AVROBIO Receives Orphan Drug Designation from the European Commission for AVR‑RD‑04, an Investigational Gene Therapy for Cystinosis

AVROBIO, Inc. announced that the European Commission has granted orphan drug designation for AVR-RD-04, the company’s investigational gene therapy for the treatment of cystinosis.
[AVROBIO, Inc.]
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Morphic Reports Positive Interim Results from Single Ascending Dose Phase I Clinical Trial of MORF-057

Morphic Therapeutic announced positive interim results from its Phase I clinical trial of MORF-057, an oral small molecule inhibitor of the α4β7 integrin in development for the treatment of inflammatory bowel disease.
[ Morphic Therapeutic ]
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Ultimovacs Starts Clinical Evaluation of Novel TET-Platform with Phase I TENDU Study Investigating Prostate Cancer-Specific Therapeutic Vaccine

Ultimovacs ASA announced the treatment of the first patient in the Phase I TENDU trial, representing the start of clinical evaluation for the company’s Tetanus-Epitope Targeting (TET)-platform.
[Ultimovacs ASA]
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Diffusion Pharmaceuticals Completes Phase Ib Study of TSC in Hospitalized COVID-19 Patients

Diffusion Pharmaceuticals, Inc. announced completion and topline data from the open-label, Phase Ib clinical trial of its novel, diffusion-enhancing therapeutic, trans sodium crocetinate, in hospitalized COVID-19 patients with confirmed hypoxemia, the most common cause of tissue hypoxia.
[Diffusion Pharmaceuticals, Inc.]
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Avacta Announces Phase I Clinical Trial Authorisation (CTA) for AVA6000 Approved by MHRA

Avacta Group plc announced that it has received approval from the Medicines and Healthcare Products Regulatory Agency for its Clinical Trial Authorisation in the UK for a Phase I study of its lead pre|CISIONTM pro-drug, AVA6000 pro-doxorubicin.
[Avacta Group plc]
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Neoadjuvant Anti-OX40 (MEDI6469) Therapy in Patients with Head and Neck Squamous Cell Carcinoma Activates and Expands Antigen-Specific Tumor-Infiltrating T Cell

Scientists describe the results from a Phase Ib clinical trial in which 17 patients with locally advanced head and neck squamous cell carcinoma received a murine anti-human OX40 agonist antibody prior to definitive surgical resection.
[Nature Communications]
Duhen, R., Ballesteros-Merino, C., Frye, A. K., Tran, E., Rajamanickam, V., Chang, S.-C., Koguchi, Y., Bifulco, C. B., Bernard, B., Leidner, R. S., Curti, B. D., Fox, B. A., Urba, W. J., Bell, R. B., & Weinberg, A. D. (2021). Neoadjuvant anti-OX40 (MEDI6469) therapy in patients with head and neck squamous cell carcinoma activates and expands antigen-specific tumor-infiltrating T cells. Nature Communications, 12(1), 1047. https://doi.org/10.1038/s41467-021-21383-1 Cite
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FDA Fast Track, ODD, and RPDD Designations for FBX-101 Gene Therapy for Patients with Krabbe Disease

Forge Biologics, Inc. announced that the FDA has granted Fast Track, Orphan Drug, and Rare Pediatric Disease (RPD) designations to FBX-101 for the treatment of patients with Krabbe disease. Forge is now actively recruiting patients for enrollment in the RESKUE phase I/II clinical trial of FBX-101, a novel, first-in-human AAV gene therapy for the disease.
[Forge Biologics, Inc.]
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TCR-Engineered T Cells Targeting E7 for Patients with Metastatic HPV-Associated Epithelial Cancers

Scientists conducted a first-in-human, phase 1 clinical trial of T cells engineered with a T cell receptor targeting HPV-16 E7 for the treatment of metastatic human papilloma virus-associated epithelial cancers.
[Nature Medicine]
Nagarsheth, N. B., Norberg, S. M., Sinkoe, A. L., Adhikary, S., Meyer, T. J., Lack, J. B., Warner, A. C., Schweitzer, C., Doran, S. L., Korrapati, S., Stevanović, S., Trimble, C. L., Kanakry, J. A., Bagheri, M. H., Ferraro, E., Astrow, S. H., Bot, A., Faquin, W. C., Stroncek, D., … Hinrichs, C. S. (2021). TCR-engineered T cells targeting E7 for patients with metastatic HPV-associated epithelial cancers. Nature Medicine, 1–7. https://doi.org/10.1038/s41591-020-01225-1 Cite
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Trefoil Therapeutics Begins Second Phase II “STORM” Clinical Trial with Regenerative Treatment for Fuchs Endothelial Corneal Dystrophy

Trefoil Therapeutics announced it has begun a Phase II clinical trial of its engineered Fibroblast Growth Factor-1, TTHX1114, to evaluate its safety and efficacy as a regenerative treatment for patients with Fuchs Endothelial Corneal Dystrophy
[Trefoil Therapeutics]
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Arch Oncology to Collaborate with Merck on Phase I/II Clinical Trial of Anti-CD47 Antibody AO-176 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Select Solid Tumors

Arch Oncology, Inc. announced that it has entered into a clinical trial collaboration and supply agreement with Merck. Under this collaboration, Arch Oncology is expanding its ongoing Phase I/II clinical trial to evaluate AO-176, the Company’s novel anti-CD47 antibody, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with select solid tumors.
[Arch Oncology, Inc.]
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Dopamine Receptor Antagonists, Radiation, and Cholesterol Biosynthesis in Mouse Models of Glioblastoma

Treatment of glioma cells with the dopamine receptor antagonist quetiapine reduced glioma cell self-renewal in vitro and combined treatment of mice with quetiapine and radiation prolonged the survival of glioma-bearing mice.
[JNCI-Journal of the National Cancer institute]
Bhat, K., Saki, M., Cheng, F., He, L., Zhang, L., Ioannidis, A., Nathanson, D., Tsang, J., Bensinger, S. J., Nghiemphu, P. L., Cloughesy, T. F., Liau, L. M., Kornblum, H. I., & Pajonk, F. (2021). Dopamine Receptor Antagonists, Radiation, and Cholesterol Biosynthesis in Mouse Models of Glioblastoma. JNCI: Journal of the National Cancer Institute, djab018. https://doi.org/10.1093/jnci/djab018 Cite
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