Corporate Overview - Cancer Therapy Powered By You · YourVaccx is a novel therapy for Patients...
Transcript of Corporate Overview - Cancer Therapy Powered By You · YourVaccx is a novel therapy for Patients...
Corporate OverviewCharles J. Link, M.D.President & Chief Medical OfficerFebruary 11, 2020
LEGAL INFORMATION & DISCLAIMERThis presentation includes forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectivesand expectations for our business operations and financial performance and condition. Any statements contained in this presentation or expressed orally in connectionherewith that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, forward-looking statements can be identified byphrases 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-lookingstatements 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 our forward-looking statements. The forward-looking statements contained in this presentation or expressed orally inconnection herewith are made only as of the date of this presentation and we undertake no obligation to update the forward-looking statements to reflect subsequentevents or circumstances, except as required by applicable law.
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www.immunsys.com 2
IMMUNSYS COMPANY OVERVIEW
www.immunsys.com 3
Headquartered in Fort Lauderdale, FL, ImmunSYS, Inc. is a clinical stage biopharmaceutical company focused on a novel therapy for metastatic solid tumors.
YourVaccx™* is a therapy for metastatic solid tumor cancers that combines autologous antigen presentation with checkpoint blockade and immune stimulation to induce systemic anticancer immune responses.
47% (RECIST), 62% (PSA) Objective Response Rate, including a 47% Complete Response Rate in a Proof of Concept (PoC) clinical study in patients with metastatic prostate cancer.
YourVaccx™ Procedure is minimally invasive and performed in an outpatient setting, resulting in a potentially better quality of life for patients during therapy.
Company Technology PoC Clinical Study Minimally Invasive Solid IP
Solid intellectual property position in development with 3 issued patents, 8 pending patent applications in the US and 24 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.
YOURVACCX™: INTRODUCTION
YourVaccx is a novel therapy for Patients with metastatic cancer
Initial clinical focus for patients with metastatic prostate cancer The American Cancer Society estimates that there will be 31,620 deaths from
prostate cancer in 20191
Large US and worldwide market opportunity with significant unmet need.
A Proof-of-Concept (PoC) study with 21 metastatic prostate cancer patients (19 evaluable by RECIST) was completed and demonstrated an encouraging 47% complete response rate. The PoC study also included an additional 6 patients with other metastatic solid tumor cancers.
1 American Cancer Society. Cancer Facts & Figures 2019. Atlanta: American Cancer Society; 2019.
www.immunsys.com 4
YOURVACCX™: ANTIGEN EXPOSURE + IMMUNOTHERAPY
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YOURVACCX™: PROPOSED COMBINATION MECHANISM
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A segment of a tumor undergoes controlled cellular
lysis, liberating tumor antigens and other molecules
that serve to activate the immune system.
A proprietary immunotherapy drug is locally injected that provides both checkpoint
blockade and immune stimulation.
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This combination approach empowers the immune system to create an in-situ autologous
vaccine that drives an abscopal effect that attacks
the metastatic cancer throughout the body.
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YOURVACCX™ VS. CAR-T
YourVaccx is similar to CAR-T in effect, but unlike CAR-T is completely done within the patient’s body via a minimally invasive outpatient procedure.YourVaccx is personalized from each patient with their autologous unique cancer antigens, while CAR-T is directed against a predetermined antigen.
Potentially lower grade toxicities
Lower cost, easier and faster to produce than CAR-T therapy
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GARY ONIK, M.D. – INVENTOR, PHYSICIAN & PATIENT
Dr. Onik was diagnosed with an aggressive metastatic prostate cancer in October 2018. Clinically symptomatic with metastasis to bone, pelvis
and distant areas PSA of 138
He underwent the YourVaccx™ therapy, receiving two cycles of treatment in early and late December 2018.
Dr. Onik achieved a Complete Response and currently remains without evidence of recurrence to date.
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DR. ONIK’S RESULTS
Scans at 8 weeks post therapyBone mets are completely inactiveSmall distant mets have resolvedLarge mass in pelvic region resolvedPSA reduction at time of scan from 138 to 0.6PSA at 12 months follow up post therapy remains at 0.8 ng/mlDemonstrates durable Complete Response
Before After
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Widespread disease prior to treatment
Absence of disease post-treatment
PoC CLINICAL STUDY TREATMENT SUCCESS
The YourVaccx™ System developer, Dr. Gary Onik* treated a series of 21metastatic prostate cancer patients (19 evaluable via RECIST) with diffuse systemic disease. 47% Complete Response Rate 47% Objective Response Rate 62% ≥ 50% PSA Decline
The Proof of Concept (PoC) study also included 6 patients with othertypes of late stage cancers with some encouraging results.
