Kimera® Labs Files First FDA Investigational New Drug (IND) Application Using XoGlo® for Treatment of ARDS Secondary to COVID-19

Prnewswire | August 18, 2020

Kimera® Labs Files First FDA Investigational New Drug (IND) Application Using XoGlo® for Treatment of ARDS Secondary to COVID-19
Kimera® Labs Inc, a privately held clinical stage biotechnology company, announces the filing of an extended FDA Investigational New Drug (IND) application to study the treatment of COVID-19 related inflammatory disease using Kimera's first-in-class XoGlo® isolated placental mesenchymal stem cell-based exosomes.  Founded in 2012, Kimera® generated the first publicly available isolated exosome product and has treated over 35,000 thousand patients for a variety of investigational uses. Kimera currently employs 40 PhDs, technicians and staff at its Miramar Florida 27,000 sq. ft. GMP manufacturing facility, the first and only laboratory dedicated solely to exosome R&D and production in the US.

Spotlight

Bioproduction is a booming industry, with more therapeutics being produced in cell culture than ever before. With increased workflow flexibility, decreased variability, and high product yields, cell-line engineering is here to stay. But before you take your bioproduction to the next level, you'll need to know a bit more about your product, your cells, and their health. It's time for a cell-line engineering check-up!

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BUSINESS INSIGHTS

Charles River and Valo Health Announce Strategic Partnership to Provide Clients with Access to AI-Enabled Drug Discovery Solutions

Charles River Laboratories International, Inc. and Valo Health, LLC, | January 20, 2022

Charles River Laboratories International, Inc. and Valo Health, LLC, the technology company using human-centric data and computation powered by artificial intelligence (AI) to transform the drug discovery and development process, today announced the formation of a multiyear strategic partnership. This agreement will combine Valo’s Opal Computational Platform with Charles River’s drug discovery and development capabilities to offer a new transformative, AI-enabled drug discovery and development platform. Recognizing the challenges of preclinical drug discovery, from high costs, time, and attrition rates, Valo and Charles River have joined forces to create enhanced drug discovery solutions that aim to transform the entire preclinical drug discovery process. Valo and Charles River intend to create and deliver offerings that produce preclinical assets with key performance characteristics optimized for client preferences. The partnership’s combined offerings will utilize Valo’s Opal Platform for small molecule development, which leverages a “closed-loop” in silico-experimental platform that rapidly iterates using program data to identify novel compounds, and leverages Charles River’s capabilities in all aspects of discovery optimization, including medicinal chemistry, ADME, biology, pharmacology, and ultimately safety testing and IND submission. The combination of Valo’s scientific innovation and deep technological expertise with Charles River’s end-to-end portfolio and industry-leading scientific bench has the potential to significantly accelerate a client’s discovery and development efforts by integrating data and compute to streamline and de-risk experimental science, enabling a faster and more effective process from de novo molecule design through lead optimization. The combined offering will be launched in the first half of 2022 and will be available exclusively from Charles River. About Valo Health Valo Health, LLC is a technology company built to transform the drug discovery and development process using human-centric data and artificial intelligence (“AI”) computation. As a digitally native company, Valo aims to full integrate human-centric data across the entire drug development lifecycle into a single unified architecture, thereby accelerating the discovery and development of life-changing drugs while simultaneously reducing the cost, time, and failure rate. The company’s Opal Computational Platform™ consists of an integrated set of capabilities designed to transform data into valuable insights that may accelerate discoveries and enable Valo to advance a robust pipeline of programs across cardiovascular metabolic renal, oncology, and neurodegenerative disease. Founded by Flagship Pioneering and headquartered in Boston, MA, Valo also has offices in Lexington, MA, San Francisco, CA, Princeton, NJ, and in Branford, CT. About Charles River Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.

