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Akari Therapeutics’ Accepted Abstract Showcasing its Novel Splicing-Targeted ADC Payload Driving Immune Activation Now Available

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Akari Therapeutics (Nasdaq: AKTX) announced its SITC 40 abstract and presentations on November 7 and 9, 2025 describing preclinical immune mechanism data for its novel ADC payload PH1.

The company reports that a Trastuzumab–PH1 ADC produced higher rates of complete colon-tumor regressions versus a comparator microtubule-inhibitor ADC when combined with an anti‑PD‑1 checkpoint inhibitor. The PH1 combination is attributed to neoantigen-driven immune activation, antigen-presenting cell, B-cell and T-cell engagement, and expansion of tumor‑killing gamma‑delta T cells. Poster and oral presentation details and times are provided for the SITC Annual Meeting.

Akari Therapeutics (Nasdaq: AKTX) ha annunciato il suo abstract SITC 40 e le presentazioni il 7 e il 9 novembre 2025, descrivendo dati preclinici sul meccanismo immunitario per il suo nuovo payload ADC PH1.

L'azienda riferisce che un ADC Trastuzumab–PH1 ha prodotto tassi più elevati di regressioni complete di tumori del colon rispetto a un ADC di confronto inibitore microtubulare quando combinato con un inibitore di checkpoint anti‑PD‑1. La combinazione PH1 è attribuita all'attivazione immunitaria guidata da neoantigeni, all'impegno di cellule presentanti l'antigene, cellule B e cellule T, e all'espansione di cellule gamma‑delta T che uccidono i tumori. I dettagli del poster e della presentazione orale e gli orari sono forniti per l'incontro annuale SITC.

Akari Therapeutics (Nasdaq: AKTX) anunció su abstract SITC 40 y sus presentaciones el 7 y 9 de noviembre de 2025, describiendo datos preclínicos sobre el mecanismo inmunológico para su nuevo payload ADC PH1.

La empresa informa que un ADC Trastuzumab–PH1 produjo tasas más altas de regresiones completas de tumores de colon en comparación con un ADC inhibidor de microtúbulos de referencia cuando se combinó con un inhibidor de punto de control anti‑PD‑1. La combinación PH1 se atribuye a una activación inmunitaria impulsada por neoantígenos, el compromiso de células presentadoras de antígenos, células B y células T, y la expansión de las células gamma‑delta T que destruyen tumores. Se proporcionan detalles del póster y de la presentación oral y los horarios para la Reunión Anual SITC.

Akari Therapeutics (Nasdaq: AKTX)가 2025년 11월 7일 및 9일 SITC 40 초록 및 발표를 발표하여 새로운 ADC 페이로드 PH1에 대한 전임상 면역 메커니즘 데이터를 설명했습니다.

회사는 Trastuzumab–PH1 ADC가 anti‑PD‑1 체크포인트 억제제와 결합될 때 비교대상 마이크로튜뉘얼 억제제 ADC에 비해 대장 종양의 완전 회복 사례를 더 많이 생성했다고 보고합니다. PH1 조합은 네오에이전트 기반의 면역 활성화, 항원 제시 세포, B세포 및 T세포의 관여, 그리고 종양을 공격하는 γ‑delta T세포의 확장으로 귀속됩니다. SITC 연차 대회에 대한 포스터 및 구두 발표의 세부 정보와 시간표가 제공됩니다.

Akari Therapeutics (Nasdaq : AKTX) a annoncé son résumé SITC 40 et ses présentations les 7 et 9 novembre 2025 décrivant des données précliniques sur les mécanismes immunitaires de son nouveau payload ADC PH1.

La société rapporte qu'un ADC Trastuzumab–PH1 a produit des taux plus élevés de régressions complètes des tumeurs du côlon par rapport à un ADC inhibiteur de microtubules de comparaison lorsqu'il est associé à un inhibiteur de point de contrôle anti‑PD‑1. La combinaison PH1 est attribuée à une activation immunitaire guidée par les neoantigènes, à l'engagement des cellules présentatrices d'antigènes, des cellules B et des cellules T, et à l'expansion des cellules gamma‑delta T qui tuent les tumeurs. Les détails du poster et de la présentation orale et les horaires sont fournis pour la SITC Annual Meeting.

Akari Therapeutics (Nasdaq: AKTX) gab sein SITC 40-Abstract und seine Präsentationen am 7. und 9. November 2025 bekannt, die vorläufige immunmechanistische Daten für seinen neuartigen ADC-Payload PH1 beschreiben.

Das Unternehmen berichtet, dass ein Trastuzumab–PH1-ADC im Vergleich zu einem Referenz-Microtubule-Inhibitor-ADC höhere Raten vollständiger Kolon-Tumor-Rückbildungen zeigte, wenn es mit einem Anti‑PD‑1-Checkpoint-Inhibitor kombiniert wird. Die PH1-Kombination wird einer neoantigen-gesteuerten Immunaktivierung, der Beteiligung von Antigen-präsentierenden Zellen, B- und T-Zellen und der Expansion der tumorabtötenden Gamma-delta-T-Zellen zugeschrieben. Details zu Poster und mündlicher Präsentation sowie Zeiten werden für das SITC Annual Meeting bereitgestellt.

Akari Therapeutics (Nasdaq: AKTX) أعلنت عن ملخص SITC 40 وعروضه في 7 و9 نوفمبر 2025، موضحة بيانات آلية مناعية قبل السريرية لحمولة ADC الجديدة PH1.

