Minghui Pharmaceutical Pty Ltd

SHANGHAI, June 3, 2024 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a late-stage clinical biopharmaceutical company, announced today that the preliminary Phase 1/2 clinical data of MHB088C (B7-H3 ADC) was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in an oral presentation. Abstract #: 3012 Results of a Phase 1/2 Study of MHB088C: a Novel B7-H3 Antibody-Drug Conjugate (ADC) Incorporating a Potent DNA Topoisomerase I Inhibitor in Recurrent or Metastatic Solid Tumors In this Phase 1/2 study, the safety/tolerability, pharmacokinetics, and efficacy of MHB088C in patients (pts) with recurrent or metastatic solid tumors were evaluated. The study results were as follows: At data cutoff, MHB088C was well tolerated. The most common TRAEs were hematological toxicities. 4 mg/kg Q3W was the DLT dose and 3 mg/kg Q3W was defined as the MTD. 1.6 mg/kg Q2W, 2.0 mg/kg Q3W and 2.4 mg/kg Q3W demonstrated favorable safety profiles with low single-digit Grade ≥3 hematological AEs for the two lower doses. No interstitial lung disease (ILD) was reported as of the data cutoff. ­ Of 98 efficacy evaluable pts with different tumor types at doses ranging from 0.8 mg/kg to 4.0mg/kg, ORR was 33.7% (33/98) and DCR was 83.7% (82/98), with DoR not reached yet. The majority of pts remain on the treatment. ­ Of 31 efficacy evaluable pts with small cell lung cancer (SCLC), ORR was 61.3% (19/31) and DCR was 93.5% (29/31). 24 pts (77.4%) remain on the treatment, and 6 pts (19.4%) achieved 60% or more tumor reduction, with 2 CRs of target lesion at 3.0 mg/kg. Among 10 pts at 1.6 mg/kg Q2W, ORR was 80% and DCR was 90%. ­ Of 7 efficacy evaluable pts with esophageal squamous cell carcinoma (ESCC), ORR was 42.9% and DCR was 85.7%. The median follow-up was over 3.0 months. Professor Lin Shen from the Beijing Cancer Hospital stated: "MHB088C represents an innovative advancement in cancer treatment as a novel B7-H3 ADC equipped with a potent DNA Topo I inhibitor. The preliminary data are highly encouraging, showcasing clinically meaningful and durable antitumor activities at very safe doses across multiple cancer types. We are optimistic about the ongoing study and anticipate further positive clinical outcomes." Dr. Guoqing Cao, CEO of Minghui Pharmaceutical, stated: "We are excited to share the results of Phase 1/2 study of MHB088C at the 2024 ASCO. MHB088C is a well-differentiated B7-H3 ADC, conjugating an optimal anti-human B7-H3 antibody with our Proprietary SuperTopoiTM payload. We are seeing robust efficacy at very safe doses without major hematological toxicity or ILD. Particularly, in SCLC, 9 out of 10 patients experienced tumor shrinkage at 1.6 mg/kg Q2W, with an ORR of 80%. The durability of responses was also notable in ESCC, with an ORR of 43% and median follow-up over 3 months. The safety profile of MHB088C is consistent with that of our other program MHB036C, a TROP-2 ADC, without major hematological toxicity or ILD either. Between the two clinical programs, with data from more than 250 patients, we are confident that we now have one of the best ADC platforms in the industry. Efficacy in other cancer types has also been observed and will be reported in future conferences. We look forward to initiating registrational trials of the monotherapy for selected tumor types by the end of 2024 and exploring the IO combination in earlier line settings for both ADC assets in the near future." About MHB088C MHB088C is a novel B7-H3 ADC generated through Minghui's SuperTopoiTM 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. About Minghui Pharmaceutical Minghui Pharmaceutical, Inc. is a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines for unmet medical needs in oncology and autoimmune diseases. Leveraging the expertise in medical science and the proprietary technology platforms, the company is developing a rich clinical-stage pipeline including a variety of first-in-class or best-in-class product candidates. For more information, please visit . Forward-Looking Statements This press release provided by Minghui Pharmaceutical Inc. (the "Company") contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "predict," "should," "will," "would" or words of similar meaning. These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s). These forward-looking statements speak only as of the date they are posted to this website, and the Company undertakes no obligation to update any forward-looking statements contained herein. SOURCE Minghui Pharmaceutical, Inc.

