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.

On July 1, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported the availability of therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for treatment with LUMAKRAS (sotorasib), a new treatment option developed by Amgen (Press release, LabCorp, JUL 1, 2021, View Source [SID1234584545]).

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Labcorp’s oncology platform brings together the company’s leadership in diagnostic testing with its comprehensive drug development services, helping to pioneer scientific breakthroughs like the KRAS companion diagnostic to identify patients eligible for cutting-edge targeted therapies.

"Every day, cancer patients across the country anxiously await test results that directly impact treatment decisions. Through our collaboration with QIAGEN and participation in their Day-One Lab Readiness Program, Labcorp is committed to ensuring critical biomarker testing for KRAS is immediately accessible to physicians to ensure every patient who may benefit from sotorasib is appropriately identified and treated," said Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp, and a triple-board certified hematology and oncology physician. "Labcorp is proud to be one of the first labs to make the therascreen KRAS test available, in addition to the many other diagnostic tests in our testing portfolio, including companion diagnostics that have been made available soon after FDA approval for breast, lung, colorectal, bladder and other cancers."

The therapy and this indicated use of the test as a companion diagnostic received approval from the U.S. Food and Drug Administration (FDA) in late May 2021. The therascreen KRAS PCR Mutation Analysis is now available for ordering from Labcorp to determine if patients carry a specific mutation in the KRAS gene.

QIAGEN (NYSE: QGEN, Frankfurt Stock Exchange: QIA) developed the assay, and Labcorp applied its scientific validation process to be able to offer the assay through its CAP accredited, CLIA-certified specialty labs. Using the lung biopsy specimen, the assay identifies whether a patient with NSCLC has a specific mutation in the KRAS gene and is eligible for treatment with LUMAKRAS (sotorasib) which was developed by Amgen (NASDAQ: AMGN). This is the first FDA-approved biomarker-driven, targeted therapy for the treatment of adults with NSCLC whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. KRAS mutations have been found to enable cells in certain cancers to grow and spread more easily.

According to the American Cancer Society, in 2020, 10-12% of the 228,000 people diagnosed with lung cancer carry the G12C KRAS mutation. Lung cancer is still one of the most common cancers worldwide. Approximately 84% of lung cancers are NSCLC.

"We have a longstanding relationship with Labcorp and are delighted to collaborate with them again to bring this new companion diagnostic indication to NSCLC patients," said Jonathan Arnold, vice president, Oncology and Partnering for Precision Diagnostics at QIAGEN. "The expanded indication on our QIAGEN therascreen KRAS test will provide clinically relevant information to aid physicians in identifying patients eligible for a new class of treatment in NSCLC."

During the last 25 years, Labcorp has played a significant role in launching hallmark testing options for the treatment of cancer. The company remains committed to further developing companion diagnostics and precision medicines. This new offering adds to its growing portfolio of tests that specialize in more personalized care, leading to more specific treatment choices. In addition to single marker tests, Labcorp offers full panels of testing powered by advanced next generation-sequencing (NGS) technology for complete profiling of a patient’s unique tumor, including mutations in KRAS.

For more information about Labcorp’s full menu of companion and complementary diagnostic tests, visit oncology.labcorp.com.

LUMAKRAS is a trademark of Amgen, Inc.

therascreen is a registered trademark of QIAGEN.

On July 1, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that Ms. Malene Brondberg has been appointed interim Chief Executive Officer with immediate effect (Press release, Nordic Nanovector, JUL 1, 2021, View Source [SID1234584561]).

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Ms. Brondberg, who is currently the Company’s Chief Financial Officer, replaces Peter Braun who has decided to leave his position with Nordic Nanovector for personal reasons. Ms. Brondberg will continue in her role as CFO. The Board has initiated a search for a new CEO.

Ms. Brondberg joined Nordic Nanovector as Vice President Investor Relations in February 2018 and was appointed CFO in May 2020. She brings over 20 years’ operational experience in the financial services sector from a career that included being Global Head of Research, managing a team of over 65 people, and a member of the Executive Committee of the Nordic investment bank ABG Sundal Collier. Ms. Brondberg has also worked as a management consultant within the financial sector, acting as an advisor in relation to investor relations and funding. In addition, she has held interim CEO, COO and Head of Compliance/HR/Finance management positions at several companies.

Jan H. Egberts, MD, Chairman of Nordic Nanovector, commented: "The Board is pleased to appoint Malene Brondberg as Nordic Nanovector’s interim CEO. As CFO, Malene has proved to be a highly competent leader and has played a key role in the overall management of the business, including raising the funding needed to progress the on-going PARADIGME study with Betalutin. On behalf of the Board, I would like to wish Peter well in his future endeavours."

On July 1, 2021 Shuwen Biotech reported that a partnership between the two companies for commercializing in China Uromonitor, a proprietary molecular test for detecting bladder cancer and monitoring bladder cancer recurrence through a non-invasive method (Press release, Shuwen Biotech, JUL 1, 2021, View Source [SID1234584752]).

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Under the terms of the agreement, Shuwen will distribute Uromonitor and offer testing services with Uromonitor in its CAP-accredited clinical labs in China.

Uromonitor is a CE-certified novel urine-based test for non-muscle invasive bladder cancer. It can be used for detecting the tumor in patients under recurrence surveillance or suspected of bladder cancer (e.g. hematuria), ancillary to cystoscopy and urine cytology. It has been validated in multicenter studies and exhibits high sensitivity and specificity.

"We are pleased to take on Uromonitor in China to offer bladder cancer patients and their physicians an innovative and accurate test for early diagnosis and early detection of cancer recurrence," commented Jay Z. Zhang, Chairman and CEO of Shuwen Biotech. "Uromonitor also adds to our growing portfolio of cancer testing products. And this partnership is another step towards our goal of benefiting patients with a full menu of the most innovative diagnostic tests for disease prevention, diagnosis and personalized treatment."

André Caldeira, VP of Stella Maris Medical Alerts, commented: "We are pleased to partner with Shuwen, a leading innovative diagnostic company in China. The collaboration with Shuwen provides us access to the Chinese market allowing Uromonitor to benefit Chinese patients. We hope that in the near future we will be able to drastically reduce cystoscopies in China."

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.