Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
Publications
Relevant Book Chapters
Scientific Advisory Roles
Publications
Relevant Book Chapters
Scientific Advisory Roles
Generic

Frank Tufaro

San Diego,CA

Summary

Senior-Level Business Executive with extensive experience in the business and science of biotech, with a proven record of developing and executing corporate business strategies, raising private capital as well as non-dilutive funding and negotiating M&A, licensing and collaboration transactions. Expertise in pre-clinical and early and late- stage clinical development for oncology, including manufacturing, operations and research. Internationally recognized research career in virology, glycosaminoglycans and oncology prior to undertaking management roles in biotechnology companies. Recognized high-performance, results-oriented leadership style in achieving goals and corporate success for a range of biotech companies.

Overview

37
37
years of professional experience

Work History

Chief Operating Officer

Replay Holdings, Inc.
05.2023 - Current
  • Oversee day-to-day operations to keep organization running smoothly while meeting business goals.
  • Aligned organizational objectives with company mission to increase business growth and integrate work strategies.
  • Identified and pursued business development opportunities to grow organization and increase revenue.
  • Identified and mitigated operational risks to minimize potential negative impacts on organization
  • Directed technological improvements, reducing waste and business bottlenecks

Chief Operating Officer

Theriva Biologics, Inc,
03.2022 - 07.2023
  • Public company headquartered in Rockville, MD dedicated to developing novel virus therapies for oncology
  • Monitored and analyzed industry trends to identify opportunities for organizational growth and competitiveness.
  • Represented organization at external meetings and events to promote and build relationships with key stakeholders.
  • Worked for 2 years with VCN (Barcelona, Spain) to raise capital, leading to acquisition by public-company Synthetic Biologics (now Theriva Biologics, NYSE: TOVX)

President

Opa Therapeutics, Inc
05.2020 - 05.2022
  • Subsidiary of Oncolys Biopharma (Tokyo)
  • Managed US interest in oncolytic virus field along with Oncolys USA
  • Generated new scientific collaboration opportunities in US

Chief Executive Officer, Director

DNAtrix, Inc
01.2010 - 11.2019
  • Privately held biopharmaceutical company dedicated to developing novel oncolytic virus therapeutic products that improve clinical outcomes in patients with cancer
  • Principal Business Executive responsible for Clinical Development, Corporate and Financial activities for company, including: Raised over US $70 M in several rounds of financing and non-dilutive funding to advance company to Phase III clinical trial stage for GBM
  • Successfully managed translational research, development, regulatory, clinical, quality, business development, manufacturing and IP
  • Led successful acquisition of VectorLogics, Inc (St Louis, MO) by DNAtrix to obtain control over their significant patented technology, including RGD
  • Successfully in-licensed significant adenovirus technology from MD Anderson, including OX-40L adenovirus technology Successfully negotiated exclusive collaboration agreement with oncolytic vaccine company Valo, Inc
  • As principal investigator, was awarded $11.7 M CPRIT grant to support clinical development for GBM
  • Successfully filed multiple patent applications to support international development of armed oncolytic viruses
  • Executed successful Phase II clinical trial of adenovirus plus pembrolizumab for GBM, with Merck
  • Established foundational processes for business operations.
  • Managed partnerships and strategic business relationships by negotiating contract terms and handling conflicts.
  • Built productive relationships with industry partners and competitors to support strategic business objectives.

Chief Executive Officer, President, Founder, Executive Board Member

Allera Health Products, Inc
01.2005 - 01.2010
  • Manufacturer and distributor of proprietary immune-focused dietary supplement products focused on improving patients' lives and supporting wellness
  • Responsible for development and commercialization of Allera Health product's marketed immune supplement products
  • Developed sales organization to distribute products at retail in US and Canada
  • Raised start-up capital to launch retail products Developed supplement products based on new ingredient in-licensed from Tampa Bay Research Institute Products currently distributed and sold at specialty stores and online throughout US and Canada
  • Managed partnerships and strategic business relationships by negotiating contract terms and handling conflicts.

