BUSINESS INSIGHTS, PHARMA TECH
Thermo Fisher Scientific | December 19, 2022
Thermo Fisher Scientific Inc., the world leader in serving science, received R&D 100 Awards from R&D World Magazine for two of its most recently launched analytical instruments. The R&D 100 Awards competition honors the latest innovations in science and technology, identifying the top 100 revolutionary technologies of the past year.
The Thermo Scientific Gallery Enzyme Master Enzyme Analyzer was recognized as an R&D 100 Award winner in the Analytical/Test category. It is the first automated discrete analyzer designed specifically for enzyme assay applications, streamlining workflows for industrial enzyme manufacturers and enzyme users in the food, beverage, biopharmaceutical, fuel ethanol and chemical, and solid waste management industries. The analysis the technology enables ultimately helps society in numerous ways, including making food taste better and helping industrial processes to become less energy intensive and more sustainable while using less hazardous chemicals.
The Thermo Scientific Orbitrap Exploris MX Mass Detector was also a recipient of an R&D 100 Award in the Analytical/Test category. The mass spectrometer was recognized for its ability to offer high resolution accurate mass data for intact analysis of monoclonal antibodies, oligonucleotide mass determination and peptide mapping in drug discovery applications. The Orbitrap Exploris MX Mass Detector is a part of a multi-attribute method workflow that is designed for efficient, scalable production, to enable drug safety and to accelerate drug approval so that new drugs become available to patients faster.
“We are honored to receive this distinguished award for two of our latest innovations, recognizing the hard work and dedication of our colleagues. We’re committed to prioritizing innovation to develop new technologies that enhance research and drive science forward, enabling our customers to make the world healthier, cleaner and safer.”
John Lesica, president, chromatography and mass spectrometry, Thermo Fisher Scientific
The renowned R&D 100 Awards have identified revolutionary technologies introduced to the market since 1963, and, in 2022, the program received entries from more than a dozen countries and regions. This year’s esteemed panel of judges included nearly 50 well-respected industry professionals from around the world.
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.
BUSINESS INSIGHTS, VIEWS AND ANALYSIS
Biodex Medical Systems | November 30, 2022
Mirion Technologies, Inc. announced that it has entered into a definitive agreement to sell the physical medicine assets of Biodex Medical Systems, Inc. to Salona Global Medical Device Corporation for $5 million in cash at closing and up to an additional $3 million in deferred cash payments. The deferred cash payments are contingent on the performance of the assets during the 12-month period following closing. The assets generated approximately $18 million in revenue with estimated gross margins of 30% during the most recent trailing twelve-month period.
“Divesting the physical medicine assets of Biodex enables Mirion Medical to focus on our strategic priorities and better aligns the group with Mirion’s mission of harnessing our unrivaled knowledge of ionizing radiation for the greater good of humanity. We are pleased to see the physical medicine business in the hands of an owner whose core mission and strategy is better aligned with investing in the future of the product line and finding valued employees the right home for their skills and contributions,”
Mike Rossi, President of Mirion Medical
Mirion Technologies is a leading provider of detection, measurement, analysis and monitoring solutions to the nuclear, defense, medical and research end markets. The organization aims to harness its unrivaled knowledge of ionizing radiation for the greater good of humanity. Many of the company's end markets are characterized by the need to meet rigorous regulatory standards, design qualifications and operating requirements. Headquartered in Atlanta (GA – USA), Mirion employs around 2,800 people and operates in 13 countries.
About Biodex Medical Systems
Biodex Medical Systems, Inc. is part of Mirion Medical, Inc., a group of healthcare-focused brands within Mirion Technologies. Mirion Technologies, Inc. uses science and technology to drive treatment innovation across physical medicine, nuclear medicine and medical imaging categories. With a history of manufacturing and engineering excellence that spans more than 60 years, the Biodex™ mission is to provide innovative solutions and customer-driven support to medical facilities and wellness centers around the globe.
PHARMACY MARKET, PHARMA TECH
Molecular Targeting Technologies, Inc | December 09, 2022
Molecular Targeting Technologies, Inc. a clinical stage radiopharmaceutical therapy company focused on therapies for rare diseases, announced today the allowance of an Investigational New Drug application by the U.S. Food and Drug Administration. It is now waiting for Institutional Review Board approval. Once approved by IRB, it will enable a Phase I/II clinical study of the Safety, Dosimetry and Efficacy of EBTATE in adult patients with metastatic, radioactive iodine non-responsive Hürthle cell thyroid cancer.”
