Case closed: CRO to pay ‘vindicated’ Cel-Sci $2.9m in damages

By Flora Southey

- Last updated on GMT

Cel-Sci has won the breach of contract ruling against its former CRO inVentiv, after it “slowed down clinical development of Cel-Sci’s Phase III cancer immunotherapy,” says CEO.

More than four years after filing an arbitration suit against Cel-Sci Corporation’s former contract research organisation (CRO) inVentiv, now known as Syneos Health​, the immunotherapy developer announced it had been awarded $2.9m (€2.5m) for damages.

According to Cel-Sci, the judge found inVentiv had “materially breached its contract with immunotherapy developer, Cel-Sci, knowingly misled Cel-Sci with respect to enrolment projections…and denied inVentiv all but one of its counterclaims against Cel-Sci.”

inVentiv’s actions slowed down clinical development of Cel-Sci’s Phase III cancer immunotherapy Multikine, said Cel-Sci CEO Geert Kersten in a statement​ released today: “The delays in the study caused by inVentiv not only delayed the potential approval of this investigational cancer drug by years, but it caused investors to wonder about the utility of the drug.

“Usually small companies do not win long legal battles against multi-billion dollar opponents, but we persevered and won our claim for breach of contract,” ​he said, adding: “With this ruling against inVentiv, we have been vindicated.”

As previously reported​, the arbitration concerns a Phase III trial of Cel-Sci’s Multikine (leukocyte interleukin, injection) – an immunotherapy candidate under development to treat patients with squamous cell carcinoma of the head and neck.

Cel-Sci had originally teamed with CRO PharmaNet to conduct the trial. inVentiv took over PharmaNet in 2011 and was charged with the Phase III study. After accusing inVentiv of failing to enroll a sufficient number of patients, Cel-Sci hired Ergomed and Icon’s Aptiv unit to take on the trial.

Cel-Sci filed​ the arbitration suit against inVentiv in October 2013, claiming an alleged breach of contract, fraud in the inducement, and common law fraud. inVentiv rejected Cel-Sci’s claims and, according to a document​ filed with the US Securities Exchange Commission (SEC) in April 2015, countersued Cel-Sci for breach of contract and defamation.

The immunotherapy developer completed enrolment for the Phase III trial, which it said​ is the largest Phase III study in the world for head and neck cancer, in September 2016.

“The patient volunteers in the study have all been treated…Cel-Sci believes that the end of the Phase III trial is approaching at which time the company will be able to assess efficacy data on the study’s primary endpoint,” ​said the firm’s CSO, Eyal Taylor, in a statement​.

Syneos Health did not respond to a request for comment ahead of publication.

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