2019 INNOVATION OFFICE of - Moffitt Cancer Center

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2019 INNOVATION OFFICE of - Moffitt Cancer Center
OFFICE of
INNOVATION
and Industry Alliances

2019
ANNUAL REPORT
2019 INNOVATION OFFICE of - Moffitt Cancer Center
Contents
3    Executive Message

4    CARs of the Future with Atara

5    Dr. List Recognized at Florida Inventors Hall of Fame

6    Manufacturing a Cure with Iovance

7    Moffitt and Precigen Team Up
     to Change Prognosis

8    Avoiding Attacks on Healthy Cells
     with TuHURA

9    FY 2019 Innovation Index

10   Matchmakers: Industry Alliances
     Builds Relationships

12   13th Annual Business
     of Biotech Conference

14   U.S. Patents Issued FY 2019
2019 INNOVATION OFFICE of - Moffitt Cancer Center
Executive Message
FISCAL YEAR 2019 has been another banner year for the Innovation
Office. Through our licensing and partnering successes, we
generated $36M in funding this year, which brings our five-year
funding to $147M. This year’s successes are due to people within
the Innovation Office and many beyond our doors. This annual
report highlights several high profile Moffitt partnerships. Among
our accomplishments this year, we collaborated with Iovance
Biotherapeutics to manufacture cells on their behalf, we are working
with Atara Biotherapeutics to discover more targeted therapies
and we are assisting a startup, TuHURA Biopharma, to improve the                           L. David de la Parte, Esq.
effectiveness of immunotherapy in cancer patients and to spare                             Executive Vice President/
                                                                                           General Counsel
patients’ healthy cells. We are offering new hope to patients with                         Office of General Counsel
relapsed or refractory acute myeloid leukemia through a clinical trial
with Precigen’s therapeutic platform.

The Innovation Office has undergone a series of organizational
changes to enhance its partnership efforts. During the year, we
established a new business unit, Innovation Services, to support
patenting, licensing and industry partnering. Staff members
that negotiate material transfer and confidentiality agreements
transitioned to the Office of General Counsel.
                                                                                           James J. Mulé, PhD
During fiscal year 2019, 24 Moffitt U.S. patents were issued. This is                      Associate Center Director,
                                                                                           Translational Science
a testament of the amazing science and innovation by Moffitt team
members. Dr. Alan List, President and CEO, is a prolific inventor with
six issued patents and 49 U.S. and international patent applications.
Ten of his technologies are currently licensed to industry partners
for ongoing development of cancer treatments. Because of Dr. List’s
breakthrough discoveries during his career, he was inducted into the
2019 Florida Inventors Hall of Fame. Congratulations to Dr. List and all
of the Moffitt inventors on their discoveries.

The successes of the Innovation Office would not have been possible
                                                                                           Jarett Rieger, Esq., MBA
without the insights and input from the Moffitt Patent Review                              Senior Director,
Committee and Moffitt Commercialization Strategy Committee.                                Innovation & Industry Alliances
The office looks forward to working with these committees and the
Moffitt team members to advance technologies through partnerships
and commercialization.

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2019 INNOVATION OFFICE of - Moffitt Cancer Center
CARs OF THE FUTURE
    with Atara
    ATARA BIOTHERAPEUTICS is a leading T-cell immunotherapy company that develops novel
    treatments for patients with cancer, as well as patients with viral and autoimmune diseases.
    Moffitt and Atara forged a strategic partnership encompassing several scientific endeavors:
    development of a genetically engineered cell therapy for patients with acute myeloid leukemia
    (AML); multi-antigen targeted CAR T-cell therapy; first-generation signaling technology for
    CARs; and next-generation signaling technology for CARs. The goal of this collaboration is to
    develop CAR T cells that are more efficient, more likely to respond, and capable of working
    against more diverse B cell or AML hematological malignancies.

    We hope to develop a better targeted therapy that will stay engaged, produce better response
    and last longer, while simultaneously sparing the healthy cells.

    “The biggest advantage is our shared commitment to bring this technology and therapeutic
    advancement to patients as quickly as possible,” stated Marco Davila, MD, PhD, Associate
                              Member of Moffitt’s Immunology Program.

                                  “Together with Moffitt, we are committed to discovering innovative
                                 medicines and enabling efficient product development. Moffitt’s
                                 ability to bring cutting-edge research, patients who need innovation
                                 and manufacturing all together in one center is unique, especially
                                 for CAR T therapy,” stated Dan Maziasz, Vice President and Head of
                                                       Business Development and Alliance Management
                                                       at Atara Biotherapeutics.

