Akari Therapeutics Files New U.S. Provisional Patent For AKTX-102, A First-In-Class CEACAM5-Targeting ADC Powered By PH1 Spliceosome-Modulating Payload

Akari Therapeutics, Plc, an oncology biotechnology company developing next-generation antibody drug conjugates (ADCs) powered by novel RNA-splicing payloads, announced that it has filed a new U.S. provisional patent application (No. 63/958,508). The application covers the company’s second pipeline candidate, AKTX-102, an ADC designed to target CEACAM5 (Carcinoembryonic Antigen-related Cell Adhesion Molecule-5), a well-studied but historically challenging oncology target.

CEACAM5 is widely expressed across several major solid tumors. It is present in 80 to 90 percent of gastrointestinal cancers, such as colorectal and pancreatic cancer, as well as in approximately 30 percent of bladder cancers and 25 percent of lung adenocarcinomas. It is also found in up to 50 percent of luminal A (HR+) breast cancers. In addition to its broad expression, CEACAM5 is associated with aggressive tumor biology, including KRAS-mutated lung cancers, which reinforces its importance as a target in high-unmet-need cancers.

AKTX-102 is designed as a first-in-class ADC that brings together a newly developed CEACAM5-targeting antibody construct with Akari’s proprietary PH1 spliceosome-modulating payload. This combination is intended to deliver both potent and differentiated tumor cell killing while also activating the innate and adaptive immune responses against the cancer.

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics, stated that the new patent filing represents a significant milestone in expanding the company’s ADC platform and pipeline. He noted that AKTX-102 builds upon Akari’s deep understanding of CEACAM5 tumor biology and showcases the flexibility of the PH1 payload, as well as the company's antibody engineering capabilities, to address difficult targets. He added that PH1 has the potential to serve as the basis for multiple ADC programs and reflects innovation not only in payload design but also in antibody and tumor antigen engineering.

He further explained that AKTX-102 aims to enhance cytotoxic activity while utilizing PH1’s unique characteristics, including immune activation and activity in KRAS-mutated cancers. Additional updates on the program will be shared as development progresses.

The newly filed patent contributes to the rapid expansion of Akari’s intellectual property estate surrounding novel ADCs and payload innovation. Akari’s earlier 2025 patent filings focused on new mechanisms of action, payload-driven biology, and ADC combination strategies. The latest application adds protection for a previously undisclosed pipeline asset, AKTX-102, and introduces new composition-of-matter claims related to the antibody design and ADC constructs built from that design.

This patent builds upon Akari’s foundational PH1 payload family (PCT/US2018/051721) and its lead clinical program, AKTX-101 (PCT/US2024/024997). Together, these filings form a layered intellectual property structure that supports the development of next-generation ADCs and positions the company to deliver multiple first-in-class and best-in-class candidates across validated cancer targets.

CEACAM5 has long been recognized as a valuable oncology target, but its complex biology has made it difficult to drug. High levels of antigen shedding and the existence of both soluble and tumor-bound forms have hindered past attempts, and no CEACAM5-directed therapy has yet achieved regulatory approval in any format. CEACAM5 also acts as an immunosuppressive checkpoint by reducing T-cell and natural killer cell activity, allowing tumors to evade the immune system. Akari’s new patent application covers antibody constructs engineered to overcome these challenges, along with ADCs incorporating the PH1 payload to utilize its dual immuno-oncology and cytotoxic mechanisms.

This comprehensive composition-of-matter protection gives Akari ownership of a new strategy for targeting CEACAM5 as a potential best-in-class ADC therapy. Akari continues advancing its lead program, AKTX-101, a Trop2-targeted ADC, toward IND/CTA submission and first-in-human clinical development. At the same time, the company is building a broader pipeline of ADCs enabled by the PH1 payload. With multiple validated tumor targets, a rapidly growing intellectual property estate, and a differentiated biological approach, Akari believes it is well positioned to create long-term value and deliver meaningful clinical impact.

Looking ahead, the company expects several key milestones for the AKTX-101 program in 2026. These include regulatory interactions with the FDA in the first half of the year to discuss its planned Phase 1 trial, presentation of new AKTX-101 data at a major scientific conference, completion of CMC and non-clinical work including GLP toxicology to support IND/CTA submissions at the end of 2026 or early 2027, and initiation of a Phase 1 clinical study during that same period, pending regulatory approval. Akari will also continue engagement with pharmaceutical companies regarding potential partnerships involving its PH1 payload and ADC programs.