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More Improved Protein Sequence Coverage and Resolution in HDX-MS, June 2023

By developing an innovative dual enzyme based digestion technology at low pH, we have further improved our protein HDX-MS platforms, which resulted in higher spatial resotion and even more complete sequence coverage reaching 100%. This will benefit many of our services including paratope mapping, epitope mapping by HDX-MS, protein conformational analyses and antibody structural characterization.

New Binding Data on Omicron, February 2022

The Omicron variant has caused complete loss of or dramatically reduced activity of several therapeutic antibodies developed against the original COVID-19. This is not surprising because the binding sites (epitope) of these mAbs are all located in the mutated region of Omicron. In contrast to these mAbs, we just found that NOVOAB-20’s binding activity remains the same (a little stronger), thanks to its highly conserved epitope (red). None of the fifteen RBD mutations of Omicron (blue) are in the epitope of this antibody. This highlights the crucial importance of detailed epitope evaluation when selecting drug candidates for antibody therapeutics development, especially for those targets that are constantly mutating.

Positive News on COVID-19 P.1 Variant, July 2021

Our latest calculation data suggests that the more concerned P.1 (Gamma) variant has no significant impact on the binding affinity of neutralizing antibody B-3-8 previously isolated from a convalescent COVID-19 patient. This mAb has a large binding epitope that overlaps with ACE2 binding. Based on this finding, it is expected that some of the antibodies generated by our body after vaccination may still work for the P.1 vatiant, in a similar action mode as that of B-3-8.

Big Success of HDX-MS on Fighting COVID-19, June 2021

With the help of epitope mapping by HDX-MS, one of the key technologies of NovoAb, a neutralizing antibody cocktail was successfully developed by Regeneron to fight SARS-Cov-2. Its phase 3 trial meets primary outcome, improving survival in hospitalized COVID-19 patients lacking an immune response to SARS-Cov-2. This cocktail contains two monoclonal antibodies (casirivimab and imdevimab) which bind to two distinct epitopes on the RBD of the spike protein, and both epitopes overlap with the ACE2 binding site.

Restoration of a SARS-Cov therapeutic antibody for SARS-Cov-2, September 2020

To help fight the ongoing COVID-19 pandemic, we successfully restored a cross-reactive SARS-Cov antibody for SARS-Cov-2 by using our FineMapping and EGAD technologies. Compared to the precursor antibody CR3022, NOVOAB-20 binds to SARS-Cov-2 RBD with a 16-fold higher affinity. Because this mAb targets a highly conserved epitope and the mutations on SARS-Cov-2 known so far are all not in this region, it also has the potential to block new SARS-Cov-2 mutants. As a fully humanized antibody, NOVOAB-20 is a promising candidate to be developed as potential therapeutics for SARS-Cov-2 either as monotherapy or in combination with other neutralizing antibodies targeting different epitopes (e.g. the ACE2 binding site). This is a mAb drug candidate that could synergize with ACE2 targeting antibodies and potentially lower the treatment dosage by >10-fold! To use or collaborate on this antibody, feel free to contact us.

Read the full article at https://chemrxiv.org (Title: Fast Restoration of a Broad-Spectrum SARS-Cov Therapeutic Antibody for SARS-Cov-2)

High-throughput drug screening for COVID-19 (2019-nCoV), February 2020

To support the discovery of drugs for COVID-19 (2019-nCoV, SARS-Cov-2) coronavirus treatment, NovoAb has just launched a MS-based high-throughput drug screening platform which can screen tens to hundreds of small molecule compounds at a time, to identify potential inhibitors of the M protease, an enzyme critical for viral infection.

Fast COVID-19 antibody screening for bnAb development, February 2020

Developing broadly neutralizing antibodies (bnAb) against viruses is possible but only those who can bind to a broadly neutralizing epitope on the target antigen can do so. To quickly screen numerous antibody candidates against a broadly neutralizing epitope, NovoAb has now developed the “TASTE” technology platform, which significantly reduces the turnaround time of the epitope mapping service. It is applicable to antigens such as Hemagglutinin of influenza, E protein of Zika, and Spike protein of coronavirus such as SARS-Cov-2 (COVID-19).

New 'AAAA' service promise for the new decade, January 2020

At the beginning of the brand new decade 2020s, we are proud to launch our new "AAAA" service platform (Accurate data with Affordable price using the most Advanced technologies by Accomplished scientists) for our old and new customers.

New paper published by our customer on PNAS, December 2019

A new article entitled "Approaching infinite affinity through engineering of peptide–protein interaction" was just published on Proc Natl Acad Sci USA by University of Oxford (UK). We are happy to assist in providing the high resolution HDX-MS data using our proprietary top/middle-down platform (FineMapping). Congratulations the Howarth team!

