Akari Therapeutics Files Key Patent and Unveils Second ADC Program AKTX-102 Targeting CEACAM5 Expressing Solid Tumors

Rhea-AI Summary

Akari Therapeutics (NASDAQ: AKTX) filed U.S. provisional patent No. 63/958,508 for AKTX-102, a CEACAM5-targeted ADC that pairs a novel antibody construct with Akari’s PH1 spliceosome payload.

The filing claims composition-of-matter protection for antibody design and ADC constructs and expands Akari’s PH1 patent family. CEACAM5 expression cited: 80–90% of gastrointestinal cancers, ~30% bladder, 25% lung adenocarcinomas, up to 50% luminal A breast. Akari plans IND-enabling work for AKTX-101 with FDA interactions in H1 2026 and aims for IND/CTA submission end-2026/early-2027.

Positive

• Filed U.S. provisional patent No. 63/958,508 for AKTX-102
• Claims include novel antibody design and ADC composition-of-matter
• Targets CEACAM5, expressed in 80–90% of GI cancers
• PH1 payload IP family expanded, layering patent protection
• AKTX-101 regulatory interactions with FDA planned in H1 2026

Negative

• No CEACAM5-directed therapy has achieved regulatory approval to date
• AKTX-102 protection is currently a provisional patent (early stage)
• AKTX-102 has no disclosed preclinical or clinical efficacy data yet

News Market Reaction – AKTX

-0.51%

7 alerts

-0.51% News Effect

+15.4% Peak Tracked

-3.5% Trough Tracked

-$64K Valuation Impact

$13M Market Cap

0.5x Rel. Volume

On the day this news was published, AKTX declined 0.51%, reflecting a mild negative market reaction. Argus tracked a peak move of +15.4% during that session. Argus tracked a trough of -3.5% from its starting point during tracking. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $64K from the company's valuation, bringing the market cap to $13M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

CEACAM5 expression in GI cancers: 80–90% CEACAM5 in bladder cancer: 30% CEACAM5 in lung adenocarcinoma: 25% +5 more

8 metrics

CEACAM5 expression in GI cancers 80–90% Expression in gastrointestinal cancers including colorectal and pancreatic

CEACAM5 in bladder cancer 30% Estimated expression in bladder cancers

CEACAM5 in lung adenocarcinoma 25% Estimated expression in lung adenocarcinomas

CEACAM5 in luminal A breast 50% Up to this expression in luminal A (HR+) breast cancers

Patent application number 63/958,508 U.S. provisional patent application for AKTX-102 ADC

Regulatory interactions timing H1 2026 Planned FDA interactions for AKTX-101 Phase 1 trial design

IND/CTA submission window End of 2026 / early 2027 Target timing to enable AKTX-101 Phase 1 trial

Phase 1 trial start Late 2026 or early 2027 Planned initiation of AKTX-101 first-in-human trial, subject to clearance

Market Reality Check

Price: $0.2292 Vol: Volume 353,143 is below 2...

low vol

$0.2292 Last Close

Volume Volume 353,143 is below 20-day average 517,783 (relative volume 0.68x). low

Technical Shares are trading below the 200-day MA, with price at 0.2736 vs 200-day MA of 0.88 and well under the 52-week high of 1.73.

Peers on Argus

Peer moves are mixed and modest: names like QTTB (-2.72%) and ALLR (-4.76%) are ...

Peer moves are mixed and modest: names like QTTB (-2.72%) and ALLR (-4.76%) are down, while RNTX (+3.01%), KZR (+0.32%) and LIXT (+0.91%) are up. No momentum scanner signals or same-day peer headlines indicate a sector-wide ADC or biotech reaction.

Historical Context

5 past events · Latest: Jan 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 09	CEO strategic update	Positive	-0.3%	CEO Corner summarizing 2025 progress and clinical transition plans for 2026.
Jan 08	Conference presentation	Positive	-1.7%	Announcement of in-person presentation at 2026 Biotech Showcase and investor meetings.
Dec 30	Year-end shareholder letter	Positive	+2.3%	End-of-year letter detailing PH1 payload progress, patents, and AKTX-101 plans.
Dec 23	Manufacturing milestone	Positive	-7.1%	Initiation of GMP manufacturing for AKTX-101 with WuXi XDC for Phase 1 supply.
Dec 18	Investor education video	Positive	-2.2%	Virtual investor segment on PH1 payload, new preclinical data, and trial timing.

