Complex biotherapeutics present unique analytical challenges for developers.

Complex Biomolecules Require Analytical Evolution

FDA Approves Additional J&J Vaccine Batch; AstraZeneca Launches Variant Trial

Full Vaccine Approval is Key to Overcoming Hesitancy

Public-private consortium is tasked with advancing domestic pharmaceutical production.

HHS Strategizes for Domestic Drug Supply

New biotherapeutics both drive and benefit from innovative development technologies.

Innovation Demands and Spurs Invention

Meeting Development and Manufacturing Demands for Emerging Therapies

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine, Spikevax, to include adolescents 12 years of age and older, Moderna announced in a 

Moderna announced data from the ongoing Phase II/III study on June 10, 2021, which enrolled more than 3,500 participants ages 12–18 years in the United States. After two doses of the Moderna COVID-19 vaccine, no cases of COVID-19 were observed in the vaccine group, and the study met its primary endpoint. The vaccine was generally well tolerated with a safety and tolerability profile consistent with the previous Phase III study in adults.

Most of the adverse events were mild or moderate in severity. Injection site pain was the most common local adverse event, while the most common systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia, and chills.

The European Commission will consider authorizing the use of the Moderna COVID-19 vaccine in adolescents younger than 12 years of age.

Moderna is also conducting the KidCOVE study, a Phase II/III study, of mRNA-1273 in children ages six months to 12 years.

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The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents 

 the selection of Onco360, an independent Oncology Pharmacy, to be a specialty pharmacy partner for Rezurock (belumosudil). Rezurock is a new oral treatment for the treatment of chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy for adult and pediatric patients 12 years and older.

, which is distributed and marketed by Kadmon Pharmaceuticals, following the Phase II KD025-213 clinical trial (NCT03640481).

Chronic GVHD is the leading cause of non-relapse mortality following allogeneic HCT and often develops within the first year after allogeneic HCT, according to the National Comprehensive Cancer Network (NCCN) Guidelines for Hematopoietic Cell Transplantation (HCT). It also can affect multiple organ systems, including skin, gastrointestinal tract, liver, lungs, and more.

First-line treatment for chronic GVHD involves systemic corticosteroids. But according to the NCCN guidelines, patients may develop steroid-refractory disease and require additional/alternative treatment.

Kadmon Pharmaceuticals selects Onco360 to be a specialty pharmacy partner for Rezurock (belumosudil).

Kadmon Pharmaceuticals Partners with Oncology Pharmacy for New Chronic Graft-Versus-Host Disease Therapy

 a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC (proteolysis targeting chimeras) estrogen receptor (ER) protein degrader.

Pfizer will pay Arvinas $650 million upfront under the agreement and will make a $350 million equity investment in Arvinas. Worldwide development costs, commercialization expenses, and profits will be shared equally between the two companies.

In an ongoing Phase II dose expansion clinical trial, ARV-471 is being assessed for the treatment of patients with ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer.

ER is the primary driver of hormone receptor positive breast cancer—the most common breast cancer subtype, according to the company. Endocrine therapy is used as monotherapy or as combination therapy across treatment settings as a standard form of care.

In December 2020, interim data indicated its potential as a novel oral ER targeted therapy from the ongoing Phase I dose escalation clinical trial of ARV-471 in patients with locally advanced or metastatic ER+/HER2- breast cancer. In addition, ARV-471 is being evaluated as a treatment for metastatic breast cancer in a Phase I dose escalation study, a Phase 1b combination study with Pfizer’s IBRANCE (palbociclib), and a Phase 2 monotherapy dose expansion study (VERITAC).

The companies expect to initiate two additional trials of ARV-471 in 2021.

The companies collaborate to develop and commercialize ARV-471, an investigational oral PROTAC (proteolysis targeting chimeras) estrogen receptor protein degrader.

Pfizer and Arvinas to Develop and Commercialize Estrogen Receptor Targeting Breast Cancer 

Johnson & Johnson and its US-based Janssen Pharmaceutical Companies announced in a 

 a nationwide settlement agreement has been finalized to resolve opioid-related claims and litigation in the United States.

This settlement agreement aims to resolve most of the litigation-based claims regarding the past sales of the company’s prescription opioid medications. According to the press release, the agreement isn’t an admission of any liability or wrongdoing, and the company said it will defend against any litigation that the final agreement doesn’t resolve.

 it will contribute up to $5 billion to the settlement. This will depend on how many state and local governments opt into the agreement in the next several months.

According to the July 21, 2021 press release, the company said its the marketing and promotion of prescription opioid medications were appropriate and responsible. Since the US launch, DURAGESIC, NUCYNTA, and NUCYNTA ER accounted for less than 1% of total opioid prescriptions.

