SOHM Inc. (OTC PINK:SHMN), a pharmaceutical and biotechnology company specializing in generic drugs and gene-editing tools, has appointed Dr. Leonardo Mirandola to its Advisory Board. Dr. Mirandola, who brings over a decade of experience in oncology and cell therapy, will lead the company's efforts to advance its CAR-T cell projects toward clinical trials and eventual commercialization.
"Dr. Mirandola's extensive background in cell therapy and his remarkable success in clinical translation make him an invaluable addition to our team," said David Aguilar of SOHM Inc. "His leadership will be instrumental as we push the boundaries of CAR-T cell production and therapy and strive to bring new treatment options to those battling cancer."
Expert in Cell Therapy Development
Dr. Mirandola holds a Ph.D. and Master's degree from the University of Milano, Italy, and has established himself as an authority in transforming scientific innovations into viable treatment options. His expertise spans operational management, research and development, and clinical development of cell therapies.
Prior to joining SOHM, Dr. Mirandola served as Chief Scientific Officer and Interim Chief Operations Officer at Kiromic Biopharma. During his tenure there, he played a crucial role in developing and overseeing clinical operations for several groundbreaking therapies, including:
- An autologous dendritic cell therapeutic vaccine for solid tumors
- An allogeneic gamma-delta T-cell therapy that received Fast-Track designation from the FDA and demonstrated positive results in Phase 1 trials for patients with Stage 4 non-small cell lung cancer
"I am excited to join SOHM Inc. and collaborate with such a talented team dedicated to making a difference in the lives of cancer patients," said Dr. Mirandola.
Proprietary ABBIE Platform to Accelerate CAR-T Development
SOHM is utilizing its proprietary gene editing platform, ABBIE, to enhance and accelerate the commercialization of CAR-T cell therapies. The company claims ABBIE offers significant advantages over traditional viral-based or CRISPR systems, including:
- Cost-efficient editing approach
- Reduced manufacturing complexity
- Fewer regulatory hurdles
- Improved genetic payload fidelity
- Broader therapeutic window
By integrating ABBIE into its CAR-T development pipeline, SOHM aims to streamline production timelines and make advanced cell therapies more accessible and scalable for a wider range of cancer patients.
Manufacturing Expertise Critical for Clinical Translation
Dr. Mirandola's track record includes securing patents for novel manufacturing techniques and AI-driven target discovery processes, which have significantly advanced the understanding and development of cell therapies. His experience in establishing cGMP-compliant manufacturing processes will be particularly valuable as SOHM prepares its CAR-T cell projects for clinical evaluation.
The appointment comes at a critical time for the cell therapy field, which continues to face challenges in manufacturing scalability, cost, and accessibility. CAR-T cell therapies have shown remarkable efficacy in certain blood cancers but remain limited by production complexities and high costs.
Market Context and Unmet Needs
CAR-T cell therapies represent one of the most promising frontiers in cancer treatment, with approved products demonstrating unprecedented response rates in certain hematological malignancies. However, current approved therapies face significant challenges:
- Manufacturing processes typically take 3-4 weeks
- Production costs can exceed $400,000 per patient
- Limited efficacy against solid tumors
- Accessibility issues for many patients
SOHM's approach with the ABBIE platform aims to address these limitations by simplifying the manufacturing process and potentially expanding the range of treatable cancers.
The company's focus on proprietary gene editing technology positions it in a competitive landscape that includes both large pharmaceutical companies and specialized biotechnology firms developing next-generation cell therapies with improved manufacturing processes, enhanced efficacy, and broader applicability.
