Purple Biotech Achieves Toxicology Milestone Demonstrating an Expanded Therapeutic Window for CAPTN-3 Platform Tri-specific Antibody, IM1240
Rhea-AI Summary
Purple Biotech (NASDAQ: PPBT) reported that its tri-specific antibody IM1240 from the CAPTN-3 platform completed a non-human primate toxicology study showing an expanded therapeutic window.
Key findings: IM1240 was tolerated at doses up to 300-fold higher than a non-capped comparator (IM1222) with significantly reduced immune-related toxicity and only modest cytokine release. IM1240 also showed a favorable PK profile with increased systemic exposure, dose-proportional AUC and Cmax, and a prolonged circulating half-life attributed to albumin incorporation and capping design. Efficacy in tumor-bearing mice occurred at exposures below those in the Study. The company plans regulatory submission toward first-in-human studies in H2 2026.
Positive
- Dosing tolerated up to 300-fold vs non-capped comparator
- Significantly reduced immune-related toxicity, including minimal cytokine release
- Favorable PK: dose-proportional increases in AUC and Cmax with prolonged half-life
- Preclinical efficacy in mice at exposures below toxicology levels
Negative
- No human data; first-in-human studies not yet initiated
- Regulatory submission and first-in-human start are planned for H2 2026, not completed
News Market Reaction
On the day this news was published, PPBT gained 0.19%, reflecting a mild positive market reaction. Argus tracked a trough of -11.0% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $12K to the company's valuation, bringing the market cap to $6M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Key biotech peers like WINT and SCNI showed notable gains today (e.g., WINT up 20.57%, SCNI up 8.75%), while PPBT’s pre-news move of +0.92% was modest, indicating a largely stock-specific setup.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 11 | Preclinical data update | Positive | -0.5% | Positive CAPTN-3 preclinical results for IM1240 and IM1305 at ESMO IO. |
| Dec 04 | Data presentation plans | Positive | +8.0% | Announcement of upcoming CAPTN-3 preclinical data presentation at ESMO-IO 2025. |
| Nov 14 | Earnings and update | Neutral | -3.0% | Q3 2025 results, cash runway into 2027, and IM1240/IM1305 pipeline updates. |
| Oct 29 | Manufacturing milestone | Positive | +81.8% | IM1240 manufacturing milestone confirming commercially viable yield and scalability. |
| Oct 20 | Nasdaq bid notice | Negative | -0.4% | Nasdaq minimum bid price notification and 180-day cure period disclosure. |
IM1240 platform milestones have sometimes driven strong upside (e.g., manufacturing win), but other positive updates saw flat or negative follow-through, showing mixed responsiveness to good news.
Over the past few months, Purple Biotech has steadily advanced its CAPTN-3 tri-specific antibody platform. An IM1240 manufacturing milestone on Oct 29, 2025 coincided with an 81.82% gain, while later preclinical data at ESMO-IO 2025 produced more muted reactions. Q3 2025 results highlighted a cash runway into 2027 and IM1240’s progress toward a 2026 IND. The October $1.00 bid-price notice underscored listing risk. Today’s toxicology milestone extends the IM1240 narrative toward first-in-human trials in 2026.
Market Pulse Summary
This announcement advances IM1240 with a toxicology study showing dosing up to 300-fold higher than a non-capped comparator and a favorable pharmacokinetic profile. It follows 2025 milestones on manufacturing and preclinical efficacy, with regulatory submission planned for the second half of 2026. At $0.6999, well below the $4.7108 52-week high, investors may track financing actions, Nasdaq bid-price compliance, and progress toward first-in-human trials.
Key Terms
tri-specific antibody medical
pharmacokinetic medical
human serum albumin medical
cytokine release syndrome medical
t cell engagers medical
cd3 medical
auc medical
cmax medical
AI-generated analysis. Not financial advice.
