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Exosome Diagnostics Announces Launch of ExoDx® Prostate(IntelliScore), a Completely Non-Invasive Liquid Biopsy Test to Help Rule Out High-Grade Prostate Cancer

On September 7, 2016 Exosome Diagnostics, Inc. reported the launch of its ExoDxProstate(IntelliScore) test (EPI) through the company’s CLIA certified laboratory in Cambridge, Massachusetts. EPI is a laboratory-developed test designed to provide clinicians and patients with information that will improve the prostate biopsy decision-making process. EPI is the first test using specific genetic information captured from a simple urine sample to provide physicians with a score to help evaluate their patient’s risk for high grade, potentially more aggressive prostate cancer.

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In the United States each year, approximately one million prostate biopsies are performed with up to 80 percent of the results indicating no cancer, or a low-grade cancer that could instead be monitored under a watchful waiting or active surveillance program. The EPI test was designed to reduce the number of unnecessary prostate biopsies and the associated overtreatment of low-grade disease. Complications associated with unnecessary prostate tissue biopsies range from discomfort and temporary incontinence or impotence, to hospitalization for serious infections in three to four percent of patients.

"Prostate cancer is really a spectrum of disease. Not all patients have the same type of tumor or the same grade of disease," stated Peter Carroll M.D., chair of urology at the University of California, San Francisco and an investigator in the EPI clinical validation trial. "Very few men need immediate treatment. Repeat PSA testing, PSA/protein based diagnostic tests, MRI scans and now molecular genetic testing with EPI will provide important data to help clinicians, patients and their families make better informed decisions about whether to proceed with an initial prostate biopsy. This test launch marks an important step forward in efforts to develop more sensitive markers for assessing the risk of aggressive prostate cancer and the ability to monitor disease progression in a completely non-invasive approach."

The scientists and clinicians at Exosome Diagnostics developed this innovative test with input from the Prostate Cancer Foundation, urologists, patients and insurance providers. The EPI test uses a simple urine catch without a digital rectal exam, making it completely non-invasive for the patient and easy to integrate into patient care. The EPI test utilizes a three-gene signature, in combination with a proprietary algorithm. The score generated is simple for physicians to understand and discuss with their patients. The EPI test is unique from other tests in this space because it is a stand-alone diagnostic, as it does not take into account other standard of care parameters in the score thus making it a powerful complement to the existing PSA test.

A final clinical evaluation study enrolled over 1,500 patients through collaborations with 26 leading urology centers across the United States. Results from the study demonstrated that the EPI test was highly accurate for ruling out the presence of high-grade cancer (Gleason score seven or higher) prior to an initial prostate biopsy. The data from this blinded, prospective U.S. clinical validation study were published in JAMA Oncology in March 2016.

"Molecular and genetic testing are improving the quality of cancer care and patient outcomes. We are excited to provide this first-of-its-kind test to men at risk for prostate cancer," said Tom McLain, Chief Operating Officer of Exosome Diagnostics. "Using our patented technology to analyze the RNA released by prostate cancer cells, we provide a simple score to help evaluate the patient’s risk for high-grade prostate cancer. This will better inform clinicians and patients and help to clarify the decision process surrounding prostate biopsy."

EPI is one test in a portfolio of diagnostic and companion diagnostic tests being developed and launched by the company. "Today’s announcement provides another demonstration of the value of Exosome Diagnostics’ platform combining patented, leading isolation methodologies, ancillary technologies to increase the signal over the noise, tissue specific exosome identification methodologies, and proprietary algorithms to develop sensitive diagnostic assays and accelerate the development of companion diagnostics," said John Boyce, President and CEO of Exosome Diagnostics. "Our tests are unique in the liquid biopsy space. By combining the information about disease from exosomes and cell-free DNA captured from any biofluid sample, we are able to achieve the clinical and analytical performance needed for liquid biopsy tests to provide clinicians with real-time, patient specific information that can be used to improve care, select the right therapy, avoid unnecessary procedures and lower overall healthcare costs."

