MIRA-1 / Aprea - LARVOL DELTA

A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects (clinicaltrials.gov) - P1 | N=444 | Completed | Sponsor: Biocad | Recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Feb 2026 | Trial primary completion date: Nov 2025 ➔ Feb 2026

Trial completion • Trial completion date • Trial primary completion date

Initial activities and prospects of MIRAY1: a youth-driven, society-endorsed initiative to cultivate future breast cancer physicians. (PubMed, Breast Cancer) - "Early activities have demonstrated high engagement among medical students and young physicians through hands-on education, digital communication, and peer-led networking. MIRAY1 represents a potentially sustainable workforce development model not only for Japan but also for other Asian countries facing similar challenges in oncology care."

Journal • Breast Cancer • Oncology • Solid Tumor

MIRAY1 Forum (JBCS 2026) - No abstract available

Committee Planning: Future Planning Committee (Young Members' Education and Training Promotion WG) - Learning from young members' groups in other academic societies about the role of young members' groups in academic society management. (JBCS 2026) - "In the discussion, based on the knowledge gained from their activities in each society, they will exchange opinions on the significance and evaluation of young doctors' activities and future prospects. They will also discuss the ideal education and training system for young doctors in the Japanese Breast Cancer Society and the future vision of MIRAY1, as well as strengthening connections between young doctor groups in each society."

Breast Cancer • Solid Tumor

Case Discussion : What would you do in this case? – There isn't always just one right answer in oncoplastic surgery. (JBCS 2026) - "We will be asked to present cases that offer valuable lessons from a professional perspective, such as "It was a close call and worked well," "This method was reasonably good, but in hindsight, that other method might have been better," or "We had to abandon the close call and proceeded with a mastectomy and reconstruction." For each presented case, leading experts in each field, including the case presenters, as well as experts recommended by MIRAY1, will act as respondents, presenting methods using flip charts...Furthermore, not all options may be available depending on the region. This session aims to present methods for each case using flip charts and other visual aids, and to share with the audience the advantages, disadvantages, limitations, and best outcomes of each approach."

Clinical • Surgery • Aesthetic Medicine • Breast Cancer • Infectious Disease • Solid Tumor

Chairman's Special Feature 1: Surgical Technique Video Session - MIRAY1's Selection of Surgeries You Want to See! (JBCS 2026) - No abstract available

Surgery • Video

MIRA-1, a p53mut reactivator, is active on Temozolomide-resistant glioblastoma in vitro. (PubMed, Mol Biomed) - No abstract available

Journal • P53mut • Preclinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

A Double-Blind, Comparative, Randomized Clinical Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL After a Single Subcutaneous Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=413 | Recruiting | Sponsor: Biocad

New P1 trial

Design, synthesis and evaluation of diphenyl ether-based kaiso inhibitors with enhanced potency. (PubMed, Bioorg Med Chem Lett) - "Notably, its inhibitory activity surpassed that of the positive control MIRA-1 (IC50 = 654.065 μM). Molecular docking and dynamic studies revealed that the binding of the compound's amino and ester moieties to the active site of kaiso protein, as well as the extension of the benzene ring towards the Asn561 position in the cavity, contributed significantly to its potency. These findings provide valuable insights for the development of new Kaiso inhibitors."

Journal • Lung Cancer • Oncology • Solid Tumor

MIRAY1 (Multi Institutional bReast cAncer Young team No.1): Fostering Young Professionals and Networks in Breast Cancer (JSMO 2025) - No abstract available

Clinical • Breast Cancer • Oncology • Solid Tumor

WWOX-mediated p53/SAT1 and NRF2/FPN1 axis contribute to toosendanin-induced ferroptosis in hepatocellular carcinoma. (PubMed, Biochem Pharmacol) - "In addition, the results from cell viability assay and the tumor xenograft model verified that co-treatment of TSN, ML385 (NRF2 inhibitor), and MIRA-1 (p53 activator) could effectively inhibit HCC cells growth in the presence of Fer-1 (ferroptosis inhibitor) in vitro and in vivo. Overall, our study contributes to the necessary understanding of the molecular mechanisms of WWOX-mediated ferroptosis regulation, and identifies TSN as a potential therapeutic agent targeting ferroptosis for HCC."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • SAT1 • SLC40A1 • WWOX

MIRAY1's activities so far (JBCS 2024) - No abstract available

Breast Cancer • Oncology • Solid Tumor

Committee Planning General Affairs Committee (Member Service Review Subcommittee) : "MIRAY" of the Breast Cancer Society is developed in each region: Activities and prospects of the young group MIRAY1 (JBCS 2024) - "Takashi Ishikawa, chairman of the Regional Revitalization Committee, and Dr. Chikako Yamauchi, chairman of the Education and Training Committee"

