November 18, 2013 -- While there are 49 products on the market incorporating nanoparticles, there are four times that many now moving through the pipeline with half of those already in Phase II or Phase III trials.
In his role as vice chair for the European Technology Platform on Nanomedicine, Laurent Levy described the state of the emerging field of nanotherapeutics to set the context for a special workshop at BIO-Europe® 2013 asking, ” Is nano becoming the next sweet spot for drug development?”
Recent deals that he values at USD 1 billion show that the pharma industry has a growing interest in the potential of this new technology with an initial focus in oncology.
It is a field dominated by SMEs, with 500 registered companies in Europe and a further 150 in the United States. Further upstream there are more than 1,000 academic groups working on projects that the European Technology Platform has identified.
“A great wave of innovation is coming with a disruptive potential,” he said. “De-risking projects and developing data becomes essential, and even more key is bringing these programs to a stage where pharma can understand them.”
“The applications and the unmet medical needs are the same for nanotherapeutics as they are for biotech, yet pharma groups have checklists based on biologics, not nano objects. If you do not tick the boxes on the checklist, it becomes very difficult to advance these programs,” he said.
Detlev Biniszkiewicz is the early adopter in this broad technological field having closed three deals over the past two years with nanotherapeutic companies. The vice president at AstraZeneca who heads Strategy for Oncology and Innovative Medicines, Biniszkiewicz admitted he is experimenting, not yet sure which approach will emerge as the first winner, whether encapsulating particles, drug modifying particles or engineered polymers.
“The second generation is very good,” he said. “We have a Phase II asset that could not go ahead because of its characteristics, so we have tried to develop it further by testing nanoparticle platforms to avoid certain toxicities. We know the molecule works, now we want to see if a nano platform can deliver it.
“The deal I am really excited about is the one we did with CytImmune. Here we really want to push the envelope by loading on one nanoparticle two different drugs that have shown to have synergistic effects in a preclinical model,” he said.
“We would have had to develop two different drugs, and after years and years, hope to combine them. Instead, we are looking for nanotechnology to develop a truly disruptive innovation,” he said.
There is much promise in the field, but the key effects that interest AstraZeneca fall in three areas:
* Changing the physical characteristics of a drug, its pharmacokinetic (PK) and the bio distribution, to make a better drug.
“The second generation is very good,” he said. “We have a Phase II asset that could not go ahead because of its characteristics, so we have tried to develop it further by testing nanoparticle platforms to avoid certain toxicities. We know the molecule works, now we want to see if a nano platform can deliver it.
“The deal I am really excited about is the one we did with CytImmune. Here we really want to push the envelope by loading on one nanoparticle two different drugs that have shown to have synergistic effects in a preclinical model,” he said.
“We would have had to develop two different drugs, and after years and years, hope to combine them. Instead, we are looking for nanotechnology to develop a truly disruptive innovation,” he said.
There is much promise in the field, but the key effects that interest AstraZeneca fall in three areas: * Changing the physical characteristics of a drug, its pharmacokinetic (PK) and the bio distribution, to make a better drug.
“Look at the pharma industry’s recognition and integration of biotechnology innovations. It has taken 20 years. How long will it take to integrate nanotechnology?” he asked. There is a lack of expertise in pharma for nanotechnology, he noted, and there is a lack of data on the part of nanotechnology to be able to assess the potential of the products.
At this point he finds more questions than answers. What is the deal-risking framework necessary to advance projects? Are we using the right models? Where is the clinical or medical value? What are patient and payer expectations? Are we only changing the life cycle of therapies? Or are we talking about real game-changers?
“There is a significant level of investment necessary to make the transition, such that no single company can handle this by itself,” he said, adding that “momentum for nanotherapeutics, such as the industry sees today for ADCs (antibody drug conjugates), will come with clear differentiation in a randomized Phase II trial.”
The Chief Business Officer at nanotherapeutic developer Cerulean Pharma, Christopher Guiffre, believes the first generation of products is not a breakthrough, but the industry will be disrupted by the next generation now coming in the pipeline.
“Five years from now every big pharma company will have nano programs, that’s a promise,” he said, adding that it will take time for pharma to work through their processes, even once they have the nano particles in their hands. Key is for companies like his own not to overpromise as nanotechnology is not yet ready for prime time. Nonetheless, what is coming is impressive.
“We have proven over and over that nanotechnology is disruptive in mice. But while what we do in mice is awesome, we do not yet know what happens in humans. Is it really differentiated?” he asked.
The wave that is coming will be enabled by partnerships among big pharma with resources, expertise and money, he said.
“What will be important is momentum, which is something hard to manufacture, to quantify or control,” he said. “It will take a lot of money to translate the science into medicine for patients, and the momentum will come the day one pharma plunks down enough money that everyone else begins asking what they know.”
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