About the EPI Test
The EPI test is a completely non-invasive, urine-based test designed to be used along with clinical assessment and other standard of care factors (including age, race and family history) to enable physicians to assess whether an individual patient presenting for an initial biopsy is at greater risk for high-grade prostate cancer. As a "rule out" test, it is designed to more accurately predict whether a patient presenting for an initial biopsy does not have high-grade prostate cancer and, thus, could potentially avoid the discomfort, complications and cost of an initial biopsy and, instead, continue to be monitored. EPI, which is intended for use in men 50 years or older with a prostate-specific antigen (PSA) result of 2-10ng/mL presenting for an initial biopsy, involves patients submitting a simple urine sample, without having to first undergo a digital rectal exam (DRE).

The EPI test analyzes the urine for three biomarkers on exosomal RNA (exoRNA) that are expressed in men with high-grade prostate cancer. Using a proprietary algorithm that combines the relative weighted expression of the three-gene signature, the test assigns an individual risk score for patients ranging from zero to 100. Scores above a pre-defined cut point are associated with an increased likelihood of high-grade prostate cancer on a subsequent biopsy.

This test was evaluated and its performance characteristics determined by Exosome Diagnostics Inc. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Exosome Diagnostics is certified under the Clinical Laboratory Improvement Amendments (CLIA) act of 1988 as qualified to perform high complexity clinical testing.

Laboratory Corporation of America® Holdings Successfully Completes Acquisition of Sequenom, Inc.

On September 7, 2016 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the successful completion of the offering period for the cash tender offer by its direct wholly owned subsidiary, Savoy Acquisition Corp. (Purchaser), for all outstanding shares of common stock of Sequenom, Inc. (NASDAQ: SQNM) (Sequenom), including the associated preferred stock purchase rights (together with the common stock, the Shares) (Press release, LabCorp, SEP 7, 2016, View Source;p=RssLanding&cat=news&id=2200115 [SID:1234514984]). The depositary for the tender offer has advised LabCorp that, as of 12:01 a.m., Eastern time, on September 7, 2016, the expiration of the offering period, stockholders of Sequenom had validly tendered 82,901,857 Shares (including Shares tendered through notices of guaranteed delivery) during the offering period, representing an aggregate of approximately 69% of Sequenom’s outstanding shares of common stock as of such time (or approximately 67% of outstanding shares excluding notices of guaranteed delivery), which Shares are sufficient to have met the minimum condition of the offer and to enable the Merger (as defined below) to occur under Delaware law without a vote of Sequenom’s stockholders. Purchaser has accepted for payment all Shares validly tendered and not properly withdrawn during the offering period, and the consideration for all such Shares either has been paid or will be paid promptly. The acceptance of the Shares effective as of September 7, 2016 constitutes a "Fundamental Change" and a "Make-Whole Fundamental Change" under the indentures related to Sequenom’s 5.00% convertible senior notes due 2017 and the Sequenom’s 5.00% convertible exchange senior notes due 2018.

"With the addition of Sequenom, LabCorp is a market leader for non-invasive prenatal testing, women’s health and reproductive genetics," said David P. King, chairman and chief executive officer of LabCorp. "This strategic acquisition also expands our reach both domestically and internationally and furthers our mission to improve health and improve lives around the globe."

LabCorp also announced that, following the completion of the offering period, Purchaser was merged with and into Sequenom (the Merger) without a vote of the stockholders of Sequenom, as permitted by the Delaware General Corporation Law. In the Merger, each Share not tendered and accepted for payment in the offer, other than those Shares with respect to which the holders properly exercise appraisal rights and Shares held by LabCorp or Purchaser, has been converted into the right to receive $2.40 net to the seller in cash, without interest thereon and subject to applicable withholding taxes. As a result of the Merger, Sequenom became a direct wholly owned subsidiary of LabCorp and Sequenom’s shares will cease to be traded on the NASDAQ Global Select Market.

