Press Release

Alexo Therapeutics Announces Initiation of Phase 1 Clinical Trial of ALX148 for the Treatment of Advanced Solid Tumors and Lymphoma

DUBLIN, Ireland and SOUTH SAN FRANCISCO, Calif. – April 10, 2017 – Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint exploited by cancer cells to evade the immune system, today announced that it has initiated dosing in its Phase 1 clinical program evaluating the safety of ALX148 in patients with advanced solid tumors and lymphoma.

“The initiation of our first clinical trial for ALX148 marks an important milestone in the Company’s development,” said Jaume Pons, Ph.D., President and Chief Executive Officer of Alexo. “Targeting CD47-SIRPα has broad therapeutic potential across many types of cancer. ALX148 is designed to enhance the efficacy of antibody-based therapies and has demonstrated excellent efficacy and safety in preclinical studies. We are eager to evaluate its clinical profile in this first-in-patient study. We believe that Alexo’s approach of targeting the CD47 pathway using ALX148 will selectively eliminate tumor cells while avoiding the dose-limiting toxicities that have been seen with other CD47-targeted approaches in the clinic.”

The Phase 1 clinical trial is a two-part study that will evaluate the safety, pharmacokinetics, and pharmacodynamics of the engineered fusion protein, ALX148. The study will begin with an ALX148 single-agent dose escalation portion followed by a combination therapy portion in which ALX148 will be administered with approved anti-cancer antibodies. The study will enroll patients with advanced/metastatic solid tumors and relapsed or refractory non-Hodgkin lymphoma. For more information, please visit clinicaltrials.gov, identifier number NCT03013218.

About ALX148

ALX148 is a fusion protein that comprises an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 potently and selectively binds CD47, blocking its interaction with SIRPĪ±, thereby inhibiting a key immune checkpoint mechanism exploited by cancer cells. In preclinical studies, ALX148 has demonstrated significant inhibition of tumor growth in combination with targeted anti-cancer antibodies and checkpoint inhibitors with no adverse effect on CD47-expressing normal blood cells.

About Alexo Therapeutics

Alexo Therapeutics is a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint mechanism exploited by cancer cells to evade the immune system. Our lead candidate, ALX148, is a fusion protein that comprises an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 is designed to enhance the efficacy of antibody-based therapies and is in clinical development for a broad range of tumor types.

Contacts

Karen Sharma or Casey R. Doucette, Ph.D.
MacDougall Biomedical Communications
(781) 235-3060