Shanghai, China, December 27, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation(FTD) for HLX42, an investigational EGFR-Targeting ADC that developed by the company based on the collaboration with MediLink Therapeutics, for the treatment of patients with advanced or metastatic EGFR-mutated non-small cell lung cancer whose disease has progressed on a 3rd-generation EGFR tyrosine kinase inhibitor. Previously, HLX42 was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and FDA.
Yongqiang Shan, general manager of Henlius’ Global Innovation Center, said: “I am glad to see the continuous progress we have made in advancing our ADC portfolio. The grant of FTD represents FDA's recognition of HLX42's potential in addressing serious diseases that filled unmet medical needs. In the future, Henlius will maintain our focus on areas of unmet medical needs and accelerate the development and delivery of innovative treatments, providing safe and effective care for patients worldwide.”
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. According to the FDA, a drug that receives Fast Track designation is eligible for certain policy support, including but not limited to: 1) more opportunities for meetings and written communication with FDA to obtain closer guidance in drug development, clinical trial design, etc.; 2) eligibility for Accelerated Approval and Priority Review if relevant criteria are met; 3) accelerate path to FDA submission through Rolling Review.
According to GLOBOCAN data, lung cancer (LC) is the second commonly diagnosed cancer globally with the highest mortality rate. It is estimated that there are more than 2,200,000 new cases with LC and accounts for 11.4% of the global cancer incidence in 2020[1]. About 80%-85% of LC are NSCLC[2], and EGFR mutations are found in approximately 10% of white patients with NSCLC and up to 50% of Asian patients[3]. At present, EGFR targeted therapies, including EGFR tyrosine kinase inhibitors (TKIs), are the first-line treatment for advanced NSCLC patients with EGFR mutations, yet patients who experience disease progression after treatment have limited options for subsequent therapies[4,5]. Therefore, an great unmet medical need exists and new therapeutic approaches are required.
HLX42 is a novel antibody-drug conjugate (ADC) candidate that targeting epidermal growth factor receptor (EGFR) and being one of the first ADC products of Henlius to enter into clinical development. Combining the selectivity of targeted mAb with the highly potent cytotoxic agent, HLX42 has exhibited good anti-tumour effects and a favorable safety profile in preclinical efficacy studies, pharmacokinetic studies and safety evaluation. Meanwhile, HLX42 has shown potent tumour suppression in several CDX and PDX models that were EGFR TKIs or cetuximab resistant, which is expected to overcome the resistance of existing EGFR targeted therapies and fill the unmet clinical needs of more patients with advanced/metastatic solid tumours. And a phase 1 clinical trial will be initiated to evaluate the safety, tolerance and pharmacokinetics of HLX42 in patients with advanced/metastatic solid tumours.
With Henlius’ diversified portfolio and cornerstone product HANSIZHUANG, the company will further explore the potential of ADCs combining immunotherapies to provide more effective treatment options to fulfill the unmet clinical needs. Looking forward, Henlius will further take efforts to promote the layout of our innovative portfolio by focusing on antibody and novel conjugating technologies, bringing more high-quality and affordable therapeutics for patients worldwide.
About HLX42
HLX42 is a novel EGFR-targeting ADC candidate, comprised of a high-affinity humanised IgG1 mAb targeting EGFR conjugated with a novel cytotoxic payload through cleavable linkers, with the drug-to-antibody ratio is about 8. The cytotoxic payload of HLX42 is a novel DNA topoisomerase-I inhibitor which can cause double-strand breaks (DSBs) of DNA, block the replication machinery, thus trigger cancer cell apoptosis. When injected intravenously into the body, HLX42 linker-payload will be cleaved and released in tumour microenvironment (TME) with strong bystander killing effects. This unique mechanism of TME activation and payload release allows HLX42 to possess a higher therapeutic index and potency for treatment of solid tumours.