Pharmaceutical Technology Editors

Lonza announced on June 21, 2021 that it has entered into an agreement with SelectImmune Pharma, a pharmaceutical company developing novel immunotherapeutics and a

ternatives to antibiotics, to collaborate on the development of processes for NlpD, a novel immunotherapy protein. SelectImmune will use Lonza’s early development services such as non-GMP expression and laboratory-scale process development. Work will be carried out at Lonza’s Cambridge, UK site.

“The discovery of NlpD is important and provides new possible strategies to treat infections with immunotherapy. Lonza is a well-known international player, and we look forward to developing the best possible process to have a robust drug candidate in our pipeline,” said Ann Gidner, CEO, SelectImmune Pharma, in a 

“De-risking early on can maximize chances of success further down the development and manufacturing pathway. We offer flexible support based on our customers’ unique therapeutic goals and timelines while improving the safety and manufacturability of therapeutics. Our early development services have been supporting companies of various sizes in advancing their drug candidates from late-stage discovery into the clinic for over 10 years. The collaboration with SelectImmune illustrates the value in establishing the foundation on which to build an optimized clinical development program,” said Yvette Stallwood, Head of Applied Protein Services, Lonza, in the press release.

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The companies have entered into an agreement to develop processes for a novel immunotherapy protein.

SelectImmune and Lonza to Develop Immunotherapeutic Drug Candidate

The University of Birmingham has been confirmed, in a June 24, 2021 press release, as the third National Training Centre in the Advanced Therapies Skills Training Network (ATSTN) initiative—an initiative that was launched in December 2020 and is coordinated by the Cell and Gene Therapy Catapult.

Other training centers included in the initiative, which is sponsored by the Department for Business, Energy and Industrial Strategy (BEIS), are RoslinCT, along with its academic partners, and the National Horizons Centre. The initiative has been designed for the development and delivery of specific practical skills to address the growing need in the United Kingdom for skills in vaccine and advanced therapy medicinal product (ATMP) manufacturing.

The University of Birmingham will provide training on advanced technology in collaboration with local companies and institutions that complement the ATSTN initiative. Courses included will be modules on ATMP manufacturing design and clinical adoption, in addition to modules on documentation and implementation of ATMPs. The training will be delivered as a combination of on-site, online learning, and virtual reality modules.

“The UK ATMP industry is expanding rapidly, and to support that tremendous growth the industry needs skilled people,” said Matthew Durdy, CEO, Cell and Gene Therapy Catapult, in the press release. “The UK is making one of the biggest commitments anywhere in the world to training in this sector, keeping it as the ‘go to’ place for the cell and gene therapy industry. As part of the ATSTN program, the University of Birmingham is well placed to develop and deliver high-impact training courses utilizing its world leading delivery technologies.”

“We are delighted to provide our leading expertise, playing such a pivotal role in delivering these much-needed skills for the UK’s advanced therapies sector,” added Phil Newsome, director of Research in the College of Medical and Dental Sciences at the University of Birmingham, in the press release. “This collaboration between industry and academia will create a truly world-class offering, ensuring the UK remains at the forefront of the manufacture and delivery of vaccines and advanced therapies. Moreover, it will further strengthen and leverage the rapidly-growing health and life science sector in Birmingham and the Midlands.”

The first courses are set to launch in September 2021, covering the fundamental aspects of ATMPS and good manufacturing practice (GMP). Furthermore, the University of Birmingham will offer master’s degree level modules on GMP standards.

The University of Birmingham has been confirmed as the third National Training Centre in the Advanced Therapies Skills Training Network (ATSTN) initiative

University of Birmingham Joins Advanced Therapies Skills Training Network

GlaxoSmithKline (GSK) announced on June 23, 2021, plans to establish a “New GSK” that will focus on vaccines and specialty medicines with a planned “demerger” with its consumer healthcare business in mid-2022.

Citing efforts since 2017 to strengthen the company’s R&D and commercial execution, as well as structural and cultural changes, Chief Executive Officer Emma Walmsley said in a statement: “Together, we are now ready to deliver a step-change in growth for New GSK and unlock the value of Consumer Healthcare. With world class capabilities across prevention and treatment of disease, New GSK is exceptionally well positioned to positively impact people’s health and to deliver strong performance and value to shareholders through the decade.”

GSK and Pfizer announced a merger of consumer healthcare product brands

 with the intention to spin off the business to a separate company within three years.

