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Legal Information & Disclaimer This presentation includes - - PowerPoint PPT Presentation
S YSTEMATICALLY T RANSFORMING C ANCER I MMUNOTHERAPY Legal Information & Disclaimer This presentation includes forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans,
Legal Information & Disclaimer
This presentation includes forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained in this presentation or expressed orally in connection herewith that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, forward-looking statements can be identified by phrases such as “plans,” “intends,” “believes,” “expects,” “anticipates,” “foresees,” “forecasts,” “estimates” or other words or phrases of similar import. Similarly, statements herein that describe our business strategy, outlook, objectives, plans, intentions or goals also are forward-looking statements. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Accordingly, you should not place undue reliance on
- ur forward-looking statements. The forward-looking statements contained in this presentation or expressed orally in connection herewith are made only as of the date of
this presentation and we undertake no obligation to update the forward-looking statements to reflect subsequent events or circumstances, except as required by applicable law. None of ImmunSYS, Inc., its affiliates or their respective directors, officers, employees or agents gives any representation or warranty, express or implied, as to: (i) the achievement or reasonableness of future projections, management targets, estimates or prospects contained in this presentation; or (ii) the accuracy or completeness of any information contained in this presentation, any other written information or oral information provided in connection herewith or any data that any of them generates. This presentation was prepared by us for informational purposes only, for delivery to a limited number of parties who may be interested in exploring a potential transaction with us, and does not constitute an offer, or solicitation of an offer, to sell any securities at any time. Any securities referred to in this presentation or orally in connection herewith have not been registered under the Securities Act of 1933, as amended, or any state securities law. Such securities have not been approved or disapproved by the Securities and Exchange Commission or by any state securities regulatory authority, nor has the Securities and Exchange Commission or any such state authority passed on the accuracy or adequacy of this presentation. Any representation to the contrary is a criminal offense. This presentation should be held in strict confidence by you, and must not be photocopied or reproduced in any other electronic or physical form and its contents must not be communicated, disclosed or distributed to any other person in whole or in part. If you wish to pursue this opportunity, you will need to rely on your own inspection and due diligence. Certain of the information contained in this presentation may be derived from information provided by industry sources. We believe that such information is accurate and that the sources from which it has been obtained are reliable; however, we cannot guaranty the accuracy of such information and have not independently verified such information.
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Company Snapshot
Company: ImmunSYS, Inc. is a clinical stage immunotherapeutic development company focusing
- n solid tumor cancers with an initial focus on metastatic prostate cancer
Technology: YourVaccx™* is a proprietary intra-tumoral combination drug/device immunotherapy system that has delivered a 46% Objective Response Rate, including a 38% Complete Response Rate of metastatic disease, with 62% of patients achieving a > 50% PSA decline in a Proof of Concept (PoC) clinical study on metastatic prostate cancer patients Minimally Invasive: Outpatient procedure, that is relatively low cost Headquarters: Fort Lauderdale, FL Strong Intellectual Property Position: An issued patent covering our foundation antigen exposure technology; 8 pending patent applications in the US; 36 additional patent applications pending worldwide
*YourVaccx is the name of the therapy, not the name of the drug or device used. The drug will be named via FDA approval process. The YourVaccx trademark has been selected to avoid confusion with other marks and provide stronger protection.
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YourVaccx™: Customized Cancer Therapy
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Since there are no known viable therapies for very late stage prostate cancer, YourVaccx™ provides tremendous advantage to patients who have been referred to hospice care and have been told to quickly settle their affairs. Currently available immunotherapies have been extensively tested in prostate cancer clinical trials with consistently poor results. Many cancers show extensive antigenic variability. YourVaccx™ is designed to expose the patient’s immune system to the antigens of his
- wn tumors, thereby eliciting immune responses that are tailored to each
patient’s unique cancer.
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YourVaccx™ Advantages Over Current Therapies
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CLINICAL DATA
www.immunsys.com
PoC Clinical Study Treatment Success
The YourVaccx™ System developer, Dr. Gary Onik* treated a series of 13 metastatic prostate cancer patients with diffuse systemic disease.