Chief Executive Officer, Founder, Chair

Nurel Therapeutics
01.2003 - 01.2005
  • Raised start-up capital UPMC
  • Negotiated licensing agreements necessary for clinical development
  • Merged Nurel with virus technology company Avira (Chicago) in all stock transaction
  • Nurel subsequently acquired by Diamyd after I left

Managing Director

Medigene US
01.2001 - 01.2003
  • Raised ~$16 million in start-up capital in two rounds as part of NeuroVir
  • Developed and published novel baculovirus system for generating oncolytic herpes simplex viruses
  • Conducted first clinical trial of oncolytic herpesviruses, NV1020, for colorectal metastases to liver
  • As CEO, negotiated acquisition of NeuroVir by MediGene, a German public company for ~$95 million in stock and cash on date of closing
  • Publicly traded biopharmaceutical company focused on development of a pipeline of products for oncology and cardiology,
  • Responsible for all aspects of developing HSV oncolytic virus products post-merger with NeuroVir
  • Built San Diego subsidiary development team of >50 employees
  • Responsible for all aspects of integration with parent MediGene AG (Martinsreid, Germany)
  • Completed move from Vancouver and finished clinical trial of NV1020 virus for liver metastases

Professor

University of British Columbia
01.1987 - 01.2003
  • Developed successful research program in area of virology, including development of oncolytic viruses and use of herpesviruses to investigate cell surface molecules critical for infection
  • Major discoveries include identification of gene encoding polymerase for heparan sulfate glycosaminoglycans, which when mutated, leads to formation of bone tumors in children
  • Trained 15 postdocs and Ph.D. students during my tenure

CEO, CSO

NeuroVir
01.1997 - 01.2001
  • Privately held biopharmaceutical company focused on development and commercialization of proprietary oncolytic virus products for multiple indications
  • Responsibility as CSO & CEO, inlicensed IP portfolio from Aviron (US)
  • Raised ~$15M in start-up capital
  • Conducted first ever Oncolytics herpesvirus clinical trial for GBM
  • Responsible for developing and leading execution of corporate business plan
  • Functional responsibilities included commercial development, business development, clinical development, corporate communications, and investor relations.
  • Led acquisition by MediGene (Martinsreid, Germany) in 2001

Education

Postdoctoral Fellowship - Virology

Carnegie Institution of Washington
Baltimore
08.1986

Postdoctoral Fellowship - Virology

Fred Hutchinson Cancer Center
Seattle, WA
01.1984

Ph.D. - Cell And Molecular Biology

McGill University
Montreal, PQ, Canada
06.1983

Bachelor of Science - Developmental Biology And Embryology

McGill University
Montreal, PQ, Canada
05.1977

Skills

  • Financial Oversight
  • Executive Leadership
  • Operational Oversight
  • Business Analysis
  • Operations Administration
  • Cost Savings and Reduction
  • Project Oversight
  • Business Development
  • Cross-Functional Collaboration
  • Industry Expertise
  • Leadership and People Development
  • Complex Problem-Solving

Affiliations

Executive Chair of the Board of Directors, Unleash Bio, Inc. 2020-present

Member, Executive Board, Emergex Vaccines (Oxford, UK) 2022- present

Reviewer (ad hoc): Molecular Therapy: Oncolytics (ongoing)

Co-Chair Research and Development Committee: Replay Bio (San Diego) 2021-ongoing


Timeline

Chief Operating Officer

Replay Holdings, Inc.
05.2023 - Current

Chief Operating Officer

Theriva Biologics, Inc,
03.2022 - 07.2023

President

Opa Therapeutics, Inc
05.2020 - 05.2022

Chief Executive Officer, Director

DNAtrix, Inc
01.2010 - 11.2019

Chief Executive Officer, President, Founder, Executive Board Member

Allera Health Products, Inc
01.2005 - 01.2010

Chief Executive Officer, Founder, Chair

Nurel Therapeutics
01.2003 - 01.2005

Managing Director

Medigene US
01.2001 - 01.2003

CEO, CSO

NeuroVir
01.1997 - 01.2001

Professor

University of British Columbia
01.1987 - 01.2003

Postdoctoral Fellowship - Virology

Carnegie Institution of Washington

Postdoctoral Fellowship - Virology

Fred Hutchinson Cancer Center

Ph.D. - Cell And Molecular Biology

McGill University

Bachelor of Science - Developmental Biology And Embryology

McGill University

Publications

Notable Peer-Reviewed Publications (complete list upon request)

Martindale, D., Hackam, A., Wieczorek, A., Ellerby, L., Wellington, C., et al, F. Tufaro , and M.R. Hayden.

