Marseilles, France – Innate Pharma (Euronext Paris: FR0010331421 – IPH) reports positive results for its first Phase IIa clinical trial with IPH 1101 (a small-molecule ?? T cell agonist) in patients with type C viral hepatitis (“HCV”). In this open-label trial, two injections of IPH 1101 were administered to patients three weeks apart to chronically infected HCV patients. IPH 1101 was administered either alone (Arm A) or combined with low-dose interleukin-2 (“IL-2”; Arm B). The objective of this clinical trial was to detect a decrease of at least 0.50 log10 of the viral load in at least 6 patients out of 13 evaluable patients in each arm.
In Arm A, 5 out of the 13 (38%) evaluable patients showed a viral load decrease of at least 0.50 log10, with a median decrease of -0.69 log10 (+/-0.15). In Arm B, 7 patients out of 12 evaluable patients (58%) showed a viral load decrease of 0.50 log10 or more, therefore meeting the objective for the primary endpoint. The median decrease of responders in Arm B was -0.65 log10 (+/-0.13). Most of the patients included in the trial had genotype I HCV, the most difficult to treat. The viral load decrease correlated with biomarkers of immune activation, such as cytokine production, thus confirming the mode of action of ?? T cell stimulation on viral load decrease*. The tolerance was very good in this trial, with no serious adverse events reported.
About Innate Pharma
Innate Pharma S.A. (“the company”) is a clinical-stage biopharmaceutical company developing first-in-class immunotherapy drugs for cancer and other severe diseases. The company was incorporated in 1999 and listed on NYSE-Euronext in Paris in 2006. The company has significant expertise in identifying new targets and bringing novel drug candidates through to clinical proof-of-concept trials. It currently has seven proprietary drug candidates in development (two of which are in clinical trials with lead compound in Phase II clinical trial) and two programs out-licensed to Novo Nordisk A/S. Innate Pharma is based in Marseilles, France, and had 88 employees as at March 31, 2009. Learn more about Innate-Pharma at www.innate-pharma.com.
About type C chronic hepatitis (“HCV”):
According to data from the World Health Organization (WHO), 170 million people may be chronically infected by HCV worldwide. There are probably about 3 or 4 million new cases of hepatitis C per year (Source: UNAIDS and WHO, 2005). Hepatitis C is known to be a major cause of cirrhosis and primary liver cancer (hepatocellular carcinoma). Furthermore, decompensated HCV-related cirrhosis is the leading cause of liver transplantation in Europe (source: Direction Générale de la Santé, France). The standard treatment is based on a combination of interferon-? and ribavirin – both of which are aimed at blocking viral replication. This combination provides long-lasting control of the disease and prevents complications in about 50% of genotype 1 and 4 patients and about 80% of genotype 2 and 3 patients. Moreover, the length of the course of treatment (6 to 12 months) and the presence of side effects mean that only the most active forms of hepatitis C are treated.
About IPH 1101:
IPH 1101, Innate Pharma’s most advanced drug candidate, is a chemical agonist of unconventional ?9?2 T lymphocytes. It is a small-molecule, structural analogue of bacterial unconventional phospho-antigens. IPH 1101 very specifically activates populations of unconventional ?9?2 T lymphocytes. In oncology indications, it potentiates the direct cytotoxic activity of V?9V?2 T cells against a large number of tumor cell lines and triggers the synthesis of pro-inflammatory cytokines – thus inducing the recruitment of other cell effectors and facilitating implementation of an adaptive response. The addition of very low-dose IL-2 then enables amplification of the ?? T cell population. Among the cytokines released upon IPH1101 stimulation, several bear a well characterized activity against viral replication and others can allow the improvement of an adaptive immune response against the virus. IPH 1101 is being tested in a Phase IIa program in oncology and infectious disease indications (www.innate-pharma.com, section product / IPH 1101).
Innate Pharma Alize Public Relations
Laure-Hélène Mercier
Director, Investor Relations
Caroline Carmagnol
Phone: +33 (0)1 41 22 07 31
Phone: +33 (0)4 30 30 30 87 Mobile: +33 (0)6 64 18 99 59
lmercier@innate-pharma.fr caroline@alizerp.com
About Gilde Healthcare Partners
Gilde Healthcare Partners (www.gildehealthcare.nl) founded in 2000 is headquartered in Utrecht, the Netherlands with representatives in London and Madrid. Gilde Healthcare Partners has over EUR 275 million under management and is actively looking to lead new investments in therapeutics, diagnostics, medical devices and enabling technologies. Gilde is a successful builder of healthcare businesses across Europe. By investing in companies with clear achievable business models, Gilde has used its financial resources and network to create significant value for both its investors and the entrepreneurs it backs.
Companies that Gilde Healthcare Partners has pro-actively supported span all aspects of healthcare and include Ablynx (Belgium), Agendia (Netherlands), AMT (Netherlands), Ascendis (Denmark), Chroma Therapeutics (UK), Conatus (US), Flowcardia (US), Glycart (Switzerland), Innate Pharma (France), Santaris (Denmark) and Symphogen (Denmark). For a full list of Gilde’s portfolio companies please visit the website.