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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 Holdings Inc. (Nasdaq: ALXO), a clinical-stage immuno-oncology company, announced participation in two upcoming virtual investor conferences. Jaume Pons, Ph.D., CEO, will engage in fireside chats at:
- H.C. Wainwright 23rd Annual Global Investment Conference on September 13 at 7:00 AM ET
- Cantor Virtual Global Healthcare Conference on September 28 at 11:50 AM ET
ALX Oncology Holdings reported its Q2 2021 financial results, revealing a net loss of $16.3 million, or $0.40 per share, compared to a loss of $14.0 million last year. Cash and equivalents were $410 million, sufficient to fund operations through 2024. Key developments include the approval of 'evorpacept' as the generic name for ALX148 and initiation of several clinical trials, including ASPEN-04 and ASPEN-03. A collaboration with Eli Lilly was also established to evaluate evorpacept with CYRAMZA for HER2-positive G/GEJ cancer.
ALX Oncology Holdings Inc. has initiated the second Phase 2 trial, ASPEN-04, in collaboration with Merck, focusing on the combination of ALX148, KEYTRUDA, and standard chemotherapy for advanced head and neck squamous cell carcinoma (HNSCC). The study includes treatment-naive patients regardless of PD-L1 expression. The trial builds on promising results from the earlier ASPEN-01 study, which led to FDA Fast Track designation for ALX148 in HNSCC.
ALX Oncology has reported promising results from its ongoing ASPEN-01 trial, demonstrating a confirmed objective response rate (ORR) of 72% in patients with >2L HER2 positive gastric or gastroesophageal junction cancer. The estimates indicate an overall survival (OS) rate of 76% at 12 months, significantly outperforming historical controls. The combination therapy of ALX148 with trastuzumab and chemotherapy shows strong tolerability, with no maximum tolerated dose reached during the study. A conference call is scheduled for July 6, 2021 to discuss these findings further.
ALX Oncology announced that the FDA has lifted a partial clinical hold on its ongoing Phase 2 studies, ASPEN-03 and ASPEN-04, for the treatment of advanced head and neck cancer. The studies will evaluate the efficacy of ALX148 in combination with KEYTRUDA in patients with unresectable, recurrent HNSCC. The ongoing enrollment for ASPEN-03 has commenced, marking a significant milestone for the company as it seeks to expedite patient recruitment and address unmet medical needs in this area.
ALX Oncology (NASDAQ:ALXO) has initiated a collaboration with Eli Lilly to conduct a randomized Phase 2/3 study evaluating ALX148 in combination with CYRAMZA (ramucirumab) for treating HER2-positive gastric cancer. This decision follows promising results from the ongoing ASPEN-01 Phase 1b trial, which showed a 64% objective response rate in patients with previously low outcomes. This agreement underscores ALX Oncology's commitment to advancing ALX148 as a key immunotherapy option. Results from the Phase 1b trial will be presented at the ESMO 23rd World Congress on July 3, 2021.
BURLINGAME, Calif., May 18, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced participation in two virtual investor conferences. The first is the UBS 2021 Global Healthcare Virtual Conference on May 24 at 4:00 PM ET, featuring a podium presentation. The second is the Jefferies 2021 Virtual Healthcare Conference on June 2 at 1:30 PM ET, structured as a fireside chat with analyst Michael Yee. Webcasts for both events will be available on the ALX Oncology website with replays accessible for 90 days.
ALX Oncology focuses on CD47 checkpoint therapies, with lead candidate ALX148 showing promising clinical results.
ALX Oncology Holdings reported a net loss of $14.2 million for Q1 2021, worsening from the prior year's loss of $7.4 million. Cash and cash equivalents totaled $429.9 million, sufficient to fund operations through 2024. Significant progress was made with the initiation of the Phase 2 ASPEN-03 study evaluating ALX148 in combination with KEYTRUDA for HNSCC. The company also strengthened its IP portfolio with a U.S. patent covering ALX148, set to expire in 2036. R&D expenses surged to $9.8 million, primarily due to increased clinical costs related to ALX148.
ALX Oncology has initiated the first Phase 2 study in collaboration with Merck, dosing the first patient in the ASPEN-03 trial. This trial evaluates the efficacy of ALX148 in combination with KEYTRUDA for treating advanced head and neck squamous cell carcinoma (HNSCC). ASPEN-03 is a randomized, open-label study building on promising data from the Phase 1 ASPEN-01 study, which led to Fast Track designation from the FDA for ALX148 in HNSCC. The trial aims to accelerate development in various cancer indications.
ALX Oncology (Nasdaq: ALXO) announced an upcoming oral presentation of their Phase 1b study results for ALX148 at the ESMO World Congress on Gastrointestinal Cancer, scheduled for July 3, 2021. The study evaluates ALX148 in combination with trastuzumab, ramucirumab, and paclitaxel for patients with advanced gastric or gastroesophageal junction cancer. This presentation may highlight the therapeutic potential of ALX148 and its impact on treatment outcomes for patients, while contributing to the ongoing clinical development of their immuno-oncology pipeline.
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