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 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.
ALX Oncology Holdings Inc. (Nasdaq: ALXO), a clinical-stage immuno-oncology company, announced participation in two upcoming virtual investor conferences. Jaume Pons, Ph.D., CEO, will engage in fireside chats at:
- H.C. Wainwright 23rd Annual Global Investment Conference on September 13 at 7:00 AM ET
- Cantor Virtual Global Healthcare Conference on September 28 at 11:50 AM ET
ALX Oncology Holdings reported its Q2 2021 financial results, revealing a net loss of $16.3 million, or $0.40 per share, compared to a loss of $14.0 million last year. Cash and equivalents were $410 million, sufficient to fund operations through 2024. Key developments include the approval of 'evorpacept' as the generic name for ALX148 and initiation of several clinical trials, including ASPEN-04 and ASPEN-03. A collaboration with Eli Lilly was also established to evaluate evorpacept with CYRAMZA for HER2-positive G/GEJ cancer.
ALX Oncology Holdings Inc. has initiated the second Phase 2 trial, ASPEN-04, in collaboration with Merck, focusing on the combination of ALX148, KEYTRUDA, and standard chemotherapy for advanced head and neck squamous cell carcinoma (HNSCC). The study includes treatment-naive patients regardless of PD-L1 expression. The trial builds on promising results from the earlier ASPEN-01 study, which led to FDA Fast Track designation for ALX148 in HNSCC.
ALX Oncology has reported promising results from its ongoing ASPEN-01 trial, demonstrating a confirmed objective response rate (ORR) of 72% in patients with >2L HER2 positive gastric or gastroesophageal junction cancer. The estimates indicate an overall survival (OS) rate of 76% at 12 months, significantly outperforming historical controls. The combination therapy of ALX148 with trastuzumab and chemotherapy shows strong tolerability, with no maximum tolerated dose reached during the study. A conference call is scheduled for July 6, 2021 to discuss these findings further.