Pharmaceutical Technology Editors

GlaxoSmithKline (GSK) and iTeos Therapeutics announced on June 14, 2021 that they have signed an agreement to co-develop and co-commercialize EOS-448, an anti-T-cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) monoclonal antibody (mAb) in a deal worth up to nearly $2.08 billion.

Under the agreement, iTeos will receive an upfront payment of $625 million and will be eligible to receive up to an additional $1.45 billion in milestone payments if certain development and commercial milestones are achieved. GSK and iTeos will share responsibility and costs for the global development of EOS-448 and will jointly commercialize and equally split profits in the United States. Outside of the US, GSK will receive an exclusive license for commercialization, and iTeos will receive tiered royalty payments.

EOS-448 is currently in Phase I development as a potential treatment for patients with cancer. GSK and iTeos plan to start combination studies of EOS-448 with dostarlimab in 2022. TIGIT, which is part of the CD226 checkpoint axis, has demonstrated potential as a promising target for the next generation of immuno-oncology therapies based on preclinical data and data from a Phase II clinical trial. With this collaboration, GSK now has access to antibodies that synergistically target all three known CD226 checkpoints—TIGIT, CD96, and poliovirus receptor-related immunoglobulin domain-containing (PVRIG).

“Immuno-oncology has transformed cancer care but unfortunately less than 30 percent of patients respond to treatment with the current leading immune checkpoint inhibitors. Based on the underlying science, we believe that combinations of a PD-1 [programmed death-1], TIGIT, CD96 and PVRIG inhibitor could become transformative medicines for many patients with cancer. We are excited to collaborate with the team at iTeos and, together, we can play a leading role in the next generation of immuno-oncology therapies,” said Hal Barron, chief scientific officer and president R&D, GSK, in a company press release.

“Through this transformative collaboration, iTeos now has access to GSK’s best-in-class resources, which will provide us with a significant advantage in a highly competitive, global market. We have chosen GSK because of their commercial capabilities, experience in immuno-oncology, and their commitment to invest in the rapid advancement of our TIGIT program and create a clear path forward for EOS-448. Inspired by the multifaceted mechanism of action of EOS-448 and promising early results in clinical trials, this collaboration allows us to accelerate and expand the clinical development of EOS-448. We are more confident than ever in our ability to succeed. This collaboration validates our science and provides a catalyst for the future of iTeos. The collaboration with GSK will allow our team to continue to develop next-generation immunotherapies starting with inupadenant, our highly differentiated clinical-stage A2A adenosine receptor antagonist, and to drive scientific innovation with our expertise in tumor immunology to build our pipeline,” said Michel Detheux, president and CEO, iTeos, in the press release.

Articles

GlaxoSmithKline and iTeos Therapeutics enter into a development and commercialization collaboration worth up to $2.08 billion for a new therapeutic anti-cancer mAb candidate.

GSK and iTeos Therapeutics Enter mAb Collaboration

Analysis by Public Health England (PHE) has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

The real-world data, which were announced in a June 14, 2021 press release, have shown that two doses of the Pfizer-BioNTech vaccine are 96% effective at preventing hospitalization and two doses of the Oxford-AstraZeneca vaccine are 92% effective against hospitalization due to the Delta variant of COVID-19. These results are comparable with the efficacy found against hospitalization from the Alpha variant of the virus.

As of yet, the level of protection offered by the vaccines against mortality from the Delta variant is not known, but further work is underway to establish these data also. However, it is anticipated that the vaccines’ level of protection against mortality will also be high, as has been the case with other variants.

“These hugely important findings confirm that the vaccines offer significant protection against hospitalization from the Delta variant,” said Mary Ramsay, head of Immunisation at PHE, in the press release. “The vaccines are the most important tool we have against COVID-19. Thousands of lives have already been saved because of them.”

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

PHE Analysis Demonstrates Efficacy of COVID Vaccines Against Delta Variant

The UK BioIndustry Association (BIA) has published a report presenting the findings of a survey on the public attitudes toward equal access to medicines for those living with rare diseases, it was announced in a June 17, 2021 press release.

Results of the survey, which was conducted by YouGov, have shown that the public strongly believe that patients living with rare diseases should have equal access to medicines via the National Health Service (NHS) as those living with more common conditions. Additionally, the majority of survey respondents agreed that patients with rare diseases should have access to medicines assured by the NHS on a basis of clinical need, irrespective of cost.

The survey findings follow recent assertions made by the National Institute for Health and Care Excellence (NICE), specifying that there isn’t an appetite among the general public for specific measures to tackle rare disease. BIA’s report, 

Public Attitudes to Rare Diseases: The Case for Equal Access

, recommends that NICE revises its position on rare conditions and medicines access, and that the body consider the value of a rarity modifier when performing health technology assessments.

“As scientific discovery delivers new and extraordinary treatments, it is essential that patients are able to benefit from them and that must include people living with rare diseases. Securing patient access to rare diseases face very specific issues, including small patient populations, relatively poor understanding of the epidemiology of these conditions, a significant diagnostic odyssey and the absence of a ‘standard of care’ to act as a benchmark,” said Steve Bates, CEO of the BIA, in the press release. “This survey once again demonstrates that there is broad public support for measures to ensure access to medicines for rare diseases based on clinical need even if that would entail higher costs. We would therefore encourage NICE and the Department of Health and Social Care to revisit their assumptions on public appetite for rarity-specific measures.”

BIA has published a report presenting the findings of a survey on the public attitudes toward equal access to medicines for those living with rare diseases.

Survey Reveals Attitudes of Public Toward Rare Diseases and Medicines Access

Horiba, a manufacturer of measurement and analytical systems, has joined a consortium headed by the Cell and Gene Therapy Catapult (CGT Catapult) aimed at accelerating the development of process analytical technologies (PAT) for cell and gene therapy manufacturing, Horiba announced in a June 17, 2021 press release.

