Novartis buys into Transgene’s lung cancer candidate

pharmafile | March 11, 2010 | News story | Research and Development Novartis, Transgene, immunotherapy, lung cancer 

French biotech company Transgene has signed a deal with Novartis for the future development and marketing of its potential lung cancer treatment.

Novartis has paid $10 million to gain exclusive rights to the targeted immunotherapy product, TG4010, which is set to enter a crucial phase IIb/III clinical trial by the end of 2010.

The deal could give Transgene a further €700 million ($950 million) if the drug reaches the market, plus royalties on sales.

TG4010 is one of a new breed of cancer treatments which behave like vaccines, stimulating the body’s own immune system to fight cancer cells. Numerous other companies are pursuing the same approach, but no product has made it to market so far.

TG4010 is designed to stimulate ‘Natural Killer’ cells (NK cells), a class of white blood cells (effector lymphocytes) that defend the body against several types of tumour and microbial infection.

The drug stimulates this response by mimicking MUC1, an antigen which 60% of patients with non-small cell lung cancer over-express.

The agreement will see Transgene fund and retain control over the pivotal, global phase IIb/III clinical trial, with Novartis taking the lead in further development if results from this trial are positive.

This study will involve around 1,000 patients with MUC1-positive NSCLC who have normal levels of activated Natural Killer (NK) cells at time of trial entry.

“We are delighted to have reached this agreement with Novartis and believe they will be an excellent partner for TG4010, given their broad expertise, experience and resources in oncology and their long standing world-class research and development capabilities in cancer immunology,” said Philippe Archinard, chief executive of Transgene.

“We believe this agreement represents the best way to accelerate development and create long term value for our shareholders. It is also consistent with the company’s goal of becoming a fully integrated biopharmaceutical company as under this agreement Transgene will maintain certain commercialisation and manufacturing rights.

“We now look forward to closely working with Novartis in order to rapidly advance the phase IIb/III development of TG4010 so that cancer patients may benefit from a new treatment option,” he added.

In total, Transgene has three compounds in phase II (TG4001/R3484, TG4010 and TG1042) and two compounds in phase I (TG4040 and TG4023). Transgene is working with Novartis’ Swiss neighbour and rival Roche on TG4001/R3484 to treat HPV-mediated diseases.

Other companies active in the field include Pfizer and GSK. Pfizer’s peptide vaccine, PF-04948568 is currently in phase II trials in patients with newly diagnosed glioblastoma.

PF-04948568 targets the mutated, tumour-specific variant III form of the epidermal growth factor receptor (EGFRvIII), which is present in about 25–40% of tumour vaccines.

GSK’s MAGE-A3 is one of the most advanced candidates in the field. Now in phase III development for non-small cell lung cancer, the immunotherapy could also be used in numerous other tumour types.

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