On September 23, 2020 LabCorp (NYSE:LH), a leading global life sciences company that is focused on advancing health and guiding patient care decisions, reported that it has launched a new, non-invasive test for patients with non-small cell lung cancer (NSCLC) (Press release, LabCorp, SEP 23, 2020, View Source [SID1234565510]). Resolution ctDx Lung is a fast and accurate liquid biopsy test that was developed and will be run by Resolution Bioscience. The test is performed on a standard blood sample and detects actionable mutations in genes associated with NSCLC, providing valuable information to help select the most effective targeted treatments for individual patients. The test is covered by Medicare.

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"Oncology is an area of intense focus for LabCorp, across our entire organization," said Dr. Brian Caveney, president of LabCorp Diagnostics. "The Resolution ctDx Lung test is the latest example of our commitment to provide patients and clinicians with cutting-edge testing and personalized information to make the best possible treatment decisions. This innovative test is an outstanding addition to our industry leading offerings for oncology patients."

"This commercial partnership with LabCorp is an important step in our quest to enable broad access to our lung cancer test and improve clinical outcomes for more people battling NSCLC," said Mark Li, CEO of Resolution Bioscience. "The Resolution ctDx Lung test consistently detects more driver and resistance mutations than competing platforms. We are excited to be joining forces with LabCorp to provide more physicians with the actionable information needed to guide NSCLC therapy selection and patient care."

To order the test, please contact LabCorp Oncology at 1-800-710-1800 or visit the LabCorp Oncology website for more information.

The Resolution ctDx Lung test relies on the Resolution Bioscience patented cell-free DNA (cfDNA) analysis platform, which includes proprietary targeted capture next-generation sequencing (NGS) biochemistry and tightly coupled, cloud-based bioinformatics. Studies have demonstrated that the test offers greater sensitivity than other currently available liquid biopsy tests for NSCLC. The test has been cited in several important scientific publications and presentations and is now being used to select the appropriate plasma-directed therapy in an ongoing study of more than 1,000 patients with stage II, III, or IV NSCLC. Thus far, the study has resulted in a positive clinical response of greater than 95%, indicating that the test has significant utility in the choice of appropriate therapy. For more information about the test, please visit View Source

On September 23, 2020 InSysBio, one of the world’s pioneers of Quantitative Systems Pharmacology (QSP) modeling, reported its collaboration with Genmab, an international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer (Press release, InSysBio, SEP 23, 2020, View Source [SID1234565536]).

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Genmab, in partnership with BioNTech, has begun clinical development of an investigational therapy, GEN1042 (DuoBody-CD40x4-1BB), for solid tumors. GEN1042 is a first-in-class bispecific agonistic antibody targeting CD40 and 4-1BB for priming and activation of a tumor-specific immune response. The key aim of InSysBio in this collaboration is to develop a quantitative system pharmacology (QSP) model that allows exploration of the relationships between dose, schedule, and tumor response in patients treated with this novel agent. These advantages of QSP modeling are enabled by the fact that such models are virtual representations of the disease based on experimental data and biological knowledge.

InSysBio’s great expertise in QSP modeling in oncology and immuno-oncology settings, allows to increase the efficiency of new drug development. Moreover, to perform such projects more efficiently InSysBio has developed internal tools and software facilitating the process of model development, several of which will be applied during this project. The Immune Response Template (IRT) is a tool for development of QSP models/platforms of different diseases associated with the immune response in humans. Application of the IRT allows simplification of the model development process by using pre-defined sub-models as building blocks. Another InSysBio tool, the CYTOCON DB, will assist in the estimation of remaining unknown factors and translation of in vitro data to in vivo situations.

Oleg Demin, CEO of InSysBio, highlights: "The project with Genmab represents ideal case for application of QSP modeling approach. The choice of the technique is supported by complexity of biological system, needs in mechanistic understanding of the data available and importance of the project deliverables for the drug development program. Genmab and BioNTech are jointly developing GEN1042 using the DuoBody technology, which is a revolutionary new approach in the oncology treatment. We are proud to be part of this process."

It should be outlined that the project absolutely coincides with InSysBio mission which is to take part in drug development thus bringing hope to patients.

On September 23, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that its marketing partner, SymBio Pharmaceuticals Limited ("SymBio"), has received regulatory approval for TREAKISYM ready-to-dilute ("RTD") (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan (Press release, Eagle Pharmaceuticals, SEP 23, 2020, View Source [SID1234565511]). The approval covers all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia). Approval for the additional indication of r/r DLBCL is currently under review by the PMDA, which will create another large market opportunity beyond the current indications. As a result of the approval of TREAKISYM, Eagle will receive a $5 million milestone payment.

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With this approval, SymBio will convert its current lyophilized formulation of TREAKISYM to the new RTD liquid formulation upon launch in January 2021.

