Akari Therapeutics announces promising data for AKTX-101, showing synergistic effects against KRAS-driven pancreatic cancer in preclinical models.
Quiver AI Summary
Akari Therapeutics has announced positive preclinical findings for its antibody drug conjugate (ADC) AKTX-101, which features a novel RNA spliceosome modulating payload called PH1. The data, presented in an online abstract for the American Society of Clinical Oncology (ASCO) Annual Meeting 2026, shows that AKTX-101, in combination with a KRAS inhibitor, demonstrates enhanced cytotoxic effects against pancreatic cancer models driven by KRAS mutations G12D and G12C. This combination exhibited synergistic activity, unlike other TROP2-targeting ADCs that rely on Topoisomerase I inhibitors, illustrating the unique potential of PH1 to degrade pre-mRNA transcripts associated with KRAS-driven tumors. Akari's research indicates that targeting RNA splicing could provide a new therapeutic avenue for challenging KRAS-driven cancers, with plans to initiate a Phase 1 clinical trial for AKTX-101 by mid-2027.
Potential Positives
- Positive preclinical data showcasing the synergistic cytotoxic activity of AKTX-101, in combination with a KRAS inhibitor, against KRAS G12D and G12C-driven pancreatic cancer models, highlighting the potential effectiveness of this treatment strategy.
- Findings presented at ASCO 2026 further validate Akari’s lead TROP2-targeting ADC, suggesting broader applicability of RNA splicing modulation in treating KRAS-driven cancers, which have been historically difficult to target.
- AKTX-101 demonstrates a fundamentally differentiated mechanism compared to existing TROP2 ADCs that use Topoisomerase I inhibitor payloads, offering potential for enhanced therapeutic efficacy.
- The advancement towards initiating a Phase 1 first-in-human clinical trial by mid-2027 signals positive progress in the progression of AKTX-101 towards potential market introduction.
Potential Negatives
- The press release contains forward-looking statements that outline various risks and uncertainties, indicating potential challenges in advancing the company’s product candidates and achieving its development timelines, which may affect investor confidence.
- The emphasis on the need for additional capital could raise concerns regarding the company’s financial stability and its ability to sustain ongoing research and development activities.
- The mention of potential delays or failures in research and development may lead to skepticism about the viability of the company's innovative approaches and the success of its clinical trials.
FAQ
What is AKTX-101?
AKTX-101 is a TROP2-targeting antibody drug conjugate developed by Akari Therapeutics, featuring a novel RNA spliceosome-modulating payload called PH1.
How does AKTX-101 work against KRAS-driven pancreatic cancer?
AKTX-101 demonstrates synergistic cytotoxic activity when combined with a KRAS inhibitor, targeting RNA splicing to effectively kill cancer cells with KRAS mutations.
What distinguishes PH1 from traditional ADC payloads?
Unlike traditional ADCs that rely on DNA-damaging agents, PH1 disrupts RNA splicing within cancer cells, enhancing therapeutic efficacy against KRAS mutations.
When is the Phase 1 clinical trial for AKTX-101 expected to start?
Akari Therapeutics aims to initiate its Phase 1 first-in-human clinical trial for AKTX-101 by mid-2027, pending successful IND-enabling studies.
What are the implications of the ASCO 2026 findings?
The ASCO 2026 findings suggest that targeting RNA splicing with AKTX-101 may open new treatment avenues for challenging KRAS-driven cancers.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$AKTX Hedge Fund Activity
We have seen 2 institutional investors add shares of $AKTX stock to their portfolio, and 23 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ARMISTICE CAPITAL, LLC removed 2,722,993 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $14,023,413
- WARBERG ASSET MANAGEMENT LLC removed 308,340 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $1,587,951
- PALO ALTO INVESTORS LP removed 146,024 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $752,023
- HIGHTOWER ADVISORS, LLC removed 79,236 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $408,065
- JANE STREET GROUP, LLC removed 71,644 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $368,966
- CWA ASSET MANAGEMENT GROUP, LLC removed 55,000 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $283,250
- XTX TOPCO LTD removed 49,019 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $252,447
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard. You can access data on hedge funds moves and 13F filings through the Quiver Quantitative API 13F endpoint.
$AKTX Price Targets
Multiple analysts have issued price targets for $AKTX recently. We have seen 2 analysts offer price targets for $AKTX in the last 6 months, with a median target of $14.0.
