SIM0505 / Simcere, NextCure - LARVOL DELTA

NextCure Announces Closing of $21.5 Million PIPE Financing in Advance of First Half 2026 Phase 1 POC Data Readouts (GlobeNewswire) - "NextCure intends to use the net proceeds from the offering for general working capital needs, extending the company’s cash runway into the first half of 2027, which is beyond the planned first half of 2026, proof of concept data readouts of its two antibody drug conjugate (ADC) programs, SIM0505 (CDH6 ADC) and LNCB74 (B7-H4 ADC)."

Financing • Solid Tumor

NextCure and Simcere Zaiming Announce Expansion of Ongoing Phase 1 Trial of SIM0505 (CDH6 ADC) into the United States (GlobeNewswire) - "...The first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552), which is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors....Multi-regional trial to accelerate time to proof-of-concept data in 1H 2026."

P1 data • Trial status • Solid Tumor

SIM0505-101: A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=414 | Recruiting | Sponsor: NextCure, Inc. | N=172 ➔ 414

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

NextCure Provides Business Update and Reports Second Quarter 2025 Financial Results (Nasdaq) - "SIM0505 (CDH6 ADC): Investigational New Drug application transferred to NextCure in June 2025, with anticipated first patient dosed in the US within the third quarter of 2025. Plan to provide a program update by the fourth quarter of 2025 and a proof of concept data readout, including data from Simcere Zaiming’s ongoing Phase 1 trial, in the first half of 2026."

P1 data • Trial status • Oncology • Solid Tumor

NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6 (The Manila Times) - "NextCure...and Simcere Zaiming...announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025....The partnership also includes a license for NextCure to access Simcere Zaiming's proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC....Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory."

Licensing / partnership • New trial • Solid Tumor

SIM0505-101: A Phase I Study of SIM0505 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=172 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase I Study of SIM0505 in Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=172 | Not yet recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor

11 Class 1 innovative drugs were approved for clinical trials in China for the first time!… [Google translation] (Sina Corp) - "The Class 1 new drug MHB009C for injection, which was applied by Minghui Pharmaceutical, has been approved for clinical trials and is intended to be developed for the treatment of patients with advanced malignant solid tumors. The specific mechanism of action of this product has not yet been found in public information, but the acceptance number shows that this is a new biological product....SIM0505, a Class 1 new drug for injection filed by Innovent, a subsidiary of Innovent, has been approved for clinical trials and is intended to be used to treat advanced solid tumors."

New trial • Solid Tumor