Timothy Lewis Wyant
Bellingham,MA
Summary
Dynamic leader with extensive immunology expertise and a proven track record in driving successful IND submissions and clinical strategies. Skilled in cross-functional leadership and translational strategy, with a focus on developing innovative biotherapeutics. Strong ability to foster team collaboration, resulting in impactful advancements in translational medicine.
Overview
30
30
years of professional experience
Work History
Cofounder and SVP Early Development
Aulos Biosciences
12.2020 - Current
- Oversee the preclinical to clinical translational research strategy for AU-007 in oncology
- Completed toxicology program to support phase 1 clinical
- Completed manufacturing of phase 1 clinical material
Chief Development Officer
Biolojic Design
Boston, MA
08.2019 - 12.2025
- Directed preclinical to clinical translational research strategy for BD antibody platform in oncology and autoimmune diseases.
- Managed toxicology assessments for Biolojic Design assets to ensure compliance and safety.
- Oversaw CMC and quality operations for Biolojic Design assets, maintaining regulatory standards.
Vice President Immunology
Abpro Inc.
09.2018 - 08.2019
- Oversee the IND filing for ABP-100 bispecific antibody T cell engager including the design and implementation of the clinical translational research plan
- Overseeing any GLP activities
- Writing of reports for support of IND
- Writing Module 2 summaries and Module 4 compilation
- Selection of new targets for antibody bispecific platform
- Oversee and manage group for the preclinical research plans for all bispecific antibodies
- From antibody generation, engineering and preclinical evaluations
Senior Director Cancer Immunology
Curis Inc.
12.2015 - 08.2018
- Oversee the non-clinical and translational research for immune-oncology programs
- Oversee non-clinical research sections for IND filings; working with consultants review and assess toxicology and DMPK package for IND filings including starting dose determination
- Devising and executing on clinical biomarker pharmacodynamics and patient selection strategies
- Responsible for assessing new targets and compounds and the overall immuno-oncology pipeline at Curis
- Oversee immunology discovery
Director of Translational Medicine
Takeda Pharmaceuticals
03.2002 - 12.2015
- Translational medicine lead for Vedolizumab (ENTYVIO) - Anti-α4β7 antagonist (toxicology studies, Phase 1 through filing, Phase 4 programs)
- Devised non-clinical research to differentiate from competitors
- Developed and managed PK/PD and immunogenicity for use in GLP Tox studies
- Developed and ran phase 1-phase 3 clinical translational program for Entyvio (vedolizumab)
- Authored sections for the BLA (MAA,NDS and other global applications) (particularly 2.7.1 and 2.7.2 and Mod5)
- Authored sections of the Label
- Participated in the FDA advisory board committee for Entyvio
- ADCETRIS (Anti-CD30 ADC) (2010-2015)
- EMEA filing and filings through 2014
- Authoring of sections for the MAA and other global applications (particularly 2.7.1 and 2.7.2 and Mod5)
- Authoring of sections of the Label
- Design and execution of post marketing trial PD and immunogenicity
- Formerly Millennium Pharmaceuticals
Part time faculty
Northeastern University
10.2003 - 10.2005
- Developed and taught an online class entitled 'New Vaccine Technologies and the Impact of Bioterrorism'
Immunology Scientist
Surromed, Inc.
Palo Alto, CA
09.1998 - 02.2002
- Development of immune assays for translational research platform
Postdoctoral fellow
University of Maryland at Baltimore
09.1995 - 09.1998
- Evaluating the cellular immune responses to S.Typhi vaccines in Dr. Marcelo Sztein’s immunology laboratories
- Center for Vaccine Development
Education
Doctor of Philosophy - immunology with a minor in microbial pathogenesis
University of Arizona
Bachelor of Science - General Biology, major emphasis- genetics and recombinant DNA
Arizona State University
Skills
- Immunology expertise
- Cross-functional leadership
- Results orientation
- Data analysis
- Team collaboration
- Strategic planning
- Clinical research
- Translational medicine leadership
- Pharmacodynamics and pharmacokinetics
- Immunogenicity assessment
- Regulatory authoring
- Clinical protocol development
- IND submission oversight
- CRO management
- Biomarker development
- Toxicology oversight
- Biotherapeutics manufacturing
Affiliations
- Member of the American Association of Immunologist
- Member of ASCO
- Member of SITC
- Past Member and chair of AAPS Biomarkers in Translational Medicine Focus Group 2011-2013
- Co-Chair of the AAPS Action Program Committee for the Ligand binding Focus groups 2010-2017
Patents
- US11851485B2 Inbar Amit et al, Engineered anti-IL2 antibodies
- WO/219 087292 A1, US-20200289477-A1 Conjoint therapies for Immunomodulation. 2019 Sasikumar; Pottayil Govindan N. et al.
