ALX Oncology Holdings Inc. is making strides in the development of evorpacept, a CD47 checkpoint inhibitor, as highlighted in its recent Form 10-Q report. The company is currently evaluating evorpacept in multiple Phase 1 and 2 clinical trials across various cancer types, demonstrating promising results and strategic advancements.
Financial Overview
For the quarter ended September 30, 2023, ALX Oncology reported a net loss of $30.7 million, a 40% decrease compared to the $51.0 million loss in the same period of 2022. Research and development expenses also decreased by 42%, from $45.8 million to $26.5 million. These financial improvements reflect the company's focus on efficient capital management while advancing its clinical programs.
Clinical Trial Updates
Evorpacept is being investigated in combination with various anti-cancer agents, including antibodies, antibody-drug conjugates (ADCs), and PD-1/PD-L1 inhibitors. Key trial updates include:
- ASPEN-06 (HER2-positive Gastric/GEJ Cancer): The Phase 2 trial evaluating evorpacept with trastuzumab, ramucirumab, and paclitaxel showed a confirmed overall response rate (ORR) of 40.3%, compared to 26.6% in the control arm. The median duration of response was 15.7 months.
- ASPEN-07 (Urothelial Cancer): Interim Phase 1 data for evorpacept combined with enfortumab vedotin-ejfv (EV) demonstrated an unconfirmed ORR of 61%, including two confirmed complete responses and six confirmed partial responses.
- ASPEN-03 and ASPEN-04 (Head and Neck Squamous Cell Carcinoma): These trials are assessing evorpacept in combination with pembrolizumab as a first-line treatment for advanced PD-L1 positive HNSCC. The FDA has granted Fast Track designation for these combinations, expediting their potential development.
Strategic Collaborations and Expansions
ALX Oncology is actively pursuing collaborations to broaden the application of evorpacept. These collaborations include partnerships with Jazz Pharmaceuticals, Quantum Leap Healthcare Collaborative, MD Anderson Cancer Center, and Sanofi, exploring evorpacept in breast cancer, non-Hodgkin lymphoma, multiple myeloma, colorectal cancer, ovarian cancer, and oropharyngeal cancer.
Furthermore, the company's acquisition of ScalmiBio has enabled the development of ADC drug candidates, with a development candidate already declared in January 2024.
ALTA-002 Program
In collaboration with Tallac Therapeutics, ALX Oncology is developing ALTA-002, a combination of a SIRPα antibody with a toll-like receptor 9 (TLR9) agonist. The FDA cleared the IND for ALTA-002 in March 2024, allowing the initiation of a Phase 1 clinical trial for advanced solid tumors.
Future Directions
ALX Oncology plans to continue advancing evorpacept through clinical trials and is exploring additional strategic partnerships and acquisitions to enhance its research and development capabilities. The company anticipates that its existing capital resources will be sufficient to fund projected operating requirements for at least the next twelve months. However, they also plan to raise additional capital through equity offerings, debt financings, and strategic alliances to support these initiatives.
