Omega Therapeutics launches with focus on epigenetic drugs

Pharmaceutical Technology | September 24, 2019

US-based Flagship Pioneering has launched a genomics medicine company, Omega Therapeutics, to develop drugs that will leverage the human genome to cure or treat various diseases. The epigenetic drugs regulate genomic expression without impacting nucleic acid sequences. Omega Therapeutics was originally founded in 2017, developing a platform to accurately control the human genome’s Insulated Genomic Domains (IGDs), the fundamental regulator, or GenomStats. Based on the mechanism, the company will engineer genomic modulators, Omega Controllers, for precise tuning of genomic activity to desired therapeutic levels to tackle the biological cause of disease. Flagship Pioneering general partner David Berry said: “Omega’s proprietary platform technology allows us to develop therapeutics for disease control and potentially impact the way we treat and manage a broad range of illnesses.

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Tasly Pharmaceuticals and Mauna Kea Technologies Announce Joint Venture and Licensing Agreements

Mauna Kea Technologies | July 12, 2022

Mauna Kea Technologies inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy platform, and Tasly Pharmaceuticals announced the execution of an agreement to form a Joint Venture. Under terms of the agreement, Tasly and Mauna Kea will form a Joint Venture that will (i) commercialize selected Cellvizio indications in China, (ii) develop and commercialize Cellvizio globally in the fields of Neurology and Neurosurgery, and (iii) manufacture Cellvizio units for the Chinese market. The JV will utilize both existing distribution partners and its own network of China-based marketing professionals to accelerate market adoption. In exchange for contributing licenses and other intellectual property to the JV, Mauna Kea will receive cash payments totaling $10 million, a 44.1% equity interest in the JV, and a 5-year commitment to purchase minimum quantities of Cellvizio systems and probes. Mauna Kea’s equity holdings are net of shares issued to Cenponts Tech Limited in consideration for strategic advisory services provided in connection to the transaction. The Joint Venture will be majority owned and funded by Tasly and jointly managed by Tasly and Mauna Kea. The Joint Venture will be in an immediate position to leverage Mauna Kea’s position as global leader in probe and needle-based confocal laser endomicroscopy, with its FDA clearance for neurosurgery applications, its broad regulatory clearances in the Chinese market as well as its significant installed based in leading hospitals in China. “We are delighted to partner with Tasly Pharmaceuticals, a life sciences leader in Asia-Pacific with a global presence. This transaction both expands the addressable market for Cellvizio and increases Mauna Kea’s capacity to invest further in product and clinical development, including molecular imaging and artificial intelligence. This announcement builds on the strategic repositioning we announced in December 2021 and our emphasis on forming capital-efficient partnerships that leverage the commercial reach of global biopharma and medtech firms while increasing patient access to Cellvizio.” Sacha Loiseau, Ph.D., founder and Chairman of Mauna Kea Technologies Kaijing Yan, Chairman of Tasly Pharmaceuticals Group, commented: “The field of biomedical engineering is an important part of Tasly Pharmaceuticals’ second growth curve strategy. The cooperation with Mauna Kea Technologies will enable us to quickly access large markets in China addressed by the multiple clinical applications of Confocal Laser Endomicroscopy. The recent advances in molecular imaging with Cellvizio are also of great interest to us since Tasly Pharmaceuticals could assist the Joint Venture in developing new combinations of Cellvizio with novel molecular markers, aligned with our vision of providing integrated solutions from diagnosis to treatment. We very much look forward to a fruitful and rich collaboration with Mauna Kea Technologies.” About Tasly Pharmaceuticals Group Adhering to the business mission of "To share the joy of health with all", Tasly has always been promoting the integrative development of traditional Chinese medicine and modern medicine. Tasly continuously focuses on the three disease fields of cardio-cerebro-vascular diseases, digestive and metabolic diseases and tumors, which have the largest market share and the fastest development in China. It is committed to providing drug R&D that is urgently needed for clinical use and even addresses the unmet needs in China's clinical market. By leveraging the coordinated development advantages of modern TCM, biological medicine and chemical medicine, it carries out the strategic layout of innovative drugs and continues to maintain its leading position in the industry and the development momentum of R&D and innovation. About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions.

