1stOncology™: Cancer Intelligence Service – Page 4924 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Minghui Pharmaceutical Inc. Announces First Patient Dosing in Phase 1 Clinical Studies of Both the ADCs Targeting TROP-2 or B7-H3 Respectively, for Treatment of Advanced or Metastatic Solid Tumors

On June 20, 2023 Minghui Pharmaceutical, Inc., a leading clinical-stage biopharmaceutical company, reported that the first dosing has been completed in two phase 1 clinical studies evaluating MHB036C and MHB088C (Press release, Minghui Pharmaceutical, JUN 20, 2023, View Source [SID1234635431]). The studies aim to determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), as well as assess the pharmacokinetics and preliminary efficacy of the ADCs in patients with selected types of advanced or metastatic solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

MHB036C and MHB088C, the two antibody-drug conjugates (ADCs) targeting TROP-2 or B7-H3, respectively, are generated through Minghui’s cutting-edge proprietary SuperTopoiTM ADC platform, which incorporates a highly potent topoisomerase (TOPO) 1 inhibitor linked through a cleavable linker. This novel payload significantly enhances the therapeutic potency of the ADCs, especially against cancer cells with moderate or low tumor-associated antigen expression.

Comprehensive in vitro and in vivo studies across a variety of cancer types demonstrated the exceptional efficacy of MHB036C and MHB088C, exhibiting 3 to 10 times more potent in killing tumor cells compared to their DXd counterparts. Additionally, preclinical GLP tox studies demonstrated an excellent safety profile, with no unique toxicities observed, particularly no severe pulmonary toxicities.

"We are delighted to announce the successful dosing of the first patient in our two ADC programs" stated Guoqing Cao, Ph.D., Chief Executive Officer at Minghui Pharmaceutical. "MHB036C and MHB088C epitomize the tremendous potential of Minghui’s SuperTopoiTM platform. These novel ADCs have undergone extensive research and development, showcasing remarkable efficacy and safety in preclinical studies. MHB036C and MHB088C hold great promise in the fight against various human solid tumors and we look forward to the results from the phase 1 studies, anticipated to conclude in early 2024. "

About MHB036C

MHB036C is an antibody drug conjugate (ADC) composed of a humanized anti-TROP-2 monoclonal antibody conjugated to Minghui’s proprietary DNA topoisomerase I inhibitor via a cleavable linker.

About MHB088C

MHB088C is an antibody drug conjugate (ADC) composed of a humanized anti-B7-H3 monoclonal antibody conjugated to Minghui’s proprietary DNA topoisomerase I inhibitor via a cleavable linker. The antibody has also shown more potent antigen binding and higher endocytosis efficiency.

Perspective Therapeutics Initiates Phase 1/2a Clinical Trials for Two Targeted Alpha Therapy Oncology Product Candidates

On June 20, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy treatment options for multiple cancers, reported that it has initiated clinical trial sites and commenced the enrollment period for its 212Pb-labeled therapeutic product candidates, VMT-α-NET and VMT01 (Press release, Perspective Therapeutics, JUN 20, 2023, View Source [SID1234632852]).

"We are excited to have our first clinical sites on board for our two lead development programs and to commence the enrollment period for these promising product candidates in patients with melanoma and neuroendocrine tumors," said Thijs Spoor, Perspective’s Chief Executive Officer.

The first product candidate, VMT-α-NET, is a result of Perspective’s intensive in-house research and development efforts to develop a best-in-class radiopeptide. The molecule incorporates the Company’s proprietary chelator technology platform that enables radiolabeling with isotopes of lead (Pb) and shows superior preclinical results as compared to other ligands in its class. On the basis of this promising preclinical data, VMT-α-NET was awarded Fast Track designation under the FDA’s expedited development program. Targeting the somatostatin type receptor 2 (SSTR2) which is over-expressed on a range of different cancer types including neuroendocrine tumors, VMT-α-NET was designed to deliver potent alpha-particle radiation directly to the tumor. Investigators at Fortis Memorial Research Institute (FMRI) located in Gurgaon, India are excited about initial patient experiences in their investigator initiated compassionate use of VMT-α-NET, results of which are expected to be presented at a major medical meeting in Q3 of 2023. An IND-enabled imaging and radiation dosimetry trial utilizing VMT-α-NET is also currently enrolling patients at the University of Iowa, IA, and similar imaging work is occurring at University Hospital Carl Gustav Carus in Dresden, Germany.

Perspective Therapeutics’ trial is a Phase 1/2a Dose Escalation of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors (NCT05636618).
The second product candidate, VMT01, also delivers alpha-particle radiation to tumors by targeting the melanocortin 1 receptor (MC1R) present on melanoma cells. This product candidate has completed clinical imaging studies at Mayo Clinic, Rochester, and results will be presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting in Chicago being held from June 24 to 27, 2023. Recent published preclinical data from Perspective’s scientists show its potential to deliver durable complete responses in treatment-resistant models when combined with existing immunotherapy drugs used to treat melanoma.

Perspective Therapeutics has initiated a Phase 1/2a Dose Escalation trial of [212Pb]VMT01 Targeted Alpha-Particle Therapy for patients with MC1R Positive unresectable and metastatic melanoma (NCT05655312).
Both US trials will be supplied with finished drug product from Perspective’s GMP manufacturing facility in Coralville, IA. Additional CDMO manufacturing sites are expected to be brought online in the coming months to enable broader coverage for sites across the US. Isotope will be supplied using Perspective’s proprietary VMT- α-GEN 212Pb benchtop generator.

