Pharmaceutical Technology Editors

Sartorius Stedim Biotech has announced, in a Feb. 8, 2022 press release, that it has completed the acquisition of the chromatography equipment division of Novasep, further to the obtainment of the relevant regulatory approvals.

Through the acquisition (the transaction of which was already agreed upon at the beginning of 2021), Sartorius will gain chromatography systems that are primarily suited to smaller biomolecules, such as oligonucleotides, peptides, and insulin, as well as innovative systems for the continuous manufacturing of biologics. Additionally, Sartorius and Novasep have been collaborating since 2018 on the development of an optimized membrane-based, low-pressure chromatography system that productively processes larger molecules.

“This achievement strengthens our relationship with the Sartorius team and represents a great opportunity for the chromatography equipment business to fully deliver its potential and accelerate its growth under this new ownership,” said Michel Spagnol, president & CEO of Novasep, in the press release. “Furthermore, this announcement is aligned with Novasep’s current strategy, which is to prioritize its core business on API [contract development and manufacturing organization] services for the pharmaceutical market.”

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Sartorius Stedim Biotech has completed the acquisition of the chromatography equipment division of Novasep.

Sartorius Acquires Novasep’s Chromatography Equipment Division

The European Patent Office has granted another patent to Salipro Biotech, a Swedish biotech company, covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

According to a Feb. 8, 2022 press release, the “Antigen and method for production thereof” patent (No. EP 3 043 814 B1) will strengthen Salipro Biotech’s proprietary platform technologies to enable the discovery and development of next-generation therapeutics against challenging drug targets.

“We’re constantly increasing our collaborations, partnerships and licensing agreements with major pharma companies on a wide range of challenging drug targets,” said Maria Knudsen, business development director at Salipro Biotech AB, in the press release. “Expanding our already strong patent portfolio further will enable us to increase the value of such collaborations for our partners as well as moving towards building our own discovery pipeline.”

“We’re excited about this important milestone that provides additional protection for our core technologies. The market for therapeutic antibodies, vaccines and biologics is ever expanding,” added Jens Frauenfeld, CEO, Salipro Biotech, in the press release. “Securing these patents protects our innovative platform and further strengthens our position by supplementing our foundational and follow-up patents that have already been granted to Salipro Biotech in many countries, including US, [European Union], China, and Japan.”

The European Patent Office has granted another patent to Salipro Biotech,  covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

European Patent Office Grants Further Patent to Salipro Biotech

Independent innovation and technology organization, the Cell and Gene Therapy Catapult (CGT Catapult), has partnered with medical technology company, MICA Biosystems, with the aim of advancing MICA’s regenerative medicine technology to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

MICA has developed a remote-controlled stem cell platform for regenerative medicine that employs nanotechnology. The initial use of the platform is for spinal fusion, but in the future the company wants to apply the technology to the field of regenerative medicine. According to a Feb. 10, 2022 press release, the collaboration between MICA and CGT Catapult is important to aid with the conversations with MHRA, with whom alignment is key to ensure smooth clinical trial transitions.

“This collaboration will provide a boost to ensure MICA is able to begin clinical trials in a timely manner and, most importantly, allow our technology to reach patients sooner,” said Michal Zurawski, CEO at MICA Biosystems, in the press release. “This new chapter in our development was made possible by an injection of investment from the UK Government and Innovate UK, recognising MICA as a real innovator and disruptor in the space of regenerative medicine. With the expertise and experience of the CGT Catapult, we aim to launch our medicines as an accessible treatment option for millions of patients with a number of life-changing diseases and injuries which currently have limited or no treatment options.”

“Our vision for the CGT Catapult is to help develop a thriving industry delivering life changing advanced therapies to the world,” added Matthew Durdy, CEO at Cell and Gene Therapy Catapult, in the press release. “We are looking forward to working with MICA as an innovative company and welcome the support from the Innovate UK EDGE fund that will enable this collaboration to leverage our unique expertise to help bring MICA’s innovative technology solutions to patients.”

CGT Catapult has partnered with MICA Biosystems to advance MICA’s regenerative medicine technology to the UK’s MHRA.