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NanOlogy Publishes Review Article of Preclinical and Clinical Research Supporting LSAM-DTX

NanOlogy | September 21, 2022

NanOlogy LLC, a clinical-stage interventional oncology drug company, announced that a review article of preclinical and clinical research supporting its investigational drug, large surface area microparticle docetaxel has been published in Drug Delivery and Translational Research. The review article entitled Local administration of large surface area microparticle docetaxel to solid carcinomas induces direct cytotoxicity and immune‑mediated tumoricidal effects: preclinical and clinical studies provides a review of preclinical research that supports tumor-directed LSAM-DTX as well as promising results from the high-risk nonmuscle invasive bladder cancer arm of a clinical trial of local LSAM-DTX in urothelial carcinoma, which were published earlier this year in The Journal of Urology. The articles also follows an earlier review of preclinical and clinical research supporting another NanOlogy investigational drug, large surface area microparticle paclitaxel published in DDTR in 2020. In addition to LSAM-DTX, NanOlogy clinical programs have advanced tumor-directed LSAM-PTX in pancreas, lung, peritoneal, ovarian, prostate, and dermal cancers. The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts active ingredients into stable large surface area microparticles (LSAMs) of pure drug optimized for tumor-directed therapy and continuous drug release to maximize drug delivered to the tumor and minimize systemic toxicity. Taxane particles are covered by composition of matter patents issued in the US Canada, Europe, Japan, China, Hong Kong, South Korea, Australia, Indonesia, and Russia valid through June 2036. The composition patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, formulations, methods, and technology. About NanOlogy NanOlogy, LLC is a private clinical-stage interventional oncology drug company formed in 2015 to improve the treatment of solid tumors based on a proprietary particle engineering technology platform for tumor-directed drug therapy to maximize drug in tumor and minimize systemic toxicity.

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Spotlight Therapeutics Appoints Visionary Global Pharma Drug Developer Antoine Yver, M.D., M.Sc. as First Independent Board Member

Spotlight Therapeutics | July 18, 2022

Spotlight Therapeutics, Inc. a biotechnology company applying new insights to develop cell-targeted in vivo CRISPR gene editing biologics, announced the appointment of Antoine Yver, M.D., M.Sc. to the Spotlight Board of Directors. Trained as an oncologist and immunologist, Dr. Yver’s extensive industry experience and perceptive acumen will be extremely valuable as Spotlight continues to strengthen its highly differentiated TAGE platform and advance lead therapeutic candidates towards the clinic. “We are thrilled to welcome Antoine to Spotlight’s Board of Directors. Few people in our industry enjoy such a remarkable track record of successful drug development, exercising extreme rigor in following the science to deliver practice-changing medicines that serve patients with significant unmet medical needs.” Mary Haak-Frendscho, Ph.D., President and Chief Executive Officer of Spotlight As Executive Vice President and Global Head of Oncology R&D at Daiichi Sankyo, Dr. Yver played a key role in the development of the new breakthrough cancer biologic, Enhertu®, that is redefining breast cancer treatment and promises to set a new standard of care, as well as other Daiichi Sankyo DXd ADCs. From 2009 to 2016, Dr. Yver held executive leadership positions at AstraZeneca, including SVP & Global Head of Oncology Development. Under his leadership, Tagrisso® and Lynparza® were successfully developed and commercialized for patients. Prior to joining AstraZeneca, Dr. Yver held roles at Merck, Johnson & Johnson, Aventis and Rhone-Poulenc Rorer. Dr. Yver is Executive Vice President and Chairman of Development at Centessa Pharmaceuticals plc and currently serves as an Independent Director of the Board of Directors at Sanofi. “I am delighted to join the Spotlight Board and support the mission to unlock the full potential of gene editing and enable effective single administration therapeutics for patients,” said Dr. Yver. “Spotlight’s biologics-based delivery approach has the potential to forge a new generation of cell-targeted in vivo CRISPR gene editing medicines across multiple therapeutic areas.” “Antoine’s deep insights and vast global pharma experience will help propel Spotlight to becoming a clinical stage company,” said Craig Gordon, M.D., Spotlight board member, Founder, CEO, and CIO of GordonMD™ Global Investments. “We look forward to working together to impact the strategic decisions of the company that will ultimately provide benefit to patients.” About Spotlight Therapeutics Established in mid-2018, Spotlight Therapeutics is a privately held biotechnology company advancing a pipeline of cell-targeted in vivo CRISPR gene editing therapies. Spotlight's proprietary technology platform TAGE is a new class of biologics, CRISPR effectors engineered for direct delivery in vivo, to achieve cell-selective therapeutic genome editing. Spotlight's pipeline is advancing its modular programmable CRISPR effectors towards clinical studies in immuno-oncology, ophthalmic diseases and hemoglobinopathies.