(1998). Length of the protein and polyglutamine tract influences localization and frequency of intracellular

aggregates of huntingtin. Nat Genet. 1998 Feb;18(2):150-4.

•

• McCormick, C., Y. Leduc, D. Martindale, L. Esford, A.P. Dyer, K. Mattison, and F. Tufaro . (1998). The

putative tumor suppressor EXT1 alters the synthesis of cell-surface heparan sulfate. Nature Genetics, 1998

Jun;19(2): 158-161.

• Lind, T., F. Tufaro, C. McCormick, U. Lindahl and K. Lidholt. (1998). The putative tumor suppressors EXT1

and EXT2 are glycosyltransferases required for the biosynthesis of heparan sulfate. J. Biol. Chem. 1998 Oct

9;273(41): 26265-8.

• Horsburgh, B., M. Hubinette, D. Qiang, ML MacDonald and F. Tufaro (1999). Allele replacement: an

application that permits rapid manipulation of herpes simplex virus type 1 genomes. Gene Ther. 1999

May;6(5):922-930.

• Horsburgh, B., M. Hubinette, F. Tufaro (1999). Genetic manipulation of herpes simplex virus using bacterial

artificial chromosomes. Methods Enzymol. 1999;306:337-52.

• McCormick, C. G. Duncan, and F. Tufaro . (1999). New perspectives on the molecular basis of hereditary bone

tumours. Mol. Med. Today. 1999 Nov; 5(11):481-6.

• Yeung SN, Bockhold K, Tufaro F . (1999). Efficient infection of mature skeletal muscle with herpes simplex

virus vectors by using dextran sulfate as a co-receptor. Gene Ther. 1999 Sep; 6(9): 1536-44

• McCormick, C., Duncan, G., Goutsos, K.T., and F. Tufaro (2000). The putative tumor suppressors EXT1 and

EXT2 form a stable complex that accumulates in the Golgi apparatus and catalyzes the synthesis of heparan

sulfate. Proc. Natl. Acad. Sci. USA, Jan 18;97(2): 668-73.

• Yeung, S.N., and Tufaro, F. (2000). Viral vectors for gene therapy of the nervous system. Methods in Neural

Tissue Culture. (S. Fedoroff, ed.).

• Yeung, S.N., and Tufaro, F. (2000). Replicating herpes simplex virus vectors for cancer therapy. Expert Opin.

in Pharmacotherapy.

• Markert, JM, Medlock MD, Rabkin SD, Gillespie GY, TodoT, Hunter WD, Palmer CA, Feigenbaum F,

Tornatore C, Tufaro F , Martuza RL (2000). Conditionally replicating herpes simplex virus mutant, G207 for

the treatment of malignant glioma: results of a phase I trial. Gene Ther. 2000 May;7(10):867-74.

• McCormick C, Duncan G, Tufaro F. (2000) Herpes simplex virus: discovering the link between heparan

sulphate and hereditary bone tumours. Rev Med Virol. 2000 Nov;10(6):373-84

• Duncan G, C McCormick, F Tufaro . (2001) The link between heparan sulfate and hereditary bone disease:

finding a function for the EXT family of putative tumor suppressor proteins. J Clin Invest, 2001

Aug;108(4):511-6. Review.

