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 clinical-stage biotechnology company whose news flow centers on the development of investigational cancer therapies. The company regularly issues updates on its lead CD47 inhibitor, evorpacept, and its EGFR-targeted antibody-drug conjugate, ALX2004, as these programs advance through clinical and preclinical milestones.
News about ALX Oncology often covers clinical trial progress for evorpacept in HER2-positive gastric and gastroesophageal cancers, HER2-positive metastatic breast cancer and indolent B-cell non-Hodgkin lymphoma. Press releases detail study designs, enrollment status, biomarker findings such as CD47 overexpression as a potential predictive biomarker, and data presented at major oncology and immunotherapy conferences, including meetings of the Society for Immunotherapy of Cancer (SITC), the American Society of Hematology (ASH) and the European Society for Medical Oncology (ESMO).
For ALX2004, company announcements highlight preclinical data, poster presentations at scientific conferences such as the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, and updates from the ongoing Phase 1 first-in-human trial in EGFR-expressing solid tumors. These items typically describe dose-escalation progress, safety observations and the rationale for further clinical evaluation.
ALX Oncology also reports quarterly financial results and corporate updates via press releases and related conference calls, which are referenced in Current Reports on Form 8-K. Additional news may include participation in investor conferences, webcasts, and changes in leadership or board composition. Readers who follow ALXO news can use this page to track clinical milestones, data disclosures and corporate developments over time.
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.
ALX Oncology Holdings reported its financial results for Q4 and full-year 2021, highlighting significant clinical advancements for evorpacept, a CD47 blocker. The company initiated two Phase 2 trials for head and neck cancer and presented promising data from Phase 1 trials in gastric and myelodysplastic cancers. Despite increasing R&D and G&A expenses, cash reserves of $363.7 million are projected to sustain operations through mid-2024. The net loss for Q4 was $28.4 million, with a full-year loss of $83.5 million, reflecting ongoing investment in clinical development.
ALX Oncology Holdings (Nasdaq: ALXO) announced that the FDA granted orphan drug designation to evorpacept for treating gastric cancer and gastroesophageal junction cancer. This designation acknowledges evorpacept’s potential to enhance patient outcomes. In initial studies, evorpacept combined with trastuzumab and paclitaxel showed a 72.2% objective response rate and median overall survival of 17.1 months. The FDA's ODD provides various benefits, including development assistance and marketing exclusivity for drugs addressing rare diseases affecting under 200,000 Americans.