CELL AND GENE THERAPY

Cellares and Poseida Therapeutics Join Forces to Speed Up Cell Therapy Manufacturing

Cellares Corporation | July 16, 2021

Cellares Corporation, a life sciences technology company that has pioneered a revolutionary automated approach to cell therapy manufacturing announced today that Poseida Therapeutics, Inc., a clinical-stage biopharmaceutical company that uses proprietary genetic engineering platform technologies to create cell and gene therapeutics with the potential to cure, has joined its Early Access Partnership Program (EAPP). Poseida joins PACT Pharma and academic partner Fred Hutchinson Cancer Research Center as the third entity to join Cellares' EAPP.

Cellares launched the EAPP in 2020 to provide participants awareness and early access to Cellares' Cell Shuttle, a next-generation cell therapy manufacturing platform that enables closed, automated, and scalable cell therapy production. Poseida's involvement in the initiative adds to the Cell Shuttle's development, range of usage, and applicability by providing insight and experience in manufacturing processes for various autologous and allogeneic cell therapies.

Poseida is presently testing two autologous CAR-T product candidates in the clinic: P-BCMA-101 for relapsed/refractory multiple myeloma and P-PSMA-101 for metastatic castrate-resistant prostate cancer. The firm, which completed an initial public offering in July 2020, is also developing off-the-shelf versions of these treatments and TCR-T, anti-c-kit CAR-T, induced pluripotent stem cells (iPSCs), genetically modified hematopoietic stem cells (HSCs), and NK cells. In addition, Carl June, M.D., an immunotherapy pioneer and renowned oncologist who advised Cellares on creating the Cell Shuttle has just joined Poseida's Immuno-Oncology Scientific Advisory Board.

Poseida will assess the Cell Shuttle prototypes and give statistics and written comments related to their function and performance as part of Cellares' EAPP. In addition, user studies will be conducted to assess the Cell Shuttle's hardware and software, product requirements, release criteria, and process processes to ensure product-market fit.

About The Cell Shuttle
The Cell Shuttle is a flexible and scalable automated and closed end-to-end production solution that allows clients to execute the precise procedures required for their cell therapy. Compared to presently existing cell therapy manufacturing methods, this next-generation platform allows for a threefold decrease in process failure rates and the ability to produce 10+ patient doses in parallel, improving manufacturing scalability by order of magnitude. For most processes, this will reduce per-patient manufacturing costs by up to 70%.

About Cellares Corporation
Cellares is rethinking cell therapy manufacturing and accelerating access to life-saving cell therapies. The business is working on a one-of-a-kind approach to solving the difficulties of generating cell therapies that are cheaper and broadly accessible to people in need. Cellares' proprietary platform, the Cell Shuttle, eliminates the need for biopharma companies, academic research centers, and CDMOs to choose between a manufacturing platform that is semi-automated but lacks workflow flexibility or one that provides customization but lacks the end-to-end automation required to manufacture at scale. The business is based in South San Francisco, California.

Spotlight

It is true that individual cells have a finite lifespan, and when they die off they are replaced with new cells. The New York Public Library's Science Desk Reference (Stonesong Press, 1995) notes, There are between 50 and 75 trillion cells in the body. Each type of cell has its own lifespan, and when a human dies it may take hours or day before all the cells in the body die.


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MEDICAL

Thermo Fisher Scientific Opens Bioprocessing Manufacturing Site in Ogden, Utah

Thermo Fisher Scientific | April 21, 2022

Thermo Fisher Scientific today celebrated the opening of its new single-use technology manufacturing site in Ogden, Utah. The state-of-the-art facility creates additional capacity to produce the high-quality technology and materials needed for the development of new vaccines and breakthrough therapies. The $44 million facility is part of Thermo Fisher’s $650 million multi-year investment, announced last year, to help ensure flexible, scalable and reliable bioprocessing production capacity exists for critical materials used in developing new and existing biologics and vaccines, including for COVID-19. The Ogden site is a 55,000-square-foot facility that will manufacture highly customizable bioprocess container (BPC) systems. These BPCs are used for the delivery, processing, separation, storage and transportation of critical liquids and readily integrate into systems across all steps in the production of life-saving biologics, vaccines and cell and gene therapies. The Ogden facility further strengthens our global manufacturing network, which has been growing to meet increasing demand for single-use consumables and critical raw materials, This new facility expands our presence in Utah and locating here gives us the ability to work closely with our Logan site, providing access to a talented workforce that is ideal for manufacturing the highly complex and customized solutions we provide our customers.” Mitch Kennedy, president, single-use technologies, Thermo Fisher Scientific. The Ogden site has hired more than 300 employees and has the potential to employ up to 450 people across safety, quality, manufacturing, HR, engineering and warehousing. Thermo Fisher currently employs more than 2,000 colleagues across the state of Utah, establishing a critical hub for bioprocessing. Thermo Fisher’s new facility in Ogden is not only an investment in Utah’s bio-tech infrastructure, but also an investment in the thriving communities of our state, Utah is a high-tech hub for businesses seeking an educated, dedicated workforce within communities and an economy that is thriving. I welcome Thermo Fisher’s investment in Utah and congratulate them on this next step on the cutting edge of biotechnology.” Senator Mike Lee. An integral part of Utah’s biotech community, Thermo Fisher has had a positive impact on Utah’s economy, providing several thousand jobs to Utahns around the state, They also have played a critical role in our country’s fight against the COVID-19 pandemic by helping pharmaceutical companies produce therapeutics and vaccines. I look forward to joining the opening of their new manufacturing site in Ogden, which shows how our state continues to be a place where companies can grow and thrive.” Senator Mitt Romney. We’re pleased to welcome a new Thermo Fisher Scientific facility to Ogden, This facility, along with campuses in Logan and South Jordan, will bring more than 400 new jobs and expand the company’s employee base to 2,000 statewide. We are grateful to have Thermo Fisher Scientific as part of Utah’s growing biotech economy." Governor Spencer Cox. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

