Diverse Biotech announces orphan-drug designation for treatment of newly diagnosed glioblastoma

Diverse Biotech | May 04, 2020

Diverse Biotech, Inc. www.diversebiotech.com has announced the U.S. Food & Drug Administration (FDA) has granted an orphan-drug designation request for one of its investigational new therapies for treatment of newly diagnosed glioblastoma, in conjunction with standard treatment, following adjuvant combined chemo-radiation.  Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, (Orphan Drug Act) including tax credits for qualified clinical testing. For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria. "We are very excited about the FDA orphan-drug designation for an investigational therapy the company is currently researching.  Glioblastoma is a devastating disease with very low 5-year survival rates.  The orphan drug designation helps Diverse Biotech to advance our program, designed to combat such a terrible disease, and potentially improve the survival rates.  We are committed to developing unique and powerful new medicines to help patients with diseases where there may be limited treatment alternatives.  Our aspiration is to develop new drugs to change the standards of care in different diseases starting with glioblastoma," said Stella Vnook, Diverse Biotech's Chief Executive Officer.

Spotlight

Humans can’t grow new teeth. But we’re not alone. Most mammals can’t. But many reptiles and fish can grow hundreds or even thousands of new teeth in a lifetime. The reason has to do with how reptiles and mammals evolved differently over 300 million years ago.

Spotlight

Humans can’t grow new teeth. But we’re not alone. Most mammals can’t. But many reptiles and fish can grow hundreds or even thousands of new teeth in a lifetime. The reason has to do with how reptiles and mammals evolved differently over 300 million years ago.

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INDUSTRIAL IMPACT

Adaptive Biotechnologies Announces New Data Demonstrating ImmunoSEQ® Technology Can Identify T-Cell Receptors Associated with Crohn’s Disease

Adaptive Biotechnologies | February 19, 2022

Adaptive Biotechnologies Corporation a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, presented data on T-cell receptor (TCR) sequences associated with Crohn’s disease (CD) during an oral presentation today at the 17th Congress of European Crohn’s and Colitis Organisation (ECCO) being held virtually February 16-19. The study identified and characterized TCR sequences associated with CD utilizing Adaptive’s immunoSEQ® technology, providing fundamental insights into the body’s response to CD at the cellular level. The immunoSEQ assay uses sequencing technology to decipher the complexity of the adaptive immune system. This multi-national study, which was also recently published in The Journal of Crohns and Colitis, utilized immunoSEQ technology to analyze TCRs from blood samples of 1,738 CD cases and 4,970 healthy donors. Intestinal tissue samples from a subset of 380 cases were also analyzed. Through this analysis, 1,121 CD-associated TCRs were identified in patients’ blood and verified in tissue. The identification of disease-specific TCRs is an important first step in identifying a signal and developing an algorithm to inform development of a diagnostic test for CD. “The study identified Crohn’s-specific TCRs in both the blood and tissue of patients with Crohn’s disease, including a large subset that are ’public,’ or shared among patients. These findings suggest that blood-based testing for this often-debilitating disease could be used to diagnose and more effectively manage the disease through the identification of these disease specific T-cell receptors.” Matthieu Allez, MD, PhD, Professor and Head, Department of Gastroenterology, Hospital Saint-Louis, Paris T cells can have a significant impact on inflammation in CD, but until now, disease-associated TCRs have been largely unknown and underleveraged in diagnostics for the disease.1 These findings show that immunoSEQ can successfully identify TCRs for CD in a blood sample, which is reflective of the TCRs in intestinal tissue. The average length of time from onset of symptoms to diagnosis for a CD patient can be 1-2 years in the US but may be much longer in other countries, so the potential to open a new path to identify the disease earlier is significant.2,3 Furthermore, the amount of Crohn’s-related TCRs can provide insights into disease characteristics such as the phenotype and location of the disease, with possible clinical implications. In addition to TCR findings, the analysis also studied the possible association between human leukocyte antigens (HLAs) alleles and CD-associated TCRs, which live on most cells in the body, by leveraging the novel immunoSEQ HLA Classifier. HLA alleles are genetic factors that have been found to contribute to a small portion of risk for CD. In this study, nearly 400 CD-associated TCRs were found to be associated with specific HLA alleles. These TCR associations highlight the importance of studying TCRs in the context of HLA type and potentially point to new risk factors and insights for CD such as the involvement of specific antigens that the immune system may be reacting to in people living with CD. “We’re excited to see these results and their potential to advance the scientific community’s understanding of the immune response to Crohn’s disease. The use of immunoSEQ and characterization of TCRs in the blood have the potential to uncover new knowledge on the development and progression of the disease, with the potential to eventually improve diagnostic options and disease management for people living with Crohn’s,” said Harlan Robins, PhD, Chief Scientific Officer and Co-Founder of Adaptive Biotechnologies. “We look forward to continuing our research and advancing the development of our T-Detect test to include an application in the diagnosis of Crohn’s disease.” CD is a subtype of inflammatory bowel disease, a group of diseases impacting about 6.8 million adults globally.4 Early treatment with effective medications can prevent disease progression towards complications, surgery and disability. However, CD is difficult to diagnose and treat, with more than half of patients initially misdiagnosed. No single blood test currently exists for diagnosis of CD. Instead, patients often undergo a series of tests – often invasive – in order to reach a conclusive diagnosis. Based on the results of this study, Adaptive is further investigating specific TCR signatures that are associated with CD related behavior and disease activity to further the development of T-Detect in this indication. Additional research will also focus on signal optimization and clinical validation to explore commercial utility. About the immunoSEQ® Assay Adaptive’s immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assay can identify millions of T- and/or B-cell receptors from a single sample in exquisite detail. The immunoSEQ Assay is used to ask and answer translational research questions and discover new prognostic and diagnostic signals in clinical trials. The immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures. About T Detect™ T-Detect™ is a highly sensitive and specific diagnostic test under development for multiple diseases, translating the natural diagnostic capability of T cells into clinical practice. In 2018, Adaptive and Microsoft partnered to build a map of the immune system called the TCR-Antigen Map. This approach uses immunosequencing, proprietary computational modeling, and machine learning to map T-cell receptor sequences to disease-associated antigens for infectious diseases, autoimmune disorders and cancer. From a simple blood draw, T-Detect will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity. T-Detect COVID is the first clinical test launched from this collaboration and the first commercially available T-cell test designed to detect recent or prior SARS-CoV-2 infections. T-Detect COVID is not FDA-cleared or approved, it has received an EUA from the FDA and is available for prescription use only. About Adaptive Biotechnologies Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in our Immune Medicine and Minimal Residual Disease (MRD) businesses. We have three commercial products and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases.

