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Sysmex Expands Strategic Alliance Agreement with QIAGEN in the Field of Genetic Testing

On August 6, 2024 Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) reported that it has expanded its strategic Alliance Agreement with QIAGEN N.V. (HQ: Venlo, The Netherlands; CEO: Thierry Bernard) to deepen their collaboration in genetic testing, including research and development, production, clinical development, and sales-marketing (Press release, Sysmex, AUG 6, 2024, View Source [SID1234645391]).

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Sysmex and QIAGEN have built a successful partnership since the initial collaboration back in 2013 and agreed to expand it to include a strategic alliance for companion diagnostics1 in 2021. As part of the newly expanded collaboration, both companies will further combine their respective products and strengths in genetic testing to deliver high-value products to their global customers.

Sysmex will implement QIAGEN’s assay to be used for clinical trials that QIAGEN provides to pharmaceutical companies and research institutions at Sysmex’s global network laboratories (Sysmex Inostics, Inc. CLIA lab2, Sysmex Research and Development Center and Sysmex affiliated company, RIKEN GENESIS Co., Ltd. (HQ: Shinagawa-ku, Tokyo; President and CEO: Kenji Iwakabe) and support QIAGEN’s global services.

For more than 50 years, Sysmex has enhanced its global presence within the in vitro diagnostics field by evolving its genetic testing portfolio. One of the ways is by bringing personalized medicine to patients and healthcare professionals through product development using liquid biopsy3 technology. Sysmex has built a global sales and services network that utilizes its world-class laboratories in Japan and the United States. Sysmex intends to accelerate the creation of high-value testing and develop diagnostic technologies further.

QIAGEN is a pioneer in precision medicine4 and the leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics. These can detect genetic abnormalities to provide insights that guide clinical decision-making about treatments. From polymerase chain reaction (PCR), multiplex PCR, digital PCR (dPCR)5 to next-generation sequencing (NGS)6, QIAGEN offers an unmatched breadth of technologies, which means it can tailor products to the needs of pharmaceutical companies. The company has master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global pharma companies worldwide.

Daiichi Sankyo and Merck Enter into Global Development and Commercialization Agreement for MK-6070

On August 6, 2024 Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the companies have expanded their existing global co-development and co-commercialization agreement for three investigational DXd antibody drug conjugates to include Merck’s MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager (Press release, Daiichi Sankyo, AUG 6, 2024, https://daiichisankyo.us/press-releases/-/article/daiichi-sankyo-and-merck-enter-into-global-development-and-commercialization-agreement-for-mk-6070 [SID1234645358]). The companies will jointly develop and commercialize MK-6070 worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for MK-6070.

MK-6070 is a T-cell engager targeting DLL3, an inhibitory canonical Notch ligand that is expressed at high levels in small cell lung cancer (SCLC) and neuroendocrine tumors, currently being evaluated in a phase 1/2 clinical trial. The companies are planning to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in certain patients with SCLC, as well as other potential combinations. Merck obtained MK-6070 through its acquisition of Harpoon Therapeutics.

"Expanding our oncology pipeline with a DLL3 T-cell engager further supports Daiichi Sankyo’s strategy to create new standards of care for patients with cancer worldwide," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We look forward to continuing our relationship with Merck with the addition of MK-6070 as it provides potential synergies with our established antibody drug conjugate collaboration, particularly ifinatamab deruxtecan, and demonstrates our shared commitment to advancing new medicines for patients."

"Small cell lung cancer is an aggressive, fast-growing form of lung cancer and new treatment approaches are urgently needed," said Dean Y. Li, MD, PhD, President, Merck Research Laboratories. "We are pleased to build upon our collaboration with Daiichi Sankyo and look forward to evaluating the combination of MK-6070 and ifinatamab deruxtecan as a novel two-pronged approach targeting the underlying biology of small cell lung cancer along with other forms of cancer."

Financial Highlights
Under the terms of the agreement, Merck will receive an upfront cash payment of $170 million and has also satisfied a contingent quid obligation from the original collaboration agreement. The companies will share R&D and commercialization expenses as well as profits worldwide, except for Japan where Merck retains exclusive rights and Daiichi Sankyo receives a royalty based on sales. R&D expenses related to MK-6070 in combination with ifinatamab deruxtecan will be shared in a manner consistent with the original agreement for ifinatamab deruxtecan. Merck will generally record sales for MK-6070 worldwide.