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RESEARCH

Pfizer/Biontech Weren't Alone: Moderna Covid-19 Vaccine Data Aimed in Ema Cyberattack

Moderna | December 16, 2020

It would appear that Pfizer and BioNTech's COVID-19 immunization was not the sole objective of a new cyberattack at the European Medicines Agency. Moderna said Monday that reports from its pre-accommodation conversations with EMA about its shot, mRNA-1273, were "unlawfully gotten to" by programmers, refering to a warning from the organization. The assailants didn't get individual data about preliminary members, Moderna said. The organization's EMA accommodation did exclude any information recognizing people in the examination. Now, no extra insights concerning the cyberattack, for example, the size of the penetrate or the character of any suspects—are accessible, and Moderna said it anticipates results from EMA's progressing examination. The disclosure came days after the EMA initially uncovered the cyberattack, and Pfizer and BioNTech's COVID-19 immunization applicant, BNT162b2, was the principal distinguished as an objective. EMA choices on the two immunizations are moving close. Medication commentators at the EMA's Committee for Medicinal Products for Human Use are booked to evaluate BNT162b2 on Dec. 29 and mRNA-1273 on Jan. 12. Moderna was recently focused by programmers looking for its COVID-19 examination, in a cyberattack supposedly upheld by the Chinese government. The U.S. Branch of Justice in July arraigned two Chinese nationals for running a 10-year hacking effort that most as of late rotated to focusing on organizations doing COVID research. Reuters later affirmed Moderna as the antibody producer referenced in the arraignment. China has denied any function in such practices. Other than Moderna and Pfizer/BioNTech, rival COVID immunization designers AstraZeneca, Johnson and Johnson and Novavax apparently have arrived in the line of sight of North Korean programmers. In those hacking endeavors, the assailants regularly conveyed noxious reports or connections by means of email under the appearance of occupation enrollment specialists, partners or different associates of the person in question, as indicated by individuals acquainted with the issue refered to by The Wall Street Journal. Country state programmers from Iran and Russia have likewise been blamed for attempting to take COVID-related data.

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PHARMACY MARKET

Eirion Therapeutics Announces Strategic Agreement for HTL Biotechnology to Become Eirion's Exclusive Botulinum API Manufacturer

Eirion Therapeutics, Inc. | September 09, 2021

Eirion Therapeutics, Inc., an aesthetic dermatology company headquartered in Woburn, Massachusetts, announced that HTL Biotechnology, the worldwide leader in biotechnology solutions using hyaluronic acid and other biopolymers, will become Eirion's exclusive botulinum active pharmaceutical ingredient (API) manufacturer. Botulinum is the active ingredient in Eirion's lead product candidate ET-01, a topical neuromodulator being developed for Crow's Feet wrinkles and primary axillary hyperhidrosis (excessive sweating) that is currently in Phase 2 clinical trials, as well as in their liquid injectable neuromodulator product candidate being developed for glabellar wrinkles, AI-09. As part of the agreement, HTL will build, validate and operate a botulinum manufacturing facility in the US. In the future, HTL expects to apply to the CDC to have the facility certified to manufacture botulinum and later apply to the FDA to have it certified as a GMP plant. Under the agreement, HTL will pay for the construction, the validation and the operation of the US manufacturing facility, which is expected to become operational in 2022. In exchange, Eirion will begin paying manufacturing fees to HTL in 2023, with HTL also later sharing in the potential commercial success of ET-01 and AI-09, if approved. "This agreement marks an important expansion of HTL's biotechnology platform beyond our already industry-leading work in hyaluronic acid and bio-polymer manufacturing, as well as a key milestone in HTL's expanding footprint in North America," commented HTL CEO Yvon Bastard. "HTL believes that Eirion's products could be game-changers in the aesthetic field thanks to their substantial benefits for patients. Providing leading, innovative companies with the solutions that will empower them to change the lives of patients is our core purpose, which explains why we are particularly excited by this partnership" added Charles Ruban, HTL deputy CEO. About Eirion Therapeutics, Inc. Eirion Therapeutics, Inc. is a privately held, clinical stage biopharmaceutical company that is developing next-generation prescription products for aesthetic dermatology. Eirion currently has a rich pipeline of products focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair greying. In the future, Eirion plans to also pursue additional indications that address other major unmet clinical needs for physicians and their patients. Earlier this year, Eirion closed a $40 million investment and licensing deal with Shanghai Haohai Biological Technology Ltd in China.

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Spotlight

Bioproduction is a booming industry, with more therapeutics being produced in cell culture than ever before. With increased workflow flexibility, decreased variability, and high product yields, cell-line engineering is here to stay. But before you take your bioproduction to the next level, you'll need to know a bit more about your product, your cells, and their health. It's time for a cell-line engineering check-up!