Akari Therapeutics Announces Filing for New Patent for Novel ADC Platform Utilizing Spliceosome Payload PH1 for the Treatment of Cancer

September 17, 2025 08:45 ET | Source: Akari Therapeutics Plc BOSTON and LONDON, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced that it has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) covering the Company’s antibody drug conjugate (ADC) platform using Akari’s spliceosome payload PH1 for treating cancer by modulating alternative splicing within cancer cells. This patent application represents a new patent family to further extend Akari’s proprietary position with respect to the Company’s novel payload, PH1 (a novel Thailanstatin analog). Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics commented, “These novel data included in our provisional patent application continue to demonstrate the advances in our understanding of spliceosome modulation and the growing potential of our PH1 payload to build first-in-class ADCs that work in unique ways from current options, and could potentially drive differentiated clinical outcomes and remissions for cancer patients in the future. We will continue to progress our exciting research on our spliceosome modulating payload PH1 and present evolving data and insights. This specific provisional patent application increases the scope of our intellectual property estate and enables long term value creation for Akari and potential partners we elect to work with on our ADC portfolio.” The new application relates to how Akari’s novel PH1 payload demonstrates its ability to modulate the spliceosome to disrupt alternative splicing drivers and the subsequent synthesis of proteins needed for cancer tumors to survive and grow. Alternative splicing (AS) leads to the production of functionally distinct protein isoforms. Cancer cells hijack this process to produce isoforms that support the "hallmarks of cancer," a set of capabilities that often tumors acquire, which contribute to the growth, proliferation, and survival of the cancer in the tumor microenvironment, and a host of other deleterious effects. Changes in AS have been linked to almost all aspects of tumor formation and cancer growth and metastasis, including changes affecting cancer cell metabolism, inhibiting apoptosis (delaying natural cell death), cell cycle control, evading the immune system, invasion of cancer cells to other tissues/organs (metastasis and spreading), and resistance of cancer cells to current therapies. Disrupting AS is a central, generalized approach to target all cancers at a fundamental level of their survival and growth, including those difficult cancers driven by specific spliced variants (i.e. AR-v7 in prostate cancer) or cancers driven by other known factors (i.e. ,VEGF, HER2, Caspase-2). This opens up the possibilities and potential for Akari to become a leader in developing therapies against a wide range of cancers utilizing spliceosome modulation using Akari’s ADC platform. This provisional patent application is a culmination of the exciting and groundbreaking work in alternative splicing Akari is progressing with its novel ADC payload PH1. This patent also adds to the body of knowledge already established around the PH1 payload including its potent cytotoxicity and robust immune cell activation demonstrated in multiple preclinical cancer models. The Company is committed to applying this expanded knowledge around disrupting alternative splicing to advance its current ADC portfolio, consisting of AKTX-101 (Trop2 ADC with PH1 payload), as well as future programs (AKTX-102, undisclosed target with PH1 payload). 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

Akari Therapeutics Announces Filing for New Patent for Novel ADC Platform Utilizing Spliceosome Payload PH1 for the Treatment of Cancer

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