9

Examples of Collaborations Relevant to Cancer

During the course of the workshop, participants cited several examples of successful collaborations in the development of investigational combination cancer therapies, including preclinical and clinical collaborations between two drug companies, as well as clinical trial collaborations involving academic institutions and multiple companies, such as I-SPY 2 TRIAL and BATTLE 1 and 2, and some research funded by Stand Up To Cancer, the latter of which encompasses both preclinical and clinical drug development.

A few preclinical collaborations between two drug companies were cited. Dr. Bachman noted that GSK and Novartis are collaborating in the development of a cancer therapy that combines GSK’s MEK inhibitor with Novartis’s PI3K inhibitor. Although GSK had its own PI3K inhibitor in the pipeline, the GSK inhibitor had different properties from the Novartis P13K inhibitor that made the collaboration worth pursuing, Dr. Bachman noted. “Rather than just us focusing on our own inhibitor, we talked to Novartis. Similarly Genentech and Roche are collaborating on the preclinical development of a combination treatment that targets both P13K and MEK, and AstraZeneca is collaborating with Merck in the preclinical development of a combination that targets PI3K and ATK,” Dr. Engelman pointed out. “It’s very exciting that these companies, when they see an idea that they think is good, are willing to go through the painful process of teaming up to codevelop molecules. What’s very telling here is that these companies are codeveloping molecules that aren’t approved—they



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9 Examples of Collaborations Relevant to Cancer During the course of the workshop, participants cited several exam - ples of successful collaborations in the development of investigational combination cancer therapies, including preclinical and clinical collabora- tions between two drug companies, as well as clinical trial collaborations involving academic institutions and multiple companies, such as I-SPY 2 TRIAL and BATTLE 1 and 2, and some research funded by Stand Up To Cancer, the latter of which encompasses both preclinical and clinical drug development. A few preclinical collaborations between two drug companies were cited. Dr. Bachman noted that GSK and Novartis are collaborating in the development of a cancer therapy that combines GSK’s MEK inhibitor with Novartis’s PI3K inhibitor. Although GSK had its own PI3K inhibitor in the pipeline, the GSK inhibitor had different properties from the Novartis P13K inhibitor that made the collaboration worth pursuing, Dr. Bachman noted. “Rather than just us focusing on our own inhibitor, we talked to Novartis. Similarly Genentech and Roche are collaborating on the pre- clinical development of a combination treatment that targets both P13K and MEK, and AstraZeneca is collaborating with Merck in the preclinical development of a combination that targets PI3K and ATK,” Dr. Engelman pointed out. “It’s very exciting that these companies, when they see an idea that they think is good, are willing to go through the painful process of teaming up to codevelop molecules. What’s very telling here is that these companies are codeveloping molecules that aren’t approved—they 69

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70 COLLABORATIONS TO DEVELOP COMBINATION CANCER THERAPIES are both being developed when neither one is really even that close to an FDA approval,” he said. Dr. Canetta noted additional clinical collaborations between two pharmaceutical companies, each contributing their own investigational drug. These collaborations included Bristol-Myers Squibb and Roche in the clinical testing of a combination for melanoma, and Bristol-Myers Squibb and Genentech in the clinical testing of a combination for colorec - tal cancer, done under the auspices of CTEP. These trials show that it is possible to do combination trials with experimental agents and address concerns about intellectual property and regulatory issues. “All that it takes is recognition of the unmet medical need and willingness to cooper- ate,” he said. Even more complex, multi-industry collaborations have been forged, as exemplified by the I-SPY 2 TRIAL and BATTLE 1 and 2 trials (see Appendix A). Mr. David Wholley, director of the Biomarkers Consortium, said that having the Foundation for the National Institutes of Health (FNIH) act as a trusted third party was key to forging the 19 agreements involved with the I-SPY 2 TRIAL. FNIH acts as the holder of the IND and as the manager of the IP rights that stem from the trials. Mr. Wholley said an outside legal counsel who has worked with the I-SPY 2 TRIAL and is skilled in the area of IP licensing said she was amazed that FNIH was able to garner these agreements, and noted it would not have been possible if FNIH was not a trusted third party and a nonprofit organization. Dr. Herbst noted that the four companies sponsoring the BATTLE 2 trial have been flexible in the choice of agents the investigators have used, even as this choice evolved when more knowledge on targeted therapies emerged. “The company allowed us to work with drugs from other com- panies and bring other collaborators in. We have a good example where academia and industry really worked well together,” Dr. Herbst said. The PI3K team funded by Stand Up To Cancer has invested $500,000 to purchase 50–100 gram quantities of 10 investigational drugs that recently entered Phase II clinical trials and that were of interest to them for combination therapies. The team’s strategy is to test these drugs as single agents and in combinations, and to immediately inform the companies that make these drugs if they observe efficacy in any of our mouse mod- els as indicated by tumor shrinkage. They then work with the companies that make the drugs to facilitate their biomarker-driven combination trials (sometimes involving two companies). Agents used for testing are obtained from both industry and CTEP, and accrual is facilitated by interactions with the Translational Breast Cancer Research Consortium, the Gynecologic Oncology Group, and other individual centers, Dr. Cantley noted. The PI3K team also lever-

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71 EXAMPLES OF COLLABORATIONS RELEVANT TO CANCER ages complementary trials that were already in the works when the PI3K team formed. “Collaborations with industry have offset many of our costs,” Dr. Cantley pointed out. But he added that in general, it takes about a year to acquire a material transfer agreement with a company in order to use their investigational agent to test in their animal models, and most agree - ments stipulate the agent cannot be combined with any other drug. That has not deterred researchers on the P13K team from combining agents in their tests, however, Dr. Cantley said. “We always tell the company we’re doing it. They may or may not tell their lawyers we’re doing it. But we do it, and if we get a result that looks exciting, we come back and tell them and I’ve yet to have anyone complain,” Dr. Cantley said. Instead, companies have been open to discussions on how to collaborate with each other to further test combinations where the agents come from different companies, according to Dr. Cantley. In two such cases those discussions have led to collaborative combination trials. “The barriers are not that high if the data are really convincing,” Dr. Cantley said.

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