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MEDICAL

SelfDecode Offers Free Kidney Health DNA Report to Celebrate National Kidney Month

SELFDECODE | March 07, 2022

SelfDecode is kicking off National Kidney Month with a national campaign to raise awareness about the importance of preventative measures to optimize kidney health. For the month of March, SelfDecode is offering a free Kidney Health DNA Report to anyone who uploads a DNA file for analysis. Through genetic testing, SelfDecode is providing people with the opportunity to gain insight regarding their genetic predisposition for health issues and receive personalized recommendations to optimize their health. Kidney health is just one of the dozens of health topics that SelfDecode offers reporting for. Your kidneys are part of your body's natural detox system. They filter your blood and remove excess water, salt, minerals, and waste. If something goes wrong with this system, chronic kidney disease (CKD) can arise. According to the CDC, about 15% of American adults have CKD, and most don't even know that anything is wrong. By the time they learn, they may have already progressed to the later stages. That's why understanding your genetic predisposition for kidney problems and taking preventative actions can be so crucial, Two kidneys working together can filter as much as 180 L of fluid a day, so there are few better ways to optimize your natural detoxification system than by taking care of your kidneys." Dr. Puya Yazdi, Chief Science Officer at SelfDecode. Typical actions to promote a healthy life, like eating a balanced diet and exercising regularly, will go a long way in maintaining good kidney health. But there are also certain factors you could monitor that may be more personal to you. For example, phosphorus is an essential mineral, but in excess it can cause a buildup of calcium in the kidneys, which has been linked to kidney damage. Variants of certain genes have been associated with higher levels of phosphorus, which has the potential to increase the risk of poor kidney health. A person who knows that they have these specific genetic variants can choose to take particular care in limiting phosphorus intake to a healthy amount. ABOUT SELFDECODE SelfDecode is a fast-growing precision health company providing consumers and companies with advanced genetic analysis and personalized insights. Using AI, SelfDecode combines DNA, lab, and environmental data to provide science-based health advice tailored to each individual.

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INDUSTRIAL IMPACT

SkylineDx raises new capital from Novalis LifeSciences and Van Herk Investments

SkylineDx | December 22, 2021

SkylineDx announced it received a capital investment from USA based investment and advisory firm Novalis LifeSciences, and one of Benelux' largest biotech investors Van Herk Investments, to further solidify its position in the USA dermatology diagnostics market. SkylineDx is at a critical growth stage in their development now that the first products are introduced to the USA market, and Novalis LifeSciences has demonstrated impressive successes with their strategic and operational advice to their portfolio companies. Marijn E. Dekkers, founder and chairman of Novalis LifeSciences, will be named board member of SkylineDx' Board of Directors. He brings a long track record of industry-related strategic leadership experience as the former CEO of Bayer AG, CEO of Thermo Fisher Scientific and his role in the recent 600M USD acquisition of Decipher Biosciences by Veracyte. SkylineDx' dermatology program, often referred to as the Falcon R&D Program, currently overarches four dedicated dermatology initiatives, focused on prognostic and predictive biomarker development covering two skin cancers: melanoma and squamous cell carcinoma. These indications affect approximately 1.9 million patients annually in the United States only. One of these initiatives generated its first commercially available product, branded as Merlin Test, for which SkylineDx aims to accelerate the clinical adoption with this joint investment. "It is a great honor to have Marijn and Novalis LifeSciences as our first specialized USA investor on board, with all their incredible experience and know-how. Together we aim to further extend SkylineDx' USA investor base and continue expanding our strong footprint there. Our mission is to improve a patient's quality of life by enabling them to benefit from personal insights at the genomic level of their disease. We are excited to be working with Marijn and his team to continue fulfilling this mission." Dharminder Chahal, CEO SkylineDx Marijn Dekkers comments: "I have monitored the progress of SkylineDx for several years now, and I am excited about the leading edge position the company has built in predictive biomarkers for melanoma and various other cancers. I very much look forward to working with the SkylineDx team to bring these sophisticated diagnostic tests to patients around the globe." About SkylineDx SkylineDx is a biotechnology company, focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam and complemented with a field medical and scientific affairs team in the USA and a CAP/CLIA certified laboratory in San Diego. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predict a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. About Novalis LifeSciences Novalis LifeSciences LLC is a boutique investment and advisory firm that was founded in 2017 by Marijn E. Dekkers, and is based in Hampton, NH, USA. With a team of experienced operating executives from the Life Science industry, Novalis funds and advises visionary Life Science entrepreneurs. The firm has approximately USD 500M under management in two investment funds.

