Inovio Pharmaceuticals Kicks Off Phase 1 Clinical Trial for Experimental COVID-19 Vaccine

The Motley Fool | April 06, 2020

Inovio Pharmaceuticals (NASDAQ:INO) has been moving fast in the race to develop a vaccine for COVID-19. The company claimed it had created a potential vaccine for the rapidly spreading coronavirus on Jan. 10, just three hours after Chinese researchers publicly released the genetic sequence of SARS-CoV-2 the virus that causes the illness. Now, it's starting human clinical trials for that potential vaccine, INO-4800.  The trial will involve up to 40 healthy adult volunteers, each of whom will receive two doses of INO-4800 four weeks apart. The goals of the phase 1 trial are to test the vaccine's safety and its immunogenicity --i.e., its ability to trigger an immune response in the body. Inovio expects initial data from this trial by late summer, and plans to move on to phase 2 clinical trials -- which will test INO-4800's efficacy -- as soon as possible. Other companies are also making headway in their efforts to develop a vaccine for COVID-19. For instance, pharma giant Johnson & Johnson (NYSE:JNJ) recently announced that it would initiate human clinical trials for its investigational COVID-19 vaccine by September.

Spotlight

Globally operating finish pharmaceutical company Orion Corporation and American publicly traded generics and specialty pharmaceutical company AMNEAL Pharmaceuticals are set to enter into a strategic partnership.

Spotlight

Globally operating finish pharmaceutical company Orion Corporation and American publicly traded generics and specialty pharmaceutical company AMNEAL Pharmaceuticals are set to enter into a strategic partnership.

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Kindeva and Meridian Combine: Create Leading Drug-Device Combination Product CDMO

Kindeva and | December 13, 2022

Kindeva Drug Delivery and Meridian Medical Technologies announced the completion of the transaction to combine the two companies. The combination has created a leading global contract development and manufacturing organization focused on drug-device combination products. The combination will operate under the Kindeva name, with Meridian operating as, “Meridian Medical Technologies, a Kindeva Company”. The new Kindeva will have a broader range of drug delivery capabilities, with expertise and technology spanning the parenteral, inhalation, transdermal, and intradermal routes of administration. Milton Boyer, formerly the CEO of Meridian, has been named CEO of the newly combined company. “The combination of Kindeva and Meridian creates a clear market leader in the drug-device CDMO sector. Customers will benefit from our enhanced scale and broader array of drug delivery solutions,” Boyer Kindeva, formerly known as 3M Drug Delivery Systems, was acquired by Altaris, LLC in 2020 from 3M Company. Kindeva is a global leader in drug-device combination products with a focus on inhalation, transdermal, and intradermal drug delivery. The company has a long track record of innovation, having invented the first metered dose inhaler in the 1950s. Meridian was acquired by Altaris in December 2021 from Pfizer Inc. Meridian is a leading manufacturer of emergency autoinjectors, having pioneered the emergency autoinjector technology in the 1950s. Meridian owns over 300 patents related to autoinjector drug-device combination products. ArentFox Schiff LLP and Kirkland & Ellis LLP acted as legal counsel. JPMorgan Chase Bank, N.A., Truist Securities, Inc. and KeyBanc Capital Markets Inc. acted as joint lead arrangers for the transaction. About Kindeva Kindeva is a global contract development manufacturing organization focused on drug-device combination products. Kindeva develops and manufactures products across a broad range of complex drug-delivery formats, including autoinjectors, inhalers, transdermal patches, and microneedles. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing and drug-device product assembly. Kindeva serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K. About Altaris, LLC Altaris is a healthcare investment firm with an exclusive focus on building companies that deliver value to the healthcare system through innovation and efficiency. Since inception in 2003, Altaris has invested in 49 healthcare companies which have generated significant value appreciation for its investors. Altaris is headquartered in New York City and manages approximately $5 billion of equity capital.

