This section highlights FDA-related milestones and regulatory updates for drugs developed by Purple Biotech (PPBT).
Over the past two years, Purple Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NT219, CAPTN-3, CM24, and CM24+Nivolumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
NT219 FDA Regulatory Timeline and Events
NT219 is a drug developed by Purple Biotech for the following indication: Adults with Advanced Solid Tumors and Head and Neck Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NT219
- Announced Date:
- September 10, 2025
- Indication:
- Adults with Advanced Solid Tumors and Head and Neck Cancer
Announcement
Purple Biotech announced that the Examining Division of the European Patent Office has issued an intention to grant a European Patent for Application No. 20168234.1, titled 'Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer'.
AI Summary
Purple Biotech Ltd. announced that the Examining Division of the European Patent Office has issued an intention to grant a European patent for Application No. 20168234.1, titled “Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer.” If granted, this patent will run through 2036 and cover the use of NT219 in combination with major immunotherapies such as anti-PD-1, PD-L1, CTLA-4, and CD20 antibodies. It also protects NT219 pairings with MEK inhibitors and with certain chemotherapies or targeted drugs to tackle tumors driven by KRAS amplification or mutation.
NT219 works by binding to IRS1/2 and blocking STAT3, two proteins that cancer cells use to resist treatment and evade the immune system. Purple Biotech is already testing NT219 in a Phase 2 study for squamous cell carcinoma of the head and neck, combining it with pembrolizumab or cetuximab to boost response rates in resistant tumors.
Read Announcement- Drug:
- NT219
- Announced Date:
- June 17, 2025
- Indication:
- Adults with Advanced Solid Tumors and Head and Neck Cancer
Announcement
Purple Biotech Ltd. announced the initiation of a Phase 2 clinical study evaluating NT219 in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
AI Summary
Purple Biotech Ltd. announced the start of a Phase 2 clinical study to evaluate NT219 in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). This novel small molecule targets key oncogenic pathways by inducing the degradation of IRS1/2 and inhibiting STAT3 phosphorylation. The study, led by Dr. Antonio Jimeno at the University of Colorado Anschutz Medical Campus, will assess NT219 in combination with standard treatments—either pembrolizumab or cetuximab—in two separate single-arm cohorts.
The trial uses a Simon 2-stage design, beginning with 10 patients per cohort and potentially expanding to 29 patients per group. This approach aims to overcome tumor resistance and improve outcomes for patients who have not responded to current treatments. The study also plans to evaluate potential biomarkers identified in previous research, reinforcing Purple Biotech’s commitment to advancing new treatment options for head and neck cancer.
Read Announcement- Drug:
- NT219
- Announced Date:
- April 28, 2025
- Indication:
- Adults with Advanced Solid Tumors and Head and Neck Cancer
Announcement
Purple Biotech Ltd. announced today that two posters reporting new NT219 data being presented at the American Association for Cancer Research (AACR 2025) Annual Meeting on Sunday and Monday, April 27-28, 2025.
AI Summary
Purple Biotech Ltd. announced that it will present two posters on new NT219 data at the AACR 2025 Annual Meeting on April 27-28, 2025. One poster shares research on NT219’s impact in head and neck cancer, showing how it suppresses key proteins like STAT3 and IRS1/2. These results suggest that the activated forms of STAT3 and IGF1R could help identify patients who may benefit most from NT219 therapy.
The second poster highlights NT219’s potential in colorectal cancer by focusing on biomarkers related to the β-catenin pathway. The study shows that the activation of β-catenin or the loss of its regulator, APC, may serve as important indicators for treatment response. These insights support continued clinical studies and suggest that NT219 could restore the effectiveness of immunotherapies while addressing tumor resistance mechanisms.
Read Announcement- Drug:
- NT219
- Announced Date:
- April 16, 2025
- Indication:
- Adults with Advanced Solid Tumors and Head and Neck Cancer
Announcement
Purple Biotech Ltd. announced the publication of an independent study titled "IRS2 as a driver of brain metastasis in colorectal cancer: a potential target for novel therapeutic strategies" in the peer reviewed journal, Neuro Oncology. NT219 is a first-in-class small molecule drug designed to target key cancer resistance mechanisms by degrading IRS1/2 and blocking downstream signaling towards AKT and b-catenin, as well as STAT3 survival pathways.
