Pharmaceutical Technology Editors

Eli Lilly and Company announced on April 12, 2021 that it has modified its purchase agreements with the US government for its emergency use authorized COVID-19 neutralizing antibody therapies, bamlanivimab and etesevimab, to be supplied and used together rather than individually.

Through the modified agreement, the supply of etesevimab will now complement the doses of bamlanivimab that the US government already purchased, concluding the purchase agreement for bamlanivimab alone and cancelling the remaining 350,856 doses that were scheduled to be delivered by the end of March 2021, Eli Lilly said in a company press release.

Currently, bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by FDA, and it is not known if the neutralizing antibody therapies are a safe treatment for COVID-19.

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Eli Lilly has modified its purchase agreements with the US government for its emergency use authorized COVID-19 neutralizing antibody therapies, bamlanivimab and etesevimab, to be supplied and used together rather than individually.

Eli Lilly Modifies COVID-19 Purchase Agreement with the US Government

Sanofi announced on April 9, 2021 that it has acquired Tidal Therapeutics, a US-based pre-clinical stage biotech company, for $470 million.

Under the terms of the agreement, Sanofi will provide an upfront payment of $160 million and up to $310 million upon achievement of certain milestones, Sanofi said in a company press release. The deal will also give Sanofi access to Tidal’s novel messenger RNA (mRNA)-based approach for 

 reprogramming of immune cells, which will expand Sanofi’s research capabilities in immuno-oncology and inflammatory diseases.

“We anticipate that this next-generation, off-the-shelf approach has the potential to bring CAR-T cell [chimeric antigen receptor T cell] therapy to a much broader patient population,” said Frank Nestle, global head of Research and chief scientific officer at Sanofi, in the press release. “We believe that the underlying mRNA targeting platform will create disruptive therapeutic approaches across a variety of oncology and autoimmune conditions.”

“Teaming up with Sanofi gives us the opportunity to further develop our unique platform and rapidly apply it to ultimately help patients across a range of diseases,” added Ulrik Nielsen, president and CEO, Tidal Therapeutics, in the press release.

The deal will give Sanofi access to Tidal’s novel mRNA-based approach for in-vivo reprogramming of immune cells, which will expand Sanofi’s research capabilities in immuno-oncology and inflammatory diseases.

Sanofi to Acquire Tidal Therapeutics for $470 Million

BeiGene, a commercial-stage biotechnology company, announced on April 7, 2021 that the China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-programmed cell death (PD)-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

The 1 million-ft.2 facility currently has 8000 Lof biologics capacity approved for commercial supply, with 64,000 additional liters planning to be added to the site by the end of 2022, BeiGene said in a company press release.

“We started building this large-scale, commercial biologics manufacturing facility in 2017 to meet our expected future demand. Since that time, tislelizumab has been approved in several indications in China, included in the National Reimbursement Drug List, and licensed to Novartis in Europe, North America, and Japan,” said Xiaobin Wu, PhD, president, chief operating officer, and general manager of China at BeiGene, in the press release. “With significantly expanded capacity for tislelizumab and for other biologics in our pipeline, we are continuing our strong commitment to the quality, safety, and compliance of our products.”

The China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

China Approves BeiGene for Commercial Manufacturing at its Biologics Facility

Takeda and CSL Behring, co-founders of the CoVIg-19 Plasma Alliance, announced on April 2, 2021 that a Phase III inpatient treatment with anti-coronavirus immunoglobulin clinical trial did not meet its endpoints. The year-long collaboration of the companies in the Alliance has ended with the end of the clinical trial, but it provides a framework for future collaboration, the companies said in the press release.

According to a Takeda press release, the trial, which was sponsored and funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, intended to determine whether CoVIg-19, an investigational anti-coronavirus hyperimmune intravenous immunoglobulin medicine, could lessen the risk of disease progression when added to standard care treatment including remdesivir in hospitalized adult patients at risk for serious complications.

“While the results of this particular clinical trial are disappointing, we are proud that as an industry we proactively and collaboratively pursued this work, and that the program may contribute to a growing understanding of this challenging virus and strategies for patient care,” said Bill Mezzanotte, MD, executive vice-president, head of Research and Development and chief medical officer, CSL Behring, and co-leader of the CoVIg-19 Alliance, in the press release. “Since we embarked on this development program, and throughout the pandemic, we have learned much from our scientific research. Importantly, we learned that as an industry we have the fortitude and capability to quickly work together for the greater good of human health.”

“We are especially proud that we pooled resources, brought our plasma expertise and infrastructure together at our own cost to benefit public health and added to our understanding of a complex field. We are extremely thankful to all those who collaborated day and night for one year in testing circumstances to develop and manufacture a potential solution for COVID-19, including those organizations from outside the industry who chose to support us,” added Julie Kim, president of Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 Alliance, in the press release. “We express our sincere gratitude to the COVID-19 survivors who generously donated their plasma to make our work possible, the patients who graciously participated in the trial, and to the regulatory and government agencies for their partnership and flexibility to support our efforts."

