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.'
European Commission approves Camurus' once-monthly octreotide treatment for acromegaly
FDA approval streamlines access to Bristol Myers Squibb CAR T cell therapies
Emmaus Life Sciences' Endari label enhancements receive US FDA approval
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress
Cumberland Pharmaceuticals reports ifetroban Phase 2 DMD heart disease trial results
Sarclisa recommended for EU approval in newly diagnosed transplant-eligible multiple myeloma