ALX Oncology presented promising preclinical data for ALX2004, an innovative antibody-drug conjugate targeting EGFR in solid tumors.
Quiver AI Summary
ALX Oncology has presented promising preclinical data on ALX2004, a novel antibody-drug conjugate (ADC) designed to target EGFR-expressing solid tumors, at the 2025 AACR-NCI-EORTC International Conference in Boston. The preclinical findings suggest that ALX2004 has potent anti-tumor activity with improved safety, positioning it as a potentially first-in-class treatment. The ADC is engineered to optimize cancer-killing mechanisms while minimizing toxicity, addressing challenges associated with previous generation ADCs. The ongoing Phase 1 trial, which commenced enrollment in August 2025, aims to assess the safety and efficacy of ALX2004 in patients with advanced or metastatic solid tumors. Initial safety data from this trial is expected in the first half of 2026.
Potential Positives
- Two poster presentations highlight the best- and first-in-class potential of ALX2004, showcasing its innovative approach to treating EGFR-expressing solid tumors.
- Robust preclinical data supports ALX2004's differentiation within the EGFR-ADC class, indicating strong potential for advancement in clinical applications.
- Initial safety data from the ongoing Phase 1 trial of ALX2004 is expected in the first half of 2026, providing a timeline for stakeholders to anticipate important developments.
Potential Negatives
- Initial safety data from the ongoing ALX2004 Phase 1 trial is not expected until the first half of 2026, indicating a prolonged timeline for potential results and the uncertainty surrounding the trial's outcomes.
- The press release highlights the challenges of earlier generation ADCs, which may raise concerns regarding the efficacy and safety of ALX2004 compared to existing treatments.
- The reliance on forward-looking statements introduces uncertainty, emphasizing the risks and potential variability in the company's future performance and success of its clinical trials.
FAQ
What is ALX2004?
ALX2004 is a novel antibody-drug conjugate designed for the treatment of EGFR-expressing solid tumors.
What are the main findings from the ALX2004 presentations?
Preclinical data showed ALX2004's potential for robust anti-tumor activity and a favorable toxicity profile.
When will initial safety data for ALX2004 be available?
Initial safety data from the ALX2004 Phase 1 trial is anticipated in the first half of 2026.
What makes ALX2004 unique compared to other ADCs?
ALX2004 utilizes a proprietary payload and linker for improved stability and therapeutic window, minimizing off-tumor skin toxicity.
Where can I find more information about ALX Oncology?
More information is available on ALX Oncology's website and their LinkedIn page.
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.
$ALXO Insider Trading Activity
$ALXO insiders have traded $ALXO stock on the open market 7 times in the past 6 months. Of those trades, 3 have been purchases and 4 have been sales.
Here’s a breakdown of recent trading of $ALXO stock by insiders over the last 6 months:
- JASON LETTMANN (CHIEF EXECUTIVE OFFICER) has made 2 purchases buying 92,233 shares for an estimated $99,352 and 1 sale selling 2,382 shares for an estimated $1,525.
- HARISH SHANTHARAM (Chief Financial Officer) purchased 75,000 shares for an estimated $58,402
- SHELLY PINTO (SVP, FINANCE AND CAO) has made 0 purchases and 3 sales selling 4,154 shares for an estimated $1,955.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$ALXO Hedge Fund Activity
We have seen 19 institutional investors add shares of $ALXO stock to their portfolio, and 66 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- BLACKROCK, INC. removed 1,597,503 shares (-69.0%) from their portfolio in Q2 2025, for an estimated $663,123
- ALMITAS CAPITAL LLC added 1,185,214 shares (+87.6%) to their portfolio in Q2 2025, for an estimated $491,982
- STATE STREET CORP removed 594,621 shares (-82.7%) from their portfolio in Q2 2025, for an estimated $246,827
- MPM BIOIMPACT LLC removed 550,000 shares (-100.0%) from their portfolio in Q2 2025, for an estimated $228,305
- GEODE CAPITAL MANAGEMENT, LLC removed 455,486 shares (-59.1%) from their portfolio in Q2 2025, for an estimated $189,072
- MILLENNIUM MANAGEMENT LLC removed 451,470 shares (-47.8%) from their portfolio in Q2 2025, for an estimated $187,405
- BANK OF AMERICA CORP /DE/ removed 416,651 shares (-28.7%) from their portfolio in Q2 2025, for an estimated $172,951
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$ALXO Analyst Ratings
Wall Street analysts have issued reports on $ALXO in the last several months. We have seen 2 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- UBS issued a "Buy" rating on 05/21/2025
- HC Wainwright & Co. issued a "Buy" rating on 05/09/2025
To track analyst ratings and price targets for $ALXO, check out Quiver Quantitative's $ALXO forecast page.
