Akari Therapeutics (NASDAQ:AKTX) executives used a recent Virtual Investor “What This Means” segment to highlight the company’s expanding antibody-drug conjugate (ADC) pipeline, including a newly disclosed second program and a growing intellectual property portfolio centered on its PH1 payload.
Second ADC candidate disclosed: AKTX-102 targeting CEACAM5
During the discussion, President and CEO Abizer Gaslightwala said Akari recently filed a new patent and introduced a second ADC pipeline candidate, AKTX-102, aimed at CEACAM5-expressing solid tumors. Gaslightwala framed the development as validation of Akari’s strategy as a “novel payload company,” stating the company believes its payload can be attached to “many different types of antigen targets and molecules” to create a broader “library or pipeline of ADC molecules.”
According to Gaslightwala, Akari has developed “novel biological insights” and an approach to “engineer around” those issues using a new antibody design. He said specific details are covered in the patent and were not discussed further, but emphasized that Akari believes its antibody is differentiated from CEACAM5-directed ADCs that have entered the clinic.
Lead program AKTX-101 remains top priority
While discussing pipeline expansion, Gaslightwala stressed that AKTX-101, Akari’s lead TROP2 ADC, remains the company’s primary focus. He said Akari began IND-enabling activities with WuXi, which he described as a high-quality partner, and that work is underway.
Gaslightwala said the company is targeting a tight timeline with the goal of reaching an IND/CTA filing by the end of the year and starting a first-in-human study soon after. He contrasted the resource needs of AKTX-101—such as manufacturing scale-up and non-clinical GLP toxicology—with the earlier-stage AKTX-102 program, which he said can be advanced with comparatively limited budget and resources because it remains in discovery.
IP strategy: expanding beyond composition-of-matter
Gaslightwala said the company’s patent estate is expanding across the payload, antibody design, and ADC architecture. He noted that Akari already has composition-of-matter patent protection for its PH1 payload, which he described as an RNA splicing targeting payload.
He added that Akari filed three patents last year aimed at protecting not only the payload’s structure but also what he called its “modes of action.” Gaslightwala argued that these protections are important because the company has observed multiple potential functional properties of the payload, beyond cytotoxic activity.
He described several areas the company believes are relevant to its payload IP position:
- Cytotoxic activity
- Activity related to splice-driven variant cancers (RNA splicing)
- Immuno-oncology properties, including potential use as a single agent or in combination with checkpoint inhibitors
Gaslightwala positioned the new CEACAM5 patent filing as an additional layer on top of the payload IP foundation, focused on antibody design that can be coupled with the PH1 payload.
What investors may watch over the next 12–18 months
Looking ahead, Gaslightwala pointed to a series of milestones he expects investors to monitor across the platform, while noting some items could not be discussed due to confidentiality. He said Akari’s stated goal, as outlined in company materials, is to achieve an IND or CTA filing by the end of 2026, enabling initiation of a first-in-human Phase 1 study.
He also said that roughly six months after initiating the trial—“a total of 18 months out”—the company hopes to obtain an initial clinical readout from the Phase 1 study, including safety, dosing, and potential activity signals.
In addition, Gaslightwala said Akari plans to build a “robust package” for the IND submission, including new preclinical data, and to present additional preclinical results for AKTX-101 at research conferences, supported by press releases. He also said the company expects to continue engaging with regulators on its strategy and may publicly share outcomes from those interactions as development progresses.
About Akari Therapeutics (NASDAQ:AKTX)
Akari Therapeutics plc is a clinical-stage biopharmaceutical company focused on the discovery and development of novel complement inhibitors for the treatment of inflammatory and immunological diseases. The company’s research centers on modulation of the complement cascade, a key component of the innate immune system, with the goal of delivering targeted therapies to patients suffering from rare and severe disorders.
Akari’s lead pipeline asset is sutimlimab, a humanized monoclonal antibody that selectively inhibits the C1s protein and is being evaluated in pivotal clinical studies for cold agglutinin disease.
