On September 25, 2015 MedImmune, the global biologics research and development arm of AstraZeneca, and 3M Drug Delivery Systems, reported a research collaboration focused on developing next generation toll-like receptor (TLR) agonists – promising agents that activate innate immune cells and enhance the visibility of cancer tumors (Press release, MedImmune, SEP 25, 2015, View Source [SID:1234509410]).

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As part of the agreement, MedImmune has in-licensed from 3M MEDI9197 (formerly 3M-052), a novel TLR 7/8 dual agonist. The U.S. Food and Drug Administration recently accepted an investigational new drug application (IND) for a Phase I study to explore the safety and tolerability of MEDI9197 as a potential treatment for patients with solid tumors.

TLR agonists are promising agents that activate antigen presenting cells such as dendritic cells, enhancing the visibility of a tumor to the immune system. MEDI9197 has been designed to activate a broad range of innate immune cells through targeting of both TLR 7 and 8, leading to a more robust adaptive immune response. A TLR7 and 8 dual agonist can additionally convert immune suppressive cells in the tumor to those with anti-tumor properties, allowing the generation of an effective anti-tumor response. MEDI9197 will also be the first dual TLR7and 8 agonist administered directly into a tumor in a clinical setting.

Preclinical studies demonstrate that intratumoral dosing of MEDI9197 may inhibit tumor growth of both the injected and distant lesions in multiple types of cancer, including melanoma. MEDI9197 is uniquely designed for intratumoral injection, allowing the compound to be retained in the tumor and provide specific immune activation, enhancing its safety and tolerability profile.

Yong-Jun Liu, MD, PhD, Senior Vice President, R&D and Head of Research, MedImmune, said: "We’re pleased to collaborate with 3M Drug Delivery Systems to explore TLR agonists as monotherapy and in combination with our internal immuno-oncology portfolio. By targeting tumor antigen presentation, MEDI9197 adds a unique mechanism of immune activation to our growing portfolio and supports our strategy of maximizing anti-tumor immunity through scientifically rational combinations."

Cindy Kent, President and General Manager, 3M Drug Delivery Systems, said: "Everyone here at 3M’s Drug Delivery Systems is very excited to collaborate with MedImmune, a world leader in cancer immunotherapy. Our companies continue to work well together on this groundbreaking program and we’re very pleased with the progression of MEDI9197 into the clinic. The acceptance of the IND marks an important step in exploring this unique TLR 7/8 agonist intratumoral immunotherapy approach in patients with solid tumors."

Under the agreement, MedImmune is responsible for the clinical development and strategy for MEDI9197. 3M will continue to develop additional TLR agonists in oncology and other therapy areas, with MedImmune holding exclusive rights to conduct research on new molecules resulting from the collaboration and to determine which to progress to clinical development. The terms of the agreement include an upfront payment and development-related milestone payments for MEDI9197 in addition to research funding paid by MedImmune to 3M. 3M retains the rights to 3M-052 in certain topical applications and use in vaccine admixtures.

Immuno-oncology is a promising therapeutic approach that harnesses the patient’s own immune system to help fight cancer. The agreement with 3M supports AstraZeneca’s strategy of developing novel combinations that target multiple mechanisms in the immune system where cancer wages its battles – T-cell activation, antigen presentation and innate immunity, and the tumor microenvironment.