Light Chain, Takeda Reach Key Milestone in Partnership Developing Bispecific Antibodies for Treating Hemophilia A

Light Chain Bioscience, a unit of Swiss biotech Novimmune, has completed the discovery phase of its collaborative program with Takeda for developing bispecific antibodies — protective proteins produced by the immune system — that mimic the activity of blood clotting factor VIII as a treatment for hemophilia A.

The agreement was signed in 2017, originally between Shire — now part of Takeda — and Novimmune. Under the original agreement, Shire acquired the global rights of antibody-based therapies that Novimmune developed to treat hemophilia A.

Now, with the completion of the program’s discovery phase, Light Chain will be eligible to receive a milestone royalty payment from Takeda. However, financial details have not been disclosed.

“We are extremely excited to have reached this important milestone in our collaborative program. The successful identification and optimization of new therapeutic candidates adds to the validation of our bispecific antibody discovery expertise,” Nicolas Fischer, CEO of Light Chain Biosciences, said in a press release.

“It has been a very fruitful collaboration and a unique learning experience for us to work with Takeda to develop a bispecific approach for an indication such as hemophilia A,” Fischer added.

A missing or defective blood clotting protein called factor VIII (FVIII) causes hemophilia A. The lack of this protein compromises the body’s natural coagulation signaling cascades — part of its blood clotting system — which include two other coagulation factors, called factors IX (FIX) and X (FX).

A bispecific antibody has the ability to bind to two different targets simultaneously. It mimics how FVIII would normally bind and interact with both FIX and FX to ensure proper blood clotting.

The goal of the partnership between Takeda and Light Chain is to create a new therapy that is more effective and safe compared with current recombinant and plasma-derived factor VIII replacement therapies. If successful, the new therapy may become a future contender of Roche’s Hemlibra (emicizumab).

Hemlibra is a bispecific antibody that targets both FIX and FX. It currently is the only prophylactic, or preventive therapy that can be given to people with and without FVIII inhibitors through subcutaneous (under-the-skin) injections and multiple dosing regimens (once weekly, or every two or four weeks).

The U.S. Food and Drug Administration (FDA) approved Hemlibra in November 2017 as a routine preventive treatment for those with hemophilia A with factor VIII inhibitors. The therapy was approved for the same use by the European Commission (EC) in March 2018.

It was later approved to also treat those without FVIII inhibitors, first by the FDA in October 2018, and then by the EC in March 2019.