Mikart, LLC Nano and PharmaSolutions, Inc. | October 12, 2022
Mikart, LLC a comprehensive contract development and manufacturing organization announced that it has entered into a collaboration agreement with Nano PharmaSolutions, Inc. an innovative nanotechnology company that has a proprietary NanoTransformer™ that enhances the solubility of pharmaceutical active ingredients.
"We are excited to bring this new technology from preclinical stage to a GMP clinical phase manufacturing environment. This differentiated, solvent-free, nano-granulation process for drug development and manufacturing provides our customers with an alternative solubility enhancement technology."
Nazar Elkarim, PhD, Vice President of Pharmaceutical Development Services at Mikart
Kay Olmstead, PhD/MBA, Chief Executive Officer at NPS, added, "Nano PharmaSolutions is excited for this collaboration which will provide us with GMP manufacturing capabilities for development of nanomedicines, using our NanoTransformer™ technology at Mikart's facility."
Louis Weber, Vice President of Business Development at Mikart, added, "Mikart is committed to offering innovative options for enhancing solubility and bioavailability to our customers. We feel this nanotechnology will further enhance our development, clinical, and commercial capabilities designed to bring value to our growing customer base."
About Mikart, LLC
Mikart, LLC is a privately held contract development and manufacturing organization founded in 1975. Mikart focuses on small molecules, potent compounds, solid oral, combination products, suspensions, liquids and serialized packaging services. The company has a full range of formulation, analytical, packaging and manufacturing services with a seamless development solution that minimizes the time-to-market from clinical work through commercial supply.
About Nano PharmaSolutions, Inc.
Nano PharmaSolutions, Inc. developed a NanoTransformer™ technology that generates nanoparticles of active pharmaceutical ingredients with physical vapor deposition (PVD), a nanocoating method without using any polymers or solvents. This robust and high drug loading technology increases bioavailability of poorly soluble drugs. The NanoTransformer™ Technology produces patient-centric dosage forms while accelerating drug candidates to the clinic by shrinking development time and R&D costs.
Jacobio Pharma | October 13, 2022
Jaco Jacobio announced it has entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio's KRAS G12C inhibitor JAB-21822 and Merck's epidermal growth factor receptor inhibitor Erbitux®.
This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer. Jacobio is the sponsor of the combination study, and Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement.
"Our preclinical studies have shown that the combination of JAB-21822 and cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, regressing tumors and delaying tumor regrowth after drug discontinuation. We look forward to new treatment options for patients through our collaboration with Merck,"
Dr. WANG Yinxiang, Chairman and Chief Executive Officer of Jacobio
JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and cetuximab.
ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells.
ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.
Jacobio Pharma is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform.
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.