Superior potency demonstrated versus leading TROP2 ADCs across bladder, lung and breast tumor models    Novel RNA spliceosome-targeting payload PH1 shows potential to overcome Topoisomerase I inhibitor resistance 

AKTX

Akari Therapeutics Reports Positive Preclinical Data for AKTX-101 Demonstrating Differentiated Cytotoxicity for First-in-Class TROP2 ADC Payload Targeting RNA Splicing

Positive AKTX-101 Data Marks Advancement in TROP2-targeting Cancer Treatment

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 <h3>Information</h3>
 Superior potency demonstrated versus leading TROP2 ADCs across bladder, lung and breast tumor models Novel RNA spliceosome-targeting payload PH1 shows potential to overcome Topoisomerase I inhibitor resistance
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 <section data-block="ai-summary-paragraph">
 <h3>AI Summary</h3>
 Akari Therapeutics presented encouraging preclinical data at AACR 2026 for AKTX-101, its lead TROP2-targeting ADC. The drug shows superior efficacy and could target a broad range of cancers resistant to current therapies, with plans to enter Phase 1 clinical trials in 2027, potentially leading to significant market opportunities.
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 <h3>Key Points</h3>
 <ul><li>AKTX-101 shows superior potency in preclinical trials versus leading TROP2 ADCs.</li><li>Preclinical data supports AKTX-101&#039;s advancement into Phase 1 studies by early 2027.</li><li>AKTX-101 could effectively target multiple cancers resistant to existing therapies.</li><li>The TROP2 ADC market projected to reach ~$12B by 2033, indicating significant commercial opportunity.</li><li>Combination therapies with AKTX-101 show enhanced anti-tumor efficacy in tumor models.</li></ul>
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 <section data-block="companies-mentioned">
 <h3>Companies Mentioned</h3>
 <ul><li>Trastuzumab deruxtecan (ENHERTU): Comparison made with AKTX-101 for efficacy in HER2 breast cancer.</li></ul>
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 <section data-block="category">
 <h3>Corporate Developments</h3>
 This news falls under Corporate Developments due to the significant advancement in Akari&#039;s drug pipeline that could influence its market position and valuation. Positive preclinical results and planned clinical trials highlight the company&#039;s efforts in the competitive oncology space.
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 <section data-block="market-moving">
 <h3>Market-Moving</h3>
 <ul><li>Positive preclinical results could drive AKTX&#039;s stock price higher ahead of clinical trials.</li><li>The broad applicability of AKTX-101 across multiple cancers presents significant market potential.</li><li>Expected FDA filing could create investor excitement, impacting stock price positively.</li><li>Entry into the Phase 1 trial could validate AKTX&#039;s therapeutic strategy and attract investor interest.</li></ul>
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 <section data-block="key-facts">
 <h3>Key Facts</h3>
 <ul><li>AKTX-101 demonstrated sub-nanomolar potency in bladder cancer lines.</li><li>First-in-human trials for AKTX-101 are planned for late 2026/early 2027.</li><li>The TROP2 ADC class is projected to exceed $12B by 2033.</li><li>AKTX-101 showcases superior cell killing compared to existing TROP2 ADCs in preclinical models.</li><li>Combination therapy with AKTX-101 and anti-PD-1 shows enhanced efficacy.</li></ul>
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 <section data-block="trading-thesis">
 <h3>Trading Thesis</h3>
 Investors should consider AKTX as a buy ahead of upcoming clinical trial results in 2027.
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<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link>Superior potency demonstrated versus leading TROP2 ADCs across bladder, lung and breast tumor models Novel RNA spliceosome-targeting payload PH1 shows potential to overcome Topoisomerase I inhibitor resistance Preclinical data support advancement of AKTX-101 into Phase 1 studies in a rapidly evolving TROP2 ADC class expected to reach ~$12B by 20331 TAMPA, Fla. and LONDON, April 20, 2026 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/AKTX">AKTX</a>), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing modulator payload, today announced the presentation of positive preclinical data for its lead TROP2-targeting