Advancing mitochondrial therapy
Made Scientific and Cellergy Therapeutics have established a manufacturing partnership to advance Cellergy’s mitochondrial therapy candidate, CLG-001, toward first-in-human studies. The collaboration will focus on implementing and scaling Cellergy’s proprietary mitochondrial isolation and purification process within Made Scientific’s GMP manufacturing environment.
Under the agreement, Made Scientific will produce clinical-grade CLG-001 to support Cellergy’s upcoming programs, including trials under Israel’s Ministry of Health compassionate-use framework and a Phase I study planned with the FDA. The therapy consists of mitochondria purified from healthy donors and is designed to restore cellular energy production. Cellergy is developing the approach for conditions associated with mitochondrial dysfunction, such as metabolic diseases, neurodegenerative disorders, and age-related decline.
Bringing cell and gene therapies to underserved communities
Caring Cross has formed a partnership with the Amrita Research Center Delhi (ARCD) and Amrita Vishwa Vidyapeetham university to develop affordable and scalable cell and gene therapy solutions for diseases that disproportionately affect underserved communities in India. The collaboration will seem to advance treatments for sickle cell disease, thalassemia, and several cancers.
“The founding vision of Amrita Vishwa Vidyapeetham is to apply science with compassion for the benefit of humanity,” said Shantikumar Nair, Associate Provost at Amrita Vishwa Vidyapeetham and Head of Research at Amrita Vishwa Vidyapeetham, Faridabad Campus. “With this collaboration, we are building upon that vision – transforming advanced research into therapies that can help heal and uplift those most in need. This is translational innovation guided by empathy.”
The partnership will be looking towards decentralized manufacturing capabilities designed to support point-of-care production and the development of TriCAR-T cell therapies for leukaemia and lymphoma, alongside additional next-generation platforms aimed at improving equity in access to cell and gene therapies.
AI to scale gene editing
Cassidy Bio has launched with an $8 million seed financing round to advance an AI-driven genomic foundation model designed to streamline and scale the development of gene editing therapies. The company aims to address persistent bottlenecks in the field by replacing traditional trial-and-error design with a predictive platform that integrates experimental data, machine learning, and population-scale genomic insights.
Cassidy Bio’s claims its technology evaluates combinations of guide RNAs, editing enzymes, and delivery modalities to match them with suitable therapeutic contexts. The platform is intended to support a fully integrated workflow, enabling more precise target selection and improving confidence early in the design phase of genome editing programs.
The company is led by CEO Rom Kshuk and Chief Scientific Officer Ayal Hendel, a researcher in genome editing and gene therapy at Bar-Ilan University. The founding team also includes AI specialist Yaniv Shmueli.
Off-the shelf CAR-NKT cell therapy
UCLA researchers have developed an engineered cell therapy that shows the ability to eliminate pancreatic tumors and their metastases in rigorous preclinical studies, offering a potential new approach for a disease with few effective treatment options. The work, published in PNAS, describes an off-the-shelf CAR-NKT cell therapy designed to overcome barriers that have long limited the success of immunotherapies in pancreatic cancer.
The therapy is built from invariant natural killer T cells produced from donated blood stem cells. Because these cells do not require patient-specific matching, they can be manufactured at scale and stored for immediate use. The researchers estimate that each dose could cost around $5,000.
To evaluate the therapy, the team tested it in several pancreatic cancer models that mimic the complexity of human disease, including orthotopic tumors growing in the pancreas and metastatic tumors in the liver. The engineered cells demonstrated strong tumor-homing capabilities, driven by high expression of chemokine receptors that guide them to cancer sites throughout the body. Across models, the therapy slowed tumor growth, prolonged survival and maintained its functional activity in the immunosuppressive environment characteristic of pancreatic cancer.
With preclinical studies completed, the UCLA team is preparing regulatory submissions to begin clinical testing. The researchers emphasize that demonstrating similar results in patients will be the next essential step in advancing the therapy toward clinical use.
CAR collaboration for solid tumors
Imugene and JW Therapeutics have entered into a strategic collaboration to investigate a combination of Imugene’s onCARlytics (CF33-CD19) oncolytic virus with JW’s CD19-directed autologous CAR-T therapy, Carteyva, for patients with advanced and refractory solid tumors. The agreement outlines a staged development plan beginning with in vitro and in vivo preclinical studies, followed by a Phase 1 investigator-initiated trial in China at established CAR-T clinical centres.
The approach is based on a first-in-class “mark and kill” mechanism. Imugene’s onCARlytics platform uses the CF33-CD19 virus to infect tumour cells and induce surface expression of the CD19 antigen, a target normally restricted to B cells. By doing so, the program aims to render solid tumors susceptible to CD19-targeted CAR-T cell killing using Carteyva, a therapy already approved in blood cancers.
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