                                                         These research projects are expected to lead to
                                                         new clinical trials and to improve the overall care
                                                         of patients.

                                                                 “The biggest advantage is our shared
                                                               commitment to bring this technology and
                                                                therapeutic advancement to patients as
                                                                         quickly as possible.”

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2019 INNOVATION OFFICE of - Moffitt Cancer Center
Dr. List
Recognized
AT FLORIDA INVENTORS
HALL OF FAME

Congratulations to ALAN LIST, MD, PRESIDENT
AND CEO of Moffitt Cancer Center, for his
induction into the 2019 Florida Inventors Hall of
Fame. The Florida Inventors Hall of Fame is an
initiative that recognizes and honors scientists who are dedicated to patient quality of care
throughout Florida and nationwide. All nominations undergo a competitive review and selection
process in which only six to eight nominees are inducted each year. Nominees must be a named
inventor on a patent issued by the United States Patent and Trademark Office, have an invention
that was commercialized, utilized or led to an important innovation and have a significant impact
to society as a whole.

Dr. List is being recognized for his dedication to finding treatments for cancer. He has contributed
to the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). As a
result of these efforts, lenalidomide (Revlimid®) was developed and approved by the FDA for
use on patients with MDS and multiple myeloma. Revlimid® transformed the history of MDS to a
condition that can be managed and treated in the outpatient setting with an oral agent.

PATENTS ISSUED FOR DR. LIST:

   • Methods of Using Aminothiols to Promote Hematopoietic Progenitor Cell Growth
   • Method of Identifying Myelodysplastic Syndromes
   • RNF41 as a Biomarker Predicting Response to Lenalidomide in Non-del(5q) MDS
   • Targeted Sensitization of Non-del(5q) Malignant Cells
   • Protein Phosphatase 2A Inhibitors for Treating Myelodysplastic Syndromes
   • Soluble CD33 for Treating Myelodysplastic Syndromes (MDS)

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2019 INNOVATION OFFICE of - Moffitt Cancer Center
MANUFACTURING A CURE
    with Iovance
    DURING THE PAST YEAR, Moffitt Cancer Center has expanded its relationship
    with Iovance Biotherapeutics, a clinical stage biotechnology company.
    Iovance is primarily focused on developing and commercializing novel cancer
    immunotherapies based on tumor infiltrating lymphocytes (TIL).

    The Iovance and Moffitt partnership began in 2014 and has resulted in the successful
    development of TIL therapies for cancer. During the first project, Iovance worked
    closely with Moffitt and became familiar with the cancer center’s resources, most
    notably Moffitt’s Cell Therapies Shared Resource.

    Moffitt’s Cell Therapies Shared Resource manufactures safe therapeutic cellular
    products in support of clinical studies. The Cell Therapies Shared Resource takes part
    in new product development, cell collection, cell therapy product manufacturing and
    product quality testing. These unique capabilities caught the attention of Iovance and
    led to Moffitt’s first manufacturing agreement. The expansion with Iovance is expected
    to result in more clinical trials for a variety of new indications.

         The partnership between
       Iovance and Moffitt began in
        2014 and has resulted in the
      successful development of TIL
           therapies for cancer.

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2019 INNOVATION OFFICE of - Moffitt Cancer Center
Moffitt and Precigen
TEAM UP TO CHANGE PROGNOSIS

MOFFITT CANCER CENTER AND PRECIGEN INC., a biopharmaceutical company specializing
in the development of innovative gene and cellular therapies, announced the first patient dosed
in their clinical trial using Precigen’s non-viral PRGN-3006 UltraCAR-T™ therapeutic platform.
These therapies are targeted toward patients with relapsed or refractory acute myeloid leukemia
(AML) or higher-risk myelodysplastic syndromes (MDS). This collaborative study is expected to
improve precision and control in targeting relapsed or refractory AML and higher-risk MDS as
well as reduce manufacturing related costs and increase process efficiencies.

The American Cancer Society estimates 21,450 new cases of AML will be diagnosed in the
United States during 2019. AML is a rare cancer that begins in the bone marrow and often
spreads to the blood. Patients with AML have an average survival rate of approximately five
years. MDS are cancerous conditions of the bone marrow that can progress to AML.

“AML is an aggressive disease with very poor prognosis,” said James J. Mulé, PhD, Associate
Center Director and Michael McGillicuddy Endowed Chair in Melanoma Research and Treatment,
at Moffitt Cancer Center. "The first patient dosed with investigational PRGN-3006 UltraCAR-T™
represents a significant development for this challenging patient population with high unmet
medical need.”

