Akari Therapeutics Reports Preclinical Success of AKTX‑101 in K‑Ras G12V Pancreatic Cancer

AKTX
December 10, 2025

Akari Therapeutics disclosed that its lead antibody‑drug conjugate, AKTX‑101, achieved single‑digit nanomolar cytotoxic potency across all tested K‑Ras G12V pancreatic ductal adenocarcinoma cell lines in preclinical models, outperforming the investigational KRAS inhibitor darxonrasib in multiple assays. The PH1 spliceosome‑modulating payload not only induces tumor cell death but also activates immune effector cells, offering a dual mechanism of action in a cancer type with limited targeted options.

The company plans to present these findings at an upcoming scientific conference and to advance AKTX‑101 toward a first‑in‑human trial expected to begin in late 2026. The preclinical data provide a strong rationale for moving the candidate into clinical development and could position Akari as a leader in next‑generation antibody‑drug conjugates for hard‑to‑treat pancreatic cancers.

CEO Abizer Gaslightwala emphasized that the results “provide a rationale for Akari to develop AKTX‑101 in areas of severe unmet need and historically very difficult cancers, such as K‑Ras mutant PDAC.” The statement underscores the company’s focus on addressing high‑unmet‑need oncology indications.

Akari remains a preclinical‑stage company with no revenue‑generating products and has reported negative earnings and a low market capitalization. The company faces significant funding and regulatory hurdles, and its financial health is described as precarious, highlighting the need for future capital raises and successful clinical outcomes to sustain its pipeline.

Investors reacted positively to the announcement, reflecting optimism about the ADC platform’s potential to address a critical unmet need in pancreatic cancer. The company’s progress is viewed as a meaningful step forward, though the preclinical nature of the data and the company’s financial challenges temper expectations.

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