With an emphasis on developing vaccines and specialty medicines, the company anticipates sales in 2031 for New GSK of £33 billion ($46.1 billion) with a focus on infectious disease, HIV, oncology, and immunology/respiratory therapeutic areas. A new General Medicines group, which will contain all of the company’s primary care brands including established products and the inhaled respiratory portfolio, will be “optimized for profitability and cash generation to support investment in Vaccines and Specialty Medicines. As part of this approach, further streamlining of the portfolio is expected through divestment or partnering of non-priority brands,” the company reported in a press statement.

The consumer healthcare business will have a portfolio which generated more than £10 billion ($14 billion) in 2020.

GlaxoSmithKline will focus on vaccines and specialty medicines while spinning off consumer healthcare business.

GSK Announces Consumer Business Demerger

The European Commission (EC) has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022. The new contract was announced by Moderna in a June 22, 2021 press release.

With this additional order, the total number of doses now confirmed and purchased by the EC has reached 460 million. Under the terms of the agreement, the additional doses, which will enable European countries to access the updated COVID-19 vaccine booster candidates, will begin to be delivered in 2022. However, the purchase is still subject to regulatory approval of the booster vaccine candidates by the European Medicines Agency (EMA).

“We appreciate the collaboration with the EC for these additional doses of the Moderna COVID-19 vaccine, which could be used for primary vaccination, including of children, or possibly as a booster if that becomes necessary to continue to defeat the pandemic,” said Stephane Bancel, Moderna’s CEO, in the press release. “We are encouraged by the initial booster data, which reinforce our confidence that our booster strategy should be protective against current variants. We will remain proactive as the virus evolves by leveraging the flexibility of our mRNA platform to stay ahead of emerging variants.”

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

EC Orders 150 Million Additional Doses of Moderna’s COVID-19 Vaccine

Clinical-stage gene therapy company, Ilya Pharma, has announced, in a June 23, 2021 press release, that it has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

ILP100 has been developed for the treatment of difficult diabetic wounds by enhancing the healing properties of immune cells at the wound site. This regulatory approval for the next stage of clinical trials comes after Phase I results indicated that the gene therapy, in its highest dose, was able to treat wounds in healthy subjects with a healing time of approximately six days on average, which is 11 days faster than controls.

“With the Phase II clinical trial, we will for the first time study the biologic effect of ILP100 in difficult wounds in patients in one of the intended patient groups for future commercial use of ILP100 where today’s standard of care is not sufficient,” said Andreas Fasth, Ilya Pharma’s head of Clinical Developments, in the press release. “We have designed this 26-week trial to both allow assessment of the clinical outcomes mentioned as the most important by patients and regulatory authorities, including detailed wound analyses with [artificial intelligence]-augmented imaging technology as well as non-invasive imaging of blood perfusion, and at the same time further characterize ILP100 in a clinical setting.”

“This is a true milestone in both the clinical development of ILP100 and proof of the concept of using local delivery of biologics by the ILP-technology platform as we move to Phase II,” added Evelina Vågesjö, Ilya Pharma’s CEO, in the press release. “We now look forward to showing biological effects on wound healing and important long-term clinical outcomes in patients with diabetes and difficult non-healing wounds. Here, ILP100 has the potential to prove superior to the only other two pharmaceuticals approved as we already have much better positioning and [proof of concept] PoC data. In addition, we will proceed with the planned clinical development in treatment of postsurgical wounds in obesity, diabetes and prediabetes, as well as pre-clinical development and clinical positioning for ulcers of the [gastrointestinal] tract.”

Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.

Ilya Pharma Receives Approval from Swedish Regulators for Phase II Study

The European Medicines Agency (EMA) has issued a positive opinion for a recombinant vaccine for rabbits that had been developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, representing a step forward for the full commercialization of the platform.

According to a June 22, 2021 press release, CrisBio offers a quick, linearly scalable solution that can meet the global demand for recombinant protein production without significant capex investment. The first regulatory validation of a biologic product produced with CrisBio will provide momentum for Algenex to expand the use of its platform into a broader range of applications in both human and animal health.

“The positive opinion of the EMA’s [Committee for Medicinal Products for Veterinary Use] CVMP for a CrisBio developed vaccine represents a significant regulatory validation for our platform and an important next step in bringing this new technology to full commercial light. We have already signed a number of commercial agreements including with Virbac for a major veterinary indication,” said Claudia Jiménez, CEO of Algenex, in the press release. “The CVMP decision further highlights the quality of our technology and underlines the potential of CrisBio to provide a versatile and robust alternative to bioreactor-based expression technologies across multiple applications in human and animal health, offering our partners significant benefits in terms of development speed, scalability, and gross margin.”

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.