Scott received a B.S. in Biology from Loyola University Maryland and subsequently obtained his M.S. in Neurobiology and Physiology from Northwestern University. He then spent 13 years at Exicure, Inc. developing novel spherical nucleic acid agents as therapeutics. He has translational, toxicology, CMC, regulatory, and clinical expertise and experience with antisense and immunomodulatory oligonucleotides including TNF, SCN9A, and IL-17RA inhibitors, FXN modulators, and TLR9 agonists. He has therapeutic area experience in CNS (neuromuscular and pain), rare diseases, immuno-oncology, and dermatology. Scott is experienced utilizing external resources and critical thinking to solve complex scientific and operational challenges and understands how to direct multidisciplinary teams consisting of 30+ CROs/CMOs, fellow consultants, and KOLs to execute relentlessly against tight timelines. 

He is experienced in operationalizing cross-functional strategies, directing translational medicine, scientific, manufacturing, regulatory, and clinical development activities to generate high-impact results and drive drugs from benchtop to bedside. He has a proven record of utilizing scientific, clinical development, and program management skills to support strategic planning and operationalize drug discovery and early development plans.

Scott specializes in establishing and managing programs, with a focus on oligonucleotides, for creation of regulatory strategy and submissions, proof-of-concept (POC) nonclinical studies, nonclinical toxicology, biomarker development, bioanalytical assay development and validation, anti-drug antibody assay development, current Good Manufacturing Practice (cGMP) manufacturing of drug substances and products, analytical development, stability programs, product formulation, process validation, and clinical strategy/operations. He has experience establishing and executing clinical trials in the US, UK, and EU and applying for and receiving Fast Track and Orphan Drug designations. Scott’s considerable experience in program and portfolio management enables him to provide clients with a more effective and cost-saving means to progress drug programs while simultaneously maximizing the potential for success.

Areas of Expertise

Multidisciplinary/Cross-Functional Team Leadership  •  Program Management, Strategy, Operations, Risk Management, & Execution  •  Immunology, Oncology, Neurology, & Dermatology Translational Research  •  CMC  •  Nucleic Acids  •  Nanoparticles  •  Liposomal Formulations  •  Clinical Development  •  First-in-Human/Phase 1 Clinical Trial Oversight & Communications  •  US/EU Regulatory Strategy & Operations  •  CMO, CRO, & KOL Management  •  GxP Compliance

Publications

Milhem, M.M., Wise-Draper, T.M., Chandra, S., Hanna, G.J., Laux, D.E., Medina, T.M., Ansstas, G., Daud, A., Kelly, C.M., O’Day, S.J., Perez, C.A., Wong, M.K., Friedlander, P.A., Kristedja, T.S., Burgess, M.A., Cowey, C.L., Hanks, B.A., Weight, R.M., Daniel, W.L., Feltner, D.E., Mix, S., Sindelar, L., Bexon, A.S., Bexon, M., Michel, R.E., and Bhatia, S. A Phase 1b/2 Study Evaluating Safety, Efficacy and Immune Activation of TLR9 Agonist, Cavrotolimod (AST-008), in Combination with Anti-PD-1 Antibodies Among Patients with Advanced Solid Tumors. Clinical Cancer Research (2023): Submitted/Under Review.

Mix, S., Schroff, M., and Daniel, W.L. Cavrotolimod, a Nanoparticle Toll-like Receptor 9 Agonist, Inhibits Tumor Growth and Alters Immune Cell Composition in Mouse Models of Skin Cancer. ACS Applied Nano Materials. 6 (2023): 2682 – 2696. doi: 10.1021/acsanm.2c05121.

Daniel W.L., Lorch, U., Mix. S., and Bexon A.S. A first-in-human phase 1 study of cavrotolimod, a TLR9 agonist spherical nucleic acid, in healthy participants: Evidence of immune activation. Frontiers in Immunology. (2022): doi: 10.3389/fimmu.2022.1073777.

Brogan, R.S., Macgibeny, M., Mix, S., Thompson, C., Puttabyatappa, M., VandeVoort C., and Charles L. Chaffin. Dynamics of intra-follicular glucose during luteinization of macaque ovarian follicles. Molecular and Cellular Endocrinology. 332 (2011): 189 – 195.

Mix, S. Estrogen mediates its protective role against high-fat diet induced obesity through interleukin-6 signaling. Northwestern University. Master of Science Degree Thesis. May, 2010.

Brogan, R.S., Mix, S., Puttabayatappa, M. VandeVoort, C.A. and C.L. Chaffin. Expression of the insulin-like growth factor and insulin systems in the luteinizing macaque ovarian follicle. Fertility and Sterility. 93 (2010): 1421-1429.

Mix, S., Macgibeny, M., VandeVoort C., Chaffin C.L., and Rebecca S. Brogan. The role of glucose and metabolites during luteinization of Macaque granulosa cells. Biology of Reproduction. 81 (2009): 580.

Brogan, R.S., Mix, S., Puttabayatappa, M. VandeVoort, C.A. and C.L. Chaffin. Role of IGFBP in granulosa cell proliferation. Human Fertility and Sterility. Feb. 2009 

Posters & Presentations

Mix, S., Soret, A., Lewis, A., Nielander, A., Ratterman, T.C., Daniel, W.L., Schroff, M. A Scalable Method for Endotoxin Reduction of Cholesteryl Ester-Modified Oligonucleotides. TIDES Europe. October 2022.