EBTATE is a new generation of peptide receptor radiotherapeutic drug that has demonstrated potential clinical superiority over standard of care. It selectively binds to somatostatin receptor 2 on neuroendocrine and other tumors, which are then killed by the radionuclide. EvaThera platform products were designed to bind to serum albumin, due to the Evans blue moiety, extending in vivo residence time, enabling lower, less frequent dosing of the radiopharmaceutical and reducing risk of renal injury vs. the current standard of care.
Dr. Joanna Klubo-Gwiezdzinska, MD, Ph.D, MHSc, acting section chief of Thyroid Tumors and Functional Thyroid Disorders in the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH) and study author commented: “Hürthle cell thyroid cancer, which currently lacks effective treatment options, is characterized by a particularly high expression of SSTR2*. With this phase I/II clinical trial, we hope to implement individualized dosimetry-based dosing for each patient with Hürthle cell thyroid cancer that spread outside of the thyroid gland and analyze how much of an active agent is being accumulated in the tumor tissue to establish a threshold associated with the best efficacy and safety.”
“The clearance of our IND is an important milestone for MTTI. Having solidified our clinical trial preparedness and manufacturing readiness, we are well-positioned to advance EBTATE to target Hürthle cell thyroid cancer.”
Dr. Chris Pak, President & CEO of MTTI
About Molecular Targeting Technologies, Inc. (MTTI)
Molecular Targeting Technologies, Inc., is a privately held, rapidly growing, well financed, clinical-stage biotech company developing next-generation targeted radiotherapeutics and diagnostics for rare cancers. Evathera platform technology product has shown application for glioblastoma multiforme (GBM) cancer patients overexpressing integrin. MTTI is committed to building value by acquiring and translating innovative imaging, radiopharmaceutical and theranostics assets to improve human health, reduce healthcare costs and reward stakeholders. MTTI expects to be orchestrating multiple clinical trials in 2023.
The content in this release is the sole responsibility of the authors and does not necessarily represent the official views or imply endorsement of the National Institutes of Health.
BUSINESS INSIGHTS, PHARMACY MARKET
Phio Pharmaceuticals Corp. | December 22, 2022
Phio Pharmaceuticals Corp., today announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL™ compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi technology is designed to make immune cells more effective in killing tumor cells. PH-762 has been shown to reduce the expression of PD-1, a protein that inhibits T cells' ability to kill cancer cells. When administered intratumorally in preclinical models PH-762 primes an anti-tumor immune response, and inhibits tumor growth.
Phio is currently conducting a Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe. Phio expects to commence a US Phase 1b clinical trial early in the 2nd half of 2023. The initial US trial is expected to focus on the treatment of cutaneous squamous cell carcinoma and other selected cutaneous malignancies, following successful regulatory review of the IND.
"Therapeutic interventions for cSCC are limited, and there is increasing unmet medical need. As cSCC tumors comprise approximately 51% of the total incidence of solid tumors in the US, excluding basal cell cancers, we recognize the growing need for alternative therapies for cSCC," said Robert Bitterman, Phio's Principal Executive Officer and Executive Chairman. Mr. Bitterman has over 25 years of executive leadership experience in the pharmaceutical and biologic life science industry with a proven track record in operations, finance and investor relations.
"While monoclonal antibody therapies are available for the treatment of cSCC, mechanistically they only block the interaction between PD-1 and PD-L1 on the cell surface. PH-762 also has the potential to address PD-1 inside the T cell, essentially further enhancing the activity of the T cell to kill the tumor cells," said Dr. James Cardia, Phio's Vice President of Scientific Operations. Dr. Cardia led the team that discovered INTASYL.
"PH-762 has the potential to meet a significant medical need in patients who have failed to respond to mAbs, as well as those with resectable and metastatic solid tumors. Phio is committed to advancing the study of PH-762 to provide a meaningful therapy for patients with a broad range of solid tumors."
Dr. Mary Spellman, Phio's Medical and Clinical Development Advisor
INTASYL compounds are chemically modified siRNAs that are designed to provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity targeting a broad range of cell types and tissues. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy applications. In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial convenience to the prescriber and patient. Phio believes that INTASYL is the only self-delivering RNA interference technology focused on immuno-oncology therapeutics.
About Phio Pharmaceuticals
Phio Pharmaceuticals Corp. is a clinical stage biotechnology company whose proprietary INTASYL™ RNAi technology is designed to make immune cells more effective in killing tumor cells. Phio believes that INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems.