Roche headlines autism alliance

Posted under autism, Blog, clinical trial, Companies, Diagnostics, Eli Lilly, Fragile X, Funding, Janssen, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Roche, Servier, Startups, Universities, Videos by Mark Hollmer

A European research effort led by Roche ($RHHBY) and others to tackle autism spectrum disorders nailed down $38.7 million in financing for what will be a massive, 5-year project seeking to come up with new diagnostic and treatment options.

According to Genetic Engineering News, Eli Lilly ($LLY), Servier, Janssen Pharmaceutica and Pfizer ($PFE) are among other bio and pharma partners in the substantial collaboration. But Roche is leading the drug-company side of things. King's College London in the U.K. and the non-profit organization Autism Speak are the other head partners. Add in about 14 additional "scientific centers," and you have lots of parties working on autism research.

Roche's involvement is interesting because it has a relatively targeted focus on Alzheimer's. The Swiss drugmaker launched a Phase II study two years ago of a drug to treat Fragile X syndrome, a rare genetic condition thought to be among the most common causes of autism. But the company has more drugs in the pipeline, by comparison, for neurological diseases such as Alzheimer's and schizophrenia, according to its web site.

The collaboration will focus on developing and testing new autism treatments, according to the story. But the consortium also plans to pick and launch multiple autism clinical trial sites throughout Europe, pursue a number of lab and animal tests and identify genetic or proteomic biomarkers to aid in more precise diagnoses and treatments. They face the challenging reality, however, that autism remains hard both to diagnose and to successfully treat.

This massive partnership even has a name: European Autism Interventions--A Multicenter Study for Developing New Medicines, or EU--AIMS, for short. The European Union's Seventh Framework Program, Autism Speaks and the members of the European Federation of Pharmaceutical Industries and Association funded the program, according to the story.

- here's the Genetic Engineering News story
- read the release

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MacroGenics pockets $20M in $450M deal with Servier

Posted under Blog, Cancer, Companies, companion diagnostics, Diagnostics, Funding, MacroGenics, Medical Devices, Medical Supply, Pharmaceuticals, Servier, Startups, Universities, Videos by Ryan McBride

Taking another step forward after the failure of a late-stage trial of its lead drug last year, MacroGenics has bagged a pharma deal to fuel development of an immune-stimulating antibody against cancer. Servier, France's second-largest drugmaker, has ponied up $20 million upfront in the deal that gives it an option to develop and commercialize the drug, dubbed MGA271, for the European market.

Rockville, MD-based MacroGenics is testing the antibody drug in a Phase I trial in patients with solid tumors. The drug is intended to target the B7-H3 immune receptor, which is overexpressed in a wide variety of malignancies such as non-small cell lung, prostate and colorectal cancers. The developer is using a companion diagnostic in the trial to screen patients for the B7-H3 receptor, the company said.

The pact with Servier gives the French drugmaker the option to license the antibody after Phase I testing, at which point payments tied to the deal would total $60 million for MacroGenics. MacroGenics could reap up to an additional $390 million in payments if other development and commercial goals are reached, and the deal enables the company to hold on to rights to the drug in North America, Japan, India and Korea, according to a press release. Servier gets rights to the drug in Europe and the rest of the world. 

This is the third pharma pact that MacroGenics has revealed since the loud failure of a Phase III trial in October 2010 of its antibody drug partnered with Eli Lilly ($LLY) for treating Type 1 diabetes. The venture-backed developer has regrouped with the tie-ups with Pfizer ($PFE), Boehringer Ingelheim and now Servier, with the former pair tapping MacroGenics for its proprietary Dual-Affinity Re-Targeting platform (DART) to identify antibody drugs.

MacroGenics CEO Dr. Scott Koenig stated that the Servier deal "will significantly broaden and accelerate our clinical plans for MGA271, enabling us to further investigate the multiple solid tumor types for which MGA271 may have activity."

- here's the release

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