Welcome to our dedicated page for Purple Biotech news (Ticker: PPBT), a resource for investors and traders seeking the latest updates and insights on Purple Biotech stock.
Overview
Purple Biotech Ltd (symbol: PPBT) is a clinical‐stage oncology company dedicated to developing first‐in‐class therapies aimed at overcoming tumor immune evasion and drug resistance. With a strong focus on innovative research and clinical development, Purple Biotech is actively engaged in advancing novel therapeutic candidates that seek to modify the tumor microenvironment and stimulate an effective immune response. Key industry terms such as immunotherapy, oncology therapies, and clinical-stage development form the cornerstone of its mission to address unmet needs in cancer treatment.
Business Model and Clinical Pipeline
The company’s core business is built around its robust oncology pipeline comprising multiple investigational agents with unique mechanisms of action that target various aspects of tumor survival and progression:
- NT219: A novel small molecule dual inhibitor that targets IRS1/2 and STAT3. This agent is designed to disrupt key intracellular pathways that facilitate cancer cell survival and drug resistance. Early-phase clinical studies have been structured to validate its safety and potential in combination with established cancer therapies.
- CM24: A humanized monoclonal antibody developed to block the CEACAM1 protein, a critical immune checkpoint implicated in tumor immune evasion. CM24 is evaluated as part of combination therapy regimens with anti-PD-1 checkpoint inhibitors, aiming to restore immune recognition and attack against cancer cells.
- IM1240: The lead tribody from a preclinical platform of conditionally-activated tri-specific antibodies that engage both T cells and NK cells. IM1240 is designed to target tumor-associated antigens, thereby unleashing both innate and adaptive immune responses within the tumor site.
Research and Technology Platforms
Purple Biotech integrates advanced biotechnological research and proprietary development platforms to support its pipeline. Through the innovative use of cleavable capping technology, the company’s tri-specific antibodies are engineered to confine therapeutic activity to the local tumor microenvironment. This precision targeting potentially enhances the therapeutic window while minimizing systemic side effects. The company’s strategy revolves around exhaustive molecular profiling, biomarker evaluation, and a collaborative approach to clinical development, ensuring that each candidate is developed with a focus on maximizing efficacy and safety.
Partnerships and Collaborations
The clinical development of its agents is supported by strategic partnerships and collaborations with renowned pharmaceutical companies. For instance, collaborative agreements with leading industry players enable combination trials that incorporate established immunotherapies, thereby broadening the clinical relevance of its investigational therapies. Such collaborations also provide access to shared expertise and resources, facilitating accelerated clinical evaluation while maintaining high research standards.
Industry Position and Market Considerations
Operating in the competitive arena of oncology drug development, Purple Biotech differentiates itself through its focused approach on mechanisms that enable the immune system to overcome tumor resistance. By targeting both the intrinsic signaling pathways and the extrinsic immune checkpoints, the company’s pipeline represents a multi-faceted approach to cancer treatment. This strategic positioning places Purple Biotech alongside a niche group of innovators tackling some of the most challenging aspects of oncology, while its emphasis on combination therapies and conditional activation of immune modulators reinforces its commitment to precision medicine.
Scientific Rationale and Clinical Development Strategy
The therapeutic design of Purple Biotech’s candidates is underpinned by robust scientific rationale and extensive preclinical research. The dual inhibitor NT219 is engineered to shut down critical signaling pathways that contribute to cancer cell proliferation and survival. Similarly, CM24 functions by targeting CEACAM1-mediated interactions known to support tumor immune evasion—a hallmark of many aggressive cancers. Complementing these efforts, the tri-specific antibody platform harnesses the synergistic interplay between T cells and NK cells to generate a potent localized immune response, an approach that embodies the precision of modern immunotherapy.
Operational Excellence and Corporate Governance
Headquartered in Rehovot, Israel, Purple Biotech operates with a clear commitment to transparency, scientific rigor, and operational excellence. The company’s leadership leverages extensive experience in both biotechnology research and clinical development to navigate the intricacies of drug development. Its clinical studies are designed with a focus on clear endpoints and adaptive methodologies, ensuring that each phase of clinical investigation yields actionable insights. The adherence to strict regulatory standards and detailed risk management strategies further underscores its dedication to quality and compliance.