Pattern Detected

Recent positive corporate and pipeline updates have often seen negative or muted next-day price reactions, with only one of the last five news events aligning positively.

Recent Company History

Over the past several months, Akari has consistently highlighted progress on its PH1-based ADC platform and lead candidate AKTX-101, including GMP manufacturing initiation, new patents, and investor communication events. Despite these seemingly constructive updates, four of the last five announcements saw negative 24-hour price moves, such as the -7.08% reaction on Dec. 23, 2025 to GMP manufacturing news. Today’s patent filing and second ADC program fit this pattern of building an ADC franchise while the stock trades near the low end of its 52-week range.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-07-29

The company has an active S-3 shelf filed on 2025-07-29 that remains effective through 2028-07-29, with at least two recorded takedowns via 424B5 prospectus supplements. This framework facilitates additional capital raises, which can be supportive for funding the ADC pipeline but also represents potential future equity issuance for existing shareholders.

Market Pulse Summary

This announcement adds AKTX-102, a CEACAM5-targeted ADC using the proprietary PH1 payload, to Akari’...

Analysis

This announcement adds AKTX-102, a CEACAM5-targeted ADC using the proprietary PH1 payload, to Akari’s growing ADC pipeline while reinforcing plans to move lead asset AKTX-101 toward Phase 1 in late 2026 or early 2027. Recent history shows multiple patents, manufacturing steps, and investor outreach around PH1. Investors may track execution against stated catalysts, regulatory interactions in H1 2026, and the company’s use of existing financing tools as the stock trades well below its 0.88 200-day MA and 1.73 52-week high.

Key Terms

antibody drug conjugates, adcs, spliceosome, ceacam5, +4 more

8 terms

antibody drug conjugates medical

"an oncology biotechnology company pioneering next-generation antibody drug conjugates (ADCs)"

Antibody drug conjugates are targeted medicines that combine an antibody, which seeks out specific markers on diseased cells, with a powerful drug that is released only when the antibody binds its target. Think of it as a guided missile that delivers a toxic payload directly to its target, reducing damage to healthy cells; investors watch them because successful ADCs can offer high-value, niche treatments and drive strong revenue and patent-based protection for developers.

adcs medical

"Company expands its ADC pipeline and patent estate for novel, differentiated ADCs"

Antibody-drug conjugates (ADCs) are targeted cancer medicines that combine an antibody, which seeks out specific markers on tumor cells, with a powerful drug payload that is released once the antibody binds its target. Think of them as a guided missile that delivers a toxic package directly to diseased cells to limit harm to healthy tissue. Investors watch ADC news closely because clinical trial results, manufacturing complexity and regulatory decisions can sharply change a biotech company’s value.

spliceosome medical

"leverages Akari’s proprietary PH1 spliceosome payload and a novel antibody construct"

A spliceosome is a cellular molecular machine that edits raw messenger RNA by cutting out noncoding segments and joining the remaining pieces so genes produce the correct proteins. Think of it as an editor or scissors that shapes the final instructions a cell uses. It matters to investors because drugs or tests that affect or measure spliceosome activity can change disease outcomes, create new therapies, or serve as biomarkers, influencing biotech valuations and clinical prospects.

ceacam5 medical

"an ADC directed against CEACAM5 (Carcinoembryonic Antigen-related Cell Adhesion Molecule-5)"

A protein found on certain cells and released into the blood that often becomes elevated in some cancers; it is commonly measured as a tumor marker. Think of it as a biological flag or smoke signal that can help doctors detect, monitor disease progression, or judge whether a therapy is working. For investors, levels and uses of this marker matter because they influence diagnostics, drug development, patient selection, regulatory decisions, and commercial markets.

t-cell medical

"functions as an immunosuppressive checkpoint, inhibiting T-cell and natural killer (NK) cell activity"

