For 75 years, the standard tools for autoimmune disease have consisted of steroids, cytotoxics and broad biologics that tamp down the entire immune system. They can help, but they are rarely curative. “They’re blunt instruments,” Regcell Inc. CEO Mike McCullar told BioWorld. “They can’t distinguish good immune cells and bad immune cells,” which is why many carry black-box warnings and must be taken for years, sometimes for life.
Jiangsu Hengrui Pharmaceuticals Co. Ltd. and Shanghai Hengrui Pharmaceutical Co. Ltd. have disclosed non-receptor tyrosine-protein kinase TYK2 inhibitors and/or degradation inducers reported to be useful for the treatment of psoriasis, cancer, rheumatoid arthritis, asthma and more.
Kaigene Inc. has entered into an exclusive global licensing agreement with Celltrion Inc. for two of Kaigene’s nonclinical-stage assets, KG-006 and KG-002. Kaigene’s pipeline leverages its technology to selectively degrade pathogenic antibodies that mainly exacerbate various autoimmune diseases.
In atopic dermatitis (AD), the itch-scratch cycle is tied to skin inflammation exacerbation that accelerates the progression of the disease, thus impacting the patient’s quality of life, where IL-31 is crucial to induce skin itching. Helixon Ltd. has developed a bispecific antibody targeting both IL-31 and OX40L, HXN-1022, for the treatment of AD.
The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George Tidmarsh, a biopharma industry veteran who’s helmed CDER for a little more than three months, resigned effective immediately Nov. 2 after being placed on administrative leave two days earlier amid a Department of Health and Human Services probe.
Innovent Biologics Co. Ltd. presented data for IBI-3034, a chimeric Fc fusion protein comprising transmembrane activator and CAML interactor (TACI) and B-cell maturation antigen (BCMA) for the treatment of autoimmune diseases.
For 75 years, the standard tools for autoimmune disease have consisted of steroids, cytotoxics and broad biologics that tamp down the entire immune system. They can help, but they are rarely curative. “They’re blunt instruments,” Regcell Inc. CEO Mike McCullar told BioWorld. “They can’t distinguish good immune cells and bad immune cells,” which is why many carry black-box warnings and must be taken for years, sometimes for life.
Boehringer Ingelheim GmbH has licensed an unnamed small-molecule preclinical candidate from Kyowa Kirin Co. Ltd. in the autoimmune disease space in a deal worth up to €640 million (US$739 million).
Vera Therapeutics Inc.’s atacicept gained still more airtime at the Cantor Fitgerald health care conference held Sept. 4, and some on Wall Street believe the appetite for the BAFF and APRIL dual inhibitor could bode well for others in the same mechanistic space.
Kali Therapeutics Inc. has developed a novel T-cell engager (TCE) bispecific antibody, KT-502, targeting CD19 and CD3 for the treatment of autoimmune diseases, including systemic lupus erythematosus and rheumatoid arthritis.
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