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

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Information

- First patient dosed in Phase 2 ASPEN-09-Breast trial evaluating evorpacept in combination with tra...

AI Summary

ALX Oncology has commenced the Phase 2 ASPEN-09 trial for evorpacept in HER2-positive breast cancer, with interim results expected in Q3 2026. Additionally, the third dose cohort for ALX2004 is underway, and the initial safety data from the trial is anticipated in the first half of 2026.

Trading Thesis

Investors should consider ALXO given the promising data and clinical advancements.

Market-Moving

ALXO's Phase 2 trial progress could boost stock valuation.
Positive interim results might trigger increased investment interest.
Initial safety data from ALX2004 could influence stock volatility.
Regulatory approval prospects for evorpacept may attract more investors.
Evorpacept's clinical success could position ALXO as a market leader.

Key Facts

First patient dosed in Phase 2 ASPEN-09 trial for evorpacept.
Evorpacept has shown promise as a CD47 inhibitor.
Phase 1 ALX2004 trial initiated a third dose cohort.
No dose-limiting toxicities were reported in prior cohorts.
Initial ALX2004 safety data expected in H1 2026.

Companies Mentioned

ALX Oncology (ALXO): Leading innovations in cancer treatment with potentially significant market impact.
ENHERTU® (n/a): Current therapy for HER2-positive cancer, with ALXO's trial potentially offering a key alternative.

Research Analysis

The oncology sector is witnessing significant innovations, especially in treatments focusing on specific cancer types. ALXO's advancements in clinical trials align with the growing demand for specialized therapies, positioning it favorably for investors and market observers.

FAQ

Why Bullish?

The progression of ALXO's clinical trials indicates strong potential for market success, a historical example being the surge in share prices for companies with successful drug trials.

How important is it?

The successful advancement of clinical trials can indicate future profitability and attract investment interest in ALXO.

Why Short Term?

Results expected within a year (interim data in Q3 2026) can significantly affect stock performance.

Related Companies

T-DXd

ALX Oncology Advances Clinical Trials for Innovative Cancer Treatments

SOUTH SAN FRANCISCO, Calif., Jan. 8, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (Nasdaq: ALXO), a clinical-stage biotechnology company dedicated to developing pioneering therapies for cancer treatment, has announced significant progress in its clinical trials. The company has dosed its first patient in the Phase 2 ASPEN-09-Breast trial, which evaluates the investigational CD47-inhibitor, evorpacept. Additionally, ALX Oncology has initiated a third dose cohort in its Phase 1 trial of the novel EGFR-targeted antibody-drug conjugate (ADC), ALX2004.

Key Developments in Clinical Trials

The first patient has been dosed in the Phase 2 ASPEN-09-Breast trial.
The trial evaluates evorpacept in combination with trastuzumab and selected chemotherapy for HER2-positive metastatic breast cancer.
Interim analysis of the ASPEN-09-Breast trial is expected in Q3 2026.
The third dose cohort for ALX2004 has commenced, with no dose-limiting toxicities observed in prior cohorts.
Initial safety data from the ALX2004 trial is anticipated in the first half of 2026.

Details on the ASPEN-09-Breast Trial

The Phase 2 ASPEN-09-Breast trial is a single-arm, open-label, multicenter study involving 80 patients with HER2-positive breast cancer who have progressed after treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki). This trial leverages participants' CD47 expression levels as biomarkers to assess treatment responses.

The primary endpoint measures the overall response rate (ORR) in patients confirmed HER2-positive via circulating tumor DNA (ctDNA). Secondary endpoints include:

ORR in the HER2 ctDNA+ subpopulation based on CD47 expression levels
Clinical benefit rate (CBR)
Duration of response (DOR)
Progression-free survival (PFS)
Overall survival (OS)

An exploratory endpoint focuses on ORR in the HER2 ctDNA-negative group. ALX Oncology expects to release interim data from this trial by Q3 2026.

Insights on ALX2004 Phase 1 Trial

The Phase 1 trial for ALX2004 is designed as a first-in-human, open-label, multicenter study focusing on patients with advanced or metastatic select EGFR-expressing solid tumors. This trial includes both a dose escalation and expansion phase.

“Preclinical data suggest that ALX2004 has the potential to overcome the toxicity challenges associated with earlier generation EGFR-targeted ADCs,” stated Jason Lettmann, CEO of ALX Oncology. He expressed optimism about advancing to a 4mg/kg dosage for the third cohort following successful results from the previous cohort.

Company Overview and Future Outlook

ALX Oncology (Nasdaq: ALXO) is focused on developing novel therapies aimed at improving cancer treatment and extending patient lifespans. The lead candidate, evorpacept, has shown promise as a cornerstone therapy in immuno-oncology and is currently in multiple trials across various cancer indications. The second candidate, ALX2004, differentiates itself as an innovative EGFR-targeted ADC.

“We are extremely pleased with the progress we are making on these clinical trials,” continued Lettmann, reflecting on the potential of both evorpacept and ALX2004. “These treatments aim to fill significant gaps in standard care for various cancer types.”

Forward-Looking Statements

This news release contains forward-looking statements regarding ALX Oncology’s future operations and financial position. Risks and uncertainties could lead to actual results diverging from those expressed. These risks are thoroughly outlined in ALX Oncology’s SEC filings, including Form 10-K and 10-Q reports.