Sequenta and Collaborators Presented Key Data Using a Novel Sequencing Technology to Predict Clinical Relapse

December 13, 2011

SAN FRANCISCO, Dec 13, 2011 -- Sequenta, Inc., announced at the annual meeting of the American Society of Hematology (ASH) the results from several studies showing the sensitivity and specificity of the company's Immune Cell Receptor Sequencing (ICRS) platform in detecting Minimal Residual Disease (MRD) and predicting clinical relapse in childhood and adult Acute Lymphoblastic Leukemia (ALL), Chronic Lymphoblastic Leukemia (CLL) and Mantle Cell Lymphoma (MCL) patient samples.

"ASH has been an important meeting for Sequenta. Our collaborators from Stanford University and St. Jude have presented compelling data demonstrating the use of the ICRS platform to predict disease in blood samples earlier than conventional methods," said Tom Willis, Ph.D., president and CEO of Sequenta. "Current methods of detecting MRD are suboptimal and can miss up to one-third of all clinical relapses in a curable disease such as childhood ALL."

Results presented during the ASH meeting held December 10-13 included the following:

Immunotransplant for Mantle Cell Lymphoma: Phase I/II Study Preliminary Results (Abstract 3068)

In collaboration with Ron Levy, MD, Professor of Medicine, Stanford Medicine Cancer Institute, Sequenta used the ICRS platform to monitor MRD in 11 retrospective MCL patient samples, which had been determined to be MRD negative by PET scans (six and 12 months post treatment). Upon reexamination of the MRD negative samples, ICRS confirmed the presence of MRD in two patients. In fact, both patients relapsed within one year, suggesting that ICRS results provide actionable information for the clinician.

"In this cohort, the ICRS assay was able to perfectly predict patients' relapse. When validated, this approach could change the treatment for these patients," remarked Ron Levy, MD.

High-Throughput Immunoglobulin Gene Sequencing Quantifies Minimal Residual Disease in CLL with 10e-6 Sensitivity and Strongly Predicts Relapse after Allogeneic Hematopoietic Cell Transplantation (Abstract 2542)

Researchers from Sequenta and Stanford University departments of Medicine and Pathology reported used the ICRS platform to detect MRD in blood samples from patients with CLL that had been deemed negative by PCR. With a demonstrated MRD sensitivity at one in a million cells, researchers examined 300 archived post-transplant blood samples from 42 CLL patients. Nearly 60 percent of tests that were negative for CLL MRD by PCR were positive by ICRS. ICRS MRD positivity was very highly predictive of ultimate relapse.

"ICRS gave me early insight into those patients who relapsed their cancer following transplantation. The predictive power of this technology will allow me to intervene earlier," said Stanford School of Medicine's David Miklos, MD.

Highly Sensitive Detection of Minimal Residual Disease in Acute Lymphoblastic Leukemia Using Next-Generation Sequencing of Immunoglobulin Heavy Chain Variable Region (Abstract 2540)

Malek Faham, MD, Ph.D., and his team at Sequenta presented results showing that the ICRS platform is highly concordant with and more sensitive than standard methods. In this study, it was found that ICRS was concordant with flow cytometry (five positive results and four negative results). However, when the disease burden fell below the detection limit of flow cytometry, ICRS was able to detect the disease.

Dario Campana, MD, collaborator on this study, offered that "detecting MRD is critical to intensifying potentially life-saving therapy for these children."

Next-Generation Sequencing of Immunoglobulin Heavy Chain Variable Region in Diagnostic Samples of Pediatric Acute Lymphoblastic Leukemia Identifies Hundreds of Clonal Subpopulations with Multiple Immunophenotypes (Abstract 1436)

In this study, Sequenta and Stanford University researchers demonstrated that Sequenta's ICRS can detect MRD in childhood ALL samples. The results demonstrated that ICRS found multiple cancer clones at diagnosis, including some that are rare which are associated with cancer biology.

Massively Parallel Immunoglobulin Gene Sequencing Provides Ultra-Sensitive Minimal Residual Disease Detection and Predicts Post-Transplant Relapse in Acute Lymphoblastic Leukemia by Three to Six Months (Abstract 4104)

A collaboration between Sequenta and Stanford University departments of Medicine and Pathology leveraged the ICRS platform to study the presence of MRD in post allo-transplant ALL patient samples. These samples had previously been found negative by standard technologies. The study demonstrated a significant correlation between detection of molecular MRD and clinical relapse in patients three to six months earlier than the comparative method.

About Sequenta, Inc.
Sequenta, Inc. is a privately held company developing and commercializing molecular diagnostic assays based on a proprietary sequencing approach to the profiling of T and B cell receptor repertoires. The company was founded in 2008 by Drs. Tom Willis and Malek Faham, two entrepreneurs who previously founded ParAllele BioScience, a company that developed and commercialized genomic technologies. ParAllele was acquired by Affymetrix in 2005. Sequenta's investors include Mohr Davidow and Index Ventures. The company is based in San Francisco, Calif., More information can be found at www.sequentainc.com .