ADC, AKTX-101, at the American Association for Cancer Research (AACR) Annual Meeting 2026. Access the poster <a href="https://www.globenewswire.com/Tracker?data=qH1jtQgQFxp2knqeEoa6MsTHAT7xuFYiZYH2DZzo6yeZz4-VBFZ0ZcvqzapXSOcx1Y132rFmYVzP_fcRJs5IwZOGH3kbNq1WUcRQO5pTtA8Jl5huHi7OwtJt4yyR15dVFZLj9xC1SgggWkPdZeD46Nsu2VlHTxow_ZhxSPKdTKc=" rel="nofollow" target="_blank">here</a>. Unlike current TROP2-targeting ADCs that use Topoisomerase I Inhibitor (Inh.) payloads, AKTX-101 has the potential to address resistance to Topoisomerase I Inh. ADCs and contribute to durable anti-tumor efficacy due to the payload's unique cytotoxic and immune-activating mechanisms of action. The preclinical data compares the performance of AKTX-101 versus TROP2 ADCs with Topoisomerase I Inh. payloads in the killing of different cancer types driven by different cancer genes (oncogenes). AKTX-101's ability to kill cancer cells at lower concentrations vs. TROP2 ADCs using Topoisomerase I Inh. payloads suggests that AKTX-101 is a more potent drug. The preclinical data was published recently as an <a href="https://www.globenewswire.com/Tracker?data=7KQAYQz1hAfiKN96SnjSLfhtoG8SzCfqbdiCLq-uslqeMK1IbJGASaS9OxaDqGiMelgNzJEuQXaC_8SasRvpGHvxlh1u6PxQdBZyYuPdJKU=" rel="nofollow" target="_blank">abstract</a> in Cancer Research, an AACR journal. Here, AKTX-101 demonstrated greater potency and/or greater maximum cancer cell killing relative to TROP2 ADC Topoisomerase I Inh. payloads in cancers of the bladder, lung and breast. AKTX-101 demonstrated sub-nanomolar potency in all bladder cancer lines tested, a key tumor in which first-in-human clinical trials for AKTX-101 are planned. AKTX-101 also demonstrated sub-nanomolar potency in several non-small cell lung cancer cell lines driven by EGFR, BRAF, and SMARCA4, as well as potent cell killing in HER2 breast cancer cell lines with inherent resistance to Topoisomerase I Inh. ADCs such as trastuzumab deruxtecan (ENHERTU&#x2122;). "These data represent a significant step forward for our lead program, AKTX-101, and reinforce our belief that a differentiated ADC payload with multiple mechanisms of action has the potential to meaningfully improve outcomes for patients with TROP2-expressing cancers," commented Satyajit K. Mitra, Ph.D., Head of Oncology Research and Development at Akari Therapeutics. "We are seeing preclinical superior AKTX-101 potency and activity as compared to TROP2 ADCs using Topoisomerase I inhibitor payloads in bladder, lung, and breast cancer models. Together, these findings show that AKTX-101 has strong potential for targeting a broad range of cancer tumors and sub-types with superior cytotoxicity than current TROP2 ADCs that use Topoisomerase I Inhibitor payloads." The TROP2 ADC class continues to emerge in terms of its potential, with revenue projections expected to reach ~$12B or greater by 2033 based on current and future entrants. Akari believes that AKTX-101, with its novel RNA splicing modulator payload, can grow this class further by addressing multiple solid tumors where TROP2 is overexpressed including bladder, lung, breast, pancreatic, head and neck, and others. Key AKTX-101 Data Presented at AACR Highlights: <ul type="disc"><li style="text-align:justify;">AKTX-101 demonstrated strong, single-agent anti-tumor activity across multiple models across bladder, lung, and breast cancers.</li><li style="text-align:justify;">AKTX-101 demonstrated greater potency and cell killing compared to current TROP2 ADCs, including Topoisomerase I inhibitor-resistant tumor models, as well as standard-of-care chemotherapies and targeted therapies. Combination of AKTX-101 with anti-PD-1 therapy resulted in synergistic anti-tumor efficacy and tumor regressions within in vivo models, supporting future combinations with checkpoint inhibition to maximize tumor remissions rates.