This section highlights FDA-related milestones and regulatory updates for drugs developed by ALX Oncology (ALXO).
Over the past two years, ALX Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ALX2004, ASPEN-04, ASPEN-06, and Evorpacept. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ALX2004 - FDA Regulatory Timeline and Events
ALX2004 is a drug developed by ALX Oncology for the following indication: For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALX2004
- Announced Date:
- May 20, 2025
- Indication:
- For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors
Announcement
ALX Oncology Holdings Inc provides an overview of the clinical development program for its highly-differentiated antibody-drug conjugate (ADC), ALX2004, at the Company's R&D webcast event today.
AI Summary
At its R&D webcast event today, ALX Oncology Holdings Inc. provided an overview of its clinical development program for ALX2004, a highly differentiated antibody-drug conjugate (ADC) designed to treat EGFR-expressing solid tumors. ALX2004 features a unique design that combines an affinity-tuned EGFR antibody with a proprietary linker and topoisomerase I inhibitor payload. This design aims to maximize the therapeutic window while reducing toxicity, offering the potential to overcome challenges observed with similar treatments in the past. The company shared preclinical data demonstrating robust activity across various tumor models and a favorable safety profile, which supports its further development. ALX Oncology plans to launch Phase 1 clinical studies for ALX2004 in mid-2025, with the initial safety data expected in the first half of 2026, signaling an exciting step forward in their cancer treatment pipeline.
Read Announcement- Drug:
- ALX2004
- Announced Date:
- April 7, 2025
- Indication:
- For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors
Announcement
ALX Oncology Holdings Inc announced receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company's potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors.
AI Summary
ALX Oncology Holdings Inc. announced that it has received U.S. Food and Drug Administration clearance for the Investigational New Drug (IND) application for its lead candidate, ALX2004. This potential best- and first-in-class antibody-drug conjugate (ADC) is specifically designed to treat solid tumors that express the epidermal growth factor receptor (EGFR). ALX2004 was entirely developed in-house using the company’s proprietary linker-payload platform, which integrates an optimized antibody backbone, a stable linker, and a potent topoisomerase I inhibitor payload. The design aims to target tumor cells more effectively while minimizing systemic toxicity. Based on this clearance, ALX Oncology plans to launch a Phase 1 clinical trial with a dose-escalation and expansion study scheduled to begin in mid-2025, with initial safety data expected in the first half of 2026.
Read Announcement
ASPEN-04 - FDA Regulatory Timeline and Events
ASPEN-04 is a drug developed by ALX Oncology for the following indication: For the Treatment of Head and Neck Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ASPEN-04
- Announced Date:
- April 25, 2025
- Indication:
- For the Treatment of Head and Neck Cancers
Announcement
ALX Oncology Holdings Inc announced topline data from its Phase 2 ASPEN-03 and ASPEN-04 clinical trials.
AI Summary
ALX Oncology Holdings Inc. announced topline data from its Phase 2 ASPEN-03 and ASPEN-04 trials evaluating evorpacept, a novel CD47-blocking agent, when combined with Merck’s KEYTRUDA® (pembrolizumab), with or without chemotherapy. The trials aimed to improve objective response rates in patients with advanced head and neck squamous cell carcinoma. However, the combination did not meet the primary endpoints compared to historical controls of pembrolizumab alone or in addition to chemotherapy. Despite these results, evorpacept demonstrated a manageable safety profile and showed promising trends in efficacy. ALX Oncology remains confident in evorpacept’s potential and will continue its clinical development in combination with other anti-cancer antibodies, based on durable clinical responses observed in previous trials with HER2-positive gastric and breast cancers. The company plans to pursue further studies in various tumor types to validate evorpacept’s unique mechanism of action.
Read Announcement
ASPEN-06 - FDA Regulatory Timeline and Events
ASPEN-06 is a drug developed by ALX Oncology for the following indication: In Patients With HER2-Positive Gastric Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ASPEN-06
- Announced Date:
- March 6, 2025
- Indication:
- In Patients With HER2-Positive Gastric Cancer
Announcement
ALX Oncology Holdings Inc provided a corporate update.
AI Summary
ALX Oncology Holdings Inc. provided a corporate update detailing strong progress in its clinical development efforts with evorpacept. The company is focusing on a strategic development plan that includes new clinical trials to evaluate evorpacept in combination with anti-cancer antibodies in breast and colorectal cancers. They also introduced a novel EGFR-targeted antibody-drug conjugate candidate, ALX2004. ALX Oncology emphasized its approach to prioritizing operations and optimizing resources, including streamlining the organization, which is expected to extend its cash runway into the fourth quarter of 2026. The update highlighted significant momentum in ongoing clinical programs and announced key leadership additions. These include new appointments such as a Chief Business Officer, Chief Medical Officer, and Chief Financial Officer, as well as new board members to support the company's vision for long-term success in advancing innovative cancer treatments.
Read Announcement- Drug:
- ASPEN-06
- Announced Date:
- January 23, 2025
- Indication:
- In Patients With HER2-Positive Gastric Cancer
Announcement
ALX Oncology Holdings Inc. announced positive updated data from the ASPEN-06 Phase 2 clinical trial demonstrating that the company's investigational CD47-blocker evorpacept generates a durable clinical response with a well-tolerated safety profile among patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
AI Summary
ALX Oncology Holdings Inc. announced positive updated results from the ASPEN-06 Phase 2 trial. The study showed that the company’s investigational CD47-blocker, evorpacept, produced a durable clinical response with a well-tolerated safety profile in patients with previously treated HER2-positive advanced gastric or gastroesophageal junction cancer. In the trial, patients with confirmed HER2-positive disease—determined either by fresh biopsy or circulating tumor DNA—experienced a markedly higher overall response rate of 48.9% compared to 24.5% in the control group. Additionally, the median duration of response improved to 15.7 months in the evorpacept arm versus 9.1 months in the control group. These findings suggest that evorpacept, when used alongside standard regimens, offers a promising therapeutic benefit in enhancing anti-tumor activity for this patient population.
