GSK Agrees to Terms to Acquire Novel Treatment for Autoimmune Diseases from Chimagen Biosciences

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GSK announced that it has agreed to terms to acquire CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE), from Chimagen Biosciences. According to the company, CMG1A46 is being developed to treat B cell-driven autoimmune diseases, mainly systemic lupus erythematosus (SLE) and lupus nephritis (LN), with potential expansion into related autoimmune diseases. GSK also stated that moving forward, it aims to leverage its understanding of lupus and its therapeutic approach to address the disease's heterogeneity and the needs of patients with severe, refractory disease.

CMG1A46 is classified as IgG-like molecule with high affinity for CD19- and CD20-positive B cells and low affinity for CD3, which could lower toxicities typically associated with TCEs, according to GSK.¹

“Through our work in systemic lupus erythematosus and lupus nephritis, we increasingly understand the underlying drivers of B cell-driven diseases. As a novel therapeutic option directed at deep B cell depletion, CMG1A46 offers exciting potential which we are pleased to take forward to address unmet need in lupus and related autoimmune conditions,” said Tony Wood, chief scientific officer, GSK, in a press release.

Under terms of the deal, Chimagen Biosciences will receive an upfront payment of $300 million, with the potential to receive a total of $550 million based on the successful development and commercial milestones for CMG1A46.

Currently, CMG1A46 is in Phase I of clinical trials in both leukemia and lymphoma in China and the United States. Plans for a Phase I trial in lupus are expected to take shape at some point next year. Preclinical studies have demonstrated rapid, deep B cell depletion both in the bloodstream and in tissues, which could lead to more durable responses in patients.¹

According to the CDC, around 204,000 people in the United States are currently living with SLE, including 184,000 females and 20,000 males. It is estimated that globally, nine out of every 10 people with lupus are women. Women of childbearing age are considered to have the highest risk of developing SLE. CDC statistics also show that Black or African American, Hispanic, Asian, and American Indian and Alaska Native populations are more commonly affected than White populations with SLE. Black patients with lupus are more likely to die earlier than White patients, with an average of more than 10 years earlier.²

According to the Lupus Foundation of America, there are four different forms of lupus. SLE accounts for an estimated 70% of all lupus cases, Cutaneous lupus, which only affects the skin, and drug-induced lupus both account for 10%. Lastly, neonatal lupus, which results from a mother's antibodies affecting the fetus, is extremely rare.

The Lupus Foundation estimates that anywhere from 10% to 15% of all people with lupus will die prematurely due to complications. A study by the foundation found that in females between five and 65 years of age, lupus was among the top 20 leading causes of death.³

“We are excited by the potential of CMG1A46 to improve the lives of patients suffering from autoimmune conditions and grateful to have GSK accelerate that vision. This agreement provides further validation of our proprietary T cell-engager platform, and we are eager to continue our mission of developing novel multi-specific antibody therapeutics,” said Zhenhao Zhou, CEO, Chimagen Biosciences, in the press release.

References

1. GSK enters agreement to acquire CMG1A46 from Chimagen Biosciences to expand immunology pipeline. GSK. October 29, 2024. Accessed October 29, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-to-acquire-cmg1a46-from-chimagen-biosciences/

2. People with Lupus. CDC. Accessed October 29, 2024. https://www.cdc.gov/lupus/data-research/index.html

3. Lupus facts and statistics. Lupus Foundation of America. Accessed October 29, 2024. https://www.lupus.org/resources/lupus-facts-and-statistics