</li><li style="text-align:justify;">Broad in vitro cytotoxicity was observed across a diverse panel of tumor models, including those with clinically oncogenic driver mutations including FGFR3, BRAF, EGFR, and SMARCA4. </li></ul> Abizer Gaslightwala, CEO of Akari Therapeutics, added, "This data continues to add to the conviction and differentiation we have in our novel ADC payload PH1 targeting RNA splicing. We are focused on rapidly advancing AKTX-101 into the clinic, with IND-enabling studies underway and plans to submit an IND in the fourth quarter of 2026, followed by initiation of a Phase 1 study in the first quarter of 2027. Our team is executing against a clear development plan designed to efficiently translate these encouraging preclinical findings into clinical proof of concept." These data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2026. Access the poster <a href="https://www.globenewswire.com/Tracker?data=qH1jtQgQFxp2knqeEoa6MtQT4UR8koBTzfHg9kwk2MpiqyNS3ddm_GqYxSbCaX_UlspOUjyN9ZnQRBtNyRBjdku0CkwbgSFnJLhRrqOrkM4rA6n2La_2fV0kow5kVn2F6gVFOpD11RxH-f61escworIQK5e6_-nUY9MnFkS_WvI=" rel="nofollow" target="_blank">here</a>. ¹ DataIntelo, TROP2-Targeted Therapies Market Report, 2026 About Akari Therapeutics Akari Therapeutics is an oncology biotechnology company developing next-generation antibody drug conjugates (ADCs) with a unique payload, PH1, which targets RNA splicing. 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 antigen target of interest. Akari's lead candidate, AKTX-101, targets the TROP2 receptor on cancer cells with a proprietary linker, enabling it to deliver its novel PH1 payload directly into the tumor with minimal off-target effects. Unlike current ADCs that use microtubule 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 both the innate and adaptive immune systems 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. The PH1 payload has also been demonstrated to be very active against cancer cells with key oncogenic drivers such as KRAS, BRAF, ARV7, FGFR3 fusions, and others. The Company has initiated IND enabling studies for AKTX-101 with a goal of starting its First-In-Human trial by late 2026/early 2027. Akari is also developing AKTX-102, an ADC candidate targeting CEACAM5 (Carcinoembryonic Antigen-related Cell Adhesion Molecule-5), a well-validated tumor antigen broadly expressed across multiple solid tumors. AKTX-102 is designed to leverage Akari's proprietary PH1 spliceosome-modulating payload and a novel antibody construct to enable differentiated tumor cell killing and immune activation. For more information about the Company, please visit <a href="https://www.globenewswire.com/Tracker?data=KHCjUeiMVsqGG-gNeMh0o7lSHXkpSeNIAJhYdnO1wmRoGz7O5YftnOVM-pTuxXDcMORRJgyTOva1Sakyd8soOQOn2tBv2h82uC8Z896skDM=" rel="nofollow" target="_blank">www.akaritx.com</a> and connect on <a href="https://www.globenewswire.com/Tracker?data=xz-5GQ-dmUr-UyYH2sVgQKI5PrieDBoQ_6MD0nQPwGAFMGAjenHVMxfbhYIBCxL2gFr3LdI1JrOWR0WJPP9aoA==" rel="nofollow" target="_blank">X</a> and <a href="https://www.globenewswire.com/Tracker?data=EpLjs3xm0ppIn0BY5zeTM_vcBpbNiv5tQhEQ6kG-3IbzhitZtjmkghoqgcXxk2EpKoUW9PRJDdt_7JjskQKccMOAiVhkQRoxcx3Ig0zNIXk=" rel="nofollow" target="_blank">LinkedIn</a>. 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, and the timing of the submission of an IND and commencement of a Phase I clinical trial. 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 <a href="http://www.sec.gov" title="www.sec.gov">www.sec.gov</a>. 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 <a href="https://www.globenewswire.com/Tracker?data=BNBTd_Ct5N38X_q22eBNTphhxqQhxl-jvNBZzoi9JLj6dS9v9iUZ5-kZWnV31eiacz6WkNo1w6A1IO0zigEy7w==" rel="nofollow" target="_blank">AKTX@jtcir.com</a> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTY5Mjc1NSM3NTQzNzc1IzIwMjAyNjM="></img> <img alt="" src="https://ml.globenewswire.com/media/NTU2NmI5ZDYtNGM4Zi00OTczLWE3ZmItN2M3NTVkYTk5M2EyLTEwMzE4MzUtMjAyNi0wNC0yMC1lbg==/tiny/Akari-Therapeutics-Plc.png" referrerpolicy="no-referrer-when-downgrade"></img><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/8d978f50-07a9-40a3-be69-45f51ccd94d9"><img src="https://ml.globenewswire.com/media/8d978f50-07a9-40a3-be69-45f51ccd94d9/small/akari-logo-1-jpg.jpg" border="0" width="150" height="130" alt="Primary Logo"></img></a>

Akari Therapeutics presented encouraging preclinical data at AACR 2026 for AKTX-101, its lead TROP2-targeting ADC. The drug shows superior efficacy and could target a broad range of cancers resistant to current therapies, with plans to enter Phase 1 clinical trials in 2027, potentially leading to significant market opportunities.

akari-therapeutics-reports-positive-preclinical-data-for-aktx-101-demonstrating-differentiated-cytotoxicity-for-first-in-class-trop2-adc-payload-targeting-rna-splicing

Akari Therapeutics Reports Positive Preclinical Data for AKTX-101 Demonstrating Differentiated Cytotoxicity for First-in-Class TROP2 ADC Payload Targeting RNA Splicing

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