Pharmacogenomics will be an area of “high interest” for Enlight Biosciences, a new Boston-based company that has received $39 million from Merck, Eli Lilly, and Pfizer to develop technologies meant to boost the industry’s innovation in drug discovery and development.
Formed last week, Enlight is the brainchild of PureTech Ventures and academics from top US institutions, including Massachusetts Institute of Technology, Harvard University, and Stanford University. Enlight will be managed by PureTech, a Boston-based venture creation firm that specializes in helping academic institutions turn healthcare research into clinical treatments.
The founders of Enlight aim to develop for their pharma partners a “wish list” of technologies that can connect preclinical research, clinical development, and medical practice.
Areas of interest for Enlight will include drug discovery, chemistry, and synthesis platforms that improve pharma’s success rate in early drug development; predictive efficacy models and predictors for pharmacokinetics and toxicology to allow companies to discern early on how humans will respond to a drug; molecular imaging and biomarkers for patient segmentation in clinical trials; and formulation technologies that will ensure that drugs are being delivered to the right target in the body.
Among these areas of interest, “pharmacogenomics and genomics technologies have potential applications in areas that we and our pharma partners have identified to be of high interest, such as biomarker discovery, prediction of safety and toxicology, and computational models of clinical trial response,” Daphne Zohar, PureTech Ventures managing partner, told Pharmacogenomics Reporter this week.
“These are areas that have the potential to play significant roles in the various stages of drug discovery and development, especially within personalized medicine,” she said.
According to Zohar, the technologies coming out of Enlight will be developed in a “pre-competitive” environment, which means that none of the pharma collaborators will own the IP, but that each will have early access to the products. As an independent entity, Enlight and any companies it spins out will own the IP to technologies they develop.
However, since Merck, Lilly, and Pfizer are the founding members of Enlight, they will have the opportunity to invest in, and have early access to, any new technologies developed by the company or its spinouts.
“The pharma companies in question all benefit if these technologies get developed,” Zohar explained.
“An example would be a drug delivery technology that addresses a specific problem — [for instance] delivery across the blood brain barrier — that can be used with the different pharma companies’ proprietary therapeutics,” she said. “The delivery platform is pre-competitive but the therapeutics are proprietary.”
“Some exciting advances being developed at research institutions are ready to be translated, but due to a funding gap, they have not been developed until this point.”
In a statement, Enlight said it has already initiated programs in the areas of molecular imaging, biologics, and drug delivery, and is planning to launch programs in other areas.
One of the first projects for Enlight will be to translate an imaging technology, which provides preclinical insight into diseases and treatments, into a device for monitoring patients in clinical trials, as well as into a point-of-care diagnostic. The imaging technology is based on intellectual property licensed from multiple academic labs, according to Zohar.
She did not elaborate on any potential pharmacogenomic projects that Enlight might initiate.
According to the founders, Enlight was launched in an effort to exploit mutually beneficial needs between academia and industry: Academic institutions need funding to commercialize their discoveries in healthcare technologies, while biopharmaceutical companies need technologies that could boost the success of products in drug development.
“Some exciting advances being developed at research institutions are ready to be translated, but due to a funding gap, they have not been developed until this point,” Zohar said. “At Enlight, we work directly with the pharma companies who have the greatest need for such technologies and the academic scientists who make the discoveries.”
Enlight comes at a ripe time as it is no secret that the pharmaceutical industry is facing an innovation crisis.
Recent figures from Deloitte estimate that approximately $65 billion worth of pharmaceuticals, representing 25 percent of annual drug sales, will go off patent in the next five years. However, the rate of new molecular entities being submitted to the US Food and Drug Administration and the number of “truly innovative” compounds in pharmaceutical companies' pipelines doesn’t come close to recouping this amount.
Even though the typical blockbuster drug has an efficacy rate of between 35 percent and 75 percent, pharma still appears to be chasing the blockbuster dream. Big pharma players such as Pfizer have acknowledged they are investing in technologies, such as pharmacogenomics, to determine the safety and efficacy of investigational products meant for broad populations earlier in clinical trials [see PGx Reporter 11-28-07].
Meanwhile, Novartis is among several big pharmas that have redesigned their R&D structures to accelerate drug development and reduce internal bureaucracy, and is investigating genomic targets that may help it develop drug/diagnostic combinations in several smaller disease markets [see PGx Reporter 03-07-2007, 11-28-2007].
The fact that Merck, Lilly, and Pfizer are collaborating with Enlight shows that they are more comfortable acknowledging the need to invest in innovative technologies and to move away from the current one-size-fits all drug-development paradigm.
The pharma partners “agreed to collaborate because of the need to improve productivity and because the technologies we are pursuing within Enlight are ‘pre-competitive,’” Zohar said. “So they don’t mind sharing, as long as they also get access to some of the innovative technologies.”
However, the challenge for academic institutions has always been funding — a sore point exacerbated by industry’s recent focus on late-stage therapeutic products that seldom originate in the academic setting.
According to Enlight’s founders, despite the development of “vital enabling technologies” such as PCR, PET, antibody humanization, RNAi, and gene microarrays, “over the last few years most traditional life science investors have focused their funding on late-stage therapeutic programs.
“As a consequence, important technologies that could be of great strategic impact to the pharmaceutical industry are not being commercialized,” Enlight said in a statement.
Enlight, by drawing its staff from academia and industry, hopes to ease academia’s funding problem and help close industry’s innovation gap.
Among Enlight’s academic cofounders are H. Robert Horvitz, Nobel Laureate and professor of biology at MIT; Sam Gambhir, professor of radiology and Stanford University; Rakesh Jain, professor of tumor biology at Harvard Medical School; and Raju Kucherlapati, professor of genetics at Harvard Medical School.
Enlight's team also draws from industry, including Frank Douglas, former executive vice president of Aventis, and Bennett Shapiro, former executive vice president of basic research and worldwide licensing at Merck.
"At a time when there is concern over productivity in R&D, Enlight Biosciences is providing a safe haven where leaders in the pharmaceutical industry can develop tools that will accelerate innovation and delivery of novel drugs to patients," Douglas, who is a PureTech Ventures partner, said in a statement.