BioWorld Assistant Managing Editor

Five-year-old French biotech Cerenis Therapeutics SA pulled in its third major venture round, adding €40 million (US$51.9 million) in Series C funding to advance its lead program, HDL-mimetic CER-001, into Phase II testing in cardiovascular disease.

Led by new investor FSI (Fund for Strategic Investment), which contributed €20 million, Cerenis' latest financing is the third largest European venture round in biotech this year, coming behind only Archimedes Pharma Ltd.'s £65 million (US$96.6 million) in March and AiCuris GmbH & Co.'s €50 million round in April.

To date, Toulouse, France-based Cerenis has raised €107 million. Co-founder and CEO Jean-Louis Dasseux attributed investor interest to the management team, the multibillion-dollar opportunity in cardiovascular disease and the fact that lead product CER-001, based on natural apolipoprotein A-I, stands out "in a field plagued with issues of manufacturing," he said.

Not that the approach of treating heart disease by raising high-density lipoprotein – the "good" cholesterol – has ever been easy. Pfizer Inc., for instance, left many investors disappointed a few years ago when patient deaths put the kibosh on a clinical program for torcetrapib, a compound designed to boost HDL by inhibiting cholesteryl ester transfer protein, and cast doubt on that entire CETP class.

And working on ApoA-I-based compounds has had its own challenges. In the past, there was no way to produce ApoA-I in a large scale and in a commercially viable process, Dasseux said.

ApoA-I has a high affinity for endotoxin, so production using an expression system based on bacteria such as E. coli wouldn't work. Cerenis' technology involves the use of a nonendotoxin cell system, like lactic acid bacteria, which is able to produce the recombinant protein.

"In the end, we have highly purified ApoA-I," Dasseux told BioWorld International, adding that "there were no drug-related adverse events in Phase I."

Cerenis is set to move into Phase II testing shortly, with a large IVUS (intravascular ultrasound) trial designed to test the ability of CER-001 to show plaque regression in patients with acute coronary syndromes. Funds from the Series C round are expected to get CER-001 through proof of concept, as well as advance other pipeline programs, including the expansion of CER-001 in orphan diseases and moving forward with CER-002, a peroxisome proliferator-activated receptor delta-specific agonist, in cardiovascular diseases.

The company should be financed until 2013, by which time "we should have results from the IVUS trial and results on a potential orphan disease indication," Dasseux said.

In addition to FSI, the Series C included participation from existing investors Sofinnova Partners, HealthCap, Alta Partners and TVM Capital, EDF Ventures, OrbiMed and Daiwa Corporate Investment.

Along with the financing, Cerenis also said it appointed Jean-Pierre Garnier to its board. Garnier, formerly the CEO at GlaxoSmithKline plc, will be a "very good complement" to the firm's board and management team, Dasseux said.

Cerenis, which has operations both in France and in Ann Arbor, Mich., is staffed by 26 employees, but Dasseux estimated that roughly 200 people outside the firm are assisting with its development programs.

In fact, Cerenix and manufacturing specialist Groupe Novasep, of Pompey, France, recently received €10.7 million in funding from the French government for development of CER-001. The two firms have collaborated sicne 2007, with about 50 Novasep staff members working on CER-001.

Under the funding and an expanded agreement, Novasep is handing global manufacturing of clinical and initial commercial supplies for CER-001's orphan development program.

Published  July 28, 2010