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ALX Oncology Holdings Inc. reports company news around a clinical-stage oncology pipeline led by evorpacept, an investigational CD47 inhibitor designed to address a cancer immune-evasion signal. Updates commonly cover clinical data presentations, biomarker analyses involving CD47 expression, and studies of evorpacept combinations in HER2-positive cancers, including breast and gastric cancer settings.
The company also reports development activity for ALX2004, an EGFR-targeted antibody-drug conjugate for EGFR-expressing solid tumors. Other recurring updates include quarterly financial results, research and development spending, cash runway commentary, registered offerings of common stock and pre-funded warrants, leadership appointments, investor conference participation, and Nasdaq inducement equity grants.
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.
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.