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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 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.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) reported its Q2 2022 financial results, showcasing significant advancements in its lead therapeutic, evorpacept. The FDA granted Fast Track designation for evorpacept in treating advanced head and neck squamous cell carcinoma, alongside Orphan Drug Designation for acute myeloid leukemia. R&D expenses surged to $26.7 million from $11.2 million YOY. The company holds $324.2 million in cash, projected to fund operations until Q4 2024, despite a net loss of $32.9 million for the quarter.
ALX Oncology has announced that the FDA has granted Fast Track designation for evorpacept, a CD47 blocker combined with KEYTRUDA, for first-line treatment of advanced head and neck squamous cell carcinoma (HNSCC). Preliminary results from the phase 1 ASPEN-01 trial showed a 40% objective response rate in patients previously treated with checkpoint inhibitors. This designation aims to expedite development for serious conditions. HNSCC is a critical health issue, with an expected rise in incidence.
Tallac Therapeutics has initiated a Phase 1/2 clinical trial for TAC-001, its lead candidate from the innovative Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform, marking a significant milestone. This trial, named INCLINE-101, aims to assess the safety and preliminary anti-tumor activity of TAC-001 in patients with advanced solid tumors. The company plans to file an investigational new drug application (IND) for its second candidate, ALTA-002, in early next year, further advancing its promising pipeline in cancer immunotherapy.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) has received orphan drug designation from the U.S. FDA for evorpacept, a CD47 blocker, aimed at treating acute myeloid leukemia (AML). This regulatory milestone highlights the potential benefits of evorpacept for patients with advanced cancers, as noted by Chief Medical Officer Sophia Randolph. The orphan drug designation provides ALX with assistance in development, tax credits, exemptions from certain fees, and seven years of marketing exclusivity. AML remains a critical health issue, with an estimated 20,050 new cases in the U.S. in 2022.
ALX Oncology (Nasdaq: ALXO) has announced updates to its clinical programs for evorpacept, a CD47 blocker. They will initiate ASPEN-07, a Phase 1 trial for urothelial carcinoma, in Q4 2022. The ASPEN-05 trial, evaluating evorpacept with venetoclax and azacitidine for AML, will pause patient enrollment to leverage upcoming data from ASPEN-02, which focuses on myelodysplastic syndrome. Ongoing studies for head and neck squamous cell carcinoma and gastric cancer are progressing, with results anticipated in 2023 and 2024.
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