The Janssen Pharmaceutical Companies of Johnson & Johnson had itself a very busy day yesterday, with two of its sister companies involved in three research and drug development collaborations announced by partner companies.
Janssen Biotech won an exclusive option to develop Effimune’s drug candidate FR104, a monoclonal antibody fragment in preclinical development for immune-mediated disorders. In return, Janssen will make payments to Effimune tied to undisclosed milestones as well as prespecified royalty payments on worldwide net sales upon commercialization of FR104. The amount of Janssen’s potential payments was not disclosed.
FR104, a pegylated Fab monoclonal antibody fragment inhibitor of CD28, is designed to promote immune tolerance by blocking CD28 signaling within the T-cell signaling pathway, thus preventing the functioning of effector T cells but not regulatory T cells. FR104 is the subject of numerous ongoing preclinical studies across autoimmune disease models that include models of rheumatoid arthritis, multiple sclerosis, and psoriasis. FR104 is also being studied in kidney transplantation models.
“FR104 opens a new avenue in the treatment of autoimmune diseases and of transplanted patients, by promoting immune tolerance,” Bernard Vanhove, senior scientific advisor at Effimune and co-inventor of FR104, said in a statement.
Janssen Pharmaceuticals agreed separately to use DCPrime’s DCOne™ technology platform in feasibility studies to develop a dendritic cell-based vaccine. Under a research and optional license agreement signed by the companies, Janssen will have the option to further develop a candidate therapeutic towardregulatory approval. Financial terms of the agreement were not disclosed.
The Effimune and DCPrime agreements were facilitated through the London Innovation Center of Johnson & Johnson Innovation, one of three such centers J&J established this year, with a fourth set to open by year’s end in Shanghai. The London center is J&J’s outpost for identifying and catalyzing early-stage innovation across the United Kingdom and Europe by building relationships with the academic institutions, biotech organizations, and venture capital firms.
In the third agreement, Janssen Pharmaceuticals’ entity Crucell Holland inked a collaboration and licensing agreement with CureVac for the development of an influenza vaccine using CureVac's RNActive® technology platform. CureVac agreed to develop optimized RNActive-based messenger RNA (mRNA) vaccines based on Crucell's proprietary antigen sequences which will be tested in various models.
Financial terms of the collaboration were not disclosed, though CureVac said the collaboration will build on CureVac's preclinical influenza studies, published in Nature Biotechnology in December 2012.
CureVac uses its RNActive tech platform to develop mRNA vaccines for cancer and prophylactic vaccines for infectious diseases. RNActive-based vaccines consist of modified and formulated mRNA translated into target antigens, with the goals of ensuring strong antigen expression, increased stability, and enhanced immune-stimulatory activity. According to CureVac, RNActive allows faster generation of vaccines than conventional methods.
Vaccines based on RNActive have demonstrated effectiveness and safety in several clinical trials. CureVac is currently running a number of clinical trials with its RNActive based vaccines, including a large randomized Phase IIb clinical trial in prostate cancer. The company has successfully completed Phase I/IIa studies with its RNActive cancer vaccines in prostate cancer and non-small cell lung cancer. Results so far have shown that mRNA-based products were safe and capable of inducing balanced immune responses including humoral and cellular, Th1 and Th2 and effector and memory responses.