Purple Biotech Announces New Data Supporting the Unique Design of CAPTN-3 Tri-Specific Antibody IM1240 in Collaboration with the Icahn School of Medicine at Mount Sinai
Purple Biotech (NASDAQ/TASE: PPBT) has announced promising new data for its CAPTN-3 tri-specific antibody IM1240 in collaboration with Mount Sinai. The research, led by Dr. Amir Horowitz, demonstrated successful tumor cell death in treatment-resistant head and neck cancer biopsies.
Key findings show synergistic effects between NK and T cell engager arms of IM1240, and analysis of 26,000 human transcriptomes validates the antibody's design targeting 5T4 and NKG2A. The company plans to submit an IND application in 2026 for first-in-human clinical trials.
The research spans multiple resistant cancers including NSCLC, HNSCC, and bladder cancer. IM1240's unique design offers potentially safer checkpoint inhibition compared to existing therapies, particularly through its selective NKG2A targeting.
Purple Biotech (NASDAQ/TASE: PPBT) ha annunciato nuovi dati promettenti sul suo anticorpo tri-specifico CAPTN-3 IM1240, frutto di una collaborazione con il Mount Sinai. La ricerca, guidata dal Dr. Amir Horowitz, ha mostrato morte selettiva delle cellule tumorali in biopsie di tumori testa-collo resistenti ai trattamenti.
I risultati principali evidenziano effetti sinergici tra le componenti che reclutano NK e T di IM1240, e l'analisi di 26.000 trascrittomi umani convalida il design dell'anticorpo che prende di mira 5T4 e NKG2A. L'azienda prevede di presentare un IND nel 2026 per avviare i primi studi clinici sull'uomo.
La ricerca copre diversi tumori resistenti, inclusi NSCLC, HNSCC e carcinoma della vescica. Il design distintivo di IM1240 potrebbe offrire un'inibizione dei checkpoint potenzialmente più sicura rispetto alle terapie esistenti, grazie alla sua selettiva azione su NKG2A.
Purple Biotech (NASDAQ/TASE: PPBT) ha anunciado datos prometedores sobre su anticuerpo trispecífico CAPTN-3 IM1240, en colaboración con Mount Sinai. La investigación, dirigida por el Dr. Amir Horowitz, demostró muerte de células tumorales en biopsias de cáncer de cabeza y cuello resistentes al tratamiento.
Los hallazgos clave muestran efectos sinérgicos entre los brazos que reclutan NK y T de IM1240, y el análisis de 26.000 transcriptomas humanos valida el diseño del anticuerpo dirigido contra 5T4 y NKG2A. La compañía planea presentar una solicitud IND en 2026 para ensayos clínicos en humanos.
La investigación abarca varios cánceres resistentes, incluidos NSCLC, HNSCC y cáncer de vejiga. El diseño único de IM1240 podría proporcionar una inhibición de puntos de control potencialmente más segura en comparación con las terapias existentes, especialmente por su selectivo objetivo sobre NKG2A.
Purple Biotech (NASDAQ/TASE: PPBT)� Mount Sinai와� 협력으로 삼중특이 항체 CAPTN-3 IM1240� 대� 유망� 신규 데이터를 발표했습니다. Amir Horowitz 박사가 주도� 연구� 치료 내성 있는 두경부�(Biopsies)에서 종양 세포 사멸� 확인했습니다.
주요 결과� IM1240� NK � T 세포 유도 부� 간의 상승효과� 보여주며, 26,000개의 인간 전사� 분석� 통해 5T4와 NKG2A� 표적하는 항체 설계가 검증되었습니다. 회사� 2026년에 IND 신청� 제출� 사람 대� 1� 임상시험� 시작� 계획입니�.
연구� NSCLC, HNSCC, 방광� � 여러 내성 암종� 포함합니�. IM1240� 독특� 설계� 특히 NKG2A� 선택적으� 표적함으로써 기존 치료보다 � 안전� 체크포인� 억제� 제공� 가능성� 있습니다.
