Clinical Trials

Date: 2016-05-12

Type of information: Initiation of the trial

phase:

Announcement:

Company: Aduro Biotech (USA - CA) Novartis (Switzerland)

Product: ADU-S100 (also known as MIW815)

Action mechanism:

• immunomodulating agent/dinucleotide. Cyclic dinucleotides (CDNs) are small molecules – naturally expressed by bacteria and immune cells – that are known to activate the STING (Stimulator of Interferon Genes) signaling pathway in immune cells. STING is known to be a central mediator of innate immune response and, when stimulated, induces the expression of various interferons, cytokines and T cell recruitment factors that amplify and strengthen immune activity. Aduro’s proprietary CDN product candidates are synthetic small molecule immune modulators that are designed to target and activate the STING receptor. Once activated, the STING receptor initiates an innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of an effective tumor antigen-specific T cell adaptive immune response. ADU-S100 is a novel synthetic CDN-based molecule that was developed based on its ability to stimulate human immune cells from a large pool of human donors that comprised all of the known STING receptors. In preclinical mouse tumor models, the data showed that direct intratumoral injection of ADU-S100 into melanoma, colon and breast tumors profoundly inhibited tumor growth both locally and systemically, with a durable response that provided protection against tumor regrowth and significantly inhibited growth of distal tumors. In addition, Aduro believes the immune-mediated destruction of distal tumors could be significantly enhanced by a combination of ADU-S100 and radiotherapy, a combination that may eventually be tested in human clinical trials.
• In March 2015 , Aduro entered into a collaboration with Novartis for the worldwide research, development and commercialization of novel immuno-oncology products derived from Aduro's STING pathway activator platform.

Disease: solid tumors, lymphoma

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

• The Phase 1, multicenter, dose escalation study, which includes dose expansion into designated indications, will enroll patients with cutaneously accessible metastatic solid tumors or lymphomas who are in need of other treatment alternatives. The trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ADU-S100 (MIW815). (NCT02675439)

Latest news:

• • On May 12, 2016, Aduro Biotech announced that the first patient has been dosed in a Phase 1 trial for ADU-S100 (also known as MIW815), a novel STING (Stimulator of Interferon Genes) pathway activator. Novartis , Aduro's collaborator for STING pathway activator compounds in the field of oncology, is conducting the study. The achievement of this milestone triggers a $35 million milestone payment from Novartis to Aduro.

 

Is general: Yes