About DLL3
Delta-like ligand 3 (DLL3), a Notch inhibitory ligand, is highly expressed on SCLC and other neuroendocrine tumors such as melanoma, small cell bladder cancer and metastatic castration resistant prostate cancer and is minimally expressed in normal tissues.1 DLL3 is a promising therapeutic target where multiple treatment approaches are being explored.1, 2

About MK-6070
MK-6070 is an investigational DLL3 directed tri-specific T-cell engager currently being evaluated in a phase 1/2 clinical trial as a monotherapy in certain patients with advanced cancers associated with expression of DLL3 and in combination with atezolizumab in certain patients with SCLC. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to MK-6070 for the treatment of SCLC in March 2022.

About the Daiichi Sankyo and Merck Collaboration
Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

Radiopharm receives US$2.0 M payment from Lantheus

On August 5, 2024 Radiopharm Theranostics (ASX:RAD) reported it has secured yet another milestone with a payment of AU$3.0 million (US$2.0 million) from Nasdaq-listed Lantheus Holdings Inc (Nasdaq:LNTH). This payment comes under their recent preclinical assets transfer and development agreement, announced on 20 June 2024.

Under this agreement, Lantheus, a US-based player in the radiopharmaceutical sector, has committed to an initial equity investment of AU$7.5 million (US$4.99 million) in Radiopharm at 5 cents per share, representing a 47% premium over the share price at that time. Additionally, Lantheus has the option to invest a further AU$7.5 million (US$5.0 million) within the next six months under the same terms.

The agreement also includes a separate transfer and development component in which Radiopharm has assigned and sublicensed two of its preclinical assets to Lantheus. These include a TROP2 targeting nanobody and an LRRC15 targeting monoclonal antibody. These assets are valued at AU$3.0 million (US$2.0 million).

Riccardo Canevari, CEO & MD of Radiopharm Theranostics, expressed enthusiasm about the partnership, stating, "I am delighted with the confidence demonstrated by Lantheus in settling the transfer and development agreement and making this payment ahead of the shareholder meeting later this month. We are well advanced in our strategic planning with Lantheus, and the collaboration between our two companies augurs well for the future."

Lantheus’ investment funds will be allocated to general working capital, drug manufacturing, and clinical trials for Radiopharm Theranostics.

In June, Radiopharm announced the completion of an AU$70 million placement, featuring a strategic investment from Lantheus. Additionally, as per its recent update, RAD aims to achieve a secondary listing on NASDAQ by 2024 end.

(Press release, Radiopharm Theranostics, AUG 5, 2024, View Source [SID1234661592])

Genor Biopharma has entered into an exclusive global licensing agreement with TRC 2004, INC.

On August 5, 2024 Genor Biopharma (Stock code: 6998.HK) reported that the company had entered into a licensing agreement and a stock purchase agreement with TRC 2004.Under the License Agreement, Genor Biopharma has agreed, among others, to grant the Licensee an exclusive worldwide license to develop, use, manufacture, commercialize and otherwise exploit GB261 (CD20/CD3, BsAb) , excluding mainland China, Hong Kong, Macau and Taiwan (Press release, , AUG 5, 2024, View Source [SID1234648372]).

According to the agreement, Genor Biopharma shall receive:

a significant equity participation in the Licensee;
a double digit million US dollars upfront payment;
up to 443 million US dollars in milestone payments;
tiered single to double digits royalty payments on net sales.

GB261 is a novel differentiated CD20 / CD3 bi-specific T-Cell Engager with ultra-low affinity to bind CD3 and has Fc-enabled functions (ADCC and CDC). GB261 has previously completed a Phase Ph1/2 multi-center study of B-NHL (DLBCL and FL) in China and Australia, which demonstrated promising efficacy and a favorable safety profile. Meanwhile, GB261 has been shown to significantly reduce cytokine release (CRS) compared with bi-specifics in the same class.

The properties of GB261 make it a very promising B-cell depletion agent and its indication potential extends beyond oncology and is also applicable to various immunological and autoimmune indications where there is a large unmet medical need in patients.

Quarterly Report of BioNTech SE for the three and six months ended June 30, 2024

On August 5, 2024 BioNTech reported the Quarterly Report of BioNTech SE for the three and six months ended June 30, 2024 (Press release, BioNTech, AUG 5, 2024, View Source [SID1234645696]).