- Context Therapeutics ( NASDAQ: CNTX ), a biotech focused on oncology, shed ~27% pre-market Thursday after announcing preliminary data from an ongoing Phase 2 trial for onapristone extended-release (ONA-XR) oral therapy in metastatic breast cancer.
- The SMILE study was designed to evaluate the progesterone receptor antagonist ONA-XR with estrogen receptor antagonist fulvestrant in patients with ER+, HER2- advanced, or metastatic breast cancer as a second-line option.
- Early data indicated that 44% of trial participants lived four months without cancer worsening (4-month progression-free survival). The data presented at the 2022 San Antonio Breast Cancer Symposium also showed a favorable safety and tolerability profile for the study drug.
- ONA-XR is also undergoing a Phase 1b/2 ELONA trial in combination with oral selective estrogen degrader, elacestrant, in certain breast cancer patients. Data from its Phase 1b portion is expected in Q4 2023.
- An early readout for ONA-XR in combination with breast cancer therapy anastrozole previously indicated a 4-month PFS rate of 77% in patients with progesterone receptor-positive (PR+) metastatic endometrial cancer.
- In September, Context ( CNTX ) announced a decision to prioritize ELONA clinical program and Claudin 6 (CLDN6) preclinical program.
For further details see:
Context drops 27% after early mid-stage data for breast cancer candidate