Korean drugmakers rush to develop next-gen CAR-T cell therapy


SOURCE: KOREABIOMED.COM
OCT 10, 2021

Korean pharmaceutical companies are speeding up developing chimeric antigen receptor T (CAR-T) cell therapies after Novartis’ Kymriah received the first approval from the domestic regulator. ?? : KBR(http://www.koreabiomed.com)

At stake is how to slash prohibitive prices

Domestic pharmaceutical companies are speeding up efforts to develop chimeric antigen receptor T (CAR-T) cell therapy after the government approved the first gene editing CAR-T treatment, Kymriah, this year, industry watchers said Thursday.

Drugmakers are competing to develop the patient-tailored treatment since they could verify the drug's efficacy even with a small number of patients.

Korea’s CAR-T treatment market is expected to grow at an annual average of 33.8 percent, from 17 billion won ($14.3 million) in 2021 to 450 billion in 2030. The global market is also likely to expand to 22.5 trillion won in 2030.

However, only a few CAR-T therapies, including Novartis' Kymriah, Gilead Sciences' Yescarta, Kite Pharma's Tecartus, and Juno Therapeutics' Breyanzi, have received approval from the U.S. Food and Drug Administration. Based on the market prospects, Korean companies have jumped into the fray to develop CAR-T treatments or try to secure pipelines.

CAR-T treatment is a new type of anticancer drug that takes out immune cells in the body and uses a viral antibody vector to express a chimeric antigen receptor specific to cancer cells and then administers back into the patients. As it uses genetic modification, it is also called gene-editing therapy.

One of the Korean frontrunners in this field is Curocell. The company received the Ministry of Food and Drug Safety’s approval for the first clinical trial of CAR-T treatment in February and began administering the drug candidate to patients in April.

Curocell confirmed two out of three patients achieved complete response a month after administrating the candidate in phase 1 clinical trial. It plans to complete the first phase of the study by the end of the year and move on to the phase 2 study next year to verify the efficacy.

Curocell's CAR-T therapy candidate is CRC01, a CD19 CAR-T treatment that can treat B-cell lymphoma and B-cell leukemia.

"CRC01, now undergoing clinical trials, is a CD19 CAR-T treatment developed with our unique CAR-T platform called OVIS," Curocell CEO Kim Gun-soo said. "We have applied the new technologies to increase the therapeutic potential of patients with lymphoma."

Closely following Curocell’s lead is AbClon.

In June, AbClon submitted plans for phase 1 and 2 clinical trials of its CAR-T treatment candidate AT101 to the food and drug safety ministry and expects to receive approval by the end of this year.

AT101 is a CAR-T treatment candidate similar to Kymriah for treating lymphoma and leukemia, and it targets large B-cell lymphoma.

AbClon has also started to establish a strategy to develop the next-generation CAR-T therapy for solid cancer by teaming up with ToolGen, which has clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing technology.

"With the recent agreement, we will grow as leading developers in CAR-T cell therapy targeting solid cancer," AbClon CEO Lee Jong-seo said. "We expect this partnership to be a starting point for improving therapeutic effect in solid cancer patients by inducing research and developments."

The biggest problem is the prohibitive price.

Most CAR-T treatments are tailored to patients and their blood, and even Kymriah, the first approved CAR-T therapy in Korea, costs about 500 million won.

The Cancer Disease Review Committee tabled the issue of providing reimbursement for Kymriah at its sixth meeting last year. Still, participants postponed its passage for the reason of the need for more discussion.

In response, patient groups called for the government to work out a plan to promptly list Kyriah for reimbursement, stressing that the authorities should help to solve the price problem.

"In principle, the drug price needs to be covered as we can see in overseas cases, but the problem is that it is too expensive," Professor Kim Seok-jin of the Department of Hematology and Oncology at Samsung Medical Center said. "There is a room for is abuse with eased access, but I think reimbursement is necessary for those who badly need the therapy."

Kim added that officials also need to consider other costs required for anticancer therapies, including repeated hospitalizations, uncovered anticancer drugs, and other visible and invisible expenses.

?? : KBR(http://www.koreabiomed.com)

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