Thermo Fisher collaborates with Ortho Clinical Diagnostics

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, has announced an international distribution and co-promotion agreement with Thermo Fisher Scientific to provide 14 assays used to monitor therapeutic drugs, immunosuppressive drugs and drugs of abuse. 

The agreement is part of Ortho's ongoing MicroTip Partnership Assays program, through which Ortho collaborates with other diagnostics companies to validate and deliver a broad range of assays to the hospitals, hospital networks and labs who use Ortho's VITROS 4600 Chemistry System and VITROS 5600 Integrated System. 

The immunosuppressive drugs tests covered by this agreement are used to monitor transplant patients to prevent over-suppression or organ rejection, while the therapeutic drug tests are used to confirm drug levels in the body and monitor compliance and toxicity. The testing menu for drugs of abuse is used to monitor both illicit and prescription drugs in cases of suspected abuse.  It includes tests used to monitor and treat opioid addiction and those used to check levels of pain medication. The assays will initially be launched in North America, Europe, Africa and the Middle East.

Constellation Pharmaceuticals, located in Cambridge, Massachusetts, closed on a financing round worth $100 million. New investors included Cormorant Asset Management, Deerfield Management, Fidelity Management and Research Company, Hillhouse Capital, NS Investment, OrbiMed, Sirona Capital, and Venrock Healthcare Partners. Current investors also participated, including The Column Group, Third Rock Ventures, Venrock, SROne, University of California Investment Office, Topspin Partners, and Casdin Capital.

The company plans to use the funds to advance several clinical trials. The two primary programs ProSTAR and ORIOn-E clinical trials, which will evaluate CPI-1205 to improve the effectiveness of current-generation androgen inhibitors in metastatic castration-resistant prostate cancer as well as cancer immunotherapies in other solid tumors, respectively. Constellation also expects to continue advancement of CPI-0610, a clinical-stage candidate for myelofibrosis as a single treatment or as a combination treatment with a JAK inhibitor. It also has a second-generation EZH2 program that it wants to move into the clinic.

"We are thrilled to welcome this new group of high-quality investors, and we are grateful for the continued support from our existing investors," said Jigar Raythatha, Constellation’s president and chief executive officer, in a statement. "Their strategic guidance and financial support will be instrumental to help accomplish our goal of improving outcomes for cancer patients. This financing gives us additional flexibility and runway to pursue the clinical development of CPI-1205 and CPI-0610, our lead product candidates, as well as advance other novel molecules from our cancer epigenetics platform into development."

Constellation launched in 2008. In 2012, Constellation signed a partnership deal with Genentech, which had a $95 million upfront fee. The two companies were to work on a new epigenetic compound, and at the end of the three-year period, Genentech had an option to buy out Constellation. However, in August 2015, Genentech and Constellation parted ways.

Constellation’s chief executive officer at the time, Keith Dionne, told FierceBiotech, "Genentech ended up wanting to cherry pick." Instead of buying the entire company, Genentech wanted to choose which parts of the pipeline it wanted and transfer it to Genentech headquarters in South San Francisco, basically shuttering Constellation.

Raythatha returned to take over the company in March 2017. He had led corporate development at Constellation but had left in 2013 to be chief business officer at Jounce Therapeutics. When asked why he came back, he said, "I really loved the science and the opportunity to return was really attractive. When I looked at the pipeline, I think it’s very rare to find a company with as broad, robust and deep a pipeline as Constellation had."

Constellation focuses on the relatively new science of epigenetics, which is how genes are turned on and off. For example, when some genes are methylated—acquire a molecule made up of a carbon atom and three hydrogen atoms—it is turned on or off under specific environmental or inherited situations.

Raythatha recently said in an interview with FierceBiotech that the company was planning to "tune up" or "tune down" genes implicated in certain diseases. For example, CPI-1205 blocks the enzyme EZH2, and is being evaluated in a Phase I dosing trial with androgen inhibitors Pfizer/Astellas’ Xtandi and Xytiga in prostate cancer.

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