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MEDICAL

Asep Medical Holdings Inc. Announces Additional Listing to the OTCQB Venture Market in the U.S.

SEPSIS | April 25, 2022

Asep Medical Holdings Inc. ("Asep Inc." or the "Company") (CSE: ASEP) (OTCQB: SEPSF) is pleased to announce its recent successful listing on the OTCQB Venture Market in the US. The Company will be trading under the stock symbolOTCQB: SEPSF and will continue to sell its common shares on the CSE under the stock symbol CSE: ASEP. Asep Inc. will officially commence trading on the OTCQB as of the market opening today. The Company is also pleased to announce that it has also met the requirements for an account with the Depository Trust Company (DTC). The DTC is one of the world's largest securities depositories and acts as a limited-purpose trust company that will provide safekeeping through electronic record-keeping of securities balances. It will also serve as the Company's clearinghouse to process and settle trades as well as providing liquidity enhancement. Trading on the OTCQB is a significant milestone. It gives us added access and visibility with U.S. institutional and retail investors interested in the biotech and healthcare industries. The listing is expected to provide us with added liquidity and a diversified investor base in a large established public market. In parallel to the CSE, we expect to develop a strong shareholder base in the U.S. to achieve an improved valuation considering the innovative nature of our therapeutic and diagnostic technologies, as we strive to impact patients around the globe." Chairman and CEO Rudy Mazzocchi. Our leading technologies are directed to major worldwide issues with enormous economic impacts. This OTCQB listing will enable us to more effectively engage with knowledgeable investors outside Canada who support innovative and effective solutions." Dr. Robert E. W. Hancock, the Company's Founder and COO. OTCQB is recognized by the United States Securities and Exchange Commission as an established public market. The OTCQB platform enables companies to provide current public information that investors need to analyze, value and trade a security. An extensive network of data distributors and media partners ensures that trade data, news and disclosure are available to broker-dealers, market data providers, and investors. On the OTCQB, investors get an exchange-comparable information experience, convenient trading through their preferred broker or financial advisor, transparent pricing with real-time quotes, and trusted disclosure. ABOUT ASEP MEDICAL HOLDINGS INC. Asep Inc. is dedicated to addressing antibiotic failure by developing novel solutions for significant unmet medical needs. The Company is a consolidation of two existing private companies (Sepset Biosciences Inc. and ABT Innovations Inc.) that are both in the advanced development of both proprietary diagnostic tools, enabling the early and timely identification of severe sepsis as well as broad-spectrum therapeutic agents to address multidrug-resistant biofilm infections. Sepset Biosciences Inc. is developing a diagnostic technology that involves a patient gene expression signature that predicts severe sepsis, one of the significant diseases leading to antibiotic failure since antibiotics are the primary treatment for sepsis. Despite this, sepsis is responsible for nearly 20% of all deaths on the planet. The SepsetER test is a blood-based gene expression assay that is straightforward to implement, and results are obtained in about an hour in the emergency room or intensive care unit. This proprietary diagnostic technology differs from current diagnostic tests in enabling diagnosis of severe sepsis within 1-2 hours of first clinical presentation (i.e., in the emergency room), while other diagnostics only provide diagnosis after 24-36 hours. Asep Inc. believes this will enable critical early decisions to be made by physicians regarding appropriate therapies and reduce overall morbidity and mortality due to sepsis. ABOUT SEPSIS Sepsis is the body's dysfunctional response to infection and is very common, occurring in 49-million individuals globally. Recently the situation has worsened since sepsis is the cause of death in most patients who die from COVID-19. Sepsis is tremendously complex, and early symptoms are relatively non-specific, including fever, fatigue, hyperventilation and a fast heart rate — symptoms can also occur in other diseases. The most severe form of the disease, which occurs for up to one-half of all patients with suspected sepsis, leads to multi-organ failure and, in 23% of cases, death. Current diagnostic tools deliver results after approximately 24-36 hours, often delaying the initiation of treatment.

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Spotlight

It is true that individual cells have a finite lifespan, and when they die off they are replaced with new cells. The New York Public Library's Science Desk Reference (Stonesong Press, 1995) notes, There are between 50 and 75 trillion cells in the body. Each type of cell has its own lifespan, and when a human dies it may take hours or day before all the cells in the body die.

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