Algenex SL, of Madrid, Spain, opened its facility in Tres Cantos, Spain, that comprises approximately 900 square meters of rearing and production areas, molecular laboratories and office space, as well as two suites that will be dedicated to commercial manufacturing. The new facility can produce up to 3.5 kg of recombinant proteins, equivalent to around 100 million vaccine doses.
Alligator Bioscience AB, of Lund, Sweden, said it launched a new concept for patient-specific immunotherapy. Called Neo-X-Prime, it is based on the company’s bispecific format Ruby and builds on bispecific antibodies that physically connect tumor debris from the patient’s cancer cells with the relevant immune cells, resulting in strong and tumor-selective immune activation. That is thought to increase both the accuracy of the immune attack and the overall antitumor effect, the company said. Data were presented at the 11th World Bispecific Summit.
CNS Pharmaceuticals Inc., of Houston, selected Image Analysis Group (IAG), of London and Philadelphia, for its upcoming clinical trials of berubicin for the treatment of glioblastoma multiforme. IAG will use its Dynamika cloud platform and artificial intelligence-driven methodologies to provide early efficacy readouts.
Dexcom Inc., of San Diego, signed a five-year collaboration agreement with the University of Virginia to study Dexcom's automated insulin delivery technology. The research will also explore the use of continuous glucose monitoring tools outside type 1 diabetes, including inpatient hospital use, type 2 diabetes and gestational diabetes.
Hoth Therapeutics Inc., of New York, reported preclinical data on HT-003, an inhibitor of retinoic acid metabolism. The drug inhibited Toll-like receptor 2 in vitro in human keratinocytes.
Ideaya Biosciences Inc., of South San Francisco, said it expanded its clinical trial collaboration and supply agreement with New York-based Pfizer Inc. for a company-sponsored clinical combination study of IDE-196, a protein kinase C inhibitor, and crizotinib, a cMET inhibitor to which Pfizer has exclusive worldwide rights. The study will evaluate the combination therapy in patients with solid tumors having GNAQ or GNA11 mutations, including metastatic uveal melanoma (MUM), skin melanoma, lung cancer and colorectal cancer. Evaluating MUM patient clinical samples, the company said it identified cMET expression or activation as a potentially valuable biomarker that may guide IDE-196 clinical treatment in this indication. It also demonstrated preclinical synergy in MUM with the combination of IDE-196 and crizotinib, which further supports the potential biomarker on cMET expression.
Kyan Therapeutics Inc., of Singapore, said it entered an exclusive license agreement with Georgetown University for novel selective class II HDAC inhibitors. The company has already begun preclinical development of the lead candidate, KYAN-001, with early positive results. In vitro and in vivo studies of KYAN-001 have shown high efficacy for multiple myeloma and prostate cancer. The company plans to explore at least four cancer indications for the compound and anticipates advancing it through to phase I trials by 2022.
Lumen Bioscience Inc., of Seattle, and the U.S. Army Medical Research and Development Command, operating through the Medical Technology Enterprise Consortium, said they entered an agreement to develop a rapid, scalable and inexpensive biologic drug cocktail to treat gastrointestinal infection in COVID-19 patients and potentially block disease transmission. The almost $4 million grant will fund rapid development of an oral SARS-CoV-2 treatment and preventative product candidates through FDA IND submission and initial engineering work for a large-scale cGMP manufacturing plant. By spring next year, the program aims to initiate phase II trials and complete siting and engineering work for a 1 billion-dose-per-year production facility, with cGMP manufacturing to commence in the summer.
Mindmed Inc., of Basel, Switzerland, and the University Hospital Basel’s Liechti Lab are collaborating on R&D to advance the understanding of altered states of consciousness induced by psilocybin and LSD. Mindmed will retain an exclusive license to all intellectual property and any patents generated from data or findings in the study and related work on psilocybin, such as pharmacokinetic data and information on the metabolism. The study is expected to finish in the second quarter of 2021.
Parexel Inc., of Waltham, Mass., and Innoplexus AG, of Eschborn, Germany, launched the COVID-19 Clearinghouse, an online resource for patients, researchers and clinical trial sponsors to directly access publications, datasets, links to active global clinical trials and current news related to COVID-19. The COVID-19 Clearinghouse incorporates information from more than 100 different geographies providing access to 22,853 datasets, 65,602 publications, 5,173 clinical trials and 229,738 news articles.
Samsung Biologics Co., of Incheon, South Korea, and Kanaph Therapeutics Inc., of Seoul, South Korea, said they will collaborate to develop KNP-301, a bispecific Fc fusion protein for treating retinal diseases. The protein is designed to target autoimmune diseases by inhibiting the alternative pathway of the complement system. Samsung will provide CDO services from cell line development, process development, nonclinical and clinical material manufacturing to IND submission.
The University of Texas MD Anderson Cancer Center and Tokyo-based Taiho Pharmaceutical Co. Ltd. said they entered a three-year strategic collaboration to accelerate the development of treatments for significant unmet medical needs in oncology, including patients with brain metastases and those with cancers refractory to available therapies. The collaboration draws on Taiho’s portfolio of preclinical and clinical brain-penetrant therapies and the translational research capabilities of MD Anderson’s Translational Research to Advance Therapeutics and Innovation in Oncology platform as well as insights and clinical development infrastructure from its Brain Metastasis Clinic.
Trisalus Life Sciences, of Westminster, Colo., having acquired SD-101, a short sequence of DNA that binds to the Toll-like receptor 9 from Dynavax Technologies Corp., of Emeryville, Calif., said it will initiate clinical trials in patients with uveal melanoma liver metastases followed by testing in patients with pancreatic ductal adenocarcinoma and colorectal cancer liver metastases.
New research from Vir Biotechnology Inc., of San Francisco, based on blood samples from nearly 650 SARS-CoV-2-infected people in Switzerland, Italy and the U.S. shows the magnitude of antibodies produced by an infected individual is proportional to disease severity. The data show that hospitalized patients possess higher antibody titers compared to non-hospitalized patients and the antibodies have a half-life of less than two months. Scientists also report that the receptor binding domain of the virus is the main target of naturally occurring neutralizing antibodies, accounting for 90% of the neutralizing activity in serum. Vir, along with London-based Glaxosmithkline plc, is working to advance COVID-19 monoclonal antibodies based on the S309 antibody, including VIR-7831 and VIR-7832.