Pharmaceutical Technology Editors

Thermo Fisher Scientific has introduced Ion Torrent Oncomine immune repertoire assays, a new suite of next-generation sequencing (NGS) assays that are designed to detect potentially malignant clones of T cells and B cells, key players in immune response. The pan-clonality assays use proprietary Ion AmpliSeq technology to target multiple parts of B- and T-cell immune receptors. This is done using a single reaction with ultra-high sensitivity, which increases the probability of detecting malignant clones and decreasing the time to results, Thermo Fisher announced in a July 19, 2021 press release.

Detection of distinct receptor DNA sequences can inform diagnostic, prognostic, and therapy development studies, which can illuminate the progression of lymphoid cancers, including leukemias, lymphomas, and diseases such as multiple myeloma. Using NGS technology, detection sensitivity can be increased—compared to traditional testing methods, such as flow cytometry or quantitative polymerase chain reaction.

One of the challenges of current NGS-based immune repertoire analysis has been the need to run multiple secondary tests because of the high test failure rates of a typical single NGS assay, the company explained in the press release. The new Oncomine pan-clonality assays overcome this challenge by uniquely targeting multiple parts of the receptor to reduce the need for secondary tests and increase the probability of a single assay detecting a potentially malignant clone.

"Genomic testing can make a significant impact on researching and understanding these [blood] cancers—but we need to bring more testing to in-house laboratories where results can be made available quickly to healthcare professionals," said Garret Hampton, president of clinical next-generation sequencing at Thermo Fisher Scientific, in the press release. "The new Oncomine immune repertoire assays unlock the power of NGS to help researchers rapidly obtain a tremendous amount of insight about a lymphoid cancer sample, including its prevalence and an understanding of how it is evolving."

"With the ability to sequence multiple targets in a single reaction, our team can now get much more information from one assay when compared to single-target NGS tests," said John DeCoteau, medical director, University of Saskatchewan, Advanced Diagnostic Research Laboratory, in the press release. "Using the Oncomine BCR Pan-Clonality Assay, we were able to achieve a positive clonality detection rate of 93 percent in a cohort of multiple myeloma samples, without the need for secondary testing. That provides a remarkable improvement for laboratory efficiency and allows us to get results faster."

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Thermo Fisher Scientific has added a new suite of immune repertoire assays that offers high detection rates of malignant clones, allowing researchers to better assess blood cancers.

Thermo Fisher Expands Hematology Oncology NGS Portfolio

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) is assessing data to evaluate whether Kineret (anakinra) can be used as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

Kineret is an immunosuppressant that has been authorized for use in the European Union for a number of inflammatory conditions since March 2002. It is believed that the API, anakinra, in Sobi’s Kineret could help reduce the inflammation and tissue damage associated with COVID-19. Anakinra works by blocking the activity of interleukin 1, which is a chemical messenger involved in immune processes that lead to inflammation.

Data from two ongoing clinical studies that are investigating the safety and efficacy of Kineret in adult patients hospitalized with COVID-19 are being evaluated by the CHMP. The committee’s opinion on whether or not Kineret’s indication can be extended will be forwarded to the European Commission, which will issue the final decision on marketing authorization for the European Union.

The outcome of the evaluation, which is expected to be released by October 2021, will be published by EMA.

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

CHMP to Assess Extended Indication of Kineret for COVID-19

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine—based on preliminary non-clinical and early clinical results. According to a July 20, 2021 press release, the early trial data suggest that Sanofi’s vaccine triggers the production of antibodies that target SARS-CoV-2 and may help protect against the disease.

Rolling reviews are employed by EMA to accelerate assessment of promising drug candidates during public health emergencies. All data on Vidprevtyn will be evaluated by EMA as soon as they become available, so that a decision on whether the vaccine benefits outweigh the risks can be made.

The rolling review process will be performed until sufficient evidence is acquired for a formal marketing authorization application. EMA has specified that further communication will be published once a formal application for marketing authorization has been submitted.

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

EMA Starts Rolling Review of Sanofi’s COVID-19 Vaccine

ERS Genomics and Japan SLC, a biotechnology company that provides animal models to the research community, have signed a non-exclusive license agreement, allowing Japan SLC access to ERS Genomics’ clustered regularly interspaced short palindromic repeats (CRISPR)/Cas9 patent portfolio. According to a July 27, 2021 press release, through this access, Japan SLC will be able to expand its offering.