AI Summary
Purple Biotech Ltd. announced the publication of an independent study in the peer-reviewed journal Neuro Oncology. The study, titled "IRS2 as a driver of brain metastasis in colorectal cancer: a potential target for novel therapeutic strategies," highlights the role of IRS2 in the spread of colorectal cancer to the brain. Researchers found that IRS2 is a key driver behind the formation of brain metastasis, and blocking this pathway could offer a new way to treat these cancers.
The study focuses on NT219, a first-in-class small molecule drug designed to degrade IRS1/2 and block downstream signaling pathways, including AKT, beta-catenin, and STAT3. In preclinical trials, combining NT219 with 5-fluorouracil (5-FU) helped reduce brain metastasis and extended animal survival, suggesting that NT219 could be a promising therapeutic strategy for patients with colorectal cancer spread to the brain.
Read Announcement- Drug:
- NT219
- Announced Date:
- March 28, 2025
- Indication:
- Adults with Advanced Solid Tumors and Head and Neck Cancer
Announcement
Purple Biotech Ltd announced upcoming poster presentations including one for CM24 in the treatment of pancreatic cancer, and two for NT219 in the treatment of colorectal and head and neck cancers, at the 2025 American Association for Cancer Research Meeting (2025 AACR), scheduled to take place from April 25th to April 30th in Chicago.
AI Summary
Purple Biotech Ltd. has announced that it will present new research at the 2025 American Association for Cancer Research Meeting in Chicago from April 25th to April 30th. The company will showcase three poster presentations that highlight its work on innovative cancer therapies. One presentation will focus on CM24, a humanized antibody being studied in combination with nivolumab and chemotherapy for the treatment of pancreatic cancer. The poster will share the final analysis of a Phase 2 study and explore potential serum biomarkers, offering insights that could lead to improved patient outcomes. In addition, two separate posters will detail findings on NT219, a novel small molecule targeting key cancer pathways, with one presentation addressing its application in colorectal cancer and the other focusing on head and neck squamous cell carcinoma. These presentations demonstrate the company’s ongoing commitment to developing therapies that overcome tumor immune evasion and drug resistance.
Read Announcement- Drug:
- NT219
- Announced Date:
- March 5, 2025
- Indication:
- Adults with Advanced Solid Tumors and Head and Neck Cancer
Announcement
Purple Biotech Ltd. announced that the U.S. Patent and Trademark Office has issued a patent for NT219 used in combination with epidermal growth factor receptor (EGFR) antibodies for treating cancer patients who have acquired resistance to EGFR therapies.
AI Summary
Purple Biotech Ltd. announced that the U.S. Patent and Trademark Office has issued a patent for NT219 when used with epidermal growth factor receptor (EGFR) antibodies. The patent covers the use of NT219 combined with drugs like cetuximab (Erbitux), panitumumab (Vectibix), and necitumumab (Portrazza) to treat cancer patients who have developed resistance to EGFR therapies. This new patent protects the combination approach in major markets including the United States, Europe, China, and Japan. NT219 is a small molecule drug designed to target cancer resistance mechanisms by degrading IRS1/2 and blocking key survival pathways that contribute to drug resistance. According to Purple Biotech CEO Gil Efron, this patent strengthens the company’s intellectual property portfolio and positions NT219 well for potential future commercialization as an innovative treatment for resistant tumors.
Read Announcement- Drug:
- NT219
- Announced Date:
- February 18, 2025
- Indication:
- Adults with Advanced Solid Tumors and Head and Neck Cancer
Announcement
Purple Biotech Ltd. announced it is advancing into a Phase 2 study with NT219 in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Read Announcement
CAPTN-3 FDA Regulatory Timeline and Events
CAPTN-3 is a drug developed by Purple Biotech for the following indication: For Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CAPTN-3
- Announced Date:
- September 4, 2025
- Indication:
- For Cancer
Announcement
Purple Biotech Ltd. announced new data on its CAPTN-3 tri-specific antibody IM1240 generated in the laboratory of Dr. Amir Horowitz of the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai.
