On September 23, 2020 Silverback Therapeutics, Inc. ("Silverback") ("the Company"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue-targeted therapeutics for the treatment of cancer and other serious diseases, reported the close of an $85 million Series C financing round. EcoR1 Capital led the round, with participation from new investors including Boxer Capital of Tavistock Group, Fidelity Management & Research Company LLC, Nantahala Capital Management, and RA Capital (Press release, Silverback Therapeutics, SEP 23, 2020, View Source [SID1234565515]). Existing investors also participating in the financing included OrbiMed Advisors, U.S. Venture Partners, Nextech Invest Ltd., Hunt Technology Ventures, and Pontifax Venture Capital. Silverback intends to use the proceeds to support its clinical development of SBT6050, a TLR8 agonist conjugated to a HER2-directed antibody currently in a Phase 1 clinical study for the treatment of HER2-expressing solid tumors, and to advance its robust pipeline of other ImmunoTAC therapeutics.

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"Silverback has made impressive progress developing a differentiated approach to immuno-oncology," said Scott Platshon, principal, EcoR1 Capital. "Broad activation of innate immune cells has been difficult to achieve due to systemic toxicities. Silverback has persisted in understanding how to deliver TLR8 agonists with a good preclinical safety and tolerability profile, and we are excited to lead an investment round that will help Silverback investigate the translatability of these findings to patients with HER2-expressing solid tumors."

The Company also announced two key executive promotions. Valerie Odegard, Ph.D., has been named president and chief scientific officer, and Naomi Hunder, M.D., has been named chief medical officer. "Drs. Odegard and Hunder bring comprehensive drug development expertise to Silverback, as well as a fierce drive for scientific excellence and improving patient outcomes," said Laura Shawver, Ph.D., chief executive officer of Silverback Therapeutics. "We are at an important growth phase for the company and their ongoing leadership will be critical as we progress SBT6050 through clinical development, as well as advance our robust preclinical pipeline. It is awesome to work with them and the entire Silverback team as we create a new generation of much-needed therapies."

Valerie Odegard, Ph.D., joined Silverback in 2016 and has served as chief scientific officer since 2018. She brings over 15 years of research and drug development experience to the Company. Prior to Silverback, Dr. Odegard served as vice president of research at Juno Therapeutics, where she was responsible for discovery, preclinical development, and translational research efforts to advance novel cancer immunotherapies into clinical development. Previously, she held research leadership positions at Novo Nordisk and Trubion Pharmaceuticals, where she oversaw the discovery and preclinical development of therapeutics for oncology and inflammatory conditions. Dr. Odegard received her Ph.D. in immunobiology from Yale University.

Naomi Hunder, M.D., joined Silverback in 2019, bringing both late-stage and early clinical development experience to the Company. Prior to Silverback, Dr. Hunder was vice president, head of clinical development and medical affairs at Acerta Pharma, responsible for the acalabrutinib clinical program and lifecycle strategy. Before joining Acerta, Dr. Hunder was vice president of clinical development at Seattle Genetics, where she led the brentuximab vedotin clinical program and early phase programs in lymphoma and myeloma. Dr. Hunder previously served as medical director at ZymoGenetics, developing therapeutics for oncology and viral hepatitis. A board-certified medical oncologist, Dr. Hunder received her M.D. from Jefferson Medical College and her internal medicine training at the University of Pennsylvania. She completed her oncology fellowship training at Fred Hutchinson Cancer Research Center/University of Washington.

On September 23, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported the publication of a manuscript in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), highlighting the development of MGC018, the Company’s investigational antibody-drug conjugate (ADC) targeting B7-H3 for the treatment of solid tumors (Press release, MacroGenics, SEP 23, 2020, View Source [SID1234565512]).

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B7-H3 has been identified as a cell surface protein with limited expression on normal tissues but over-expressed on the epithelium and tumor-associated vasculature in solid tumors. Overexpression of this molecule has been shown to be associated with cancer disease severity, risk of recurrence and reduced survival. The Company’s early studies showed that ligation of B7-H3 by select monoclonal antibodies (mAbs) led to mAb internalization and antitumor activity toward B7-H3-expressing tumor cells when conjugated to a toxic payload. Based on these results, MacroGenics selected a lead candidate mAb and developed MGC018, an ADC targeting B7-H3 for the treatment of cancer.

As described in the paper "Preclinical Development of MGC018, a Duocarmycin-based Antibody-drug Conjugate Targeting B7-H3 for Solid Cancer," the authors report on preclinical studies that showed that MGC018 mediated specific in vitro killing across a range of B7-H3-expressing solid tumor cell types. Furthermore, the preclinical studies showed that MGC018 mediated bystander in vitro killing of B7-H3-negative tumor cells in the presence of B7-H3-positive tumor cells.

