BUSINESS INSIGHTS, PHARMA TECH
Tonix Pharmaceuticals | February 14, 2023
On February 13, 2023, Tonix Pharmaceuticals, a leading clinical-stage biopharmaceutical firm, announced that it has exercised an option to acquire an exclusive license from Columbia University to develop a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the prophylaxis or treatment of SARS-CoV-2 infection. COVID-19 is caused by SARS-CoV-2. Tonix Pharmaceuticals and Columbia University announced a research collaboration and option agreement in 2020, which resulted in the development of the licensed mAbs.
Although the FDA granted emergency use authorization (EUA) to five mAb products containing seven distinct mAbs for either prophylaxis or treatment of COVID-19, none stayed available or functional since January 26, 2023, when the FDA stated that the last remaining mAb, Evusheld®, is no longer authorized. Previously, either FDA or the National Institutes of Health COVID Treatment Guidelines Panel had revoked recommendations or clearances for the other mAbs.
Until recently, the earlier EUA-approved products were obtained from the blood of humanized mice or COVID-convalescent patients. Columbia University's TNX-3600 fully human mAbs were generated utilizing a proprietary system that involved a human hybridoma fusion partner.
The firm feels that murine monoclonal antibodies, such as TNX-4100, have the capacity to generate antibodies with a high affinity that detect distinct epitopes on the SARS-CoV-2 spike protein. This is due to the fact that mice have a different antibodies repertoire than humans, and the technology for making antibodies optimizes the selection of relevant B cells via harvesting approach, immunization timing and screening platform.
About Tonix Pharmaceuticals
Founded in 2007, Tonix Pharmaceuticals is a clinical-stage biopharmaceutical firm committed to finding, acquiring, licensing, and developing therapies for the treatment and prevention of diseases and the alleviation of human suffering. Its pipeline is focused on rare diseases, immunology, infectious diseases, and central nervous system (CNS) product candidates. The company's immunology portfolio consists of biologics for the treatment of organ transplant rejection, cancer and autoimmunity. At the same time, its infectious disease portfolio includes next-generation COVID-19 vaccines and vaccinations against smallpox and monkeypox.
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BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 24, 2023
Curia, a leading contract research, development and manufacturing organization, today announced a collaboration with Corning Incorporated to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration with Corning’s Advanced-Flow™ Reactor (AFR) team includes the first installation of Corning’s G1 production system, designed for the continuous industrial production of active pharmaceutical ingredients (API).
Continuous flow chemistry is critical for the development and manufacture of pharmaceutical intermediates and APIs, and provides advantages compared with traditional batch processing. It is an inherently safer technology that delivers faster and more robust material production with a higher selectivity of desired products.
“Innovation in drug development and production calls for safety at high speed,” said Christopher Conway, president, Research & Development, Curia. “The implementation of Corning’s G1 Production Reactor at our Albany facility expands our capability to provide scalable solutions that address complex development and manufacturing requirements facing the pharmaceutical industry. Using advanced technology and standardized workflows, Curia offers continuous flow chemistry from targeted development to commercial scale globally.”
The G1 production reactor includes an updated set of dosing lines and controls that enable continuous operations and compliance to cGMP standards.
“Collaborating with an innovation-focused company like Curia will help drive advancements in the chemical-processing industry,” said Alessandra Vizza, business director, Corning Advanced-Flow Reactors. “The implementation of Corning’s G1 production system can deliver a host of benefits. The system is an inherently safer technology that will help Curia reduce time to market with higher-quality chemical and API processing, increased efficiency of chemical and API synthesis, and lower production costs.”
“Additionally, the space-saving, energy-conserving, and waste-reducing benefits of Corning’s AFR Technology may help customers reduce the environmental impact of their manufacturing business – a key attribute as the field continues to gain momentum in the U.S. and around the world,” said Vizza.
Curia’s expertise and global network of facilities, combined with Corning’s continuous flow technology, can help drive business efficiencies and, ultimately, improve patients’ lives.
About Curia
Curia is a leading contract research, development, and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s nearly 4,000 employees at 29 locations across the U.S., Europe, and Asia help its customers advance from curiosity to cure.
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PHARMA TECH
Lantheus | February 07, 2023
On February 6, 2023, Lantheus Holdings, Inc. (Lantheus), a company dedicated to improving patient outcomes through radiotherapy, diagnostics, and AI solutions that help clinicians to Find, Fight, and Follow® diseases, announced the acquisition of Cerveau Technologies, Inc. (Cerveau).
Cerveau's primary asset is MK-6240, which is a second-gen F 18-labeled positron emission tomography (PET) imaging agent that targets Tau tangles present in Alzheimer's disease.
Alzheimer's disease is a neurodegenerative condition that causes a steady and gradual deterioration in cognition and function. Alzheimer's disease affects an estimated 6.5 million people in the United States. As the population ages, the frequency of this disease is expected to climb further, and by 2050, the number of persons 65 and older with Alzheimer's disease may reach 12.7 million.
MK-6240 is a clinical-stage PET development candidate that is designed to identify Tau protein that accumulates as neurofibrillary tangles in the brains of individuals suffering or suspected of Alzheimer's disease. MK-6240 has the potential to help in Alzheimer's disease diagnosis, staging, treatment selection and response to therapy. Despite being in clinical development, MK-6240 is now being employed in over 60 academic and industrial clinical studies worldwide for various late-stage Alzheimer's disease therapeutic candidates, being explored by more than 16 pharmaceutical firms.
Following the terms of the agreement, Lantheus will make an upfront payment as well as potential further development and commercial milestone payments. It will also pay double-digit royalties on research revenue and commercial sales. In addition, the deal, which is structured as a stock acquisition, stipulates, among other things, that the seller would offer transition and clinical development services for a specified period after the conclusion of the transaction.
In this transaction, Chestnut Partners, Inc. served as the exclusive financial advisor to Cerveau. At the same time, Lantheus was advised by Foley Hoag LLP in connection with the acquisition.
About Lantheus
Founded in 1956, Lantheus offers novel diagnostics, targeted medicines, and artificial intelligence (AI) solutions to help clinicians Find, Fight, and Follow® diseases. It has been delivering life-changing research to patients and clinicians for over 60 years, going above and beyond to enhance lives and outcomes. Lantheus Holdings is the parent company of Progenics Pharmaceuticals, Lantheus Medical Imaging, Inc., Inc. and EXINI Diagnostics AB. Headquartered in North Billerica, Massachusetts, the company has offices in New Jersey, Canada and Sweden.
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