Purple Biotech (NASDAQ/TASE: PPBT) a annoncé de nouvelles données prometteuses sur son anticorps tri-spécifique CAPTN-3 IM1240, en collaboration avec le Mount Sinai. Les travaux dirigés par le Dr Amir Horowitz ont montré une destruction des cellules tumorales dans des biopsies de cancers tête-et-cou résistants aux traitements.
Les résultats clés mettent en évidence des effets synergiques entre les bras engageant les NK et les cellules T d'IM1240, et l'analyse de 26 000 transcriptomes humains valide la conception de l'anticorps ciblant 5T4 et NKG2A. La société prévoit de soumettre une demande IND en 2026 pour lancer des essais cliniques chez l'humain.
La recherche couvre plusieurs cancers résistants, notamment NSCLC, HNSCC et cancer de la vessie. La conception unique d'IM1240 pourrait offrir une inhibition des checkpoints potentiellement plus sûre que les thérapies existantes, notamment grâce à son ciblage sélectif de NKG2A.
Purple Biotech (NASDAQ/TASE: PPBT) hat vielversprechende neue Daten zu seinem tri-spezifischen Antikörper CAPTN-3 IM1240 in Zusammenarbeit mit Mount Sinai bekanntgegeben. Die von Dr. Amir Horowitz geleitete Forschung zeigte erfolgreiches Tumorzellsterben in biopsien von behandlungsresistentem Kopf-Hals-Krebs.
Zentrale Befunde zeigen synergistische Effekte zwischen den NK- und T-Zell-Engager-Teilen von IM1240, und die Analyse von 26.000 menschlichen Transkriptomen bestätigt das Antikörperdesign zur Zielerfassung von 5T4 und NKG2A. Das Unternehmen plant, 2026 einen IND-Antrag zur Einleitung erster klinischer Studien am Menschen einzureichen.
Die Studie umfasst mehrere resistente Tumorarten, darunter NSCLC, HNSCC und Blasenkrebs. Das einzigartige Design von IM1240 könnte eine potenziell sicherere Checkpoint-Blockade bieten als bestehende Therapien, insbesondere durch die selektive Anvisierung von NKG2A.
- Successful demonstration of tumor cell death in treatment-resistant cancer biopsies
- Synergistic effects observed between NK and T cell engager arms, validating platform design
- Analysis of 26,000 transcriptomes supports the therapeutic approach
- Potential for safer checkpoint inhibition compared to existing therapies
- Targeting multiple treatment-resistant cancers with high unmet medical need
- IND submission not planned until 2026, indicating lengthy timeline to clinical trials
- Early-stage research with no human clinical trial data yet
Insights
Purple Biotech's tri-specific antibody IM1240 shows promising tumor-killing activity in treatment-resistant cancers through innovative dual-targeting mechanism.
The data presented by Purple Biotech (NASDAQ/TASE: PPBT) represents a significant advancement in cancer immunotherapy. Their lead candidate, IM1240, employs a novel tri-specific antibody design targeting three distinct molecules: CD3 (on T cells), NKG2A (primarily on NK and CD8+ T cells), and 5T4 (a tumor-associated antigen). What makes this approach particularly innovative is the synergistic effect observed between the NK and T cell engager components - something unique to their CAPTN-3 platform.
The results from Dr. Horowitz's lab at Mount Sinai demonstrate IM1240's ability to induce apoptosis in treatment-resistant head and neck cancer cells that have previously failed anti-PD1 therapy. Critically, this effect was not observed with bispecific variants missing either functional arm, supporting the tri-specific design rationale. Similar results in NSCLC tumor explants further validate this approach across multiple solid tumor types.
The transcriptomic analysis of approximately 26,000 human samples provides compelling biological evidence for the antibody's design. The co-expression pattern of NKG2A with 5T4 in solid tissues (but not blood) suggests the antibody will preferentially target tumor environments while potentially reducing systemic toxicity - a critical consideration for immunotherapy safety.
