SKB315 / Sichuan Kelun Pharma - LARVOL DELTA

A Study of SKB315 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=206 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: May 2024 ➔ Feb 2026 | Trial primary completion date: May 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Solid Tumor • CLDN18

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002) (clinicaltrials.gov) - P1/2 | N=304 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2026 ➔ Jun 2025 | Trial primary completion date: Jan 2026 ➔ Jun 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

MK-1200-002: Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=304 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Oncology • Solid Tumor

Kelun Pharmaceutical’s latest announcement: Merck will return the global rights of the SKB315 project to Kelun Biotech [Google translation] (new.qq.com) - "Kelun Pharmaceutical announced that the cooperation project between its holding subsidiary Kelun Biotech and Merck has made progress....Kelun Biotech recently received a written notice from Merck that Merck will exercise its exclusive option for the SKB571 project and pay Kelun Biotech US$37.5 million, and will pay Kelun Biotech further milestone payments after achieving certain development and sales milestones, and will pay tiered royalties calculated based on net sales after SKB571 is commercialized. Kelun Biotech will retain the right to develop, use, manufacture and commercialize SKB571 in mainland China, Hong Kong and Macau. At the same time, Merck will return the global rights of the SKB315 project to Kelun Biotech."

Licensing / partnership • Oncology • Solid Tumor

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=304 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Phase classification: P2 ➔ P1/2 | Trial completion date: Mar 2027 ➔ Jan 2026 | Trial primary completion date: Jan 2027 ➔ Jan 2026

Metastases • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Comments on Kelunbotai's 2023 annual report: SKB264's overseas and domestic clinical advancement exceeds expectations, and the nuclear drug track has promising prospects [Soochow Pharmaceutical Zhu Guoguang Team] [Google translation] (Sohu.com) - "Kelonbotai has deeply laid out the popular ADC track, and a number of hot products are ready for launch: A166 (HER2 ADC), the first indication for HER2+ breast cancer, has completed the NDA submission and is expected to become the first domestic ADC in the country to treat HER2-positive BC. Clinical studies on HER2+ GC (2L) and HER2+ CRC (3L) are in progress. SKB315 (CLDN 18.2 ADC) is the second ADC with the same target in the world to start patient enrollment."

Non-US regulatory • Trial status • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=304 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=304 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

Metastases • New P2 trial • Oncology • Solid Tumor

Merck terminates some of the exclusive licenses granted to it by Colombote. The latter's stock price fell more than 7% today. [Google translation] (Daily Economic News - NBD) - "Early...Kelun Pharmaceutical announced that Kelonbotai received notice from Merck that the latter would terminate the development, manufacturing and commercialization of a preclinical ADC ( Antibody drug conjugate) assets; not exercise the exclusive option granted to it by Colombote to obtain an exclusive license for another preclinical ADC asset....Kelen Pharmaceutical also said that Merck said it would continue to advance SKB264/MK-2870, SKB315/MK-1200, an undisclosed phase I project and other preclinical ADC projects. It also plans to accelerate the clinical development project of SKB264/MK-2870, and recently announced the initiation of phase III clinical trials for specific non-small cell lung cancer patients."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

"SKB315: developed by Kelun, licensed to Merck" (@Pharmews)

"SKB315https://www.adcreview.com/drugmap/skb315/" (@OncoZine)

Review

"$MRK 2nd licensed ADC from Kelun likely Claudin18.2 (SKB315) as well, utilizing same belotecan-derived payload as $MRK previously licensed only now disclosed TROP2 ADC SKB264." (@jq1234t)

CLDN18 • CLDN8 • TROP2

A Phase 1 Clinical Study of SKB315 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=206 | Recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

New P1 trial • Oncology • Solid Tumor • CLDN18