Moore, L., Corbett, G., Mix, S., Schook, A., Nallagatla, S., Daniel, W.L., Kelly, L., Anderson, B. Biodistribution of Spherical Nucleic Acids in the Nonhuman Primate Central Nervous System. American Neurological Association. October 2020.

Corbett, G., Moore, L., Mix, S., Schook, A., Nallagatla, S., Daniel, W.L., Kelly, L., Anderson, B. Spherical Nucleic Acids (SNAs) for the Treatment of Neurologic Diseases. Abstract 1832. American Academy of Neurology. April 2020.

Kandimalla, E.R., Daniel, W.L., Mix, S., Nallagatla, S., Kentala, D., Zasadny, K., Schook, A., Cedrone, L., Marks, P. Spherical Nucleic Acids Show Increased Distribution and Longer Persistence than Linear Oligonucleotides in Rat Brain Following Intrathecal Administration. Abstract P1.6-032. American Academy of Neurology. April 2019.

Daniel, W.L., Lorch, U., Coates, S., Bexon, A.S., Mix, S. AST-008, a TLR9 agonist spherical nucleic acid, activated NK cells, T cells and cytokines in healthy subjects in a Phase I clinical trial. Abstract CT044. AACR. Atlanta, GA. March 2019.

Mix, S., Kang, R., Iyer, S., Kandimalla, E.R. Targeting Dermal Disorders with Antisense-Spherical Nucleic Acids. 12th Annual Oligonucleotide Therapeutics Society meeting. Montreal, Canada. September, 2016.

Kang, R., Mix, S., Goel, A., Agarwal, R., Olyva, I., Iyer, S., Anderson, B., Nallagatla, S., Kandimalla, E.R. Spherical Nucleic Acids: Characterization and application for antisense targeting. 18th Annual TIDES meeting. Long Beach, CA. May, 2016.

Mix, S., Park, C., Levine, J.E. Estrogen mediates its protective role against high-fat diet induced obesity through interleukin-6 and IL-6R. Society for the Study of Reproduction. Milwaukee, WI, July 30-August 3, 2010.

Mix, S., Macgibeny, M., VandeVoort C., Chaffin, CL. and R.S. Brogan. The role of glucose and metabolites during luteinization of macaque granulosa cells. Society for the Study of Reproduction, Pittsburg PA, July18-22 2009.

Rivers, D., Ciarlo, T, Spelman, M., Tilmman, C., Mix, S., and R. S. Brogan. Changes in development and protein expression in two species of flies [Sarcophaga bullata (Diptera:Sarcophagidae) and Protophormia terraenovae (Diptera: Calliphoridae)] reared in different sized maggot masses. 7th Annual NAFE meeting. July 16-17, 2009.

Mix, S., VandeVoort, C., Chaffin, C., Brogan, R. IGFBP Expression in Follicular Fluid during Luteinization of Rhesus Macaque Granulosa Cells. 19th annual Research Symposium, St. Joseph’s University, Philadelphia, PA. 2008. 

Patents

EP3452598A4 Liposomal Spheric Nucleic Acid (SNA) Constructs with Antisense Oligonucleotides (ASO) for the Specific Knockdown of Interleukin-17 Receptor mRNA

CA3023451A1 Liposomal spherical nucleic acid (sna) constructs presenting antisense oligonucleotides (aso) for specific knockdown of interleukin 17 receptor mrna

KR20190003986A 인터류킨 17 수용체 mRNA의 특이적 녹다운을 위한 안티센스 올리고뉴클레오티드 (ASO)를 제시하는 리포좀 성 구형 핵산 (SNA) 구축물

AU2017261360A1 Liposomal Spherical Nucleic Acid (SNA) constructs presenting Antisense Oligonucleotides (ASO) for specific knockdown of interleukin 17 receptor MRNA

WO2017193087A1 Liposomal spherical nucleic acid (sna) constructs presenting antisense oligonucleotides(aso) for specific knockdown of interleukin 17 receptor mrna

JP2019522462A インターロイキン１７受容体ｍＲＮＡの特異的ノックダウンのためのアンチセンスオリゴヌクレオチド（ＡＳ Ｏ）を提示するリポソーム系球状核酸（ＳＮＡ）構築物

EP3452598A4 Liposomal spherical nucleic acid (sna) constructs presenting antisense oligonucleotides (aso) for specific knockdown of interleukin 17 receptor mrna

US20200308579A1 Liposomal spherical nucleic acid (sna) constructs presenting antisense oligonucleotides (aso) for specific knockdown of interleukin 17 receptor mrna

CN109415731A 呈递用于特异性敲低白介素17受体mRNA的反义寡核苷酸(ASO)的脂质体球形核酸(SNA)构建体

WO2016115320A1 Nucleic acid nanostructures with core motifs

CA2973702A1 Nucleic acid nanostructures with core motifs

CN108064295A Nucleic acid nano structure with core motif

EP3247796A4 Nucleic acid nanostructures with core motifs

JP2018503377A Nucleic acid nanostructures with core motifs

US10704043B2 Nucleic acid nanostructures with core motifs

KR20170104550A Nucleic acid nanostructure with core motif

AU2016206658A1 Nucleic acid nanostructures with core motifs

US20200339989A1 Nucleic acid nanostructures with core motifs