MEM-288

P1, N=40, Recruiting, Memgen, Inc. | N=61 --> 40 | Trial completion date: Nov 2026 --> Dec 2031 | Trial primary completion date: Nov 2025 --> Feb 2027

The tumor microenvironment had a higher proportion of anti-tumor macrophages and decreased markers of angiogenesis. MEM-288 is a promising immunotherapy agent in HGSOC, with further pre-clinical studies required to understand the mechanism of action in the peritoneal microenvironment and clinical activity in combination with other therapies.

P1, N=61, Recruiting, Memgen, Inc.

P1, N=61, Recruiting, Memgen, Inc. | N=18 --> 61

05), and subsequently developed a partial response (7 months) to carboplatin/etoposide rechallenge. Although no RECIST responses were yet met, tumor shrinkage associated with an immune-active TME in the injected tumors, systemic immune response activation, and strong benefit to chemotherapy rechallenge and long-term disease control. These proof-of-concept results guided the design of an expansion study of MEM-288 with nivolumab for second-line treatment of metastatic NSCLC refractory to anti-PD(L)1 ± chemotherapy.

Of note, a pt with strong stimulation of tumor and systemic T cell immunity after MEM-288 had subsequent CR (ongoing > 7 months) to docetaxel + ramucirumab following prior treatment failure with platinum doublet + ICI received before MEM-288. Preliminary safety, antitumor and immune response data are encouraging. Updated results and immune data from this study will be presented. An expansion arm is planned with combination MEM-288 and anti-PD1 antibody in pts with advanced NSCLC refractory to ICI.

An oncolytic adenovirus (MEM-288) expressing MEM40+IFNβ in phase 1 clinical testing induced cancer cell loss concomitant with enhanced T-cell infiltration and increased systemic presence of tumor T-cell clonotypes in NSCLC patients. This approach to simultaneously target two major DC-activating pathways has potential to significantly impact the solid tumor immunotherapy landscape.

Following completion of the monotherapy study, an expansion arm is planned where MEM-288 will be combined with anti-PD1 antibody in patients with advanced NSCLC refractory to ICI. Ethics Approval The studies described received IRB approval (Moffitt: Adverra IRB, # Pro00060205, Duke: DUHS IRB, #Pro00109517) prior to commencement, and in the clinical trial described all participants gave informed consent before taking part.

MEM-288 has potent anti-tumor activity in an immune competent ovarian cancer mouse model, likely through recruitment of cytotoxic T-cells and promotion of a systemic anti-tumor T-cell response.

MEM-288 drives MEM40 + IFNβ expression in freshly resected human lung tumors and generates potent anti-tumor responses as a monotherapy and in combination with immune checkpoint inhibitors. Furthermore, MEM-288 induced enhancement of tumor-reactive TILs and provides a rationale for studies to determine whether MEM-288 pre-treatment generates a superior TIL product for more effective adoptive T cell therapy.

P1, N=18, Recruiting, Memgen, Inc. | Not yet recruiting --> Recruiting | Initiation date: Nov 2021 --> Feb 2022

P1, N=18, Not yet recruiting, Memgen, Inc.