Akari Therapeutics Files Two New Patents for Immuno-Oncology Mode of Action for Novel ADC Platform Utilizing Spliceosome Modulating Payload PH1

Rhea-AI Summary

Akari Therapeutics (Nasdaq: AKTX) filed two provisional patent applications with the USPTO on Oct 9, 2025 to broaden intellectual property around its novel spliceosome‑modulating payload PH1. One filing claims PH1's immuno‑oncology mode of action via spliceosome modulation; the second claims combination therapies pairing PH1 ADCs with checkpoint inhibitors, citing preclinical synergy. These filings build on a late‑September provisional covering alternative splicing targeting and are intended to protect disclosures planned for an oral presentation at SITC on Nov 9, 2025. The release highlights AKTX‑101 (Trop2‑PH1 ADC) and future programs including AKTX‑102 as part of the expanding PH1 ADC pipeline.

Positive

• Filed two USPTO provisional patents on Oct 9, 2025
• Patents claim PH1 spliceosome MOA with immuno‑oncology focus
• Claims cover PH1 ADC + checkpoint inhibitor combination synergy
• Planned oral presentation at SITC on Nov 9, 2025
• Pipeline includes AKTX‑101 (Trop2 PH1 ADC) and AKTX‑102

Negative

• Filings are provisional; patent rights not yet granted
• Synergy evidence described is limited to preclinical models

Insights

Biotech IP & Clinical Strategist

Provisional patent filings for PH1 ADC immuno-oncology claims expand IP and set milestones ahead of an oral SITC presentation on November 9, 2025.

Akari’s filings seek protection for a novel spliceosome‑modulating payload, PH1, and for combinations of PH1 ADCs with checkpoint inhibitors. These actions increase the company’s documented IP perimeter around a mechanism that the company says may engage the host immune response and create synergy with ICIs. The inclusion of combination claims and multiple ADC targets (eg, AKTX-101) signals an intent to protect both payload biology and therapeutic pairings.

Key dependencies include the quality and scope of the provisional disclosures and the ability to convert them into granted patents; provisional filings alone do not guarantee claims will issue. The clinical and preclinical data supporting the immuno‑oncology mechanism and synergy will determine prosecutability and partner interest. Note the statement that ICIs have response rates of 20-30% in approved indications; the filings frame PH1 combinations as a path to broaden benefit but provide no clinical efficacy evidence today.

Watch for the oral presentation at November 9, 2025 for disclosed data details, subsequent non‑provisional filings, and any peer‑reviewed data releases. Near term (weeks–months): assess the depth of experimental data presented at SITC and whether specific claims map to measurable endpoints. Medium term (12–24 months): monitor prosecution outcomes and whether partners cite these patents in collaborations or licensing discussions.

BOSTON and LONDON, Oct. 09, 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 two new provisional patent applications with the United States Patent and Trademark Office (USPTO). The first application includes claims protecting Akari’s novel immuno-oncology payload, PH1 (a novel Thailanstatin analog), and its spliceosome modulatory mechanism of action, which is expected to provide a therapeutic benefit by activating the host immune system in the fight against cancer. The second patent filing includes claims for a combination therapy of PH1 pipeline ADCs with other immuno-oncology drugs that alleviate checkpoint inhibition and have demonstrated synergy with immune checkpoint inhibitors (ICIs) in preclinical models. These new patent applications are part of a growing patent portfolio strategy designed to further extend Akari’s proprietary position with respect to the Company’s novel PH1 payload. These filings also build upon Akari’s recent provisional patent filing in late September covering the use of Akari’s ADC platform to target cancer by modulating alternative splicing drivers within cancer cells.

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics commented, “The filing of these two patent applications furthers our strategy to establish a framework for building a new class of immuno-oncology ADC therapies and build on the tremendous success of checkpoint inhibitors. We believe the data within our patent applications enable the potential of our PH1 payload to build novel first-in-class immune-oncology ADCs and continue to demonstrate Akari’s advances in our understanding of spliceosome modulation as a strategy to attack cancer. In particular, these two patent applications include data that highlight the unique immuno-oncology action that the PH1 payload can potentially unlock to drive differentiated clinical outcomes and remissions for cancer patients in the future.”

“We look forward to sharing more details at the upcoming presentation at the Society for Immunotherapy Cancer (SITC) Congress as an oral presentation on November 9^th to highlight the progress of our exciting research on Akari’s spliceosome modulating payload PH1. These specific provisional patent applications are designed to protect our disclosures at the SITC conference and increase the scope of our intellectual property estate, which we anticipate will enable long term value creation for Akari and potential partners we elect to work with on our ADC portfolio,” concluded Mr. Gaslightwala.

To build on the Company’s current patent estate around the PH1 spliceosome modulating payload, these patent filings include data that highlights the immuno-oncology properties of Akari’s proprietary ADCs as a single agent, as well as a synergistic gain-of-function effects from the synergy created when Akari’s proprietary ADCs are combined with certain checkpoint inhibitors, as compared to either single agent-ADC or immune checkpoint inhibitor therapy.   

Checkpoint inhibitors have seen historic success across several cancer types but have only benefited roughly 20-30% of patients as measured by response rates in approved cancer types. Akari’s data underscore the potential for creating a new ADC paradigm for targeting cancer via spliceosome modulation and unlocking the potential of a combination checkpoint inhibitor-PH1 ADC regimen in new and exciting ways.

The Company continues to expand its current ADC pipeline to encompass multiple targets, such as 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 plans 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 announce on Oct 9, 2025 regarding PH1 patents?

Akari filed two provisional USPTO patent applications claiming PH1's spliceosome immuno‑oncology mode of action and PH1 ADC combinations with checkpoint inhibitors.

How do the Oct 9, 2025 patent filings affect Akari Therapeutics' IP position (AKTX)?

The provisional filings broaden Akari's PH1 patent estate to protect spliceosome MOA disclosures and combination therapy claims for its ADC platform.

When will Akari present PH1 data at SITC and what will be presented?

Akari will deliver an oral presentation at SITC on Nov 9, 2025 to highlight research and disclosures related to the PH1 spliceosome‑modulating payload.

Which AKTX pipeline programs were mentioned in the Oct 9, 2025 release?

The release references AKTX‑101 (Trop2 ADC with PH1 payload) and a future program AKTX‑102 with undisclosed target.

Do the Oct 9, 2025 patent filings include clinical efficacy data for PH1 ADCs?

No; the release describes immuno‑oncology action and synergy based on preclinical data, not clinical readouts.

Are the Oct 9, 2025 patents issued and enforceable now for Akari (AKTX)?

No; the company filed provisional patent applications, which are not issued patents and require subsequent non‑provisional filings for grant.