Akari Therapeutics Bolsters Global IP Estate for its Novel Antibody Drug Conjugate (ADC) Immuno-Oncology Payload, PH1, with Recent Granting of Patent Protection Across India
- Patent protection secured in India, a key market with growing cancer incidence
- Technology shows significant tumor-killing activity in preclinical models
- Strong global IP portfolio with patents in US, China, and Israel
- Pipeline advancement of potentially first-in-class ADC candidates
- ADC candidates still in preclinical stage, indicating long path to commercialization
- Multiple pending patent applications still under examination in various countries
Insights
Akari's new Indian patent strengthens global IP protection for their novel cancer ADC payload technology in a key growing market.
The granting of Patent No. 562,919 in India represents a significant strategic victory for Akari Therapeutics' global intellectual property estate. This patent specifically protects their PH1 payload - a spliceosome inhibitor with a novel mechanism of action that disrupts RNA splicing in cancer cells. The protection extends to their proprietary cleavable and non-cleavable linkers and overall ADC technology platform.
This Indian patent builds upon Akari's existing IP portfolio, which includes three US patents, plus recent grants in China and Israel, with applications pending across nine additional international markets. The timing is particularly strategic as India faces projected growth in cancer cases to 2.08 million by 2040, representing an expanding market opportunity.
From a technical perspective, Akari's PH1 payload offers a differentiated approach in the competitive ADC landscape. While most payloads focus solely on direct cytotoxicity, PH1 appears designed for dual mechanisms - both direct tumor cell killing through disruption of RNA processing and immune system activation. This immunological component could potentially enhance durability of response, addressing a key challenge in cancer treatment.
For investors, patent protection is fundamental to biotech valuation, particularly for platform technologies with applications across multiple cancer targets. This patent not only secures market exclusivity in India but specifically covers manufacturing activities (CMC), creating additional barriers to competition. While Akari's candidates remain in preclinical development, this expanding IP portfolio enhances partnering potential and builds a foundation for future clinical and commercial development.
Differentiated PH1 payload is a spliceosome inhibitor designed to inhibit RNA splicing, leading to cancer cell death and activation of immune system through multiple mechanisms
India represents a key territory with a rapidly growing incidence rate of cancer cases, projected to increase to 2.08 million by 20401
BOSTON and LONDON, June 18, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel immuno-oncology payload antibody drug conjugates (ADCs) for the treatment of cancer, today announced the Intellectual Property India (IPI) has issued Patent No. 562,919 titled, “Thailanstatin Analogs”.
The issued patent covers claims for the Company’s potent immuno-oncology PH1 payload, proprietary non-cleavable and cleavable linkers and ADC technology which has applications across various cancer targets.
“We believe our innovative ADC payload PH1 has the potential to provide therapies that disrupt cellular function, trigger cancer cell death and most importantly, enhance the immune system to fight cancer beyond the cells targeted by the ADC molecule. The issuance of this patent further strengthens our global intellectual property estate and importantly, provides additional patent protection around our CMC manufacturing activities for this PH1 payload and related analogs. Importantly, as cancer rates and diagnosis continue to rise significantly in India, we believe the need for innovative cancer therapies continue to increase. We are pleased to bolster our intellectual property portfolio to include this key market for future opportunities to potentially help cancer patients with our immuno-oncology ADCs,” commented Abizer Gaslightwala, President and CEO of Akari Therapeutics.
The issued India patent is a divisional patent of the Company’s R&D toxin portfolio on PH1 and builds on the portfolio of previously issued patents (Patent No. US 10,815,246 B2, Patent No. US 10,301,319 B2 and Patent No. US 11,691,982 B2). Grant Patent right for PCT/US2018/051721 family was issued by China National Intellectual Property Administration in August 2023, and in Israel in September 2023. Corresponding foreign patent applications are pending and currently undergoing examination in Patent Cooperation Treaty (“PCT”) countries - Brazil, Canada, member states of the European Patent Organisation (“EPO”), Hong Kong, Japan, New Zealand, Singapore, & South Africa.
Leveraging its innovative payload platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates across a wide range of cancer tumor targets. These initial candidates have shown significant tumor-killing activity in preclinical models with the ability to robustly activate the immune system to drive durable, and sustained outcomes.
About Akari Therapeutics
Akari Therapeutics is an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs). The Company has developed its first novel payload, PH1, a spliceosome inhibitor designed to disrupt RNA splicing within cells. PH1 is highly differentiated in its mechanism of action against cancer cells from current ADC payloads that use Topoisomerase1 inhibitors or tubulin inhibitors. This splicing inhibition has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. Using this novel payload, Akari has the ability to generate multiple ADC molecules based on the desired application to a range of cancer targets 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. 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; the Company’s targets, plans, objectives or goals for future operations, including those related to its product candidates. 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 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
1 https://pmc.ncbi.nlm.nih.gov/articles/PMC10231735/#R2
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