Pharmaceutical Technology Editors

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences.

According to a May 4, 2021 press release, CHMP’s decision to start the rolling review has been based on preliminary results from laboratory studies and clinical studies, which suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2. All data will be evaluated by EMA as it becomes available on a rolling basis and will continue until sufficient evidence is available for a formal marketing authorization application.

Compliance of Vero Cell will be assessed by EMA, according to the usual European Union standards for effectiveness, safety, and quality. Further communications will be published by EMA when the marketing authorization application for the vaccine has been submitted.

The EU applicant for the medicine is Life’On S.r.l.

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The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences. 

EMA’s CHMP Starts Rolling Review of Inactivated COVID-19 Vaccine

Researchers from the University of East Anglia (UEA) and Loughborough University, in the United Kingdom, have identified a new additive manufacturing method that enables the three-dimensional printing of medicine in highly porous structures.

According to a May 3, 2021 press release, the 3D printed drugs with highly porous structures can be used to regulate the rate of drug release from the medicine to the body when taken orally. The team, which was led by Sheng Qi, a reader in Pharmaceutics at UEA’s School of Pharmacy, investigated a newly developed 3D printing method that can rapidly produce porous pharmaceutical tablets without the use of filaments.

The results of the research highlighted that through varying the size of the structures pores, the rate of release of the active ingredient into the body can be controlled. However, further research is required to determine how the structure porosity can be used to tailor the dose and dosing frequency to each individual patient. Additionally, the team will look at ways of creating a ‘poly-pill’, a single pill incorporating multiple medicines, for patients that are on complex regimens.

“Currently our medicines are manufactured in 'one-size-fits-all' fashion. Personalized medicine uses new manufacturing technology to produce pills that have the accurate dose and drug combinations tailored to individual patients. This would allow the patients to get maximal drug benefit with minimal side effects,” Qi said in the press release. “Such treatment approaches can particularly benefit elderly patients who often have to take many different types of medicines per day, and patients with complicated conditions such as cancer, mental illness, and inflammatory bowel disease.”

Researchers from the United Kingdom, have identified a new additive manufacturing method that enables the 3D printing of medicine in highly porous structures.

University Researchers Identify New Additive Manufacturing Method for 3D Printed Medicines

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of its investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy.

Ciltacabtagebe Autoleucel (cilta-cel) has been developed for the treatment of relapsed and/or refractory multiple myeloma and is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. Janssen’s MAA has been submitted based on positive Phase Ib/II data from the CARTITUDE-1 study, which is investigating the safety and efficacy of the therapy.

“Despite advances in the treatment of multiple myeloma, there remains a high unmet need, especially for patients whose disease continues to progress,” said Peter Lebowitz, global therapeutic area head, Oncology, Janssen Research & Development, LLC, in an April 30, 2021 press release. “Through our collaboration with Legend Biotech, we continue to expedite the development of cilta-cel with a focus and priority on the patients who may benefit from this novel immunotherapy in the future.”

“Janssen has been advancing the science of oncology for more than 30 years, and we see great opportunity in the area of cell therapy and through our innovative platforms,” added Mathai Mammen, global head, Janssen Research & Development, Johnson & Johnson, in the press release. “We are continuing to harness our deep scientific expertise in multiple myeloma as we look to advance therapeutic options, deepen clinical responses, and drive towards improved patient outcomes.”

“Today’s submission to the EMA epitomizes how we strive to make a meaningful impact in the multiple myeloma landscape through advancing innovative treatments for patients,” stated Saskia De Haes, vice-president, EMEA Regulatory Affairs, Janssen R&D BE, in the press release. “We look forward to working in partnership with health authorities, as part of the accelerated assessment process, to support these patients by ensuring timely access to the latest therapeutic options.”

The therapy is also under evaluation by FDA via a biologics license application.

Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.

Janssen Seeks European Approval of BCMA CAR-T Therapy

Solentim, a global provider of workflows for antibody and cell-based therapies, has announced the expansion of its European operations, with the establishment of a new entity in Ireland, in a May 5, 2021 press release.