A Phase III clinical trial of anti-coronavirus immunoglobulin did not meet its endpoints, concluding the year-long CoVIg-19 Plasma Alliance, Takeda and CSL Behring announced.

Plasma-Based COVID-19 Treatment Alliance Ends its Project as Trial Fails to Meet Endpoints

Merck, known as MSD outside of the United States and Canada, and Alkermes, a biopharmaceutical company headquartered in Ireland, announced on April 7, 2021 that they have entered into a collaboration and supply agreement to conduct a Phase III study to evaluate nemvaleukin alfa, Alkermes' novel investigational engineered interleukin-2 (IL-2) variant immunotherapy, in combination with Merck’s Keytruda (pembrolizumab), in patients with platinum-resistant ovarian cancer.

The combination is currently being evaluated in two 1/2 phase studies, ARTISTRY-1 and ARTISTRY-2, to determine its safety, tolerability, efficacy, and pharmacokinetic and pharmacodynamic effects, Alkermes said in a company press release.

"We are pleased to collaborate with [Merck] to evaluate nemvaleukin in combination with Keytruda in patients with platinum-resistant ovarian cancer, a patient population for which there are limited treatment options available and overall survival remains low. Importantly, there are no anti-PD-1 treatments currently approved for this tumor type," said Jessicca Rege, PhD, vice-president, head of Oncology at Alkermes. "Nemvaleukin in combination with Keytruda has demonstrated antitumor activity in heavily pre-treated patients with platinum-resistant ovarian cancer in the ongoing ARTISTRY-1 study, with durable and deepening responses observed. We look forward to initiating this Phase III study to further evaluate the potential clinical utility of this combination in this tumor type and advancing our interactions with regulatory authorities related to potential registration strategies for the combination in platinum-resistant ovarian cancer."

The Phase III study will evaluate nemvaleukin alfa, Alkermes' novel investigational engineered interleukin-2 variant immunotherapy, in combination with Merck’s Keytruda (pembrolizumab), in patients with platinum-resistant ovarian cancer.

Merck and Alkermes Collaborate on Phase III Study for Ovarian Cancer Treatment

The National Horizons Centre (NHC) in the United Kingdom has been confirmed as a National Training Centre that will deliver on-site advanced therapies and vaccine manufacturing specific practical and digital training.

NHC was announced as a preferred bidder in December 2020 to become one of the initial three centers to provide hands-on training for advanced therapy medicinal products (ATMPs) and vaccine manufacture as part of the Advanced Therapies Skills Training Network (ATSTN)—a UK-wide initiative. ATSTN has been awarded funding by the Department for Business Energy and Industrial Strategy for the delivery of training centers across the UK that will help to develop practical skills and address the growing need in vaccine and ATMP manufacturing.

The on-site training being offered by NHC will be focused on good practice (GxP) manufacturing, process development, and bioprocessing techniques. In addition to hands-on training, NHC will also create a virtual reality (VR) training facility, which will include four VR stations alongside a tutor demonstration station. The VR facility will be used in conjunction with the NHC laboratory and teaching facilities to deliver the training courses.

“The UK cell and gene industry is a great place for people to build their future. We want to see that opportunity opened up to everyone,” said Matthew Durdy, CEO at Cell and Gene Therapy Catapult, in a March 31, 2021 press release. “With its cutting-edge training facilities, the [NHC] will be an integral part of the [ATSTN’s] unique offering to anyone in the UK who wants to advance their career in advanced therapies.”

“With the rush to develop and deliver a COVID-19 vaccine, the importance of the biomanufacturing and bioprocessing sectors has never been so apparent,” added Jen Vanderhoven, director of NHC, in the press release. “We’ve worked very closely with leading figures across the bioindustry sector to ensure that each of these courses will address the requisite technical and digital needs. We pride ourselves on our ability to be responsive to the sector’s needs, so we’re very pleased to have been able to react quickly and develop these courses, which will deliver vital skills needed for vaccine manufacturing and advanced therapies and to grow this important industry.”

The training courses will be available at NHC from May 2021. Courses will cover upstream and downstream bioprocessing, analytical techniques for bioprocessing, process control and automation, viral vector manufacturing, biologics manufacturing, data integrity, computer systems validation and IT compliance, good manufacturing practice for biologics, practical proteomics, and flow cytometry for bioprocessing.

The UK's National Horizons Centre has been confirmed as a National Training Centre that will deliver on-site advanced therapies and vaccine manufacturing specific training.