Category: Clinical Trial Update Region: Asia Company: Minghui Pharmaceutical Shanghai Ltd

Minghui Pharma Soon to Present Phase I/II Study Results of MHB088C

Minghui Pharma Soon to Present Phase I/II Study Results of MHB088C

Minghui Pharma to present phase I/II study results of MHB088C to treat patients with recurrent or metastatic solid tumors at ASCO meeting

Overview

Minghui Pharmaceutical, a late-stage clinical biopharmaceutical company focused on autoimmune diseases and oncology, will feature Dr. Lin Shen from Beijing Cancer Hospital at the upcoming ASCO Annual Meeting in Chicago. Dr. Shen will present the results from the phase I/II clinical study of MHB088C, a well-differentiated B7-H3-targeting antibody-drug conjugate (ADC) for recurrent or metastatic solid tumors, in an oral presentation.

MHB088C

  • MHB088C is a novel B7-H3 antibody-drug conjugate generated through Minghui's SuperTopoi ADC platform. 
  • Minghui's proprietary payload is 5 to 10 times more potent than Dxd, retaining key advantages such as bystander effect while eliminating the risk of interstitial lung disease. 
  • Conjugated with Minghui's proprietary B7-H3 antibody, which has superior binding and internalization compared to the competitor's antibodies, MHB088C has demonstrated remarkable anti-tumor efficacy across various cancer types. 
  • It was 3 to 10 times more potent in killing tumor cells than the competitor's compound in xenograft models.

Pharmacokinetics Studies

  • Preclinical GLP tox studies revealed an excellent safety profile, with no unique toxicities, particularly no pulmonary toxicities. 
  • The highest non-severely toxic dose (HNSTD) was identified at 30 mg/kg, administered once every two weeks (Q2W) for a total of seven doses. 
  • The first patient in the phase I/II study was enrolled on June 20, 2023. 
  • Since then, over 150 patients with different tumor types have been enrolled and received at least one dose of MHB088C, showing promising efficacy and a favorable safety profile. 
  • Registrational trials for selected tumor types are expected to start by the end of the year.

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