Marseille, France-based Innate enlisted aseptic filling service provider Rentschler Fill Solutions (RFS) to support its Phase II trial of lacutamab, an anti-KIR3DL2 antibody in development as a treatment for the rare cancer cutaneous T-cell lymphoma (CTCL).
That relationship is now causing major problems for Innate. RFS recently withdrew the Certificate of Conformity for batches produced at its plant, including the supplies of lacutamab Innate needs for its Phase II CTCL trial.
The withdrawal of the certificate, which shows a batch conforms to agreed quality specifications, led Innate to stop administering lacutamab to new patients. That restriction will remain in place until Innate receives additional feedback from the regulatory agencies overseeing the trial.
Innate will continue treating patients who are already in the study, at least until further notice. The one exception to that plan is the portion of the trial taking place in Italy, where Innate has stopped dosing all patients in light of feedback from local regulatory authorities.
The problems have arisen despite RFS’ recent track record of regulatory compliance. The Austrian Agency for Health and Food Safety awarded RFS good manufacturing practice (GMP) certification in August 2018. The authority confirmed the certification two months ago, according to Innate.
While that suggests all was well at RFS, other events show the fill and finish service provider has been facing difficulties. RFS has filed for bankruptcy, according to Innate.
The events come early in the life of RFS. Rankweil, Austria-based RFS was founded in 2015 and, after building a facility and getting it certified by regulators, began GMP production in September 2018.
RFS had big plans when it began GMP production. The site RFS constructed in Rankweil has around 6,000 square metres of usable space, plus room for several phases of expansion that could take place without disrupting activities at the existing capacity.
Reinhold Elsässer, the former vice president of information service and organization at Rentschler Biopharma, was central to the rise of RFS, serving as its managing director from July 2016 and playing a key role in the conception and construction of the company. However, Elsässer left RFS earlier this year.
Friedrich Sernetz, formerly of Greek contract manufacturer Famar, took over as CEO of RFS in June but lasted only four months in the role. Sernetz is now working as an independent consultant.