Company expands its ADC pipeline and patent estate for novel, differentiated ADCs

New pipeline candidate AKTX-102 leverages Akari’s proprietary PH1 spliceosome payload and a novel antibody construct to address one of oncology’s most challenging and valuable solid tumor targets, CEACAM5

TAMPA and LONDON, Jan. 26, 2026 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company pioneering next-generation antibody drug conjugates (ADCs) powered by novel RNA-splicing payloads, today announced the filing of a new U.S. provisional patent application (No. 63/958,508) covering its second pipeline candidate, AKTX-102, an ADC directed against CEACAM5 (Carcinoembryonic Antigen-related Cell Adhesion Molecule-5), a well-validated but historically difficult-to-drug oncology target.

CEACAM5 is expressed in 80–90% of gastrointestinal cancers, including colorectal and pancreatic cancer, approximately 30% of bladder cancers, 25% of lung adenocarcinomas, and up to 50% of luminal A (HR+) breast cancers. Importantly, CEACAM5 expression has also been linked to aggressive genetic subtypes, including KRAS-mutated lung cancers, underscoring its relevance across multiple high-unmet-need solid tumor indications.

AKTX-102 is a first-in-class ADC that combines a novel CEACAM5-targeting antibody construct with Akari’s proprietary PH1 spliceosome-modulating payload, designed to deliver potent, differentiated tumor cell killing while simultaneously activating both the innate and adaptive immune responses to the tumor.

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics, commented, “This patent filing marks another important step in expanding Akari’s differentiated ADC platform and rapidly growing pipeline. AKTX-102 builds on our deep and unique insights into CEACAM5 tumor biology and we believe demonstrates the versatility of our PH1 payload and our antibody expertise to unlock previously intractable targets. We believe PH1 can serve as the foundation for a pipeline of novel ADCs, and this program highlights our innovation on novel payloads for ADCs as well as with tumor antigen biology and antibody engineering to build best-in-class ADCs.”

“With AKTX-102, we aim to improve cytotoxic efficacy while harnessing PH1’s unique properties, including innate and adaptive immune activation and activity against KRAS-mutated cancers. We look forward to sharing additional progress as we continue to advance this exciting program,” added Mr. Gaslightwala.

Rapidly Expanding and Deepening Patent Estate Around Novel ADCs and Payload Innovation

This newly filed patent further accelerates Akari’s rapid build-out of a broad and defensible intellectual property portfolio spanning payload biology, ADC architecture, and combination strategies. While Akari’s 2025 patent filings (US63/882,631, US63/891,856, and US63/891,861) focused on novel mechanisms of action, payload-driven biology, and ADC combination approaches, this new filing extends protection to a previously undisclosed pipeline asset, AKTX-102, and introduces new composition-of-matter claims around novel antibody design and ADC constructs utilizing this antibody design.

These filings build upon Akari’s foundational PH1 payload patent family (PCT/US2018/051721) and its lead clinical program AKTX-101 (PCT/US2024/024997), collectively creating a layered and rapidly expanding patent moat around next-generation ADCs. Together, Akari expects this growing estate positions the Company to generate multiple first- and best-in-class ADC candidates across a wide range of validated cancer targets.

Cracking One of Oncology’s Toughest Targets

CEACAM5 has long been viewed as a high-value oncology target, but its unique and challenging biology—including extensive antigen shedding and the presence of both soluble and tumor-bound forms—has historically limited therapeutic success. Despite decades of effort, no CEACAM5-directed therapy has yet achieved regulatory approval, whether as a naked antibody, ADC, or T-cell engager.

Beyond its role in tumor growth and metastasis, CEACAM5 also functions as an immunosuppressive checkpoint, inhibiting T-cell and natural killer (NK) cell activity to promote immune evasion. Akari’s newly filed patent covers novel antibody constructs engineered to address these biological challenges, as well as ADCs that pair these antibodies with the Company’s PH1 payload, enabling a differentiated therapeutic approach utilizing PH1’s unique immuno-oncology and cytotoxic modes of action.

This broad composition-of-matter protection provides Akari with ownership over a unique strategy to effectively target CEACAM5 as a best-in-class ADC therapeutic.

Execution, Momentum and Path to the Clinical Stage with Lead Program AKTX-101

As previously announced, Akari continues to execute on its strategy of advancing AKTX-101, its lead Trop2-targeted ADC, toward IND/CTA submission and first-in-human clinical evaluation, while simultaneously expanding a pipeline of next-generation ADCs enabled by its proprietary PH1 payload. With multiple validated targets, a growing IP estate, and a differentiated biological approach, the Company believes it is well positioned to deliver meaningful clinical impact and long-term value creation.

Key Catalysts and Milestones for AKTX-101 Development Program in 2026

• Regulatory interactions with FDA in H1 2026 for feedback on our planned Phase 1 trial
• Presentation of AKTX-101 data highlighting key areas of differentiation vs current Trop2 ADCs at a major scientific congress upcoming
• Completion of CMC and non-clinical work including final GLP Toxicology for AKTX-101 to enable IND/CTA submissions at the end of 2026/ early 2027
• Initiation of the Phase 1 clinical trial in late 2026 or early 2027, subject to regulatory clearance
• Continued partnership discussions with pharmaceutical companies on our unique and differentiated PH1 payload/ADC approach and key catalysts forthcoming
  

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 and 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 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 both the innate and adaptive immune system 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, and is also advancing AKTX-102, an ADC against a novel target highly relevant in GI and lung cancers. 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