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 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.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced significant progress in its clinical-stage immuno-oncology development during 2021. Key achievements included the initiation of multiple clinical trials and promising data from trials of its lead product evorpacept, particularly in HNSCC and gastric cancers. Collaborations with Tallac Therapeutics and the acquisition of ScalmiBio were highlighted, enhancing ALX's therapeutic capabilities. The company anticipates further advancements in 2022, including new trial initiations and data readouts, supported by a strong cash reserve of approximately $385.1 million.
ALX Oncology Holdings Inc. (Nasdaq: ALXO), a clinical-stage immuno-oncology company, announced that its CEO, Jaume Pons, Ph.D., will present a company overview at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 10:30 am ET. The presentation will focus on ALX Oncology’s lead product candidate, evorpacept, which targets the CD47 checkpoint pathway and shows promise in treating various malignancies. Investors can access the live webcast and replay via ALX Oncology’s website.
DURECT Corporation (Nasdaq: DRRX) has expanded its board of directors with the appointment of Peter García, a seasoned expert in biopharmaceutical finance. García's over 25 years of leadership in the industry, including raising over $2 billion in capital, is expected to enhance DURECT's strategic direction as it advances its AHFIRM Phase 2b trial for larsucosterol, aimed at treating alcohol-associated hepatitis. CEO James E. Brown emphasized García’s experience will be crucial as DURECT transitions from development to the commercial stage. DURECT continues to focus on innovative treatments for acute organ injury and chronic liver diseases.
ALX Oncology announced promising initial data from its ongoing trial of evorpacept in combination with azacitidine for treating myelodysplastic syndrome (MDS). In patients with previously untreated higher-risk MDS, significant responses were noted, including complete remissions and transfusion independence. The therapy was well-tolerated, showing no dose-limiting toxicities. The data were presented at the 63rd ASH Annual Meeting, highlighting the potential of evorpacept as a viable treatment for difficult MDS cases.
ALX Oncology (Nasdaq: ALXO) reported its third-quarter financial results for 2021, highlighting significant advancements in its lead program, evorpacept (ALX148). The company presented new clinical data at ESMO and initiated several clinical trials, including ASPEN-04 and ASPEN-05. ALX acquired ScalmiBio, enhancing its immuno-oncology pipeline. As of September 30, 2021, cash and equivalents stood at $385.1 million, expected to fund operations through 2024. However, the net loss was $24.6 million, reflecting increased R&D expenses driven by higher clinical costs.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) reported promising results from its ASPEN-01 Phase 1b study, showcasing evorpacept's effectiveness in patients with advanced cancers. Key findings include:
- In >2L HER2 positive gastric cancer (n=18), an overall response rate (ORR) of 72.2%, median duration of response (mDOR) of 14.8 months, and 12-month overall survival (OS) rate of 79%.
- In 1L head and neck cancer (n=13), an ORR of 38.5%, with a 12-month OS rate of 87.5%, and median OS not reached.
- In >2L head and neck cancer (n=10), a 12-month OS rate of 80% and mOS of 24.5 months.
The company will discuss these results in a conference call on November 9, 2021.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced the presentation of early clinical data from its Phase 1/2 ASPEN-02 study at the upcoming ASH Annual Meeting on December 12, 2021. The study evaluates evorpacept combined with azacitidine for treating myelodysplastic syndromes (MDS). As of July 15, 2021, 13 subjects were enrolled, with promising responses observed, including complete and marrow complete responses in patients with TP53 mutations. No dose-limiting toxicities were noted, indicating a favorable safety profile. Further results will be disclosed at the conference.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced participation in four virtual investor conferences. CEO Jaume Pons and senior executives will engage in fireside chats at the following events: Credit Suisse's 30th Annual Healthcare Conference on November 8 at 2:40 PM ET, Stifel's 2021 Healthcare Conference on November 16 at 10:00 AM ET, Jefferies' London Healthcare Conference on November 18-19, and Piper Sandler's 33rd Virtual Healthcare Conference on November 22 at 10:00 AM ET. Webcast links are available for interested investors.
ALX Oncology has announced the first patient dosed in the Phase 1/2 ASPEN-05 study, evaluating evorpacept combined with venetoclax and azacitidine for treating acute myeloid leukemia (AML). This trial focuses on patients with relapsed/refractory AML and those who are not candidates for intensive therapy. The study builds on preclinical evidence of evorpacept's effectiveness and aims to address the urgent need for effective therapies in this patient population. AML remains a critical health challenge, with only a 29% five-year survival rate.