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Homepage 2019-02-19T15:41:09+00:00

Lipocalyx Enters R&D Agreement with BioNTech

Halle, Jan 24th, 2018. Lipocalyx, a leading developer of drug delivery systems for nucleic acids, has entered into a research and development agreement with BioNTech AG exclusive for certain fields. Under the agreement, Lipocalyx will apply its Viromer® technology for the delivery of certain mRNA’s and BioNTech will assume responsibility for the development of the resulting mRNA therapeutics. Both parties will cooperate in the clinical development of Viromer-based mRNA formulations.

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The Viromer® Solution

Viromers are polymers emulating endosomal escape properties of the influenza virus. Specifically, they undergo a hydrophobic shift in the endosome, which leads to a highly efficient escape and delivery of the payload into the cytosol.

How is this achieved? Viromers have a PEI backbone, which binds to the DNA or RNA payload.  But in contrast to standard PEI, Viromers are heavily decorated with alkyl groups which provide a hydrophobic shell.  And these groups act synergistically with long-chain fatty acids, which sense the low pH inside endosomes and eventually trigger the escape mechanism.

In the experiment below, we followed the cellular uptake and endosomal release of an siRNA in HeLa cells.

Viromers Work Across Many Cell Types

What you have just seen for HeLa cells and siRNA works across many cell types – from cancer cell lines through various myocytes, hepytocytes, epithelia, stem cells through to neurons or macrophages. More than 120 cell types including many primary ones were reported to us working with Viromers in vitro. On a different level, we adopted the Viromers to work with all major payloads such as mRNA, pDNA, RNA Replicons, Cas9 RNP or the smaller siRNA or antisense oligos, to name the most important ones.

macrophage

fibroblasts

cardiomyocytes

lung epithelia

hepatic stem cells

C6 glioma

cortical neurons

Viromers Translate IN VIVO

The results obtained in the culture dish can be translated to in vivo conditions. Viromers have been shown to work in all local applications tested so far. We started from muscle or dermal applications and can demonstrate protein expression or subsequent vaccination results. Expression of mRNA was also shown for lung, brain, in the peritoneum and even upon local application within the intestine. Upon systemic injection, Viromers deliver payloads predominantly to spleen followed by the liver.

mRNA vaccination

mRNA in rat brain

mRNA in mouse lung

Viromer® mRNA in vivo HQ

Local Delivery of Therapeutic mRNA

Technology

Viromer® mRNA in vivo HQ is a preformulated nanocarrier for the local delivery of therapeutic mRNA. Our HQ line of products is made for preclinical applications and has a clear development path towards GMP.

Performance

FLuc mRNA expression in mice

FLuc mRNA delivered by Viromer® mRNA in vivo HQ shows a dramatic improvement over Lipocalyx‘s historical benchmark product

Viromer® mRNA in vivo HQ was complexed with FLuc mRNA (TriLink®). 10μg of the Viromer® / mRNA complexes were injected into the M. quadriceps (IM) or into the ventral skin of mice (ID). Image shows luciferase expression after 6 hours.

Mice treated with FLuc mRNA complexed with Viromer® mRNA in vivo HQ consistently showed 2 to 5-fold increase in expression over different time points and via different routes of administration compared to Lipocalyx‘s benchmark mRNA delivery reagent.

Product

Each pack contains:
• 6 vials of Viromer® mRNA in vivo HQ
• sterile buffer for dilution
• each vial formulates 100μg of mRNA in 250μl
• certificate of analysis

Price

Price per pack is € 4.000.

Access and IP

Viromer® mRNA in vivo HQ is protected under patents US 9677078, JP 6395711 and AU 2013329889 and other pending patents.
Customer may obtain Viromer® mRNA in vivo HQ from Lipocalyx after execution of an MTA.

For more information please contact us here.

Downloads

Download Brochure here
Download manual here

Viromer Status

The Viromer platform was independently developed by Lipocalyx. Starting from the concept of exploiting a viral fusion mechanism for delivery of nucleic acids, we synthesized and screened large combinatorial libraries and developed optimal solutions for payloads such as mRNA, pDNA or siRNA. Our expertise in formulation science guided us to developed nanoparticle solutions for modern pharma applications. Viromers are

  • Ready to use, lyophilized materials

  • Widely applicable on many different routes

  • Efficient carries for vaccination, immunooncology, enzyme replacement studies and many more applications

Fully synthetic polymers with active endosome escape

Orthogonal to the standard cationic, PEGylated LNP paradigm

  • EP2125029 Construction and Use of Transfection Enhancer Elements
  • US20150275220 Carboxyalkylated Polyamine Derivatives as Transfection Reagents
  • US20150259678 Hydroxyalkylated Polyamine Derivatives as Transfection Reagents
  • Viromer ® is a registered trademaerk in the EU, Switzerland, United States and Japan

3 libraries comprising 20.000 compounds describe chemical space and SAR

5 Lead Viromers – Lyophilized Product – Pilot Production

Preclinical stage with multiple mRNA or siRNA

Experienced Team. Hands-On Approach

Steffen Panzner

CEO & Founder

Steffen has a name in the industry for being a constant innovator and drug delivery expert. He is the main inventor of the Viromer® and Smarticles® technologies and other delivery solutions for protein depots or small molecule targeting.

