Boehringer, Hanmi to develop third generation EGFR targeted therapy in lung cancer

Boehringer Ingelheim has entered into an exclusive license and collaboration agreement with Hanmi Pharmaceutical for the development and global commercialisation rights of HM61713, a new third generation EGFR targeted therapy to treat EGFR mutation positive lung cancer.

HM61713 is a new 3rd generation, orally active, irreversible EGFR mutation selective tyrosine kinase inhibitor (TKI).

As part of the deal, Hanmi will receive an initial payment of $50m and is entitled to potential milestone payments of $680m plus tiered double-digit royalties on future net sales.

The deal is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, similar requirements outside the US, and other customary closing conditions.

The global commercialisation rights exclude countries such as South Korea, China and Hong Kong.

Boehringer Ingelheim Therapy Area Head Oncology corporate senior vice-president Dr Jörg Barth said: “This exclusive license agreement with Hanmi Pharmaceutical is a significant step towards our vision of providing a wide-range of lung cancer treatment options as we better understand the underlying drivers of this devastating disease.

“The in-licensing of a third generation EGFR agent bolsters our existing lung cancer portfolio and reiterates our commitment towards improving the lives of people with cancer through innovation and tailored treatment options.”

Recently, the company has reported interim results of the Phase I/II clinical trial which showed strong efficacy signals, combined with a favourable safety profile.

Currently, the compound is in Phase II clinical development for patients with non-small cell lung cancer (NSCLC) with T790M mutations who have developed resistance to previous EGFR targeting agents.

The company has also started preparations for a broader Phase III trial program, which is scheduled to be started next year.

With the inclusion of HM61713, the company now has more than ten compounds in clinical development in a wide variety of oncology indications, including immune oncology approaches like an mRNA based therapeutic vaccine under development in collaboration with CureVac.