Welcome to our dedicated page for Alx Oncology Holdings news (Ticker: ALXO), a resource for investors and traders seeking the latest updates and insights on Alx Oncology Holdings stock.
Overview
ALX Oncology Holdings Inc (NASDAQ: ALXO) is a clinical‐stage biotechnology company dedicated to advancing innovative immuno‐oncology therapies. With a deep expertise in protein engineering, ALX Oncology is focused on developing treatments that block the CD47 immune checkpoint—a mechanism by which cancer cells signal the immune system not to attack. This approach is particularly significant in the context of enhancing both the innate and adaptive immune responses against malignancies. Keywords such as immuno‐oncology, CD47 blockade, and checkpoint inhibitor are central to the company’s identity and strategic direction.
Core Technology and Therapeutic Approach
The company’s lead product candidate, evorpacept, is a fusion protein that integrates an engineered, high-affinity CD47 binding domain with an inactivated Fc region, designed to minimize hematologic toxicities common to other CD47 blocking agents. This strategic design not only optimizes safety but also allows for potentially higher dosing in combination regimens. By mitigating the "don't eat me" signal of CD47, the therapy aims to restore the immune system’s ability to recognize and eliminate cancer cells. This precision in molecular design underlines ALX Oncology’s commitment to developing next-generation immunotherapies.
Clinical Development and Research Focus
ALX Oncology has built a robust clinical-stage pipeline that explores various combination strategies, investigating evorpacept with established anti-cancer antibodies, ADCs, and checkpoint inhibitors. The company conducts multiple studies across hematologic and solid malignancies, using its therapeutic candidate as a combinatorial partner to address complex cancer pathologies. While avoiding specific numerical data and time-sensitive details, it is evident that the clinical program is designed with a strong emphasis on advanced safety profiles and meaningful anti-tumor activity.
Market Position and Competitive Differentiation
Within the competitive landscape of immunotherapies, ALX Oncology differentiates itself through its innovative approach to CD47 blockade. Unlike competitors using active Fc domains, evorpacept employs an inactivated Fc region to reduce overlapping toxicities, potentially allowing effective higher dosing when used in combination with other therapies. This nuanced approach not only enhances its safety profile but also positions the company as an important contributor to evolving cancer treatment paradigms. The company’s strategic focus on combination therapies reflects a broader industry trend, wherein multi-modality treatment regimens are increasingly recognized for their potential to overcome resistance mechanisms in cancer cells.
Scientific and Clinical Expertise
ALX Oncology’s efforts are supported by a team with extensive experience in oncology, immunology, and biopharmaceutical research. The company integrates cutting-edge scientific advancements with clinical insights to drive its development programs. The rigorous, data-driven approach in its clinical trials underscores a commitment to high standards of scientific inquiry and patient safety. Moreover, the use of rational design principles in developing evorpacept demonstrates the company’s methodical and evidence-based approach to overcoming conventional therapeutic limitations.
Strategic Focus
The company remains focused on enhancing therapeutic outcomes by leveraging its product pipeline to bridge innate and adaptive immunity. Through collaborations and combination studies, ALX Oncology aims to address complex oncologic challenges while ensuring that its therapies maintain a broad applicability across multiple cancer indications. Each study is designed to provide insights into treatment efficacy and safety, contributing to an evolving landscape of immuno-oncology research that emphasizes precision, tolerability, and synergistic potential with other anti-cancer modalities.
Conclusion
In summary, ALX Oncology Holdings Inc. embodies a forward-thinking approach in the realm of immuno-oncology by targeting the CD47 checkpoint with a uniquely engineered candidate. The company’s integration of advanced protein design, strong clinical trial data, and a focus on combinational therapies places it in a notable position within the competitive biotechnology sector. This comprehensive approach not only highlights its scientific and clinical rigor but also provides a clear understanding of its business model and market significance for investors and industry observers alike.
ALX Oncology (Nasdaq: ALXO) announced that updated results from its Phase 2 ASPEN-06 clinical trial will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium. The trial evaluates evorpacept, a CD47-blocking therapeutic, in combination with trastuzumab, CYRAMZA® (ramucirumab) and paclitaxel for treating HER2-positive gastric/gastroesophageal junction cancer patients who previously received anti-HER2 therapy.
The presentation will be delivered by Dr. Kohei Shitara from the National Cancer Center Hospital East in Japan on January 23, 2025. The study results will be presented during the Rapid Oral Abstract Session focusing on Cancers of the Esophagus and Stomach.
ALX Oncology (ALXO) announced a virtual event scheduled for December 17, 2024, at 8:00 AM EST to discuss new clinical data from their Phase 1b/2 trial. The trial evaluates evorpacept, their CD47-blocker, in combination with Jazz Pharmaceuticals' zanidatamab for treating heavily pretreated patients with metastatic breast cancer. The data was presented at the 2024 San Antonio Breast Cancer Symposium (SABCS).