A T-cell is a type of immune cell that acts like a trained security guard, identifying and attacking infected or abnormal cells in the body. Investors care because many drugs and vaccines are designed to boost, redirect, or mimic T-cell activity; positive clinical results or regulatory approvals for T-cell–based therapies can drive significant changes in a company’s valuation, while safety or efficacy setbacks can hurt it.

natural killer (nk) cell medical

"inhibiting T-cell and natural killer (NK) cell activity to promote immune evasion"

A natural killer (NK) cell is a type of white blood cell in the immune system that acts like a rapid-response security guard, identifying and destroying infected or cancerous cells without prior training. For investors, NK cells matter because therapies or tests that harness, enhance, or measure them are central to many cancer and infectious disease treatments; progress or setbacks in NK-related products can affect clinical trial outcomes, regulatory decisions, and the commercial value of biotech firms.

t-cell engager medical

"no CEACAM5-directed therapy has yet achieved regulatory approval, whether as a naked antibody, ADC, or T-cell engager"

A T-cell engager is a type of medicine designed to help the body's immune system attack cancer cells more effectively. It works by acting like a bridge that brings immune cells (T-cells) close to cancer cells, prompting a targeted attack. For investors, T-cell engagers are significant because they represent innovative treatments that could lead to new growth opportunities in the healthcare and biotech sectors.

ind/cta regulatory

"to enable IND/CTA submissions at the end of 2026/ early 2027"

An IND/CTA is a formal regulatory submission that asks health authorities for permission to test an experimental drug or treatment in humans — IND is the U.S. route, CTA is the equivalent in many other countries. Think of it as the safety permit a developer must obtain before starting human trials; investors watch these filings because approval clears a major regulatory hurdle, changes development timelines and risk, and can materially affect a program’s value and funding needs.

AI-generated analysis. Not financial advice.

Company expands its ADC pipeline and patent estate for novel, differentiated ADCs

New pipeline candidate AKTX-102 leverages Akari’s proprietary PH1 spliceosome payload and a novel antibody construct to address one of oncology’s most challenging and valuable solid tumor targets, CEACAM5

TAMPA and LONDON, Jan. 26, 2026 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company pioneering next-generation antibody drug conjugates (ADCs) powered by novel RNA-splicing payloads, today announced the filing of a new U.S. provisional patent application (No. 63/958,508) covering its second pipeline candidate, AKTX-102, an ADC directed against CEACAM5 (Carcinoembryonic Antigen-related Cell Adhesion Molecule-5), a well-validated but historically difficult-to-drug oncology target.

CEACAM5 is expressed in 80–90% of gastrointestinal cancers, including colorectal and pancreatic cancer, approximately 30% of bladder cancers, 25% of lung adenocarcinomas, and up to 50% of luminal A (HR+) breast cancers. Importantly, CEACAM5 expression has also been linked to aggressive genetic subtypes, including KRAS-mutated lung cancers, underscoring its relevance across multiple high-unmet-need solid tumor indications.

AKTX-102 is a first-in-class ADC that combines a novel CEACAM5-targeting antibody construct with Akari’s proprietary PH1 spliceosome-modulating payload, designed to deliver potent, differentiated tumor cell killing while simultaneously activating both the innate and adaptive immune responses to the tumor.

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics, commented, “This patent filing marks another important step in expanding Akari’s differentiated ADC platform and rapidly growing pipeline. AKTX-102 builds on our deep and unique insights into CEACAM5 tumor biology and we believe demonstrates the versatility of our PH1 payload and our antibody expertise to unlock previously intractable targets. We believe PH1 can serve as the foundation for a pipeline of novel ADCs, and this program highlights our innovation on novel payloads for ADCs as well as with tumor antigen biology and antibody engineering to build best-in-class ADCs.”

“With AKTX-102, we aim to improve cytotoxic efficacy while harnessing PH1’s unique properties, including innate and adaptive immune activation and activity against KRAS-mutated cancers. We look forward to sharing additional progress as we continue to advance this exciting program,” added Mr. Gaslightwala.