تفيد الشركة بأن ADC-Trastuzumab–PH1 أظهر معدلات أعلى من الانحدار الكامل لورم القولون مقارنةً بـ ADC مثبّط أحادي الطور لِالميكانيكية المدفوعة عندما يُدمج مع مثبّ PD‑1. تُعزى مجموعة PH1 إلى تفعيل مناعي قائم على مستقبل neoantigen، ومشاركة الخلايا المعروضة للمضاد، والخلايا B وT، وتوسع الخلايا gamma‑delta T القاتلة للورم. يتم توفير تفاصيل الملصق والعرض الشفهي ومواعيدها لاجتماع SITC السنوي.

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Data to be presented at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting on November 7th and 9th

BOSTON and LONDON, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payloads for antibody drug conjugates (ADCs), today announced its abstract highlighting immune mechanism-of-action data for its novel ADC payload, PH1. The abstract is now available on the 40th Annual SITC Meeting website, and the Company will present the abstract in oral and poster presentations at the SITC Annual Meeting being held November 5-9, 2025 in National Harbor, MD.

Utilizing its innovative ADC payload platform, Akari is advancing a new class of immuno-oncology ADCs built on the platform of a novel PH1 payload, a spliceosome modulator that has a unique preclinical efficacy and safety profile with the potential to address unmet need for oncology patients singly or in combination with checkpoint inhibitors.

The full SITC abstract, which included 2 figures, is now available here with the results summarized as follows:

In this work, Akari investigates the mechanism behind preclinical colon tumor regressions induced by a Trastuzumab PH1 ADC with/without anti-PD-1 and contrasts that against a first-in-class ADC with a microtubule inhibitor payload. A higher rate of complete regressions in the PH1 ADC combination vs comparator ADC combination is attributed to an immune response stimulated by neoantigen, activation of antigen-presenting cells, B, and T-cells, and a mechanistic synergy between the PH1 payload and the checkpoint inhibitor. Interestingly, while neither single agent induced gamma-delta T cells, a kind of T-cell that is not limited by low neoantigen expression in tumors or low numbers of antigen-presenting cells, the PH1 ADC together with anti-PD-1 agent expanded this tumor-killing T-cell population.

Further details will be released in the poster and oral presentations. Details are as follows:

Title: A Novel Splicing-Targeted ADC Payload Drives Immune Activation, Synergy with Checkpoint Inhibitors, and Enhanced Therapeutic Potential beyond Cytotoxicity
Presenter: Satyajit Mitra Ph.D., Executive Director, Head of Oncology at Akari Therapeutics
Abstract No: 951

Poster Session: Exhibits & Poster Viewing 1 & 2
Date and Time: Friday, November 7, 2025,11:30 AM-12:15 PM ET and 5:35 PM-7:00 PM ET, respectively
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center.

Oral Session: 302 Beyond Cytotoxic Chemotherapy: the Next Generation of ADCs for Immune Modulation
Date and Time: Sunday, November 9, 2025, 11:05-11:20 AM ET
Location: Gaylord National Resort and Convention Center – Ballroom Level – Potomac Ballroom

For more information about the SITC Annual Meeting, please visit sitcancer.org. Additionally, for those registered to attend the conference, if you would like to schedule a meeting with Akari, please contact AKTX@jtcir.com.

About Akari Therapeutics

Akari Therapeutics is an oncology biotechnology company developing next-generation spliceosome payload antibody drug conjugates (ADCs). Utilizing its innovative ADC discovery platform, the Company has the ability to generate ADC candidates and optimize them based on the desired application to any target of interest. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and with a proprietary linker, delivers its novel PH1 payload directly into the tumor. Unlike current ADCs that use tubulin inhibitors and DNA damaging agents as their payloads, PH1 is a novel payload that is a spliceosome modulator designed to disrupt RNA splicing within cancer cells. This splicing modulation has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. In preclinical studies, AKTX-101 has shown to have significant activity and prolonged survival, relative to ADCs with traditional payloads. Additionally, AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival as both a single agent and in combination with checkpoint inhibitors, as compared to appropriate controls. The Company is generating validating data on its novel payload PH1 to continue advancing its lead asset, as well as other undisclosed targets with this novel payload.

For more information about the Company, please visit www.akaritx.com and connect on X and LinkedIn.

Cautionary Note Regarding Forward-Looking Statements 

This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding the ability of the Company to advance its product candidates for the treatment of cancer and any other diseases, and ultimately bring therapies to patients. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the Company’s need for additional capital; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the business; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, including as a result of potential tariffs; the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; risks related to competition for the Company’s product candidates; and the Company’s ability to successfully develop or commercialize its product candidates. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release except as required by law.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
908-824-0775
AKTX@jtcir.com   


FAQ

What did Akari Therapeutics (AKTX) present about the PH1 ADC at SITC 2025?

Akari reported preclinical data showing the Trastuzumab–PH1 ADC plus anti‑PD‑1 produced higher complete tumor regressions and immune activation versus a comparator ADC.

When and where will Akari (AKTX) present the PH1 data at the SITC 40th Annual Meeting?

Poster presentations are on November 7, 2025 (11:30 AM–12:15 PM ET and 5:35 PM–7:00 PM ET) and an oral talk is on November 9, 2025 at 11:05–11:20 AM ET in National Harbor, MD.

What immune effects did the PH1 ADC combination produce in Akari's preclinical study?

The PH1 ADC plus anti‑PD‑1 stimulated neoantigen responses, activated antigen‑presenting cells, B and T cells, and expanded tumor‑killing gamma‑delta T cells.

How does PH1 compare to a microtubule‑inhibitor ADC in Akari's preclinical results?

In the reported preclinical models, the PH1 ADC combination showed a higher rate of complete regressions than the first‑in‑class microtubule‑inhibitor ADC combination.

Who is presenting Akari's SITC abstract on PH1 and what is the abstract number?

The presenter is Satyajit Mitra, Ph.D., and the abstract number is 951.
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