Pharmaceutical Technology Editors

Societal CDMO, a contract development and manufacturing organization (CDMO) focused on small-molecule therapeutic development, announced on April 27, 2022 that it has been awarded a new manufacturing and packaging task order agreement by the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTC).

The contract is an individual task order of more than $400,000 to manufacture and package ammonium tetrathiomolibdate (ATTM) capsules. Under the terms of the contract, Societal CDMO will develop and provide DCTD with a scalable manufacturing and packaging process for current good manufacturing practice (CGMP) production of 100 mg ATTM capsules. The project is being funded by the National Cancer Institute, National Institutes of Health, Department of Health and Human Services.

ATTM acts to interfere with intestinal uptake of copper when administered with meals. It also acts to bind plasma copper when taken between meals. The compound may have the potential to enhance the activity of platinum-based antitumor agents.

“We are pleased to support the NCI and the important research its scientists are undertaking on behalf of cancer patients. By delivering cGMP batches of ATTM to the DCTD, we will be playing an important role in activities designed to advance the battle against cancer, which aligns well with Societal CDMO’s mission and our tagline of ‘Bringing Science to Society,’” said David Enloe, CEO of Societal CDMO, in a press release. “It is validating to be chosen by the NCI to execute this work and we strongly value the trusted relationship we have established with a number of groups within the National Institutes of Health in recent years. We look forward to delivering the high quality process and product that our customers expect from Societal CDMO.”

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Societal CDMO has been awarded a new manufacturing and packaging task order agreement by National Cancer Institute.

Societal CDMO Awarded Manufacturing and Packaging Task by National Cancer Institute 

Thermo Fisher Scientific announced on April 28, 2022 that it has expanded its new R&D and engineering facility, India Engineering Center (IEC) in Hyderabad, India. The IEC is part of the company’s R&D Center of Excellence in India and is anticipated to bring an additional 140 new jobs to the region.

The company reported in a press release that the new expansion of the IEC will employ over 450 engineers and vendor partners and support new product development. The facility, which is 42,000 sq. ft, will be used to design and develop instruments, perform product reliability performance testing and verification, and validate products.

“Hyderabad city is a hotspot for talent acquisition, home to world-renowned R&D institutes, and is one of India's fastest-growing engineering, life sciences, and IT knowledge hubs,” said Tony Acciarito, president, Asia Pacific & Japan, Thermo Fisher Scientific, in a press release. “The expansion of the facility is a testament to Thermo Fisher’s unwavering commitment to supporting change by accelerating innovation, improving time to market for new products.”

Thermo Fisher Scientific has expanded its state-of-the-art R&D facility in Hyderabad, India.

Thermo Fisher Scientific Expands R&D Facility in Hyderabad

GeoVax Labs, a biotechnology company focused on the development of vaccines and immunotherapies, announced on April 26, 2022 that the US Patent and Trademark Office has issued a patent that covers the company’s modified vaccinia Ankara (MVA) vector expressing certain antigens from the malaria parasite.

According to a company press release, malaria causes 228 million infections and 405,000 deaths annually. Vaccine candidates have failed to induce substantial protection despite decades of vaccine research. Most of these vaccines target only one stage of the malaria parasite’s life cycle. GeoVax’s MVA–virus-like particle (VLP) malaria vaccine candidates are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses by incorporating antigens derived from multiple stages of the parasite’s life cycle.

GeoVax’s vaccine platform utilizes MVA, which is capable of carrying several vaccine antigens and expresses proteins that assemble into VLP immunogens in the person receiving the vaccine. VLP production can mimic the virus production that naturally occurs in an infection, which can help the immune system recognize, prevent, and control the target infection.