• Tufaro, F (2002). Host-microbe interactions: viruses - Viral strategies for breaching host defenses: tipping the

balance towards survival – Current Opinion in Microbiology 5:393 Frank Tufaro, Ph.D. Page 7 of 7

• Lang, F, C Conrad, C. Gomez-Manzano, W. Yung, R. Sawaya, J Weinberg, S Prabhu, G Rao, G Fuller, K

Aldape, J Gumin L Vence, I. Wistuba J Rodrigues, P Villalobos, C. Dirven, S. Tejada, R Diez Valle, M Alonso,

B Ewald, J Peterkin, F Tufaro , J Fueyo (2018) Phase 1 Study of DNX-2401 (Delta-24-RGD) Oncolytic

Adenovirus: Replication and Immunotherapeutic Effects in Recurrent Malignant Glioma. J. Clinical Oncology

(Feb. 2018)

Zadeh, G, F. Lang, M. Daras…13 authors… F. Tufaro , J. Peterkin 2019. Interim results of a phase II multicenter

study of the conditionally replicative oncolytic adenovirus DNX-2401 with pembrolizumab (Keytruda) for

recurrent glioblastoma; CAPTIVE study (Keynote-192). November 2018. Neuro-Oncology 20(suppl)

R. Aiken…15 authors…. F. Tufaro and J. Peterkin., Interim Results of a Phase II Multicenter Study of Oncolytic

Adenovirus DNX-2401 with Pembrolizumab for Recurrent Glioblastoma; CAPTIVE Study (KEYNOTE-192).

Neuro-Oncology, Volume 21, Issue Supplement_6, November 2019,

Relevant Book Chapters

Horsburgh, B., M. Hubinette, F. Tufaro (1999). Genetic manipulation of herpes simplex virus using bacterial

artificial chromosomes. Methods Enzymol. 1999;306:337-52.

Duncan, G, and Tufaro, F. 2001. EXT Genes. Encyclopedia of Molecular Medicine, 5 Volume Set John Wiley

& Sons, Inc. (Editor) ISBN: 0-471-37494-6

Yeung, S.N., and Tufaro, F. 2000. Viral vectors for gene therapy of the nervous system. Methods in Neural

Tissue Culture. (S. Fedoroff, ed.)

Tufaro, F., and Markert, J. 2006 Therapeutic uses of herpesviruses. Cambridge University Press

Yeung, S.N., and Tufaro, F. 2009. Viral vectors for gene therapy of the nervous system. Methods in Neural

Tissue Culture. (S. Fedoroff, ed.)

Scientific Advisory Roles

Senior Advisor for Tungsten Advisors (New York)

Advisor, SAB member, ADZE Biotechnology

Advisor, Theriva Biologics (Maryland)

Advisor, Oncolys Biopharma (Tokyo, Japan)

Publications

Notable Peer-Reviewed Full Papers (complete list upon request)


Martindale, D., Hackam, A., Wieczorek, A., Ellerby, L., Wellington, C., et al, F. Tufaro and M.R. Hayden. (1998). Length of the protein and polyglutamine tract influences localization and frequency of intracellular aggregates of huntingtin. Nat Genet. 1998 Feb;18(2):150-4


• McCormick, C., Y. Leduc, D. Martindale, L. Esford, A.P. Dyer, K. Mattison, and F. Tufaro . (1998). The putative tumor suppressor EXT1 alters the synthesis of cell-surface heparan sulfate. Nature Genetics, 1998 Jun;19(2): 158-161


• Lind, T., F. Tufaro, C. McCormick, U. Lindahl and K. Lidholt. (1998). The putative tumor suppressors EXT1 and EXT2 are glycosyltransferases required for the biosynthesis of heparan sulfate. J. Biol. Chem. 1998 Oct 9;273(41): 26265-8


• Horsburgh, B., M. Hubinette, D. Qiang, ML MacDonald and F. Tufaro (1999). Allele replacement: an application that permits rapid manipulation of herpes simplex virus type 1 genomes. Gene Ther. 1999 May;6(5):922-930


• Horsburgh, B., M. Hubinette, F. Tufaro (1999). Genetic manipulation of herpes simplex virus using bacterial artificial chromosomes. Methods Enzymol. 1999;306:337-52


• McCormick, C. G. Duncan, and F. Tufaro . (1999). New perspectives on the molecular basis of hereditary bone tumours. Mol. Med. Today. 1999 Nov; 5(11):481-6


• Yeung SN, Bockhold K, Tufaro F . (1999). Efficient infection of mature skeletal muscle with herpes simplex virus vectors by using dextran sulfate as a co-receptor. Gene Ther. 1999 Sep; 6(9): 1536-44


• McCormick, C., Duncan, G., Goutsos, K.T., and F. Tufaro (2000). The putative tumor suppressors EXT1 and EXT2 form a stable complex that accumulates in the Golgi apparatus and catalyzes the synthesis of heparan sulfate. Proc. Natl. Acad. Sci. USA, Jan 18;97(2): 668-73


• Yeung, S.N., and Tufaro, F. (2000). Viral vectors for gene therapy of the nervous system. Methods in Neural Tissue Culture. (S. Fedoroff, ed.)


