4D Pharma plc, of Leeds, U.K., said it inked a clinical trial collaboration and supply agreement with Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York, for Bavencio (avelumab), under which 4D Pharma intends to begin a clinical trial to test Bavencio in combination with MRx-0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
Atara Biotherapeutics Inc., of South San Francisco, presented preclinical data at the Transplantation & Cellular Therapy Meeting of the American Society for Transplantation and Cellular Therapy and the Center for International Blood & Marrow Transplant Research. Results detail new findings from a comprehensive multiomic analysis of modes of activation for tabelecleucel (tab-cel), demonstrating that, upon stimulation, tab-cel exhibits a consistent activation signature at the level of gene expression, T-cell receptor engagement (TCR), and secretion of factors associated with effective T-cell responses. Results further illustrated that the tab-cel manufacturing process results in complementary clonal expansion and consistent enrichment of TCRs associated with productive engagement of EBV-driven diseases.
Elicio Therapeutics Inc., of Cambridge, Mass., said data published in Science Advances showed the enhanced lymph node-targeting ability of COVID-19 vaccine ELI-005 magnified T-cell and antibody responses that were persistent for months after immunization. Data showed up to 25-fold higher numbers of T cells than benchmark vaccines detected in peripheral blood (>40% of CD8) and sites that provide the first line of defense against COVID-19, including lung tissue (>70% CD8) and respiratory fluid. The vaccine also demonstrated induction of 265-fold higher neutralizing antibody responses to coronavirus protein antigens than were present in convalescent COVID-19 patients. Durable responses with no decline in T-cell or antibody levels were seen six weeks after completion of the vaccine regimen.
Entera Bio Ltd., of Boston, disclosed a new research program for an oral glucagon-like peptide-2 (GLP-2) analogue based on the company’s platform technology. GLP-2 is known to enhance intestinal absorption, specifically the increased absorption of nutrients. The only GLP-2 analogue currently on the market, teduglutide, was approved in 2012 as a once-daily injection for the treatment of short bowel syndrome in the U.S. and Europe, registering global sales of $574 million in 2019, the company noted.
Eton Pharmaceuticals Inc., of Deer Park, Ill., sold its neurology portfolio to Azurity Pharmaceuticals Inc., of Wilmington, Mass. The portfolio includes Eton’s lamotrigine (ET-105), zonisamide (ET-104) and topiramate (ET-101) product candidates, which have all been submitted to the FDA as new drug applications and are under review. Azurity is paying $15 million at closing, of which $5.5 million has been held in escrow until certain product-related milestones are achieved; $15 million upon achievement of approval and product launch milestones; and $15 million upon achievement of commercial sales milestones, plus a single-digit royalty.
Lineage Cell Therapeutics Inc., of Carlsbad, Calif., signed an exclusive option and license agreement with Neurgain Technologies Inc., of La Jolla, Calif., a medical device company that is commercializing technology developed by neurosurgeons at the University of California San Diego. The firms will collaborate on the clinical testing of Neurgain’s novel parenchymal delivery injection system, which is designed to allow for the administration of cells to the spinal cord without stopping the patient’s respiration. Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk and variability of administering cells to the area of injury, the firms noted.
Magenta Therapeutics Inc., of Cambridge, Mass., disclosed data presentations across its stem cell mobilization and targeted conditioning programs at the Transplantation and Cellular Therapy annual meeting. Data from a preclinical study demonstrate the potential of the company’s MGTA-145 plus plerixafor (Mozobil, Sanofi SA) to serve as an efficient, single-dose mobilization regimen for in vivo hematopoietic gene therapy where stem cells could be gene corrected or edited without having to remove them from the body.
Moleculin Biotech Inc., of Houston, said the Medical Research Agency, a Polish state agency responsible for development of scientific research in the field of medical and health sciences, awarded a grant equivalent to $1.5 million to the Maria Sklodowska-Curie National Research Institute to fund a phase Ib/II trial of annamycin, a next-generation anthracycline, for the treatment of soft tissue sarcoma lung metastases. The grant-funded clinical trial will be led by Piotr Rutkowski at the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Poland.
Nanoviricides Inc., of Shelton, Conn., said its broad-spectrum anti-coronavirus drug candidate for the treatment of COVID-19 infections was well-tolerated in safety pharmacology studies. NV-CoV-2 was found to be safe in studies performed by a contract research organization in rat and nonhuman primate models, the firm said. Nanoviricides said it believes it will be possible to administer repeated dosages of NV-CoV-2 in a human trial, if needed, to achieve control over the coronavirus infection from SARS-CoV-2 or its variants.
