ALX Oncology Advances Separate Clinical Trials Evaluating Investigational CD47-Inhibitor Evorpacept and Novel EGFR-Targeted Antibody-Drug Conjugate ALX2004

ALX Oncology (Nasdaq: ALXO) announced clinical progress for two investigational therapies.

Rhea-AI Summary

ALX Oncology (Nasdaq: ALXO) announced clinical progress for two investigational therapies. The company dosed the first patient in the Phase 2 ASPEN-09-Breast trial of evorpacept combined with trastuzumab and physician’s choice chemotherapy in HER2-positive metastatic breast cancer post-ENHERTU; an interim analysis is anticipated in Q3 2026. The Phase 1 study of EGFR-targeted ADC ALX2004 advanced to a third dose cohort at 4 mg/kg after no dose-limiting toxicities in the first two cohorts; an initial safety update is expected in 1H 2026.

The ASPEN-09 trial will enroll ~80 patients and use CD47 expression and HER2 ctDNA as biomarkers; primary endpoint is overall response rate (ORR).

Positive

• First patient dosed in Phase 2 ASPEN-09-Breast
• ASPEN-09 will enroll approximately 80 patients
• Interim ASPEN-09 data expected in Q3 2026
• ALX2004 advanced to 4 mg/kg third cohort
• No dose-limiting toxicities in first two ALX2004 cohorts
• Initial ALX2004 safety update expected in 1H 2026

Negative

• ASPEN-09 is a single-arm, open-label trial (limits comparative evidence)
• No efficacy readouts reported yet; interim data not available until Q3 2026

Argus Jan 8 session

+5.08% close to close Open Argus

Details

News Market Reaction – ALXO

On Jan 8, the day this news came out, ALXO closed 5.08% above the previous close.

Data tracked by StockTitan Argus for the Jan 8 session.

Key Figures

ASPEN-09-Breast size: 80 patients ALX2004 dose cohort 3: 4 mg/kg ALX2004 prior dose cohort: 2 mg/kg +5 more

ASPEN-09-Breast size

80 patients

Phase 2 HER2-positive metastatic breast cancer trial

ALX2004 dose cohort 3

4 mg/kg

Third dose cohort in Phase 1 trial

ALX2004 prior dose cohort

2 mg/kg

Second dose cohort cleared without dose-limiting toxicities

ASPEN-09-Breast interim data

Q3 2026

Planned timing for interim analysis

ALX2004 safety update

1H 2026

Planned initial safety data from Phase 1 trial

Phase

Phase 2

ASPEN-09-Breast evorpacept trial

Phase

Phase 1

First-in-human ALX2004 EGFR-ADC trial

Price move

9.26%

Pre-news 24h change for ALXO

Historical Context

5 past events · Latest: Dec 07

5 events

1. Dec 07

   Clinical trial data

   24h Move

   +1.4%

   Strong Phase 2 evorpacept responses in indolent B‑cell lymphoma.

2. Nov 18

   Investor conferences

   24h Move

   +4.5%

   Announced participation in two upcoming healthcare investor conferences.

3. Nov 07

   Earnings and pipeline

   24h Move

   +16.9%

   Q3 2025 results plus favorable ASPEN‑06 biomarker data and cash runway.

4. Oct 30

   Earnings preview

   24h Move

   -2.5%

   Scheduled Q3 results and previewed upcoming evorpacept biomarker data.

5. Oct 23

   Preclinical update

   24h Move

   +8.7%

   Presented ALX2004 preclinical data and first‑in‑human trial design.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cd47-inhibitor, her2-positive, antibody-drug conjugate, overall response rate, +4 more

8 terms

cd47-inhibitor medical

"investigational CD47-Inhibitor evorpacept"

A CD47 inhibitor is a type of drug that blocks a surface protein called CD47, which some abnormal cells use like a “do not touch” signal to avoid being cleared by the immune system. For investors, it signals a therapeutic approach aimed at helping the body’s cleanup cells remove diseased or cancerous cells; success depends on clinical trial results, safety (for example effects on blood cells), and regulatory approval, so it carries both high potential and development risk.

her2-positive medical

"HER2-positive metastatic breast cancer"

HER2-positive describes cancer cells that have too many copies of the HER2 gene or make too much of the HER2 protein, which acts like an overactive growth switch that drives tumor growth. For investors, HER2 status matters because it determines whether patients can receive specific, often expensive targeted therapies and diagnostic tests, so trial results, approvals, or competing drugs tied to HER2 can strongly affect drug sales and company value.

antibody-drug conjugate medical

"epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC) ALX2004"

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

overall response rate medical

"The primary endpoint of the trial is overall response rate (ORR)"

Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

clinical benefit rate medical

"Key secondary endpoints are ORR... clinical benefit rate (CBR), duration of response"

The clinical benefit rate is the share of patients in a medical study who experience a meaningful positive treatment effect — usually tumor shrinkage, disappearance, or disease staying stable for a set period — rather than their condition worsening. Investors care because it gives a broader picture of a therapy’s real-world usefulness beyond quick responses, like judging how many cars in a road test actually arrive without breaking down, which helps predict commercial and regulatory prospects.

