Russia Opens the Door for Stem Cell Clinical Trials

Biospace.com | March 25, 2019

The widespread global outreach potential of stem cell therapies is becoming apparent, especially given the recent news of a second person going into long-term remission (some saying “cured”) of HIV after undergoing a stem cell transplant. Regenerative medicine is becoming a powerful instrument for providing cures to previously incurable diseases. According to a recent statement, the US FDA expects to receive over 200 investigational new drug (IND) applications per year by 2020, many of which include cell and gene therapies. In fact, the FDA estimates that 10 to 20 new cell and gene therapy products per year will be approved by 2025. The number of stem cell trials carried out globally has also been growing exponentially, having over 7000 trials registered on ClinicalTrials.gov with 16 FDA-approved cellular and gene therapies. While the US, Europe, and some Asian countries have had a fully functional, comprehensive regulatory platform for BCP procedures for over two decades, Russia is relatively new to the area, only recently approving a regulatory framework. 2018 marked a key breakthrough for the Russian market and the global pharmaceutical arena when the Russian government enacted a law involving amendments to biomedical cell product guidelines, which officially opened the door for Russia to enter the stem cell technologies industry. The regulation stipulates and defines what a BCP is, specifying that both registered medical products and pharmaceuticals can be classified as BCPs.

Spotlight

Bolstered with a successful launch in Germany and the UK of its anemia treatment Feraccru, Shield Therapeutics is looking to expand both the label and its market reach. Co-Founder and CEO Carl Sterritt reveals to Mike Ward, Informa Pharma Intelligence’s insights global director of content, his ambitions to build a West European and US-focused specialty pharma while seeking in-country specialists to partner other markets.

Spotlight

Bolstered with a successful launch in Germany and the UK of its anemia treatment Feraccru, Shield Therapeutics is looking to expand both the label and its market reach. Co-Founder and CEO Carl Sterritt reveals to Mike Ward, Informa Pharma Intelligence’s insights global director of content, his ambitions to build a West European and US-focused specialty pharma while seeking in-country specialists to partner other markets.

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CELL AND GENE THERAPY

Curi Bio Closes $10M Series A in Oversubscribed Round

Curi Bio Inc. | December 30, 2021

Curi Bio Inc., a leading developer of human stem cell-based platforms for drug discovery, announced the second closing of a $10 million oversubscribed Series A financing. New investors include UTC Investment and DS Asset Management, joining current Curi Bio investor and Series A lead Dynamk Capital. The investment will be used to scale Curi’s existing business and accelerate the development of its innovative engineered tissue analysis platforms, including its Mantarray™ platform. “Curi Bio is thrilled to partner with the distinguished teams at UTC Investment, DS Asset Management, and Dynamk Capital to fuel our next stage of growth. To discover new therapies requires human-relevant disease models. Curi is working to close the gap between preclinical results and clinical outcomes, not only in small molecule discovery, but also in frontier areas like next-generation genetic medicines and cell therapies.” Michael Cho, JD, CEO of Curi Bio With costs to develop a single new medicine now exceeding $2Bn, the need for more human-relevant disease models to improve translational efficiency in the drug development process has never been greater. Curi’s core platform – the Curi Engine™ – integrates human stem cells, tissue specific biosystems, and A.I./M.L.-enabled data analysis to accelerate the discovery and development of new therapeutics. With this three-pronged strategy — human cells, systems and data — Curi is rapidly becoming a market leader in creating high-fidelity models of human diseases for drug discovery, especially for striated muscle, including cardiac and skeletal muscle, and neuromuscular models. “Curi Bio’s technology platforms create significant value for pharma and biotech companies by accelerating discovery timelines and increasing the chances of success for new therapies in development,” said Dr. Gustavo Mahler, Managing Partner, Dynamk Capital. “We look forward to strong growth in Curi Bio’s customer portfolio.” Curi Bio’s core technologies and products include NanoSurface™ Plates for structural maturation, Cytostretcher™ cell-stretching instruments, and the Mantarray platform for contractility analysis. The Mantarray platform enables researchers to generate and analyze 3D engineered human muscle tissues, providing clinically relevant functional readouts, and reducing reliance on poorly predictive animal models. Curi also offers a suite of customized research services utilizing the Curi Engine, including new assay and model development and phenotypic screening. Curi Bio counts all of the top-ten global pharmaceutical companies among its clients, customers, and partners. About Curi Bio Curi Bio’s preclinical discovery platform combines human stem cells, systems, and data to accelerate the discovery of new medicines. The Curi Engine is a seamless, bioengineered platform that integrates human iPSC-derived cell models, tissue-specific biosystems, and A.I./M.L.-enabled phenotypic screening data. Curi’s suite of human stem cell-based products and services enable scientists to build more mature and predictive human iPSC-derived tissues—with a focus on cardiac, musculoskeletal, and neuromuscular models—for the discovery, safety testing, and efficacy testing of new drugs in development. The company’s proprietary technologies are supported by over 100 publications and 19 patents. By offering drug developers an integrated preclinical platform comprising highly predictive human stem cell models to generate clinically-relevant data, Curi is closing the gap between preclinical data and human results, accelerating the discovery and development of safer, more effective medicines.

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MEDICAL

Controlant now Providing Monitoring and Supply Chain Visibility for Pfizer-BioNTech COVID-19 Vaccine's Global Distribution

Controlant | December 16, 2020

Controlant, an leader in real-time supply chain monitoring and perceivability technologies for vigorously controlled ventures, for example, pharmaceuticals and life sciences and food and drink areas, today reported it is giving observing and Supply Chain Visibility administrations to Pfizer, comparable to the conveyance of Pfizer's mRNA-based Pfizer-BioNTech COVID-19 vaccine's worldwide circulation. In addition to the visibility and monitoring arrangements that Controlant is providing to Pfizer to mRNA-based Pfizer-BioNTech COVID-19 vaccine distribution supply chain, the organization is likewise working straightforwardly with the U.S. Government and wellbeing authorities, for example, the Center for Disease Control (CDC), U.S. Division of Health and Human Services (HHS), and stakeholders in Operation Warp Speed, to give nearby observing at U.S. Government-preferred designated vaccination areas to help consistently guarantee coherence during hand-off, actionable communication, and visibility, all through the entirety of the U.S. supply chain journey of the vaccines.

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INDUSTRIAL IMPACT

Vaxess Technologies Announces Grand Opening of GMP Manufacturing Facility

Vaxess Technologies | October 27, 2021

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