The scientific approach appears well-reasoned: by simultaneously blocking the HLA-E/NKG2A checkpoint (which suppresses immune response) while engaging T cells through a masked CD3 binding site, IM1240 potentially offers both enhanced efficacy and improved safety compared to existing checkpoint inhibitors. The planned IND submission in 2026 indicates the program is advancing toward clinical evaluation, though still in preclinical stages.
Purple Biotech's IM1240 shows promising preclinical efficacy in resistant cancers with potential competitive advantages in the crowded immunotherapy landscape.
Purple Biotech's announcement provides encouraging validation for their proprietary CAPTN-3 platform technology. The collaboration with Mount Sinai's Dr. Horowitz significantly enhances the company's scientific credibility and provides access to patient-derived tissue samples that closely simulate clinical conditions - a valuable asset for preclinical development.
The data demonstrates two key competitive advantages for IM1240. First, the synergistic effect between the antibody's NK and T cell engager components appears to drive superior cancer cell killing compared to bispecific alternatives. Second, the transcriptomic analysis across 26,000 human samples suggests a favorable targeting profile that could translate to better safety margins than competing approaches.
Strategically, Purple has positioned IM1240 to address significant market gaps by targeting treatment-resistant cancers including NSCLC, head and neck, and bladder cancers. These indications represent substantial market opportunities where resistance to existing immunotherapies creates significant unmet needs.
The company's focus on the NKG2A/HLA-E axis represents a differentiated approach in the crowded immuno-oncology landscape. While major players have focused primarily on PD-1/PD-L1 and CTLA-4 pathways, Purple's targeting of NKG2A could potentially complement these existing therapies, opening partnership opportunities.
Timeline-wise, with IND submission planned for 2026, investors should recognize this remains a preclinical-stage program with significant development milestones ahead before potential commercialization. The continued validation of the platform technology, however, enhances the company's scientific foundation as they advance toward clinical trials.
Mt. Sinai Principal Investigator, Dr. Amir Horowitz, demonstrates tumor cell death induced by IM1240 in patient-derived treatment-resistant head and neck biopsies
Synergistic effects were observed between the NK and the T cell engager arms of IM1240, a unique combination in the CAPTN-3 platform
Analysis of approximately 26,000 human transcriptomes suggests that NKG2A expression is consistently accompanied by 5T4 in solid tissues, but not in blood, supporting the design of IM1240
IM1240, the first CAPTN-3 tri-specific antibody targeting 5T4, a novel tumor-associated antigen, advances toward first-in-human clinical trials, with IND submission planned for 2026
REHOVOT, Israel, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech� or “the Company�) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, today 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.
“The collaboration with Dr. Horowitz, a leading expert in cancer immunology and immunotherapy, enables us to evaluate the effects of the CAPTN-3 antibody on patient-derived tumor biopsies, where tumor cell heterogeneity, the immune cell array and other tumor microenvironment (TME) components are preserved, providing a reliable representation of the clinical condition of a patient. Dr. Horowitz’s research is assessing the efficacy and mechanism of action of the CAPTN-3 antibody in several cancer types, including treatment-resistant Non-Small Cell Lung Cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and bladder cancer, which represent areas of significant unmet medical need,� said Gil Efron, CEO of Purple Biotech.
Using fresh biopsies of HNSCC patients who have acquired resistance to anti-PD1 therapy, Dr. Horowitz’s results have shown induction of cancer cell apoptosis by the tri-specific IM1240 (capped-CD3x5T4xNKG2A), while none of the related variant bispecifics, having either a non-functional CD3 arm (5T4xCD3) or NKG2A arm (5T4xNKG2A), showed an effect. The results correlate with patient-derived NSCLC tumor explants previously reported and suggest a synergistic effect of the CD3 and the NKG2A arms, a design which is unique to Purple’s CAPTN-3 platform.