Calithera Biosciences Announces CB-839 Clinical Data Selected for Oral Presentation at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

On September 7, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that clinical data for its lead drug candidate CB-839, the company’s novel, orally bioavailable glutaminase inhibitor, will be presented at the 28th Annual EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, which is being held from November 29 to December 2, 2016 in Munich, Germany (Press release, Calithera Biosciences, SEP 7, 2016, View Source;p=RssLanding&cat=news&id=2200049 [SID:1234514965]). Clinical results to be presented in a plenary session will be focused on data from Calithera’s CB-839 Phase I combination trial with everolimus in renal cell carcinoma.

Phase 1 Study of CB-839, a small molecule inhibitor of glutaminase, in combination with everolimus in patients with clear cell and papillary renal cell carcinoma
Presenter: Funda Meric-Bernstam, M.D. Anderson Cancer Center
Plenary Session 2, Proffered Paper Session, Room 14
Wednesday, November 30, 2016, 4:30 p.m. CET
Two additional posters will be presented with preclinical results from CB-839 and the company’s novel metabolic immune checkpoint inhibitor CB-1158, respectively.

CB-839, a selective glutaminase inhibitor, has anti-tumor activity in renal cell carcinoma and synergizes with everolimus and receptor tyrosine kinase inhibitors
Presenter: Ethan Emberley, Calithera Biosciences
Poster Session: Molecular Targeted Agents II, Board P055
Thursday, December 1, 2016, 10:15 a.m.-5:00 p.m. CET
Arginase inhibitor CB-1158 elicits immune-mediated anti-tumor responses as a single agent and enhances the efficacy of other immunotherapies
Presenter: Suzanne Steggerda, Calithera Biosciences
Poster Session: Immunotherapy, Board P121
Wednesday, November 30, 2016, 10:15 a.m.-5:00 CET

Aurigene to Invest in Curis at Premium Through Waiver of Certain Milestone Payments Under Collaboration Agreement

On September 7, 2016 Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of cancer, reported that its collaborator, Aurigene Discovery Technologies Ltd., will receive 10.2 million shares of Curis’s common stock, priced at $2.40 per share, representing a 39% premium to the closing price on September 2, 2016, in lieu of receiving up to $24.5 million of milestone and other payments from Curis that may become due under the companies’ 2015 collaboration agreement.

In January 2015, Curis and Aurigene established an exclusive collaboration focused on the discovery, development and commercialization of small molecule drug candidates in the fields of immuno-oncology and selected precision oncology targets. Under the collaboration agreement, Curis licensed CA-170, the first orally available, small molecule drug candidate designed to target the immune checkpoints programmed death ligand-1 (PD-L1) and V-domain Ig suppressor of T cell activation (VISTA), and a second candidate, CA-4948 that targets Interleukin-1 receptor-associated kinase 4 (IRAK4). Curis is currently evaluating CA-170 in a Phase 1 trial in patients with advanced tumors, while Aurigene is conducting IND enabling studies with CA-4948. In addition, Curis has selected a second program within the immuno-oncology field of the collaboration that is focused on orally available, small molecule antagonists that are designed to target PD-L1 and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) immune checkpoints.

"We are pleased with the progress of our collaboration and drug candidates, and welcome Aurigene’s confidence in Curis as we further advance our pipeline of small molecule checkpoint antagonists," said Ali Fattaey, Ph.D., Curis’s president and CEO. "We are especially excited about the Phase 1 trial of CA-170, the first oral checkpoint inhibitor being taken by patients. We also expect to license a second oral immuno-oncology candidate into Curis later this year that targets PD-1 and TIM3 checkpoint pathways. We look forward to continued progress with Aurigene as we seek to discover and develop multiple first-in-class oral, small molecule checkpoint inhibitors for the treatment of patients with cancer."

"We are delighted with our collaboration that has led to the advancement of the first small molecule checkpoint inhibitor into the clinic, a PD-L1/ VISTA targeting molecule that came out of Aurigene’s discovery efforts over many years," said CSN Murthy, Aurigene’s CEO. "Our investment into Curis exhibits our belief and commitment for this program and beyond as we work with Curis to focus our collective resources to advance these exciting drug candidates."

Further information regarding the terms of the agreement with Aurigene, as documented in the associated Stock Purchase Agreement, Registration Rights Agreement, and Amendment to Collaboration Agreement, was provided by Curis in a form 8-K filed with the SEC today.