"These clinical trials represent a significant advancement in our relentless pursuit of innovative and potent treatments for cancer," said Markus Puhlmann, Chief Medical Officer at Perspective. "We know that despite recent improvements in therapies for neuroendocrine cancers and melanoma, many patients become refractory to treatment. The targeted alpha-particle therapies that are being developed at Perspective have the potential to revolutionize the treatment of these and many other cancers. We look forward to seeing the results emerge over the coming months."

Preliminary results from the initial cohorts for both trials are expected to be available by the end of 2023.

Corporate presentation

On June 20, 2023 Portage biotech presented its corporate presentation (Presentation, Portage Biotech, JUN 20, 2023, View Source [SID1234632827]).

Study Published in Nature Medicine Highlights use of Vizgen MERSCOPE® Platform for Understanding Effects of Neoadjuvant Immunotherapy for Patients with Hepatocellular Carcinoma (HCC)

On June 20, 2023 Vizgen, the life science company dedicated to improving human health by visualizing single-cell spatial genomics information, reported publication of a study in the June issue of Nature Medicine conducted by Drs. Assaf Magen and Pauline Hamon in the Miriam Merad lab at the Icahn School of Medicine at Mount Sinai, in collaboration with Regeneron Pharmaceuticals, Inc (Press release, Vizgen, JUN 20, 2023, View Source [SID1234632814]). The spatial characterization described in this study was enabled by the company’s spatial transcriptomics MERSCOPE Platform, which simplifies and empowers the entire workflow from sample preparation through data visualization.

The study, "Intratumoral dendritic cell–CD4+ T helper cell niches enable CD8+ T cell differentiation following PD-1 blockade in hepatocellular carcinoma," leveraged a large neoadjuvant PD-1 blockade trial in patients with hepatocellular carcinoma (HCC) to search for correlates of response to immune checkpoint blockade (ICB) within T-cell rich tumors. Integration of single-cell RNA and TCR sequencing, together with several imaging approaches suggested that T cell activation and expansion occurs predominately at the tumor site and is promoted by CXCL13+ CD4 T cells and mregDCs (mature dendritic cells that have captured tumor antigens). These data provide the closest cellular resolution of T cell diversity in PD-1 treated patients seen in HCC. These findings could be used to develop new therapies targeting these cellular triads.

"Vizgen was developed precisely for the type of work conducted in this study and it is immensely gratifying to see our spatial transcriptomics platform play an important role in evaluating and imaging gene panels and in understanding cellular role and function in this clinical trial, which could ultimately improve tumor response to treatment," said Terry Lo, President and CEO of Vizgen. "We look forward to the continued demonstration of Vizgen’s multiplexing, high resolution in situ MERSCOPE Platform’s potential in empowering future breakthrough biological discoveries."

Surgical resection is traditionally the preferred treatment for HCC, a rare, aggressive type of liver cancer that is only variably responsive to chemotherapy, and more than half of these tumors recur within 2 years. Neoadjuvant immune checkpoint blockade targeting the PD-1/PD-L1 axis has been successful in inducing pathological response and preventing recurrence in multiple tumor types, in part by driving the expansion of tumor-specific T cells, which may also induce systemic immunity and eliminate micrometastases. This neoadjuvant clinical trial for early-stage HCC patients, led by Drs. Thomas Marron and Myron Schwartz, in which treatment-naive patients received two doses of PD-1 blockade prior to surgery, observed a 30% pathological response rate, which prompted a more detailed investigation into the cellular and molecular pathways that promote an effective anti-tumor immune response.

"I am excited about the high quality of the data produced by this study and the important implications this has for HCC and cancer biology as a whole," said Jiang He, PhD, Scientific Co-founder and Senior Director of Scientific Affairs of Vizgen. "We hypothesize that this interaction between mregDCs, helper cells and T cells could be critical across multiple other cancers. We hope this is the first of many discoveries driving insight into PD-1 therapy and advancing our treatment of cancer patients."

MAIA Biotechnology Announces Updates in Enrollment in Phase II Clinical Trial: THIO-101 Has Enrolled 29 Patients

On June 20, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported that 29 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) (Press release, MAIA Biotechnology, JUN 20, 2023, View Source [SID1234632813]). With the addition of sites in Hungary, Poland, and Bulgaria in March 2023, THIO-101 has rapidly increased the number of patients enrolled and dosed with THIO. Thirteen sites were activated with another two new additional sites ready to open in the coming weeks.

THIO is a first-in-class cancer telomere targeting agent administered in sequence with a checkpoint inhibitor (CPI). The main objectives of the THIO-101 trial are to evaluate the safety, tolerability, and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy. The trial dosed its first patient in Australia in July 2022 and expanded to include European patients in March 2023.

"We are very pleased with the progress of enrollment in Europe. Since our last update, we have more than doubled the number of patients dosed to 29, bringing us closer to our target of 184 patients planned to be treated in the trial. With a large number of lung cancer cases in Europe, we anticipate a robust rate of enrollment in the upcoming weeks," stated Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.

"With rapid enrollment in the trial, we project a substantial number of patients completing 3-6 months of treatment by the fall which will allow us a preliminary evaluation of the treatment efficacy," added Mihail Obrocea, MD, MAIA’s Chief Medical Officer.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose selection Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in advance of administration of an immune checkpoint inhibitor allowing for immune activation and PD-1 sensitivity to take effect. The trial is testing the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC, who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent and (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.