On January 25, 2022 SNIPR BIOME ApS, a leading CRISPR and microbiome biotechnology company, reported that it has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for SNIPR001 (Press release, SNIPR Biome, JAN 25, 2022, View Source [SID1234606793]). SNIPR001 is the company’s first development candidate targeting E. coli in patients with hematological malignancy at risk of neutropenia. This announcement comes only a few weeks after the FDA approved the Investigational New Drug (IND) Application paving the way initiating the first clinical trial in humans.

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"At SNIPR BIOME, we are extremely proud to have been granted Fast Track designation by the FDA. It underlines SNIPR001’s potential to be a game-changer for hematological cancer patients at increased risk of life-threatening bloodstream infections caused by E. coli" says Dr. Christian Grøndahl, Co-founder & CEO and continues, "E. coli was recently highlighted as one of the leading pathogens associated with anti-microbial-resistance (AMR) and death in a systematic review published by the scientific journal The Lancet, so there is an urgent need for new medicines targeting E. coli."

Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met.

Dr. Milan Zdravkovic, Chief Medical Officer and Head of R&D at SNIPR Biome, adds: "With the FDA’s Fast Track designation, we have reached yet another milestone and we are very pleased, that the FDA shares our view on the need to target AMR. Now, all our attention is directed towards initiating our first clinical trial, which is expected in H1 2022."

SNIPR001 is being developed in collaboration with the non-profit organisation CARB-X. The aim is to target E. coli bacteria in the gut, and thereby prevent translocation of these bacteria from the gut into the bloodstream, while leaving the commensal bacteria in the patient’s microbiome unaffected.

This precision medicine approach is harnessing a novel application of SNIPR BIOME’s proprietary CRISPR/Cas technology, hereby potentially transforming the way E. coli infections are prevented and treated, especially in the cancer ward.

Today, there are no approved therapies for prophylactic therapy in this setting.  

On January 25, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that it will be releasing its preliminary results for the full year ended 30 September 2021 on 27 January 2022 (Press release, Redx Pharma, JAN 25, 2022, View Source [SID1234606762]).

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A live webcast for analysts and investors will be held at1.00pm GMT (8.00am ET) on 27 January 2022. To join the webcast, please register in advance at https://bit.ly/3IobDLs

A recording of the webcast will be made available on Redx’s website following the results meeting.

On January 25, 2022 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported their ongoing collaboration with Monte Rosa Therapeutics to develop a cellular systems pharmacology model for cereblon (CRBN)-based molecular glue degraders (MGDs) targeting GSPT1 (Press release, Applied BioMath, JAN 25, 2022, View Source [SID1234606794]). The model will be used to predict and explain CRBN-based GSPT1 target degradation in various cellular disease settings and to answer mechanistic questions.

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"We chose to work with Applied BioMath based on their scientific expertise across various modalities and disease areas," said Sharon Townson, PhD, Chief Technology Officer at Monte Rosa Therapeutics. "Our hope is that the cellular systems pharmacology model we develop will accelerate our understanding of small molecule MGDs and we look forward to leveraging this advantage."

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "A fit-for-purpose mechanistic model allows our partners to gain better insight into their therapeutic’s mechanism of action in various disease conditions more quickly than with traditional experimental approaches," said John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "Monte Rosa Therapeutics is doing novel work and we’re excited to partner with them on this project."

To learn more about Applied BioMath’s solutions, visit View Source

On January 25, 2022 48Hour Discovery and Fusion Pharmaceuticals to Develop Radiopharmaceuticals for the Treatment of Cancer Tumours (Press release, 48Hour Discovery, JAN 25, 2022, View Source [SID1234606763]).

48Hour Discovery Inc. (48HD), a biopharmaceutical company specializing in peptide-derived drug discovery reported that the company has entered into a strategic research collaboration with Fusion Pharmaceuticals. This is 48HD’s first collaboration with a Canadian company. The goal of the collaboration is to discover novel, peptide-based radiopharmaceuticals for the treatment of various solid tumours.

"We are excited to work with a dynamic oncology company like Fusion Pharmaceuticals" said Ratmir Derda, CEO of 48Hour Discovery "In this collaboration, 48Hour Discovery will identify potent ligands for targets selected by Fusion. This project will further validate the potential of our billion-scale molecular libraries and cloud-based discovery pipeline to accelerate the advance of peptide drug candidates in the radiopharmaceutical field."

"Fusion’s versatile platform, supported by our internal research capabilities, allows us to create targeted alpha therapies (TATs) using different classes of targeting molecules, tailoring the approach based upon the disease target," said Fusion Chief Executive Officer John Valliant, Ph.D. "With our antibody, bispecific, and small molecule programs in the clinic or progressing through investigational new drug-enabling studies, we are excited to announce our work with peptides. Partnering with a global leader like 48Hour Discovery in peptide discovery further diversifies our capabilities and assets needed to create differentiated TATs in multiple areas of high unmet medical need."

On January 25, 2022 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported an exclusive supply and technology agreement with Corning Incorporated (NYSE: GLW) (Press release, West Pharmaceutical Services, JAN 25, 2022, View Source [SID1234606779]). The new collaboration includes a multimillion-dollar investment to expand Corning’s Valor Glass technology to enable advanced injectable drug packaging and delivery systems for the pharmaceutical industry with the goal of advancing patient safety and expanding access to life-saving treatments.

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By combining West’s industry-leading NovaPure components, with Daikyo Flurotec coating technology, and Corning’s Valor Glass and Velocity Vials, the strategic collaboration will enable new, advanced pharmaceutical packaging solutions. The collaboration optimizes the materials science and manufacturing expertise of both companies to help bio-pharma producers navigate the complex regulatory environment and mitigate risk in bringing drugs to market.

"West and Corning have developed this exceptional collaboration to offer leading elastomer-glass system solutions for the containment and delivery of injectable medicines," said Eric M. Green, President and Chief Executive Officer, West. "At West, we value the state-of-the-art products offered by Corning and are excited to build together the next generation of integrated packaging and delivery innovations."

This portfolio of new elastomer-glass system offerings and supportive data services will utilize West’s NovaPure components along with Corning’s Valor Glass technology. West’s NovaPure components adhere to Quality by Design principles and processing, representing the highest standards in pharmaceutical components. For customers, it provides the assurance of components with the tightest specifications applicable within today’s formulation and manufacturing process capabilities at West. Corning’s Valor Glass is intended to enhance the storage and delivery of drugs, providing more reliable access to state-of-the-art medicines essential to public health. Valor Glass packaging can enable increased throughput and offers high chemical durability, strength, and damage resistance.

"This partnership and investment enable the development and industry-leading solutions that enhance patient safety, increase quality and reliability in highly regulated markets, and ensure greater capacity for life-saving drugs. West is a great partner. The combination of Corning’s Valor Glass, along with West’s NovaPure components, is a win-win for customers and patients all over the world," said Wendell P. Weeks, Chairman and Chief Executive Officer, Corning.