Olix Pharmaceuticals Inc., of Suwon, South Korea, disclosed the establishment of Mcurex Therapeutics Inc., a subsidiary focused on the research and development of mRNA vaccines and therapeutics. The firm will initially focus on developing mRNA-based vaccines for human diseases including COVID-19, as well as animal diseases.
Orion Corp., of Espoo, Finland, and Bayer AG, of Leverkusen, Germany, will expand their collaboration to develop the oral androgen receptor inhibitor (ARi) darolutamide for treating prostate cancer with a new phase III trial. The study will combine the compound and androgen deprivation therapy (ADT) vs. placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC). The primary endpoint is radiological progression-free survival from randomization to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first. About 555 men are expected to enroll by the end of the first quarter of 2021. The study adds to the compound’s program, including a phase III investigating darolutamide in a triple combination with ADT and docetaxel compared to docetaxel and ADT alone in men with mHSPC.
A compassionate use program from Orpha Labs AG, of Baar, Switzerland, makes ORL-101, an L-fucose formulation, available to physicians in Israel caring for patients with leukocyte adhesion deficiency type II patients. Orpha Labs said it expects to enroll LAD-II patients in a phase III trial soon. The FDA has granted a rare pediatric disease designation to ORL-101 for treating the indication.
Q-State Biosciences Inc., of Cambridge, Mass., said it achieved the primary program completion milestone in its research collaboration with Chamishi Therapeutics Inc., of Deerfield, Ill., and the Silverstein Foundation for Parkinson’s with GBA. Q-State said it designed a series of optimized preclinical antisense oligonucleotide candidates as potential treatments for a number of neurological disorders including glucosylceramidase beta acid-Parkinson’s disease. Completing the milestone entitles Q-State a prespecified grant of equity in Chamishi. The preclinical antisense oligonucleotide candidates were generated for an undisclosed neuroinflammation target using Q-State’s technologies.
Repligen Corp., of Waltham, Mass., and Navigo Proteins GmbH, of Halle, Germany, said they completed development and initiated commercial launch of NGL COVID-19 Spike Protein Affinity Resin, a novel affinity resin to be used in purifying COVID-19 vaccines. The resin will be manufactured and marketed by Repligen.
Seneca Therapeutics Inc., of Philadelphia, said it will expand its R&D pipeline with six new armed gene therapy/oncolytic constructs directed against cancer targets and indications. The company also said it began an SVV-001 program developing precision medicine constructs expressing patient-specific neoantigens. Each of the new gene therapy technologies targets cancer cells with TEM 8 expression. Normal cells lack significant expression of TEM 8 and are therefore not infected by SVV-001, so the armed transgene will not express in normal cells, the company added. Studies in multiple human tumor types indicate TEM 8 expression is an adverse indicator of long-term survival and is associated with cancer metastasis.
Sigilon Therapeutics Inc., of Cambridge, Mass., said new preclinical data show its platform can treat a range of chronic diseases. These data span four distinct lysosomal diseases, including MPS-1, Fabry, MPS-2 and MPS-6, the company added. The candidates are composed of engineered human cells shielded within spheres designed to avoid immune rejection and fibrosis.
Therapeutics Solutions International Inc., of Elk City, Idaho, said it filed a new patent application using data demonstrating that mice immunized with Stemvacs possess a type of "memory" NK cells that are capable of transferring immunity to naïve mice. Typically, the concept of "immunological memory" applies only to cells of the adaptive immune system such as T cells and B cells, but not to NK cells, which are considered part of innate immunity, the company added. In a series of experiments, mice bearing B16 melanoma were treated with Stemvacs, inducing regression and eventual disappearance of the tumor. One month later, mice were sacrificed and NK cells were transferred to mice that were not treated with Stemvacs. The mice receiving NK cells were resistant to development of melanoma upon challenge. Therapeutic Solutions is advancing Stemvacs, an umbilical cord-generated dendritic cell immunotherapy candidate, to treat solid tumors.
Preclinical research from Unity Biotechnology Inc., of South San Francisco, revealed a novel mechanism for treating age-related eye diseases, such as diabetic retinopathy and diabetic macular edema, by restoring vascular health in the retina, the company said. By selectively eliminating senescent cells accumulating in diseased blood vessels of the eye, researchers identified a way to target diseased vasculature while leaving healthy blood vessels intact, thus enabling the retina to repair itself, the company added. The study is featured in the April issue of Cell Metabolism.