Research Highlights and Scientific Communication
Through a series of published studies and presentations at high-profile conferences, Purple Biotech actively communicates its research findings to the broader scientific and investment communities. The dissemination of early-phase clinical data, alongside biomarker analyses and exploratory endpoints, contributes to a growing body of evidence supporting its therapeutic approach. This commitment to scientific communication not only enhances its credibility but also encourages collaborative innovation and peer validation.
Comprehensive Risk Management
In the realm of early-stage drug development, inherent risks exist concerning clinical efficacy, regulatory approvals, and market acceptance. Purple Biotech addresses these challenges through meticulous clinical planning, ongoing evaluation of safety profiles, and adaptive trial designs. By proactively engaging with regulatory authorities and external research bodies, the company strives to mitigate risks, ensuring that its therapeutic candidates are developed in a controlled, scientifically robust manner.
Conclusion
Purple Biotech Ltd represents a focused, science-driven approach to cancer therapy development. Its targeted strategies to counteract tumor immune evasion, along with innovative technologies like dual inhibition and tri-specific antibody engineering, compose a comprehensive assault on tumor survival mechanisms. The company’s commitment to detailed clinical research, strategic collaborations, and a robust risk management framework establishes it as a significant participant within the oncology R&D landscape. This thorough, research-oriented approach equips Purple Biotech with the tools necessary to contribute meaningfully to the future of precision oncology.
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
Purple Biotech (NASDAQ/TASE: PPBT) reported positive interim data from its Phase 2 CM24 pancreatic cancer study at ASCO 2024. The CM24+nivolumab+NAL-IRI/5FU/LV combination showed improvements in overall survival, progression-free survival, and objective response rate compared to standard-of-care. The company is evaluating expanding CM24's clinical program based on its novel CEACAM1 target on Neutrophil Extracellular Traps.
Financial highlights for Q2 2024 include:
- R&D expenses decreased 35.1% to $2.4 million
- Operating loss decreased 31.4% to $3.5 million
- Net loss decreased to $2.4 million ($0.09 per ADS)
- Cash runway extended to Q3 2025
Purple Biotech expects additional interim data in Q3 2024 and final topline results in Q4 2024.
Purple Biotech (NASDAQ/TASE: PPBT), a clinical-stage oncology company, has received a 180-day extension from Nasdaq to regain compliance with the minimum $1.00 bid price requirement. The company now has until January 21, 2025, to meet this requirement, which involves maintaining a closing bid price of at least $1.00 for its American Depositary Shares (ADSs) for a minimum of 10 consecutive business days. This extension does not immediately affect Purple Biotech's listing on Nasdaq or the Tel Aviv Stock Exchange. The company will monitor its ADS price and consider options to regain compliance within the given timeframe.
Purple Biotech (NASDAQ/TASE: PPBT) will host a virtual event on July 11, 2024, to discuss positive interim results from its Phase 2 study of CM24 in treating second-line metastatic pancreatic ductal adenocarcinoma (PDAC). The event will feature key opinion leaders Dr. Michael Cecchini from Yale School of Medicine and Dr. E. Gabriela Chiorean from the University of Washington School of Medicine. They will present data showing a reduction in the risk of death and disease progression, improved overall survival (OS) and progression-free survival (PFS), higher objective response rate (ORR), and disease control rate (DCR). The study also revealed that baseline serum myeloperoxidase (MPO) might be a predictive biomarker for the treatment's effectiveness. CM24, combined with nivolumab and standard chemotherapy, showed promising results. Management will outline future plans for CM24, followed by a Q&A session.
Purple Biotech announced the closing of an exercise of existing warrants, resulting in gross proceeds of approximately $2 million. The company issued new unregistered Series A-1 and A-2 warrants in consideration for the exercise of the existing ones.
The new warrants are exercisable immediately, with varying terms of twenty-four months to five years, and an exercise price of $0.40 per ADS. Net proceeds will fund oncology therapeutic candidates' development and general corporate purposes.