Viral Immunotherapy Trial Failure Causes French Biotech Stocks to Drop 43%

genticel hpv neoplasm phase II fail

Genticel (France) is a clinical biotech developing a cervical cancer immunotherapy against the Human papillomavirus. However, their 24-month phase II trial has failed to meet primary endpoint at its halfway point, and their stocks dropped 43% overnight. 

genticel_hpv_biotechAround 70% of cervical cancer cases are caused by 2 types of Human papillomavirus (HPV): 16 and 18. And among the 300 million women around the world currently infected with HPV, there is a strong relationship to the development of Cervical cancer (of which 275,000 women die each year).

Genticel aims to the address the risk of Cervical cancer at an early stage with GTL001, its first immunotherapeutic candidate to act against the infection. Branded ProCervix, GTL001 is a bivalent HPV vaccine. However, it is only designed for treatment of HPV infection before the appearance of high-grade cervical lesions or cancer.

The transformation of all cells of the epithelium means cervical cancer – and from HPV infection to cervical carcinoma usually takes 5 to 15 years. More than 50% of invasive cervical cancers are lethal… (Source: Genticel)

The phase II trial with GTL001 (being used with imiquimod) has enrolled 239 patients across 7 Western European countries and is only at its midway point. Nonetheless, given the 12 month mark data failed to meet primary endpoint (i.e. virus clearance rate of the HPV infection), morale has taken a turn for the worse with investors.

Stocks opened this morning at €3.55, after a €6.25/share price closure last night; a 43% drop in value. So what does this mean for this biotech – can they recover from such a disappointing set of results, and will they continue with their GLT001 program?


Genticel’s Stock dropped 43% since yesterday, with shares opening at 3.55 each. #oops (Source: Google Finance)

Well Genticel has issued a statement with surprising optimism – and as the trial continues to extend to an 18-24 month period, there could still be hope for the program yet. As the CEO of Genticel, Benedikt Timmerman, explained:

The analysis to date shows clear separation in the viral clearance rates in two key subgroups and support our expectations to see superiority in viral clearance in the treated group at 18 months.”

He also concluded, that despite this stockdrop, Genticel had €21.7M in cash & equivalents at the end of the last financial year and therefore enough enough financial resources to complete this 24-month duration study.

And indeed as of 10am this morning, the value price already seems to be climbing again, so perhaps this is not such as disastrous turn of events after all… Genticel now have until the 18-month mark to deliver statistically significant results – the requirement for this potential Cancer prophylactic to progress to phase III.

Literally, time will tell. 

Feature Image Credit: Human Papilloma Virus © Lexxlam (BigStock ID96761777)

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