Pharmaceutical Technology Editors

Touchlight, a biotechnology company specializing in enzymatic DNA production, entered into a non-exclusive patent license agreement with Pfizer on July 6, 2022. Under the agreement, Pfizer gains rights to Touchlight’s enzymatic doggybone DNA (dbDNA) patent portfolio. Pfizer will have rights to use dbDNA worldwide for the manufacture and commercialization of its messenger RNA (mRNA)-based vaccines, therapeutics, and gene therapies.

Through the agreement, Touchlight will receive an upfront payment as well as clinical and commercial milestone payments and royalties upon commercialization. The financial terms of the deal were not disclosed.

Touchlight’s dbDNA technology has been shown to produce a minimal, linear, double stranded, covalently closed DNA vector via an enzymatic manufacturing process. dbDNA enables the rapid, synthetic manufacture of good manufacturing practice (GMP)-compliant DNA product from a small, simple footprint. Furthermore, it is a scalable GMP manufacturing process.

The technology can manufacture genes >20 kb. It also has the added advantage of being able to accommodate sequences typically unstable as plasmid DNA in 

; these include sequences found in viral vector and mRNA production. Beyond mRNA vaccine production, the technology is suited for the development of DNA vaccines, advanced therapies, and other therapeutics, according to a company press release.

“We are delighted to establish this agreement with Pfizer to license our mRNA manufacturing platform. This agreement is an example of our technology’s potential to enable companies across the genetic medicine sector to simplify and accelerate DNA manufacturing through the clinic and towards commercialization,” said Jonny Ohlson, founder and executive chair, Touchlight, in the press release.

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Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

Pfizer and Touchlight Enter Patent License Agreement for Use of dbDNA

Wacker Biotech, a microbial contract development and manufacturing organization within the Wacker Group, announced on July 5, 2022, that it has begun the development of its biotech site in Halle, Germany, into a messenger RNA (mRNA) competence center. Moving forward, active drug substances based on mRNA, such as mRNA coronavirus vaccines, will be manufactured at this site.

Wacker is investing more than €100 million (US$100.5 million) into this expansion, which will triple production capacity and more than double the number of employees at the Halle site, according to a company press release.

The expansion will include four new production lines for mRNA vaccine production, among other products. Under pandemic preparedness contracts, part of the new capacity at Halle will be made available to the German federal government as and when required. The expansion will also include new storage areas and quality control laboratories. The company intends to hire around 200 new employees as part of the expansion. Production is expected to start in 2024.

“We are happy that our expertise in making mRNA vaccines will contribute to the fight against future pandemics. The expansion of our Halle site will create capacity to prepare for pandemics and beyond,” said Christian Hartel, CEO, Wacker, in the press release.

“With this expansion into a competence center for mRNA actives, W[acker] is bringing a technology of the future to Halle,” said Melanie Käsmarker, managing director of Wacker Biotech in Halle, in the release. “mRNA actives are not only used as vaccines, for example to protect against coronavirus, but the mRNA technology also allows completely new treatment options, such as in cancer therapy. We see a lot of potential here and going forward want to serve the increasing demand for mRNA actives from Halle.”

Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.

Wacker Biotech Expands Germany Site with Construction of New mRNA Competence Center

Coya Therapeutics, a clinical-stage biotechnology company, secured an option agreement in June 2022 for exclusive worldwide rights to a novel technology platform from Carnegie Mellon University. The technology platform enables exosome engineering.

The agreement will grant Coya intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids (EPHs), according to a June 15, 2022 press release. The company will use a tether-based exosome strategy that enables regulatory T-cells (Tregs) exosomes to be homed to proteins of interest while delivering select payloads into the targeted cells.

According to the release, the use of EPHs differs from traditional techniques that modify exosomes via complex molecular biology tools or degradation of exosomes' innate functionality; EPHs overcome these limitations by modifying exosomes with a DNA-cholesterol tether. By leveraging single stranded synthetic DNA with attached cholesterol, this approach binds a complementary strand of DNA to a bioactive agent. Ultimately, this allows a number of different types of cargos to be attached to the exosome surface while also tethering immune modulating cargos inside the exosome.

“This collaboration with Carnegie Mellon University further solidifies Coya’s thought leadership in the global exosome therapeutics field, beyond Treg-derived exosomes alone,” said Howard Berman, CEO, Coya Therapeutics, in the press release. “Nanoengineering exosomes with such manufacturing efficiency to produce EPHs that can be customized to any surface protein, delivering growth factors or drugs, while enhancing cellular uptake and bioactivity is the future of targeted therapies.”

Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.