In addition, SymBio is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation and will seek approval in the second half of 2022. Upon approval of the RI formulation, SymBio intends to convert from the RTD product to the new 50 ml liquid version licensed from Eagle. The RTD and RI liquid formulations bring key benefits to patients and healthcare providers in Japan by eliminating the need for manual reconstitution and significantly reducing preparation time.

"We are pleased that SymBio has received regulatory approval for TREAKISYM in Japan. SymBio is an innovator, and we look forward to their successful commercialization of the ready-to-dilute bendamustine product, enabling patients in Japan to benefit from TREAKISYM’s key advantages. This approval represents another significant extension of the durability of this important franchise and the successful execution of our business development activities to bring value for Eagle and our shareholders," stated Scott Tarriff, Chief Executive Officer.

According to SymBio, sales in Japan for its current TREAKISYM product totaled $84.8 million in the twelve months ended June 30, 2020. Together, milestones and royalty payments for the RTD and RI formulations could generate from $10 million to $25 million annually for Eagle.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of TREAKISYM in Japan utilizing Eagle’s proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

The $5 million milestone payment due upon approval of TREAKISYM RTD is in addition to a $12.5 million upfront milestone payment Eagle received upon execution of the agreement with SymBio. Eagle is entitled to royalties on future net sales and an additional milestone payment upon achievement of a cumulative sales threshold.

On September 23, 2020 Metabolon, Inc., the global leader in metabolomics solutions advancing drug development and precision medicine, reported the close on $72 million in combined debt and equity financing (Press release, Metabolon, SEP 23, 2020, View Source [SID1234565537]). This round of financing included Perceptive Advisors as a new participant. EW Healthcare Partners and other existing investors also participated in the financing.

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"We are thrilled by this strong show of support from Perceptive Advisors and our current investors," said Rohan (Ro) Hastie, President and CEO, Metabolon. "I am also extremely excited that some of the company’s earliest investors participated in this round of investment as well. The incremental funding will help accelerate our growth and expand our client base, in addition to helping further our R&D programs in machine learning to enable novel biomarker discovery and expand our precision medicine platform."

Metabolomics, the large-scale study of all small molecules in a biological system, is the only ‘omics technology that provides a current-state functional readout of a biological system. By leveraging the world’s largest proprietary metabolite database, Metabolon can decipher thousands of discrete chemical signals from genetic and non-genetic factors to reveal biological pathways. Metabolon’s technology makes connections where other ‘omics cannot and provides the definitive representation of the phenotype.

The company today also announced the appointment of Robert A. Cascella, Chief Business Leader, Precision Diagnostics, and Executive Vice President of Phillips, as one of three independent members of the Metabolon Board of Directors.

"Rob’s 30-year career in the healthcare industry comprises an impressive track record of value creation and delivering integrated solutions," said Hastie, "We are honored to have his expertise on the board to help lead Metabolon to our next stage of growth."

Cascella joins Todd Schermerhorn, retired senior vice president and chief financial officer of C. R. Bard, Inc, and Jan Lundberg, formerly President of Lilly Labs and head of R&D, as independent board members.

On September 23, 2020 Viva Biotech reported that it is putting down $80 million to buy preclinical contract research organization SYNthesis and boost its outsourcing business (Press release, Vivia Biotech, SEP 23, 2020, View Source [SID1234565573]).

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Hong Kong-based SYNthesis is a preclinical small-molecule drug discovery service contract organization selling pharmaceutical chemistry and synthetic chemistry services to its clients.

Headquartered in Hong Kong, it also has service platforms in Suzhou in Shanghai and Australia as well as offices in the U.K. and the U.S.; a part of its plan is to broaden its geographic reach.

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It will now fall under the umbrella of Shanghai-based Viva Biotech, an integrated drug discovery platform focused on preclinical-stage innovative drug development, covering the full spectrum of our customers’ needs for early-stage drug discovery.

"We are very delighted to achieve the strategic acquisition agreement with SYNthesis. We believe that SYNthesis’s technical platform and international team in the field of pharmaceutical chemistry and synthetic chemistry will quickly strengthen the capabilities of Viva Biotech from early drug discovery service to drug R & D downstream business, as well as boost The Company’s downstream integration to CMC and CDMO fields," said Cheney Mao, Ph.D., chairman and CEO of Viva.

"I am thrilled and delighted to have my team at SYNthesis join forces with the Viva team," added Xian Bu, Ph.D., managing director of SYNthesis. "Our preclinical small molecule pharmaceutical chemistry platform will be organically combined with the structure-based drug discovery and bioassay platforms of Viva Biotech, to provide a comprehensive preclinical R&D services for more customers. Together we will become a force to be reckoned with in the high-end medicinal chemistry space."