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BUSINESS INSIGHTS, PHARMACY MARKET

Caris Life Sciences and Xencor Expand Target Discovery Collaboration

Caris Life Sciences and Xencor | January 06, 2023

Caris Life Sciences®, a molecular science and technology company, and Xencor, Inc., a clinical-stage biopharmaceutical company, have announced that they will work more closely together to research, develop, and sell new bispecific and multispecific XmAb® antibodies. This expanded relationship will boost the number of targets and cancer types that Caris will investigate with Caris Discovery, a proprietary multi-omics discovery engine platform. The foundation for drug candidate development on Xencor's XmAb platform will be novel targets and their accompanying validation packages. Under the terms of the new contract, Xencor will receive worldwide commercial rights to study, develop, and market products aimed at up to three targets discovered through collaboration. In addition, Caris will get an upfront payment and may receive up to $187 million in commercial milestone payments and development. The company will also be eligible for royalties on the net sales of products commercialized as a result of the agreement, as well as future rights for molecular profiling and companion diagnostics. Caris Discovery leverages the collective force of its unmatched platform by combining the data generated from the primary patient tissues' molecular interrogation using ADAPT™, which integrates the company's extensive catalog of molecular and clinical data. About Caris Life Sciences Caris Life Sciences® is a Texas-based molecular science firm revolutionizing healthcare. Its market-leading molecular profiling products analyze DNA, RNA, and proteins to produce a molecular blueprint. This plan shows how patients, doctors, and researchers can use the information to improve outcomes and save lives. The company also uses cutting-edge algorithms for artificial intelligence (AI) and machine learning (ML) to improve precision medicine. About Xencor Xencor develops modified antibodies and cytokines for cancer and autoimmune illnesses. More than 20 XmAb® candidates are in clinical development while three are sold by partners. The company’s XmAb technology modifies protein structures to create new therapeutic pathways.

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PHARMACY MARKET

Nephron and Sharps Announce Manufacturing and Research Partnership

Nephron Pharmaceuticals Corporation | November 15, 2022

Nephron Pharmaceuticals Corporation and Sharps Technology, Inc. announced a brand new partnership focused on developing and sharing best practices in innovative manufacturing, product development, customer support, and quality as Nephron prepares to launch the InjectEZ component of expansion. Sharps Technology is a medical device and pharmaceutical packaging company specializing in developing and manufacturing innovative drug delivery systems. Nephron Pharmaceuticals is known across the country to health systems and hospitals as a leader in the production of affordable generic inhalation solutions and suspension products, as well as pre-filled sterile syringes, luer-lock vials, IV bottles, and IV bags. InjectEZ is part of the Nephron investment of hundreds of millions of dollars of expansion in Lexington County, S.C., over the last two years. Lou Kennedy, Nephron CEO, knows that when launching an endeavor as ambitious as InjectEZ, partnerships are key. "We are excited to kick off a partnership with Sharps Technology, as our InjectEZ expansion project opens, for a variety of innovative initiatives, including research and development," said Kennedy. "Just as the InjectEZ syringe manufacturing facility is poised to play a critical role in assisting those with whom we work on tackling emerging public health crises, Sharps Technology also offers key solutions to healthcare challenges. We look forward to working with them." Sharps product lines have historically focused on low waste and ultra-low waste syringe technologies, which allow up to 40% more injections per vial of therapy while incorporating multiple passive safety features. These features protect front-line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. The partnership with Nephron opens up opportunities for Sharps to expand its portfolio and make an impact on the specialized pre-fillable syringe and drug delivery systems market. "Sharps Technology has identified a unique opportunity to collaborate with a leader in the industry like Nephron. Through my previous industry experience supporting and working with most of the leading healthcare and pharmaceutical companies in the world, it was easy for me to evaluate Nephron Pharmaceuticals as a potential partner. They truly are a leader in all areas of business and an example of best in class for the industry. I appreciate and look forward to the opportunity to work with Bill and Lou Kennedy and their leadership team to make this collaboration a success for both companies." Robert Hayes, CEO of Sharps Technology Sharps Technology brings extensive expertise in syringes to Nephron, including experience with specialized pre-filled syringe systems and ready-to-use processing. The pre-filled syringe lines will utilize the highly automated equipment and controlled environments established by Nephron. These premium pre-filled polymer offerings will be made from the highest quality raw materials, on the most innovative technology, and will be compliant with the USP standards required in the United States as well as the EP and JP international standards. The products that will be developed and commercialized provide solutions to support the current Nephron fill/finish strategies as well as their pipeline of new drug applications and sets forward a strategy to support branded pharma and advanced therapies, including ophthalmic and biologic applications. Sharps Technology will also be partnering with Nephron Pharmaceuticals in the development of a Pharmaceuticals Services Program designed to support healthcare customers that need innovative solutions and products to support their business. The development of this program will help create new fill/finish project opportunities for Nephron that will utilize innovative packaging solutions developed by Sharps Technology. These new customer projects will fuel the growth of both companies, and the opportunity to create new technologies to support the healthcare industry will be transformative for Nephron and Sharps as they navigate a bright future working together.

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