Review • Breast Cancer • Oncology • Solid Tumor

MIRAY1: Forming a cross-sectional network of young breast specialists, to foster attractive breast specialists MUJI collaboration event Japanese Breast Cancer Society MIRAY1, Cancer Institute Ariake Hospital Breast Center Surgery, Showa University Breast Surgery, St. Luke's International Hospital Breast Surgery, Hiroshima University Hospital Breast Surgery, Ehime University Hospital Breast Cen (JBCS 2024) - "[Summary] Through the preparation and holding of the event, the MIRAY1 members were able to get closer to each other and spend a meaningful time together. We hope that the image of us "working happily" will lead to the recruitment of young doctors and students"

Clinical • Surgery • Breast Cancer • Oncology • Solid Tumor

Bulk and single-cell sequencing identified a prognostic model based on the macrophage and lipid metabolism related signatures for osteosarcoma patients. (PubMed, Heliyon) - "Finally, our meticulous drug sensitivity analysis identified a spectrum of potential therapeutic agents for OS, including AZD2014, Sapitinib, Buparlisib, Afuresertib, MIRA-1, and BIBR-1532. These findings significantly augment the therapeutic arsenal available to clinicians managing OS, presenting a promising avenue for elevating treatment outcomes."

Journal • Metabolic Disorders • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

About the activation of breast cancer medical treatment and younger training by young groups (MIRAY1) for doctors involved in breast cancer medical treatment (JSMO 2024) - No abstract available

Breast Cancer • Oncology • Solid Tumor

Towards Machine Learning in Heterogeneous Catalysis-A Case Study of 2,4-Dinitrotoluene Hydrogenation. (PubMed, Int J Mol Sci) - "The aim of the MIRA21 (MIskolc RAnking 21) model is to characterize heterogeneous catalysts with bias-free quantifiable data from 15 different variables to standardize catalyst characterization and provide an easy tool to compare, rank, and classify catalysts...In this study, exploratory data analysis (EDA) has been used to understand the relationships between individual variables such as catalyst performance, reaction conditions, catalyst compositions, and sustainable parameters. The results will be applicable in catalyst design, and using machine learning tools will also be possible."

Heterogeneity • Journal • Machine learning • MIR21

The Safety of Phentolamine Ophthalmic Solution for Reversal of Pharmacologically Induced Mydriasis from Multiple Late-Stage Clinical Trials (ASCRS-ASOA 2022) - "ConclusionThe safety results from MIRA-1/2/3 late-stage registration clinical trials have demonstrated a tolerable safety profile with primarily mild AEs (e.g. conjunctival hyperemia and instillation site discomfort). The safety database is expected to support a POS regulatory submission as a treatment option to reverse pharmacologically-induced mydriasis."

Clinical • Ophthalmology

Phase 3 Clinical Trial to Evaluate the Efficacy of Phentolamine Ophthalmic Solution on the Reversal of Pharmacologically Induced Mydriasis (ASCRS-ASOA 2021) - "POS has been studied in a Phase 2 MIRA-1 clinical trial with positive reversal of mydriasis results and demonstrated tolerable safety profileMethodsThe MIRA-2 study is a Phase 3, multi-center, randomized, placebo-controlled, double-masked clinical trial. Subjects will be randomized to receive one of three mydriatic agents: phenylephrine, tropicamide, or Paremyd (1% hydroxyamphetamine hydrobromide and 0.25% tropicamide) followed by 1 or 2 drops of 0.75% POS or placebo vehicle...Adverse effects, graded mild, were instillation site discomfort (38% POS vs. 9% placebo) and conjunctival hyperemia (13% POS vs. 0% placebo).ConclusionOne or two drops of POS returned a statistically greater number of subjects to their baseline PD as soon as 1 hour using all mydriatic agents tested with a faster response seen in subjects dilated with phenylephrine. The safety profile was favorable and all adverse events rated as mild."

Clinical • P3 data • Ophthalmology

Expression of the potato late blight resistance gene Rpi-phu1 and Phytophthora infestans effectors in the compatible and incompatible interactions in potato. (PubMed) - "It is a first report that the Avr-vnt1 effector expression is not switched off permanently in virulent isolates to avoid recognition by an R protein, but can reappear in a post-biotrophic phase and is present constantly when infecting plants without the corresponding R gene. Both plant and a pathogen can react to the other interacting side by changing the transcript accumulation of R genes or effectors."

Journal • Biosimilar • Immunology

Acute cytotoxicity of MIRA-1/NSC19630, a mutant p53-reactivating small molecule, against human normal and cancer cells via a caspase-9-dependent apoptosis. (PubMed) - "Third, combined pharmacological and genetic approaches showed that MIRA-1 acute cytotoxicity was mediated by a caspase-9-dependent apoptosis. In conclusion, our strategy unveils the limitations of the targeted action of a small molecule designed to reactivate mutant p53."

Journal • Biosimilar • Oncology