- Each patient was incurable with available therapies.
The Proof of Concept (PoC) study also included patients with other types of late stage cancers which resulted in very encouraging results. ClinicalTrials.gov Identifier: NCT03695835 Expect to publish the PoC clinical study results in 2019
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- Dr. Onik and his collaborators achieved a 46% Objective Response Rate, including
a 38% Complete Response Rate of metastatic disease, with 62% of patients achieving a > 50% PSA decline that has been durable up to 49 months thus far,
which constitutes unprecedented success and PoC.
*Dr. Onik is the Executive Vice President, Chief Medical Officer, a director and an indirect stockholder of ImmunSYS, Inc.
www.immunsys.com
Metastatic Prostate Cancer PoC Study Methodology
Retrospective Analysis of Practice of Medicine Proof of Concept (PoC) Single Center Case Series Institutional Review Board (IRB) Approved Contract Research Organization (CRO) Monitored N =13 patients with metastatic prostate cancer who signed informed consent to participate in the study Each received YourVaccx™ as the only therapy for metastatic disease
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PoC Prostate Cancer Patient Efficacy Data (range: 5 to 49 months)
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Studies of Provenge (the only approved immunotherapy for prostate cancer) did not show objective PSA or radiographic responses
For clarification of abbreviations and terms, please refer to the Key Terminology & Definitions slide at the end of the presentation.
Result # Patients % Objective Response Rate (ORR) 6 / 13 46% Complete response (CR) of metastatic disease 5 / 13 38% CRs for metastases successfully treated for residual primary 2 / 2 100% CR castrate resistant (CRPC) 2 / 5 40% PSA decline ≥ 50% 8 / 13 62% www.immunsys.com
PoC Prostate Cancer Patient Safety Data (range: 5 to 49 months)
3 patients had SAEs, including nausea and vomiting (prolonged hospitalization); prostate abscess; and left perinephric abscess 1 unrelated death 19 months post treatment due to complications of subsequent hiatal hernia surgery
Adverse Events # Patients = 13 Hyperkalemia 1/13 (8%) Hypothyroidism 1/13 (8%) Elevated BUN and creatinine 1/13 (8%) Urinary retention 1/13 (8%) Elevated ALT and AST 1/13 (8%) SIAHS 1/13 (8%) Short term memory loss 1/13 (8%) Chest pain 1/13 (8%) www.immunsys.com
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Gary Onik, M.D. – Inventor, Physician & Patient
- Dr. Onik was diagnosed with a very aggressive metastatic
prostate cancer in October 2018.
- Metastasized to bone, pelvis and distant areas
- PSA of 137
He underwent the YourVaccx™ therapy, receiving the standard 2 treatments (one in early December 2018 and
- ne in late December 2018).
His first follow-up was February 1st, 2019
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- Dr. Onik’s Initial Results
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CRF #29 Scans at 6 weeks post therapy Bone mets are completely inactive Small distant mets have resolved Large mass in pelvic region is almost completely absent PSA reduction at time of scan from 138 to 0.6 PSA at 5 months remains at 0.6 Demonstrates durable Complete Response
Before After
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CRF #7 - Representative Patient Case Study
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CRF #7 75 yr old male with bladder and rectal invasion, obstruction of both ureters and a suprapubic tube and nodal metastases Previous surgical procedures and therapies:
- Radical prostatectomy (failed)
- Radiation therapy (failed)
- CRPC
» Failed Lupron, Casodex, Zytiga » Failed 13 rounds of chemo (Taxotere, Carbazetaxel)
Hospice was scheduled Patient is now 4 years post- therapy and still free of disease
Before After
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FDA approved immuno-therapeutics (off label use) were used as component drugs in the PoC study for YourVaccx™ Therapy. However, all of the currently available component drugs are formulated for systemic delivery and not optimized for the focal intra-tumoral delivery associated with the YourVaccx™ Therapy Our development of an optimized combination intra-tumoral depot formulation increases:
- Efficacy
- Efficiency
- Repeatability
Patent applications directed to the formulation are pending. We intend to develop our intra-tumoral combination formulation under a Breakthrough Designation as an FDA approved new drug. Negotiations are underway with multiple suppliers of each component of our proprietary intra-tumoral drug formulation. We anticipate filing an investigational new drug (IND) application, with a request for expedited drug and development review for our proprietary drug formulation in Q4 2019. 14
YourVaccx™ New Immuno-Therapeutic Drug
www.immunsys.com
ImmunSYS anticipates filing for IDE/IND (investigational device exemption and investigational new drug applications) approval. The ANTIGENerator™ reusable generator unit and related single-use consumables, as well as its full documentation package, expected to be ready for the FDA filing by Q4 2019. If the IDE/IND is approved, the ANTIGENerator™ could be in human clinical use testing as early as Q4 2019.