MGC018 displayed potent antitumor activity in preclinical tumor xenograft models of breast, ovarian and lung cancer, as well as melanoma. Additionally, antitumor activity was observed toward patient-derived tumor xenograft models of breast, prostate and head and neck cancer displaying heterogeneous expression of B7-H3. Importantly, MGC018 exhibited an acceptable pharmacokinetic and safety profile in cynomolgus monkeys following repeat-dose administration.

"With its overexpression on a wide range of solid cancers but limited presence on normal tissues, B7-H3 is an attractive candidate for an ADC-targeting approach," said Deryk Loo, Ph.D., Senior Director of Research at MacroGenics and the lead author of the paper. "The published preclinical antitumor activity data and safety profile provided evidence of a potentially favorable therapeutic index to support the development of MGC018 for the treatment of solid tumors."

Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics, further commented: "Encouraged by the MGC018 interim clinical dose escalation data presented at ASCO (Free ASCO Whitepaper) in May, we have recently initiated recruitment of patients with metastatic castration-resistant prostate, triple negative breast and non-small cell lung cancers in the dose expansion portion of the Phase 1 clinical study. We expect to provide an update on this study next year."

About MGC018

MGC018 is comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. MGC018 is being evaluated in a Phase 1 study (NCT03729596). Preliminary clinical results from the dose escalation portion of this study were presented at the 2020 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Scientific Program. MacroGenics retains full worldwide rights to MGC018.

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 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 Bio-Techne Corporation (NASDAQ:TECH) reported an important publication in BMC Urology, entitled A urine-based Exosomal gene expression test stratifies risk of high-grade prostate Cancer in men with prior negative prostate biopsy undergoing repeat biopsy (available here) (Press release, Bio-Techne, SEP 23, 2020, View Source [SID1234565509]). Principal investigator Dr. James McKiernan, Professor of Urology at Columbia University, and colleagues demonstrated that using the ExoDx Prostate test, or EPI, resulted in good performance ruling out high-grade (Gleason 7 or higher) prostate cancer (HGPCa) in prior negative biopsy patients with the previously validated 15.6 cut point that was developed on an initial biopsy cohort. The EPI test yielded a negative predictive value (NPV) of 92% independent of other clinical features and would have avoided 27% of unnecessary prostate biopsies in men while missing only five patients with HGPCa (2.1%).

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Initial prostate biopsy often fails to identify prostate cancer, resulting in patient anxiety especially when clinical features such as prostate specific antigen (PSA) remain elevated, and leading to the need for repeat biopsies. For example, in the landmark PROMIS trial study, results showed that a 12-core TRUS-biopsy failed to correctly identify high-grade prostate cancer (Gleason 7 and higher) 37% of the time when cancer was present. These concerns drive many men to undergo repeat biopsy. In fact, the Surveillance, Epidemiology, and End Results (SEER) data indicates that ~12% of men with a prior negative biopsy have a repeat biopsy within 1 year and 44% of men younger than 70 years old have a repeat biopsy.

The EPI test was previously validated in patients presenting for an initial biopsy, and previous data demonstrated that EPI would benefit men with a prior negative biopsy. This study confirms that the ExoDx Prostate test performs exceptionally well in a cohort of men with prior negative biopsies.

Prostate cancer (PCa) is a leading cause of cancer death among men in the United States, with more than 3.6 million men living with prostate cancer. It is estimated that 174,650 newly diagnosed cases occurred in 2019. Prostate needle biopsies are typically recommended for men with elevated serum PSA levels and/or a suspicious digital rectal exam (DRE) with added considerations based on family history, age, and race. The anxiety, pain, and potential complications associated with prostate biopsy are well documented. Furthermore, a large percentage of newly diagnosed prostate cancers are indolent, clinically insignificant, and with low metastatic potential. These cancers typically do not require definitive treatment and may be managed most effectively with Active Surveillance (AS). The low specificity of PSA which contributes to the high frequency of newly-diagnosed low-risk PCa suggests that 60–70% of men may be able to avoid biopsy.

Dr. Johan Skog, Chief Scientific Officer for Exosome Diagnostics, stated, "This study builds upon the results of the original validation study evaluating men considering initial biopsy. Here we further demonstrated the clinical benefit for men with a prior negative biopsy to utilize the EPI test. A score below the validated cut-point of 15.6 indicates lower risk for finding high-grade prostate cancer on biopsy, with an NPV of 92% indicating a biopsy can be avoided with a high degree of confidence."

"This study has especially important implications for men who have had a prior negative biopsy but where clinical factors suggest a repeat biopsy may be necessary," commented Chuck Kummeth, President and Chief Executive Officer of Bio-Techne Corporation. "The ExoDx Prostate test use in the prior negative biopsy population can increase confidence in both the patient and the physician to determine if an additional biopsy is warranted or if it can be safely deferred. The ExoDx Prostate Test provides the information necessary for men to make more informed decisions about initial or repeat biopsies."