Sysmex Forms Strategic Alliance with QIAGEN for Providing Global Cancer Companion Diagnostics that Uses Ultra-sensitive Liquid Biopsy NGS Technology(PDF?205KB)

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, Sysmex, JUL 1, 2021, View Source [SID1234584531]).

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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.

Completion of share buy-back program

On July 1, 2021 Genmab A/S (Nasdaq: GMAB) reported that its share buy-back program has been completed on June 30, 2021.

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On February 23, 2021 Genmab announced the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program.

The share buy-back program was expected to be completed no later than June 30, 2021 and comprised up to 200,000 shares.

The following transactions were executed under the program from June 28, 2021, to June 30, 2021:

Details of each transaction are included as an appendix to this announcement.

Genmab’s accumulated share buy-back from 24 February 2021 to 30 June, 2021 amounts to 200,000 shares at a total cost of DKK 446.23 million. The announced share buy-back program has thus been completed.

Following these transactions, Genmab holds 299,206 shares as treasury shares, corresponding to 0.46% of the total share capital and voting rights.

The share buy-back program was undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

The Bi-specific CD47XHER2 fusion protein, IMM2902 approved for clinical trial by National Medical Products Administration (NMPA)

On June 30, 2021, Shanghai, China. ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") reported that the first-in-Class drug candidate, Bi-specific recombinant fusion protein targeting human CD47and HER2 named IMM2902 received clinical trial approval from the National Medical Products Administration (NMPA) (Press release, ImmuneOnco Biopharma, JUN 30, 2021, View Source [SID1234655624]). This is the third new drug product based on CD47 of ImmuneOnco entered the clinical stage of development, and it is the cutting-edge product targeting CD47 and Her2 for immunotherapy of solid tumors, another major milestone for the company.

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"We are pleased to learn that our clinical trial application for IMM2902 has been approved by the NMPA. IMM2902 is a bi-specific molecule for binding CD47 and HER2, developed based on our MAB-TRAP technology platform. The high affinity activity of HER2 enables the molecule to bind preferentially to tumor cells. at the same time, it retains the advantage feature of avoiding binding to human red blood cells, the "Antigenic sink", which greatly strengthens the tumor-specific synergistic effect of double targets. "We believe that IMM2902 has promising clinical value." Dr. Tian Wenzhi, founder of the company, is confident in IMM2902 clinical development.

Incurix secures license of ‘STAT3 inhibitor anti-cancer drug’ from NCC and KRICT

On June 30, 2021 Incurix reported that the company in-licensed the STAT3 inhibitor anti-cancer substance from the National Cancer Center (NCC) and the Korea Research Institute of Chemical Technology (KRICT) (Press release, Korea Research Institute of Chemical Technology, JUN 30, 2021, View Source;idx=71&page=1&code=news [SID1234643572]). The agreement is the second after last year’s in-licensing of the c-myc inhibitor. Company officials explained that securing another pipeline of new transcription factor inhibitor is meaningful, following the c-myc inhibitor ‘ICX-101,’ currently in pre-clinical studies. As a transcription factor that controls cell development, survival and immune function, STAT3 is known to be over-expressed in several cancers, causing tumor formation and metastasis. The direct inhibitor of STAT3 is yet to be developed.

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"Through Incurix’s differentiated new drug development know-hows and system, we will succeed in developing an additional transcription factor targeting anti-cancer drug that we in-licensed," Incurix CEO Kyung-chae Jeong said. Meanwhile, Incurix was founded by NCC Senior Director Dr. Kyung-Chae Jeong. The newly licensed compound is a new target anti-cancer substance that Dr. Jeong co-developed with Hwan-jung Lim, Head of New Drug Pipeline Research at KRICT, and Senior Researcher Sung-joon Park.

Bioasis Technologies Inc. and Oxyrane UK Ltd. enter into a Research Collaboration

On June 30, 2021 Bioasis Technologies Inc. and Oxyrane UK are repored to announce the initiation of a research collaboration (Press release, Oxyrane, JUN 30, 2021, View Source [SID1234625993]).

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Bioasis is a pre-clinical, research-stage biopharmaceutical company developing a proprietary xB3 TM platform technology for the delivery of therapeutics across the blood-brain barrier (BBB) and the treatment of CNS disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases.

Oxyrane is developing enhanced enzyme replacement therapies (ERT) for lysosomal storage diseases (LSDs) using a proprietary, glyco-engineered yeast expression system for efficient targeting of enzymes to the lysosome. The research collaboration will focus on combining xB3 TM technology and Oxyrane’s OxyCAT platform to deliver an undisclosed enhanced enzyme replacement therapy into the brain.

Dr. Deborah Rathjen, Bioasis’ Executive Chair said, "We are excited to be collaborating with Oxyrane on this initiative to evaluate the combination of both our technologies to meet an unmet need for patients with LSDs for enzyme replacement therapies with greater efficacy. Bioasis’ technology has demonstrated preclinical success in delivering enzyme replacement therapy into the brain and the aim of this collaboration is to fast track the development of a next generation approach to enzyme replacement therapy with the potential for improved peripheral activity combined with brain penetrance to address neurological symptoms".

"We have been impressed by Bioasis’ technology for BBB delivery of enzyme replacement therapy and our technologies are very complementary so this collaboration is a natural fit. Oxyrane’s technology produces ERTs with enhanced cellular uptake and superior pharmacodynamics in a cost-efficient manner which we believe will be an overall benefit to patients", commented Dr. Wouter Vervecken the CEO of Oxyrane.

On behalf of the Board of Directors of Bioasis Technologies Inc.
Deborah Rathjen