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Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company based in Rehovot, Israel, dedicated to developing innovative cancer therapies that harness the tumor microenvironment to overcome immune evasion and drug resistance. The company's oncology pipeline includes two main drug candidates, CM24 and NT219, along with a pioneering platform of conditionally-activated tri-specific antibodies.
CM24 is a multi-functional immune checkpoint inhibitor undergoing Phase 2 clinical trials for the treatment of pancreatic ductal adenocarcinoma (PDAC). This study, in collaboration with Bristol Myers Squibb, is evaluating CM24 combined with nivolumab and chemotherapy as a second-line treatment. The primary endpoint is overall survival, with interim results expected by mid-2024 and topline data by the end of the same year.
NT219 is a small molecule dual inhibitor targeting IRS1/2 and STAT3. It has shown promising results in a Phase 1/2 dose escalation study for recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). A Phase 2 study is planned for NT219 in combination with cetuximab, set to begin in the first half of 2024.
Additionally, Purple Biotech’s tri-specific antibody platform aims to conditionally activate T cells and natural killer (NK) cells within the tumor microenvironment. The platform's lead candidate, IM1240, targets 5T4, a tumor-associated antigen, and is designed to induce a localized immune response while minimizing off-tumor side effects.
Recent financial reports indicate that Purple Biotech has a solid cash runway into the first half of 2025, thanks to strategic funding and partnerships. The company’s research and development expenses have seen a slight increase due to ongoing clinical trials, while selling, general, and administrative expenses have decreased.
For more detailed information and the latest updates, visit Purple Biotech’s website.
Purple Biotech (NASDAQ/TASE: PPBT) has completed its previously announced registered direct offering of 472,668 American Depositary Shares (ADSs) at $6.00 per ADS, with each ADS representing 200 ordinary shares. The offering generated gross proceeds of approximately $2.8 million, before deducting placement agent fees and other expenses.
H.C. Wainwright & Co. served as the exclusive placement agent for the offering. The company plans to use the net proceeds to fund the development of its oncology therapeutic candidates and for general working capital and corporate purposes. The offering was made pursuant to a shelf registration statement previously filed with and declared effective by the SEC.
Purple Biotech (NASDAQ/TASE: PPBT) has announced a $2.8 million registered direct offering of 472,668 American Depositary Shares (ADSs) at $6.00 per ADS. Each ADS represents 200 ordinary shares. The offering, expected to close around December 4, 2024, is being facilitated by H.C. Wainwright & Co. as the exclusive placement agent. The company plans to use the proceeds to fund the development of its oncology therapeutic candidates and for general working capital purposes. The offering is made pursuant to a previously filed and effective shelf registration statement.
Purple Biotech (NASDAQ/TASE: PPBT) reported positive final results from its randomized Phase 2 study of CM24 in second-line pancreatic cancer. The study evaluated CM24, combined with nivolumab and Nal-IRI/5FU/LV chemotherapy, showing significant improvements across efficacy endpoints. In a biomarker-enriched patient population, the treatment demonstrated a 79% reduction in death risk (HR 0.21, P = 0.04) with 5.1 months median OS improvement, and over 90% reduction in progression risk (HR < 0.1, P = 0.003) with 2.9 months median PFS improvement. The company plans to proceed with a Phase 2b study in multiple selected indications, targeting patients based on biomarkers.
Purple Biotech (NASDAQ/TASE: PPBT) reported Q3 2024 financial results and clinical updates. The company expects topline data from Phase 2 CM24 pancreatic cancer trial by end of 2024. New biomarker data showed patients with specific serum CEACAM1 levels demonstrated 79% reduction in death risk. Q3 financial highlights include reduced R&D expenses to $1.3M (71.7% decrease), operating loss of $2.1M (63.2% decrease), and net loss of $0.7M. Cash position stands at $6.3M with runway extending into Q4 2025. The company plans to commence Phase 2 study of NT219 in head and neck cancer in H1 2025.
