Dive Brief:
- Virginia-based biotech Cel-Sci touted a victory over contract research organization inVentiv (now Syneos Health) in a breach of contract arbitration related to the Phase 3 trial of its immunotherapy Multikine in the treatment of patients with head and neck cancer.
- The CRO was hired to conduct the clinical trial from 2011 to 2013. An arbitrator found inVentiv knowingly misled Cel-Sci about projections for study enrollment, which reached 117 patients during the CRO's time overseeing the trial.
- Cel-Sci originally hired the CRO Pharmanet in 2010 (which was later acquired by inVentiv) with the intent of enrolling 880 patients within 15 to 18 months. The trial was originally slated to end in late 2015. Cel-Sci terminated the contract in April 2013 and instead sought the services of CROs Ergomed and Icon.
Dive Insight:
Cel-Sci calls itself vindicated after years of arbitration. The small biotech touted its win, calling the decision the "first ever decision in favor of a pharmaceutical/biomedical company against a CRO for breach of contract" and noting that "small companies do not win long legal battles against multi-billion dollar opponents."
Cel-Sci is far from the first small company to cry foul about CRO conduct, however. Many small biotech execs have talked about the difficulties of working with large contract researchers and how many have felt their trials got neglected in favor of larger pharma clients. (Read more about the challenges of working with a CRO.)
"InVentiv's actions slowed down the clinical development process of our Phase 3 cancer immunotherapy Multikine. 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. This affected the reputation and share price of the company." said Cel-Sci CEO Geert Kersten in a statement.
InVentiv will be responsible for the arbitrator's fees.
While the ruling came down in Cel-Sci's favor, the delays related to Multikine's development certainly cannot be all attributed to inVentiv, or to the enrollment issues.
Multikine exemplifies the pitfalls that can befall a small biotech with limited funding. The immunotherapy has been in development since 2003 and did not begin the Phase 3 trial until 2011. Cel-Sci eventually enrolled its target 880 patients, but was further delayed when the event rate in the trial was too slow and the company realized more patients were needed. The trial eventually enrolled roughly 928 patients.
Further complicating matters for the company — and also putting pressure on the share price — was a partial clinical hold placed on the trial by the Food and Drug Administration in 2016. The agency cited unreasonable and significant risk of illness, the absence of prompt reports to the Independent Data Monitoring Committee, errors in the investigator brochure and deficiencies in the protocol.
The hold was lifted almost a year later in August 2017, and the study has yet to report out final results.
Cel-Sci stock hasn't exactly been a winner over the last several years. The stock was trading as low as 50 cents in 2010 and is currently trading around $1.50 per share. Shares hit a 52-week high of $3.66 on June 18.
At the time of publication, Syneos Health (formerly inVentiv) did not respond to requests for comment.