“We remain strongly committed to advancing innovation towards improving public health worldwide, and this patent reflects a potentially significant advance relative to malaria prevention,” said David Dodd, CEO and president of GeoVax, in the press release. “Our development priorities continue to be our COVID-19 vaccine, currently in Phase II clinical trials, and our cancer immunotherapy program, with Gedeptin as our lead product in a Phase I/II clinical trial for head and neck cancer. However, developing vaccines against global public health threats such as malaria, is also part of our longer-term focus. Collaborations with government and academic institutions, such as the NIH National Institutes of Health, USAID United States Agency for International Development, and the Burnet Institute, will continue to be components of our efforts to design, produce, and test novel vaccines against malaria. Our goals include developing such vaccines that are affordable, highly effective, safe, and can be distributed and administrated across various regions of the world in a simple manner.”

GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.

USPTO Issues Malaria Vaccine Patent to GeoVax

Pfizer and BioNTech have submitted an application to FDA for Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children five through 11 years of age. The companies also plan to submit authorization applications to the European Medicines Agency (EMA) and other regulatory agencies around the world. 

The companies submitted data from a clinical trial in children ages five through 11 years who received a booster dose approximately six months after the second dose of the Pfizer-BioNTech COVID-19 vaccine two-dose primary series, which was previously authorized under EUA for this age group in October 2021. The data demonstrated strong immune response in this age group following a booster dose of the vaccine.

The vaccine was developed by both BioNTech and Pfizer based on BioNTech’s proprietary messenger RNA technology. BioNTech is the marketing authorization holder in the United States, the European Union, the United Kingdom, Canada, and equivalent authorizations in other countries.

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children. 

Pfizer and BioNTech Submit EUA Application for Pediatric COVID-19 Vaccine Booster Dose

Johnson & Johnson (J&J) announced on April 25, 2022 the launch of the J&J Satellite Center for Global Health Discovery (Satellite Center) at the Holistic Drug Discovery and Development (H3D) Centre, University of Cape Town, in Cape Town, South Africa.

This launch expands the J&J Centers for Global Health Discovery (J&J Centers), a global network of research collaborations between the company and leading research institutions to address some of the world’s most pressing global health challenges. The Satellite Center at H3D will work to address the present and rising threat of antimicrobial resistance (AMR) with a specific focus on multidrug-resistant Gram-negative bacteria (MDR-GNB), which is a prevalent threat globally, and specifically in Africa.

The World Health Organization (WHO) has named AMR to be one of the top 10 global health threats because of its potential to transform easily treatable diseases into deadly killers by rendering medicines and treatments ineffective. According to a press release, more than 5 million deaths were attributed to AMR in 2019, making it one of the leading causes of death worldwide.

“Investing to increase the capacity of the innovation ecosystem in Africa is critical to strengthening the R&D pipeline for entrenched and emerging global health challenges,” said Ruxandra Draghia-Akli, MD, PhD, global head, global public health R&D at Janssen Research & Development, LLC. “By leveraging the unique strengths of H3D and the J&J Centers, we can cultivate the talent and capacity needed to drive innovation in the global fight against AMR.”

Johnson & Johnson has launched its next Satellite Center for Global Health Discovery at Holistic Drug Discovery and Development Centre, University of Cape Town.

Johnson & Johnson Launches Next Satellite Center for Global Health Discovery

AstraZeneca’s biologics license application (BLA) for tremelimumab has been accepted for Priority Review in the United States for the treatment of patients with unresectable hepatocellular carcinoma (HCC) in combination with Imfinzi. A supplemental BLA has also been submitted for Imfinzi.

This novel dose and combination is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), which refers to a single priming dose of the anti-CTLA4 antibody added to Imfinzi. Imfinzi and tremelimumab were granted Orphan Drug Designation in the US for the treatment of HCC in January 2020.

According to AstraZeneca, HCC is the most common type of liver cancer and is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide. Approximately 26,000 people in the US suffer from advanced, unresectable HCC each year. There is a critical unmet need for patients with HCC who face limited treatment options.

“The HIMALAYA Phase III trial showed an unprecedented three-year overall survival in this setting with a single priming dose of tremelimumab added to 

, highlighting the potential for this regimen to improve longer-term survival outcomes,” said Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, in a press release. “Patients with advanced liver cancer are in great need of new treatment options, and we are working closely with the FDA to bring this novel approach to patients in the US as soon as possible.”

Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.