HLX42 / Fosun Pharma, MediLink - LARVOL DELTA

A Study of HLX42 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=102 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=42 ➔ 102 | Trial completion date: Jul 2026 ➔ Jun 2027 | Trial primary completion date: Apr 2026 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Henlius to Make Its Debut at the World ADC Asia 2024 (Henlius Press Release) - "From June 25-27, 2024, World ADC Asia 2024 will be held in Incheon, South Korea. Henlius will make a big debut at the conference and showcase its multiple ADC (Antibody Drug Conjugate) assets as well as self-developed ADC technical platform....During the World ADC Asia 2024, Dr. Yongqiang, Shan, General manager of Henlius Global Innovation Centerwill present as a speaker on the company’s latest innovative practice and achievements in ADC area. Meanwhile, the updated data of two potential first/best-in-class ADC products, HLX42, the novel EGFR-targeting ADC, and HLX43, the PD-L1 targeting ADC, will be published as posters at the conference."

Clinical data • Solid Tumor

Henlius to Showcase at BIO 2024 (Henlius Press Release) - "Henlius, along with its wholly-owned subsidiary, Aton Biotech, a biologics CDMO will showcase a wide range of innovative research and development accomplishments for conference attendees. As an innovative global biopharma company, Henlius has always been guided by clinical needs to build up a high-quality, affordable and differentiated pipeline to effectively meet the needs of patients and the market...HLX22, has been approved by the FDA. Besides, the company is promoting the clinical development of two potential first/best-in-class products, HLX42 (EGFR ADC) and HLX43 (PD-L1 ADC)....Henlius is determined to offer high-quality, affordable, and innovative biologic medicines for patients worldwide, focuses on game-changing innovations, and aggressively pursues anti-tumour research and international collaboration. We warmly invite you to visit and connect with us at booth #1719 at San Diego Convention Center."

Clinical • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of HLX42 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Henlius (02696): Injectable HLX42 (EGFR-targeting antibody-novel DNA topoisomerase I inhibitor drug conjugate) was granted fast track status by the U.S. Food and Drug Administration [Google translation] (Zhitong Finance) - "Zhitong Finance APP News, Fuhong Hanlin...announced that recently, HLX42 (EGFR-targeting antibody-novel DNA topoisomerase I inhibitor conjugate drug) for injection (HLX42) is used for the treatment of third-generation EGFR cases. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the treatment of patients with EGFR-mutated advanced or metastatic non-small cell lung cancer whose disease has progressed after treatment with an amino acid kinase inhibitor....The Phase 1 clinical trial application of HLX42 for the treatment of advanced/metastatic solid tumors was approved by the National Medical Products Administration (NMPA) and FDA in October 2023 and November 2023 respectively."

Fast track designation • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First Subject Dosed for Phase 1 Clinical Trial of Henlius’ ADC Candidate HLX42 (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the first subject was dosed for a phase 1 clinical trial of HLX42 (NCT06210815), an investigational EGFR-Targeting antibody-drug conjugate (ADC), for the treatment of advanced/metastatic solid tumours....This open-label, dose-escalation, first-in-human phase 1 clinical trial aims to evaluate the safety and tolerability of HLX42 in patients with advanced/metastatic solid tumours. Patients will receive HLX42 intravenously every three weeks at seven dose levels (0.1 mg/kg, 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.0 mg/kg, 3.0 mg/kg, and 4.0 mg/kg) following a '3+3' design."

Trial status • Solid Tumor

A Study of HLX42 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Metastases • New P1 trial • Oncology • Solid Tumor

Fosun Pharma (02196.HK): Henlius has received approval from the US FDA to launch clinical trials of HLX42 for injection in the treatment of advanced/metastatic solid tumors. [Google translation] (jrj.com) - "Fosun Pharma...announced that Shanghai Henlius Biotechnology Co., Ltd...recently received a request from the U.S. FDA (i.e., the U.S. Food and Drug Administration). Letter of consent to conduct clinical trials of HLX42 for injection...for the treatment of advanced/metastatic solid tumors (IND number: 168491 ). Henlius plans to launch a Phase I clinical trial of the new drug in the United States when conditions are met."

IND • New P1 trial • Oncology • Solid Tumor

Henlius Announces NMPA Approvals of Two ADC Candidates for IND (PRNewswire-Asia) - "Shanghai Henlius Biotech...announced that the investigational new drug (IND) applications of HLX42 for Injection, a novel EGFR-targeting antibody-drug conjugate (ADC) as well as HLX43, a novel PD-L1-targeting ADC, have been approved by the National Medical Products Administration (NMPA), for the treatment of advance/metastatic solid tumours. The two products were developed by the company based on the collaboration with MediLink Therapeutics and become first ADC candidates of Henlius that are entering into clinical development."

New trial • Solid Tumor

Preclinical evaluation of HLX42, a novel EGFR-targeting ADC, for cetuximab or TKI resistant cancer (ESMO 2023) - "Furthermore, the combination of HLX42 and osimertinib exhibited strong synergy in the LU3075 PDX model which poorly responded to osimertinib alone. In our pilot toxicity studies, HLX42 was well tolerated in rats and non-human primates (severely toxic dose in 10% of animals = 50 mpk in rats; highest non-severely toxic dose = 20 mpk in non-human primates). Conclusions Taken together, these preclinical data strongly suggest that HLX42 is a potential best-in-class EGFR-targeting ADC which is worth further clinical investigations."

Preclinical • Oncology

Results From the Preclinical Study of HLX42, a Potential BIC EGFR-Targeting ADC Released at 2023 ESMO (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the results from the preclinical study of HLX42, the novel EGFR targeting ADC which was developed by the company based on the collaboration with MediLink Therapeutics was released as poster at the 2023 European Society of Medical Oncology (ESMO) Congress....In in vivo studies, HLX42 showed potent tumour suppression in several CDX and PDX models that were cetuximab or TKIs resistant. As in the HT-29 model, weekly administration of HLX42 at 8 mg/kg for 3 weeks resulted in 90.2% TGI. Likewise, HLX42 showed better in vivo efficacy and elicited more durable antitumour responses in a head-to-head comparison with conventional ADC technologies such as VC-MMAE."

Preclinical • Oncology