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Sysmex Forms Strategic Alliance with QIAGEN to Provide Global Cancer Companion Diagnostics that Uses Ultra-sensitive Liquid Biopsy NGS Technology

On July 1, 2021 Sysmex Corporation (HQ: Kobe, Japan, Chairman and CEO: Hisashi Ietsugu) repored that it has formed a global strategic alliance with QIAGEN N.V. (HQ: Hilden, Germany, CEO: Thierry Bernard) for the development of cancer companion diagnostics (Press release, Sysmex Inostics, JUL 1, 2021, View Source [SID1234586872]).1

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Sysmex is working to strengthen its global relationship with pharmaceutical companies in order to develop companion diagnostics and timely launch them by capitalizing on Plasma-Safe-SeqS technology,2 a liquid biopsy developed by Sysmex using a next-generation sequencer (NGS),3 while leveraging QIAGEN’s experience in developing companion diagnostics.

The effective cancer treatment requires companion diagnostics that identifies drug treatment suitable to patients. For the past few years, growing attention has been focused on companion diagnostics based on blood testing (liquid biopsy testing), which reduces the physical burden on the patients.

Sysmex currently offers the "OncoBEAMTM5 RAS CRC Kit" as companion diagnostics for colorectal cancer. It uses highly-sensitive digital PCR technology, and is regulatory approved and covered by national insurance in Japan. In addition to this, the ultra-sensitive liquid biopsy testing utilizing NGS is also being developed and offered via CRO service for pharmaceutical companies and research use only kits.

Following this, Sysmex has entered into a global strategic alliance with QIAGEN, a company with extensive experience in companion diagnostics in the oncology field. This alliance is intended to promote early clinical implementation of ultra-sensitive liquid biopsy companion diagnostics using Plasma-Safe-SeqS technology by expediting field work with pharmaceutical companies that develop molecularly targeted drugs for cancer.

Sysmex will continue to contribute to the improvement of patients’ quality of life (QOL), the standardization of medical care, and the advancement of personalized medicine by developing and disseminating tests with significant clinical value.

References
1. August 2, 2019 news release: "Sysmex Obtains First Manufacturing and Marketing Approval in Japan for Blood-Based RAS Gene Mutation Testing for Colorectal Cancer" View Source
2. March 5, 2020 news release: "Sysmex Presents Academic Report Related to the Clinical Utility of RAS Gene Mutation Testing for Colorectal Cancer Using Liquid Biopsy" View Source
3. August 3, 2020 news release: "Insurance Coverage Received for Liquid Biopsy RAS Gene Mutation Testing for Colorectal Cancer Using High-Sensitivity Digital PCR" View Source

Terminology
1. Companion diagnostics:
Test to predict the efficacy or risk of side effects of specific drugs before prescription.
2. Plasma-Safe-SeqS technology:
By tagging each molecule of a gene fragment to be analyzed, this technology allows differentiation between true genetic mutations and errors (errors generated in the process of preparing and reading NGS samples). One of the vital issues with traditional NGS is the existence of a certain possibility of error in principle, which always brings doubts to the mutation detection results on whether it is a true mutation or a false positive generated from reading errors. Plasma-Safe-SeqS technology is expected to be the solution to this problem.
3. Liquid biopsy:
A type of biopsy based mainly on the blood. It is designed to impose less burden on the patient, while having the performance equivalent to that of a conventional biopsy collected from solid tissue, such as a tumor dissection.
4. Next-generation sequencer (NGS):
An analyzer capable of simultaneously sequencing large quantities of DNA molecules in parallel.
5. OncoBEAM:
The name of Sysmex’s product to detect minute gene mutations circulating in the blood with a high degree of sensitivity using BEAMing technology. BEAMing technology is a gene analysis method combining digital PCR and flow cytometry technologies for highly sensitive analysis of genetic mutations.

QIAGEN forms strategic alliance with Sysmex Corporation for global cancer companion diagnostics development and commercialization using NGS and Plasma-Safe-SeqS technology

On July 1, 2021 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a global strategic alliance with Japan’s Sysmex Corporation (Tokyo Stock Exchange, First Section [Ticker Code: 6869]) for the development and commercialization of cancer companion diagnostics, which will leverage both QIAGEN’s leadership in this field and Sysmex’s Plasma-Safe-SeqS technology for next generation sequencing (NGS) (Press release, Qiagen, JUL 1, 2021, View Source [SID1234586595]).