“AML and MDS patients have few treatment options,
and time is critical when selecting the best treatment
path," said David A. Sallman, MD, lead investigator                 The collaboration between Moffitt
for the PRGN-3006 study. “We are hopeful that this               Cancer Center and Precigen is expected
study will be the beginning of the development of
                                                                     to yield key advancements in the
                                                                  treatment of AML and MDS patients.
a therapy that may result in a critically needed new,
safe and efficacious treatment option that allows for
rapid treatment.”

We are hopeful that this collaboration between Moffitt and Precigen will yield key
advancements in the treatment of AML and MDS.

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2019 INNOVATION OFFICE of - Moffitt Cancer Center
Avoiding Attacks
    On Healthy Cells
    WITH TuHURA

    TUHURA BIOPHARMA, a startup biotechnology company, and
    Moffitt Cancer Center have partnered to develop a new generation of
    targeted immunotherapies that can be applied to a greater number of
    cancers and a larger patient population. Moffitt will have the opportunity to
    develop its first-in-class bifunctional immunoconjugates, which are cancer
    cell binding agents that help target the tumor’s microenvironment while
    avoiding non-cancerous cells. These novel bifunctional immunoconjugates
    are designed to improve the effectiveness of immunotherapy and may
    potentially spare healthy cells to reduce a patient’s chance of developing
    severe side effects.

    TuHURA was impressed with Moffitt’s research. “Having reviewed more
    than 100 new technologies among 40 leading academic institutions and
    cancer research centers across the United States, we found the technology
    developed at Moffitt has the greatest potential to advance the field of
    cancer immunotherapy. Decreasing the immune suppression caused
    by the tumor microenvironment is an area of intense research among
    both academic and pharmaceutical research,” said James A. Bianco,
    MD, TuHURA's Principal Founder and Executive Chairman.

    Moffitt is equally eager to be working on this project with TuHURA.
    “With this agreement, Moffitt can build on the incredible
    advancements we have seen in immuno-oncology, bringing
    novel treatments to patients, while delivering a safer and
    more effective approach,” said Alan List, MD, Moffitt
    President and CEO.

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2019 INNOVATION OFFICE of - Moffitt Cancer Center
FY 2019
Innovation Index

56           original U.S. patent
                 applications
                                                                     licenses
                                                                                             12
                          global                   $      36                                 funding

11
                                                         MILLION
              active startups

                                       intellectual property
                                            disclosures
                                                                                     59
  213
worldwide patent
  applications
                                                    24                     U.S. patents issued

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2019 INNOVATION OFFICE of - Moffitt Cancer Center
Matchmakers:
     INDUSTRY ALLIANCES
     BUILDS RELATIONSHIPS

     THE INNOVATION OFFICE’S INDUSTRY ALLIANCES BUSINESS UNIT launched five years ago.
     The unit started with one person, Dr. Latanya Scott, and has steadily grown to a four-person
     workgroup. In this short time, Industry Alliances has generated over $100M in global revenue for
     Moffitt. This is a remarkable feat for a newly created team.

                                                 Finalizing deals is not easy and it certainly is not
        Industry Alliances’ focus is to make     fast. We know what companies want, but Industry
          sure that the faculty needs and        Alliances’ focus is to make sure that the faculty’s
        Moffitt's goals are front and center     needs and Moffitt’s goals are front and center
              throughout any process.            throughout the process. We ask faculty, “Would
                                                 additional funding be beneficial to support your
                                                 lab personnel? Is access to data from Moffitt
     biospecimens too costly for you to generate on your own? Can we help you gain access to
     novel technologies that will help springboard your research interests and support new grant
     applications and publications”?

     Our office acts as the matchmaker to align scientific interests between faculty and industry.
     After a match is identified, the hard steps begin. It is similar to a dance with many twists, turns
     and spins to determine statements of work and budgets. This initial stage of the relationship
     involves faculty and maintaining a focus to keep a prospective company’s interest alive and well.
     Industry Alliances shepherds the process along and negotiates the terms for Moffitt. This is a
     challenging process with only about half of the potential relationships surviving this phase. As a
     project comes together, usually following a lengthy negotiation period, the matchmaking is almost
     complete and the final approval steps begin.

     There is no “usual” to matchmaking. Each faculty member, each company and each project is
     unique. The Industry Alliances staff works diligently to develop relationships that will be beneficial
     to Moffitt and its faculty.

