Memgen, Inc. has dosed the first patient in its Phase 1 combination cohort evaluating intratumoral MEM-288 plus standard-of-care docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC). The milestone represents a significant step forward for the clinical-stage biotechnology company's lead oncolytic immunotherapy program.
The combination approach addresses a critical gap in NSCLC treatment, where docetaxel remains a backbone therapy in the second-line setting despite disappointing outcomes. According to Mark Cantwell, Ph.D., Chief Scientific Officer at Memgen, median overall survival with current standard of care is typically less than one year.
Clinical Trial Design and Patient Population
Part 1C of Memgen's Phase 1 program is an open-label cohort specifically designed for adults with advanced or metastatic NSCLC whose disease has progressed after first-line immune checkpoint inhibitor therapy. The trial will evaluate safety and tolerability through adverse event monitoring, while also assessing preliminary antitumor activity including objective response rate, disease control rate, progression-free survival, and overall survival.
The study incorporates exploratory biomarker analyses and aims to establish the recommended Phase 2 dose. Results will inform a planned randomized Phase 2 trial of MEM-288 plus docetaxel, conducted in collaboration with Moffitt Cancer Center.
MEM-288 Mechanism and Previous Clinical Experience
MEM-288 is an investigational oncolytic immunotherapy engineered to prime dendritic cells, activate effector T cells, and inflame the tumor microenvironment—conditions that promote immunogenic tumor cell lysis. The therapy's design supports combination with multiple therapeutic classes, including standard chemotherapies, antibody-drug conjugates (ADCs), and immune checkpoint inhibitors.
In earlier clinical experience, MEM-288 demonstrated clinically meaningful tumor reductions in patients with advanced NSCLC refractory to standard therapies. Notably, multiple patients experienced durable responses to subsequent chemotherapy rechallenge after receiving MEM-288, providing the biological rationale for evaluating MEM-288 with chemotherapy in the current cohort.
Disease Burden and Unmet Medical Need
NSCLC represents a substantial clinical challenge, with an estimated 226,650 people in the United States expected to be diagnosed with lung cancer in 2025. NSCLC accounts for approximately 87% of lung cancer cases, and lung cancer remains the leading cause of cancer death in the U.S., responsible for about one in five cancer deaths annually.
Andreas Saltos, M.D., principal investigator of the study and associate member of the Thoracic Oncology Department at Moffitt Cancer Center, emphasized the significance of the trial for patients with very limited treatment options. The collaboration between Memgen and Moffitt includes translational research by Dr. Amer Beg, a senior member in Immunology at Moffitt Cancer Center, highlighting MEM-288's potential as a potent cancer immunotherapy.
Strategic Development Approach
The combination strategy reflects Memgen's broader development approach for MEM-288, which is being evaluated across multiple settings and combinations to improve outcomes in difficult-to-treat cancers with high unmet medical need. The company's focus on next-generation oncolytic immunotherapy positions MEM-288 as a potential solution for patients facing significant treatment challenges in solid tumor oncology.
