Silverback Therapeutics Raises $85 Million in Series C Financing; Company Announces Executive Promotions

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.

InSysBio announces its collaboration with Genmab

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.

ITI’s VP to Participate at Precision Medicine’s Webinar on Oncolytic Therapeutic Development

On September 23, 2020 Immunomic Therapeutics, Inc. reported that it will be participating in Precision Medicine’s webinar on utilizing liquid biopsy to promote oncolytic therapeutic development. On Thursday, September 24, Vice President of Clinical Development at Immunomic, Dr. Andrew Eisen, will be discussing methods and tools to utilize liquid biopsy to promote oncology therapeutic development alongside Akoya Biosciences’ CMO, Dr. Gerald Messerschmidt and Sr. Vice President, Dr. Darren Davis (Press release, Immunomic Therapeutics, SEP 23, 2020, View Source [SID1234565516]).

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This webinar will examine:

– Clinical utility of liquid biopsy and specifically of circulating tumor cells (CTC) biomarkers
– Methods to capture and concentrate CTCs to enable effective analysis
– Tools to image CTCs and analyze CTC biomarkers
– Case study exploring CTCs as a tool to understand drug pharmacodynamics in melanoma patients

Webinar details are as follows:

Title: Utilizing Liquid Biopsy to Promote Oncolytic Therapeutic Development

Date and Time: Thursday, September 24, 2020 12:00 PM ET

Register here: View Source

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

Metabolon, Inc. Announces $72 Million in Debt and Equity Financing to Accelerate Advancements in Precision Medicine and Innovative Drug Development Technologies

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.

China’s Viva Biotech snaps up Hong Kong CRO SYNthesis to boost preclinical offering

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."