Here are some recent targets:
- Sean Lee from HC Wainwright & Co. set a target price of $27.0 on 04/01/2026
- Aydin Huseynov from Ladenburg Thalmann set a target price of $1.0 on 01/05/2026
Full Release
An ADC with a novel RNA spliceosome modulating payload PH1 paired with a KRAS inhibitor demonstrates synergistic cytotoxic activity against KRAS G12D and G12C- driven pancreatic cancer models
Data supports the broader applicability of targeting RNA splicing to attack difficult-to-treat KRAS-driven cancers
Findings featured in ASCO 2026 online abstract further differentiate AKTX-101 from TROP2 ADCs utilizing Topoisomerase I inhibitor payloads
TAMPA, Fla. and LONDON, May 21, 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 positive preclinical data featured in an online abstract released in connection with the American Society of Clinical Oncology (ASCO) Annual Meeting 2026 highlighting synergistic cytotoxic activity of AKTX-101 in combination with KRAS inhibition in KRAS-mutated pancreatic cancer models. Access the abstract here .
The data further expands the potential opportunity for Akari’s lead TROP2-targeting ADC, AKTX-101, and its proprietary RNA spliceosome-modulating payload beyond the Company’s current Phase 1 development plan and supports the broader applicability of targeting RNA splicing as a potential way to treat difficult-to-treat KRAS-driven cancers.
The ASCO abstract evaluated the activity of AKTX-101 in combination with adagrasib, a KRAS inhibitor, across pancreatic cancer cell lines harboring KRAS G12D and KRAS G12C. In these studies, the combination of AKTX-101 and adagrasib demonstrated synergistic cell killing in KRAS mutant cell lines driven by G12C and G12D. This synergistic inhibition was not observed with the comparator first-in-class topoisomerase I-targeting TROP2 ADCs. Instead, these ADCs exhibited antagonism when paired with adagrasib. These results suggest that AKTX-101 synergy with KRAS inhibitor may be linked to the novel biology of PH1 targeting RNA splicing. The synergy was explained by PH1’s unique ability target pre-mRNA transcripts for degradation, including those bearing KRAS mutations driving these cancer models.
“KRAS has long been considered one of oncology’s most important but difficult targets, and while recent KRAS inhibitors have represented meaningful progress, there remains a significant opportunity to further enhance activity and broaden therapeutic impact,” said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. “These data suggest that our PH1 RNA splicing modulator payload may offer a fundamentally differentiated mechanism capable of enhancing KRAS inhibitor activity in ways not observed with conventional ADC payloads. We believe this represents an exciting opportunity not only for AKTX-101, but potentially for RNA splicing modulation as a new therapeutic strategy across KRAS-driven tumors.”
Dr. Satyajit Mitra, Executive Director and Head of Oncology, stated, “Historically, KRAS mutations have been incredibly difficult to drug, and one may need to approach this problem with drugs of different modalities and mechanisms of action. AKTX 101 synergy with an approved drug, like adagrasib, in an unapproved KRAS setting offers exciting combination possibilities. The PH1 spliceosome modulator payload ADC has the potential to unlock efficacy of cancer therapeutics in cancers with oncogene dependency. We have previously demonstrated combination with AR-v7 oncogenes with enzalutamide and now KRAS oncogenes with adagrasib.”
The data featured in the ASCO 2026 online abstract build upon Akari’s previously reported AACR 2026 findings demonstrating differentiated cytotoxicity and superior potency of AKTX-101 versus current TROP2 ADCs utilizing Topoisomerase I inhibitor payloads across multiple tumor models, including bladder, lung (including KRAS G12V mutated NSCLC) and breast cancers.
Akari’s lead program, AKTX-101, is a TROP2-targeting ADC powered by the Company’s proprietary PH1 RNA spliceosome-modulating payload. Unlike traditional ADC payloads that primarily rely on microtubule or DNA-damaging mechanisms, PH1 is designed to disrupt RNA splicing within cancer cells while also activating innate and adaptive immune responses.
Akari has initiated IND-enabling studies for AKTX-101 and is targeting initiation of a Phase 1 first-in-human clinical trial by mid-2027.
For more information about the ASCO Annual Meeting 2026, please visit www.asco.org .
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 been 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 mid-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 the timing of 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
[email protected]