According to the press release, Horiba’s A-TEEM fluorescence technology, which has shown promise for fast quality control/quality assurance (QC/QA) of complex biological systems, will be assessed by the consortium as a way of reducing batch failures and manufacturing costs. The fluorescence technology powers the company’s Aqualog Industrial QC/QA Analyzer and is a “column-free” spectroscopic technique that measures absorbance, transmittance, and a fluorescence excitation emission matrix simultaneously.

“This consortium offers a unique blend of expertise and capability covering technology, pharmaceutics, therapy, and patient need. Our continued spirit of addressing new scientific challenges with an ever-evolving suite of core technologies comes together perfectly within this consortium, where the power of A-TEEM Molecular Fingerprinting will be truly explored and harnessed,” said Simon FitzGerald, technical manager at Horiba UK, in the press release. “Data and knowledge in context are key to progress—this consortium will deliver both, helping to bring advanced therapies to patients more quickly.”

Matthew Durdy, CEO at CGT Catapult added, in the press release, “The industry needs to make a giant leap in terms of analytical capability and the dynamic use of information to control and improve processes, product, and costs. The coming together of these leaders in the field is a very important first step towards achieving this.”

Horiba has joined a consortium aimed at accelerating the development of process analytical technologies for cell and gene therapy manufacturing

Horiba Joins CGT Catapult Consortium to Accelerate Development of PAT

Evonik and Stanford University have entered into a three-year sponsored research collaboration to develop a new polymer-based drug delivery system. The new technology can deliver messenger RNA (mRNA) to tissues and organs in a manner that goes beyond the capabilities of lipid nanoparticles (LNPs), Evonik announced on June 10, 2021. Evonik will license and commercialize the polymer-based platform, which complements its existing portfolio of lipid-based drug delivery, including LNPs.

Under the collaboration, Evonik will work together with Stanford University scientists to scale up the synthesis and formulation of the drug delivery platform and further develop the technology for organ-selective delivery based on a non-animal-derived, synthetic degradable polymer. Evonik aims to make this technology good manufacturing practice-compliant for use in clinical-stage developments and, ultimately, for commercial-scale manufacturing. The new polymer-based delivery platform, known as CART (Charge Altering Releasable Transporters), was developed by Professor Robert Waymouth, Professor Paul Wender, and Professor Ronald Levy of Stanford University.

“We are proud to collaborate with Stanford University and combine our innovative power in advanced drug delivery. Through this project we look forward to enabling the next generation of mRNA-based medicine,” said Dr. Thomas Riermeier, head of Evonik’s Health Care business line, in a company press release.

“If we are to harness the full potential of mRNA therapeutics, we will need a toolbox of drug delivery technologies to target an expanded range of tissues and organs. Therefore, it is a great pleasure to collaborate with Stanford University and bring our expertise in advanced drug delivery to commercialize the new platform,” said Stefan Randl, vice-president of Research, Development & Innovation for Evonik Health Care, in the press release.

Evonik and Stanford University have signed a research collaboration to develop and market a new drug delivery platform for mRNA and gene therapy.

Evonik and Stanford University Partner to Develop mRNA Drug Delivery Technology

Yposkesi, a contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, announced on June 14, 2021 the launch of project SKY, which includes the construction of its second commercial cell and gene therapy manufacturing facility on its campus in Corbeil-Essonnes, France. Project SKY is intended to be a new global resource for drug developers of biologics.

To accelerate innovation, SK Pharmteco, a global CDMO, became a new majority equity shareholder in Yposkesi in March 2021. With financial backing from SK Pharmteco, Yposkesi is investing €58 million (US$71 million) in the new 5000 m2 (50,000 ft²) site, which makes it one of the largest advanced therapy medicinal product (ATMP) facilities in Europe, Yposkesi said in a company press release. The new facility is scheduled to be qualified and operational in conformance with European Medicines Agency (EMA) and FDA regulations in 2023. Project SKY will create approximately 80 new jobs by 2023.

The new state-of-the-art facility, designed for European and American good manufacturing practice (GMP) compliance, will double Yposkesi’s production surface to 10,000 m2 (100,000 ft²), equipping the company to meet the shortage in manufacturing capacity for drug developers seeking to advance to clinical trials and commercialize new therapeutic drugs.

The new building will house two additional production lines with several 1000-L scale bioreactors, supporting projects from early process development phases up to large-scale

manufacturing of approved drugs. Construction on the facility began on May 25, 2021 on a site adjacent to Yposkesi’s current 5000-m2 commercial facility. Equipment consisting of several 1000-L bioreactors, chromatography, and purification skids will be installed by 2023. The new facility will also incorporate a centralized warehouse, capacity for media, and solutions and mountings preparation. It will also house drug substance production suites and storage and quality control lab resources.

“Yposkesi is proud and excited to embark full speed on this new phase in our development. SKY is the culmination of our industrial strategy, guaranteeing clients a range of quality services from early clinical drug development through all phases to the manufacture of large-scale commercial batches of ATMPs,” said Alain Lamproye, executive chairman of Yposkesi, in the press release. “This project will also showcase our outstanding technological know-how in bioproduction for gene therapy drugs.”

“Manufacturing is an essential part of any drug developer’s success in delivering its product to patients,” said Morad El Gueddari, production director and head of project SKY, in the press release. “Yposkesi has the world-class skills and expertise, ambition, and drive to be among the global leaders in gene therapy manufacturing. SKY is the key to getting us there.”

Yposkesi is building its second commercial facility for cell and gene therapy manufacturing at its campus on Corbeil-Essonnes, France.