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) announced its participation in two upcoming investor conferences in November 2024. The company will participate in the UBS Global Healthcare Conference on November 12 at 3:30 PM PST in Rancho Palos Verdes, CA, featuring a fireside chat with analyst Trung Huynh. Additionally, they will attend the Jefferies London Healthcare Conference on November 19 at 9:00 AM GMT in London, with analyst Michael Yee. Both events will include 1x1 meetings and webcasts accessible through ALX Oncology's website, with replays available for up to 90 days.
ALX Oncology (Nasdaq: ALXO) announced that results from their Phase 1b/2 trial combining evorpacept with zanidatamab in HER2-positive and HER2-low metastatic breast cancer will be presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. The presentation will showcase data from their two-part, open-label, multicenter study (NCT05027139) evaluating evorpacept, a CD47 blocker, combined with zanidatamab, a dual HER2-targeted bispecific antibody. Dr. Alberto J. Montero from University Hospitals Seidman Cancer Center will present the findings on December 12, 2024.
ALX Oncology Holdings (Nasdaq: ALXO), an immuno-oncology company focusing on CD47 immune checkpoint pathway therapies, has announced its participation in the 2024 Cantor Fitzgerald Global Healthcare Conference. The event will take place in New York City from September 17-19, 2024.
Key details of ALX Oncology's participation include:
- A fireside chat with analyst Li Watsek on Tuesday, September 17, 2024, at 1:55 PM ET
- One-on-one meetings with investors
- A live webcast of the fireside chat accessible through the company's website
- Archived replay available for up to 90 days after the event
This conference provides ALX Oncology an opportunity to showcase its progress and engage with the investment community.
ALX Oncology (Nasdaq: ALXO) has announced the dosing of first patients in a randomized Phase 1/2 UMBRELLA study, evaluating evorpacept in combination with Sanofi's SARCLISA® (isatuximab-irfc) for relapsed or refractory multiple myeloma (RRMM). Evorpacept is ALX Oncology's investigational CD47-blocking therapeutic, while SARCLISA is Sanofi's approved CD38 monoclonal antibody.
The study aims to assess the safety, efficacy, pharmacokinetics, and biomarker data of this combination. Part 1 will evaluate dosing, while Part 2 will investigate efficacy and safety in an expanded RRMM patient population. This collaboration leverages the potential synergy between evorpacept and SARCLISA, as CD47 expression increases with multiple myeloma progression, potentially re-sensitizing tumors to CD38 treatment.
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.