[Featured Stock] Appclon Nears Overcoming Limits of Miracle Anticancer Drug... "Continuing Alteogen's Success Story"

Appclon is showing strong performance. Expectations that it can address the high relapse rates, a major drawback of existing chimeric antigen receptor T-cell (CAR-T) therapies, appear to be influencing its stock price. Analysts suggest that it will demonstrate superior efficacy in clinical trials compared to CAR-T therapies from global pharmaceutical companies with market capitalizations exceeding 300 trillion KRW. If the Phase 2 clinical trial results prove better than those of Phase 1, Appclon is expected to become a new legend in the domestic biotech industry, following Alteogen.

As of 1:57 PM on the 14th, Appclon's stock is trading at 16,860 KRW, up 14.62% from the previous day.

Byungyong Oh, a researcher at Hanyang Securities, explained, "Blockbuster CAR-T therapies like Kymriah and Yescarta have been called miracle treatments that achieve complete remission (CR) in patients with advanced blood cancers," but added, "a significant number of patients relapse after more than six months post-treatment." He further noted, "Although Appclon is a latecomer, it is developing a CAR-T therapy with a much lower relapse rate than Kymriah or Yescarta."

Appclon's key new drug candidate, AT101, targets diffuse large B-cell lymphoma (DLBCL), which has the highest incidence among lymphomas. Currently, a Phase 2 clinical trial is underway involving 82 patients. Approximately 40 patients will complete dosing for interim analysis this summer, with interim results expected to be announced within this year. Compared to Kymriah and Yescarta, which use the existing mouse-derived FMC63 antibody, Appclon has developed AT101 based on a differentiated new antibody and eliminated immunogenicity.

The Phase 1 clinical trial of AT101 involved a total of 12 patients: 6 at low dose, 3 at medium dose, and 3 at high dose. The low and medium doses were only 1/25 and 1/5, respectively, of the Kymriah dose.

Researcher Oh stated, "Despite the low doses, 9 out of 12 patients achieved complete remission, with an objective response rate (ORR) of 92%," and added, "As of July this year, two years after Phase 1 dosing, 7 of the 9 patients who achieved complete remission have not relapsed." He continued, "We have been presenting follow-up results of non-relapsing Phase 1 patients at global conferences since last year," emphasizing, "A paper on the low relapse rate was also published in the December issue of the journal Molecular Cancer."

He added, "The Phase 2 clinical trial of AT101 is being conducted at high doses similar to Kymriah," and emphasized, "Given the higher dose, the results are expected to be superior to those of Phase 1."

The global CAR-T market size is projected to grow from $3.7 billion last year to $18.2 billion by 2030, with an average annual growth rate of 26%. Novartis's market capitalization exceeds 300 trillion KRW.

Immune cell therapy CAR-T is a treatment that genetically engineers T cells extracted from a patient's blood to attack and kill targeted cancer cells. CAR-T therapies have been called "miracle anticancer drugs" as complete remission (CR) has been confirmed in 70-80% of patients with acute lymphoblastic leukemia. Despite these advantages, there are many drawbacks, including safety concerns, relapse rates, manufacturing time, and efficacy in treating solid tumors. Kymriah, launched in 2017, was approved for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and acute lymphoblastic leukemia (ALL). It is an ultra-high-cost therapy, with a single dose costing 360 million KRW, primarily used to treat pediatric and young patients under 25 years old.

Songhyeop Han, a researcher at Daishin Securities, said, "Currently, more than 60% of patients treated with CAR-T therapies experience non-response or relapse," and analyzed, "If AT101 shows meaningful therapeutic outcomes in patients who are refractory or relapsed after existing CAR-T therapies in investigator-led clinical trials, it could attract the attention of global big pharma." He also predicted, "This could become an event that increases the possibility of global technology licensing."