Neelam Sharma, MS, Tara Innovations, LLC
Lakshmi Lavanya Kundurthy, BE, Tara Innovations, LLC
Hemant N. Joshi, Ph.D., MBA, Tara Innovations, LLC
Cellular Reprogramming to Reverse Aging and Promote Organ and Tissue Regeneration
D. A. Sinclair and Y. Lu; President and Fellow Harvard College, Cambridge, US; U.S. Patent # 12,409,207, September 9, 2025.
Epigenetics looks into how certain chemicals and other factors control how genes work. Epigenetics turns genes “on” and “off” and it changes as we age or by exposure to environmental factors. The cellular aging process is caused by the loss of both genetic and epigenetic information. The composition in the present patent comprises the transcription factors OCT4, SOX2 and KLF4, the “Yamanaka factors”. Yamanaka factors are typically used to reprogram cells to a completely pluripotent state. Pluripotent pertains to the ability of a cell to differentiate into many cell types. The patent discloses a composition comprising OCT4 protein, SOX2 protein, and KLF4 protein but does not include a c-Myc protein and a Nanog protein.
Method for Preparing Transmembrane pH-Gradient Vesicles
J.C. Leroux, V. Forster, and V. Agostoni; Versantis AG, Zurich, CH; U.S. Patent # 12,427,112; September 30, 2025.
Traditional methods for preparing transmembrane pH-gradient liposomes typically involve hydration in an acidic or basic medium, followed by titration. The traditional method has its own limitations such as the need for freeze-drying (costly and difficult to scale) or heating above the lipid phase transition, which can complicate manufacturing, sterilization, and stability. The present invention provides an improved method for producing transmembrane pH gradient vesicles, comprising three main steps: 1. Vesicle formation: Prepare vesicles from amphiphilic lipids or block copolymers in an aqueous medium with osmolarity ≤ 200 mOsm/L. 2. Osmotic shock loading: Transfer the vesicles into a basic or acidic buffer with osmolarity ≥ 200 mOsm/L higher than the initial medium, generating buffer-filled vesicles and 3. Gradient establishment: Dilute the mixture with a neutralizing solution to create a transmembrane pH gradient, with the suspension buffer pH differing from the internal buffer. This approach reduces or eliminates the need for freeze-drying and high-temperature steps, improving manufacturability and scalability, while producing vesicles that are stable under sterilization and maintain a robust pH gradient, making them suitable for applications such as detoxification, metabolite removal, or drug loading.
Adagrasib Solid Pharmaceutical Compositions
C. Nunes, M.Kheiripour, and M. Gavireddi; Mirati Therapeutics, Princeton, US; U.S. Patent # 12,383,503; August 12, 2025.
Adagrasib is used to treat non-small cell lung cancer in adults. It is especially used in patients for whom the cancer has spread to other parts of body and can’t be removed by surgery. The patent claims a tablet formulation of adagrasib where the Cmax for the drug is lower as compared to Cmax provided by the capsule formulation under fasted conditions. Lower Cmax (about 13% lower) helps to reduce the side effects of drugs, such as nausea, vomiting, diarrhea etc. The AUC of this tablet formulation is also about 10% lower than the capsule formulation.
Stable Fusion Protein Formulation
M. Jayaraman and L. Kanakadurga M; Dr. Reddy’s Laboratories Ltd., Hyderabad, India; U.S. Patent # 12,428,464; September 30, 2025.
The invention provides a stable pharmaceutical formulation of a CTLA4-Ig fusion protein comprising a buffer, sugar, amino acid, and surfactant. The formulation is designed to minimize aggregation, fragmentation, and chemical degradation of the fusion protein during storage and handling. Histidine is combined with sugar in the formulation, which together impart colloidal and chemical stability to the CTLA4-Ig molecule. Histidine acts as the sole amino acid stabilizer. The formulation is free of other amino acids such as arginine, lysine, glycine, or methionine, commonly used in protein stabilization. The CTLA4-Ig formulation is stable across protein concentrations of 10–200 mg/mL, maintaining <10% aggregation for at least four weeks at 25°C or two weeks at 30°C. The composition is suitable for both liquid and lyophilized dosage forms, providing a robust and manufacturable platform for stable fusion protein therapeutics.
Therapeutic Eye Treatment With Gases
J. Berdahl and G. Tsai; Balance Ophthalmic, Inc., Sioux Falls, US; Patent # 12,414,898; September 16, 2025.
The present invention relates to devices and methods for maintaining and regulating a controlled environment over the anterior surface of a patient’s eye. The apparatus comprises an enclosure sized and shaped to seat around the patient’s eye and form a sealed cavity surrounding the anterior eye surface. The enclosure is configured to contain a fluid medium other than ambient air in contact with the eye, such as a gaseous or humidified therapeutic fluid. A fluid regulator is in communication with the enclosure and is configured to control the composition, humidity, temperature, or flow rate of the fluid contained within the cavity. The system can introduce therapeutic gases. The invention enables extended, controlled delivery of therapeutic fluids or gases to ocular tissues such as the cornea, sclera, and conjunctiva, thereby enhancing contact time, improving absorption, and promoting treatment efficacy for various ocular conditions.
Chemically and Physically Stable Topical Ophthalmic Nepafenac-Based Formulations
D. Aleo, M.G. Saita, B. Melilli, S. Mangiafico and M. Cro; Medivis S.R.I., Tremestieri Etneo, (IT); U.S. Patent # 12,390,429; August 19, 2025.
Nepafenac, a nonsteroidal anti-inflammatory drug (NSAID), is used to treat ocular inflammation. Nepafenac exhibits poor water solubility and instability in conventional liquid eye-drop formulations. Currently, the only marketed ophthalmic preparations are nepafenac suspensions, which often result in poor patient compliance due to their particulate nature. The present patent introduces stable, fully liquid (non-suspension) eye-drop formulations of nepafenac that preserve both chemical and physical stability for up to 24 months at room temperature. The innovation lies in the strategic use of methyl-β-cyclodextrin combined with specific polymer ratios, enabling the development of a aqueous solution that maintains its potency, clarity, and long-term shelf stability.
System for Inducing Sonoporation of a Drug into Cancer Cells and Method Thereof
P. Glustettol and D. Faletto; Freedom Waves S.R.I. T. (IT); U.S. Patent # 12,397,056; August 26, 2025.
Liposome formulations have shown promise to deliver drugs to tumors but have limitations. They release medicines spontaneously. Shock waves and other techniques used to overcome the drawbacks of liposomes have shown promise but are not perfect. In this patent, ultrasonic waves are used to induce sonoporation. Pulsed low intensity non-focused ultrasound (pLINFUs) perform insonation of liposomes and sonoporation of cell membranes. Insonation refers to the induction of the drug release from inside to the outside of liposomes. Sonoporation refers to the creation of transient non-lethal perforations in the cell membrane to aid ingress of liposomes into the cell. Based on the tumor type, size etc., the frequency and duty cycle values are predetermined prior to the ultrasonic treatment.
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