On June 20, 2023 Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, reported that the company will deliver an oral presentation including highlights from its ongoing preclinical studies of CD421, a CD73-targeting drug-Fc conjugate (DFC), as well as the development of its novel DFCs from Cidara’s Cloudbreak platform, at the 2nd Annual Adenosine-Pathway Targeted Cancer Immunotherapy Summit in Boston, MA, which is being held June 20-22, 2023 (Press release, Cidara Therapeutics, JUN 20, 2023, View Source [SID1234636986]).

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"We are pleased to be presenting preclinical data demonstrating the potential of CD421, as well as on the utility and flexibility of our Cloudbreak DFC platform," said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. "We believe CD421 combines the best attributes of small molecule and monoclonal antibody therapies and can serve as a potentially beneficial alternative treatment option for patients with cancer. We look forward to continuing to advance this candidate towards the clinic."

Oral presentation details are as follows:

Title: Cidara Drug-Fc-Conjugates (DFCs): A new approach to treatment of cancer
Presenter: James Levin, Ph.D., Senior Director, Preclinical Development at Cidara Therapeutics
Session Date/Time: Thursday, June 22, 2023 at 9:30 a.m. ET
Session Location: Boston, MA

To view the full schedule, visit the Adenosine Pathway Targeted Cancer Immunotherapy Summit website here.

About Cloudbreak DFCs
Cidara is developing a new generation of immunotherapeutic agents from its Cloudbreak platform that couple targeted small molecule and peptide drugs to a human antibody fragment (Fc). These highly potent, long-acting drug-Fc conjugates (DFCs) are designed to inhibit specific disease targets while simultaneously engaging the immune system. In addition to multiple oncology programs, Cidara is advancing its antiviral DFC CD388 through Phase 1 and Phase 2a clinical trials in partnership with Janssen for the universal prevention and treatment of influenza.

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.

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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.

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]).

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"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.

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

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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.

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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."