As an entrepreneur, Steffen started Lipocalyx in 2011 and developed the company from its initial Viromer research and reagent applications to a renowned application specialist for therapeutic delivery applications for mRNA.

In 2018, Steffen led a re-launch of the Smarticles technology to further expand capabilities for therapeutic mRNA, siRNA, saRNA or miRNA delivery. Smarticles are in phase I clinical trials with MiNA (www.minatx.com).

Steffen holds a Ph.D. in cell biology from the Humboldt University of Berlin and a diploma in biochemistry from the U of Halle. He enjoyed doing research at Harvard, the Bioacademy of Athens and the European Synchrotron Facility in Grenoble.

Christian Reinsch

Head of Development & Co-Founder

Christian has known the drug delivery field for more than 12 years and is co-inventor of several patents for the Smarticles and Viromer Technology. He has responsibility for our formulation development and core lab activities since 2013.

He started his venture in drug delivery in 2005 at novosom AG. Initially working on depot formulations for proteins or peptides he quickly joined the team that developed Smarticles, a novel, amphoteric class of liposomes. he was the first to analyze the stunning PK properties of long-circulating amphoter II liposomes and analyzed their delivery of siRNA and ASO in vivo.

In 2011, Christian was one of the founders of Lipocalyx  (actually its employee number 1) and helped building the company and the Viromer Technology from scratch. Christian’s main expertise is the development of our in-vivo formulations and process development.

Christian participated in a research fellowship at the Bioacademy of Athens and holds a Ph.D. in pharmaceutical biotechnology and a diploma in Molecular Genetics, both from the University of Halle.

Antje Sahm

Head of QA

Antje has been working in the field of quality control of biopharmaceuticals and ATMPs for more than 20 years using methods like HPLC, LC-MS, ELISA, FACS and very recently NMR.

She knows the business of method development as well as the routine of the quality control lab in the GMP world of a clean room manufacturing facility. Start-up companies like Siegfried Biologics GmbH and Cell Medica Ltd. employed her as a Head of QC for several years. Now she is giving input to the development of quality aspects at Lipocalyx to supply Viromer in GMP-equivalent grade.

Antje holds a diploma in Biochemistry from the University of Halle and a Ph. D. in Pharmaceutical Biology from the University of Würzburg.

Lipocalyx Corporate History

Christian and I started Lipocalyx in 2011 as one of the first virtual biotechs in Germany. We had a concept on paper and some initial funding from HTGF and IBG Sachsen-Anhalt, so instead of doing hardware investments we teamed up with Chiroblock out of Wolfen, who also became co-founders and are our chemistry partners.

Together we laid the foundations of the Viromer chemistry, constructed the first library and quickly realized that this could be a success. Betatesters confirmed our findings and we did our first product roll-out in Jan 2013, 18 months after starting the company.

Meanwhile back in Halle we built our sales force and created a network of distributors now spanning the globe. Still, it was the tough times probably any small business goes through when creating and selling an innovation from scratch.

It was in summer 2014, when a German startup trusted us with their formulation development. We were thrilled to be back in the therapeutics game and our partner is now using the recipe in clinical trials. Good luck! We owe you guys.

So why not following up with Viromers in vivo? So we did with mRNA and it worked on the first try.  And on the second again (so it was not an artefact).  And in many other people‘s hands.  We went for improvements, created our library 3 which gave phenomenal leads not only for mRNA, but also for all other major payloads, such as siRNA, pDNA, RNA replicons or Cas9 RNP.

More data are coming in and as we know from prior experience, this is only the beginning.

Lipocalyx is now looking forward to bring its technology to the next level, providing GMP grade materials and licenses to our partners.

Contact us and find out what we can do for you specifically.

News

2401, 2018

Lipocalyx Enters R&D Agreement with BioNTech

Halle, Jan 24th, 2018. Lipocalyx, a leading developer of drug delivery systems for nucleic acids, has entered into a research and development agreement with BioNTech AG exclusive [...]

1702, 2017

Notice of Allowance for Viromer IP in the United States

Today, Lipocalyx reports the issuance of a Notice of Allowance for its application 14/432,361 by the US Patent and Trademark Office and positive examination of a related [...]

412, 2016

Lipocalyx Unveils its Viromer ONE Platform

Lipocalyx, a biotech company based in Halle, Germany, today lifted the shades on its Viromer ONE platform. The novel compound/device combo allows the straightforward transfer of DNA [...]

1210, 2016

Grant of European Patent on Transfection Enhancer Elements

The EPO, Europe’s Patent Agency, today announced the grant of patent EP 2125029 to Lipocalyx GmbH. The invention of “Construction and Use of Transfection Enhancer Elements” introduces [...]

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