Liss' Lowdown #26 - 1000 Subscribers!

Preclinical Breakthrough of the month:

Breakthrough in Herpes Cure: Gene Therapy Shows 90% Reduction in Preclinical Models

Fred Hutch Cancer Center researchers have achieved a major breakthrough in gene therapy for herpes, eliminating over 90% of HSV-1 in preclinical models of oral and genital herpes. Published in Nature Communications, the study by Martine Aubert , and Keith Jerome , demonstrates the therapy also reduces viral shedding, potentially lowering transmission.

The innovative treatment uses gene editing molecules to target and disable the herpes virus's DNA. This approach led to a 90% reduction in facial infections and 97% in genital infections in mouse models. Simplifying previous methods, the new technique uses one vector and meganuclease, enhancing safety and production.

Future efforts will focus on adapting this technology for HSV-2 and preparing for clinical trials. Supported by the The National Institutes of Health , CALADAN FOUNDATION , and individual donors, this promising therapy could significantly impact global health by providing a potential cure for herpes.

Clinical Breakthrough of the month:

Sanofi Utilizes AI and Virtual Patients to Revolutionize Drug Development

Sanofi is leading efforts to harness artificial intelligence (AI), introducing "digital twins" or virtual patient populations. While real patients remain crucial in late-stage studies, virtual patients allow early testing of drug candidates, improving safety and efficacy assessments and potentially reducing the number of patients needed in trials. This approach aims to address the 90% failure rate of new drug candidates in clinical development and accelerate breakthroughs.

Digital trials use quantitative systems pharmacology (QSP) modelling, integrating data on disease biology, pathophysiology, and pharmacology into a computational framework. This enables simulation of a drug's mechanism of action (MOA) to predict its performance in treating diseases. For example, Sanofi's virtual asthma patients helped evaluate a novel compound's efficacy by predicting trial outcomes, matching observed data.

Sanofi's investment has generated virtual patient populations for various therapeutic areas, enhancing predictive modelling and speeding up R&D processes. Future goals include developing algorithms for complex diseases and creating a "biology foundation model" to predict clinical efficacy widely. This vision aims to deliver advanced medicines swiftly and seamlessly to patients.

Partnership of the month:

Merger Creates Expanded European Contract Research Organization: OCT Global SA and Palleos Healthcare Join Forces

OCT Clinical and palleos healthcare have merged under the Palleos brand. Philip Raeth , managing director at Palleos, stated the merger would enhance expertise and offer significant synergies. Geographically, Germany-based Palleos operates in Western and Central Europe, while OCT covers Eastern Europe. The merged entity now provides services from pre-clinical consulting to regulatory affairs and clinical trials across the entire region.

Prior to the merger, Palleos focused on oncology product development, including preclinical and clinical research strategy, trial management, and post-market data collection. OCT was a full-service CRO handling trials in oncology, rheumatology, infectious disease, and other conditions. The merger was facilitated by Swiss Xlife Sciences AG , a life sciences incubator and major Palleos shareholder.