Pharmaceutical Technology Editors

Sinovac Biotech’s Eupolio vaccine, which is a Sabin inactivated poliovirus vaccines (sIPV) developed by Intravacc and out licensed to Sinovac, has gained marketing authorization in China from the Chinese National Medical Products Administration (NMPA).

The approval, which was announced in a July 20, 2021 press release, is a positive result for the ongoing efforts to eradicate the globe of polio. Intravacc had originally developed the vaccine for the purpose of providing low- and middle-income countries with the opportunity to produce their own safe polio vaccine.

According to the company press release, many vaccination campaigns to eradicate polio were put on hold or delayed during the COVID-19 pandemic. So, the approval of the Eupolio vaccine in China will help to close the gap between the supply and demand of inactivated polio vaccines for infants.

“This is a great example project in which Intravacc’s innovation and knowledge have been the foundation of the development of an affordable vaccine that contributes to the reduction of infectious disease burden on a global level,” said Jan Groen, Intravacc’s CEO, in the press release. “We have recently launched a similar program for our Avacc 10 COVID-19 nasal spray vaccine, intending to make this vaccine available to the world.”

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Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

Sinovac’s Eupolio Vaccine Gains Market Authorization in China

Artificial intelligence (AI)-driven pharmatech company, Exscientia, and Shanghai-based oncology specialist, GT Apeiron Therapeutics, have entered into a strategic research and development collaboration agreement.

According to a July 21, 2021 press release, the oncology joint venture will involve leveraging Exscientia’s patient-centric AI-first capabilities and GT Apeiron’s expertise to speed up the discovery of multiple small-molecule therapeutic drug candidates, designed to selectively treat aberrant cell cycle-driven cancers. The ultimate goal of the collaboration will be to build a pipeline of cyclin-dependent kinase (CDK) novel therapies.

This joint venture expands upon previous work, where multiple selective CDK7 compounds were designed. These compounds have demonstrated consistent tumor responses in xenograft models, it was reported in the press release. Additionally, the CDK7 inhibitors were found to enhance tumor cell cytotoxicity and selectivity over immune cells in live primary tissue samples from ovarian cancer patients.

“Based on what they have already achieved, Exscientia is clearly the leader in AI-driven drug discovery, and we have witnessed this first-hand in our collaboration so far,” stated Mingxi Li, president of GT Apeiron Therapeutics, in the press release. “We have been incredibly impressed by the combined power of the AI design and use of patient data to optimize and select molecules that are more likely to give positive effects in the clinic. This joint venture is a significant step in building GT Apeiron’s valuable and robust pipeline of CDK inhibitor drugs and substantially accelerates our early-stage output and progression towards being a clinical-stage biotech company.”

“We are driven to bring drugs to market that make a difference for patients,” added Andrew Hopkins, CEO of Exscientia, in the press release. “Apeiron bring a focus and an expertise on the biological basis of multiple cancers and helps us to create better drugs for better outcomes in the clinic and beyond. This collaboration has already proven to be capable of delivering potential drug candidates with promising patient-relevant data, and we look forward to extending that into a portfolio of multiple clinical assets.”

Exscientia and GT Apeiron Therapeutics have entered into a strategic R&D oncology collaboration agreement.

Exscientia and GT Apeiron Form Strategic R&D Collaboration Agreement

Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany for the treatment of acromegaly, grade 1 and a subset of grade 2 gastroenteropancreatic neuroendocrine tumors and symptoms associated with neuroendocrine tumors.

“Until now, prescriber choice has been limited. The launch of a generic alternative means we are able to improve access and choice while helping to drive down costs,” said David Johnson, global director, Commercial Excellence, Advanz Pharma, in a July 21, 2021 press release.

“It is through our successful partnerships with regulators, manufacturers, and distributors across the region that [this] news has been made possible. We’re proud to announce the launch of this medicine in Germany […] and look forward to expanding this to other countries across Europe in the near future,” added Paul Burden, chief commercial officer, Strategic Business Unit, Advanz Pharma, in the press release. “This launch is the first of what we hope will be many, as we continue to expand into the complex and value-added medicines space, to the benefit of healthcare professionals and patients in Europe.”

Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany.

Advanz Pharma Launches Generic Lanreotide in Germany

Catalent has announced, in a July 21, 2021 press release, that it will start the first phase of a $100-million expansion program at its Italian facility in Anagni to increase its manufacturing capabilities for biologics drug substance.

This first phase of the expansion will involve the installation of two 2000-L single-use bioreactors in new, purpose-built manufacturing suites. Additionally, early phase clinical development and late-stage and commercial tech transfers will be supported through associated investments. Infrastructure for a further six 2000-L single-use bioreactors will also be created in the initial phase.

