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.
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) recently announced a collaboration with Sanofi to evaluate the combination of evorpacept, a CD47 blocker, and SARCLISA (isatuximab-irfc) in treating patients with relapsed or refractory multiple myeloma (RRMM). This collaboration involves a Phase 1/2 study focused on assessing the safety, efficacy, and pharmacokinetics of the combination therapy. The study aims to identify the optimal dosing and evaluate its efficacy in a broader patient population. ALX will supply evorpacept while Sanofi will provide SARCLISA. This partnership represents a significant step in developing combination therapies for multiple myeloma, which currently lacks a definitive cure.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced dosing of the first patient in the I-SPY-P1-TRIAL, sponsored by Quantum Leap Healthcare Collaborative, for treating unresectable or metastatic HER2-positive and HER2-low breast cancer. This Phase 1 study evaluates evorpacept, a CD47 blocker, combined with ENHERTU® (fam-trastuzumab deruxtecan-nxki) to assess safety, tolerability, and efficacy. Dr. Laura Esserman highlighted that this treatment may be transformative for patients resistant to other therapies. The I-SPY TRIAL aims to rapidly screen and test novel therapies tailored to specific patient subgroups.
ALX Oncology Holdings reported its financial results for Q4 and the full year 2022, highlighting significant progress in clinical trials for its lead product, evorpacept. The company experienced a GAAP net loss of $30.7 million for Q4 2022, up from $28.4 million in Q4 2021, and a full-year GAAP net loss of $123.5 million, compared to $83.5 million in 2021. R&D expenses rose to $25.2 million for Q4 and $98.4 million for the year, reflecting ongoing development efforts. ALX has sufficient cash reserves of $282.9 million, expected to fund operations through mid-2025. The company anticipates key trial data presentations and IND filings in 2023.
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.
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