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ANTIGENerator™ Latest Generation of Antigen Exposure Technology
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Potential YourVaccx™ Therapy Market for Late Stage Metastatic Prostate Cancer
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*International Market is estimated to be approximately the same size as US Market
Proprietary Pharmaceutical Formulation 29,430
Annual Deaths
Pharmaceutical Post-Op Immuno-stimulant 29,430
Annual Deaths
ANTIGENerator Capital Equipment 200
Generators
Device Consumable 29,430
Annual Deaths
$100,000
2 Treatments
$2.94 B
Market
$15,200
2 Treatment Cycles
$447 M
Market
$400,000
Per Generator
$80 M
Market
$2,000
Per Therapy
$60 M
Market
$3.52 B
Total Addressable Market
www.immunsys.com
Intra-Tumoral Drug Formulation Pipeline
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*”IMD110” is an experimental compound code name; the drug will ultimately be named via the FDA approval process.
PORTFOLIO CANDIDATE PROGRAM PRE-CLINICAL POC/PHASE I PHASE II PHASE III COMMERCIAL
IMD110* Pro rost state Cance ncer IMD110* Pancr ncreatic c Cance ncer IMD110* Mel elanoma ma
Immuno-
IMD110* Br Breast C Cance ncer
Oncology
IMD110* Bladde dder Cance ncer IMD110* Small C ll Cell ll Lung ung C Cance ncer IMD110* Ovar varian an Cance ncer IMD110* Br Brain C n Cance ncer
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Regulatory / Clinical Development Strategy
Regulatory - Combination drug & device product
- BLA and PMA
- Drug and Device labeling references and is dependent on each other
- CDER (Division of Oncology Products [DOP1]) is Lead Center
- Pursuing Breakthrough Designation with FDA
- Parallel CMS/FDA review planned
www.immunsys.com
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STAGE 1 STAGE 2
Journal Submission Pharma Partnerships Refinement of Device/System/ Procedure
STAGE 3 STAGE 4
$6 Million
YourVaccx™ Development Timeline
Phase I mCRPC Multicenter Clinical Trial Depot Formulation Development Breakthrough Designation Phase I/II mCRPC Multicenter Clinical Trial BLA Submission & Accelerated Approval Phase I‘s in other Adenocarcinomas With Accelerated Approval: Reimbursement Established/Broad Commercialization If necessary: Phase III mCRPC Clinical Trial
2018 2019 2020 2021 2022 2023 2024 2025
$30 Million* $88 Million
*Post journal publication $30 million cash investment will be sought from institutional investors prior to a potential IPO, but non-dilutive financing from potential Pharma partners that may negate the need for institutional investment will also be sought.
Dollar amounts indicate use of funds in each stage of development:
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Key Team Members
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Eamonn Hobbs
Chairman & Chief Executive Officer
- Entrepreneurial senior executive with
- ver 30 years of demonstrated
success in profitable pharmaceutical and combination drug/device product business creation and growth.
- Co-founded AngioDynamics (multiple
drug/device products) in 1988 and took company public in 2004.
- Currently serves as a Visiting Scholar
and Expert in Residence for the Translational Accelerator at Brigham and Women’s Hospital, Harvard Medical School.