SHANGHAI, May 8, 2024 /PRNewswire/ -- Minghui Pharmaceutical, Inc., 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. Oral Presentation Abstract Title: Results of a Phase 1/2 Study of MHB088C: a Novel B7-H3 Antibody-Drug Conjugate (ADC) Incorporating a Potent DNA Topoisomerase I Inhibitor in Recurrent or Metastatic Solid Tumors Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Session Date and Time: 6/3/2024; 8:00 AM-9:30 AM CDT Presentation Time/Duration: 8:00 AM – 8:06 AM CDT Presenter: Dr. Lin Shen Abstract ID: 3012 About MHB088C MHB088C is a novel B7-H3 ADC generated through Minghui's SuperTopoiTM 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. 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. About Minghui Pharmaceutical Minghui Pharmaceutical, Inc. is a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines for unmet medical needs in oncology and autoimmune diseases. Leveraging the expertise in medical science and the proprietary technology platforms, the company is developing a rich clinical-stage pipeline including a variety of first-in-class or best-in-class product candidates. For more information, please visit . Forward-Looking Statements This press release provided by Minghui Pharmaceutical Inc. (the "Company") contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "predict," "should," "will," "would" or words of similar meaning. These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s). These forward-looking statements speak only as of the date they are posted to this website, and the Company undertakes no obligation to update any forward-looking statements contained herein. SOURCE Minghui Pharmaceutical, Inc.

One of a trio of antibody-drug conjugates (ADCs) that formed the basis of a multi-billion-dollar alliance between Merck & Co. and Daiichi Sankyo last fall is making a quick advance into Phase III testing. According to a recent update on ClinicalTrials.gov, the study of ifinatamab deruxtecan (I-DXd) is expected to get underway in March to evaluate the B7-H3–targeting ADC in patients with relapsed small-cell lung cancer (SCLC).The partnership, signed last October, is a lucrative one for Daiichi Sankyo. In addition to receiving $4 billion upfront, the company is also eligible for another $18 billion in other potential payments and milestones. In exchange, Merck received ex-Japan rights to I-DXd, as well as two other ADC candidates – HER3-directed patritumab deruxtecan and raludotatug deruxtecan, which targets CDH6. While the companies predict the drugs could generate "multi-billion dollar worldwide commercial revenue" by the mid-2030’s, the deal – and a greater focus on ADCs in general – may also help Merck weather looming patent expirations for Keytruda coming in the latter half of the decade.Recruitment in the upcoming Phase III trial has not yet started, but it is expected to enroll 468 participants and will compare the efficacy and safety of I-DXd monotherapy with treatment of physician's choice. Objective response rate (ORR) and overall survival (OS) are the primary endpoints. Hints of promiseDaiichi Sankyo said in September that I-DXd had shown an "encouraging" ORR of 52.4% in heavily pretreated patients with extensive-stage SCLC enrolled in a Phase II trial. This included one complete response and 10 partial responses. Meanwhile, median progression-free survival was 5.6 months and median OS was 12.2 months as of data cutoff of January 31, 2023.Despite the confidence with which Merck embarked on the Daiichi partnership, there is some question as to whether it may have been overly generous betting on targets that have been the focus of significantly fewer prior deals in comparison to HER2 and TROP2.For example B7-H3 – so far, more popular for cell therapies than ADCs – has a limited deal history, with no public ADC deals addressing the target since 2021. However, companies such as MacroGenics, Mabwell Therapeutics and Minghui Pharmaceutical are working on some in-house candidates. Others that have shown an interest include GSK, which recently struck a deal to co-develop Hansoh Pharmaceutical's B7-H3-targeting compound HS-20093.