Transgene SA’s drug to treat chronic hepatitis C has attracted the attention of about a dozen companies interested in helping to develop the product, Chief Financial Officer Stephane Boissel said.
Transgene, based near Strasbourg, France, is beginning talks today with potential partners on the compound, called TG4040, Boissel said in a telephone interview. Interim results of a mid-stage trial on 153 patients showed virus suppression that was “substantial” after 12 weeks of use of TG4040 in combination with the current standard of care, Transgene said in an e-mailed statement today.
“We have a dozen meetings” scheduled with potential partners, said Boissel, who called the efficacy results “excellent.” “That doesn’t mean we will strike a deal in the very close future. We have to discuss with them, present the data and then together elaborate a development plan.” He declined to name the companies Transgene will be meeting.
Novartis AG, Abbott Laboratories and Roche Holding AG are some of the drugmakers developing experimental treatments for hepatitis C, which is caused by a virus that leads to chronic disease in 75 percent to 85 percent of those infected, according to the U.S. Centers for Disease Control and Prevention. About 3.2 million people in the U.S. are infected, the CDC says on its website.
“Big pharma, large biotechs, all the usual suspects in the hepatitis C field could potentially be interested in this compound,” Boissel said. He wouldn’t elaborate further. Transgene, whose biggest shareholder is the French family headed by Alain Merieux, aims to reach a partnership agreement on TG4040 during 2012 or 2013, Boissel said.
The compound came under scrutiny last month after Transgene said three patients in the mid-stage trial, dubbed HCVac, developed blood disorders, prompting the company to propose changing the study’s design. These side effects are still under investigation and it will probably take about six to 12 months to draw conclusions, Boissel said.
In an early-stage trial involving about 40 patients who hadn’t received treatment for hepatitis C, no such side effects occurred, he said. Those patients received “much larger” doses of TG4040 than patients in HCVac, according to Boissel.
Also, no side effects were reported at the beginning of the mid-stage study in those patients who were only administered TG4040, he said. The three adverse events occurred only after patients started taking other treatments on top of TG4040, he said. This may have induced “blood toxicities,” Boissel said.
Given that no blood disorders were reported in patients who took only TG4040 and “given the magnitude of the efficacy data we have, we are confident we will be able to move this product forward,” Boissel said. For the time being “there’s no issue” with potential partners about the safety of TG4040, he said.
The HCVac trial is being conducted on three different groups of patients. In the first group, the so-called control arm, patients were treated with pegylated interferon alpha and ribavirin, the current standard of care for patients suffering from hepatitis C. In the other two arms, patients got shots of TG4040 on top of the standard of care. The difference between the two groups is the number of TG4040 injections and the lapse of time between the shots, Boissel said. In the third arm, TG4040 was introduced before the standard of care and no adverse events were reported then, Boissel said.
After 12 weeks, the study showed “substantial early viral suppression” in the third arm, with 64 percent of patients achieving early virologic response, the primary endpoint of the study, compared with 30 percent in the control arm. These results are being presented today at the American Association for the Study of Liver Diseases conference taking place in San Francisco, Boissel said.
Transgene said Oct. 11 it was changing the study’s protocol to avoid exposing patients to possible similar blood disorders. Patients on the trial will continue receiving standard of care but no other TG4040 injections, the company said.
“A good set of efficacy figures could help the market regain confidence in the potential of the drug,” Cedric Moreau, an analyst at Bryan, Garnier & Co. in Paris, wrote in an Oct. 12 note to clients. It also “could attract future partners interested in continuing the development of TG4040 in monotherapy or in combination with other drugs,” Moreau wrote.
Transgene could potentially enter “two or more” co-development partnerships for TG4040, “with different combinations,” he said.
Final data for the mid-stage TG4040 trial will be published during the fourth quarter next year, Boissel said. The drug is a so-called therapeutic vaccine designed to trigger the body’s immune system to prevent the virus from replicating.