Read Announcement- Drug:
- ASPEN-06
- Announced Date:
- January 21, 2025
- Estimated Event Date Range:
- January 23, 2025 - January 23, 2025
- Target Action Date:
- January 23, 2025
- Indication:
- In Patients With HER2-Positive Gastric Cancer
Announcement
ALX Oncology Holdings Inc. announced that the company will host a virtual event on Thursday, January 23, at 1:00 p.m. PT/4:00 p.m. ET to discuss updated data from the ASPEN-06 Phase 2 clinical trial evaluating the company's investigational CD47-blocker evorpacept in patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
AI Summary
ALX Oncology Holdings Inc. announced a virtual event on Thursday, January 23 at 1:00 p.m. PT/4:00 p.m. ET. During the webcast, company leadership will review updated data from the ASPEN-06 Phase 2 clinical trial. This trial is focused on the investigational CD47-blocker evorpacept, which is being tested in patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction (GEJ) cancer.
The updated data, first presented earlier on the same day at the 2025 ASCO Gastrointestinal Cancers Symposium, will now be discussed in more detail for investors and interested parties. The virtual event offers an opportunity to gain insights into the potential of evorpacept as an innovative treatment option that might improve outcomes for patients battling these aggressive cancers.
Read Announcement- Drug:
- ASPEN-06
- Announced Date:
- July 31, 2024
- Indication:
- In Patients With HER2-Positive Gastric Cancer
Announcement
ALX Oncology announced topline data from its Phase 2 ASPEN-06 clinical trial.
AI Summary
ALX Oncology announced topline data from its Phase 2 ASPEN-06 clinical trial, which evaluated evorpacept in combination with trastuzumab, CYRAMZA, and paclitaxel. The trial focused on patients with HER2-positive advanced gastric and gastroesophageal junction cancer who had previously been treated with HER2-targeted therapy. In the overall study population, the evorpacept combination achieved an overall response rate (ORR) of 40.3%, compared to 26.6% in the control arm. Notably, in patients with fresh HER2-positive biopsies, the ORR reached 54.8% versus 23.1% for the control group. The median duration of response for the evorpacept arm was 15.7 months compared to 7.6 months with the control treatment. These results validate evorpacept’s mechanism of action and support its continued development as a promising therapy in immuno-oncology.
Read Announcement
Evorpacept - FDA Regulatory Timeline and Events
Evorpacept is a drug developed by ALX Oncology for the following indication: For the Treatment of Patients with Gastric Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Evorpacept
- Announced Date:
- April 25, 2025
- Indication:
- For the Treatment of Patients with Gastric Cancer
Announcement
ALX Oncology Holdings Inc. announced encouraging data from an ongoing Phase 1/2 investigator-sponsored trial (IST) of the company's lead clinical candidate, evorpacept, in combination with standard-of-care rituximab and lenalidomide (R2) in patients with indolent and aggressive relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).
AI Summary
ALX Oncology Holdings Inc. announced encouraging data from an ongoing Phase 1/2 investigator-sponsored trial evaluating its lead clinical candidate, evorpacept, in combination with standard-of-care rituximab and lenalidomide (R2) in patients with indolent and aggressive relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). In this study, the combination was well-tolerated and showed promising anti-tumor activity. Notably, among patients with indolent B-NHL, an 83% complete response rate was observed—much higher than the historical 34% rate achieved with R2 alone. Evorpacept works as a CD47-blocker to activate the innate immune system and engage macrophages, which may help overcome resistance to R2. The Phase 2 part of the trial, focusing on patients with untreated indolent NHL, is currently ongoing and has completed enrollment.
Read Announcement- Drug:
- Evorpacept
- Announced Date:
- April 9, 2024
- Indication:
- Castric cancer and gastroesophageal junction cancer (GC)
Announcement
ALX Oncology Holdings reported encouraging clinical data from the ongoing Phase 1/2 investigator-sponsored trial ("IST") of evorpacept in combination with R2 in patients with indolent and aggressive R/R B-NHL. The new data were presented in an oral presentation at the 2024 American Association for Cancer Research ("AACR") Annual Meeting.
AI Summary
ALX Oncology Holdings presented encouraging clinical data from their ongoing Phase 1/2 investigator-sponsored trial (IST) during an oral presentation at the 2024 American Association for Cancer Research Annual Meeting. The study evaluated evorpacept in combination with the standard R2 regimen (rituximab and lenalidomide) in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma. In the trial, 20 patients participated, including 18 with indolent and 2 with aggressive disease. The combination treatment was well tolerated and exhibited a safety profile similar to that of historical R2 data. Importantly, among patients with indolent R/R B-NHL, the therapy achieved a promising best overall response rate of 94% and a complete response rate of 83%, notably surpassing the historical CRR benchmark of 34%. These findings support further exploration of evorpacept and R2 as a novel treatment option for patients with R/R B-NHL.
Read Announcement
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