The alliance aims to foster collaborations with pharmaceutical companies for the development of drug treatments for cancer and promote early clinical adoption of ultra-sensitive liquid biopsy companion diagnostics. QIAGEN and Sysmex have a longstanding partnership, which, for example, provides the ipsogen JAK2 blood-cancer test in Japan. Cancer companion-diagnostics products will be launched by QIAGEN and Sysmex in various regions of the world.

Genetic analysis of tumors makes it possible to identify the genes responsible for the development and spread of a tumor and to target treatment accordingly. But the traditional analysis of solid tumors is constrained by their heterogeneity – varying concentrations of cancer cells, for example – and by sample availability. Liquid biopsy addresses these challenges and, in combination with sensitive NGS, allows the evaluation of patients at different points of their cancer treatment. It enables doctors to spot new anomalies and adjust treatments to make them more precise, and to develop novel targeted therapies.

"Combining QIAGEN’s global reach with Sysmex’s NGS capabilities is an important milestone in advancing the use of NGS technologies in clinical decision-making and is a testament to our shared vision of using this powerful technology to improve outcomes for patients worldwide," said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. "This alliance will add strong NGS capabilities to our regulatory and clinical expertise and commercialization, and help our partners in the pharmaceuticals industry by expanding our strong position and product offering in companion diagnostics. We look forward to this alliance creating significant benefits for our pharma partners – and ultimately for treating patients."

"The alliance with QIAGEN promises Sysmex a great application for Sysmex’s Plasma-Safe-SeqS technology, which can detect gene mutations of cancer in blood with ultra-high sensitivity. We believe that QIAGEN is the best for Sysmex to expand this globally," said Hiroshi Kanda, Member of the Managing Board and Senior Executive Officer, Head of Corporate Business Development at Sysmex.

QIAGEN is a pioneer in precision medicine. It is the global leader in collaborating with pharmaceuticals and biotechnology companies to co-develop companion diagnostics that detect genetic abnormalities and guide clinical decision-making. QIAGEN has an unmatched breadth and depth of technologies – from NGS to polymerase chain reaction (PCR) – for companion-diagnostics development. QIAGEN’s portfolio includes ten PCR-based companion-diagnostics products that are approved by the FDA. They include therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer and NSCL (including the G12C mutation), therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples, and the therascreen BRAF kit for colorectal cancer.

QIAGEN has master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostics for drugs in development – a pipeline of potential products to advance precision medicine and benefit patients. QIAGEN has partnered with Illumina to broaden the use of NGS-based companion and other in-vitro diagnostics (IVD) kits in patient management.

Ensysce Biosciences to Commence Trading on the OTC on July 1, 2021

On July 1, 2021 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (OTC: LACQ, LACQW) reported that, in connection with the closing of its previously announced merger with Leisure Acquisition Corp. ("LACQ"), the combined company, Ensysce Biosciences, Inc., will commence trading its common stock and warrants under the ticker symbols "LACQ" and "LACQW," respectively, on the OTC Market on July 1, 2021 (Press release, Ensysce Biosciences, JUL 1, 2021, View Source [SID1234585503]).

As previously announced, the merger was approved by LACQ’s shareholders on June 28, 2021 and closed on June 30, 2021. The Company will announce further trading information at a later time.

Ensysce Biosciences to Begin Trading its Common Stock on The Nasdaq Capital Market on July 2, 2021

On July 1, 2021 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: ENSCW) reported that the Company will begin trading its common stock under the ticker symbol "ENSC" on The Nasdaq Capital Market and warrants under the ticker symbol "ENSCW" on the OTC Market on July 2, 2021 (Press release, Ensysce Biosciences, JUL 1, 2021, View Source [SID1234585502]).

As previously announced, the Company closed its merger with Leisure Acquisition Corp. ("LACQ") on June 30, 2021, which was approved by LACQ’s shareholders on June 28, 2021.

Hubro Therapeutics raises 61.5 million NOK in funding

On July 1, 2021 Hubro Therapeutics, a clinical stage company advancing a pipeline of proprietary peptide cancer vaccines, reported that successful closing of a private placement that will allow the company to initiate clinical development of its lead product candidate FMPV-1 targeting TGFbR2 neo-antigen present in colorectal-, stomach and endometrial-cancer (Press release, Hubro Therapeutics, JUL 1, 2021, View Source [SID1234584938]).

Hubro Therapeutics announced today that the company has raised 61,5 million NOK (≈6,5 mill.euro) in a heavily oversubscribed financing round backed by existing investors Jandersen Kapital, Investinor, RADFORSK Investeringsstiftelse, Algot Invest and others. The company is grateful for existing shareholders’ continued belief in the company. The company also welcomed new investors, most notably Canica Holding AG who was offered about fifty percent of the newly issued shares.