On April 10, 2023 Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui Pharma"), a global pharmaceutical company, reported that there will be five poster presentations showcased at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Orlando, April 14-19, 2023 (Press release, Hengrui Pharmaceuticals, APR 10, 2023, View Source [SID1234633493]). The plasma stability of an antibody-drug conjugate (ADC) is of crucial importance as it impacts both safety and efficacy. The free payload in plasma contributes to certain adverse events that are commonly seen in marketed ADCs. Hengrui Pharma developed a unique ADC platform with an improved molecular design to increase plasma stability and enhance bystander effect. Better safety and efficacy were observed in both preclinical and clinical studies for multiple ADC assets of Hengrui Pharma. These posters will highlight:
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Superior bystander effect of SHR-A1811, a novel anti-HER2 antibody-drug conjugate (ADC), with optimal drug-antibody ratio (DAR), and favorable safety profiles;
Clinical data of SHR-A1811 in phase 1 study for patients with HER2-expressing/mutated advanced solid tumors;
Clinical data of SHR-A1811 in phase 1/2 study for patients with advanced HER2-mutant non-small cell lung cancer (NSCLC);
An optimized design and well-balanced profile between efficacy and safety of SHR-A1921, a novel TROP-2 ADC; and
Clinical data of SHR-A1921 in phase 1 study for patients with advanced solid tumors.
Details of the presentations are as follows:
Title: SHR-A1811, a novel anti-HER2 ADC with superior bystander effect, optimal DAR and favorable safety profiles
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 1
Session Date and Time: Sunday April 16, 2023 1:30 PM – 5:00 PM
Location: Poster Section 35
Poster Board Number: 23
Abstract Presentation Number: LB031
Title: Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: a global phase 1, multi-center, first-in-human study
Session Title: First-in-human Phase 1 Clinical Trials 2
Session Date and Time: Tuesday April 18, 2023 9:00 AM – 12:30 PM
Location: Poster Section 45
Poster Board Number: 7
Abstract Presentation Number: CT175
Title: Safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811, an antibody-drug conjugate, in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC): a multi-center, open-label, phase 1/2 study
Session Title: Phase 1 Clinical Trials 1
Session Date and Time: Tuesday April 18, 2023 9:00 AM – 12:30 PM
Location: Poster Section 46
Poster Board Number: 17
Abstract Presentation Number: CT204
Title: SHR-A1921, a novel TROP-2 ADC with an optimized design and well-balanced profile between efficacy and safety
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 1
Session Date and Time: Sunday Apr 16, 2023 1:30 PM – 5:00 PM
Location: Poster Section 35
Poster Board Number: 22
Abstract Presentation Number: LB030
Title: A first-in-human (FIH), phase 1 study of SHR-A1921, a TROP-2 targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors
Session Title: First-in-human Phase 1 Clinical Trials 2
Session Date and Time: Tuesday April 18, 2023 9:00 AM – 12:30 PM
Location: Poster Section 45
Poster Board Number: 13
Abstract Presentation Number: CT181
About SHR-A1811
SHR-A1811, a HER2-targeted ADC, features an optimized molecular design to enhance plasma stability and bystander effect. Hengrui Pharma is currently conducting more than 10 clinical studies of SHR-A1811 from phase 1 to phase 3 to evaluate its safety and efficacy as single agent or combination therapy in a wide variety of cancer indications. Breakthrough Therapy Designations were granted to SHR-A1811 by the China National Medical and Products Administration for three indications, which include:
For the treatment of HER2-mutant, advanced NSCLC after platinum-based chemotherapy
For the treatment of HER2-positive, recurrent or metastatic breast cancer
For the treatment of HER2-low, recurrent or metastatic breast cancer
About SHR-A1921
SHR-A1921 consists of an anti-TROP-2 antibody attached to a novel topoisomerase I inhibitor payload via a cleavable linker. This molecular design enhances plasma stability and bystander effect with a well-balanced profile between efficacy and safety. A pivotal phase 3 trial of SHR-A1921 versus docetaxel for the second- or later-line treatment of NSCLC is expected to be initiated in China in 2023.