On April 20, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing modulator payload, reported the presentation of positive preclinical data for its lead TROP2-targeting ADC, AKTX-101, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. Access the poster here.

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Unlike current TROP2-targeting ADCs that use Topoisomerase I Inhibitor (Inh.) payloads, AKTX-101 has the potential to address resistance to Topoisomerase I Inh. ADCs and contribute to durable anti-tumor efficacy due to the payload’s unique cytotoxic and immune-activating mechanisms of action.

The preclinical data compares the performance of AKTX-101 versus TROP2 ADCs with Topoisomerase I Inh. payloads in the killing of different cancer types driven by different cancer genes (oncogenes). AKTX-101’s ability to kill cancer cells at lower concentrations vs. TROP2 ADCs using Topoisomerase I Inh. payloads suggests that AKTX-101 is a more potent drug.

The preclinical data was published recently as an abstract in Cancer Research, an AACR (Free AACR Whitepaper) journal.

Here, AKTX-101 demonstrated greater potency and/or greater maximum cancer cell killing relative to TROP2 ADC Topoisomerase I Inh. payloads in cancers of the bladder, lung and breast. AKTX-101 demonstrated sub-nanomolar potency in all bladder cancer lines tested, a key tumor in which first-in-human clinical trials for AKTX-101 are planned.

AKTX-101 also demonstrated sub-nanomolar potency in several non-small cell lung cancer cell lines driven by EGFR, BRAF, and SMARCA4, as well as potent cell killing in HER2 breast cancer cell lines with inherent resistance to Topoisomerase I Inh. ADCs such as trastuzumab deruxtecan (ENHERTU).

"These data represent a significant step forward for our lead program, AKTX-101, and reinforce our belief that a differentiated ADC payload with multiple mechanisms of action has the potential to meaningfully improve outcomes for patients with TROP2-expressing cancers," commented Satyajit K. Mitra, Ph.D., Head of Oncology Research and Development at Akari Therapeutics. "We are seeing preclinical superior AKTX-101 potency and activity as compared to TROP2 ADCs using Topoisomerase I inhibitor payloads in bladder, lung, and breast cancer models. Together, these findings show that AKTX-101 has strong potential for targeting a broad range of cancer tumors and sub-types with superior cytotoxicity than current TROP2 ADCs that use Topoisomerase I Inhibitor payloads."

The TROP2 ADC class continues to emerge in terms of its potential, with revenue projections expected to reach ~$12B or greater by 2033 based on current and future entrants. Akari believes that AKTX-101, with its novel RNA splicing modulator payload, can grow this class further by addressing multiple solid tumors where TROP2 is overexpressed including bladder, lung, breast, pancreatic, head and neck, and others.

Key AKTX-101 Data Presented at AACR (Free AACR Whitepaper) Highlights:

AKTX-101 demonstrated strong, single-agent anti-tumor activity across multiple models across bladder, lung, and breast cancers.
AKTX-101 demonstrated greater potency and cell killing compared to current TROP2 ADCs, including Topoisomerase I inhibitor-resistant tumor models, as well as standard-of-care chemotherapies and targeted therapies. Combination of AKTX-101 with anti-PD-1 therapy resulted in synergistic anti-tumor efficacy and tumor regressions within in vivo models, supporting future combinations with checkpoint inhibition to maximize tumor remissions rates.
Broad in vitro cytotoxicitywas observed across a diverse panel of tumor models, including those with clinically oncogenic driver mutations including FGFR3, BRAF, EGFR, and SMARCA4.
Abizer Gaslightwala, CEO of Akari Therapeutics, added, "This data continues to add to the conviction and differentiation we have in our novel ADC payload PH1 targeting RNA splicing. We are focused on rapidly advancing AKTX-101 into the clinic, with IND-enabling studies underway and plans to submit an IND in the fourth quarter of 2026, followed by initiation of a Phase 1 study in the first quarter of 2027. Our team is executing against a clear development plan designed to efficiently translate these encouraging preclinical findings into clinical proof of concept."

These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. Access the poster here.

(Press release, Akari Therapeutics, APR 20, 2026, View Source [SID1234664531])