Notice of Preliminary Results

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.

Applied BioMath, LLC Announces Collaboration with Monte Rosa Therapeutics for Systems Pharmacology Modeling in Cereblon-based Molecular Glue Degraders

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

OSE Immunotherapeutics Receives First Notice of Allowance of a Patent for Use of Tedopi® after Failure with PD-1 or PD-L1 Immune Checkpoint Inhibitor Treatment in HLA-A2 Positive Cancer Patients

On January 25, 2022 OSE Immunotherapeutics reported that the Japanese Patent Office has issued the notice of allowance for a new patent covering Tedopi, a combination of neoepitopes, for use after failure with PD-1 or PD-L1 immune checkpoint inhibitor treatment in HLA-A2 positive cancer patients (Press release, OSE Immunotherapeutics, JAN 25, 2022, View Source [SID1234646967]). This patent, which will further strengthen Tedopi’s global intellectual property portfolio in immuno-oncology, will provide the product with a new protection until 2037.

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This new patent recognises the innovation of a multiepitope composition (all peptides included in Tedopi) administered after immune checkpoint inhibitor (progression of the cancer), in particular in secondary resistance situation.

Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics, comments:
"This first notice of allowance for a Japanese patent for Tedopi after failure with immune checkpoint inhibitors, issued in a significant territory, is of major interest and is the first step to the corresponding patent family that has been filed internationally in many other territories.

In addition, it further supports the product’s clinical development focus and the positive results of the Atalante 1 Phase 3 trial of Tedopi in patients with advanced non-small cell lung cancer (NSCLC) with secondary resistance to PD-1/PD-L1 immune checkpoint inhibitor, a hard-to-treat patient population with high unmet medical need. Based on the finalized positive results of Atalante 1, we are preparing discussions with regulatory agencies on optimal paths for potential approval of Tedopi in patients with NSCLC in secondary resistance after immune checkpoint inhibitor treatment."

The Atalante 1 clinical trial evaluated the benefit of Tedopi in an HLA-A2 positive patient population with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following checkpoint inhibitor failure. The Tedopi treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial.

Tedopi demonstrated a favourable benefit/risk ratio versus standard of care (SoC) docetaxel or pemetrexed in advanced HLA-A2 positive NSCLC patients with secondary resistance to PD-1 or PD-L1 immune checkpoint inhibitors.

ABOUT LUNG CANCER
Lung cancer is the leading cause of cancer death (18.0% of the total cancer deaths) with an estimated 2.2 million
new cancer cases per year and with 1.8 million deaths (1). About 85% of lung cancers are Non-Small Cell Lung
Cancers (NSCLC) and for metastatic NSCLC, the 5-year survival rate is 7% (2)
.
Treatment regimens including immune checkpoint inhibitors (ICIs) have become the new standard of care for
the majority of patients with NSCLC. However, with the increasing use of ICIs in clinical practice, disease
progression can be observed in several patients. This therapeutic escape is described as a secondary resistance
(3)when it occurs after initial clinical benefit under ICI treatment. Over half of the patients will eventually develop
secondary resistance to ICIs.

48Hour Discovery and Fusion Pharmaceuticals to Develop Radiopharmaceuticals for the Treatment of Cancer Tumours

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."

West Announces Landmark Collaboration with Corning in Pharmaceutical Injectable Drug Delivery

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.