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- Quotient Sciences has launched what it believes to be the first Phase I clinical study of an AI-designed oral drug formulation, marking a landmark achievement in pharmaceutical development. - The study received approval from the UK's MHRA and will assess safety and pharmacokinetics of the AI-developed oral solid dose formulation in healthy volunteers. - The trial leverages Intrepid Labs' advanced machine learning algorithm combined with Quotient Sciences' Translational Pharmaceutics® platform to accelerate formulation design and improve clinical predictability. - This milestone represents the beginning of Quotient Sciences' broader strategy to integrate AI-enabled approaches across formulation development and clinical workflows.
- Quotient Sciences has extended its commercial manufacturing partnership with Ipsen to produce Sohonos (Palovarotene), an FDA-approved treatment for Fibrodysplasia Ossificans Progressiva affecting fewer than 1,000 people worldwide. - The collaboration includes Ipsen's investment in specialized equipment at Quotient's Pennsylvania facility, featuring a Pneumatic Closed Transfer System and Flexible Dispensing Isolator to safely handle the highly potent molecule. - The partnership expands Quotient's capabilities for manufacturing highly potent API compounds with occupational exposure limits at or below 1 µg/m³, addressing critical needs in rare disease treatment.
- Quotient Sciences and Intrepid Labs announced a multi-year strategic partnership to advance artificial intelligence use in early drug development through the ANDROMEDA AI platform. - The collaboration integrates Intrepid's machine learning model with Quotient's Translational Pharmaceutics® platform to reduce experimental burden and accelerate formulation optimization. - Boston Consulting Group analysis suggests AI-enabled approaches could reduce time and cost in early development by 25-50%. - The partnership aims to minimize drug substance requirements, shorten development cycles, and enhance data-driven decision making in pharmaceutical formulation science.
- Larkspur Biosciences has dosed the first participant in a Phase 1 clinical study of LRK-4189, a first-in-class targeted protein degrader targeting PIP4K2C for microsatellite stable colorectal cancer treatment. - The oral drug represents a novel therapeutic approach that destroys cancer cells by targeting cancer cell fitness mechanisms, specifically degrading the lipid kinase PIP4K2C to trigger intrinsic cancer cell death. - The single-ascending dose trial will evaluate safety, tolerability, and pharmacokinetics in approximately 40 healthy volunteers in the UK before advancing to patient studies. - MSS colorectal cancer accounts for about 85% of the approximately 150,000 annual CRC cases diagnosed in the U.S., representing a significant unmet medical need.
- Quotient Sciences and Biorasi have announced a strategic partnership to deliver fully integrated early phase clinical trial solutions from IND to proof-of-concept. - The collaboration combines Quotient's clinical pharmacology expertise and 230-bed facilities with Biorasi's global patient recruitment network spanning multiple therapeutic areas. - Sponsors will benefit from a single provider model offering unified contracts and protocols to reduce outsourcing complexity and accelerate development timelines. - The partnership enables seamless transitions from healthy volunteers to patient groups within first-in-human Phase I/IIa clinical trials through hybrid protocol designs.
- Quotient Sciences and CPI have signed a memorandum of understanding to form a joint venture combining Quotient's Translational Pharmaceutics® platform with CPI's RNA manufacturing expertise. - The collaboration promises to reduce clinical batch production timelines from plasmid to clinical dose to as little as two months, significantly accelerating early-phase clinical trials. - The integrated platform will combine mRNA synthesis, LNP formulation development, clinical manufacturing, and early-phase clinical testing under one collaborative framework. - This joint venture extends Quotient's proven Translational Pharmaceutics® approach, previously used on over 500 small molecule and peptide programs, into mRNA-based therapeutics.
• Blend-in-capsule (BiC) formulation simplifies early-stage clinical trials by directly encapsulating the active pharmaceutical ingredient (API), reducing development time and costs. • Expedited first-in-human (FiH) trials provide crucial data on drug safety, efficacy, and pharmacokinetics, enabling informed decisions on further development and risk mitigation. • A case study demonstrates BiC's effectiveness in oncology drug development, facilitating rapid progression from initial trials to larger patient studies and commercial-ready tablets. • Strategic partnerships and integrated services streamline technology transfer and project management, accelerating drug development and benefiting both developers and patients.
• Medicines for Malaria Venture (MMV) and Quotient Sciences have initiated a Phase I trial of MMV371, a long-acting injectable (LAI) antimalarial drug. • The trial aims to assess the safety, tolerability, and pharmacokinetics of MMV371 in healthy participants, with potential for quarterly malaria prevention. • MMV371, derived from atovaquone, could provide up to three months of protection from malaria with a single intramuscular dose, pending successful trial outcomes. • Future plans include combining MMV371 with another drug like MMV055 to reduce the risk of resistance and conducting trials in malaria-endemic countries by 2026.
• Medicines for Malaria Venture (MMV) and Quotient Sciences have initiated a Phase 1 clinical trial for MMV371, a long-acting injectable malaria preventive. • The trial, conducted in healthy volunteers in the UK, will assess the safety, tolerability, and pharmacokinetics of the single-dose intramuscular injection. • MMV371, a derivative of atovaquone, aims to provide up to three months of protection against both Plasmodium vivax and Plasmodium falciparum malaria parasites. • If successful, MMV371 could offer an affordable and accessible solution, particularly beneficial for young children at high risk of malaria infection.
- Vasa Therapeutics' lead drug candidate, VS-041, has entered Phase I clinical trials to evaluate its potential as a treatment for heart failure with preserved ejection fraction (HFpEF). - The trial leverages Quotient Sciences' Translational Pharmaceutics platform for rapid drug manufacturing and clinical program execution, aiming for efficient data acquisition. - VS-041 is being developed as a personalized medicine-based treatment for HFpEF, a condition affecting millions globally and characterized by a stiffened heart. - The Phase I trial will assess the safety, tolerability, and initial efficacy insights of VS-041 in healthy volunteers, marking a significant step in its development.