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Cipla and Stempeutics Join Forces for the Launch of Stempeucel® in India

Cipla | August 24, 2020

Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) referred to as "Cipla" today announced that its partner Stempeutics Research Pvt. Ltd has received regulatory approval by the Drug Controller General of India (DCGI) for the launch of Stempeucel® in India. The product is indicated for the treatment of CLI due to Buerger's Disease and Atherosclerotic Peripheral Arterial Disease. It is the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved globally for CLI treatment.The product has been developed by Stempeutics over a period of twelve years. The company's proprietary pooling approach provides for an efficient manufacturing process thereby enabling the product to be made accessible to patients at an affordable cost. More than one million doses can be produced from a single set of master cell banks, which is unique in regenerative medicine, thus providing consistent product to patients. The proprietary technology also helps Stempeucel® extend the therapeutic potential of the drug across multiple disease categories. Under the agreement signed between the two companies, Cipla has received exclusive rights to market and distribute the product in India by leveraging its expansive distribution strengths across the country.

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MEDICAL

Sosei Heptares' COVID-19 Program Identifies Potent Broad Spectrum Anti-Viral Small Molecules for Further Development

Sosei Heptares | November 21, 2020

Sosei Group Corporation ("the Company") (TSE: 4565) announces a progress update for its R&D program focused on the design and development of novel drugs targeting the SARS-CoV-2 coronavirus and to treat COVID-19.The program was initiated in April 2020. To date, the Company has applied its world-leading structure-based drug design (SBDD) capabilities and cutting-edge technologies to precision-design new inhibitors of the SARS-CoV-2 Mpro protease, which plays a crucial role in viral replication1-4.The Company is also aiming to leverage the highly conserved structure of the SARS-CoV-2 Mpro protease as a basis for the design of novel oral small molecules against predicted future variants of SARS-CoV-2 and other related human viruses.

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