AI Summary
Purple Biotech Ltd. reported new preclinical results for IM1240, its first CAPTN-3 tri-specific antibody, developed in Dr. Amir Horowitz’s lab at Mount Sinai. Using fresh biopsies from head and neck cancer patients resistant to anti-PD1 therapy, IM1240 triggered tumor cell apoptosis while related bispecific antibodies without either the CD3 or NKG2A arm showed no effect. Researchers observed a strong synergy between the T-cell engager (CD3) and the NK-cell engager (NKG2A) arms, highlighting the unique design of the CAPTN-3 platform.
IM1240 targets 5T4, a tumor-associated antigen, and blocks the NKG2A/HLA-E checkpoint to boost antitumor cytotoxicity and minimize off-target activation. Analysis of approximately 26,000 human transcriptomes revealed that NKG2A, HLA-E and 5T4 are co-expressed in solid tissues but not in blood, supporting the antibody’s tumor-selective activity and safety profile.
Purple Biotech plans to submit an IND for IM1240 in 2026, moving this novel tri-specific therapy closer to first-in-human trials.
Read Announcement- Drug:
- CAPTN-3
- Announced Date:
- September 3, 2025
- Indication:
- For Cancer
Announcement
Purple Biotech Ltd. announced its second CAPTN-3 trispecific antibody, targeting TROP2 in development.
AI Summary
Purple Biotech Ltd. announced its second CAPTN-3 tri-specific antibody called IM1305, which targets TROP2. IM1305 is built on a platform that activates both innate and adaptive immunity. It has three arms: a masked anti-CD3 arm released only in the tumor microenvironment, an anti-NKG2A arm, and an anti-TROP2 arm. The cleavable cap on the CD3 arm is designed to reduce side effects and allow higher dosing.
In mouse models of triple negative breast cancer, IM1305 caused lasting tumor regression with no recurrence after treatment. It also killed cancer cells in tongue, pancreatic, and gastric tumor models at very low doses (EC50 1–5 pM). TROP2 is found on many solid tumors and tied to poor outcomes. By linking T cells and NK cells at the tumor site, this antibody may offer a new way to treat diverse cancers.
Read Announcement- Drug:
- CAPTN-3
- Announced Date:
- June 23, 2025
- Indication:
- For Cancer
Announcement
Purple Biotech Ltd. announced the presentation of new preclinical data on its novel CAPTN-3 tri-specific antibody platform in a poster presentation at the 2025 Annual Congress of the European Association for Cancer Research (EACR 2025), that was held in Lisbon, Portugal from June 16-19, 2025.
AI Summary
Purple Biotech Ltd. presented new preclinical data on its novel CAPTN-3 tri-specific antibody platform at the 2025 Annual Congress of the European Association for Cancer Research held in Lisbon, Portugal. The CAPTN-3 platform is designed to activate both the innate and adaptive immune systems to attack tumors. It combines a conditionally activated anti-CD3 arm with an NK cell-engaging arm and an additional component targeting tumor-associated antigens. This approach may help re-invigorate exhausted T cells and enhance the anti-tumor response, as shown in in vivo experiments. The poster highlighted that the CAPTN-3 lead product showed sustained tumor regression in a breast cancer model, demonstrating its potential effectiveness and safety profile. Overall, the presentation underscored the flexibility and promise of the CAPTN-3 platform in developing future cancer therapies.
Read Announcement- Drug:
- CAPTN-3
- Announced Date:
- June 4, 2025
- Indication:
- For Cancer
Announcement
Purple Biotech Ltd. announced a poster presentation on its novel CAPTN-3 tri-specific antibody platform, will be featured at the Annual Congress of the European Association for Cancer Research (EACR) 2025, being held in Lisbon, Portugal from June 16 – 19, 2025.
AI Summary
Purple Biotech Ltd. announced that it will present a poster on its innovative CAPTN-3 tri-specific antibody platform at the Annual Congress of the European Association for Cancer Research (EACR) 2025. This event will take place in Lisbon, Portugal from June 16 to 19, 2025. The poster, titled "CAPTN-3: A novel platform of conditionally activated T cell and NK cell engagers," explains how the platform aims to boost immune responses by engaging both T cells and natural killer (NK) cells within the tumor microenvironment. Dr. Hadas Reuveni, the Vice President of R&D at Purple Biotech, will lead the presentation during the Immunotherapy session on June 17, 2025. The detailed abstract will be published online after the conference, offering further insights into the company’s progress in developing therapies that target tumors and overcome immune evasion.
