Immune-oncology therapy that restores the immune system

Preventing the binding to T cells and proteins

and attacks to cells recognized as normal

 

 

Low chance of tolerance and excellent therapeutic effects

Focusing on next-generation cancer treatment research

 

 

Led by Y-Biologics PD-1

Development of YBL-006 with proprietary technology

 

 

 

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△Photograph description [Source: KT Image Bank]​​​

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The American Association for Cancer Research (AACR) Annual Meeting, American Society of Clinical Oncology (ASCO) Annual Meeting, and European Society for Medical Oncology (ESMO) Congress are some of the most prestigious academic conferences in the field of cancer research.

 

 

It is an event that garners much attention with the participation of more than 20,000 representatives of pharmaceutical and biotechnology companies from all over the world annually. Every year, pharmaceutical companies, healthcare companies, and preeminent experts attend these conferences to discuss various issues related to cancer treatment. There is a topic that has been discussed time and time again in recent years. It is none other than PD-1 immune checkpoint inhibitors.

 

 

One of the biggest anticancer drug trends this year was PD-1 immune checkpoint inhibitors. Research findings concerning PD-1 accounted for the majority of the top 10 issues discussed at ASCO Annual Meeting 2021 that ended in June. Not only that, but 1,906 out of thee 1,988 abstracts presented at the ESMO Congress 2021 concerned PD-1. A wide range of research findings related to PD-1 were also presented at the AACR-NCI-EORTC International Conference on Molecular Target and Cancer Therapeutics 2021.

 

 

What are PD-1 immune checkpoint inhibitors? Immuno-oncology drugs, including PD-1, are expected to be the third-generation anticancer agents to come after chemotherapy drugs (“first-generation”) and targeted therapy drugs (“second-generation”). Immuno-oncology drugs work in a way that allows maximum use of the immune system of the body to attack cancer. It has a lower chance of tolerance and superior therapeutic effect compared to the targeted therapy. It is also widely known that former U.S. President Jimmy Carter won his battle against melanoma, a type of skin cancer, with immunotherapy.

 

 

Immuno-oncology drugs work by using the immune system to attack cancer cells. On the surface of T cells, which are immune cells, there is a protein called PD-1, and on the surface of cancer cells there is a protein called PD-L1 that reacts with PD-1. When PD-L1 on cancer cells binds with PD-1 on T cells, immune cells view cancer cells as normal cells, and when this happens, the body’s immune system fails to attack cancer cells.

 

​△ YBL-006 is a PD-1 immune checkpoint inhibitor and is the sole anti-PD-1 antibody that a domestic biotech company is conducting a clinical trial on. When the PD-L1 protein on the surface of cancer cells binds to the PD-1 protein on the surface of T cells, these immune cells are unable to recognize cancer cells. However, when YBL-006 is introduced into the body, it attaches to the PD-1 receptor on T cells and inhibit the immune escape mechanism of cancer cells.​

PD-1 immune checkpoint inhibitors are capable of inhibiting the immune escape mechanism by binding to the PD-1 protein on T cells, thereby preventing them from binding to the PD-L1 protein on cancer cells. This in turn prevents the immune escape of cancer cells. In a 2021 preview and 2026 forecast report on the global biopharmaceutical industry, the Biotechnology Policy Research Center predicted that PD-1 immune checkpoint inhibitors would drive the growth in sales in the anticancer drug sector. In addition, it was predicted that Keytruda, a PD-1 immune checkpoint inhibitor from MSD (Merck, USA), would be the best-selling drug in 2026.

 

 

Which company has taken leadership in this field in Korea? Y-Biologics is in the limelight for presenting significant research results on PD-1 at the most prestigious academic conferences in the field of cancer and recently published the interim clinical results on YBL-006, a PD-1 immune checkpoint inhibitor. The company’s pipelines include PD-1, PD-L1, and LAG-3. Among the few biotech companies with a LAG-3 pipeline, Y-Biologics is among the top of the list.

 

 

YBL-006 is a PD-1 immune checkpoint inhibitor developed by Y-Biologics with its own biotech technology. In May last year, it received approval for Phase 1 clinical trials in Korea and Australia and conducted a dose escalation study. The interim results from the Phase 1 first-in-human clinical trial of YBL-006 in solid tumors were reported at the ASCO Annual Meeting held this past June, and on July 1, a dose escalation cohort study was initiated in Australia.

 

At the ESMO Congress, Y-Biologics presented the interim results from the dose escalation cohort study of the Phase 1 clinical trial. According to the presentation, a total of 11 patients with advanced solid cancer were enrolled in the cohort. The study was conducted by administering 0.5 mpk and then increasing the dose to 2, 5, or 10 mpk intravenously. A complete response (CR) and a partial response (PR) were observed in one subject each. A pharmacokinetic (PK) profile was observed when evaluating the area under the blood drug concentration-time curve (AUC). 

 

 

An official from Y-Biologics said, “When the drug dose was raised to 10 mpk, no dose-limiting toxicity (DLT) was observed, and the maximum tolerated dose (MTD) was not reached. YBL-006 was shown to have sufficient tolerability, and it was found that the adverse effects caused by drugs were manageable.”

 

 

[By Si Gyun Kim]ⓒ Maeil Business Newspaper

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