Joe Gerardi
EVP , Chief Financial Officer
- Entrepreneurial C-Level executive
and a consummate financial strategist who partners with company leadership as a trusted adviser and plays a pivotal role in influencing strategy, planning and growth.
- In 2004 helped to spearhead an
Initial Public Offering (IPO) of AngioDynamics that was subsequently recognized as one of the most successful IPOs of the year.
Gary Onik, M.D.
EVP , Chief Medical Officer
- Considered a world-leader in prostate
cancer, Dr. Onik is the pioneer of focal prostate cancer therapy and inventor of the male lumpectomy.
- The concepts and techniques he
developed have had a major impact on the treatment of cancer patients throughout the world and his work has been recognized by awards given to him by major societies in both medicine and engineering.
- Dr. Onik is also an Adjunct Professor of
Mechanical Engineering at Carnegie Mellon University, working closely with his colleagues to develop the next generation
- f cancer fighting technologies.
Jon Condra, Ph.D.
EVP , Chief Scientific Officer
- Senior Scientific Leader with extensive
career in biomedical research, biotechnology, and drug discovery (small molecules / biologics / vaccines), with experience ranging from target identification through post-marketing studies.
- Broad and deep expertise in multiple
scientific and technological areas including molecular virology, biologics / therapeutic antibody discovery, & bacterial / viral genetics.
- Spent 28 years at Merck, most
recently as Distinguished Senior Investigator / Head of Antibody Display Technology, Biologics Research.
www.immunsys.com
Key Team Members
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Marlene Wright-Barton
EVP , Chief Regulatory & Compliance Officer
- Renowned expert in regulatory affairs
with significant experience in worldwide approvals and coordination of FDA panel meetings.
- Active participant in the AdvaMed PMA
& 510 (k) Working Groups since 1997, where she worked in conjunction with FDA to re-engineer their systems and develop numerous guidance documents for combination drug/device products.
- Served as the VP of Regulatory Affairs at
CRO Syntactx, where she was responsible for worldwide regulatory approvals for biologics, drugs, medical devices and combination products.
Agustin Gago
EVP , Chief Commercial Officer
- Twenty-five years of progressive management /
leadership positions focusing on Global Sales, Marketing, Product Development, Product Management and Logistical Operations
- Worked with a range of pharmaceuticals, capital
equipment, medical devices and single-use accessories, with a focus on the medical specialties of cardiology, oncology, surgery and radiology.
- Extensive oncology experience as VP
International Oncology Sales at AngioDynamics and EVP Global Marketing at oncology company Delcath
Dan Recinella
EVP , Medical Devices
- Over thirty years of medical device research and
development and operations experience in numerous medical specialties, including cardiology, radiology, surgery and oncology.
- Most recently VP of Technology, Regulatory
and Clinical Affairs at Veniti, a venous stent company acquired by Boston Scientific in August 2018.
- VP of Research & Development at
AngioDynamics from 2004-2012, where he
- versaw a full complement of radiology and
- ncology medical devices.
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Board of Directors
Eamonn Hobbs
Chairman & Chief Executive Officer
- Entrepreneurial senior executive with over 30
years of demonstrated success in profitable pharmaceutical and combination drug/device product business creation and growth.
- Co-founded AngioDynamics (multiple drug/device
products) in 1988 and took company public in 2004.
- Currently serves as a Visiting Scholar and Expert in
Residence for the Translational Accelerator at Brigham and Women’s Hospital, Harvard Medical School.
Gary Onik, M.D.
EVP, Chief Medical Officer
- Considered a world-leader in prostate cancer,
- Dr. Onik is the pioneer of focal prostate cancer
therapy and inventor of the male lumpectomy.
- The concepts and techniques he developed
have had a major impact on the treatment of cancer patients throughout the world and his work has been recognized by awards given to him by major societies in both medicine and engineering.
- Dr. Onik is also an Adjunct Professor of
Mechanical Engineering at Carnegie Mellon University, working closely with his colleagues to develop the next generation of cancer fighting technologies.