The Irish entity will enable the company to progress with frictionless business within the European Union (EU), now that the United Kingdom is no longer a member. Additionally, the company has revealed that it has opened a new warehousing and logistics hub in Germany to facilitate customer service in the EU.

“Europe is a fast-growing part of our business both in our core therapeutic antibody business and in new development areas including cell and gene therapies,” said Mark Truesdale, CEO, Solentim, in the press release. “This changing therapeutic landscape, in addition to our launch of two major new products, has rapidly increased demand. We want to be closer and more responsive to the needs of the European market and our office in Ireland will ensure ease of operation for customers while our new warehouse facility in Germany will mean that we can deliver products more quickly and easily.”

Solentim has announced the expansion of its European operations, with the establishment of a new entity in Ireland.

Solentim Establishes New European Entity

Inhalation contract development and manufacturing organization, Vectura, and UK-based company focused on developing therapies for respiratory and infectious diseases, Inspira Pharmaceuticals, have joined forces to develop a potential inhaled therapy for COVID-19.

As per the agreement, the companies will develop an inhaled formulation of Inspira’s lead drug candidate from its proprietary IPX formulations for the potential treatment of COVID-19. Inspira’s IPX formulations are based on processed and purified extracts from a plant source that contain proteolytic enzymes, which have been shown to inactivate the SARS-CoV-2 virus 

Feasibility studies have been undertaken on Inspira’s inhaled IPX formulation candidates by Vectura with positive results so far. Through this new agreement, Vectura will perform further testing and development work at its Chippenham (UK) facility to prepare for Phase I clinical studies of IPX formulations delivered directly to the lungs via Vectura’s FOX vibrating mesh nebulizer.

“We are delighted to have partnered with Vectura, a company with a strong track record in the successful development of pharmaceuticals for respiratory indications. Leveraging Vectura’s expertise and network, Inspira is well placed to accelerate the development of our novel IPX formulations for pulmonary delivery,” said Rory McGoldrick, CEO of Inspira, in a May 6, 2021 press release. “As we move from pandemic to endemic COVID-19, it will be ever more important to have new treatments that are cost effective, easy to distribute and easy to administer. We are targeting a treatment that has the potential to be effective at the early phase of infection, to minimize the risk of hospitalization and reduce the need for ventilatory support in intensive care. We hope that our human clinical trials of IPX formulations will prove as successful as our initial laboratory studies.”

“The work we have carried out to date for Inspira demonstrates the potential to develop a highly-effective treatment for COVID-19, and our initial studies show that Vectura’s FOX nebulizer platform offers an extremely efficient delivery method,” added Mark Bridgewater, Vectura’s chief commercial officer, in the press release. “We are excited to continue supporting Inspira on this lead program, combining our expertise in formulation and device development with this innovative research.”

Vectura and Inspira Pharmaceuticals have joined forces to develop a potential inhaled therapy for COVID-19.

Vectura, Inspira Pharmaceuticals Team Up to Develop Potential Inhaled COVID-19 Treatment

Merck, known as MSD outside of the United States and Canada, announced on May 5, 2021 that FDA has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The approval was based on positive data from the ongoing Phase III KEYNOTE-811 trial, where patients who received trastuzumab with Keytruda had a complete response rate of 11% and a partial response rate of 63%, while patients who received trastuzumab and chemotherapy alone had a complete response rate of 3.1% and a partial response rate of 49%, Merck said in a company press release.

“Today’s approval marks an important milestone, as this is the first time an anti-PD-1 therapy has been approved in combination with anti-HER2 therapy and chemotherapy as a first-line treatment for these patients,” said Dr. Roy Baynes, senior vice-president and head of global clinical development, chief medical officer, Merck Research Laboratories, in the press release. “From the start of Keytruda’s development, we have thoughtfully pursued novel combinations to help more patients with cancer. We are pleased to bring a new first-line combination regimen with Keytruda that has shown meaningful improvement in ORR (objective response rate) over standard treatment to patients with HER2-positive gastric and GEJ cancer.”

FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.