On September 7, 2016 Fate Therapeutics, Inc. (NASDAQ:FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported a partnership with Memorial Sloan Kettering Cancer Center for the development of off-the-shelf T-cell product candidates using engineered pluripotent cell lines (Press release, Fate Therapeutics, SEP 7, 2016, View Source [SID:1234515009]). Research and development activities under the multi-year collaboration will be led by Michel Sadelain, M.D., Ph.D., Director of the Center for Cell Engineering and the Stephen and Barbara Friedman Chair at Memorial Sloan Kettering Cancer Center.

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"This partnership brings together Memorial Sloan Kettering’s excellence in the manufacture and delivery of cell-based immunotherapies, and our established expertise in pluripotent cell generation, engineering and differentiation," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Together, we are at the forefront of an off-the-shelf paradigm shift, seeking to broaden patient access to revolutionary T-cell immunotherapies through a renewable, robust and standardized product approach."

"Engineering therapeutic attributes into pluripotent cell lines, such as antigen specificity, lack of alloreactivity, enhanced persistence and histocompatibility, is a breakthrough approach to renewably generate potent T-cell immunotherapies," said Dr. Sadelain. "This unique approach offers the prospect for off-the-shelf delivery of T-cell immunotherapies with enhanced safety and therapeutic potential at the scale necessary to serve significant numbers of patients."

The collaboration unites research, preclinical development and manufacturing work currently being conducted independently at Fate Therapeutics and Memorial Sloan Kettering to accelerate the clinical translation of T-cell product candidates derived from engineered pluripotent cells. Collectively, the groups have amassed significant and complementary expertise necessary to deliver off-the-shelf T-cell immunotherapies, including the engineering, maintenance and expansion of induced pluripotent cell lines and the scalable generation of T cells with enhanced safety profiles and effector functions.

In connection with the partnership, Fate Therapeutics has exclusively licensed from Memorial Sloan Kettering foundational intellectual property covering induced pluripotent cell-derived immune cells, including T cells and NK cells derived from pluripotent cells engineered with chimeric antigen receptors, for human therapeutic use. Additionally, Fate Therapeutics maintains an option to exclusively license intellectual property arising from all research and development activities under the collaboration.

Off-the-Shelf Immunotherapy Opportunity
Cellular immunotherapies are poised to transform the treatment of cancer and immunological conditions. However, cellular immunotherapies currently undergoing clinical investigation are patient-specific and their delivery requires the extraction, engineering, expansion and re-introduction of each individual patient’s T cells. This multi-step manufacturing process is logistically challenging and complex, and significant hurdles remain to ensure that patient-specific T-cell immunotherapies can be efficiently and consistently manufactured, and safely and reliably delivered, at the scale necessary to support broad patient access and wide-spread commercialization.

Induced pluripotent cells possess the unique dual properties of self-renewal and differentiation potential into all cell types of the body including T cells. Similar to master cell lines used for the manufacture of monoclonal antibodies, engineered pluripotent cell lines can repeatedly deliver clonal populations of T cells with broad histocompatibility and enhanced effector functions. These highly-stable pluripotent cell lines have the potential to serve as a renewable cell source for the consistent manufacture of homogeneous populations of effector cells for the treatment of many thousands of patients.

Exclusive License & Development Plan
Through the three-year collaboration, the group aims to leapfrog the field’s current patient-specific approach to T-cell immunotherapy. Over the last decade, Fate Therapeutics has developed a proprietary, patent-protected platform to efficiently generate, genetically engineer, isolate and bank pluripotent cell lines. Memorial Sloan Kettering is leading the field in generating pluripotent cell-derived, tumor-targeting T cells that are capable of profound tumor clearance in vivo. The scientific teams will combine forces to create pluripotent cell lines that have been engineered for enhanced antigen specificity and functionality, optimize T-cell differentiation protocols, and clinically translate off-the-shelf engineered T-cell product candidates.

New Subsidiary Formed
Fate Therapeutics has also launched a new venture company, Tfinity Therapeutics, Inc., which will focus exclusively on the advancement of off-the-shelf T-cell immunotherapies across a wide range of diseases using Fate’s proprietary, patent-protected pluripotent cell platform. Fate Therapeutics has an intellectual property portfolio consisting of over 60 issued patents and 90 pending patent applications, which are owned or exclusively licensed by Fate Therapeutics, that cover compositions and methods critical for deriving, engineering, maintaining and differentiating induced pluripotent cells. Tfinity Therapeutics is a majority-owned subsidiary of Fate Therapeutics, and holds an option to license from Fate Therapeutics intellectual property covering pluripotent cell-derived T-cell immunotherapies.

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.

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.

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"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.

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.

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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