Coya Therapeutics Secures Rights to Exosome Engineering Technology from Carnegie Mellon University

Bio-Rad Laboratories has launched its EconoFit Low-Pressure Prepacked Chromatography Column Packs. The EconoFit columns are designed for resin screening, allowing customers that are developing protein purification workflows to select the optimal chemistry for different targets.

The columns offer various resins in a prepacked format, including mixed-mode, cation, and anion exchange resin columns, as well as a pack designed for polyhistidine protein purification. According to a June 28, 2022 press release, they are fully compatible with Bio-Rad’s next-generation chromatography systems in addition to other commonly used chromatography systems. The columns are available in 1 mL and 5 mL sizes.

“Similar resins can give different results for different target molecules, and with Bio-Rad’s EconoFit Column Packs our customers can easily perform resin scouting to identify the one [that] yields the best outcome for their chromatography application,” said Ertan Ozyamak, global product manager for lab-scale chromatography products, Bio-Rad, in the press release. “Our columns deliver run-to-run uniformity to support preparative scale purifications and/or method development for new target proteins, as well as to improve existing workflows.”

Bio-Rad’s EconoFit Chromatography Column Packs support resin screening experiments in the development of protein purification workflows.

Bio-Rad Launches New Chromatography Column Packs

VeriSIM Life (VeriSIM), a US-based artificial intelligence (AI)-enabled company that provides drug discovery and drug development services, has entered into a collaboration with Mayo Clinic to improve the preclinical translation of promising drug candidates for development.

Under the agreement, VeriSIM will use its proprietary BIOiSIM platform and Translational Index technology to reduce the number of outsourced preclinical experiments. These platforms are also expected to help de-risk R&D decisions early on to ensure expedited development of novel, safe, and highly efficacious drugs, according to a June 28, 2022 company press release. Mayo Clinic physician researchers will work with VeriSIM in key disease areas, including oncology, hematology, bone/joint-disorders, and neurological diseases.

“This collaboration will explore the full potential of our combined approach to developing best-in-class drug candidates to serve patients’ unmet needs,” said Jo Varshney, founder and CEO of VeriSIM Life, in the press release.

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.

VeriSIM Life and Mayo Clinic Team Up to Co-develop New Therapies

NRG Therapeutics, a UK-based neuroscience company targeting mitochondrial dysfunction, and Domainex, a UK-based integrated medicines research service company, have formed a collaboration to develop novel small-molecule, disease-modifying drugs to treat Parkinson's disease, motor neuron disease (MND), and other debilitating chronic neurodegenerative disorders.

Under the deal, Domainex will provide fully integrated lead optimization services, including assay biology and medicinal and computational chemistry, according to a June 30, 2022 company press release. Over the course of a one-year period, NRG Therapeutics is expected to potentially invest more than £1 million (US$1.2 million) in the project. This program follows a £2.68 million (US$3.2 million) early stage Biomedical Catalyst award granted to NRG Therapeutics by Innovate UK.

NRG Therapeutics’ previous work, funded by Parkinson’s Virtual Biotech, the drug development arm of Parkinson’s UK, has resulted in the identification of a series of small-molecule leads that inhibit the mitochondrial permeability transition pore (mPTP), a transmembrane protein in the mitochondrial inner membrane that is critical for cell signaling and regulated cell death. It has been shown that inhibition of mPTP in brain cells has neuroprotective benefits, as demonstrated in several preclinical models of Parkinson’s and other neurodegenerative diseases, according to the press release.

Domainex’s previous work, which has also been funded by Innovate UK, include a project targeting IκB kinase epsilon/TANK binding kinase 1 for treating inflammatory disease.

In their collaboration, NRG Therapeutics and Domainex will carry out an integrated lead optimization program to optimize the pharmaceutical properties of small-molecule mPTP inhibitors. Their ultimate aim is to nominate a pre-clinical candidate for treating Parkinson’s or MND.

“We hope that this program will result in a new treatment for neurodegenerative diseases, such as Parkinson’s, which will ultimately benefit patients who desperately need new treatment options for these devasting disease,” said Tom Mander, CEO of Domainex, in the press release.

“Mitochondrial dysfunction is a common underlying pathology in many degenerative diseases, and there is a substantial body of preclinical data available, which demonstrates that inhibition of the mPTP in the brain prevents neuronal cell death, reduces neuroinflammation, and extends survival in animals. We look forward to working with Domainex to progress the development of these compounds into potentially life-changing medicines,” said Neil Miller, co-founder and CEO of NRG Therapeutics, in the release.

NRG Therapeutics and Domainex aim to develop novel small-molecule drugs to treat neurodegenerative disorders, such as Parkinson’s disease.