• Yeung, S.N., and Tufaro, F. (2000). Replicating herpes simplex virus vectors for cancer therapy. Expert Opin. in Pharmacotherapy


• Markert, JM, Medlock MD, Rabkin SD, Gillespie GY, TodoT, Hunter WD, Palmer CA, Feigenbaum F, Tornatore C, Tufaro F , Martuza RL (2000). Conditionally replicating herpes simplex virus mutant, G207 for the treatment of malignant glioma: results of a phase I trial. Gene Ther. 2000 May;7(10):867-74


• McCormick C, Duncan G, Tufaro F. (2000) Herpes simplex virus: discovering the link between heparan sulphate and hereditary bone tumours. Rev Med Virol. 2000 Nov;10(6):373-84


• Duncan G, C McCormick, F Tufaro . (2001) The link between heparan sulfate and hereditary bone disease: finding a function for the EXT family of putative tumor suppressor proteins. J Clin Invest, 2001 Aug;108(4):511-6. Review


• Tufaro, F (2002). Host-microbe interactions: viruses - Viral strategies for breaching host defenses: tipping the balance towards survival – Current Opinion in Microbiology 5:393


• Lang, F, C Conrad, C. Gomez-Manzano, W. Yung, R. Sawaya, J Weinberg, S Prabhu, G Rao, G Fuller, K Aldape, J Gumin L Vence, I. Wistuba J Rodrigues, P Villalobos, C. Dirven, S. Tejada, R Diez Valle, M Alonso, B Ewald, J Peterkin, F Tufaro , J Fueyo (2018) Phase 1 Study of DNX-2401 (Delta-24-RGD) Oncolytic Adenovirus: Replication and Immunotherapeutic Effects in Recurrent Malignant Glioma. J. Clinical Oncology (Feb. 2018)


Zadeh, G, F. Lang, M. Daras…13 authors… F. Tufaro , J. Peterkin 2019. Interim results of a phase II multicenter study of the conditionally replicative oncolytic adenovirus DNX-2401 with pembrolizumab (Keytruda) for recurrent glioblastoma; CAPTIVE study (Keynote-192). November 2018. Neuro-Oncology 20(suppl)


R. Aiken…15 authors…. F. Tufaro and J. Peterkin., Interim Results of a Phase II Multicenter Study of Oncolytic Adenovirus DNX-2401 with Pembrolizumab for Recurrent Glioblastoma; CAPTIVE Study (KEYNOTE-192). Neuro-Oncology, Volume 21, Issue Supplement_6, November 2019,

Relevant Book Chapters

Horsburgh, B., M. Hubinette, F. Tufaro (1999). Genetic manipulation of herpes simplex virus using bacterial

artificial chromosomes. Methods Enzymol. 1999;306:337-52.

Duncan, G, and Tufaro, F. 2001. EXT Genes. Encyclopedia of Molecular Medicine, 5 Volume Set John Wiley

& Sons, Inc. (Editor) ISBN: 0-471-37494-6

Yeung, S.N., and Tufaro, F. 2000. Viral vectors for gene therapy of the nervous system. Methods in Neural

Tissue Culture. (S. Fedoroff, ed.)

Tufaro, F., and Markert, J. 2006 Therapeutic uses of herpesviruses. Cambridge University Press

Yeung, S.N., and Tufaro, F. 2009. Viral vectors for gene therapy of the nervous system. Methods in Neural

Tissue Culture. (S. Fedoroff, ed.)

Scientific Advisory Roles

Senior Advisor for Tungsten Advisors (New York)

Advisor, SAB member, ADZE Biotechnology

Advisor, Theriva Biologics (Maryland)

Advisor, Oncolys Biopharma (Tokyo, Japan)

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