The event will feature Dr. Alberto J. Montero, Clinical Director of Breast Cancer Medical Oncology at University Hospitals Seidman Cancer Center, who will present the data and participate in a fireside chat with ALX's Chief Medical Officer, Dr. Alan Sandler. CEO Jason Lettmann will discuss the company's progress and upcoming milestones for the evorpacept program.
ALX Oncology (Nasdaq: ALXO) announced promising results from a Phase 1b/2 clinical trial evaluating evorpacept in combination with zanidatamab for HER2-positive breast cancer. The study showed significant efficacy in heavily pretreated patients, with a 55.6% confirmed objective response rate and 7.4 months median progression-free survival in HER2-positive patients by central assessment.
The trial included three cohorts: HER2-positive breast cancer patients (n=21), HER2-low breast cancer patients (n=15), and other HER2-expressing cancers (n=8). Most treatment-related adverse events were grade 1 or 2, with common effects including fatigue, nausea, diarrhea, and infusion-related reactions. No treatment-related deaths or non-infectious pulmonary toxicities were reported.
ALX Oncology (Nasdaq: ALXO) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference in New York City. CEO Jason Lettmann will engage in a fireside chat with analyst Christopher Raymond on December 3, 2024, at 9:30 AM EST. The event will also include one-on-one meetings.
The fireside chat will be accessible via webcast through ALX Oncology's website investor section, with a replay available for up to 90 days following the event. ALX Oncology is a clinical-stage biotechnology company focused on developing immune system-boosting cancer therapies to extend patient lives.
ALX Oncology Holdings (Nasdaq: ALXO) has appointed Alan Sandler, M.D. as Chief Medical Officer. Dr. Sandler brings over 30 years of experience in oncology and drug development, having previously served as Executive Vice President and CMO at Mirati Therapeutics, President and Global Head of Development in Oncology at Zai Lab, and Senior Vice President at Genentech. He will lead the clinical development of evorpacept, the company's investigational lead compound, into late-stage clinical trials. Dr. Sandler, who previously served on ALX Oncology's Board of Directors, has co-authored over 300 publications and holds an M.D. from Rush Medical College.
ALX Oncology (NASDAQ: ALXO) reported Q3 2024 financial results and clinical progress. The company's lead candidate evorpacept showed promising results in the ASPEN-06 Phase 2 trial, achieving a 40.3% overall response rate compared to 26.6% in the control arm for HER2-positive gastric cancer treatment.
Financial highlights include cash position of $162.6 million, sufficient until Q1 2026. Q3 net loss was $30.7 million ($0.58 per share), improved from $51.0 million loss year-over-year. R&D expenses decreased to $26.5 million from $45.8 million, while G&A expenses reduced to $6.1 million from $7.5 million.
ALX Oncology (Nasdaq: ALXO) announced its participation in two upcoming investor conferences in November 2024. The company will participate in the UBS Global Healthcare Conference on November 12 at 3:30 PM PST in Rancho Palos Verdes, CA, featuring a fireside chat with analyst Trung Huynh. Additionally, they will attend the Jefferies London Healthcare Conference on November 19 at 9:00 AM GMT in London, with analyst Michael Yee. Both events will include 1x1 meetings and webcasts accessible through ALX Oncology's website, with replays available for up to 90 days.
ALX Oncology (Nasdaq: ALXO) announced that results from their Phase 1b/2 trial combining evorpacept with zanidatamab in HER2-positive and HER2-low metastatic breast cancer will be presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. The presentation will showcase data from their two-part, open-label, multicenter study (NCT05027139) evaluating evorpacept, a CD47 blocker, combined with zanidatamab, a dual HER2-targeted bispecific antibody. Dr. Alberto J. Montero from University Hospitals Seidman Cancer Center will present the findings on December 12, 2024.
ALX Oncology Holdings (Nasdaq: ALXO), an immuno-oncology company focusing on CD47 immune checkpoint pathway therapies, has announced its participation in the 2024 Cantor Fitzgerald Global Healthcare Conference. The event will take place in New York City from September 17-19, 2024.
Key details of ALX Oncology's participation include:
- A fireside chat with analyst Li Watsek on Tuesday, September 17, 2024, at 1:55 PM ET
- One-on-one meetings with investors
- A live webcast of the fireside chat accessible through the company's website
- Archived replay available for up to 90 days after the event
This conference provides ALX Oncology an opportunity to showcase its progress and engage with the investment community.
ALX Oncology (Nasdaq: ALXO) has announced the dosing of first patients in a randomized Phase 1/2 UMBRELLA study, evaluating evorpacept in combination with Sanofi's SARCLISA® (isatuximab-irfc) for relapsed or refractory multiple myeloma (RRMM). Evorpacept is ALX Oncology's investigational CD47-blocking therapeutic, while SARCLISA is Sanofi's approved CD38 monoclonal antibody.
The study aims to assess the safety, efficacy, pharmacokinetics, and biomarker data of this combination. Part 1 will evaluate dosing, while Part 2 will investigate efficacy and safety in an expanded RRMM patient population. This collaboration leverages the potential synergy between evorpacept and SARCLISA, as CD47 expression increases with multiple myeloma progression, potentially re-sensitizing tumors to CD38 treatment.
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