Purple Biotech PPBT, a clinical-stage oncology company, reported positive final results from the mid-stage study of its lead candidate, CM24, for treating pancreatic ductal adenocarcinoma (“PDAC”) patients. CM24 is a humanized monoclonal antibody that blocks CEACAM1, supporting tumor immune evasion and survival through multiple pathways.
Purple Biotech states that treatment with CM24 in the phase II study demonstrated a clear and consistent improvement across all efficacy endpoints. A potential patient subgroup was also identified which may benefit from targeting CEACAM1 and NET serum levels. Such findings have the potential to position CM24 as an encouraging treatment option. Shares of PPBT surged 150.4% on Monday in response to the news.
The phase II study evaluated CM24 in combination with Bristol Myers’ BMY blockbuster immuno-oncology drug Opdivo (nivolumab) plus stand-of-care (SoC) chemotherapy in second-line metastatic PDAC patients compared with SoC chemotherapy alone. The study's primary endpoint is overall survival (OS) and the secondary endpoints include progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR).
The enrolled patients were randomly divided into two study cohorts, with two arms per cohort. In the experimental arms, second-line PDAC patients received CM24 and Bristol Myers’ Opdivo in combination with either gemcitabine/nab-paclitaxel or liposomal irinotecan (Nal-IRI)/5-fluorouracil (5-FU) and leucovorin (LV) (Nal-IRI/5FU/LV) chemotherapies. Patients in the control arms received either of the respective chemotherapy alone.
Purple Biotech reported that the gemcitabine/nab-paclitaxel-based part of the study was unsuitable for analysis and hence the data readout is only from the CM24+Opdivo+Nal-IRI/5FU/LV portion of the study.
Year to date, shares of PPBT have plunged 46.2% compared with the industry’s 7% decline.
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PPBT’s CM24 Therapy Shows Superior Efficacy in PDAC Study
The data showed that PDAC patients treated with the combination of CM24, Bristol Myers’ Opdivo and Nal-IRI/5FU/LV achieved improved outcomes compared with those receiving Nal-IRI/5FU/LV monotherapy. The combination therapy resulted in a median OS of 7.92 months compared with 5.55 months for the chemotherapy arm with higher 6-month OS rates (53% and 47%, respectively).
Purple Biotech also reported that the median PFS was also longer at 3.9 months versus two months, with better three and six-month PFS rates in the combination group. The ORR in the CM24+BMY’s Opdivo+Nal-IRI/5FU/LV arm was 25%, significantly higher than the 7% observed in the Nal-IRI/5FU/LV arm. The DCR of 63% in the combo arm surpassed the 47% in the monotherapy arm.
Additionally, in the experimental arm, CA19-9 levels, a clinically validated biomarker for PDAC, showed a consistent and steady decline, with a median reduction of approximately 80% from baseline compared with a 40% increase observed in the control arm.
A biomarker-enriched analysis based on pretreatment serum CEACAM1 levels revealed significantly better outcomes in the treatment arm compared with the control. The treatment arm showed a 79% reduction in the risk of death, with a median OS improvement of 5.1 months. Additionally, there was more than a 90% reduction in the risk of progression or death, with a median PFS improvement of 2.9 months. The ORR was also notably higher in the treatment arm, achieving 50% compared with 0% in the control. Similar efficacy benefits were observed in patients with pretreatment serum MPO levels of 200 ng/mL and 600 ng/mL.
The investigational combo therapy was overall well-tolerated with an acceptable safety profile, consistent with the SoC arm. Based on the encouraging results, Purple Biotech plans to initiate a three-arm phase IIb study comparing either CM24 plus a PD1 inhibitor or CM24 monotherapy to SoC in multiple tumor types selected based on their NET and CEACAM1 expressions. The study is expected to enroll patients with higher serum levels of CEACAM1 and MPO, as they are potentially more likely to benefit from CM24 treatment.
Purple Biotech Ltd. Sponsored ADR Price and Consensus
Purple Biotech Ltd. Sponsored ADR price-consensus-chart | Purple Biotech Ltd. Sponsored ADR Quote
PPBT’s Other Clinical Pipeline Candidates
Apart from CM24, Purple Biotech is also currently evaluating another clinical-stage candidate, NT219, a first-in-class, small molecule dual inhibitor of IRS1/2 and STAT3, in its pipeline, for head and neck and colorectal cancer indications. The company is currently gearing up to initiate a phase II study in the first half of 2025 to treat head and neck cancer.
Please note that Bristol Myers’ Opdivo is approved, both as a monotherapy and in combination with Yervoy to treat a plethora of cancer indications in many countries, including the United States and the European Union.
PPBT’s Zacks Rank & Other Stocks to Consider
Purple Biotech currently carries a Zacks Rank #2 (Buy).
Some other top-ranked pharma stocks are Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 10.3% year to date.
Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.
In the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 16.1% year to date.
Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.
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