Why Is Purple Biotech Stock Trading Higher On Monday?

Zinger Key Points

CM24 combo therapy improved median overall survival to 7.92 months versus 5.55 months with chemotherapy alone in metastatic PDAC patients.
The experimental arm showed an 80% reduction in CA19-9 levels compared to a 40% increase in the control group.
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On Monday, Purple Biotech Ltd PPBT reported the final results from the randomized Phase 2 study of its lead oncology drug, CM24, a humanized monoclonal antibody that blocks CEACAM1, in patients with pancreatic ductal adenocarcinoma (PDAC).

Purple Biotech stock is trading higher with a strong session volume of 9.7 million, compared to an average volume of 48.73K as per data from Benzinga Pro.

The Phase 2 study evaluated CM24 in combination with Bristol Myers Squibb & Co’s BMY immune checkpoint inhibitor nivolumab plus stand-of-care (SoC) chemotherapy in second-line metastatic PDAC patients versus SoC chemotherapy alone.

In the intent-to-treat cohort population, the median overall survival rate was 7.92 months in the CM24 combo treatment arm versus 5.55 months in the chemo arm.

The median progression-free survival was 3.9 months versus 2.0 months.

The overall response rate was 25% versus 7%, and the disease control rate was 63% compared to 47% in the CM24 combo arm vs. chemo alone group.

A consistent and continuous decrease of CA19-9, a clinically validated PDAC biomarker, was observed in the experimental arm, reaching a median percentage reduction from baseline of approximately 80% vs. an increase of 40% in the control arm.

A biomarker-enriched patient population analysis based on pretreatment ranges of serum CEACAM1 demonstrated significant improvement in the treatment arm over the control, with a 79% reduction in the risk of death and a median overall survival improvement of 5.1 months.

Over 90% reduction in risk of progression or death was observed, with a median progression-free survival improvement of 2.9 months and improvement in the treatment arm over the control, resulting in an overall response rate of 50% vs. 0%.

The CM24+nivolumab+Nal/IRI/5FU/LV regimen was well tolerated. The most frequent treatment-emergent Grade 3 or higher adverse events were diarrhea, fatigue, and neutropenia.

Accordingly, no meaningful differences in safety and tolerability were observed between the experimental arm and the SoC arm.

Price Action: PPBT stock is up 54.1% at $5.17 during the premarket session at last check Monday.

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