- TW-201735949-A Title: Methods Of Treating Gastrointestinal Immune-Related Adverse Events In Anti-Ctla4 Anti-Pd-1 Combination Treatments Brake, Kelly, Wyant, Rosario(2017)
- US 2017/0360926 A1 Predicting outcome of treatment with an anti alpha 4-Beta 7 integrin antibody. Rosario, Wyant, Abhyankar
- Method for monitoring resting and activated platelets in unfixed blood samples. Wyant Timothy L, Raju P, Kantor AB. US20050214877 A1, US 7387880 B2
Personal Information
Title: Ph.D.
Awards
- 2015 Takeda Oncology Innovativeness Award
- Takeda (Millennium) Outstanding team contributor for 2007, 2010, 2011 and 2 in 2012
- Takeda global award 2011
- Millennium 'Star Awards' (greater than 10)
Select Publications (8 of 42)
Preclinical Imaging in Oncology: Considerations and Recommendations for the Imaging Scientist, Daniel Bradley, Tim Wyant, Pharmaco-Imaging in Drug and Biologics Development Fundamentals and Applications, Moyer, Cheruvu, Hu, 2013, Springer and AAPS press, 187-213
Translating Molecular Biomarkers into Clinical Assays – Techniques and Applications, Peter J. O’Brien, Tim Wyant, Virginia Litwin, 2016, Springer publications
Development of vedolizumab as a therapeutic biologic., Maria Rosario, Nathanael L. Dirks, Diane R. Mould, Catherine Scholz, Timothy Wyant, Asit Parikh, Irving Fox, 2018
Negative Feedback Expansion of Tregs Caused by Endogenous IL-2 Limits the Activity of IL-2-based Therapies, Inbar Amit, et al J Cancer Immunol, 2023, 5, 1, 29-39,
Comparison of the ELISA and ECL assay for vedolizumab anti-drug antibodies: assessing the impact of pharmacokinetics and safety outcomes of the phase 3 GEMINI trials., Wyant, Yang, Rosario, AAPS J, 2020-11-16, 23, 1, 3
Sergio Rutella, et al The Society for the Immunotherapy of Cancer biomarkers resource document: Clinical biomarkers and data sharing, Volume I-Clinical Concepts, Sergio Rutella, et al, JITC, 2020-10-30, 8, 12
Sergio Rutella, et al The Society for the Immunotherapy of Cancer biomarkers resource document:Clinical biomarkers and data sharing, Volume II-Practical challenges. JITC Dec 15 2020;8:e001472
Fecal Calprotectin Responses Following Induction Therapy With Vedolizumab in Moderate to Severe Ulcerative Colitis: A Post Hoc Analysis of GEMINI 1., Reinisch W, Bressler B et al Inflamm Bowel Dis, 2019, 14, 4, 803-810
Brian G. Feagan, et al “Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis” NEJM Aug 2013, 369(8):699-710
Keywords
- Immunologist
- Translational medicine and research strategy lead
- Pharmacodynamic/pharmacokinetic assay leader
- Immunogenicity assay leader
- FDA and EMEA module author
- Clinical protocol development and author
- IND development
- CRO management
- Biomarker discovery and development
- Toxicology oversight
- Manufacturing of biotherapeutics (CMC)
Professional Highlights
- Approval of Entyvio (vedolizumab) (US and EMEA) and ADCETRIS (brentuximab vedotin) (EMEA)
- 25+ years in pharmaceutical and biotech companies with 22+ years translational research lead for biotherapeutics and small molecules (Oncology and non-oncology)
- 18+ years developing PD and biomarker assays in support of drug candidate development from pre-IND through post marketing clinical trials
- Cellular immunologist in vaccine development - first to demonstrate pro-inflammatory effect of flagellin in human primary peripheral blood mononuclear cell cultures evaluating immune responses to vaccines
- Developed and taught online course on vaccines and bioterrorism for Northeastern University
- Chair Biomarkers in Translational Medicine Focus Group for AAPS 2011-2013 and co-chair of the AAPS Action Program Committee of the Ligand Binding Assay Bioanalytical from 2011
Timeline
Cofounder and SVP Early Development
Aulos Biosciences
12.2020 - Current
Chief Development Officer
Biolojic Design
08.2019 - 12.2025
Vice President Immunology
Abpro Inc.
09.2018 - 08.2019
Senior Director Cancer Immunology
Curis Inc.
12.2015 - 08.2018
Part time faculty
Northeastern University
10.2003 - 10.2005
Director of Translational Medicine
Takeda Pharmaceuticals
03.2002 - 12.2015
Immunology Scientist
Surromed, Inc.
09.1998 - 02.2002
Postdoctoral fellow
University of Maryland at Baltimore
09.1995 - 09.1998
Doctor of Philosophy - immunology with a minor in microbial pathogenesis
University of Arizona
Bachelor of Science - General Biology, major emphasis- genetics and recombinant DNA
Arizona State University