Adlai Nortye to Present Short Talk on AN4035 Preclinical Results at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Rhea-AI Summary

Adlai Nortye (NASDAQ: ANL) will present preclinical data for AN4035 at the AACR-NCI-EORTC conference in Boston on October 25, 2025.

Key highlights: AN4035 showed strong intracellular payload retention with nanomolar-to-picomolar cytotoxicity in CEACAM5-positive/RAS-addicted cell lines, a potent bystander-killing effect, deep regressions in CEACAM5-positive/RAS-addicted CDX and PDX models with a 73% objective response rate (N=26), and a favorable preliminary toxicology profile in cynomolgus monkeys.

The program is a CEACAM5-targeting ADC delivering a proprietary pan-RAS(ON) inhibitor payload designed to limit systemic toxicity and broaden the therapeutic window. Oral presentation: October 25, 2025, 11:45 AM ET; Poster session: October 25, 2025, Poster C (LB-C001).

Insights

Translational oncology expert

Preclinical data for AN4035 show strong tumor activity and a preliminary nonclinical safety signal, meriting close attention but remaining early.

AN4035 demonstrated nanomolar–picomolar cytotoxicity in CEACAM5-positive/RAS-addicted cell lines, a potent bystander effect, deep regressions in CDX and PDX models with a reported 73% objective response rate in a N=26 PDX trial, and a "favorable preliminary toxicology profile in cynomolgus monkeys". These findings describe the core biological mechanism: a CEACAM5-targeting antibody–drug conjugate delivering a pan‑RAS(ON) inhibitor payload to increase intratumoral exposure while aiming to limit systemic on‑target, off‑tumor toxicity.

The dependencies and risks remain clear and limited to the disclosed facts: translation from cell lines and xenografts to human safety and efficacy is not shown here, and the company frames prior clinical pan‑RAS(ON) programs as limited by on‑target, off‑tumor toxicities. The nonclinical monkey toxicology is described only as "preliminary"; that limits confidence about human tolerability. The presented data therefore support scientific plausibility without demonstrating clinical benefit.

Watch the oral presentation on Oct. 25, 2025 for detailed methods, dose/exposure metrics, and full toxicology results; key near‑term milestones to monitor are any disclosed GLP toxicology end points, IND filing details, and first‑in‑human study design and endpoints.

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Oct. 22, 2025 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it will deliver an oral presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held from October 22-26, 2025, in Boston, MA.

Key highlights of the presentation include:

• AN4035 demonstrated strong intracellular payload retention, driving nanomolar to picomolar cytotoxicity in CEACAM5-positive/RAS-addicted cancer cell lines, along with a potent bystander-killing effect
• AN4035 induced deep regression in CEACAM5-positive/RAS-addicted CDX and PDX models, achieving a 73% objective response rate in a patient-derived xenograft trial (N=26)
• AN4035 exhibited a favorable preliminary toxicology profile in cynomolgus monkeys
  

Tricomplex pan-RAS(ON) inhibitors currently in clinical development have demonstrated encouraging efficacy; however, their therapeutic potential has been limited by presumably on-target, off-tumor toxicities, particularly in the skin and gastrointestinal tract. AN4035, Adlai Nortye’s novel CEACAM5-targeting antibody-drug conjugate (ADC), was specifically designed to address these limitations. By delivering a proprietary pan-RAS(ON) inhibitor payload directly to tumors, AN4035 aims to reduce systemic toxicities, widen the therapeutic window and enable rational combination therapies.

“We are delighted that AN4035, our first-in-class CEACAM5-targeting ADC armed with our proprietary pan-RAS(ON) inhibitor payload, has been selected for an oral presentation at this prestigious conference,” said Archie Tse, MD, PhD, Head of Research and Development at Adlai Nortye. “We hypothesized that an ADC approach could overcome some of the limitations of pan-RAS(ON) inhibitors by focusing their activity within tumors, thereby improving efficacy while minimizing on-target, off-tumor toxicities. The encouraging preclinical results we have seen to date support this hypothesis and reinforce our belief that AN4035 could represent the next generation of therapies against RAS-addicted tumors --- either as stand-alone treatments or in rational combinations, especially for CEACAM5 overexpressing tumors such as colorectal cancer.”

This recognition underscores the strength of Adlai Nortye’s integrated ADC and small molecule discovery platforms and reflects the Company’s continued commitment to delivering transformative oncology therapies that expand the therapeutic window for patients with difficult-to-treat cancers.