Rapidly Expanding and Deepening Patent Estate Around Novel ADCs and Payload Innovation

This newly filed patent further accelerates Akari’s rapid build-out of a broad and defensible intellectual property portfolio spanning payload biology, ADC architecture, and combination strategies. While Akari’s 2025 patent filings (US63/882,631, US63/891,856, and US63/891,861) focused on novel mechanisms of action, payload-driven biology, and ADC combination approaches, this new filing extends protection to a previously undisclosed pipeline asset, AKTX-102, and introduces new composition-of-matter claims around novel antibody design and ADC constructs utilizing this antibody design.

These filings build upon Akari’s foundational PH1 payload patent family (PCT/US2018/051721) and its lead clinical program AKTX-101 (PCT/US2024/024997), collectively creating a layered and rapidly expanding patent moat around next-generation ADCs. Together, Akari expects this growing estate positions the Company to generate multiple first- and best-in-class ADC candidates across a wide range of validated cancer targets.

Cracking One of Oncology’s Toughest Targets

CEACAM5 has long been viewed as a high-value oncology target, but its unique and challenging biology—including extensive antigen shedding and the presence of both soluble and tumor-bound forms—has historically limited therapeutic success. Despite decades of effort, no CEACAM5-directed therapy has yet achieved regulatory approval, whether as a naked antibody, ADC, or T-cell engager.

Beyond its role in tumor growth and metastasis, CEACAM5 also functions as an immunosuppressive checkpoint, inhibiting T-cell and natural killer (NK) cell activity to promote immune evasion. Akari’s newly filed patent covers novel antibody constructs engineered to address these biological challenges, as well as ADCs that pair these antibodies with the Company’s PH1 payload, enabling a differentiated therapeutic approach utilizing PH1’s unique immuno-oncology and cytotoxic modes of action.

This broad composition-of-matter protection provides Akari with ownership over a unique strategy to effectively target CEACAM5 as a best-in-class ADC therapeutic.

Execution, Momentum and Path to the Clinical Stage with Lead Program AKTX-101

As previously announced, Akari continues to execute on its strategy of advancing AKTX-101, its lead Trop2-targeted ADC, toward IND/CTA submission and first-in-human clinical evaluation, while simultaneously expanding a pipeline of next-generation ADCs enabled by its proprietary PH1 payload. With multiple validated targets, a growing IP estate, and a differentiated biological approach, the Company believes it is well positioned to deliver meaningful clinical impact and long-term value creation.

Key Catalysts and Milestones for AKTX-101 Development Program in 2026

• Regulatory interactions with FDA in H1 2026 for feedback on our planned Phase 1 trial
• Presentation of AKTX-101 data highlighting key areas of differentiation vs current Trop2 ADCs at a major scientific congress upcoming
• Completion of CMC and non-clinical work including final GLP Toxicology 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
  

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 and 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 tubulin 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 system 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, and is also advancing AKTX-102, an ADC against a novel target highly relevant in GI and lung cancers. 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. 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

FAQ

What did Akari announce about AKTX-102 (AKTX) on January 26, 2026?

Akari filed U.S. provisional patent No. 63/958,508 for AKTX-102, a CEACAM5-targeted ADC using the PH1 payload.

How common is CEACAM5 expression in cancers targeted by AKTX-102 (AKTX)?

CEACAM5 is reported in 80–90% of gastrointestinal cancers, ~30% of bladder, 25% of lung adenocarcinomas, and up to 50% of luminal A breast cancers.

What intellectual property did Akari strengthen with the AKTX-102 filing?

The filing extends Akari’s PH1 patent family with composition-of-matter claims for novel antibody constructs and ADC architectures.

What are the near-term development milestones for Akari’s lead ADC AKTX-101 (AKTX)?

Akari plans FDA interactions in H1 2026, complete IND-enabling CMC and GLP toxicology, and target IND/CTA submission end-2026/early-2027.

Does Akari report clinical data for AKTX-102 (AKTX) in this announcement?

No; the announcement covers a provisional patent filing and program rationale but does not disclose preclinical or clinical readouts.