The article can be accessed here.

Technology improvement for disulfide mapping, November 2019

The experimental workflow and data analysis software are further improved for more accurate and complete mapping of disulfide bridges in proteins and antibodies. Well done Protein Characterization team!

New technology breakthrough at NovoAb, July 2019

A novel HDX-MS platform is successfully developed for characterizing the structure and dynamics of membrane proteins, including but not limited to GPCR and transporters.

New advancement in paratope mapping, Feb 2019

At NovoAb we are continuously exploring new startegies to further improve the workflow of our services and lower the cost for our customers. This month we succeeded in developing a new specific digestion based middle-down HDX-MS workflow for paratope mapping which significantly simplified the experimental process as well as the data analysis. The direct benefit of this advancement is that now we can offer a 30% lower rate for paratope mapping service compared to the traditional nonspecific digestion workflow. Contact us for more details.

Technology breakthrough at NovoAb, Dec 2018

New advancements were made on NovoAb’s epitope mapping technology. By combining subzero technology with 2D LC-MS separation, it can now accurately determine antibody binding sites for unpurified antigens. It successfully maps conformational epitopes in complex protein mixtures, with single amino acid resolution. It directly uses unpurified antigen and the whole antibody, therefore antigen purification and pre-digestion of the antibody to Fab fragments are no longer needed. This new technology is also amenable to epitope mapping for other difficult targets and bispecific antibodies.

US FDA published “Data Requirements for Biosimilars”, May 2018

FDA-approved biosimilars require data from multiple studies and analytical tools to demonstrate analytical similarity to reference products. Dr. Steve Kozlowski, M.D., Director at FDA’s Center for Drug Evaluation and Research, Specifically emphasized the role of modern high-resolution mass spectrometry in characterizing the analytical similarity of biosimilars. “Biosimilar development talks about three types of data. It talks about analytical data, it talks about animal data, and it talks about one or more clinical studies. Those are generally needed although there is ability to waive one of those… More importantly, the type of data in each of those categories may differ. For instance, if the manufacturer has a really powerful analytical comparison, that information is viewed at in the context of the whole assessment, and that may change what’s expected in some of the other categories of data. So concept of totality of evidence, it’s not there is a fixed amount in each bucket that’s needed, but it’s that overall information about whether this molecule is a truly biosimilar to the reference product. The analytical similarity is the foundation.”

“…That analytical piece really sets the stage for biosimilarity. There is a requirement to be analytically highly similar, and that’s necessary for approvalism of a biosimilar, but there may be ways of doing that that provides greater confidence, and that may affect how much information you need in the other buckets.” Watch full video here.

Technology advancements at NovoAb, Apr 2018

A proprietary NovoAb HDX-MS workflow was successfully developed taking advantage of limited proteolysis at cold acidic conditions with enhanced specificity. It provides higher-order structure (HOS) comparability data for antibody biosimilars with 100% sequence coverage and amino acid level resolution. In other words, it can provide complete structural information that covers the whole antibody, without any missed regions or residues. This unique feature offers unparalleled confidence in assessing the structural similarity between antibody biosimilars and the reference drug.

Skipping clinical trials for biosimilar development, Apr 2018

Skipping the phase 3 clinical trials would greatly speed up biosimilar drug development and result in significant savings for the biosimilar manufacturer and consequently the patients. On Europe’s 16th annual biosimilars conference in London, Niklas Ekman, vice-chair of EMA’s biosimilars working party, noted: “When we discuss the possibility of waiving clinical trials – there’s added pressure on the analytical side … and transparent pre-planning for statistical approaches needs to be better.”

Schiestl further explained to Focus that there must be enough scientific data to make this conclusion that Phase 3 trials can be skipped, and only in certain circumstances – “meaning the quality comparison is good enough to allow skipping a Phase 3 trial, also that there’s a sensitive enough PK model … it must be grounded in scientific data.”

Read full article at https://www.raps.org/news-and-articles/news-articles/2018/4/biosimilars-experts-discuss-possible-interchangea

Comparison of various epitope mapping methods published on PNAS, Feb 2013

A systematic comparison of various epitope mapping methods including peptide scanning, phage display, HDX-MS, and X-ray crystallography, was conducted using the same antigen-antibody complex, and the results were published on the top journal PNAS. HDX-MS epitope mapping was concluded to be the most effective method to rapidly supply near-complete information about epitope structure. The full article can be found at PNAS's website (http://www.pnas.org/content/110/9/

3304). NovoAb has made further improvements to the traditional HDX-MS technology and now single amino acid resolution can be obtained. More technology details can be found here.