Celyad Oncology Announces Clinical Trial Collaboration to Evaluate CYAD-101 with KEYTRUDA® (pembrolizumab) in Patients with Microsatellite Stable mCRC

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.
[Celyad Oncology]
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Sarepta Therapeutics Investigational Gene Therapy SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E Shows Sustained Functional Improvements 18-months After Administration

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.]
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AVROBIO Receives Orphan Drug Designation from the European Medicines Agency for AVR-RD-02, an Investigational Gene Therapy for Gaucher Disease

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.
[AVROBIO, Inc.]
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Ad26 Vector-Based COVID-19 Vaccine Encoding a Prefusion-Stabilized SARS-CoV-2 Spike Immunogen Induces Potent Humoral and Cellular Immune Responses

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.
[npj Vaccines]
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
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Morphic Therapeutic Announces First Healthy Volunteers Dosed in Phase I Clinical Trial of MORF-057

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.
[Morphic Therapeutic]
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Sarepta Therapeutics Investigational Gene Therapy SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E Shows Sustained Functional Improvements 18-months after Administration

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.)]
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Clinical Effects of Intrathecal Administration of Expanded Wharton Jelly Mesenchymal Stromal Cells in Patients with Chronic Complete Spinal Cord Injury: A Randomized Controlled Study

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.
[Cytotherapy]
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
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Tmunity Announces First Patient Dosed in Phase 1 Clinical Trial with CART-TnMUC1

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.]
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Fourth Large-Scale COVID-19 Vaccine Trial Begins in the United States

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]
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ALX Oncology to Collaborate with Merck on Phase II Immuno-Oncology Studies Evaluating ALX148, Targeting CD47, in Combination with KEYTRUDA® (Pembrolizumab) in Patients with Head & Neck Cancer

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.
[ALX Oncology]
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The Use of Mesenchymal Stromal Cells in the Treatment of Coronavirus Disease 2019

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]
Canham, M. A., Campbell, J. D. M., & Mountford, J. C. (2020). The use of mesenchymal stromal cells in the treatment of coronavirus disease 2019. Journal of Translational Medicine, 18(1), 359. https://doi.org/10.1186/s12967-020-02532-4 Cite
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