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.'
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion
BioCryst wins FDA approval for oral HAE prophylaxis in young children
NanOlogy launches drug development program for diffuse intrinsic pontine glioma treatment