Johnson & Johnson no longer sells prescription opioid medications in the US.

J&J to contribute up to $5 billion to the settlement agreement to resolve opioid-related claims and litigation in the United States. 

Johnson & Johnson Finalizes National Opioid Settlement Agreement 

On July 20th, soft capsule producer Aenova announced plans to open a new production line in Cornu, Romania. The new can and bottle filling plant in Cornu will be able to fill approximately 12 to 14 million plastic or glass bottles per year. It packs in bottles with a diameter of 44 to 76 mm and a height of 55 to 165 mm, made of glass or plastic, with screw cap or so-called press lid.

At Aenova in Cornu, up to 10 billion softgel capsules are produced annually, packaged in either cans or bottles. These include not only soft gelatin capsules for pharmaceuticals as well as dietary supplements, but also Aenova's vegan VegaGels.

Aenova has stated their intent to position themselves as a “one-stop shop” for various companies looking to produce and package their products.

"The advantages of the ‘one-stop shop’ for customers are obvious: with a competitive price, customer companies receive production and packaging from a single source, have only one contact person and only one manufacturing plant to qualify and register," said Michael Ammann, senior vice president of the Softgel Capsules Business Unit and Managing Director at the Cornu site, in a 

. “This means real added value for our customers.”

Aenova has announced plans to open a new new can and bottle filling production line in Cornu, Romania. 

Aenova Announces Plans for New Production Line

 on July 20th that it has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider.

G-CON manufactures turnkey current good manufacturing practice (CGMP)-compliant suites called PODs. PODs are cleanrooms built offsite and differ from traditional structures due to their ease of scalability, mobility, and the ability to repurpose them after the completion of the production process.

"We are proud to partner with G-CON for the next, exciting chapter of its growth trajectory," says Marika Vitiä, director at Summa Equity, in a press release. "We strongly believe G-CON has the potential to significantly accelerate bioprocessing production timelines, to help biopharma manufacturers get to market earlier and fully meet their capacity requirements after launch. This is a vitally important element of the healthcare value chain, ensuring that more of society has access to the right healthcare when they need it."

Founded in 2009 in College Station, Texas, G-CON has sold more than 300 cleanrooms since its inception. Following the acquisition, Summa has stated their goal to support G-CON in expanding their local market while also establishing an overseas presence. The transaction was completed on July 15th.

Summa Equity has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider. 

Summa Equity Acquires Cleanroom Provider G-CON Manufacturing

On July 21, 2021, Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

Biovac will utilize Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and feature more than 20 manufacturing facilities. They will receive drug substances from facilities in Europe.

Biovac’s Cape Town facility is expected to be incorporated into the vaccine supply chain by the end of 2021, while manufacturing of finished doses is slated to commence in 2022. Annual production will exceed 100 million finished doses once full operational capacity is reached. All doses be exclusively distributed within the 55 states of the African Union.

“From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 vaccine to everyone, everywhere,” said Albert Bourla, chairman and chief executive officer at Pfizer, in a 

. “Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of COVID-19 vaccines.”

Pfizer and Biovac have worked together since 2015 on the sterile formulation, fill/finish, and distribution of the Prevenar 13 vaccine.

To date, Pfizer and BioNTech have shipped more than 1 billion COVID-19 vaccine doses to over 100 countries and territories. They have also pledged to supply 500 million doses to the US Government at a not-for-profit price, which the US will in turn donate to COVAX 92 Advanced Market Commitment (AMC) countries.

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa

On July 22, 2021, Catalent announced the launch of its next-generation cell-line development technology, GPEx Lightning, which combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines.

The benefits of the GPEx cell line expression system include titers of up to 10 g/L for traditional monoclonal antibodies, with no need to test for genetic stability. The new GPEx Lightning platform combines multiple, advanced engineering technologies into a single process, which can provide high yielding cell lines while reducing development steps. This reduction in steps can potentially save six to 12 weeks of development timelines.

“Speed to clinic is of critical importance to our customers and the patients they serve, and GPEx Lightning builds on a proven platform to accomplish that goal,” said Mike Riley, region president, Biologics, North America, Catalent, in a company press release. “We continue to develop innovative offerings from cell line development through to CGMP [current good manufacturing practice] manufacturing to enable accelerated timelines with the highest level of rigor and quality.”

Catalent Biologics has launched its new cell line expression technology, GPEx Lightning, which aims to shorten drug substance development timelines by up to three months.

Catalent Biologics Launches New Cell Line Expression Technology

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.”

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.

Featured Content

Complex Biomolecules Require Analytical Evolution

Full Vaccine Approval is Key to Overcoming Hesitancy

HHS Strategizes for Domestic Drug Supply

Innovation Demands and Spurs Invention

Technology Forum