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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 (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.
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.
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