Citius Pharmaceuticals | September 23, 2020
Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has achieved a number of significant milestones over the past several weeks for Mino-Lok®. Mino-Lok is an antibiotic lock solution being developed as an adjunctive therapy for patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). Mino-Lok contains three active drug substances (minocycline, ethanol and EDTA) which are combined into two vials, MLT01 (minocycline) and MLT02 (ethanol and EDTA). Citius has manufactured three registration lots of Mino-Lok using the commercial manufacturing process, which will be filed in the planned New Drug Application (NDA).
Avacta | November 29, 2021
Avacta Group plc, a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000. This will allow the Group to expand its Phase I clinical trial, ALS-6000-101, into clinical trial sites in the United States.
AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ platform to improve its safety and therapeutic index. Anthracyclines such as doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 20241, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity. AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues. The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.
The FDA has completed its 30-day review of Avacta’s IND application, which was submitted ahead of schedule in October 2021, and has concluded that the Group may proceed with its proposed clinical investigation. This allows Avacta to enroll eligible patients into US clinical trial sites for the company’s Phase I multi-centre study, ALS-6000-101. As previously announced in August 2021, the Company has begun recruiting and dosing patients for this study at several clinical trial sites in the UK, and continues to expect the dose escalation phase for this trial to complete by Q2 2022 followed by completion of the dose expansion phase around mid-2023. Enrollment in US clinical trial sites is expected to begin in early 2022.
“We are delighted to have received approval from the FDA to add clinical trial sites in the United States as part of the Phase I study for AVA6000. This is a major milestone in our development of pre|CISION™ chemotherapies and is testament to the performance of our clinical development team and the quality of the pre-clinical data for AVA6000.
Dr. Alastair Smith, Chief Executive of Avacta Group
Provided that the study shows that the pre|CISION™ technology is effective in reducing systemic toxicity of Doxorubicin, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION™ chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 20272.
We now look forward to opening up clinical trial sites in the United States and additional clinical trial sites in the UK.”
Neil Bell, Chief Development Officer of Avacta Life Sciences, commented: “We are excited to bring the first FAP-activated chemotherapeutic to the clinic in the US, which has the potential to meaningfully impact patients with difficult-to-treat tumours. The clearance of the AVA6000 IND by the FDA enables the opening of key US sites to support the ALS-6000-101 clinical trial which is currently recruiting patients across clinical sites in the UK.”
Charles River Laboratories International, Inc. and Valo Health, LLC, | January 20, 2022
Charles River Laboratories International, Inc. and Valo Health, LLC, the technology company using human-centric data and computation powered by artificial intelligence (AI) to transform the drug discovery and development process, today announced the formation of a multiyear strategic partnership. This agreement will combine Valo’s Opal Computational Platform with Charles River’s drug discovery and development capabilities to offer a new transformative, AI-enabled drug discovery and development platform.
Recognizing the challenges of preclinical drug discovery, from high costs, time, and attrition rates, Valo and Charles River have joined forces to create enhanced drug discovery solutions that aim to transform the entire preclinical drug discovery process. Valo and Charles River intend to create and deliver offerings that produce preclinical assets with key performance characteristics optimized for client preferences.
The partnership’s combined offerings will utilize Valo’s Opal Platform for small molecule development, which leverages a “closed-loop” in silico-experimental platform that rapidly iterates using program data to identify novel compounds, and leverages Charles River’s capabilities in all aspects of discovery optimization, including medicinal chemistry, ADME, biology, pharmacology, and ultimately safety testing and IND submission.
The combination of Valo’s scientific innovation and deep technological expertise with Charles River’s end-to-end portfolio and industry-leading scientific bench has the potential to significantly accelerate a client’s discovery and development efforts by integrating data and compute to streamline and de-risk experimental science, enabling a faster and more effective process from de novo molecule design through lead optimization.
The combined offering will be launched in the first half of 2022 and will be available exclusively from Charles River.
About Valo Health
Valo Health, LLC is a technology company built to transform the drug discovery and development process using human-centric data and artificial intelligence (“AI”) computation. As a digitally native company, Valo aims to full integrate human-centric data across the entire drug development lifecycle into a single unified architecture, thereby accelerating the discovery and development of life-changing drugs while simultaneously reducing the cost, time, and failure rate. The company’s Opal Computational Platform™ consists of an integrated set of capabilities designed to transform data into valuable insights that may accelerate discoveries and enable Valo to advance a robust pipeline of programs across cardiovascular metabolic renal, oncology, and neurodegenerative disease. Founded by Flagship Pioneering and headquartered in Boston, MA, Valo also has offices in Lexington, MA, San Francisco, CA, Princeton, NJ, and in Branford, CT.
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.