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MEET THE MATCHMAKERS

                                                                         L ATA N YA S C OT T

                                                                          Associate Director
                                                                          Industry Alliances

                                     INDUSTRY
                                     COLLABORATION BENEFITS
                                     •   Funding Faculty Research

                                     •   Collaborate with Industry
                                         Scientists

                                     •   Translational & Clinical
                                         Applications of Faculty Studies

                                     •   Data for High Quality Publications

                                     •   Access to Novel Drugs/Proprietary
                                         Pipelines
A LE X I S K A R A N D R E A                                                                      RUA N C OX
                                     •   Access to Cutting Edge Research
   Industry Alliance                     Technologies                                        Industry Alliance
 Development Manager                                                                       Development Manager
                                     •   Generation of Novel Intellectual
                                         Property

           V E RO N I K A F E D O RC H U K

                 Industry Alliance
              Development Specialist

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13TH ANNUAL
                                         BUSINESS OF BIOTECH
                                            CONFERENCE

       Cracking the Cancer Code
                         THE 13TH ANNUAL BUSINESS OF BIOTECH conference held Feb.22, 2019,
                      set a new attendance record of 458 diverse individuals from biotech companies,
                  universities, startups, investors and international entrepreneurs.

     The keynote address was conducted as a fireside chat between Dr. Reid Huber (Partner at Third
     Rock Ventures and former Chief Scientific Officer at Incyte) interviewed by Cokie Roberts*
     (ABC News Political Commentator, NPR Contributing Senior News Analyst and member of
     Moffitt’s National Board of Advisors). During the interview, Dr. Huber described the process
     of creating a new company with two major components: the initial therapeutic drug discovery
     program and the future product engine.

     The four educational sessions were well attended and received excellent reviews. Guests
     enjoyed time discussing collaboration and partnering opportunities. On the day prior to the
     conference a record breaking Partnering Forum was held, which included 60 individual industry
     partnering meetings.

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FOUR EDUCATION SESSIONS:
                                                                •   Navigating FDA Approvals for Cell Therapy

                                                                •   Clinical Pathways: Tackling Value-Based Cancer Care

                                                                •   Artificial Intelligence in Cancer Care Delivery:
                                                                    The Robot Will See You Now

                                                                •   E-I-E-I-O! Sowing, Growing and Reaping Immune
                                                                    Oncology Production

                                                                                               SAVE THE DATE:
ACCOMPLISHMENTS:
•   ATTENDEES: 458
                                                                                          February 7, 2020
    44 Biotech Companies, 14 Economic Development                                     14th Business of Biotech
    Groups/Investors, 9 Colleges/Universities and 7 Science Institutions                    Conference
                                                                                           Visit MoffittIP.com to register.
•   MEDIA COVERAGE: Moffitt press release distributed to
    69 journalists                                                                           Partnering Forum
•   SOCIAL MEDIA COVERAGE: 46 posts using the “MoffittBOB”                                   February 6, 2020
    hashtag                                                                                      BY INVITATION ONLY

•   SPONSORSHIPS: $57,500 raised; 21 sponsors                                                  To find out more, email
                                                                                             INNOVATION@Moffitt.org
•   PARTNERING FORUM/NETWORKING EVENTS: 75 interactions

* As this annual report went to press, we learned that our dear colleague
  Cokie Roberts passed away. She will be greatly missed.

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24 U.S. Patents Issued FY 2019
     PATENT                                                                                     INVENTORS

     Anesthesia Gas Delivery and Monitoring System                                              Chaudhry, Tariq

     Biomarkers and Methods for Predicting Benefit of                                           Cress, Douglas
     Adjuvant Chemotherapy                                                                      Chen, Dung-Tsa

     CD28 Expression During Lenalidomide Immune Modulation                                      Burnette, Pearlie
                                                                                                McDaniel, Jessica

     Cyclic Peptide Conjugates and Methods of Use                                               Hazlehurst, Lori
                                                                                                McLaughlin, Mark
                                                                                                Rader, Christoph
                                                                                                Li, Xiuling

     Histone Deacetylase 6 Inhibition for Enhancing T-Cell Function                             Sotomayor, Eduardo
     During Anti-Tumor Response and Tumor-Peptide Vaccination                                   Villagra, Alejandro

     Immune Gene Signatures in Cancer                                                           Mulé, James
                                                                                                Yeatman, Timothy
                                                                                                Coppola, Domenico
                                                                                                Loboda, Andrey
                                                                                                Nebozhyn, Michael

     Inhibitors of ACK1/TNK2 Tyrosine Kinase                                                    Mahajan, Nupam
                                                                                                Lawrence, Nicholas
                                                                                                Lawrence, Harshani
                                                                                                Mahajan, Kiran

