A drug cannot be transported or distributed across state lines until its marketing application has been approved/cleared, so getting this clearance is crucial for many drug developers and physicians who are working to run clinical studies. Clearance comes in the form of an approved Investigational New Drug (IND) application. In December 2023, biotechnology company Century Therapeutics, Inc. shared via news release that the FDA cleared its IND for CTNY-101, an investigational immunotherapy. The company may now proceed to run a Phase 1 clinical study evaluating CTNY-101 for people with moderate-to-severe lupus for whom two prior immunosuppressive therapies have not worked.

What is CNTY-101?

Developed using Century Therapeutics’ proprietary Allo-Evasion™ technology, CNTY-101 uses iPSC-derived NK cells with a CD19-directed chimeric antigen receptor. Armed with multiple genetic edits, CNTY-101 can evade the immune system, avoiding CD8+ T cell, NK cell, and CD4+ T cell recognition. This means that individuals can be dosed multiple times without the immune system rejecting the treatment. Century Therapeutics believes that CNTY-101’s unique formulation will allow for easier dosing, better tolerability, and better safety than currently available therapies. Further, the company hopes that CNTY-101 will allow users to experience more remission while decreasing the risk of morbidity (death).

In the Phase 1 clinical study, researchers will evaluate how safe and well-tolerated the treatment is. Further, they will look at clinical response and pharmacokinetics. Data from the study should be available later this year.

Outside of lupus, Century Therapeutics is exploring CNTY-101 as a potential therapy for individuals living with relapsed or refractory (R/R) CD-19+ B-cell lymphoma.

The Key Facts on Lupus

Lupus is an autoimmune disease, meaning that the immune system mistakenly attacks its own bodily tissues and organs. This disease causes inflammation in the body, which can cause damage to organs like the joints, skin, blood, kidneys, brain, and heart. If you are female, between ages 15-45, or African-American, Asian-American, or Hispanic, you are more likely to develop lupus.

There is no singular experience for people with lupus. Some individuals have mild symptoms; others have severe. For some, symptoms are temporary or have periods of relief; in others, symptoms are permanent. Symptoms may develop suddenly or slowly. Every person has their own combination of symptoms and severity. Symptoms, which appear during “flares,” can include:

• A red, butterfly-shaped rash in the center of the face
• Hair loss
• Fatigue and general malaise
• Swelling in the hands, feet, or around the eyes
• Low fever
• Chest pain that worsens when breathing deeply
• Joint pain
• Skin lesions that worsen with sun exposure / sensitivity to sunlight
• Mouth ulcers
• Raynaud’s phenomenon

If you have lupus and are searching for support, consider joining LupusConnect, an online support group.