Immunovant, the U.S. partner of Hanall Biopharma, said it would develop additional indications for HL161 (batoclimab), an autoimmune disease treatment candidate it licensed from Hanall. Accordingly, Hanall Biopharma is expected to receive an additional milestone payment from Immunovant.
In a conference call on Wednesday, Immunovant unveiled its plan to develop HL161 (batoclimab).
After Immunovant licensed in HL161 from Hanall Biopharma in 2017, Immunovant named the investigational drug IMVT-1401.
Immunovant said it would resume developing HL161 to treat thyroid eye disease (TED), an autoimmune disorder. The company said it received FDA’s approval for a phase 3 trial of HL161 to treat TED.
Earlier, Immunovant had suspended a phase 2b trial in TED due to a trial participant’s LDL cholesterol level increase.
On the latest conference call, Immunovant predicted it would start a phase 3 TED trial in the second half of this year and hoped to see the results in 2025.
Pete Salzmann, CEO of Immunovant, said TED represents an unmet need despite recent therapeutic innovation.
“In our TED phase 2 program, we observed batoclimab’s potential to provide deep reductions of stimulating anti-TSHR autoantibodies,” he said.
Also, Immunovant is to initiate a phase 3 study of batoclimab in myasthenia gravis (MG) in June and expects to gain a top-line outcome in the second half of 2024. Within the U.S., about 66,000 people suffer from MG, the company said.
Immunovant said it would announce two new indications of batoclimab in August, in addition to the three under development – TED, MG, and warm autoimmune hemolytic anemia.
Hanall Biopharma’s Chinese partner, Harbour BioMed, is developing HL161 to win five indications – MG, TED, thrombocytopenia, optic neuromyelitis, and chronic inflammatory polyneuropathy.
However, Hanall Biopharma said Immunovant has yet to share which new indications the U.S. company plans to add.
Jeong Seung-won, CEO of Hanall Biopharma, said, “As HL161 comes in a subcutaneous injection, allowing patients to administer the drug themselves conveniently, it will reduce the medical expense by saving hospital visits.”
“We will continue to expand HL161’s indications to contribute to more patient lives.”