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COVID-19 Treatments and Vaccines Update

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Cell Therapy Manufacturing Amid Pandemic 

Full-day virtual event exploring the latest developments in formulation, manufacturing, innovative drug dosage forms and other crucial topics impacting the industry

2020 Bio/Pharma Virtual Congress: November 11, 2020

Samsung Biologics has integrated Solentim’s VIPS single cell seeding platform and Cell Metric CLD platform to its R&D facility in San Francisco, CA. These instruments are designed for single-cell cloning and can ensure monoclonality to increase the speed and efficiency of master cell bank development.

With the additions, Samsung’s San Francisco R&D facility can offer rapid, high quality development services, including cell line development. Solentim’s VIPS and Cell Metric CLD instruments will be used in conjunction with Samsung Biologics’ recently launched proprietary cell line platform, S-CHOice, which Samsung Biologics debuted in September 2020. The VIPS and Cell Metric CLD platforms were added in October 2020.

“We’re pleased to extend our long-standing partnership with Samsung Biologics, which has previously purchased and enjoyed success with our equipment in its headquarter operations,” said Mark Truesdale, CEO of Solentim, in an Oct. 7, 2020 company press release.

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Samsung Biologics has adopted Solentim’s cell seeding and cell metric platforms at its new R&D center in San Francisco, CA. 

Samsung Biologics Incorporates Solentim’s Cell Line Development Technology into New R&D Center 

A new technology platform, EpiMOGRIFY, now offered by Mogrify, a UK-based biotechnology company specializing in cell therapies, supports the development of allogeneic (i.e., “off-the-shelf”) cell therapies by modeling the epigenetic state of a cell to predict the switches that are important for cell identity, cell maintenance, directed differentiation, and cell conversion.

The new platform, introduced in October 2020, is an extension of the company’s proprietary direct cellular conversion technology, MOGRIFY, that enables the identification of the optimal culture conditions required to maintain cells in chemically defined media. The platform can be applied in current good manufacturing practice (cGMP) manufacture and enhances directed differentiation or cell conversion to support the development of scalable off-the-shelf therapies, Mogrify stated in an Oct. 9, 2020 press release.

EpiMOGRIFY combines gene-regulatory information with a model of a cell’s epigenetic landscape, allowing it to leverage changes in the level of DNA–histone methylation (H3K4me3 modifications). The platform uses data from more than 100 human cell/tissue types (available via the ENCODE and Epigenome Roadmap consortia) to accurately define culture conditions that can maintain the cell identity or induce cell conversion. In both cell maintenance and differentiation, EpiMOGRIFY defined conditions performed as well or better in all cases when compared to existing undefined conditions, significantly increasing cell growth and survival as well as resulting in a higher differentiation efficiency, according to Mogrify.

Duke-NUS (Enrico Pettreto, associate professor, and Owen Rackham, assistant professor, at Duke-NUS Medical School), Monash University (Jose Polo, professor at Monash University), and Mogrify are the co-developer and co-owner of the EpiMOGRIFY platform, patent, and know-how.

“Building on our development of the Mogrify technology to identify transcriptomic switches for cell conversion, this new technology published in Cell Systems adds an important layer of epigenetic specificity in our continuous search to drive cell identity with an increasing level of control. The ability to systematically identify the optimal culture conditions, closely mimicking the 

 microenvironment, will enable scientists to convert and maintain any cell type more efficiently and with even greater accuracy,” said Rackham in the press release.

“The co-development and successful validation of this technology is a testament to our commitment to work with Mogrify’s founding laboratories and support the continuous innovation in the field of cellular reprogramming. This represents a unique opportunity to transform the development of existing cell therapies and will become instrumental in our bid to engineer scalable off-the-shelf therapies for diseases with a high unmet clinical need,” said Julian Gough, PhD, co-founder and chief scientific officer, Mogrify, in the press release.

Mogrify’s new technology platform, EpiMOGRIFY, can predict cellular switches important for determining cell identity, cell maintenance, directed differentiation, and cell conversion.

New EpiMOGRIFY Technology Platform Offers Development Support for Allogeneic Cell Therapies

BioSkryb, a US-based developer of genomic amplification technologies, now offers its ResolveDNA product line for the accurate and uniform reproduction of single-cell genomes for commercial use. The product line incorporates novel primary template-directed amplification (PTA) technology, which captures more than 95% of the genomes of single cells, providing high-quality, scalable analysis of single-cell genomic heterogeneity. The company launched the product line at the American Society Human Genetics (ASHG) 2020 conference, held virtually from Oct. 27–30, 2020.