It is anticipated that the initial phase will be commissioned and operational for customer projects in April 2023. Later phases of the expansion program are set to provide 16,000 L of flexible manufacturing capacity, which will allow for 2000 L to 8000 L batch production scale.

“Catalent is committed to supporting customers from small and virtual biotechs to large biopharma companies that require the right capabilities, scale of capacity, and integrated solutions to meet their needs for new biologic therapies and vaccines,” said Mario Gargiulo, Catalent’s region president, Biologics, Europe, in the press release. “Catalent was an early adopter of single-use technology because of its flexibility, and we continue to invest in technology that enables adaptable, scalable solutions for the fast-growing segment of biologics addressing mid-sized and orphan patient populations.”

Catalent commences the first phase of a $100-million expansion program Anagni site to increase its manufacturing capabilities for biologics drug substance.

Catalent Invests $100 Million to Expand European Biologics Manufacturing Capabilities

The European Commission (EC) has granted marketing authorization to bluebird bio for its gene therapy SKYSONA, which is a one-time therapy for the treatment of early cerebral adrenoleukodystrophy (CALD) in patients under 18 years old without matched sibling donor.

CALD is a rare, progressive, and irreversible neurodegenerative disease that involves the breakdown of myelin. SKYSONA is custom designed to treat the underlying cause of CALD with the goal of halting disease progression and preserving as much neurological function as possible. The gene therapy works via 

 transduction with the Lenti-D lentiviral vector to add the functional copies of the ABCD1 gene into the patient’s own hematopoietic stem cells.

The marketing authorization of SKYSONA was supported by clinical data that demonstrated the treatment had a durable effect on major functional disabilities-free survival. The therapy has been evaluated as part of the European Medicines Agency’s Priority Medicines scheme (PRIME) and had previously been granted orphan medicinal product status.

“SKYSONA is the first and only one-time gene therapy approved in the EU [European Union] for patients with CALD, a devastating neurodegenerative disease, and we are immensely grateful to all who have brought us to this milestone, from the patients and their loved ones, to all study investigators, regulators, the ALD community and, of course, the extended bluebird family,” said Andrew Obenshain, president, severe genetic diseases, bluebird bio, in a July 21, 2021 press release. “bluebird bio was founded with the mission of developing a therapy to recode CALD on the genetic level, and today’s announcement represents over twenty years of research and development that has laid the groundwork for future gene therapies to be possible.”

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD. 

EC Grants Marketing Authorization for bluebird bio’s Gene Therapy SKYSONA

On July 20, 2021, Samsung Biologics announced that it has signed a strategic partnership agreement with Kineta, a clinical-stage biotech company developing novel immunotherapies, under which Samsung Biologics will provide end-to-end contract development and manufacturing organization (CDMO) services to Kineta, including cell line development, clinical drug substance, and drug product manufacturing services, to support an investigational new drug (IND) filing for KVA12.1, Kineta’s novel anti-V-domain immunoglobulin suppressor of T cell activation (anti-VISTA) antibody in development for the treatment of solid tumors.

Under the agreement, the manufacturing cell line will be developed with support from Samsung Biologics’ R&D Center in San Francisco. Additionally, corresponding clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.

VISTA is a key driver of the immunosuppressive tumor microenvironment (TME). It has been shown to be overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint and blocking VISTA can reprogram suppressive myeloid cells and reactivate anti-tumor immune function. Preclinical studies demonstrate single agent anti-tumor activity with KVA12.1. Furthermore, targeting VISTA in combination with programmed cell death-1 (PD-1), PD ligand 1 (PD-L1), or cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) was demonstrated to significantly improve the anti-tumor efficacy of those checkpoint inhibitors. Kineta’s KVA12.1 aims to reprogram the TME in hard-to-treat solid tumors.

“We are very glad to be partnering with Kineta, to provide support in bringing this cancer immunotherapy to market,” said John Rim, CEO of Samsung Biologics, in a company press release. “We will fully utilize our capabilities and streamlined end-to-end processes from both our headquarters and US R&D Center, to enable high-quality development of KVA12.1 with faster speed to accelerate Kineta’s success.”

“Establishing this strategic partnership with Samsung is a critical step for Kineta as we advance KVA12.1 to IND and into first-in-human clinical trials next year,” said Shawn Iadonato, PhD, CEO at Kineta, in the press release.“We are excited to collaborate with Samsung to initiate and scale up drug product manufacturing of our VISTA immunotherapy”.

Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic. 