FDA Approves Yale Medical Cannabis Human Trials

Ganjapreneur | November 12, 2019

The Food and Drug Administration has granted approval to the Yale School of Medicine and CT Pharma for human drug trials to study the efficacy of cannabis-based medicines, according to a Connecticut Public Radio report. The study will be the first with FDA approval to test cannabis on human subjects. Yale University School of Medicine’s Dr. Rajita Sinha, the lead researcher for the clinical trial, said the studies will attempt to figure out how medical cannabis works, who it works for, what symptoms can be alleviated, dosages, and whether there is “a need for refinement.” Michael Fedele, board chair of the Portland, Connecticut-based CT Pharma, told CPR that he hopes the study will result in the first FDA-approved cannabis-based medicine to be manufactured in the U.S. According to the FDA, the agency “is aware that there is considerable interest in the use of marijuana to attempt to treat a number of medical conditions” and does support “research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research.”

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Rancho BioSciences Welcomes BenevolentAI as Fifth Member of SCDS Consortium

Rancho BioSciences | February 02, 2023

On February 1, 2023, Rancho Biosciences, a leading provider of data sciences services, announced that BenevolentAI has joined the SCDS consortium as its fifth member. Rancho Biosciences launched its Single Cell Data Science (SCDS) pre-competitive consortium on February 26, 2022, with four Charter Members: Bristol Myers Squibb, Janssen Research & Development LLC, a subsidiary of Johnson & Johnson's Janssen Pharmaceutical Companies, Novartis, and Vesalius Therapeutics. The consortium's mission is to establish a uniform industry standard for creating and formatting single-cell datasets through a systematic effort to build data models and ensure that public data are curated consistently. Due to the evident impact of single-cell transcriptomics technology on drug discovery, pharmaceutical firms continue to adopt single-cell sequencing techniques at an exponential rate. The availability of ever-increasing volumes of single-cell datasets in the public domain enables pharmaceutical companies to vastly increase their universe of single-cell experiments over those generated internally. However, harnessing this enormous public data lake by locating, downloading, and curating single-cell data is difficult and time-consuming compared to the resources required for scientists to analyze data to derive value for biomedical research collectively. To date, Rancho has provided 83 analysis-ready datasets by using its extensive curation knowledge and expertise. Each dataset contains 79 columns of curated metadata that have been verified against a 4-entity data model developed by Rancho for SCDS. Based on member priorities, Rancho will continue to contribute a steady stream of harmonized single-cell datasets to the consortium. With this shared cost model, these may be supplied at a far higher throughput and much more cost-effectively than a single company could do. About Rancho BioSciences Founded in 2012, Rancho BioSciences is a global fee-for-service data curation firm that provides analysis and development services to clients, including pharma, foundations, government, and biotech. With a global team of qualified Ph.D. and Ph.D./MD scientists that provide high-quality work based on their expertise and domain knowledge in biology, diseases, and clinical data, it strives to find cures for diseases by serving its clients and saving lives through Data. It aims to be the world's leading provider of data services and harness domain skills and expertise to address complex problems.

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BUSINESS INSIGHTS, PHARMA TECH

Neochromosome Announces Successful Collaboration with Sumitovant Biopharma

Sumitovant Biopharma, Inc. | January 20, 2023

On January 19, 2023, Neochromosome, Inc., announced a partnership with Sumitovant Biopharma, Inc., a technology-driven biopharmaceutical firm expediting the discovery and commercialization of novel therapeutics. This collaboration blends Neochromosome's neoYeast™ platform with Sumitovant's DrugOME™ computational ecosystem to identify new proteins that would benefit from non-canonical amino acid chemistries that are unavailable in nature. As part of the collaboration, Sumitovant used a combination of natural language processing (NLP), artificial intelligence (AI), machine learning (ML), and computational algorithms to identify opportunities for Neochromosome to enhance the discovery and production of proteins limited by evolution and traditional fabrication processes. For example, non-canonical amino acid inclusion allows new-to-nature proteins with improved structures and functions but often requires chemical synthesis, which is expensive, size- and complexity-restricted, and environmentally damaging. neoYeast™, based on Neochromosome's world-leading genome-scale cell engineering technology stack, enables the highly efficient and environmentally friendly integration of non-canonical amino acids into proteins, with both discovery and manufacturing possible in a single genome-engineered yeast strain. Sumitovant used DrugOME to explore libraries of traditional and non-traditional sources of data to recommend targeted protein development candidates for neoYeast. Co-Founder and CEO of Neochromosome, Leslie Mitchell, commented, "The combination of Sumitovant's technology platform and life-sciences expertise with Neochromosome's ability to both discover and biomanufacture novel proteins in a single system enables Neochromosome to accelerate and streamline the delivery of better therapies for patients." She added, "We are excited to partner with the world-class team at Sumitovant to identify opportunities to create better versions of existing drugs, along with new-to-nature compounds, and to manufacture them efficiently at scale." (Source – Business Wire) Sumitovant Biopharma, Inc. The firm has supported the development of multiple FDA-approved products and a strong pipeline of early-through late-stage investigational assets addressing unmet needs in pediatrics, oncology, urology, women's health, specialty respiratory, and infectious diseases through its proprietary computing and data platforms, scientific expertise, and diverse company portfolio. It is a wholly-owned subsidiary of Sumitomo Pharma.

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PHARMACY MARKET

TC BioPharm Begins Dosing Phase 2B Clinical Study Evaluating its Lead Compound, OmnImmune®, in Patients with Acute Myeloid Leukemia

TC BioPharm | November 23, 2022

TC Biopharm a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer today announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune®, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia. The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient. "The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune®, for patients with AML and for TC BioPharm's emerging pipeline of 'off-the-shelf' gamma-delta T cell therapies. This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7x10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023." Bryan Kobel, CEO of TC BioPharm TC BioPharm's Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes conditions that can occur when the blood-forming cells in the bone marrow become abnormal. The trial is expected to enroll approximately 37 patients. About TC BioPharm PLC TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target and eradicate both liquid and solid tumors in cancer. TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia using the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors as well as a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns our manufacturing facility to maintain cost and product quality controls.

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