$ALXO Price Targets
Multiple analysts have issued price targets for $ALXO recently. We have seen 2 analysts offer price targets for $ALXO in the last 6 months, with a median target of $1.5.
Here are some recent targets:
- Colin Bristow from UBS set a target price of $1.0 on 05/21/2025
- Swayampakula Ramakanth from HC Wainwright & Co. set a target price of $2.0 on 05/09/2025
Full Release
-Two poster presentations showcase best- and first-in-class potential of ALX2004, a novel, antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors
-Robust body of preclinical data supports ALX2004 differentiation in EGFR-ADC class and continued evaluation in first-in-human trial
- Initial safety data from ongoing ALX2004 Phase 1 trial anticipated in the first half of 2026
SOUTH SAN FRANCISCO, Calif., Oct. 23, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the “Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today presented preclinical data and the trial design for the ongoing Phase 1 clinical trial for its ADC candidate, ALX2004, in two poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 – 26, 2025 in Boston, Massachusetts. ALX2004-01 is a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of ALX2004 in patients with advanced or metastatic solid tumors that are known to express EGFR.
“Our preclinical findings have shown potent anti-tumor activity and a favorable toxicity profile supporting our advancement of ALX2004 into the clinic," said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Given that toxicity challenges of earlier generation ADCs have limited the therapeutic window in the treatment of EGFR-expressing solid tumors; we are encouraged by our preclinical data that this unique molecule, ALX2004 could potentially overcome these limitations. Enrollment in this trial began in August and continues to be on track to allow us to deliver initial safety data in the first half of next year. We are pleased to present extensive preclinical data supporting ALX2004’s potential to break new ground in ADC innovation in the EGFR-targeting class at the AACR-NCI-EORTC Conference.”
The Company’s first ADC, ALX2004, is the result of a rigorous internal drug design process. Developed in house by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is designed to optimize all mechanisms of ADC cancer killing while maximizing the therapeutic window. ALX2004 uses a matuzumab-derived EGFR antibody selected to minimize off tumor skin toxicity and maximize therapeutic window, with a binding epitope distinct from U.S. Food and Drug Administration approved EGFR antibodies. Additionally, ALX2004 has a proprietary linker-payload and Top1i payload engineered to offer improved linker stability for on-target delivery of payload and enhanced bystander effect.
ALX2004 is currently being evaluated in a first-in-human, open-label multicenter study in participants with advanced or metastatic select EGFR-expressing solid tumors. The design of this Phase 1 clinical trial (NCT07085091) will also be presented at the meeting.
Details for ALX Oncology’s poster presentations are as follows:
Title
: ALX2004, A Novel Anti-EGFR Topoisomerase I Inhibitor Antibody-Drug Conjugate for the Treatment of EGFR-Expressing Solid Tumors
Presenter:
Marja Vrljic, Ph.D., Vice President, Antibody Technologies, ALX Oncology
Abstract
: #A119
Date and Time
: Thursday, October 23, 12:30-4:00 p.m. ET
Session:
Poster Session A
Location
: Hynes Convention Center, Level 2, Exhibit Hall D
Title
: A Phase 1, First-in-Human, Open-Label Multicenter Study to Evaluate ALX2004, Antibody-Drug Conjugate Targeting EGFR, in Patients With Advanced or Metastatic Select Solid Tumors (ALX2004-01)
Abstract
: LB-A004
Date and Time
: Thursday, October 23, 12:30-4:00 p.m. ET
Session:
Poster Session A
Location
: Hynes Convention Center, Level 2, Exhibit Hall D
About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
[email protected]
Media Contact:
Audra Friis, Sam Brown Healthcare Communications
[email protected]
(917) 519-9577
