Purple Biotech (PPBT) said Monday the phase 2 study evaluating its lead oncology drug, CM24, in combination with nivolumab and standard-of-care chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma, or PDAC, showed positive final results.
The study involved 63 patients and compared CM24 plus nivolumab with chemotherapy in second-line metastatic PDAC versus chemotherapy alone.
The company said the CM24 plus nivolumab and chemotherapy demonstrated "clear and consistent improvement across all efficacy endpoints."
Key results showed a median overall survival of 7.92 months in the experimental arm versus 5.55 months in the control arm. The progression-free survival was also improved, with a median of 3.9 months compared with 2 months in the control group. The overall response rate was 25% for the experimental arm, compared with the 7% observed in the control group.
The regimen was well tolerated, with "no meaningful difference in safety and tolerability were observed between the experimental arm and SoC arm."
Purple Biotech said it plans a 3-arm phase 2b trial comparing CM24 plus a PD1 inhibitor or CM24 monotherapy to SoC in multiple tumor types.
Purple Biotech shares were up over 53% in recent premarket trading.
Price: 5.14, Change: +1.78, Percent Change: +53.20
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