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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- 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.

- 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.
- FDA Approval: Vanda Pharmaceuticals' NEREUS (tradipitant) has received FDA approval for the prevention of motion-induced vomiting in adults, marking a significant advancement in the company's neuropharmaceutical portfolio and is expected to drive future sales growth.
- Stock Surge: Following the FDA approval announcement, Vanda's shares jumped 17.5% to $8.26 in pre-market trading, reflecting strong market confidence in the new drug's potential and likely attracting increased investor interest.
- Market Outlook: The approval of NEREUS not only opens new market opportunities for Vanda Pharmaceuticals but also enhances its market share in the competitive antiemetic drug sector, strengthening the company's long-term profitability prospects.
- Investor Confidence: This FDA approval boosts investor expectations for Vanda's future performance, potentially prompting more institutional investors to reassess their portfolios, further driving the stock price upward.

- Strategic Milestones: In 2025, Akari Therapeutics made significant strides in the antibody-drug conjugate (ADC) space, particularly with its PH1 payload-based ADC designed to overcome limitations of existing therapies, thereby offering more effective treatment options for cancer patients.
- Lead Program Progress: AKTX-101 achieved notable results in 2025, especially demonstrating strong anti-tumor activity in pancreatic and prostate cancer models, which is expected to lay a solid foundation for clinical trials and enhance the company's competitiveness in cancer treatment.
- GMP Manufacturing Partnership: The collaboration with WuXi XDC marks Akari's transition from a preclinical discovery company to a clinical biotechnology player, ensuring the production of high-quality clinical products to support upcoming trials in 2026.
- Intellectual Property Enhancement: Akari filed three new patents in 2025 to protect the uniqueness of its PH1 payload, further solidifying its market position in the ADC field and providing legal safeguards for future R&D efforts.
- Innovative Drug Progress: In 2025, Akari Therapeutics significantly advanced its lead antibody-drug conjugate AKTX-101, demonstrating notable activity against deadly cancers like pancreatic and prostate cancer, which is expected to yield positive outcomes in clinical trials.
- Manufacturing Partnership Initiated: The partnership with global leader WuXi XDC marks the initiation of GMP production for AKTX-101, signifying Akari's transition from a preclinical discovery company to a clinical-focused biotechnology player.
- Intellectual Property Enhancement: Throughout 2025, Akari filed three new patents to protect its unique PH1 payload platform, further solidifying its competitive edge in the oncology sector.
- Future Outlook: 2026 is anticipated to be a pivotal year for Akari, with plans to submit IND applications by the end of the year and initiate Phase 1 clinical trials for AKTX-101, potentially attracting increased investor interest.
- GMP Manufacturing Initiation: Akari Therapeutics announced the initiation of GMP manufacturing for its lead antibody-drug conjugate, AKTX-101, marking a pivotal step toward its planned Phase 1 clinical trial expected to start in late 2026 or early 2027, reflecting the company's confidence in its scientific approach.
- Innovative Drug Mechanism: AKTX-101 utilizes a proprietary PH1 payload designed to target the Trop2 receptor on cancer cells, combining direct cytotoxicity with immune activation, which could potentially offer superior therapeutic outcomes compared to existing options.
- Strategic Partnership: Akari has partnered exclusively with WuXi XDC, a global leader in ADC development and manufacturing, leveraging their integrated platform to accelerate the production of GMP-grade material, thereby enhancing the company's competitive positioning in the market.
- Upcoming Milestones: The company plans to complete GMP manufacturing to support IND submission within the next 12 months and continue validating the PH1 payload across undisclosed targets in its pipeline, which, if successful, could redefine the therapeutic landscape for antibody-drug conjugates.