It is expected that this proprietary technology will enable new insights into human disease at the cellular level, the company stated in an Oct. 26, 2020 press release. A poster presented by BioSkryb at the conference also demonstrated the use of PTA technology to study genetic variants that drive therapeutic resistance. The poster, “Primary template-directed amplification for single-cell elucidation of targeted therapy resistance mechanisms in acute myeloid leukemia and triple-negative breast cancer,” is available for viewing at ASHG 2020 (Session 202: Cancer, Abstract 2406).

Whole genome amplification (WGA) is a requirement for the analysis of low-input DNA and single-cells analysis, but current WGA technologies cover only a fraction of the genome. Current technologies also have a limited capacity to detect genetic variation in each cell, according to BioSkryb. The company’s novel PTA technology accurately calls variants in genomes in addition to reproducibly captures more than 95% of single-cell genomes. PTA does this in a more consistent and accurate manner than existing approaches, the company stated in its press release.

“Single-cell approaches are imperative to understanding, diagnosing, and treating human diseases involving genomic heterogeneity, like cancer,” said Jay West, PhD, CEO, and co-founder of BioSkryb, in the press release. “With our ResolveDNA products, researchers can accurately and efficiently decipher genetic diversity at the cellular level to make transformative discoveries that improve human health.”

“The BioSkryb team was a great partner in assisting us with single-cell sequencing and analysis. They were responsive to our unique needs and we felt confident in the high quality of the sequencing data and analysis that we received. The results and insights their technology provided far exceeded our expectations, and BioSkryb’s commitment to supporting us in our fight against cancer using cell and gene therapies was present every step of the way,” said Susan Nichols, CEO of Falcon Therapeutics, in the press release.

With the presentation of research supporting the use of PTA technology, BioSkryb also launched its ResolveDNA platform for commercial use at ASHG 2020, held virtually on Oct. 27–30, 2020.

Novel Single-Cell Whole Genome Amplification Technology Made Commercially Available at ASHG 2020

Takeda and Moderna announced on Oct. 29, 2020 that they are entering into a three-way agreement with the Government of Japan’s Ministry of Health, Labor, and Welfare to import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, beginning in the first half of 2021.

Through the agreement, Takeda will handle securing the regulatory approvals before distributing the doses, while Moderna will supply the finished product, a Takeda press release said. Currently, a Phase III clinical trial for the vaccine candidate in the United States is fully enrolled.

This collaboration follows Takeda’s recent announcement that it is planning to manufacture Novavax’s COVID-19 vaccine candidate at its facilities in Japan to support the long-term supply of the treatment to the Japanese population.

“Takeda is collaborating with the Japanese Government and vaccine developers to provide rapid and sustained access to COVID-19 vaccines in Japan,” said Rajeev Venkayya, MD, president of the Global Vaccine Business Unit, Takeda, in the press release. “We have chosen to work with Novavax and Moderna, both of which have promising vaccine candidates, and will continue to support the global response to COVID-19 through R&D efforts across Takeda.”

Through the agreement, Takeda will handle securing the regulatory approvals before distributing the doses, while Moderna will supply the finished product.

Takeda, Moderna, and the Government of Japan to Collaborate to Distribute 50 Million COVID-19 Vaccine Doses

AstraZeneca and Daiichi Sankyo announced on Oct. 28, 2020 that their supplemental biologics license application (sBLA) for Enhertu (trastuzumab deruxtecan), an antibody drug conjugate (ADC) for treating HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma, was accepted by FDA and granted priority review.

FDA’s acceptance of the sBLA was based on positive results from a Phase II trial (Destiny-Gastric01), which showed improvement in objective response rate, the primary endpoint, and overall survival in patients treated with the therapeutic, according to an AstraZeneca press release.

“Once patients with HER2-positive metastatic gastric cancer progress following initial treatment with an anti-HER2 regimen, there are no approved HER2-directed medicines,” said José Baselga, executive vice-president, Oncology R&D, AstraZeneca, in the press release. “The prognosis for these patients is poor, as available treatment options offer only limited clinical benefit. This milestone brings us one step closer to delivering a potentially practice-changing medicine to patients with gastric cancer in the [United States].”

“The results of the Destiny-Gastric01 trial are unprecedented as they represent the first time a HER2-directed medicine has demonstrated an improvement in survival following chemotherapy and HER2 treatment in the metastatic setting,” added Antoine Yver, executive vice-president and global head, Oncology R&D, Daiichi Sankyo, in the press release. “Building on the recent [b]reakthrough [t]herapy [d]esignation, the filing of the application, and [p]riority [r]eview by [FDA] for this potential new indication for Enhertu reflects the importance of the data and the significant unmet need for patients with previously treated HER2-positive metastatic gastric cancer.”

