Strategic Partnership Enables Akari to Accelerate IND Filing By Late 2026
TAMPA, Fla. and LONDON, April 06, 2026 (GLOBE NEWSWIRE) — Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulating payloads announced a strategic partnership with WuXi XDC, a global leader in ADC development and manufacturing, to accelerate the development of Akari’s novel PH1 payload.
“This strategic partnership with WuXi XDC represents a major milestone for Akari and a powerful validation of our novel PH1 payload technology,” said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. “WuXi XDC is widely recognized as a global leader in ADC innovation, and with this partnership, we believe Akari can rapidly advance and further validate our PH1 payload on AKTX-101 in future clinical studies.”
WuXi XDC’s CEO, Jimmy Li, Ph.D., added, “We are pleased to work with Akari to advance the novel PH1 payload into more advanced studies. WuXi XDC has a proven record of advancing novel ADC payloads and strives to remain at the forefront of ADC innovation. We believe we are the trusted and best partner to help Akari advance this first-in-kind RNA splicing modulating ADC payload for its use in its lead program, as well as other future ADC molecules. There is a strong need for ADC payload innovation to improve on current therapies, and WuXi XDC wants to be at the forefront working with partners like Akari to bring novel ADCs to cancer patients.”
Akari’s lead program AKTX-101 is initially targeting metastatic urothelial cancer, where there continues to be significant unmet medical need particularly in the second-line treatment setting. Patients with metastatic disease that progress following first-line therapies often have limited options beyond standard chemotherapy, which offers only modest clinical benefit in this setting. The Company believes that AKTX-101 with its novel PH1 payload may provide a promising new therapeutic approach for urothelial cancer patients, while also demonstrating the broader potential of Akari’s PH1 payload platform.
AKTX-101 features Akari’s proprietary PH1 payload, a novel spliceosome modulator designed to disrupt RNA splicing in cancer cells. By targeting RNA splicing, PH1 represents a new direction for next-generation ADC therapies. Unlike traditional ADC payloads that are microtubule inhibitors or DNA-damaging agents, PH1 offers a differentiated mechanism of direct cytotoxicity as well as the unique activation of the innate and adaptive immune systems to attack cancer. In preclinical studies, AKTX-101 has demonstrated superior anti-tumor regression and complete remissions relative to other ADCs. Akari believes this differentiated mechanism positions PH1 as part of a new wave of ADC payload innovation aimed at significantly improving the therapeutic potential of antibody-drug conjugates.
Akari is working to advance its lead program, AKTX-101, into a Phase 1 clinical trial expected to initiate in late 2026 or early 2027 subject to regulatory clearance. This key clinical milestone reinforces Akari’s ongoing progress to advance its novel payload and execute its strategy to develop ADC therapies with novel payloads that have the potential to improve outcomes for cancer patients.
About WuXi XDC
WuXi XDC Cayman Inc. (stock code: 2268.HK) is a globally recognized contract research, development, and manufacturing organization (CRDMO) specializing in bioconjugates. The company offers a wide range of innovative conjugation and payload-linker technologies to facilitate the development of next-generation antibody-drug conjugates (ADCs). Focused on early-stage research and development of ADCs and other bioconjugates, WuXi XDC offers comprehensive one-stop services from preclinical to commercial manufacturing. Its services cover antibody intermediates and other biologics intermediates, chemical payloads and linkers, as well as bioconjugate drug substances and drug products. For more information about WuXi XDC, please visit: www.wuxixdc.com.
About Akari Therapeutics
Akari Therapeutics is an oncology biotechnology company developing next-generation antibody drug conjugates (ADCs) with a unique payload, PH1, which targets RNA splicing. 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 antigen target of interest. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells with a proprietary linker, enabling it to deliver its novel PH1 payload directly into the tumor with minimal off-target effects. Unlike current ADCs that use microtubule 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 both the innate and adaptive immune systems 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. The PH1 payload has also been demonstrated to be very active against cancer cells with key oncogenic drivers such as KRAS, BRAF, ARV7, FGFR3 fusions, and others. The Company has initiated IND enabling studies for AKTX-101 with a goal of starting its First-In-Human trial by late 2026/early 2027. Akari is also developing AKTX-102, an ADC candidate targeting CEACAM5 (Carcinoembryonic Antigen-related Cell Adhesion Molecule-5), a well-validated tumor antigen broadly expressed across multiple solid tumors. AKTX-102 is designed to leverage Akari’s proprietary PH1 spliceosome-modulating payload and a novel antibody construct to enable differentiated tumor cell killing and immune activation.
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 its expectations regarding its strategic manufacturing partnership with WUXI and its expectations regarding the timing of the submission of an IND and commencement of a Phase 1 clinical trial. 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
