ALX Oncology Holdings Inc. reports company news around a clinical-stage oncology pipeline led by evorpacept, an investigational CD47 inhibitor designed to address a cancer immune-evasion signal. Updates commonly cover clinical data presentations, biomarker analyses involving CD47 expression, and studies of evorpacept combinations in HER2-positive cancers, including breast and gastric cancer settings.
The company also reports development activity for ALX2004, an EGFR-targeted antibody-drug conjugate for EGFR-expressing solid tumors. Other recurring updates include quarterly financial results, research and development spending, cash runway commentary, registered offerings of common stock and pre-funded warrants, leadership appointments, investor conference participation, and Nasdaq inducement equity grants.
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.
ALX Oncology Holdings (Nasdaq: ALXO) announced participation in the Jefferies 2022 Healthcare Conference on June 8 at 10:00 am ET. CEO Jaume Pons, Ph.D. will engage in a fireside chat during this event, highlighting the company's clinical-stage immuno-oncology advancements.
A live webcast is available on their website and will be archived for 90 days post-event. ALX Oncology is known for developing therapies targeting the CD47 checkpoint pathway, with its lead candidate evorpacept showing promise in treating various cancers.
ALX Oncology (Nasdaq: ALXO) reported its Q1 2022 financial results, posting a net loss of $24.5 million or $0.60 per share, compared to a net loss of $14.2 million or $0.35 per share in Q1 2021. Cash, cash equivalents, and investments stood at $341.7 million, sufficient to fund operations through mid-2024. Notable clinical advancements include the initiation of ASPEN-06, a Phase 2/3 trial for evorpacept in HER2-positive gastric cancer, and FDA's Orphan Drug Designation for evorpacept. R&D expenses increased to $17.1 million from $9.8 million due to expanded clinical activities.
ALX Oncology has appointed Itziar Canamasas, Ph.D., to its Board of Directors as of April 11, 2022. With over 20 years in the biopharmaceutical sector, Dr. Canamasas brings extensive experience in oncology product launches and strategic growth. The appointment is expected to enhance ALX Oncology's efforts in developing its lead product, evorpacept, an innovative CD47 blocking therapeutic with promising clinical results. ALX focuses on therapies targeting both hematologic and solid tumors, aiming to advance evorpacept for multiple indications in cancer treatment.
ALX Oncology has initiated the Phase 2/3 ASPEN-06 study in collaboration with Eli Lilly to evaluate evorpacept in combination with CYRAMZA, trastuzumab, and paclitaxel for HER2-positive gastric cancer. The study aims to enroll about 450 patients whose tumors progressed after HER2-targeted therapy. Prior studies showed an objective response rate of 72.2% and a median overall survival of 17.1 months with evorpacept. This trial is crucial as gastric patients need more effective treatment options.