OFFICE of INNOVATIONand Industry Alliances

2019 A N N U A L R E P O R T

Contents3 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

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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 effectiveness of immunotherapy in cancer patients and to spare patients’ healthy cells. We are offering new hope to patients with 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.

During fiscal year 2019, 24 Moffitt U.S. patents were issued. This is 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 without the insights and input from the Moffitt Patent Review Committee and Moffitt Commercialization Strategy Committee. The office looks forward to working with these committees and the Moffitt team members to advance technologies through partnerships and commercialization.

James J. Mulé, PhDAssociate Center Director, Translational Science

Jarett Rieger, Esq., MBASenior Director, Innovation & Industry Alliances

L. David de la Parte, Esq.Executive Vice President/ General Counsel Office of General Counsel

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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.

CARs OF THE FUTURE with Atara

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

quickly as possible.”

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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)

Dr. List Recognized AT FLORIDA INVENTORS HALL OF FAME

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The partnership between Iovance and Moffitt began in 2014 and has resulted in the

successful development of TIL therapies for cancer.

MANUFACTURING A CURE with IovanceDURING 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.

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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 for the PRGN-3006 study. “We are hopeful that this study will be the beginning of the development of 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.

Moffitt and Precigen TEAM UP TO CHANGE PROGNOSIS

The collaboration between Moffitt Cancer Center and Precigen is expected

to yield key advancements in the treatment of AML and MDS patients.

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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.

Avoiding Attacks On Healthy Cells WITH TuHURA

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213worldwide patent

applications

original U.S. patent applications56

U.S. patents issued24

active startups11

licenses 12$36

MILLION

global funding

intellectual property disclosures 59

FY 2019 Innovation Index

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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 fast. We know what companies want, but Industry Alliances’ focus is to make sure that the faculty’s needs and Moffitt’s goals are front and center 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.

Matchmakers: INDUSTRY ALLIANCES BUILDS RELATIONSHIPS

Industry Alliances’ focus is to make sure that the faculty needs and

Moffitt's goals are front and center throughout any process.

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L ATANYA SCOT 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

• Access to Cutting Edge Research Technologies

• Generation of Novel Intellectual Property

VERONIK A FEDORCHUK

Industry Alliance Development Specialist

RUAN COX

Industry Alliance Development Manager

ALE XIS K AR ANDRE A

Industry Alliance Development Manager

MEET THE MATCHMAKERS

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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.

13TH ANNUAL BUSINESS OF BIOTECH

CONFERENCE

Cracking the Cancer Code

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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

13TH ANNUAL BUSINESS OF BIOTECH

CONFERENCE

Cracking the Cancer CodeSAVE THE DATE:

February 7, 2020 14th Business of Biotech

ConferenceVisit MoffittIP.com to register.

Partnering Forum February 6, 2020

BY INVITATION ONLY

To find out more, email INNOVATION@Moffitt.org

ACCOMPLISHMENTS:• ATTENDEES: 458

44 Biotech Companies, 14 Economic Development Groups/Investors, 9 Colleges/Universities and 7 Science Institutions

• MEDIA COVERAGE: Moffitt press release distributed to 69 journalists

• SOCIAL MEDIA COVERAGE: 46 posts using the “MoffittBOB” hashtag

• SPONSORSHIPS: $57,500 raised; 21 sponsors

• 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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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

24 U.S. Patents Issued FY 2019

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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

PATENT INVENTORS

For business development opportunities please contact:

Haskell Adler, PhD, MBASenior Licensing ManagerHaskell.Adler@Moffitt.org 813.745.6596

Ruan Cox, PhDIndustry Alliance Development ManagerRuan.Cox@Moffitt.org813.745.6851

Veronika Fedorchuk, PhDIndustry Alliance Development SpecialistVeronika.Fedorchuk@Moffitt.org 813.745.2887

Alexis Karandrea, PhDIndustry Alliance Development ManagerAlexis.Karandrea@Moffitt.org813.745.2257

Jarett Rieger, Esq., MBASenior Director, Innovation & Industry AlliancesJarett.Rieger@Moffitt.org813.745.6828

Latanya Scott, PhDAssociate Director, Industry AlliancesLatanya.Scott@Moffitt.org813.745.6902

MoffittIP.com

OFFICE of INNOVATIONand Industry Alliances