Celyad Oncology SA, announced that the Company has entered into a clinical trial collaboration with MSD, a tradename of Merck & Co., Inc., through a subsidiary. Celyad Oncology will conduct the Phase Ib KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology’s investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI preconditioning chemotherapy, with MSD’s anti-PD-1 therapy, KEYTRUDA® in refractory metastatic colorectal cancer patients with microsatellite stable/ mismatch-repair proficient disease.
Sarepta Therapeutics, Inc. announced positive results from the ongoing study of SRP-9003 the company’s investigational gene therapy for limb-girdle muscular dystrophy Type 2E.
[Sarepta Therapeutics, Inc.]
AVROBIO, Inc. announced that the European Commission has granted orphan drug designation for AVR-RD-02, the company’s investigational gene therapy for the treatment of Gaucher disease.
Scientists evaluated design elements previously shown for other coronavirus S protein-based vaccines to be successful, e.g., prefusion-stabilizing substitutions and heterologous signal peptides, for selection of a S-based SARS-CoV-2 vaccine candidate.
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Bos, R., Rutten, L., van der Lubbe, J. E. M., Bakkers, M. J. G., Hardenberg, G., Wegmann, F., Zuijdgeest, D., de Wilde, A. H., Koornneef, A., Verwilligen, A., van Manen, D., Kwaks, T., Vogels, R., Dalebout, T. J., Myeni, S. K., Kikkert, M., Snijder, E. J., Li, Z., Barouch, D. H., … Schuitemaker, H. (2020). Ad26 vector-based COVID-19 vaccine encoding a prefusion-stabilized SARS-CoV-2 Spike immunogen induces potent humoral and cellular immune responses. Npj Vaccines, 5(1), 1–11. https://doi.org/10.1038/s41541-020-00243-x Cite
Morphic Therapeutic announced that the first healthy volunteers have received MORF-057 in a Phase I clinical trial designed to evaluate MORF-057’s safety and pharmacokinetic profile in addition to predictive pharmacodynamic signals. MORF-057 is in clinical development as an oral small molecule inhibitor of the α4β7 integrin for the treatment of inflammatory bowel disease with an initial focus on ulcerative colitis.
Sarepta Therapeutics, Inc. announced positive results from the ongoing study of SRP-9003, the company’s investigational gene therapy for limb-girdle muscular dystrophy Type 2E.
[Sarepta Therapeutics, Inc. (GlobeNewswire, Inc.)]
Patients were randomly assigned to receive a single dose of intrathecal ex vivo-expanded Wharton’s jelly-MSCs from human umbilical cord or placebo and were then switched to the other arm at six months.
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Albu, S., Kumru, H., Coll, R., Vives, J., Vallés, M., Benito-Penalva, J., Rodríguez, L., Codinach, M., Hernández, J., Navarro, X., & Vidal, J. (2020). Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy, 0(0). https://doi.org/10.1016/j.jcyt.2020.08.008 Cite
Tmunity Therapeutics, Inc. announced that it has dosed the first patient in its Phase I CART-TnMUC1-01 clinical trial with the Tn/STn glycoform of mucin 1 chimeric antigen receptor T-cell therapy in patients with TnMUC1-positive advanced cancers.
[Tmunity Therapeutics, Inc.]
A fourth Phase III clinical trial evaluating an investigational vaccine for coronavirus disease 2019 has begun enrolling adult volunteers. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.
[National Institute of Allergy and Infectious Diseases]
ALX Oncology announced it has entered into a clinical trial collaboration with Merck to evaluate the combination of ALX148, an investigational next generation CD47 blocker, and KEYTRUDA®, Merck’s anti-PD-1 therapy, for the treatment of patients with Head & Neck Squamous Cell Carcinoma.
The use of mesenchymal stromal cells for COVID-19 has become an attractive avenue down which almost 70 different clinical trial teams have ventured.
[Journal of Translational Medicine]