“We are proud to add Japan SLC to our growing list of partners in Japan applying CRISPR/Cas9 technology to its service offerings,” said Eric Rhodes, CEO of ERS Genomics, in the press release. “Japan SLC’s animal production and supply are of high quality, and we are very pleased that it has chosen to license CRISPR/Cas9 technology through ERS Genomics.”

“Our production and supply of laboratory animals will benefit greatly through the use of the revolutionary CRISPR/Cas9 technology,” added Hirotaka Takagi, president, Japan SLC, in the press release. “We are very excited to sign this licensing agreement with ERS Genomics which will enable us to produce CRISPR-edited mouse and rat models.”

The financial details of the non-exclusive agreement were not disclosed.

ERS Genomics and Japan SLC have signed a non-exclusive license agreement, allowing Japan SLC access to ERS Genomics’ CRISPR/Cas9 patent portfolio.

ERS Genomics Adds Japan SLC to List of Partners

On July 27, 2021, Byondis, a Netherlands-based clinical-stage biopharmaceutical company, and Glycotope, a Germany-based biotechnology company specializing in antibodies that target tumor-specific-carrying carbohydrate structures, have entered into a platform access agreement to discover and develop antibodies that target specific tumor-associated protein/carbohydrate combined glyco-epitopes (GlycoTargets).

Under the agreement, Byondis has gained exclusive rights to evaluate and develop antibodies against selected novel GlycoTargets and has the option to in-license these antibodies for development as antibody-drug conjugates (ADCs). Financial terms were not disclosed.

Glycosylation is strongly altered in cancer cells, which reflects the drastic changes in tumor metabolism. This alteration, in turn, results in new, highly tumor-specific GlycoTargets. Specific antibodies against these GlycoTargets might be highly cancer specific and have the potential to target a broad range of oncology indications, the companies stated in a press release.

Formulating the antibodies into ADCs can improve their cell-killing capability. But while earlier generation ADCs improved targeting and cell-killing, they were unstable in the bloodstream, which led to premature release of the cytotoxic payload that impacted healthy tissue and narrowed the therapeutic window. Byondis’s next generation ADCs are designed to be highly stable in circulation and carry an intricate, inactivated, and potent cytotoxic drug that rapidly self-destructs if prematurely released, thus limiting damage to healthy tissue and improving the therapeutic window, according to a Byondis press release.

“Selective tumor targeting is key to maximiz[ing] the potential of our linker-drug platforms to generate effective ADCs with low systemic toxicity. The antibodies generated by Glycotope are designed to deliver very high tumor selectivity. We are excited to join forces and align our highly complementary technologies to provide effective and safe ADCs for the benefit of cancer patients,” said Byondis Chief Scientific Officer Wim Dokter in the press release.

“This agreement with Byondis highlights the potential of our GlycoTarget discovery and technology platform,” said Henner Kollenberg, managing director of Glycotope, in the press release. “GlycoTargets are a unique class of highly tumor-specific antigens that offer reduced on-target/off-tumor toxicities. We believe that combining antibodies against these GlycoTargets with Byondis’ linker-drug platform has great potential to produce novel treatments for people suffering from diseases for which no adequate medical treatment option has been found so far.”

Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.

Byondis and Glycotope Partner on Discovery and Development of Glyco-Epitope-Targeting Antibodies

Summa Equity has acquired a majority stake in Axion BioSystems, a US life science tools business specializing in microelectrode arrays (MEA) and impedance technology for single-cell analysis. Axion provides an integrated technology platform for cell activity monitoring, typically used by academia or biopharma customers for non-invasive, real-time study of cells. Axion’s technology was of particular interest to Summa with regards to cell and gene therapy (CGT), which could be instrumental in curing various acquired and genetic diseases.

“Summa has been focused on solutions in the CGT market for a long period of time, due to its alignment with our strategy and its significant potential for growth,” said Tommi Unkuri, a partner at Summa Equity, in a press release from July 16, 2021. “Axion BioSystems impressed us with its … scalable technology, which gives both academics and biopharma organizations the ability to go much deeper in their understanding of cell behavior, enabling faster, more accurate and more cost-efficient drug discovery, development and quality control.”

“We have been highly impressed with Summa’s understanding of the life sciences market, and belief in the potential of our technology to accelerate innovation in many areas of pharmaceuticals and healthcare,” said Tom O’Brien, CEO and president, Axion BioSystems in the press release. “We believe that they will bring tremendous value in helping us to increase our commercial capacity, reach, and market awareness to scale up significantly and have an even greater impact in the years to come.”

Summa Equity has acquired a majority stake in science tools business Axion BioSystems with the intent of further entering the CGT market. 