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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 Holdings (Nasdaq: ALXO) announced the dosing of the first patient in the ASPEN-07 study, evaluating evorpacept, a novel CD47 blocker, in combination with PADCEV (enfortumab vedotin-ejfv) for urothelial cancer (UC). This Phase 1, open-label study aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with unresectable advanced UC (NCT05524545). Given the poor outcomes and limited treatments available post-chemotherapy for this patient group, the study seeks to investigate a new therapy that may enhance efficacy without increasing toxicity.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) provided an update on its clinical progress and corporate milestones for 2023. The company is advancing its lead candidate, evorpacept, in several cancer indications, including a Phase 1 trial in urothelial cancer and trials in combination therapies for colorectal and breast cancer. Key accomplishments from 2022 include regulatory designations and financial support through a $100 million loan facility. ALX Oncology expects to present pivotal data in 2023, aiming for continued growth in clinical development.
ALX Oncology Holdings Inc. (Nasdaq: ALXO), a clinical-stage immuno-oncology company, will be presenting at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 10:30 am PT. CEO Jaume Pons, Ph.D., will provide a company overview at the event taking place in San Francisco.
A live webcast of the presentation will be accessible through ALX Oncology's website, and a replay will be available for 30 days post-event. The company focuses on developing therapies that block the CD47 checkpoint pathway, with their lead candidate, evorpacept, showing promise in treating various cancers.
ALX Oncology (Nasdaq: ALXO) announced promising clinical data from the Phase 1a dose escalation of the ASPEN-05 trial, evaluating evorpacept in combination with azacitidine and venetoclax for acute myeloid leukemia (AML). The treatment showed antileukemic activity in patients with both relapsed/refractory and newly diagnosed AML, with responses observed among 10 r/r patients and all 3 newly diagnosed patients. Notably, no evorpacept-related cytopenias were reported. A conference call is scheduled for December 13, 2022 to discuss these findings.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced the appointment of Scott Garland to its Board of Directors, effective November 29, 2022. With over 30 years in the biopharmaceutical industry, Garland brings significant commercial and executive experience. As CEO of PACT Pharma and former CEO of Portola Pharmaceuticals, he has led successful product launches and has deep expertise in immuno-oncology. This addition aims to enhance ALX's strategic direction, particularly in developing its lead candidate, evorpacept, a novel therapy for treating cancer.
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.
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