On January 26, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company pioneering next-generation antibody drug conjugates (ADCs) powered by novel RNA-splicing payloads, reported 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.
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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
(Press release, Akari Therapeutics, JAN 26, 2026, View Source [SID1234662202])