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Asahi Kasei Bioprocess to Showcase Award-winning MOTIV™ Buffer Management Technology for Pharmaceutical Manufacturing at ACHEMA 2022

Asahi Kasei Bioprocess | August 01, 2022

Asahi Kasei Bioprocess America, subsidiary of diversified Japanese multinational company Asahi Kasei, will be featuring their MOTIV™ Buffer Management Technology at ACHEMA 2022 in Frankfurt this August. Winner of “Best in Show” at Interphex in 2017, “Technology of the Decade” from Bioprocess international in 2012 and originator of the concept for inline buffer formulation (IBF™), Asahi Kasei Bioprocess is a market leader that keeps pharmaceutical production moving efficiently and precisely through solutions like MOTIV with built-in automation software so that medicine can get to patients sooner and safer. Buffers are used for the vast majority of processes in pharmaceutical development, which has traditionally required storage in extremely large tank farms to be utilized as necessary. MOTIV can blend buffers from concentrates in small, single-use bags and is controlled with sensors to maintain and assure precision. It is also able to blend buffers to exact specifications as needed during a downstream development process and can handle a wide variety of buffer formulations. In addition, it is automated by the integrated OCELOT™1 System Control software to be repeatable and also helps to reduce waste created in the development process, so it is a more sustainable means of pharmaceutical manufacturing. “We have been working to ‘standardize’ system designs as much as we can, to make them more readily available with shorter lead times; but are also very capable at building custom systems to meet the specific needs of customers,” says Chris Rombach, Vice President of Sales and Marketing at Asahi Kasei Bioprocess America. “One of our strengths is not only having an innovative product, but also an extensive family of MOTIV systems to choose from. Buffer is the lifeblood of pharma manufacturing and with the R&D opportunities of being a part of the Asahi Kasei Group we have been able to develop MOTIV to be the most reliable and efficient IBF technology in the market today. Not to mention, Operation Warp Speed helped push capacity to expand globally and billions of dollars are being invested by manufacturers to ramp up production as quickly as possible. This drives a new sense of value for systems like our MOTIV family that can streamline processes.” 1 The OCELOT System Control is an Asahi Kasei Bioprocess proprietary technology that integrates and/or interfaces with plant-wide control systems in a universally compatible format, allowing for far-reaching data collection and analysis. About Asahi Kasei Bioprocess The Fluid Management Business Unit of Asahi Kasei Bioprocess is devoted to solving therapeutic product safety, efficiency and purity challenges within the pharmaceutical and bioprocessing industries. With technology platforms for virus filtration, chromatography, inline buffer formulation and oligonucleotide synthesis, our bioprocessing systems, columns, and automation solutions advance GMP manufacturing of critical drug substances around the world. Built with pride, built with quality, built to exceed your high expectations. “Built for You.” About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.

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