FDA has granted priority review for the companies’ sBLA for Enhertu, an ADC for treating gastric cancers.

AstraZeneca and Daiichi Sankyo Granted Priority Review for Gastric Cancer sBLA

On Oct. 27, 2020, the United States filed a civil complaint against Med-Pharmex (MPX), a Pomona, CA-based animal health company, regarding its manufacturing and distribution of adulterated animal drugs.

According to a press release from the Department of Justice, the complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality. In the complaint, it is noted that FDA inspected the company site several times, which resulted in a warning letter in 2017 that noted deficiencies at the company including the failure to properly clean and disinfect areas used to manufacture sterile drugs and the failure to conform to current good manufacturing practices. Additionally, the complaint also mentions MPX’s failure to sufficiently examine reports of the death or illness of animals receiving MPX drugs, the press release said.

“Americans depend on animal drugs being safe and effective,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division, in the press release. “We will continue working with FDA to ensure all drug manufacturers abide by public safety requirements.”

“Ensuring FDA-approved animal medications are safe, effective, and manufactured using current good manufacturing practices is an important part of the FDA’s mission to protect human and animal health,” added FDA Chief Counsel Stacy Amin, in the press release. “The FDA will continue to pursue actions against those who put animal patients in harm’s way by manufacturing and distributing adulterated animal drug products.”

The complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality.

The Department of Justice Files a Complaint Against Animal Health Company for the Distribution of Adulterated Animal Drugs

Contract development and manufacturing organization (CDMO), 3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement, it was announced in an Oct. 26, 2020 press release.

SpyBiotech’s SpyCatcher/SpyTag platform technology enables antigens to be displayed onto virus-like particles with a covalent, irreversible bond in a stable and effective way with specific orientation/epitope presentation and high density. The company states that the technology has broad applicability in vaccine development and has established proof of concept data in viral, bacterial, parasitic diseases, chronic diseases, and cancer.

In June 2019, SpyBiotech selected 3P Biopharmaceuticals for the manufacture of a current good manufacturing practice (CGMP) batch of its virus-like particle carrier, with the aim for production to be completed in 2021. Through this latest agreement, 3P Biopharmaceuticals will demonstrate its capacity to perform processes and manufacturing of molecules developed for diverse therapeutic applications.

“It is amazing being part of a project which presents an opportunity to develop treatments for a broad range of diseases,” said Dámaso Molero, CEO of 3P Biopharmaceuticals, in the press release. “We are helping to support manufacturing which we believe will open the door for pioneering vaccines which could offer a hope for improving the lives of many people. That is extremely exciting.”

Genevieve Labbe, senior scientist and GMP project manager for SpyBiotech added in the press release, “It’s critical to have a trusted partner in place for cell line and CGMP production. SpyBiotech is looking forward to advancing this product and we are delighted to be working with 3P Biopharmaceuticals.”

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

3P Biopharmaceuticals and SpyBiotech Sign Vaccine Manufacturing Agreement

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS), which is a subsidiary of Bone Therapeutics. The acquisition, which is expected to close in November 2020, was announced in an Oct. 29, 2020 press release.

Under the terms of the agreement, Catalent will acquire the subsidiary company, and all of its assets located in Gosselies, Belgium, through the purchase of all SCTS shares that are currently owned by Bone Therapeutics. The deal will include a purpose-built current good practice (CGxP) facility of approximately 41,000 ft2, which incorporates quality control and product development laboratories, warehouse, grade C and B cleanrooms and equipment, and land for further development. Additionally, Catalent will take on the manufacturing of clinical material for Bone Therapeutics’ ALLOB—an allogenic osteoblastic cell therapy product derived from 

The acquired facility is located next to Catalent’s existing cell therapy site, which will enable Catalent to expand its cell therapy capabilities and advanced clinical and commercial supply, as well as create an integrated European center of excellence in cell therapy. All the SCTS manufacturing employees will remain with the company and become part of the Catalent workforce.

“Catalent is committed to supporting the development and manufacture of next-generation therapies and bringing life-changing treatments to patients in need,” said Manja Boerman, president, Catalent Cell & Gene Therapy, in the press release. “Following the acquisition of MaSTherCell, the additional manufacturing capacity and technical expertise that this deal with Bone Therapeutics gives us will immediately expand our functional clinical and commercial capacity for current late-stage customers. This addition also creates a strong center of cell therapy excellence for Catalent in Europe and will serve as a hub for the growing cell therapy pipeline.”