Purple Biotech has identified serum CEACAM1 as a potential new blood biomarker for its lead oncology candidate CM24. Pancreatic cancer patients with serum CEACAM1 levels between 6K-15K pg/mL showed significantly improved outcomes when treated with CM24 and nivolumab combined with chemotherapy. The treatment demonstrated a 79% reduction in death risk, improving median overall survival from 3.6 to 8.7 months, and progression-free survival to 4.6 months. CM24, a CEACAM1 inhibitor, is currently in Phase 2 trials with topline results expected in Q4 2024.
Purple Biotech presented new data for its CAPTN-3 platform at the EORTC-NCI-AACR Symposium. The platform demonstrates sustained tumor regression in triple negative breast cancer models and dose-dependent activity in non-small cell lung cancer. The lead tribody IM1240 showed 5T4-dependent cytokine release with improved safety profile through conditional activation. The platform enables development of tri-specific antibodies targeting both T cells and NK cells to fight cancer, with potential first human clinical studies by 2026. The technology showed synergistic effects in tumor suppression and demonstrated plug-and-play capabilities for targeting different cancer types.
Purple Biotech (NASDAQ/TASE: PPBT) has been selected to present data on its CAPTN-3 platform at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, from October 23-25, 2024. The poster, titled "CAPTN-3: A novel platform of conditionally activated T cell and NK cell engagers," will be presented by Dr. Hadas Reuveni, VP R&D of Purple Biotech.
CAPTN-3 is a first-in-class platform of conditionally activated tri-specific antibodies that engage both T cells and NK cells with tumors, creating an enhanced immune response against cancer. The company's lead candidate, IM1240, targets 5T4, a tumor-associated antigen overexpressed in various solid tumors and linked to poor clinical outcomes. 5T4's specific expression pattern in cancer cells makes it an ideal target for therapeutic approaches in lung, gastric, head and neck, and other cancers.
Purple Biotech (NASDAQ/TASE: PPBT) reported positive interim data from its Phase 2 study of CM24, its lead oncology therapeutic candidate, for pancreatic ductal adenocarcinoma (PDAC) treatment. Key findings include:
1. High CEACAM1 and low PDL1 expression in tumors associated with improved overall survival (OS).
2. Improved OS for patients with serum neutrophil extracellular trap (NET) marker myeloperoxidase (MPO).
3. NETs proposed as a novel mechanism of action and potential biomarker for CM24-based therapy.
4. Data supports potential for biomarker-led studies and exploration of CM24's efficacy in other cancers.
The study evaluates CM24 combined with nivolumab and chemotherapy as a second-line PDAC treatment. Topline data expected in Q4 2024.
Purple Biotech (NASDAQ/TASE: PPBT) has been selected to present data on its lead oncology drug CM24 at the AACR Special Conference on Advances in Pancreatic Cancer Research in Boston, Massachusetts, from September 15-18, 2024. The poster presentation, scheduled for September 17, will focus on exploratory biomarker evaluation from the randomized Phase 2 study of CM24 in combination with nivolumab and chemotherapy for advanced/metastatic pancreatic cancer.
The ongoing Phase 2 study involves 63 patients across 18 centers in the U.S., Spain, and Israel. Interim data presented at the 2024 ASCO Annual Meeting showed improvements in overall survival, progression-free survival, and objective response rate in the experimental arm compared to standard of care. Topline data from this study are expected in Q4 2024.
Purple Biotech (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies for tumor immune evasion and drug resistance, will participate in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024. The company's executive management will engage in a virtual Fireside Chat presentation and one-on-one meetings with institutional investors.
Key points:
- Virtual Fireside Chat available on-demand from September 9 at 7:00 AM ET
- Presentation accessible for 30 days on Purple Biotech's website
- CEO Gil Efron to conduct in-person meetings at the Lotte New York Palace Hotel
- Investors can register for the conference at www.hcwevents.com/annualconference
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