Read Announcement
CM24 FDA Regulatory Timeline and Events
CM24 is a drug developed by Purple Biotech for the following indication: Multiple Advanced Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CM24
- Announced Date:
- April 30, 2025
- Indication:
- Multiple Advanced Cancers
Announcement
Purple Biotech Ltd. announced that a poster presentation titled "Final analysis of the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer & potential serum biomarkers" is being presented during the session "Liquid Biopsy: Circulating Nucleic Acids 4 / Predictive Biomarkers 1" at the Annual Meeting of the American Association of Cancer Research (AACR 2025) on Wednesday, April 30, 2025.
AI Summary
Purple Biotech Ltd. announced that it will present a poster titled "Final analysis of the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer & potential serum biomarkers" at the Annual Meeting of the American Association of Cancer Research (AACR 2025). This presentation is scheduled for Wednesday, April 30, 2025, during the session "Liquid Biopsy: Circulating Nucleic Acids 4 / Predictive Biomarkers 1."
The poster will detail final results from a Phase 2 study in pancreatic cancer patients treated with CM24, nivolumab, and chemotherapy. The data highlights significant reductions in the risk of death and disease progression in patients with specific serum and tumor biomarkers. These findings are seen as a promising step in using predictive biomarkers to select patients for a future biomarker-driven Phase 2b study, potentially advancing treatment options for cancers with major unmet needs.
Read Announcement- Drug:
- CM24
- Announced Date:
- December 2, 2024
- Indication:
- Multiple Advanced Cancers
Announcement
Purple Biotech Ltd. reported positive 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).
AI Summary
Purple Biotech Ltd. announced positive final results from its randomized Phase 2 study evaluating CM24 in patients with pancreatic ductal adenocarcinoma (PDAC). CM24 is a humanized monoclonal antibody designed to block CEACAM1, a protein that helps tumors evade the immune system. In the study, CM24 was combined with the checkpoint inhibitor nivolumab and Nal-IRI/5FU/LV chemotherapy. The treatment arm showed clear improvements in all efficacy endpoints compared to chemotherapy alone.
Specifically, a subgroup of patients with certain pretreatment serum CEACAM1 levels experienced a 79% reduction in the risk of death and over a 90% reduction in the risk of progression or death. These promising results, including better overall survival and progression-free survival, support further development of CM24. The company is planning a Phase 2b study to explore this treatment further in multiple tumor types where CEACAM1 is expressed.
Read Announcement- Drug:
- CM24
- Announced Date:
- November 15, 2024
- Indication:
- Multiple Advanced Cancers
Announcement
Purple Biotech Ltd provided Clinical updates
AI Summary
Purple Biotech Ltd recently provided promising clinical updates focused on its Phase 2 study of CM24 in pancreatic cancer. Interim results from the trial demonstrated efficacy when CM24 was used in combination with nivolumab and chemotherapy. The data revealed that certain serum biomarkers, such as CEACAM1, PD-L1, and the neutrophils extracellular trap marker myeloperoxidase, may help identify patients who could experience improved overall survival. These biomarker findings support the potential to refine patient selection in future studies and further enhance treatment outcomes.
Additionally, the company presented new data on its CAPTN-3 tri-specific antibody platform, which showed encouraging activity in in-vivo models. This platform targets both T cells and natural killer cells, offering a promising approach to overcoming tumor immune evasion and drug resistance in various cancers.
Read Announcement- Drug:
- CM24
- Announced Date:
- September 18, 2024
- Indication:
- Multiple Advanced Cancers
Announcement
Purple Biotech Ltd. today reported new positive biomarker findings for its lead oncology therapeutic candidate CM24.
AI Summary
Purple Biotech Ltd. reported promising new biomarker results for its lead oncology candidate, CM24. The study focused on patients with pancreatic ductal adenocarcinoma (PDAC) and showed that combining CM24 with the PD-1 inhibitor nivolumab and chemotherapy might improve patient outcomes. The data revealed that tumors with high levels of CEACAM1 and low levels of PDL1 were linked to a 90% reduction in death risk and a median overall survival extension of 4.1 months. In addition, lower levels of the serum NET marker, myeloperoxidase (MPO), were associated with better survival trends. These findings suggest that CEACAM1 is an important target in cancer therapy and offer a path for future biomarker-guided studies, potentially widening CM24’s use in treating PDAC and other cancers where immune evasion plays a key role.
