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 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.
ALX Oncology has acquired ScalmiBio to enhance its oncology pipeline with novel drug candidates utilizing ScalmiBio's proprietary SHIELD platform for antibody activation in tumors. The acquisition aims to develop targeted therapies, addressing unmet cancer needs alongside ALX's lead candidate, evorpacept. The deal includes an initial payment of approximately $4.5 million and potential future milestone payments based on the clinical development of ScalmiBio's technology, which is designed to improve the safety and efficacy of anti-cancer treatments.
Zymeworks Inc. (NYSE: ZYME) and ALX Oncology Holdings Inc. (NASDAQ: ALXO) have initiated a Phase 1b/2 clinical trial, dosing the first patient to assess the safety and efficacy of zanidatamab combined with evorpacept for advanced HER2-positive breast and solid tumors. This combination aims to improve immune clearance of cancer cells. Zanidatamab, a bispecific antibody, is designed to target HER2, while evorpacept blocks the CD47 pathway, potentially enhancing therapeutic effects. This collaboration follows promising results from prior studies involving evorpacept in gastric cancers.
ALX Oncology Holdings Inc. has announced the acceptance of four abstracts for the SITC 36th Annual Meeting in Washington D.C. from November 10-14, 2021. These presentations will feature new clinical data from the ASPEN-01 Phase 1b study of evorpacept (ALX148) in head and neck squamous cell carcinoma and gastric/gastroesophageal cancer. Additionally, updates on ASPEN-03 and ASPEN-04 Phase 2 studies in collaboration with Merck will be presented. Preclinical data on ALTA-002, a novel SIRPα-directed TLR9 agonist antibody conjugate, will also be showcased.
ALX Oncology initiated a Phase 1/2 study of evorpacept (ALX148) at The University of Texas M.D. Anderson Cancer Center for treating non-Hodgkin lymphoma (NHL). This trial combines evorpacept with rituximab and lenalidomide to enhance efficacy and maintain tolerability. With NHL being a challenging cancer, this combination aims to provide more therapeutic options for patients. Approximately 500,000 NHL cases are diagnosed globally each year, highlighting the urgent need for innovative treatments.
Lightstone Ventures has successfully closed its third fund, raising $375 million to invest in early-stage biotech and medtech companies. The fund was oversubscribed, indicating strong interest from both new and existing investors. The firm has appointed Christina Isacson and Young Kwon as Partner and Operating Partner, respectively, enhancing its leadership team. Since 2012, Lightstone has invested in over 30 companies, including AlX Oncology (NASDAQ: ALXO), Cyteir Therapeutics (NASDAQ: CYT), and Gemini Therapeutics (NASDAQ: GMTX), aiming to transform innovative ideas into impactful therapies.
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