On November 3, 2021 Memgen, Inc. reported that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for MEM-288, the company’s wholly-owned cancer immunotherapy candidate for the treatment of multiple solid tumors (Press release, Memgen, NOV 3, 2021, View Source [SID1234594268]). Memgen intends to initiate screening of patients by year-end in a Phase 1 first-in-human study.

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"The FDA’s acceptance of our IND for MEM-288 is an important milestone in our pursuit of developing life-saving cancer immunotherapies in collaboration with leading cancer centers including the Moffitt Cancer Center and the Duke Cancer Institute," said Mark Cantwell, Ph.D., Chief Scientific Officer of Memgen. "We expect to initiate this first-in-human study in patients with non-small cell lung cancer, as well as those with other types of cancer, by year-end."

Memgen’s Phase 1 trial is an open-label, dose escalation study designed to evaluate the safety, tolerability, biologic activity and anti-tumor effects of MEM-288. In addition to non-small cell lung cancer (NSCLC), the trial may enroll patients with triple-negative breast cancer, pancreatic cancer, head and neck cancer, melanoma, cutaneous squamous-cell carcinoma, and Merkel cell carcinoma. Except for patients with pancreatic cancer, these are patients whose disease has progressed following treatment with anti-PD-1/PD-L1 therapy, and who have tumor lesions accessible for injection.

Duke Cancer Institute and the H. Lee Moffitt Cancer will be the initial clinical trial sites. Memgen expects patient recruitment to begin by December 31, 2021. Additional information about the study, including patient inclusion and exclusion criteria, can be found at ClinicalTrials.gov under study identifier NCT05076760.

The study will evaluate the oncolytic effect of MEM-288 as well as the activation of the patients’ immune system including T-cells. While the focus of the initial Phase 1 study will be patients with NSCLC, MEM-288 has shown robust anti-tumor effects in 13 different types of cancer. Once safety and tolerability have been evaluated in this trial, Memgen plans to expand clinical development of MEM-288 across multiple cancers and in combination with an immune checkpoint inhibitor.

About MEM-288
MEM-288 is an oncolytic adenovirus encoding transgenes for human interferon beta (IFNß) and the company’s proprietary recombinant chimeric CD40 ligand. MEM-288, armed with Memgen’s proprietary CD40 ligand, leverages a validated target that powerfully activates the patient’s immune system. The company’s proprietary CD40 ligand has been evaluated in earlier clinical studies and demonstrated significant immune activation without the toxicity that had previously prevented development of safe CD40-based therapeutics. Because the CD40 system works as a master "on switch" for the immune system upstream from the immune checkpoint inhibitors, it holds promise in those patients whose disease has progressed despite treatment with immune checkpoint inhibitors.