JCAR014 Clinical Data Published in Science Translational Medicine: Patients with Advanced Lymphoma in Remission after T-cell Therapy

On September 7, 2016 In a paper published today in Science Translational Medicine, researchers from Fred Hutchinson Cancer Research Center reported data from an early-phase study of patients with advanced non-Hodgkin lymphoma (NHL) who received JCAR014, a Chimeric Antigen Receptor (CAR) T cell treatment, and chemotherapy (Press release, Juno, SEP 7, 2016, View Source [SID:1234514995]). CAR T cells are made from a patient’s own immune cells that are then genetically engineered to better identify and kill cancer cells.

The paper reported the results of the first 32 patients in a dose-finding trial of JCAR014 following a round of chemotherapy, called lymphodepletion, designed to create a more favorable environment for the CAR T cells to grow in the patient’s body. Key findings of the study demonstrated the importance of the choice of lymphodepletion regimen and the effects of different doses of CAR T cells. 50 percent of the 18 patients who were evaluable for efficacy after receiving CAR T cells and chemotherapy agents fludarabine and cyclophosphamide (Cy/Flu) had a complete response, which compares favorably to the 8 percent complete response rate in patients who received JCAR014 plus cyclophosphamide-based chemotherapy without fludarabine. As previously reported, dose-limiting toxicities were observed in some patients in this dose-finding study who received the highest CAR T-cell dose. The study continues with the intermediate CAR T-cell dose.

In patients that received Cy/Flu lymphodepletion and the intermediate dose of JCAR014, the data showed a promising early efficacy and side effect profile. Specifically:
Overall Response rate: 82 percent (9/11)
Complete Response rate: 64 percent (7/11)
Severe Cytokine Release Syndrome: 9 percent (1/11)
Severe neurotoxicity: 18 percent (2/11)

JCAR014’s hallmark is its use of a one-to-one ratio of helper (CD4+) and killer (CD8+) CAR T cells, which join forces to kill tumor cells that produce CD19, a molecule found on the surface of many blood cancer cells, including lymphoma and leukemia. By controlling the mixture of T cells that patients receive, the researchers can see relationships between cell doses and patient outcomes that were previously elusive. The data also suggest that with a defined one-to-one composition of cells, efficacy of treatment is increased, while toxic side effects are minimized.

"With the defined composition treatment, we are able to get more reproducible data about the effects of the cells – both the beneficial impact against the cancer and any side effects to the patient," said Fred Hutch clinical researcher Dr. Stan Riddell, one of the senior authors of the paper, along with Dr. David Maloney. "We are then able to adjust the dose to improve what we call the therapeutic index – impact against the tumor, with lower toxicity to the patient."

"This study shows that at the right dose of CAR T cells and lymphodepletion, we can achieve very good response rates for NHL patients who have no other treatment options," said Dr. Cameron Turtle, an immunotherapy researcher at Fred Hutch and one of the study leaders.

For Juno Therapeutics (NASDAQ: JUNO), these insights from the JCAR014 study are key to its development of JCAR017, a similar product candidate for the treatment of CD19 positive blood cancers. Like JCAR014, JCAR017 uses a one-to-one ratio of helper and killer CAR T cells, and the company believes it has the potential to be a "best-in-class" treatment for non-Hodgkin lymphoma, chronic lymphocytic leukemia, and adult and pediatric acute lymphoblastic leukemia. JCAR017 is currently in a phase I, multi-center study.

"We are encouraged by the efficacy and duration of response that we are seeing with defined composition CAR T treatment in patients with lymphoma and other B-cell malignancies," said Mark J. Gilbert, Juno’s Chief Medical Officer. "We hope that the insights from JCAR014 will make it possible to bring more life-saving treatments to more patients with blood cancers."

In addition to Fred Hutch researchers, the study team also included scientists from Juno and the University of Washington. Juno provided one of the trial’s sources of funding, along with the National Institutes of Health, Washington state’s Life Science Discovery Fund and the Bezos Family Foundation.