Cullinan Therapeutics, Inc. (NASDAQ: CGEM) has received approval to initiate its global phase 1 clinical trial of CLN-978 for the treatment of systemic lupus erythematosus (SLE). The trial, which is designed to assess the safety, pharmacokinetics, and initial clinical activity of CLN-978 for SLE patients, will be conducted in multiple sites in Australia as well as in other countries around the world.
SLE affects approximately 430,000 individuals globally, and currently available treatments do not routinely induce treatment-free remission. CLN-978 is a novel CD19 bispecific T cell engager designed to deliver T cell-directed potency with off-the-shelf access and convenient dosing.
Cullinan Therapeutics recently announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for this study. CLN-978 is described as a novel, highly potent, half-life extended CD19xCD3 bispecific T cell engager construct, which has the potential to offer a convenient, off-the-shelf therapeutic option for patients with autoimmune diseases such as SLE and rheumatoid arthritis.
SLE is a chronic, heterogeneous autoimmune disease in which the immune system attacks a patient’s own tissues. It affects approximately 430,000 individuals globally, with the most common manifestations including skin rashes, arthritis, swelling in the feet and around the eyes, extreme fatigue, and low fevers. Lupus nephritis (LN), a kidney disease, is the most common severe manifestation of SLE, and approximately 40% of patients with SLE develop LN, which has a 10-year 30% mortality rate.
Cullinan Therapeutics, Inc. is a biopharmaceutical company focused on creating new standards of care for patients with a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. The company's portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
This is a significant development in the field of autoimmune diseases and could potentially offer new hope for patients suffering from SLE and other related conditions. As a result of these announcements, the company's shares have moved -5.7% on the market, and are now trading at a price of $16.93. For the full picture, make sure to review Cullinan Therapeutics's 8-K report.
