Phanes Therapeutics, Inc., a US-based company involved in oncology discovery, research and clinical development, announced on Thursday that it has received orphan drug designation from the US Food and Drug Administration (FDA) for PT886 intended to treat pancreatic cancer.
The product is a first-in-class bispecific antibody targeting claudin 18.2 (CLDN18.2) and cluster of differentiation 47 (CD47) being developed for patients with pancreatic cancer and gastric and gastroesophageal cancers.
Dr Ming Wang, Phanes Therapeutics founder and CEO, said, 'PT886 has the potential to be a transformative treatment option for pancreatic cancer patients whose current standard of care is severely limited. This orphan drug designation comes in the same month with our recent IND clearance for PT886, which we are rapidly progressing into the clinic. These important milestones the company has achieved in Q2 this year follow the March IND clearance for PT199, an anti-CD73 monoclonal antibody for the treatment of multiple solid tumours.'
Privo Technologies reports progress in oral cancer trial
BeOne Medicines' sonrotoclax receives FDA Breakthrough Therapy Designation for MCL
Ascletis selects once-monthly SQ GLP-1R/GIPR dual peptide agonist, ASC35, for clinical development
Celltrion's biosimilar EYDENZELT (aflibercept-boav) approved by US FDA
Rigel Pharmaceuticals begins dose expansion phase of R289 study in lower-risk MDS
Precision NeuroMed's glioblastoma multiforme treatment granted FDA Orphan Drug Designation
Merck completes acquisition of Verona Pharma to expand cardio-pulmonary portfolio
Oxford Biomedica expands US operations with acquisition of viral vector facility in North Carolina
DarioHealth and OneStep partner to integrate fall risk technology into digital health platform
Ananda Pharma achieves key Phase 1 milestone for MRX1 CBD program
Alvotech and Advanz Pharma announce EMA acceptance of AVT23 marketing application