     Integrin Interaction Inhibitors for the Treatment of Cancer                                Dalton, William
                                                                                                Hazlehurst, Lori
                                                                                                McLaughlin, Mark
                                                                                                Jain, Priyesh

     Method of Assessing Breast Density for Breast Cancer                                       Sellers, Thomas
     Risk Applications                                                                          Heine, John
                                                                                                Fowler, Erin E

     Method of Ex Vivo Enhancement Of Immune Cell Activity for Cancer                           Pilon-Thomas, Shari
     Immunotherapy With A Small Molecule Ablative Compound                                      Sarnaik, Amod
                                                                                                Singer, Jamie
                                                                                                Liu, Hao
                                                                                                Wachter, Eric

     Method of Increasing Intratumoral pHe and Reducing                                         Gillies, Robert
     Acid-Mediated Invasion                                                                     Morse, David
                                                                                                Gatenby, Robert
                                                                                                Silva, Ariosto
                                                                                                Martinez, Gary
                                                                                                Ibrahim Hashim, Arig

     Methods and Systems for Performing Segmentation and                                        Guo, Yanhui
     Registration of Images Using Neutrosophic Similarity Scores                                Gonzalez, Segundo Jaime

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PATENT                                                                                    INVENTORS

Methods and Systems for Predicting Cancer Outcome                                         Eschrich, Steven
                                                                                          Bloom, Gregory
                                                                                          Yeatman, Timothy

MicroRNA Assay for Detection and Management of                                            Malafa, Mokenge
Pancreatic Cancer Precursors                                                              Chen, Dung-Tsa
                                                                                          Permuth Wey, Jennifer

Pathology Case Review, Analysis and Prediction                                            Bui, Marilyn Yuanxin Ma
                                                                                          Lloyd, Mark
                                                                                          Rejniak, Katarzyna
                                                                                          Puri, Munish

Personalized Myeloma Detection                                                            Koomen, John

PET Probes of Radiofluorinated Carboximidamides for                                       Gillies, Robert
IDO-Targeted Imaging                                                                      Tian, Haibin

Potent Dual BRD4-Kinase Inhibitors as Cancer Therapeutics                                 Lawrence, Nicholas
                                                                                          Lawrence, Harshani
                                                                                          Schonbrunn, Ernst

Protein Phosphatase 2A Inhibitors for Treating                                            List, Alan
Myelodysplastic Syndromes                                                                 Sallman, David
                                                                                          Kovach, John

Protein-Protein Interaction as Biomarkers                                                 Haura, Eric

Selective Histone Deactylase 6 Inhibitors                                                 Sotomayor, Eduardo
                                                                                          Bergman, Joel
                                                                                          Kozikowski, Alan
                                                                                          Villagra, Alejandro
                                                                                          Woan, Karrune (Winston)

Small Molecule Inhibitors of STAT3 with Anti-Tumor Activity                               Sebti, Saïd
                                                                                          Turkson, James
                                                                                          Lawrence, Nicholas
                                                                                          Lawrence, Harshani
                                                                                          Guida, Wayne
                                                                                          Yip, Man Lun (Richard)
                                                                                          Greedy, Benjamin

Stabilized Peptoid-Peptide Hybrids and Uses Thereof                                       Sarnaik, Amod
                                                                                          McLaughlin, Mark

Toll-Like Receptor 2 (TLR2) Ligands and Methods of Making                                 McLaughlin, Mark
and Using Thereof                                                                         Gillies, Robert
                                                                                          Morse, David
                                                                                          Huynh, Amanda
                                                                                          Doligalski, Michael
                                                                                          Vagner, Josef

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OFFICE of
INNOVATION
and Industry Alliances

For business development opportunities
please contact:

Haskell Adler, PhD, MBA
Senior Licensing Manager
Haskell.Adler@Moffitt.org
813.745.6596

Ruan Cox, PhD
Industry Alliance Development Manager
Ruan.Cox@Moffitt.org
813.745.6851

Veronika Fedorchuk, PhD
Industry Alliance Development Specialist
Veronika.Fedorchuk@Moffitt.org
813.745.2887

Alexis Karandrea, PhD
Industry Alliance Development Manager
Alexis.Karandrea@Moffitt.org
813.745.2257

Jarett Rieger, Esq., MBA
Senior Director, Innovation & Industry Alliances
Jarett.Rieger@Moffitt.org
813.745.6828

Latanya Scott, PhD
Associate Director, Industry Alliances
Latanya.Scott@Moffitt.org
813.745.6902

MoffittIP.com
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