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ALX Oncology Presents New Data from Fully Enrolled ALX148 Clinical Trial Combination Cohorts for the Treatment of Patients with Advanced Solid Tumors.

M2 PHARMA-June 3, 2019-ALX Oncology Presents New Data from Fully Enrolled ALX148 Clinical Trial Combination Cohorts for the Treatment of Patients with Advanced Solid Tumors

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- Irish clinical-stage immuno-oncology company ALX Oncology has presented new results from its Phase 1 ALX148 solid tumor program at the 2019 ASCO annual meeting, the company said.

As of April 18, 2019, eighty-two patients with various advanced malignancies were administered ALX148 in combination with standard regimens of either trastuzumab or pembrolizumab.

Objective responses were observed in expansion cohorts for both gastric/gastroesophageal junction cancer (G/GEJ) and squamous cell carcinoma of the head and neck (HNSCC). Key results are:

In response-evaluable patients with HER2 positive G/GEJ whose tumors had failed prior HER2-targeted therapy, an overall response rate of 22% and a disease control rate of 28% were observed.

In patients with HNSCC whose tumors had failed prior platinum therapy, an ORR of 16% and a DCR of 26% were observed. In checkpoint naive subjects, an ORR of 30% and a DCR of 30% were observed.

ALX148 was well tolerated and the most common treatment-related adverse event in combination with trastuzumab was grade 1/2 fatigue, and with pembrolizumab was grade 1/2 increased AST.

Preliminary data from paired pre- and on-study tumor biopsies from combination cohorts showed a statistically significant increase in intra-tumoral macrophages following ALX148 treatment, consistent with ALX148's mechanism of action as a myeloid checkpoint inhibitor.

ALX148, designed for combination therapy, is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRP? linked to an inactive Fc region of human immunoglobulin.

ALX148 potently and specifically binds CD47 and blocks its interaction with SIRP?, thus inhibiting a key immune checkpoint mechanism exploited by cancer cells.

In preclinical studies, ALX148 bridges innate and adaptive immunity to maximize anti-tumor response in combinations with targeted anti-cancer antibodies and checkpoint inhibitors via Fc-dependent and Fc-independent mechanisms. No adverse effects on CD47-expressing normal blood cells were seen in ALX148 preclinical studies.

The ALX148 Phase 1 clinical trial is a two-part study that evaluates the safety, pharmacokinetics, and pharmacodynamics of ALX148.

Enrollment to the combination therapy portion in which ALX148 is administered with approved anti-cancer antibodies is ongoing.

ALX Oncology is a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint mechanism, which is exploited by cancer cells to evade the immune system.

Its lead candidate, ALX148, is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRP? linked to an inactive Fc region of human immunoglobulin.

ALX148 is designed to maximize the clinical benefit of antibody-based therapies and is in clinical development for a broad range of tumor types.

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Publication:M2 Pharma
Date:Jun 3, 2019
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