“Targeting NKG2A offers a selective checkpoint inhibition strategy that enhances antitumor cytotoxicity while minimizing off-target immune activation. The selective expression of NKG2A mainly on cytotoxic lymphocytes such as Natural Killer (NK) cells and CD8� cytotoxic T cells (CTLs), makes NKG2A blockade a potentially safer approach compared with other checkpoint inhibitors, and a complementary therapy which acts synergistically with the CD3 engager function of CAPTN-3� commented Dr. Horowitz. “Additionally, robust data analysis representing of approximately 26,000 human transcriptomes across most solid tissues suggests that NKG2A expression is consistently accompanied by both HLA-E and 5T4 in solid tissues, but not in blood, supporting the design of IM1240 that targets 5T4 and potentially reducing safety concerns.�
At the American Society of Gene and Cell Therapy’s (ASGCT) Annual Meeting earlier this year, Dr. Horowitz presented the role of the NKG2A/HLA-E axis in different applications and outlined the unique design and potential advantages of Purple Biotech’s CAPTN-3 T-cell and NK-cell engager platform as a novel immunotherapeutic strategy. He highlighted that the masked-CD3xNKG2AxTAA (tumor associated antigen) trispecific antibodies block the HLA-E/NKG2A checkpoint and enable the activation of NKG2A-expressing immune cell subsets, which are known to have high anti-tumor activity. The conditional activation of the masked CD3 binding site is designed to emphasize the safety profile with enhanced efficacy through cooperation with the NKG2A arm, due to the high expression of NKG2A, HLA-E, and 5T4 in the TME.
Dr. Horowitz is an Associate Professor of Immunology & Immunotherapy and Oncological Sciences, at the Icahn School of Medicine at Mount Sinai, The Lipschultz Precision Immunology Institute and The Tisch Cancer Institute in New York. His research focuses on harnessing NK and CD8 T cells for antitumor effector functions and has demonstrated a novel immunotherapeutic target axis involving the interaction between HLA-E expressing tumor cells and NKG2A-positive NK and CD8 T cells, which suppresses immune responses in treatment-resistant patients. Dr. Horowitz and others have demonstrated that the HLA-E/NKG2A axis is a dominant inhibitory checkpoint pathway in solid tumors and metastasis.
About Purple Biotech
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company’s oncology pipeline includes CAPTN-3, CM24 and NT219. The Company is advancing CAPTN-3, a preclinical platform of conditionally activated tri-specific antibodies, which engage both T cells and NK cells to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines the compound’s therapeutic activity to the local tumor microenvironment, thereby potentially increasing the anticipated therapeutic window in patients. The third arm specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to mount an optimal anti-tumoral immune response. IM1240 is the first tri-specific antibody in development that targets the 5T4 antigen, which is expressed in a variety of solid tumors and is associated with advanced disease, increased invasiveness, and poor clinical outcomes. CM24 is a humanized monoclonal antibody that blocks CEACAM1, which supports tumor immune evasion and survival through multiple pathways. CEACAM1 on tumor cells, immune cells and neutrophil extracellular traps is a novel target for the treatment of multiple cancer indications. As proof of concept of these novel pathways, the Company completed a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC) with CM24 as a combination therapy with the anti-PD-1 checkpoint inhibitor nivolumab and chemotherapy, demonstrating clear and consistent improvement across all efficacy endpoints and the identification of two potential serum biomarkers and other potential tissue biomarkers. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study was concluded as a monotherapy and in combination with cetuximab, in which NT219 demonstrated anti-tumor activity in combination with cetuximab in second-line patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). A Phase 2 study in collaboration with the University of Colorado, to treat R/M SCCHN patients with NT219 in combination with cetuximab or pembrolizumab was initiated. The Company’s corporate headquarters are located in Rehovot, Israel. For more information, please visit .
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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�, “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 IM1240; 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, .
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