“This agreement with Catalent is an important strategic step for Bone Therapeutics and is the result of our continuous effort to optimize our operations,” added Miguel Forte, CEO, Bone Therapeutics, in the press release. “The integration of our manufacturing subsidiary into Catalent, one of the premier contract manufacturers in the cell therapy space, significantly increases our operational flexibility. It enables Bone Therapeutics to maximize the efficient use of our manufacturing assets by combining the manufacturing facility and specialist operators with Catalent’s global network of clinical and commercial manufacturing facilities. This will ensure the most efficient ongoing global production of ALLOB.”

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS).

Catalent Acquires Bone Therapeutics’ Cell Manufacturing Facility 

Novartis and Molecular Partners announced on Oct. 28, 2020 that they have entered into a collaboration for the development, manufacture, and commercialization of Molecular Partners’ anti-COVID-19 DARPin program, which comprises two therapeutic candidates, MP0420 and MP0423.

As per the terms of the agreement, during the option period, Molecular Partners will perform Phase I clinical trials for MP0420, expected to begin in November 2020, and perform all remaining preclinical work for MP0423. Novartis will be charged with conducting the Phase II and Phase III clinical trials, which will be sponsored by Molecular Partners.

Upon option exercise, Novartis will be responsible for all further development and commercialization activities. During the clinical development stage, Molecular Partners will provide clinical supply. Manufacturing capacity scale-up will be a collaborative effort of Novartis and Molecular Partners, along with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply.

“Novartis remains unwavering in its support for tackling COVID-19 and it is clear that this pandemic calls for not just scientific solutions, but also for collaboration between companies to provide treatments in an area of high unmet need,” said Vas Narasimhan, CEO of Novartis, in the press release. “This Swiss led partnership, which could deliver both prophylactic and treatment options at scale for COVID-19 patients across the globe, is another demonstration of our sustained commitment to addressing one of the greatest health challenges of our time.”

“Our team rapidly mobilized to deliver a unique DARPin-based approach to address the overwhelming need for effective therapeutics against COVID-19. As a class, DARPins have demonstrated over years of clinical research a number of characteristics that enhance their profile as antiviral therapeutics for a global pandemic. We have built on this long-term research with these two candidates, which have demonstrated extremely potent neutralization of the virus through inhibiting multiple viral mechanisms,” added Patrick Amstutz, CEO of Molecular Partners, in the press release.

Novartis and Molecular Partners are collaborating on the development, manufacture, and commercialization of Molecular Partners’ anti-COVID-19 DARPin program.

Novartis Collaborates with Molecular Partners on Two Anti-COVID-19 Therapies 

A United Kingdom consortium of biotech companies, charities, and academia, the UK BIA Antibody Taskforce, has identified differentiated antibody combinations that will be taken into development as COVID-19 antibody therapy candidates.

According to an Oct. 29, 2020 press release, the taskforce developed an accelerated and rigorous multifaceted approach that allowed them to create a pool of more than 600 novel candidates and identify a set of antibodies with the greatest potential to treat and protect against SARS-CoV-2. These antibodies are the first to be selected for the next stage of development and assessment of their efficacy as a ‘cocktail’ is on-going.

“We have accelerated the standard timelines for antibody discovery, taking seven months rather than the industry standard 18 months, establishing a pathway that can be applied to future pandemics,” said Dr. Jane Osbourn OBE, chief scientific officer at Alchemab and leader of the taskforce, in the press release. “We believe that the most effective tool against COVID-19 will most likely be a defined mixture of two to three antibodies—so the effectiveness of different combinations must also be assessed.”

“This ground-breaking taskforce has brought together UK-based industry experts who share a joint commitment to help fight the COVID-19 pandemic,” added Steve Bates OBE, CEO of the UK BioIndustry Association (BIA), in the press release. “Contributing their expertise and specialist resources, the team has worked tirelessly to identify the most promising antibodies with the potential to positively impact treatment of those affected by this devastating virus. The next stage will involve securing external funding to facilitate the further development and manufacture of the candidates.”

The UK BIA Antibody Taskforce has identified differentiated antibody combinations that will be taken into development as COVID-19 antibody therapy candidates.

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COVID-19 Treatments and Vaccines Update

Cell Therapy Manufacturing Amid Pandemic

2020 Bio/Pharma Virtual Congress: November 11, 2020