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 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 (Nasdaq: ALXO) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Topline data from ASPEN-06 Phase 2 trial showed evorpacept improved tumor response in HER2-positive gastric/GEJ cancer patients.
2. Evorpacept combination with PADCEV demonstrated promising activity in urothelial cancer.
3. Phase 1/2 trial of evorpacept in B-cell non-Hodgkin lymphoma showed 94% ORR and 83% CRR.
4. Cash position of $186.2 million, sufficient to fund operations into Q1 2026.
5. Q2 2024 R&D expenses increased to $34.7 million, while G&A expenses decreased to $6.9 million.
6. GAAP net loss was $39.4 million ($0.76 per share) compared to $34.2 million ($0.84 per share) in Q2 2023.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) has appointed Alan Sandler, M.D., to its Board of Directors effective August 5, 2024. Dr. Sandler brings over 30 years of experience in oncology and drug development. This appointment comes at a important time for ALX, following the recent data read-out of the ASPEN-06 Phase 2 clinical trial for evorpacept.
Simultaneously, Jaume Pons, Ph.D., and Sophia Randolph, M.D., Ph.D., have resigned from the Board to focus on their senior leadership roles as the company's clinical program advances. Dr. Sandler's expertise is expected to be invaluable as ALX advances evorpacept into multiple late-stage clinical programs and explores new indications.
ALX Oncology (Nasdaq: ALXO) announced topline data from its Phase 2 ASPEN-06 clinical trial, evaluating evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel (TRP) for HER2-positive gastric or gastroesophageal junction cancer. Key findings include:
1. In the full population (N=127), evorpacept + TRP showed an overall response rate (ORR) of 40.3% vs 26.6% for TRP alone.
2. In patients with fresh HER2-positive biopsies (n=48), evorpacept + TRP achieved an ORR of 54.8% vs 23.1% for TRP alone.
3. Median duration of response was 15.7 months for evorpacept + TRP vs 7.6 months for TRP alone.
4. Evorpacept + TRP was generally well-tolerated.
These results mark evorpacept as the first CD47 blocker to show durable clinical benefit in a randomized trial, supporting its development in combination with anti-cancer antibodies for various tumor types.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) has announced an investor conference call and webcast scheduled for July 31, 2024, at 4:30 PM EDT. The purpose of this event is to share topline data results from the Phase 2 ASPEN-06 clinical trial of evorpacept, their investigational therapy for advanced HER2-positive gastric cancer. Evorpacept is designed to block the CD47 immune checkpoint pathway.
Investors and interested parties can access the live conference call by dialing (800) 715-9871 (U.S./Canada) or +44.800.260.6466 (international) with Conference ID 9637001. A live and archived webcast of the call, along with a slide presentation, will be available on the company's website in the News & Events section.
ALX Oncology presented promising data from its Phase 1 ASPEN-07 clinical trial at the 2024 ASCO Annual Meeting. The trial investigated the combination of evorpacept and PADCEV in patients with advanced bladder cancer. Key results include a 59% overall response rate (ORR) as of April 3, 2024, with no maximum tolerated dose reached and no treatment-related deaths. Most adverse events were low-grade. Continued follow-up and new cohort enrollment are underway. ALX will host a virtual event on June 7, 2024, to discuss these findings.
ALX Oncology announced its participation in the Jefferies Global Healthcare Conference. The event will take place on June 5, 2024, at 1:00 PM ET in New York, NY. The company, focused on developing therapies to block the CD47 immune checkpoint pathway, will engage in a fireside chat with analyst Michael Yee and hold one-on-one investor meetings. A live webcast of the chat will be accessible via the Investors section of ALX Oncology's website, with a replay available for 90 days.
ALX Oncology reported positive financial results for the first quarter of 2024 and provided a corporate update. The company achieved significant milestones in its clinical trials, including positive data in various cancer treatments. They also announced key appointments and upcoming milestones for their pipeline. Financially, ALX Oncology reported cash, cash equivalents, and investments of $184.5 million as of March 31, 2024, with additional funding secured through an ATM offering.
ALX Oncology Holdings Inc. announced the appointment of Allison Dillon, Ph.D., as Chief Business Officer. With her extensive experience in oncology product development, she is expected to drive the growth of the company during a promising period. The company is focused on developing therapies that target the CD47 immune checkpoint pathway, with upcoming clinical study readouts for evorpacept. Dr. Dillon's background in commercial strategy and portfolio development positions ALX Oncology for further success in the oncology market.
ALX Oncology announced the initiation of a Phase 2 Investigator-Sponsored Trial of neoadjuvant radiation and evorpacept in combination with pembrolizumab for patients with untreated HPV-mediated oropharyngeal cancer. The trial aims to address the need for novel therapies in this patient population.
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