received approval of an amendment to its contingent value rights (CVR) agreement from a majority of the holders of a majority of the outstanding CVRs, incentivizing evaluation of gemcabene as a COVID-19 treatment. The CVRs were distributed to holders of Gemphire Therapeutics Inc. common stock Dec. 30, 2019, immediately before its merger with Neurobo. The CVR amendment will allow Neurobo to pursue gemcabene as a therapy for COVID-19 with its own resources. In exchange, CVR holders receive 10% of certain gross proceeds received by the company for any indication outside of treating cardiometabolic diseases. CVR holders retain the original CVR for 80% of any proceeds of gemcabene for cardiovascular conditions.
Probiogen AG, of Berlin, signed a service agreement for a vaccine project by Nobelpharma Co. Ltd., of Tokyo. Earlier work confirmed the versatility and benefit of Probiogen’s vaccine development platform, consisting of the AGE1.CR.pIX suspension cell line and its high performance cell culture medium, for the propagation of Nobelpharma’s virus strain, the company said. The duck cell line AGE1.CR.pIX was designed to serve the industrial, GMP-compliant production of a wide variety of viruses in large bioreactors and is free of any adventitious agents.
Valence Discovery, of Montreal, disclosed a multitarget discovery collaboration leveraging its platform for generative drug design with Servier Pharmaceuticals LLC, of Suresnes, France. The deal will take advantage of Valence’s generative chemistry and multiparameter optimization to rapidly generate drug candidates. Valence will receive an up-front payment and is eligible for milestone payments.