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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) has initiated an underwritten public offering of 2,000,000 shares of its common stock, with plans to grant underwriters a 30-day option for an additional 300,000 shares. The proceeds from this offering are expected to support ongoing clinical development of ALX148, a next-generation cancer therapy targeting the CD47 pathway. Jefferies, Credit Suisse, and Piper Sandler are managing the offering. A registration statement has been filed with the SEC, but it has not yet become effective, meaning the offering is subject to market conditions.
ALX Oncology announced promising results from its clinical trial of ALX148 combined with rituximab for treating patients with advanced relapsed and refractory non-Hodgkin lymphoma (NHL). The updated data, presented at the 62nd ASH Annual Meeting, indicates a 70.0% objective response rate (ORR) among those receiving the higher 15 mg/kg dose. The treatment was well tolerated, with no dose-limiting toxicities reported, supporting further investigation in a Phase 2 program targeting a range of cancers. The data were cut off as of October 1, 2020.
ALX Oncology announced updates regarding its planned Phase 2 head and neck cancer studies for ALX148. The FDA has requested the completion of a standard non-clinical safety study prior to the initiation of the potentially pivotal trials. Enrollment is capped at 50 subjects, but no delays are expected in the clinical timelines. ALX148 has shown promising results in earlier studies, with a 75% overall response rate noted in a Phase 1b cohort. The company plans to advance ALX148 in combination with KEYTRUDA and intends to seek accelerated approval for HNSCC.
ALX Oncology Holdings Inc. (Nasdaq: ALXO), a clinical-stage immuno-oncology company, will participate in two virtual investor conferences in December 2020. The Piper Sandler 32nd Annual Virtual Healthcare Conference runs from November 30 to December 3, while the 3rd Annual Evercore ISI HealthCONx Conference is scheduled for December 3 at 10:30 AM ET. Both events feature fireside chats with analysts, and recordings will be available on ALX Oncology’s website. The company is focused on developing therapies that block the CD47 checkpoint pathway, with promising clinical responses from its lead product, ALX148.
BURLINGAME, Calif., Nov. 12, 2020 -- ALX Oncology (ALXO) reported Q3 2020 financial results, revealing a net loss of $10.8 million compared to $4.1 million in Q3 2019. Cash reserves stand at $259.5 million, projected to sustain operations through 2023. Clinical updates include the initiation of a Phase 1/2 study of ALX148 with azacitidine and promising results in advanced gastric cancer, showing a 64% objective response rate (ORR) in combination with trastuzumab. Collaboration with Merck for ALX148 and KEYTRUDA in head and neck cancer further solidifies its clinical development pipeline.
ALX Oncology announced promising results from its ASPEN-01 study at the SITC 35th Annual Meeting. For patients with >2L HER2 positive gastric cancer, a 64% objective response rate (ORR) was observed using ALX148 with trastuzumab and chemotherapy. Additionally, a 75% ORR, including one complete response, was seen in treatment-naïve patients with 1L head and neck cancer using ALX148 plus pembrolizumab and chemotherapy. Preliminary data indicates that ALX148 can be safely combined with existing regimens, reinforcing its potential in advanced cancers.
ALX Oncology announced updated results from the ASPEN-01 phase 1b study of ALX148 in combination with rituximab for patients with relapsed/refractory non-Hodgkin lymphoma (NHL). Both clinical and preclinical results will be presented at the 62nd ASH Annual Meeting on December 5-8, 2020. The clinical updates aim to showcase new efficacy data for ALX148, demonstrating its potential to transform cancer care. The poster presentations will occur on December 6 and 7, detailing the performance of ALX148 in improving treatment responses.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced participation in two upcoming virtual investor conferences. CEO Jaume Pons and senior executives will engage in fireside chats at the 29th Annual Credit Suisse Virtual Healthcare Conference on November 9 and the Jefferies Virtual London Healthcare Conference on November 19. ALX Oncology is focused on developing therapies that inhibit the CD47 checkpoint pathway, with its lead product candidate, ALX148, showing promising clinical results against various cancers. Webcast links are provided for interested investors.
ALX Oncology (Nasdaq: ALXO) has initiated the Phase 1/2 ASPEN-02 study to evaluate the safety and efficacy of ALX148 combined with azacitidine for treating higher-risk myelodysplastic syndrome (MDS). The first patient has been dosed in this clinical trial, which is based on promising preclinical and clinical data. The trial aims to assess the safety of this combination in patients with previously untreated or relapsed MDS. If successful, the Phase 2 component will follow, focusing on efficacy. ALX148 has previously shown potential in multiple malignancies.
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