CGT Catapult Partners with MICA Biosystems

Synaffix, a biotechnology company, announced on Feb. 3, 2022 that it has entered into a technology agreement with MacroGenics, a company interested in oncology therapies. Under the terms of the agreement, MacroGenics will pay up to $586 million to use various Synaffix platforms to investigate antibody-drug conjugates (ADCs).

In addition to its own proprietary antibody and bispecific dual-affinity re-targeting antibody platforms, MacroGenics will now also have access to Synaffix’s:

GlycoConnect antibody conjunction technology

Select toxSYN linker-payloads: SYNtecan E, SYNeamicin D, and SYNeamicin G.

“We are delighted to be working with Synaffix to produce next generation ADCs with potentially superior therapeutic properties,” said Ezio Bonvini, chief scientific officer of MacroGenics, in a company press release. “The ability to obtain all essential ADC technologies from Synaffix, and easily and rapidly combine those with our antibody-based molecules, will enable us to expand our existing portfolio of ADC product candidates and further strengthen our position in the growing ADC field.”

“The collaboration with MacroGenics is an important milestone for Synaffix as our ADC technology will be deployed for the generation of both monospecific and bispecific ADCs,” said Peter van de Sande, CEO of Synaffix, in the press release. “We are pleased to further expand the use of our technology with another leading biotech company that has deep product development capabilities and a long-term commitment to delivering novel therapies for the treatment of cancer.”

MacroGenics will use Synaffix’s technology to investigate next-generation ADCs.

Synaffix Inks $586 Million Deal with MacroGenics to Enable Next Generation ADCs

Intellia Therapeutics announced on Feb. 3, 2022 that the clinical-state genome editing company was acquiring Rewrite Therapeutics, a biotechnology company that develops novel DNA writing technologies, including DNA writing via CRISPER/Cas9-guided polymerases. According to Intellia, Rewrite’s precise editing strategies include target corrections, insertions, deletions, and a range of single-nucleotide changes. The company hopes these strategies will provide new ways to edit disease-causing genes.

“Rewrite also has developed an approach that could improve the efficiency of genome editing in non-dividing cell types, a key challenge for some existing editing platforms. Rewrite’s technology could potentially be delivered using Intellia’s lipid nanoparticle (LNP) technology and adeno-associated virus (AAV) vectors,” the company stated in a press release.

Rewrite shareholders will receive $45 million in an upfront payment as part of the transaction, with an additional $155 million in pre-specified research and regulatory approval milestones through stock and cash.

“At Intellia, we have built the industry’s broadest and deepest genome editing platform by staying at the forefront of new techniques, while also extending the capabilities of CRISPR/Cas9 editing to make precisely targeted changes to DNA,” said Intellia President and Chief Executive Officer John Leonard, M.D., in the press release. “We could not be more excited to add Rewrite’s additional capabilities to our growing platform, offering us new possibilities and the potential to target diseases beyond those currently being explored in our pipeline.”

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.

Intellia Therapeutics Acquires Rewrite Therapeutics

Roche announced on Jan. 31, 2022 that FDA approved Vabysmo (faricimab-svoa) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The bispecific antibody targets and inhibits two disease pathways that are linked to vision loss by neutralizing angiopoietin-2 and vascular endothelial growth factor-A.

The FDA approval is based on results from four Phase III studies that showed patients given the drug at intervals up to four months had “non-inferior vision gains versus aflibercept given every two months in the first year.” Patients with either nAMD or DME would receive four monthly treatments and may need additional treatments based on treatment outcomes. “A second approved treatment regimen for DME involves six monthly loading doses, followed by treatment every two months. Some people with nAMD and DME may be treated monthly if needed, although additional efficacy was not demonstrated in most people given Vabysmo every month,” the company stated in a press release.

“Vabysmo provides a new approach to treating vision-threatening retinal conditions through a mechanism of action that targets two pathways simultaneously,” said Levi Garraway, M.D., PhD, Roche’s Chief Medical Officer and Head of Global Product Development, in the press release. “This is our second FDA approval in ophthalmology in recent months, underscoring our commitment to people living with retinal conditions.”

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.