Akari Therapeutics Reports Positive Preclinical Data for AKTX-101 Demonstrating Differentiated Cytotoxicity for First-in-Class TROP2 ADC Payload Targeting RNA Splicing
Rhea-AI Summary
Akari Therapeutics (Nasdaq: AKTX) reported positive preclinical results for AKTX-101, a TROP2-targeting ADC using a novel RNA splicing modulator payload (PH1). AKTX-101 showed sub-nanomolar potency in bladder and selected lung and breast cancer models and greater cytotoxicity versus TROP2 ADCs with Topoisomerase I inhibitor payloads.
The company plans an IND submission in Q4 2026 and initiation of a Phase 1 study in Q1 2027; data were presented at AACR 2026.
Positive
- Sub-nanomolar potency demonstrated across all tested bladder cancer lines
- Greater potency and/or maximum killing versus Topoisomerase I inhibitor TROP2 ADCs in bladder, lung, breast
- Synergy with anti-PD-1 observed in vivo leading to tumor regressions
- IND planned Q4 2026 with Phase 1 start targeted Q1 2027
Negative
- Data are preclinical only; no human clinical proof yet
- Planned IND timing is not guaranteed and depends on IND-enabling study outcomes
News Market Reaction – AKTX
In the Apr 20 session, AKTX gained 2.41%, reflecting a moderate positive market reaction. Argus tracked a trough of -48.6% from its starting point during tracking. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility. Trading volume was exceptionally heavy at 7.4x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 09 | Strategic partnership | Positive | +1.0% | CEO discussed WuXi XDC partnership aimed at accelerating AKTX-101 IND. |
| Apr 06 | Partnership announcement | Positive | -20.8% | Formal WuXi XDC partnership to speed PH1 payload and AKTX-101 into clinic. |
| Mar 18 | AACR abstract news | Positive | -24.7% | AACR 2026 poster acceptance for differentiated Trop2 ADC rationale. |
| Mar 17 | ADS ratio change | Negative | -24.7% | One-for-forty ADS reverse split to support Nasdaq bid-price compliance. |
| Mar 13 | Pipeline strategy | Positive | -10.7% | CEO Corner outlining PH1 ADC platform, AKTX-101/102 progress and IND plans. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Shares have often sold off on positive strategic and R&D updates, while reacting in line with structurally negative actions like the ADS ratio change.
Over the past months, Akari has laid groundwork for AKTX‑101 and its PH1 RNA‑splicing ADC platform. A Mar 13 CEO Corner and subsequent Apr 6–9 WuXi XDC partnership news emphasized IND‑enabling work and timelines to late 2026/early 2027, yet saw mixed price reactions, including a -20.81% drop on partnership announcement. The Mar 31 ADS ratio change, tied to Nasdaq compliance, coincided with a -24.72% move. Today’s detailed preclinical AACR data further develops the same AKTX‑101 narrative, now with stronger mechanistic differentiation versus existing TROP2 ADCs.
Key Terms
antibody drug conjugates medical
trop2 medical
topoisomerase i inhibitor medical
rna spliceosome medical
rna splicing medical
anti-pd-1 medical
checkpoint inhibition medical
ind-enabling studies regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Superior potency demonstrated versus leading TROP2 ADCs across bladder, lung and breast tumor models
Novel RNA spliceosome-targeting payload PH1 shows potential to overcome Topoisomerase I inhibitor resistance
Preclinical data support advancement of AKTX-101 into Phase 1 studies in a rapidly evolving TROP2 ADC class expected to reach ~
TAMPA, Fla. and LONDON, April 20, 2026 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing modulator payload, today announced the presentation of positive preclinical data for its lead TROP2-targeting ADC, AKTX-101, at the American Association for Cancer Research (AACR) Annual Meeting 2026. Access the poster here.
Unlike current TROP2-targeting ADCs that use Topoisomerase I Inhibitor (Inh.) payloads, AKTX-101 has the potential to address resistance to Topoisomerase I Inh. ADCs and contribute to durable anti-tumor efficacy due to the payload’s unique cytotoxic and immune-activating mechanisms of action.
The preclinical data compares the performance of AKTX-101 versus TROP2 ADCs with Topoisomerase I Inh. payloads in the killing of different cancer types driven by different cancer genes (oncogenes). AKTX-101’s ability to kill cancer cells at lower concentrations vs. TROP2 ADCs using Topoisomerase I Inh. payloads suggests that AKTX-101 is a more potent drug.
The preclinical data was published recently as an abstract in Cancer Research, an AACR journal.
Here, AKTX-101 demonstrated greater potency and/or greater maximum cancer cell killing relative to TROP2 ADC Topoisomerase I Inh. payloads in cancers of the bladder, lung and breast. AKTX-101 demonstrated sub-nanomolar potency in all bladder cancer lines tested, a key tumor in which first-in-human clinical trials for AKTX-101 are planned.
AKTX-101 also demonstrated sub-nanomolar potency in several non-small cell lung cancer cell lines driven by EGFR, BRAF, and SMARCA4, as well as potent cell killing in HER2 breast cancer cell lines with inherent resistance to Topoisomerase I Inh. ADCs such as trastuzumab deruxtecan (ENHERTU™).
“These data represent a significant step forward for our lead program, AKTX-101, and reinforce our belief that a differentiated ADC payload with multiple mechanisms of action has the potential to meaningfully improve outcomes for patients with TROP2-expressing cancers,” commented Satyajit K. Mitra, Ph.D., Head of Oncology Research and Development at Akari Therapeutics. “We are seeing preclinical superior AKTX-101 potency and activity as compared to TROP2 ADCs using Topoisomerase I inhibitor payloads in bladder, lung, and breast cancer models. Together, these findings show that AKTX-101 has strong potential for targeting a broad range of cancer tumors and sub-types with superior cytotoxicity than current TROP2 ADCs that use Topoisomerase I Inhibitor payloads.”
The TROP2 ADC class continues to emerge in terms of its potential, with revenue projections expected to reach ~
Key AKTX-101 Data Presented at AACR Highlights:
- AKTX-101 demonstrated strong, single-agent anti-tumor activity across multiple models across bladder, lung, and breast cancers.
- AKTX-101 demonstrated greater potency and cell killing compared to current TROP2 ADCs, including Topoisomerase I inhibitor-resistant tumor models, as well as standard-of-care chemotherapies and targeted therapies. Combination of AKTX-101 with anti-PD-1 therapy resulted in synergistic anti-tumor efficacy and tumor regressions within in vivo models, supporting future combinations with checkpoint inhibition to maximize tumor remissions rates.
- Broad in vitro cytotoxicity was observed across a diverse panel of tumor models, including those with clinically oncogenic driver mutations including FGFR3, BRAF, EGFR, and SMARCA4.
Abizer Gaslightwala, CEO of Akari Therapeutics, added, “This data continues to add to the conviction and differentiation we have in our novel ADC payload PH1 targeting RNA splicing. We are focused on rapidly advancing AKTX-101 into the clinic, with IND-enabling studies underway and plans to submit an IND in the fourth quarter of 2026, followed by initiation of a Phase 1 study in the first quarter of 2027. Our team is executing against a clear development plan designed to efficiently translate these encouraging preclinical findings into clinical proof of concept.”
These data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2026. Access the poster here.
¹ DataIntelo, TROP2-Targeted Therapies Market Report, 2026
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 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, and the timing of the submission of an IND and commencement of a Phase I 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