progression-free survival medical

"duration of response (DOR), progression-free survival (PFS) and overall survival (OS)"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"progression-free survival (PFS) and overall survival (OS), and safety"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

circulating tumor dna medical

"confirmed HER2 positive by circulating tumor DNA (ctDNA)"

Fragments of DNA shed by cancer cells into the bloodstream that act like tiny fingerprints of a tumor; they can be detected with a blood test rather than a biopsy. Investors care because circulating tumor DNA (ctDNA) enables faster, lower-cost ways to detect disease, track treatment response, identify emerging resistance and enroll patients in trials—factors that can materially affect the commercial prospects of diagnostics and therapeutics.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- First patient dosed in Phase 2 ASPEN-09-Breast trial evaluating evorpacept in combination with trastuzumab and physician’s choice of chemotherapy in HER2-positive metastatic breast cancer; interim analysis anticipated Q3 2026 –

- Third dose cohort initiated in Phase 1 trial of ALX 2004; study remains on track to provide initial safety data in 1H 2026 -

SOUTH SAN FRANCISCO, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (“ALX Oncology,” Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, announced that the first patient has been dosed in the Company’s Phase 2 ASPEN-09-Breast trial evaluating its investigational CD47-inhibitor evorpacept. This trial will evaluate the combination of evorpacept with trastuzumab and physicians’ choice of chemotherapy in patients with HER2-positive metastatic breast cancer whose disease has progressed after ENHERTU^® (T-DXd).

Additionally, after successfully clearing the second dose cohort, the Phase 1 trial evaluating the Company’s epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC) ALX2004 for the treatment of EGFR-expressing solid tumors has begun enrolling patients in the third dose cohort at 4mg/kg. No dose-limiting toxicities were observed in the prior two dose cohorts.

“We are extremely pleased with the progress we are making on these clinical trials,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “We believe both evorpacept and ALX2004 have the potential to fill significant gaps in the standard of care for many types of cancer.”

Evorpacept is the first CD47 inhibitor to show substantial tumor response and a well-tolerated safety profile in a randomized trial. Data from this prior gastric cancer trial, ASPEN-06, show that evorpacept demonstrated benefit across all efficacy parameters in patients with HER2-positive disease and high CD47 expression levels. Research has demonstrated that increased CD47 expression is correlated with poor patient outcomes in many tumor types, including breast cancer.

The Phase 2 ASPEN-09-Breast clinical trial (NCT07007559) is a single-arm, open-label, multicenter study evaluating evorpacept plus trastuzumab and physicians’ choice of chemotherapy in 80 patients with HER2-positive breast cancer previously treated with ENHERTU^® (fam-trastuzumab deruxtecan-nxki), which was recently approved as first-line therapy. The trial will utilize participants’ CD47 expression levels as a biomarker to assess responses.

The primary endpoint of the trial is overall response rate (ORR) in patients who are confirmed HER2 positive by circulating tumor DNA (ctDNA). Key secondary endpoints are ORR in the HER2 ctDNA+ subpopulation by level of CD47 expression, clinical benefit rate (CBR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS), and safety. ORR in the HER2 ctDNA-negative subpopulation is an exploratory endpoint. ALX Oncology anticipates sharing interim data from the trial in Q3 2026.

The ALX2004 Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label, multicenter trial evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by optional dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial is enrolling patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC).

“Preclinical data suggest that ALX2004 has the potential to overcome the toxicity challenges associated with earlier generation EGFR-targeted ADCs,” said Lettmann. “It is encouraging that, after clearing the second dose cohort in our Phase 1 trial at 2mg/kg, we are able to double the dosage to 4mg/kg in the third cohort.”

ALX Oncology expects to provide an initial safety update from the Phase 1 ALX2004 trial during 1H 2026.

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. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors.

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.

More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
ewebb@alxoncology.com

Media Contact:
Michele Parisi, SparkPoint Healthcare Communications
mparisi@sparkpointpr.com
(925) 864-5028

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What milestone did ALX Oncology (ALXO) announce on January 8, 2026 for evorpacept?

ALX Oncology dosed the first patient in the Phase 2 ASPEN-09-Breast trial of evorpacept in HER2-positive metastatic breast cancer.

When does ALX Oncology expect interim data from the ASPEN-09-Breast (ALXO) trial?

The company anticipates sharing an interim analysis from ASPEN-09 in Q3 2026.

What dose milestone did ALX2004 reach in ALX Oncology’s (ALXO) Phase 1 trial?

ALX2004 moved into the third dose cohort at 4 mg/kg after clearing the 2 mg/kg cohort with no dose-limiting toxicities.

How many patients will ALX Oncology enroll in the ASPEN-09-Breast trial (ALXO)?

The ASPEN-09 trial is planned to enroll about 80 patients with HER2-positive breast cancer previously treated with ENHERTU.

What biomarkers will ALX Oncology use in the ASPEN-09 (ALXO) study?

The trial will use participants’ CD47 expression levels and HER2 ctDNA status to assess responses.

When will ALX Oncology provide an initial safety update for ALX2004 (ALXO)?

An initial safety update from the ALX2004 Phase 1 trial is expected in 1H 2026.