AbClon to Expand Indications of CAR-T Therapy ‘AT101’ into Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL), Aiming for IND Approval This Year

April 10th – AbClon (CEO Lee Jong-seo) announced that the company will expand the indications of its CAR-T (Chimeric Antigen Receptor T-cell) therapy ‘AT101’ into follicular lymphoma (FL) and marginal zone lymphoma (MZL). AbClon aims to obtain Investigational New Drug (IND) approval in Korea within this year.

Currently, AT101 is in Phase 2 clinical trial in Korea for diffuse large B-cell lymphoma (DLBCL), a subtype of blood cancer. Through this expansion of indications, AbClon aims to strengthen its competitiveness and position in domestic and international CAR-T therapy markets. The company anticipates that this study will provide broader treatment options for domestic hematologic cancer patients and secure an advantageous position in global technology transfer negotiations by the enhancement of platform's value.

‘AT101’, a CD19 CAR-T therapy independently developed in Korea, is based on AbClon's proprietary platform technology. The Phase 2 clinical trial targeting DLBCL patients, who account for over 40% of non-Hodgkin lymphoma (NHL) patients, is progressing smoothly, and the company plans to pursue accelerated approval within the first half of this year.

Separately, FL and MZL account for over 25% of NHL cases worldwide, with approximately 1,500 new patients diagnosed annually in Korea. Both are CD19-expressing hematologic cancers, making them potential targets for CAR-T therapy. AbClon believes that AT101 can secure a relative therapeutic advantage based on its efficacy and mechanism of action, potentially becoming an effective treatment for both domestic medical institutions and patients.

Regarding its global technology transfer strategy, the company stated that this expansion of indications offers significant meaning. While the global CD19 CAR-T therapy market is experiencing a high compound annual growth rate of over 30%, CAR-T therapy has not yet actively penetrated the FL and MZL sectors. If AT101 secures clinical evidence for FL and MZL in addition to DLBCL, it can maximize its competitiveness in global licensing-out negotiations as a platform technology covering multiple indications with a single pipeline.

An AbClon representative stated, "The expanded application of efficacy, securing original technology, and flexibility in clinical trial design are key factors that will allow Abclon to gain a strategic advantage in the global market." They added, "AT101 is a next-generation gene-modified cell therapy that overcomes the fundamental limitations of CAR-T therapies."

The representative further emphasized, "This expansion of indications is part of multi-purpose strategy to broaden treatment opportunities for domestic patients as well as laying a practical foundation for global technology export." [End]