ALX Oncology Announces First Patient Dosed in ASPEN-07, a Phase 1 Study of Evorpacept for the Treatment of Patients with Urothelial Cancer
ALX Oncology Holdings (Nasdaq: ALXO) announced the dosing of the first patient in the ASPEN-07 study, evaluating evorpacept, a novel CD47 blocker, in combination with PADCEV (enfortumab vedotin-ejfv) for urothelial cancer (UC). This Phase 1, open-label study aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with unresectable advanced UC (NCT05524545). Given the poor outcomes and limited treatments available post-chemotherapy for this patient group, the study seeks to investigate a new therapy that may enhance efficacy without increasing toxicity.
- Initiation of ASPEN-07 study signals potential advancement in treatment options for advanced urothelial cancer.
- Evorpacept's combination with PADCEV may improve clinical outcomes for patients unable to tolerate current therapies.
- None.
SOUTH SAN FRANCISCO, Calif., Feb. 16, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the first patient has been dosed in the ASPEN-07 study evaluating evorpacept, a next generation CD47 blocker, in combination with PADCEV® (enfortumab vedotin-ejfv), an antibody drug conjugate (“ADC”), in patients with urothelial cancer (“UC”).
ASPEN-07 is a phase 1, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of evorpacept in combination with enfortumab vedotin-ejfv in subjects with unresectable locally advanced or metastatic UC (NCT05524545).
“Outcomes for patients diagnosed with locally advanced or metastatic UC remain poor, and treatment options after initial chemotherapy and immunotherapy are limited," said Sophia Randolph, M.D., Ph.D., ALX Oncology’s Chief Medical Officer. "We are excited to initiate ASPEN-07 to investigate this novel combination therapy that has the potential to change the treatment course of advanced UC. We are encouraged that PADCEV is the first ADC therapy to demonstrate meaningful clinical activity in these difficult-to-treat patients, and the addition of a CD47 blocker is expected to act through different but complementary mechanisms to positively impact efficacy without increasing toxicity.”
About Bladder and Urothelial Cancer
As estimated by the National Cancer Institute, bladder cancer is the sixth most common cancer type in the United States. Urothelial cancer is the most common type of bladder cancer and accounts for approximately
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology’s lead product candidate, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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