Transgene SA (TNG) expects to start enrolling patients for advanced tests of its experimental lung cancer medicine as early as next summer after a mid-stage trial helped determine which people are most likely to benefit.
The intermediate trial, whose preliminary results the company released today, suggests the medicine known as TG4010 is well tolerated and showed researchers they needed to refine the criteria used to select non-small cell lung cancer patients.
Novartis AG is considering whether to buy rights for the product from Transgene, which stands to get as much as 700 million euros ($951 million) from the deal. The Swiss drugmaker will have 90 days to decide whether to exercise its option once Transgene submits a report on the latest study by mid-month, Chief Executive Officer Philippe Archinard said in a phone interview.
“We can move into phase 3 with this product and this biomarker,” Archinard said. “We hope to be able to have the first patient in phase 3 in the summer.”
The part of the trial whose results were unveiled today was designed to help identify patients who may respond best to the treatment by measuring a biomarker known as TrPAL, Illkirch, France-based Transgene said in an e-mailed statement today. The research shows the level of TrPAL used to select patients needs to be adjusted to a lower threshold.
“Under this new threshold we have very positive data,” Archinard said. “That said, Novartis has its own way of assessing things. We can’t speak for them.”
TG4010 is often described as a vaccine because it’s designed to stimulate the immune system to fight cancer. The number of new lung cancer cases in the U.S. probably reached 228,190 last year, according to estimates by the American Cancer Society. Non-small cell lung cancer is the most common form of the disease.
The French biotechnology company, controlled by the billionaire Merieux family, will meet regulatory authorities to discuss the next level of tests and the best threshold for patient selection, it said in the statement.
The product may garner as much as $1 billion in annual sales, Transgene Chief Financial Officer Stephane Boissel said in a July 12 interview.
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