Akari Therapeutics Looks Ahead to Key Milestones in 2026
Akari Therapeutics issued a letter to shareholders from its President and CEO, Abizer Gaslightwala, which read in part, "As 2025 concludes, I am pleased to reflect on a year of meaningful progress and significant achievements towards creating best-in-class ADCs to transform current cancer therapies. With each forward step and each new milestone, we are advancing our mission to bring our innovative and uniquely designed ADCs to cancer patients with the highest unmet needs. The scientific and operational strides made this year have positioned Akari for what we believe will be a pivotal and transformational year ahead for the Company...Looking ahead, I am very excited to have Akari progressing to critical inflection points that could significantly increase the Company's value and clinical impact: Key Catalysts and Milestones on the Horizon: Regulatory interactions with FDA for feedback on our planned Phase 1 trial; Presentation of differentiating data on AKTX-101 vs other Trop2 ADCs; Completion of CMC and non-clinical work for AKTX-101 to enable IND/CTA submissions at the end of 2026/ early 2027; Initiation of the Phase 1 clinical trial in late 2026 or early 2027, subject to regulatory clearance; Continued partnership discussions with pharmaceutical companies on our unique and differentiated PH1 payload/ADC approach and key catalysts forthcoming. Entering Phase 1 clinical studies will be a unique inflection point for Akari as an ADC oncology company, a milestone that historically correlates with increased visibility, investor interest and potential strategic partnerships with large pharmaceutical companies or strategic investors. Our excitement as a team for 2026 is unbounded, and we look forward to executing with urgency. We remain grateful for your continued trust and support in our path forward as an oncology ADC company, and we are excited by the potential ahead. Thank you for your continued belief in our mission and focus on developing therapies that could make a significant difference for cancer patients in their continued fight. We look forward to updating you throughout 2026 as we work diligently and with impatience every day to bring innovative therapies to patients, and reward you as shareholders for your conviction and belief in our plan and execution."
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Akari Therapeutics Highlights 2025 Progress, Plans First-in-Human Trials in 2026
- Strategic Partnership: Akari Therapeutics has established a strategic manufacturing partnership with WuXi Biologics to support its clinical trial preparations for 2026, marking a significant advancement in the company's oncology drug development.
- Innovative Drug Platform: The company is leveraging its unique PH1 payload platform to develop next-generation antibody-drug conjugates (ADCs), which have demonstrated compelling preclinical efficacy and safety, potentially transforming cancer treatment paradigms.
- Clinical Trial Plans: Akari plans to initiate its First-in-Human trial by the end of 2026, aiming to validate the efficacy of its lead candidate AKTX-101, which is expected to create new growth opportunities for the company.
- Market Potential: AKTX-101 targets the Trop2 receptor on cancer cells with a proprietary linker, anticipated to significantly enhance therapeutic efficacy and potentially synergize with checkpoint inhibitors, thereby strengthening the company's competitive position in the market.

Akari Therapeutics Presents ADC Platform and 2026 Strategic Priorities at Biotech Showcase
- Strategic Presentation: Akari Therapeutics' CEO Abizer Gaslightwala will present the company's antibody-drug conjugate (ADC) platform and 2026 strategic priorities at the Biotech Showcase on January 13, 2026, aiming to attract investor interest in its innovative drug development.
- Innovative Drug Development: Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells with its unique PH1 payload, showing significant effects in inducing cancer cell death and activating the immune system in preclinical studies, potentially offering new hope in cancer treatment.
- Clinical Trial Plans: The company has initiated IND enabling studies for AKTX-101, with plans to start its First-In-Human trial by late 2026 or early 2027, marking a significant step in its development and market potential in oncology.
- Multipronged Target Strategy: In addition to AKTX-101, Akari is advancing AKTX-102, an ADC targeting a novel antigen highly relevant in gastrointestinal and lung cancers, showcasing the company's broad pipeline and research capabilities across multiple cancer treatment areas.