Oral Presentation details:

Abstract title: Discovery of AN4035: A novel CEACAM5-targeting antibody drug conjugate (ADC) armed with a proprietary pan-RAS(ON) inhibitor payload, designed to broaden the therapeutic window (Abstract# LB-C001)

Date and Time: Saturday, October 25, 2025; 11:45 AM – 12:15 PM ET

Session Title: Spotlight on Proffered Papers 3: Novel Therapeutic Agents

Location: Level 3, Ballroom AB, Hynes Convention Center, Boston, MA

Poster Presentation details:

Poster Title: Discovery of AN4035: A novel CEACAM5-targeting antibody drug conjugate (ADC) armed with a proprietary pan-RAS(ON) inhibitor payload, designed to broaden the therapeutic window

Poster Session date and time: Saturday, October 25, 12:30 AM – 16:00 PM ET

Location: Poster Session C

Poster Number: LB-C001

For more information, please refer to the AACR website and conference app.

About AN4035

AN4035 is a proprietary CEACAM5-targeting antibody drug conjugate (ADC) designed to deliver potent anti-tumor activity with an improved therapeutic window. It is armed with Adlai Nortye’s first-in-class pan-RAS(ON) inhibitor payload, which effectively target a broad spectrum of CEACAM5-expressing, RAS-driven cancers.

About Adlai Nortye

Adlai Nortye (NASDAQ: ANL) is a global clinical-stage company focused on the development of innovative cancer therapies, with global R&D centers in the U.S. and China. We are advancing a portfolio of innovative drug candidates across two key therapeutic areas: next-generation PD-1/L1 modulation, including AN8025, a multifunctional fusion protein designed to modulate both T cells and antigen-presenting cells, and AN4005, a first-in-class oral small-molecule PD-L1 inhibitor; and RAS-targeted therapies, including AN9025, an oral pan-RAS(ON) inhibitor with potential to address multiple RAS-driven cancers, and AN4035, a novel CEACAM5-targeting antibody-drug conjugate armed with a potent pan-RAS(ON) inhibitor payload.

Forward-Looking Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets” and similar statements. Among other things, statements that are not historical facts, including statements about the Company’s beliefs and expectations, the business outlook and quotations from management in this announcement, as well as the Company’s strategic and operational plans, are or contain forward-looking statements.

The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. Factors that could cause the Company’s actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of the Company’s preclinical studies, clinical trials and other therapeutic candidate development efforts; the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results will be predictive of real-world results; the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of the Company’s therapeutic candidates; the Company’s ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; the implementation of the Company’s business model and strategic plans for its business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the PRC and United States or elsewhere. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this announcement and in the attachments is as of the date of this announcement, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Company contact:
Investor Relations
Email: ir@adlainortye.com

FAQ

What preclinical efficacy did Adlai Nortye report for AN4035 (ANL) on October 22, 2025?

AN4035 produced nanomolar-to-picomolar cytotoxicity in CEACAM5-positive/RAS-addicted cell lines and achieved a 73% objective response rate (N=26) in a PDX trial.

When and where will Adlai Nortye present AN4035 data at AACR-NCI-EORTC 2025?

Oral presentation on October 25, 2025 at 11:45 AM ET in Ballroom AB, Hynes Convention Center, Boston; poster session same day (Poster LB-C001).

What safety data did Adlai Nortye disclose for AN4035 in the October 22, 2025 announcement?

The company reported a favorable preliminary toxicology profile for AN4035 in cynomolgus monkeys.

How does AN4035 aim to improve pan-RAS(ON) inhibitor therapy according to the announcement?

AN4035 is a CEACAM5-targeting ADC designed to deliver a pan-RAS(ON) inhibitor payload to tumors to reduce systemic, on-target off-tumor toxicities and widen the therapeutic window.

What preclinical models supported AN4035 activity reported by Adlai Nortye?

AN4035 showed deep tumor regressions in CEACAM5-positive/RAS-addicted CDX and PDX models, including the reported PDX trial with N=26.

What is the abstract number and title for Adlai Nortye’s AN4035 presentation?

Abstract LB-C001: "Discovery of AN4035: A novel CEACAM5-targeting antibody drug conjugate (ADC) armed with a proprietary pan-RAS(ON) inhibitor payload, designed to broaden the therapeutic window."