Genticel said today it could shrink its workforce approximately 30% by deferring earlier plans to ramp up industrial GMP production at commercial scale of its lead product, the cervical cancer immunotherapy GTL001.
Genticel had 33 employees as of November 2015, according to a corporate profile posted by the company on its website.
The company plans to eliminate eight to 10 people once the workforce reduction takes full effect in four to five months, Valerie Leroy, senior director, corporate communications and investor relations, told GEN this morning.
“According to French law, the proposed workforce reduction still needs 1) to be discussed with employee representatives, 2) be approved by the relevant regulatory body, and then 3) a notice period between 1 to 3 months will apply,” Leroy said.
The company's workforce elimination disclosure was tucked within a press release announcing 2015 annual results and a strategic update for this year. Genticel said its workforce reduction would occur in the company’s Labège laboratories and in support functions.
In its announcement, Genticel said it will continue work on a pair of ongoing clinical trials for GTL001, a Phase II study in Europe, and a Phase I study in the U.S.
On January 27, Genticel reported initial results from the Phase II trial, designed to clear human papillomavirus (HPV) types 16 and/or 18 infection. The company acknowledged that there was no statistical difference in viral clearance between treatment and placebo in the overall study population at 12 months—but added that it saw a clear separation in results from two predefined subgroups, patients with normal cytology and patients less than 30 years old.
According to the company, GTL001 is more than halfway through the Phase II trial, a 24-month proof-of-concept study involving 39 investigation sites in seven Western European countries. Data at 15, 18, and 24 months is intended to confirm the design of further clinical developments—either in the overall population before high-grade lesions or in subgroups including the largest target group, HPV 16/18-positive patients with normal cytology (NILM).
As a result, Genticel said, Phase III preparation activities will begin only once the Phase II data has been obtained and analyzed. The company said it will defer by 12 months earlier plans for industrial GMP production at commercial scale for GTL001 Phase III, as well as semi-industrial production planned for a Phase I trial of another Genticel cervical cancer candidate, GTL002.
GTL002 is a multivalent HPV immunotherapy designed to target six of the most relevant HPV types, including HPV 16 and 18, which collectively cause 85% of cervical cancer. GTL002 generated “very encouraging” preclinical results last year, according to Genticel—namely achievement of proof of concept, demonstrating simultaneous delivery of multiple antigens of several oncogenic HPV types using the Vaxiclase technology, with in vivo induction of antigen-specific T cell responses and E7 oncoprotein-specific tumor regression.
The U.S. study began after Genticel submitted an IND for GTL001 to the FDA and was granted IND status in June 2015. The first of 20 patients planned for that study was treated in October 2015, and results are expected in Q3 2016, Genticel said.
[This report updates an earlier version to include comment from a Genticel representative].