Signaling the pathway to antibody development

NovImmune enters into exclusive antibody licensing agreement with Genentech

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PLAN-LES-OUATES, Switzerland—NovImmune, an antibody-focused research and development biotech company, announced in late July that it inked an exclusive licensing agreement with Genentech Inc., a member of the Roche Group, for a proprietary anti-IL-17 fully human monoclonal antibody, and access to back-up antibodies.

Under the terms of the agreement, NovImmune will receive an upfront payment and is eligible to receive additional payments for clinical milestones and royalties on sales.
Neither side of the deal was willing to offer more specific comment on the details of the financial arrangements.

Recently, the IL-17 signaling pathway has received significant academic and corporate interest, as its manipulation may potentially provide new treatment opportunities for major medical conditions. Therapies developed could help address autoimmune diseases such as rheumatoid arthritis.

James Sabry, vice president of Genentech Partnering, said in a prepared statement that  "Genentech is very pleased to have the opportunity to work with NovImmune on the development and potential commercialization of this anti-IL-17 antibody. We are hopeful that it has the potential to benefit patients across a range of autoimmune diseases."

The anti-IL-17 antibody was generated by NovImmune's research team and is currently in late preclinical development. The company says inking a deal with one of the world's leading biotechs means it is a force to be reckoned with regarding its in-house aptitude in development of novel monoclonal antibodies.

"The deal with Genentech gives validation to our company and our process," says Jack Barbut, CEO of NovImmune. "Genentech does relatively few product deals like ours. That is significant."

Barbut adds, "We believe Genentech is the right partner for NovImmune for this program. Genentech brings an in-depth understanding of IL-17 biology and extensive experience in its ability to potentially identify patient populations that may benefit from such a compound thus maximizing chances of successful development."

NovImmune's in-house expertise involves three established and validated technologies, including the UltiMAb system to obtain fully human therapeutic monoclonal antibodies using transgenic mice (technology licensed from Medarex); antibody display selection on bacteriophages; and humanization, or grafting of the small sequences responsible for the recognition and binding of the antigen from a non-human species to a fully human monoclonal antibody backbone.

Barbut says his company is becoming adept at bringing potential new therapies through the preclinical to the proof-of-concept stages, and then securing a partner to launch the product into a product pipeline.

"At this stage, continuation of the development is best handled by a large pharma," he says. "For us, for each molecule we seek to find the right partner in each space."

In this case, he continues, Genentech was working with IL-17 signaling pathway within its own pipeline, so the partnership was a natural fit.

"They understand the antibodies, and they will go on to identify the exact patient population as we proceed," he adds.

Barbut characterizes the deal as a "classical licensing agreement."

"We believe that, without a hiccup, the first compound will enter the clinical phase in 2011," he says.

Barbut says his company has, since its inception in 2000, secured more than $145 million in four rounds of venture capital funding. To date, NovImmune has generated seven proprietary monoclonal antibodies. The pipeline is a balance of preclinical and clinical compounds, with a mix of both clinically validated as well as novel targets. The company's lead product, NI-0401/anti-CD3 is already being evaluated in Crohn's disease, type 1 diabetes, and transplantation.

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