Sichuan Kelun Biotech recently announced that it has obtained approval from the U.S. FDA for its new drug clinical trial (IND) application to initiate clinical research on SKB518, a potential first-in-class ADC drug.

According to a press release from Kelun Biotech, SKB518 is an antibody-drug conjugate (ADC) targeting protein tyrosine kinase 7 (PTK7) developed using Kelun Biotech's OptiDCTM platform technology based on the biological characteristics of the target. It has shown good efficacy and safety window in preclinical trials and is intended to be used to treat advanced solid tumors. Previously, in June 2024, the drug had obtained IND approval from NMPA for advanced solid tumors. The clinical approval in both China and the United States indicates that the global synchronous development strategy of SKB518 is progressing steadily.

Protein tyrosine kinase 7 (PTK7) is a Wnt coreceptor that is expressed at low levels in normal epithelial, endothelial, and hematopoietic tissues, but shows significant upregulation of mRNA transcription levels in malignant tumors such as colon cancer, gastric cancer, lung cancer, and acute myeloid leukemia. This cross-cancer overexpression feature makes it an emerging therapeutic target for ADC therapy.

In addition to SKB518, there are currently several PTK7 ADC drugs under development around the world, and some of them have been successfully licensed overseas:

In June 2024, Day One Biopharmaceuticals announced the acquisition of global rights outside of Greater China for Mabcare Therapeutics' PTK7 ADC new drug MTX-13. Under the agreement, Day One paid $55 million in upfront payment, $1.152 billion in milestone payments, and low to mid-single-digit sales royalties.

In November 2024, IDEAYA Biosciences announced the selection of IDE034, a potential first-in-class B7H3/PTK7 TOP1-loaded bispecific antibody-drug conjugate (BsADC), as a development candidate and exercised its exclusive global license rights to Biocytogen's potential first-in-class B7H3/PTK7 BsADC program. Pursuant to the Option and License Agreement between IDEAYA and Biocytogen, the option was exercised for an exclusive global license to Biocytogen. IDEAYA will pay Biocytogen an upfront payment and option exercise fee, as well as additional development and regulatory milestone payments, commercial milestone payments, and royalties on net sales, totaling $406.5 million, including up to $100 million in development and regulatory milestone payments.

It is worth noting that the three clinical-stage projects SKB264 (MK-2870), SKB315 (MK-1200) and SKB410 (MK-3120) previously authorized by Kelun Biotech to Merck all adopted the same toxin linker strategy. However, the new generation of ADC projects represented by SKB518 have shifted from the original solution to the industry's mainstream technology GGFG-Dxd platform in terms of toxin linker selection, reflecting Kelun Biotech's self-evolution and upgrading.

At present, Kelun Biotech has 1 ADC project approved for marketing, 1 ADC project is in the NDA stage, and multiple ADC or new ADC projects are in the clinical or preclinical research stage.

Kelun Biotech is a subsidiary of Kelun Pharmaceuticals, a leading domestic ADC company and a representative of innovative drugs going global. It has reached a cooperation agreement with multinational pharmaceutical company Merck worth tens of billions of dollars. In China, it has successfully launched the first domestic TROP2-targeted ADC, Lukang Satuzumab.

The approval of IND for SKB518 in the United States further strengthens Kelun Biotech's ADC drug team going global, and also demonstrates the continuous innovation capabilities of domestic companies in the ADC field.

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