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ALX Oncology Holdings Inc. (Nasdaq: ALXO) is a forward-thinking clinical-stage immuno-oncology company committed to developing innovative therapies to aid cancer patients. The company is at the forefront of therapeutic advancements by targeting the CD47 immune checkpoint pathway, which cancer cells exploit to avoid detection and elimination by the immune system.
Lead Product Candidate: Evorpacept
ALX Oncology’s flagship product, evorpacept, is a next-generation CD47 blocker designed to overcome limitations inherent in other CD47 blocking approaches. Evorpacept combines a high-affinity CD47 binding domain with an inactivated Fc region, ensuring minimal hematologic toxicity while enabling higher dosage. This design aims to augment the immune response against cancer cells.
Clinical Trials and Achievements
Evorpacept is being evaluated in multiple clinical trials—including Phase 1 and Phase 2 trials—across a spectrum of hematologic and solid malignancies. The ASPEN-06 Phase 2 clinical trial for HER2-positive gastric/gastroesophageal junction cancer has shown promising results, demonstrating an overall response rate of 52% compared to 22% for the control group.
Another significant milestone was achieved in the ASPEN-07 trial, where evorpacept was combined with PADCEV® (enfortumab vedotin) in patients with advanced bladder cancer. The combination demonstrated promising activity with a 61% overall response rate. This study, among others, highlights evorpacept's potential to work synergistically with antibody-drug conjugates (ADCs) and checkpoint inhibitors.
Financial Health and Corporate Development
ALX Oncology has maintained a robust financial position, reporting $184.5 million in cash, cash equivalents, and investments as of the first quarter of 2024. The company recently completed a public offering, generating gross proceeds of approximately $63.2 million. This financial strength supports its extensive clinical pipeline and ongoing research efforts.
Strategic Partnerships and Future Outlook
The company collaborates with leading institutions and pharmaceutical companies to enhance its therapeutic offerings. Upcoming milestones include top-line results from multiple Phase 2 clinical trials and the initiation of a Phase 3 registrational trial. ALX Oncology is poised to make significant strides in the oncology landscape by focusing on therapies that bridge the innate and adaptive immune systems.
For more information, visit the company’s official website at www.alxoncology.com.
ALX Oncology (Nasdaq: ALXO) reported Q3 2022 financials, noting a GAAP net loss of $35.3 million, or $0.87 per share, versus $24.6 million, or $0.61 per share, in Q3 2021. R&D expenses rose to $29.4 million, driven by increased clinical trial costs. The company secured a non-dilutive loan facility to extend its cash runway to mid-2025, with $293.1 million in cash and equivalents as of September 30, 2022. Evorpacept's clinical development continues, including new treatment arms in the I-SPY-P1 TRIAL and ongoing trials for advanced colorectal cancer and head and neck squamous cell carcinoma.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) will present clinical data from the dose escalation portion of ASPEN-05, a Phase 1 study, at the 64th American Society of Hematology Annual Meeting from December 10-13, 2022. The study evaluates evorpacept in combination with azacitidine and venetoclax for treating acute myeloid leukemia (AML). The poster presentation is scheduled for December 12, 2022, highlighting promising clinical responses from evorpacept across various hematologic and solid malignancies.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) is participating in four investor conferences to discuss its immuno-oncology therapies targeting the CD47 checkpoint pathway. Key events include the Credit Suisse 31st Annual Healthcare Conference on November 9, Stifel 2022 Healthcare Conference on November 15, Jefferies London Healthcare Conference on November 17, and Piper Sandler 34th Annual Healthcare Conference on November 29. The company is focused on the clinical development of its lead product candidate, evorpacept, aimed at treating various cancers.
ALX Oncology Holdings Inc. (ALXO) announced a loan agreement for up to $100 million of non-dilutive financing with Oxford Finance and Silicon Valley Bank. This funding will support the development of evorpacept, a CD47 blocking therapeutic. ALX has accessed $10 million of an initial $50 million tranche, with the remaining funds available at its discretion through 2023. The financing extends their cash runway to mid-2025, allowing for further clinical trials and milestones.
ALX Oncology (Nasdaq: ALXO) announced the acceptance of two Trials in Progress abstracts for ASPEN-03 and ASPEN-04, Phase 2 studies on advanced head and neck cancer, at the SITC 37th Annual Meeting in Boston from November 8-12, 2022. The abstracts detail studies on evorpacept (ALX148) combined with pembrolizumab, with session times on November 10-11, 2022. ALX Oncology focuses on developing therapies that block the CD47 checkpoint pathway, with evorpacept showing promising results for various cancers.
ALX Oncology Holdings Inc. (Nasdaq: ALXO), a clinical-stage immuno-oncology company, announced its participation in the Cantor Oncology, Hematology & HemeOnc Conference on September 28, 2022, in New York. CEO Jaume Pons, Ph.D., will be part of a moderated panel titled “Building Combinations: What are the Novel Ideas?” at 10:40 AM ET. Additionally, Dr. Pons and CFO Peter Garcia will conduct one-on-one investor meetings during the event. ALX Oncology is advancing its lead product candidate, evorpacept, aimed at treating various cancers by blocking the CD47 checkpoint pathway.
ALX Oncology Holdings Inc. (Nasdaq: ALXO), a clinical-stage immuno-oncology company, announced participation in two investor conferences. The first is Citi's 17th Annual BioPharma Conference on September 7 in Boston, MA. The second event is the H.C. Wainwright 24th Annual Global Investment Conference on September 12, featuring a fireside chat with analyst Swayampakula Ramakanth at 7:00 AM Eastern Time, available virtually. ALX is focused on developing therapies that target the CD47 checkpoint pathway, with promising results for its lead candidate, evorpacept.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced the selection of its CD47 blocker, evorpacept, for an investigational arm in the I-SPY-P1 TRIAL, targeting HER2-positive and HER2-low breast cancer. This Phase 1 study, sponsored by Quantum Leap Healthcare Collaborative, will explore evorpacept in combination with ENHERTU (fam-trastuzumab deruxtecan-nxki) to assess safety and efficacy. The trial aims to address the need for effective treatments in patients resistant to other therapies, with ALX providing funding and drug supply.
ALX Oncology Holdings (Nasdaq: ALXO) has announced that its CD47 blocker, evorpacept, has been selected for a new investigational treatment arm in the I-SPY-P1 TRIAL. This partnership with Quantum Leap Healthcare Collaborative will evaluate the safety and efficacy of evorpacept combined with ENHERTU for patients with HER2-positive and HER2-low breast cancer. The study aims to provide novel treatment options for advanced breast cancer patients who have developed resistance to existing therapies. ALX will supply evorpacept and fund the study, while Quantum Leap manages the trial.
ALX Oncology (Nasdaq: ALXO) announced the initiation of a Phase 2 investigator-sponsored study for evorpacept, a CD47 blocker. The trial aims to assess the drug's efficacy in combination with ERBITUX® and KEYTRUDA® in patients with refractory microsatellite stable metastatic colorectal cancer (mCRC) who have failed at least two systemic therapies. With notable collaboration from Merck and Eli Lilly, the study is expected to address a significant medical need, given the low 5-year survival rate of 15.1% for metastatic CRC patients. Findings from prior studies indicated promising activity and tolerability for evorpacept.