Akari Therapeutics Highlights Preclinical Data Demonstrating Therapeutic Potential of Lead Candidate, AKTX-101, for Hard-to-Treat K-Ras Mutant Pancreatic Cancer
Data highlights the ability of Akari’s Trop2 ADC, AKTX-101, to kill K-Ras G12V mutated cancer cell lines in preclinical models, potentially addressing one of the most lethal cancers with the lowest survival rates
The K-Ras G12V mutation is the oncogenic driver for 1/3 of all pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer
Significant unmet need in pancreatic cancer where median overall survival (OS) is1.4 years1
TAMPA, Fla. and LONDON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced key preclinical data demonstrating the therapeutic potential of its novel ADC targeting Trop2, AKTX-101, in pancreatic cancer driven by K-Ras mutations, one of the deadliest and most treatment-resistant forms of cancer.
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer2, and about 50,000 people will die from this aggressive disease. The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, account for the vast majority of cases3 and have few effective treatment options, particularly for tumors driven by the K-Ras G12V mutation.
Current standard of care in K-Ras G12V-driven PDAC are 5-fluorouracil (5-FU) containing chemotherapy regimens such as FOLFIRINOX (Overall Survival = 1.5 years) or gemcitabine plus nab-paclitaxel (Overall Survival = 1.3 years), which offer poor outcomes, significant toxicities, and poor quality of life. Currently, there is a real void of targeted therapies for K-Ras driven PDAC, making this still one of the highest unmet need cancers. Current K-Ras inhibitors, such as Lumakras® and Krazati®, are only approved in K-Ras G12C mutated non-small cell lung cancer and colorectal cancer further emphasizing the void and the significant unmet need for K-Ras G12V targeted therapy options in PDAC patients.
AKTX-101 is an antibody-drug conjugate that delivers a novel RNA spliceosome modulating payload, PH1, into cancer cells that express Trop2 which is a protein commonly found at high levels in pancreatic and other hard-to-treat solid tumors. Once inside the tumor, the PH1 payload disrupts normal RNA splicing, a fundamental process cancer cells depend on to survive, grow, and spread. Trop2 is a ubiquitously expressed protein at high levels in PDAC and potentially a good ADC target4 in pancreatic cancer, and has been validated in other solid tumors including lung and breast cancers. Within pancreatic cancer, K-Ras mutated PDAC is associated with higher levels of Trop2 protein4 compared to PDAC with normal K-Ras, making a Trop2 ADC like ATKX-101 a potential precision therapeutic in this specific tumor mutation.
The latest data for AKTX-101 in KRas-G12V PDAC builds on preclinical evidence disclosed earlier in a patent filing. In this new study, AKTX-101 exhibited single digit nanomolar cytotoxic potency in all K-Ras G12V PDAC cell lines tested. Of significance, AKTX-101 also outperformed daraxonrasib in multiple PDAC cell lines (daraxonrasib is an investigational therapy being developed by Revolution Medicines to treat patients with cancers driven by K-Ras mutations).
Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics commented, “These preclinical data 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. We aspire to tackle hard-to-treat cancers and are excited to see our novel spliceosome-modulating payload PH1, conjugated to an ADC, demonstrate activity against aggressive cancers like K-Ras mutant tumors.”
From this early data, the Company believes that AKTX-101 may have therapeutic potential to control an aggressive form of untreatable pancreatic cancer and its preliminary data support K-Ras G12V-mutated PDAC as another high unmet need opportunity for AKTX-101. These data continue to demonstrate the promise of the PH1 payload in treating some of the most difficult cancers like K-Ras mutant tumors.
The Company plans to present this preclinical data at an upcoming scientific conference and is currently advancing AKTX-101 towards a first-in-human trial, expected to initiate in late 2026, and preliminary safety and efficacy data in 2027. In parallel, the Company is pursuing discussions with potential partners on developing the PH1 payload for new ADCs targeting other antigens expressed in a range of cancer tumors. For more information, visit www.akaritx.com.
About Akari Therapeutics
Akari Therapeutics is an oncology biotechnology company developing next-generation spliceosome payload antibody drug conjugates (ADCs). Utilizing its innovative ADC discovery platform, the Company has the ability to generate ADC candidates and optimize them based on the desired application to any target of interest. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and with a proprietary linker, delivers its novel PH1 payload directly into the tumor. Unlike current ADCs that use tubulin inhibitors and DNA damaging agents as their payloads, PH1 is a novel payload that is a spliceosome modulator designed to disrupt RNA splicing within cancer cells. This splicing modulation has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. In preclinical studies, AKTX-101 has shown to have significant activity and prolonged survival, relative to ADCs with traditional payloads. Additionally, AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival as both a single agent and in combination with checkpoint inhibitors, as compared to appropriate controls. The Company is generating validating data on its novel payload PH1 to continue advancing its lead asset, as well as other undisclosed targets with this novel payload.
For more information about the Company, please visit www.akaritx.com and connect on X and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding the ability of the Company to advance its product candidates for the treatment of cancer and any other diseases, and ultimately bring therapies to patients. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the Company’s need for additional capital; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the business; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, including as a result of potential tariffs; the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; risks related to competition for the Company’s product candidates; and the Company’s ability to successfully develop or commercialize its product candidates. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release except as required by law.
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
AKTX@jtcir.com
1 Ebia et al 2025, https://doi.org/10.1200/PO-24-00684
2 Siegel RL, et al. CA Cancer J Clin. 2024;74:12-49
3 Hallbrook CJ, et al. Cell.2023;186:1729-1754
4 Mas et al 2023, https://doi.org/10.1016/j.clinre.2023.102108
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