At last year's BIO 2013 convention in Chicago, the Personalized Medicine forum attracted a packed "standing room only" attendance and it is highly likely that the next iteration of the event, scheduled to run at BIO 2014 will again be a popular draw for delegates.

That will be no surprise given the growing importance of the field with its potential to improve the quality of care and treatment outcomes. It is not uncommon for new medicines under development to now have a parallel companion diagnostic or biomarker program designed to assist in speeding development times and ultimately to target therapies. The forum is designed to address the challenges currently facing both drugmakers and diagnostics companies that need to be overcome before personalized medicine can fully impact the landscape of modern health care.

A significant agenda item at this year's forum is the role that companion diagnostics play in the personalized medicine environment. Certainly they are becoming pivotal, holding huge potential for pharma companies.

As regulators, payers and drug developers become more comfortable with their use, interest in companion diagnostics to help direct targeted medicines to the right patient populations has surged in the past couple of years. Drug companies are recognizing that companion diagnostics, when co-developed with a potential therapeutic can assist in its regulatory approval.

DEALMAKING

Not surprisingly, in the past year alone the number of deals involving companion diagnostics has been on the rise. For example, in May, pharma company Abbott signed a collaboration with Cambridge, Mass.-based Idera Pharmaceuticals Inc. for the development of an in vitro companion diagnostic test for use in Idera's clinical development programs to treat certain genetically defined forms of B-cell lymphoma with IMO-8400.

Under the agreement, Abbott will develop a test utilizing polymerase chain reaction (PCR) technology to identify the presence of the MYD88 L265P oncogenic mutation in tumor biopsy samples. That mutation, which can be identified in approximately 90 percent of patients with Waldenström's macroglobulinemia and approximately 30 percent of patients with the ABC subtype of diffuse large B-cell lymphoma, plays a key role in activating the Toll-like receptor pathways targeted by IMO-8400.

"This companion diagnostic will be an important tool for the clinical community in evaluating whether their patients are potential candidates for IMO-8400 therapy for the treatment of these genetically defined forms of B-cell lymphoma," noted Lou Brenner, senior vice president and chief medical officer at Idera.

Other recent deals in the space include:

• Daiichi Sankyo Co. Ltd., of Tokyo, and Agendia BV, of Amsterdam, which inked an oncology drug development and personalized medicine deal calling for Agendia's oncology biomarker technology to be used in the assessment of pharmaceuticals now being researched in certain Daiichi clinical trials. As part of the deal, Agendia's technology will be used to assess patient samples. Terms and other aspects of the agreement were not disclosed. (See BioWorld Today, April 25, 2014.)

• London, Ontario-based Kalgene Pharmaceuticals Inc. reported last week that it is accelerating development of a prognostic marker and companion therapeutic that specifically targets aggressive cancers. The complex project is a multistage and multiyear undertaking involving the Centre for Imaging Technology Commercialization, Sunnybrook Research Institute, and Ontario Cancer Biomarker Network at Queen's University.

• Ventana Medical Systems Inc., of Tucson, Ariz., a member of the Roche Group, inked a multiyear deal with Bayer AG, of Leverkusen, Germany, to develop companion diagnostics, with a focus on immunohistochemistry, across Bayer's portfolio of targeted therapy projects. The agreement extends an existing collaboration and focuses on the development of diagnostic tests for Bayer's biomarker-targeted therapeutics from early discovery through commercialization.

• Foundation Medicine Inc., of Cambridge, Mass., and Clovis Oncology Inc., of Boulder, Colo., expanded their ongoing collaboration to incorporate a coordinated regulatory strategy for the development of a premarket approval companion diagnostic test, designed for use by physicians to identify patients most likely to respond to rucaparib, Clovis' poly (ADP-ribose) polymerase inhibitor. Financial terms were not disclosed. Rucaparib is in phase II and phase III trials in ovarian cancer. (See BioWorld Today, April 4, 2014.)

ONLINE REGISTRY

Earlier this month, Myriad Genetics Inc., of Salt Lake City, announced that it was teaming up with cancer experts from the Memorial Sloan Kettering Cancer Center (MSKCC), Mayo Clinic, Abramson Cancer Center of the University of Pennsylvania and other laboratories to form a new partnership called the Prospective Registry of Multiplex Testing (PROMPT).

The goals of the study are to create an online registry of individuals consenting to a prospective follow-up after having been tested with a pan-cancer panel test; provide infrastructure for the curation of specific genetic variants detected; and to facilitate additional studies to characterize the significance of the genetic mutations. The PROMPT registry is a database that will include patients identified with deleterious or suspected deleterious mutations in any of the cancer susceptibility genes targeted in this research study.

Foundation Medicine also has partnered with a coalition including patient advocacy organization Friends of Cancer Research, federal health and regulatory agencies, pharmaceutical companies and research organizations to develop the trial design for the Master Protocol study in patients with squamous cell carcinoma of the lung. Master Protocol is a biomarker-driven, multidrug, multiarm, multicenter phase II/III registration trial in which a genomic testing platform will be used to stratify patients into appropriate target-specific arms. Foundation Medicine's genomic profile was selected as the common platform to determine the investigational targeted therapy each patient will receive during the trial, based on molecular alterations in their tumors. As part of the study, cooperative groups will collaborate for patient accrual and screening of approximately 6,000 lung cancer patients over five years. The research coalition will seek to evaluate whether the concept and design of the Master Protocol study may serve as a model for future trials to accelerate the development of targeted cancer therapies. (See BioWorld Today, Nov. 8, 2013.)

[Editor's note: The Personalized Medicine forum runs Wednesday and Thursday during BIO 2014 and we will be reporting on the proceedings in the June 30 issue of BioWorld Insight.]