Nuclea and Aelan partner to develop, commercialize novel biomarker tests using STEM cells as models

Nuclea Biotechnologies Inc. announced today that it is partnering with Aelan Cell Technologies Inc. (San Francisco, California) for the development, validation and commercialization of novel biomarker tests and companion diagnostics using human STEM cells as models. Their collaboration has the potential to impact disease monitoring and drug development for cancer, metabolic disorders, neurodegeneration, aging and aging-related pathologies.

Nuclea and Aelan will apply their expertise in the fields of proteomics and genomics, respectively, for this collaboration. Nuclea will provide protein analysis of human STEM cells to identify and validate biomarkers while Aelan will provide DNA and MRNA analysis.

"Nuclea is committed to developing novel companion diagnostics to aid medical professionals as they identify the best treatment options for their patients in a world of ever-expanding disease therapeutics," said Dr. Mary Lopez, COO and VP of Proteomic Discovery at Nuclea Biotechnologies.

Companion diagnostics are devices that provide essential information for the safe and effective use of a corresponding therapeutic. In the era of precision medicine, the development of companion diagnostics is key to success in clinical trials.

A recent publication by Aelan scientists in Oncotarget demonstrated that drugs such as the myeloid cancer drugs interleukin-2 or interleukin-2 derivatives in combination with cell therapies boost survival odds of some patients but not others. This discovery may help identify patients that respond well to the drugs.

"The rapid evolution of high-accuracy and high-throughput genomic and proteomic technologies has created many opportunities for translational and clinical applications," said Dr. Victoria Lunyak, CEO of Aelan Cell Technologies. "Incorporating prognostic and predictive biomarkers into clinical trial strategies, in addition to therapeutic decision-making, is essential to disentangling the complexities of the pathogenic process, drug pharmacodynamics and epidemiological heterogeneity. Our goal is to develop tests based on biomarker panels identified in next-generation sequencing and mass spectrometry-based proteomics studies," continued Dr. Lunyak.

Additionally, Aelan scientists will investigate biological pathways associated with aging and life extension, using next generation "omics" technologies to reveal precisely which age-related biological processes are activated in various patient populations during interventions including supplements, drugs and exercise. This approach will enable identification of age-related biomarkers across multiple diseases such as early stage cancer and neurodegeneration. Application of these biomarkers in companion diagnostic tests may be useful in disease monitoring and therapeutic management, thereby improving patient outcomes.

"We are very enthusiastic about our partnership with Aelan Cell Technologies since this relationship provides access to novel biomarkers and data analysis platforms as well as Aelan's expertise in stem cell biology and epigenetics. Nuclea has complementary manufacturing and commercialization capabilities that facilitate the development of diagnostics with robust clinical utility," said Patrick Muraca, President and CEO of Nuclea Biotechnologies .

Financial details of the partnership were not disclosed, however the global companion diagnostics market crossed the $1 billion threshold in 2013 and sales are expected to accelerate significantly over the next 5 years.