Douglas Watson
Lead Independent Director
- Former President and Chief Executive Officer of
Novartis Corporation, the US subsidiary of Novartis AG. Mr. Watson’s career spanned 33 years with Geigy/Ciba-Geigy/Novartis, during which time he held a variety of positions in the UK, Switzerland and the US.
- Currently serves as board member of BZL Inc.,
and a member of the advisory board of Cancer Expert Now Inc. Mr. Watson recently retired as Chairman of the board of OraSure Technologies Inc.
- Prior board memberships include Novartis,
Dendreon, Engelhard, Summit Bank, Wright Medical Group, BioMimetic Therapeutics, Delcath Systems, Javelin Pharmaceuticals, Genta, and Bionor Immuno AS.
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Board of Directors (Cont.)
Charles J. Link , MD FACP
Chairman & Chief Executive Officer NewLink Genetics, Inc.
- Entrepreneurial Oncologist with over 170
peer reviewed publications.
- NCI trained with over $2 million in NIH
research grant funding.
- Currently serves as Chairman & CEO
NewLink Genetics, Inc. (NASDAQ: NLNK)
- Strong clinical and research background in
immunotherapy development coupled with public company leadership experience.
- Attended the United States Airforce
Academy followed by Stanford University of Medicine, from which he graduated with Research Honors. He completed fellowship training in medical oncology at the National Cancer Institute.
Jeffery L. Cleland, PhD
Executive Chair and Co-founder Orpheris, Incorporated
- Serial biotech entrepreneur having raised
- ver $450 million in growth capital.
- Over 25 years in R&D including over 10
years at Genentech.
- Dr. Cleland has authored more than 100
articles and four books and holds several issued patents.
- Strong biotech industry experience in
immunotherapy development and financing.
- He holds a BS in Chemical Engineering
from the University of California, Davis and a PhD in Chemical Engineering from the Massachusetts Institute of Technology.
Joseph C. Maroon, MD, FACS
Independent Director
- Clinical professor and vice chairman of the
Department of Neurological Surgery and Heindl Scholar in Neuroscience at the University of Pittsburgh Medical Center.
- Regarded as a premiere specialist in the
surgical treatment of injuries and diseases
- f the brain and spine, specializing in
minimally invasive procedures.
- In addition to being a renowned
neurosurgeon, he is a sports medicine expert, health and nutrition expert, Ironman triathlete and prolific author.
- Has conducted extensive research into
neurotrauma, brain tumors and diseases of the spine, which has led to many innovative techniques for diagnosing and treating these disorders.
Norman D. Schwartz
President, Chief Executive Officer and Chairman of the Board at Bio-Rad Laboratories, Inc.
- Assumed the Chief Executive Officer
position in January 2003.
- During this time, the company listed on the
NYSE and gained investment grade status for its debt securities. The public value of Bio-Rad has increased eight-fold to $8 Billion, since 2003.
- Extensive international experience, including
Managing Director of the Microscience division in the U.K. and President of Nippon Bio-Rad in Japan.
- Prior to becoming CEO, Mr. Schwartz was
Vice President of the Diagnostics Group, followed by Vice President of the Life Science Group of Bio-Rad.
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Scientific Advisory Board
Steven J. O’Day, MD
Executive Director of John Wayne Cancer Institute and Cancer Clinic at Providence Saint John's Health Center
- A board-certified medical oncologist, he is recognized as
- ne of the world’s preeminent thought leaders in
immune-based therapies across many cancer types.
- At the forefront of new drug development and
immunotherapies for cancers over the last two decades and has been a principal investigator for more than 100 clinical trials.
- Played a leadership role in the development of the
breakthrough immune checkpoint inhibitor ipilimumab as well as the anti- PD1 antibodies pembrolizamab and nivolumab.
- Dr. O’Day’s medical training was at Johns Hopkins in
Baltimore and the Dana Farber Cancer Institute in Boston.