IM1240 demonstrated improved safety in a toxicology study at doses up to 300-fold higher than a non-capped comparator
IM1240's pharmacokinetic profile showed increased systemic exposure and a prolonged circulating half-life enabled by its human serum albumin moiety and capping design
IM1240 on track towards first-in-human clinical trials, with regulatory submission planned for the second half of 2026
REHOVOT, Israel, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech” or the “Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing a next-generation immunotherapy platform designed to maximize anti-cancer potency while minimizing toxicity, today announced successful completion of a non-human primates toxicology study (the “Study”) of IM1240, a tri-specific antibody from its CAPTN-3 platform that targets 5T4, a tumor-specific antigen expressed on multiple solid tumors.
The Study demonstrated that IM1240's proprietary capping technology enabled dosing at levels up to 300-fold higher than a non-capped comparator, with significantly reduced immune-related toxicity, including minimal cytokine release. These results highlight the unique safety profile of this approach, which may address a key limitation of certain current T cell engagers, where cytokine release syndrome can restrict dosing.
“In the Study, IM1240 demonstrated a favorable safety and tolerability profile, with hematologic findings that align with its expected pharmacodynamic effects on immune activation. The CD3 capping design of IM1240 showed clear differentiation compared with the non-capped comparator, IM1222, enabling a significant reduction in immune-related effects, including cytokine release, which remained modest, even at doses up to 300-fold higher than those of the non-capped antibody,” stated Gil Efron, CEO of Purple Biotech. “Purple Biotech continues to deliver on its stated milestones and we believe that collectively, these data provide translational guidance that may inform optimal dose selection, dosing strategy, and safety monitoring plans for the next phase of advanced toxicological assessments. We are working to advance IM1240 toward first-in-human studies as efficiently as possible and expect to provide updates on our progress over the course of 2026.”
IM1240 demonstrated a favorable pharmacokinetic (PK) profile in the Study, characterized by increased systemic exposure and a prolonged circulating half-life. PK analyses showed dose-dependent and proportional increases in exposure, as reflected by both AUC and Cmax. The Company believes these findings support dose-exposure relationship and provide proof of concept for the capping design and albumin incorporation as a contributor to IM1240’s favorable PK profile. In addition, efficacy observed in vivo in tumor-bearing mice occurred at exposures meaningfully lower than those achieved in the Study, further supporting IM1240’s advantageous therapeutic window.
About the CAPTN-3 Platform
CAPTN-3, Purple Biotech's lead program, is a platform of capped tri-specific antibodies that simultaneously target tumor-associated antigens while engaging both T cells and NK cells. Proprietary capping technology confines immune activation to the tumor microenvironment by masking the CD3-binding arm in circulation and activating it only at the tumor site, significantly expanding the therapeutic window versus conventional T-cell engagers. The platform’s lead candidates, IM1240 (targeting 5T4) and IM1305 (targeting TROP2), are in preclinical development.
About Purple Biotech
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage oncology company developing first-in-class therapies to overcome tumor immune evasion and drug resistance. The Company is focused on advancing its lead program, CAPTN-3 - a platform of capped tri-specific antibodies that simultaneously target tumors while engaging both T cells and NK cells. Proprietary capping technology confines immune activation to the tumor microenvironment, significantly expanding the therapeutic window versus conventional T-cell engagers. The platform’s lead candidate, IM1240 is advancing toward the clinic and IM1305 is in preclinical development. The Company’s pipeline also includes additional clinical-stage assets, including CM24, a CEACAM1-blocking antibody that demonstrated improved outcomes across all efficacy endpoints in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma, and NT219, a dual IRS1/2 and STAT3 inhibitor in a Phase 2 study for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck. The Company is headquartered in Rehovot, Israel. For additional information about the Company, please visit: https://purple-biotech.com
Forward-Looking Statements and Safe Harbor Statement
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “suggest”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and CAPTN-3; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission (“SEC”), including our cautionary discussion of risks and uncertainties under “Risk Factors” in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date on which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC’s website, https://www.sec.gov.
CONTACTS:
Company Contact:
IR@purple-biotech.com
FAQ
What toxicology result did Purple Biotech announce for IM1240 (PPBT) on January 7, 2026?
How did IM1240 perform on cytokine release measures in the PPBT toxicology study?
What pharmacokinetic (PK) changes were observed for IM1240 in the Study?
Does the IM1240 toxicology data include efficacy evidence?
When does Purple Biotech expect to file for first-in-human studies for IM1240 (PPBT)?
