MHB039A

SHANGHAI, Nov. 6, 2024 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a late-stage biopharmaceutical company focused on developing transformative medicines in immunology and oncology, today announced initial results from its Phase I clinical trial of MHB039A, a novel PD-1 x VEGF bispecific antibody, in patients with relapsed/refractory solid tumors. The primary objectives of the trial are to evaluate safety and determine the recommended Phase 2 dose (RP2D). Secondary objectives include characterizing pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. The study included a heavily pretreated patient population, with a median of three prior lines of therapy. Robust PD-1 receptor occupancy and circulating VEGF biomarker responses were observed across all dose levels. The 20 mg/kg Q3W regimen demonstrated substantial and sustained inhibition of both PD-1 and VEGF. Tumor volume reduction was noted in patients with sqNSCLC and non-sq NSCLC without actionable genomic alterations (AGA) who had previously received PD-1 inhibitors and chemotherapy, as well as in NSCLC patients with EGFR mutations who had relapsed following third-generation TKI therapy. MHB039A was well tolerated at doses up to 20 mg/kg. The maximum tolerated dose (MTD) was not reached, and no dose-limiting toxicities were observed. The overall safety profile was consistent with findings from previously reported clinical studies on the PD-1 x VEGF bispecific antibody. "We are highly encouraged by the initial clinical results from this phase I study," said Guoqing Cao, Ph.D., Chief Executive Officer at Minghui Pharmaceutical. "MHB039A has demonstrated a favorable safety profile and promising anti-tumor activity in heavily pretreated patients with relapsed/refractory solid tumors. As a PD-1 x VEGF bispecific antibody, it integrates two broad-spectrum anti-tumor mechanisms within a single agent. Importantly, this bispecific antibody offers more than an additive effect, with enhanced anti-tumor activity and significantly improved safety reported in recent clinical studies, indicating its potential to serve as a next-generation immunotherapy backbone." "The phase I dose escalation study has been completed." Dr. Cao added, "Given the overall profile of MHB039A, it is well-suited for development in combination with other therapies, such as chemotherapy, ADCs, small molecule, vaccines, and T cell engagers. We are looking forward to exploring strategic partnerships to facilitate this development." About MHB039A MHB039A, developed by Minghui Pharmaceutical, is a novel bispecific antibody targeting PD-1 and VEGF. It demonstrated full blocking activities against both PD-1 and VEGF with superior PD-1 activity compared to competitor antibodies. The unique molecular design enhances druggability and physicochemical properties, offering high protein yield and great stability. As a next-generation immunotherapy backbone, MHB039A can be combined with various treatment modalities—including immuno-oncology agents, small molecule inhibitors, antibody-drug conjugates, vaccines, and T cell engagers—broadening its potential in solid tumor treatment. About Minghui Pharmaceutical Inc. Minghui Pharmaceutical, established in 2018, is a late-stage biopharmaceutical company committed to developing innovative therapies for unmet medical needs in oncology and autoimmune diseases. Leveraging expertise in medical science and proprietary technology platforms, the company is advancing a robust clinical-stage pipeline that features a range 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 of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or circumstances, except as required by law. SOURCE Minghui Pharmaceutical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Chinese biopharma Minghui Pharmaceutical is jostling for a piece of the growing PD-1/VEGF bispecific pie, unveiling what it calls "promising" initial results from a Phase I trial of its MHB039A candidate in patients with relapsed/refractory solid tumours.The data, announced Wednesday, highlight MHB039A's favourable safety profile and signs of anti-tumour activity in a heavily pre-treated patient population — a tantalising prospect as dual-action bispecifics that target both PD-1 and VEGF gain traction in the hunt for next-wave immuno-oncology treatments."We are highly encouraged by the initial clinical results from this Phase I study," said CEO Guoqing Cao. "This bispecific antibody offers more than an additive effect, with enhanced anti-tumour activity and significantly improved safety reported in recent clinical studies, indicating its potential to serve as a next-generation immunotherapy backbone."The trial's primary objectives were to evaluate safety and determine the recommended Phase II dose, with secondary goals of characterising pharmacokinetics, pharmacodynamics, and preliminary antitumour activity. The study enrolled a patient population treated with a median of three prior lines of therapy."Given the overall profile of MHB039A, it is well-suited for development in combination with other therapies, such as chemotherapy, ADCs [antibody-drug conjugates], small molecule, vaccines, and T cell engagers," Cao added. "We are looking forward to exploring strategic partnerships to facilitate this development."Tumour volume reductionsThe study revealed "robust PD-1 receptor occupancy and circulating VEGF biomarker responses…across all dose levels," according to Minghui, with the 20 mg/kg regimen once every three weeks showing "substantial and sustained inhibition of both PD-1 and VEGF." Tumour volume reductions were also seen in several cohorts, including squamous and non-squamous non–small-cell lung cancer (NSCLC) patients without actionable genomic alterations who had previously received PD-1 inhibitors and chemotherapy, as well as EGFR-mutant NSCLC patients who had relapsed following third-generation tyrosine kinase inhibitors.MHB039A exhibited a favourable tolerability profile up to 20 mg/kg, with the maximum tolerated dose not reached and no dose-limiting toxicities observed.There has been a surge of interest in the PD-1/VEGF bispecific modality, spurred by the recent success of Summit Therapeutics' ivonescimab in the Phase III HARMONi-2 trial, where it demonstrated a nearly 50% reduction in the risk of disease progression or death compared to Merck & Co.'s PD-1-blocking antibody Keytruda (pembrolizumab) in first-line NSCLC (see – Physician Views Results: Oncologists look ready to kick Keytruda to the curb and KOL Views Q&A: Is HARMONi-2's success in 1L NSCLC too good to be true?).Crescent Biopharma, a recent Paragon Therapeutics spinout, is also advancing its own PD-1/VEGF bispecific, CR-001, which is slated to enter the clinic around early 2026 and have interim data in the second half of that year. Meanwhile, Ottimo Pharma recently emerged from stealth with former Seagen CEO David Epstein leading efforts to develop a PD-1/VEGFR2-targeting bispecific called jankistomig.