Immunic Will Develop IMU-856, Promising IBD Therapy

Immunic Will Develop IMU-856, Promising IBD Therapy

Immunic earned the exclusive rights to develop a group of innovative disease-modifying therapies, now renamed IMU-856, for inflammatory bowel disease (IBD).

IMU-856, originally developed by Daiichi Sankyo, is an oral small molecule whose target is yet undisclosed but is a key player in the onset and relapse of both forms of IBD, ulcerative colitis and Crohn’s disease.

“We are very excited that Daiichi Sankyo selected the Immunic team as their partner to take over the future development of this unique drug candidate,” Daniel Vitt, CEO of Immunic, said in a press release.

“During the last two years, we reviewed multiple therapeutic products in the field of IBD and we are convinced that the disease-modifying concept of IMU-856 offers outstanding new therapeutic potential for patients suffering from ulcerative colitis and Crohn’s disease,” Vitt said.

The therapy’s mode of action is not immune-modulatory, meaning that the immune system’s surveillance is maintained.

“This product offers unique potentially disease-modifying properties and will act in a way that is very different from all currently available therapies. Most therapies for IBD patients act by unintentionally decreasing the body’s immune surveillance, resulting in higher risks regarding, for example, infections or malignant tumors,” said Andreas Mühler, MD, chief medical officer at Immunic AG.

Daiichi Sankyo identified IMU-856 after a systematic screening and selectivity assessment for its target and structure. Moreover, IMU-856 was validated in genetic studies and in animal models of IBD.

IMU-856 is currently undergoing preclinical testing and its first-in-human Phase 1 trial with healthy volunteers is expected to begin in the near future.

Daiichi Sankyo has decided to out-license IMU-856 despite its high potential as a highly selective disease-modifying IBD therapy, because IBD is not in the company’s commercial objectives. The company will receive a one-time payment and is eligible for milestone payments and royalties.

“We are delighted that Immunic takes over development responsibility for IMU-856 which was developed by Daiichi Sankyo VSL researchers. We recognize Immunic AG as a leading expert for IBD and the underlying technology of the target and we are convinced that IMU-856 has the highest chance of success in the hands of the Immunic team,” said Takashi Fukuoka, Head of Venture Science Laboratories (VSL) at Daiichi Sankyo.

“There is a high need for effective therapies in IBD that offer long-term relapse-free treatment of IBD patients while maintaining the full immune competency. The Immunic team believes that IMU-856 due to its innovative mechanism of action may be developed into such new option for IBD patients,” Mühler said.

Furthermore, the agreement gives Immunic the opportunity to combine this therapy with its own molecule IMU-838, an oral immune modulator, currently in a Phase 2 trial in patients with ulcerative colitis.  “Targeting acute inflammation with IMU-838 and combining this concept with the complementary mode of action of IMU-856 could lead to a big step in the therapy of IBD beyond the current state-of-the-art in this disease,” said Hella Kohlhof, chief scientific officer at Immunic AG.