Source: www.biopharmadive.com
Author: Joe Cantlupe

Dive Brief:

  • Transgene announced Tuesday it is teaming up with Merck KGaA of Darmstadt, Germany, and Pfizer to evaluate the possibilities of the combination of its human papillomavirus (HPV)-positive head and neck cancer vaccine TG40001 with big pharma’s avalumab in a Phase 1/2 study.
  • The incidence of HPV-related head and neck cancers has increased significantly, with one variation, HPV-16 accounting for 90% of all HPV-related head and neck cancers. HPV-16 is a subset of head and neck squamous cell carcinoma (HNSCC), a group of cancers that can affect the mouth and throat. Global spending on head and neck cancer indications amounted to $1 billion in 2010, according to the companies’ recent estimates.
  • Current treatments for the disease include surgical resection with radiotherapy or chemo-radiotherapy; the companies say they are exploring better options for advanced and metastatic HPV and HNSCC.

Dive Insight:
The current deal between the big pharma partners and Transgene highlights the industry’s efforts to create combination therapies to treat cancer. Virtually every company in the space has embraced the idea that using multiple modes of attack could be the only way to eventually find cures for the many forms of cancer; companies have been teaming up in hopes of finding that crucial pairing.

In previous clinical trials, TG4001 has demonstrated promising activity in terms of HPV viral clearance and was well tolerated, according to Transgene. TG4001 is one of the few drugs targeting HPV-associated cancers that can be combined with an immune checkpoint inhibitor such as avelumab.

TG4001 is an active immunotherapeutic designed by Transgene to express the coding sequences of the E6 and E7 tumor associate antigens of HPV-16, and the cytokine, L IL-2. Avelumab is an investigational fully human antibody specific for a protein found on tumor cells called PD-L1. It is considered to have a mechanism that may enable an immune system to locate an attack cancer cells. In 2014, Merck KGaA and Pfizer signed a strategic alliance to co-develop and commercialize avelumab.

“The preclinical and clinical data that have been generated with both TG4001 and avelumab individually suggest this combination could potentially demonstrate a synergistic effect, delivering a step up in therapy for HPV- positive HNSCC patients,” said Philippe Archinard, chairman and CEO of Transgene, in a statement.

Christophe Le Tourneau, the principal investigator of the study, said HPV-induced head and neck cancers are now treated with the same regimen as non-HPV-positive HNSCC tumors, and that is not enough. “Their different etiology clearly suggests that differentiated treatment approaches are needed for HPV-positive patients,” he said in a statement. “Targeting two distinct steps in the immune response could deliver improved efficacy for patients who have not responded to or have progressed after a first line of treatment,” added Le Tourneau, who is also head of the Early Phase Program at Institut Curie.

This trial is expected to begin in France, with the first patients expected to be recruited in the beginning of 2017, said Le Tourneau. The companies will seek to recruit patients with recurrent and/or metastatic virus-positive oropharyngeal squamous cell carcinoma that have progressed after definitive local treatment or chemotherapy, and cannot be treated with surgical resection and/or re-irradiation.

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