Read Announcement - Drug:
- CM24
- Announced Date:
- September 10, 2024
- Indication:
- Multiple Advanced Cancers
Announcement
Purple Biotech Ltd. announced it has been selected for a poster presentation at the American Association for Cancer Research® (AACR) Special Conference on Advances in Pancreatic Cancer Research which will be held on September 15-18, 2024, in Boston, Massachusetts.
AI Summary
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) announced it has been selected to present a poster at the American Association for Cancer Research® (AACR) Special Conference on Advances in Pancreatic Cancer Research in Boston, Massachusetts, from September 15-18, 2024. The poster presentation, scheduled for September 17 from 6:45 to 9:00 pm ET, is titled “Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer.”
The study evaluates the combination of CM24, an experimental agent, with Bristol Myers Squibb’s PD-1 inhibitor nivolumab and standard chemotherapy in patients with pancreatic ductal adenocarcinoma. This Phase 2 trial, which has enrolled 63 patients across multiple centers, aims to compare the effectiveness of the experimental treatment against standard chemotherapy alone. The poster presentation highlights Purple Biotech’s ongoing commitment to advancing novel immunotherapy approaches in the fight against pancreatic cancer.
Read Announcement
CM24+Nivolumab + Nal-IRI/5FU/LV FDA Regulatory Events
CM24+Nivolumab + Nal-IRI/5FU/LV is a drug developed by Purple Biotech for the following indication: For Pancreatic Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CM24+Nivolumab + Nal-IRI/5FU/LV
- Announced Date:
- June 27, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- For Pancreatic Cancer
Announcement
Purple Biotech Ltd. announced that Further data and top line results are expected in the second half of 2024
AI Summary
Purple Biotech Ltd. recently shared promising interim findings from its Phase 2 study of CM24 combined with nivolumab and standard chemotherapy for treating metastatic pancreatic ductal adenocarcinoma. The study suggests that patients with lower serum myeloperoxidase levels may experience better overall survival and improved response rates compared to standard treatment alone. The regimen showed a reduced risk of death and slower disease progression, indicating potential benefits for those with advanced disease.
Emphasizing future developments, the company announced that further detailed study data and top-line results are expected to be reported in the second half of 2024. Purple Biotech also has plans to host a virtual event on July 11, 2024, where experts will discuss these encouraging results and the potential impact of the new treatment strategy.
Read Announcement- Drug:
- CM24+Nivolumab + Nal-IRI/5FU/LV
- Announced Date:
- June 27, 2024
- Indication:
- For Pancreatic Cancer
Announcement
Purple Biotech Ltd reported additional positive interim data from its randomized, controlled, open label, multicenter Phase 2 study (NCT 04731467) of CM24, in combination with Bristol Myers Squibb's immune checkpoint inhibitor nivolumab and standard of care (SoC) chemotherapy, in second-line metastatic pancreatic ductal adenocarcinoma (PDAC)..
AI Summary
Purple Biotech Ltd. reported additional positive interim findings from its randomized, controlled, open-label, multicenter Phase 2 study (NCT 04731467) in patients with second‐line metastatic pancreatic ductal adenocarcinoma (PDAC). The study evaluated the combination of CM24, a humanized antibody that blocks the CEACAM1 immune checkpoint, with Bristol Myers Squibb’s immune checkpoint inhibitor nivolumab and standard of care chemotherapy (Nal-IRI/5FU/LV). Results showed promising improvements, including a 26% reduction in the risk of death and a 28% reduction in progression risk, as well as longer overall survival and progression-free survival compared to chemotherapy alone.
An exploratory biomarker analysis suggested that patients with baseline serum myeloperoxidase (MPO) levels below a defined threshold experienced greater survival benefits, with a median overall survival improvement of 3.6 months. Purple Biotech plans to reveal further data in the second half of 2024 and will host a virtual key opinion leader event on July 11, 2024.
Read Announcement
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