Neal Shore, MD, FACS
Director, CPI, Carolina Urologic Research Center
- Dr. Shore is a Certified Physician Investigator who has
numerous publications in peer-reviewed journals and has lectured extensively on the treatment of prostate cancer and prostate enlargement. He has conducted more than 300 clinical trials, focused primarily on GU oncology.
- Serves on several industry advisory boards as well as
academic and advocacy networks, including the Society Urologic Oncology Clinical Trials Consortium and the Bladder Cancer Advocacy Network.
- A graduate of Duke University, and Duke University
Medical School, Dr. Shore completed a six-month clinical research fellowship in Pretoria, South Africa, and then completed his general surgery/urology training at New York Hospital Cornell Medical Center and Memorial Sloan-Kettering Cancer Center in New York City.
- E. David Crawford, MD
Head of the Section of Urologic Oncology, University of Colorado Anschutz Medical Campus
- Dr. Crawford is an internationally renowned urologist,
distinguished endowed Professor of Surgery, Urology, and Radiation Oncology. He is an expert in benign prostate hypertrophy, urologic cancers, and in particular, prostate cancer.
- Has authored more than 600 scientific articles, as well as
textbook and book chapters and is an editorial reviewer or consultant for many publications, including Urology, Journal of Urology, and the Journal of Clinical Oncology.
- Founder and Chairman of the Prostate Conditions
Education Council, which is responsible for raising awareness and screening of millions of men for prostate health issues.
- Dr. Crawford has been involved in numerous clinical trials
and is a world renown expert on prostate cancer and biomarkers.
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Scientific Advisory Board
Timothy P . Murphy, MD, FSIR
Chief Executive Officer, Summa Therapeutics
- Dr. Murphy has spent the past 25 years as a clinician and
clinical researcher in the field of interventional radiology. He was most recently an interventional radiologist at Rhode Island Hospital and a Full Professor, Research Track, in the department of Diagnostic Imaging at Alpert School of Medicine at Brown University.
- 2011 President of Society of Interventional Radiology
- Founded the Vascular Disease Research Center at Rhode
Island Hospital, which conducts a range of clinical, pre- clinical, and epidemiologic studies of cardiovascular disease.
- Served as the principal investigator of NIH funded
Claudication: Exercise Vs. Endoluminal Revascularization Study (CLEVER) study and was co-principal investigator of the NIH funded CORAL (Cardiovascular Outcomes with Renal Atherosclerotic Lesions).
Donald L. Trump, MD, FACP FASCO
Recently Retired CEO and Executive Director, Inova Schar Cancer Institute
- Dr. Trump is a medical oncologist who specializes in the
treatment of patients with genitourinary cancers, especially prostate and bladder cancer.
- Previously President and CEO of Roswell Park Cancer
Institute in Buffalo, NY where he lead a clinical research program in vitamin D-based cancer prevention and treatment, and care for patients with prostate cancer and
- ther urologic cancers.
- Over the span of his career, Dr. Trump has held clinical
positions at The Johns Hopkins University, University of Wisconsin, Duke University, University of Pittsburgh, and State University of New York at Buffalo.
- Received his medical education and completed his
residency and fellowship at Johns Hopkins University in Baltimore, MD
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Summary
YourVaccx is a new type of intra-tumoral Immunotherapy that is designed to empower the patient’s
- wn immune system to recognize and fight off the cancer on a systemic basis.
Focal antigen exposure and intra-tumoral delivery of novel immunotherapeutic drug presents a revolutionary new “Operating System For Solid Tumor Immunotherapy”. Exceptional 46% objective response rate including a 38% complete response rate of metastatic disease with 62% of patients achieving a > 50% PSA decline in PoC metastatic prostate cancer study with a durable complete responses of up to 49 months. Platform technology that is an outpatient, minimally invasive, relatively low cost therapy with broad potential in numerous solid tumor cancer types Large, multi-billion dollar market with a tremendous unmet need for an effective late stage metastatic prostate cancer therapy Industry veteran team with multiple successes in start-ups, disruptive drug and device technologies, IPOs and public companies
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