ClinicalTrials.gov Identifier: NCT03695835
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*Dr. Onik is a founder and a stockholder of ImmunSYS, Inc.
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PoC PATIENT SAFETY DATA FOR ALL 27 PATIENTS
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19 of 27 patients had Grade 1/2 AE’s. This included several cases of autoimmune hypothyroidism probably related to therapy.
5 of 27 patients had Grade 3/4 AE’s. Pancreatitis was possibly related to the therapy. All grade 4 AE’s were observed in a single patient who had surgical complications.
There were 6 patient deaths (mostly progressive disease) determined by the investigator to be probably not related to YourVaccx treatment. One patient with adenocarcinoma of unknown primary died by cardiac arrest possibly related to the therapy during follow-up.
ENCOURAGING PROOF OF CONCEPT DATA
The encouraging PoC case series serves as supportive data to allow ImmunSYS to plan and pursue an aggressive clinical development plan Patients with metastatic Castrate Resistant Prostate Cancer (mCRPC) and patients who refuse
initial chemotherapy and hormone therapy will be considered This should provide for a large eligible patient population for the planned Phase I/II study
Breakthrough Designation will be pursued via: A Phase I/II trial with approximately 80 Patients with mCRPC
o May also include Patients with newly diagnosed metastatic Prostate Cancer who refuse standard of care (ADT/Chemo)
A 70 patient Phase II Basket Study will be conducted in other recurrent metastatic solid tumors (10 patients per histology): Cancer Types planned include: Pancreatic, NSCLC, Melanoma, Colon, Bladder, Ovarian, Renal
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KEY TEAM MEMBERSEamonn HobbsChairman & Chief Executive Officer Founded AngioDynamics & lead IPO in
2004 Former CEO of Delcath, an oncology
drug/device combination company Extensive combination drug/device
experience
Joseph GerardiEVP, Chief Financial Officer Spearheaded IPO of AngioDynamics in
2004 CFO Paradigm Spine, Centinel Spine,
Genesis Global Healthcare COO/CFO of Centinal Spine and Knee
Creations (sold to Zimmer)
Jon Condra, Ph.D.EVP, Chief Scientific Officer 28 years at Merck Research
Laboratories in drug discovery research
Distinguished Senior Investigator / Head of Antibody Display Technology, Biologics Research
Internationally recognized leader in HIV therapy
Agustin GagoEVP, Chief Business Officer VP International Oncology Sales at
AngioDynamics Chief Commercial Officer at Delcath,
an oncology drug/device combination company
Extensive combination drug/device experience
Marlene Wright BartonEVP, Chief Regulatory & Compliance Officer VP of Regulatory at Cordis (J & J) Prior chairman of AdvaMed PMA
Working Group Extensive combination drug/device
experience
Dan RecinellaEVP, Medical Device Development
VP of Technology, Regulatory and Clinical Affairs at Veniti
VP of Research & Development at AngioDynamics from 2004-2012
Extensive experience in medical devices including combination drug/devices
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Charles Link, M.D.President & Chief Medical Officer Founder and Former Chairman & CEO of
NewLink Genetics Corp. Entrepreneurial Oncologist with over 150
peer reviewed publications. Expertise in cancer immunotherapy
David Vaughan, M.D.EVP, Clinical Operations Second physician to perform our
YourVaccx therapy Extensive experience in renal
transplantation and urologic oncology Former Partner of Orlando Urology
Associates Former Chairman of Department of
Urology at Florida Hospital & Winter Park Hospital
BOARD OF DIRECTORS
Eamonn HobbsChairman & Chief Executive Officer Founded AngioDynamics & lead IPO in 2004 Former CEO of Delcath, an oncology drug/device
company Extensive combination drug/device experience
Douglas WatsonLead Independent Director Former President and Chief Executive Officer of
Novartis Corporation Prior board memberships include Dendreon,
Orasure, Wright Medical, BioMimetic Therapeutics, Delcath Systems
Joseph Maroon, M.D.Director Clinical professor and vice chairman of the
Department of Neurological Surgery and Heindl Scholar in Neuroscience at the University of Pittsburgh Medical Center
Pittsburgh Steelers team physician
Charles Link, M.D.Director, President & Chief Medical Officer Founder and Former Chairman & CEO of NewLink
Genetics Corp. Entrepreneurial Oncologist with over 150 peer reviewed
publications. Expertise in cancer immunotherapy
Jeffery Cleland, Ph.D.Director Executive Chair and Co-founder Orpheris,
Incorporated Serial biotech entrepreneur having raised over $450
million in growth capital.
Norman SchwartzDirector President, Chief Executive Officer and Chairman of the
Board at Bio-Rad Laboratories, Inc. Previously Managing Director of the Microscience
division in the U.K. and President of Nippon Bio-Rad in Japan.
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SCIENTIFIC ADVISORY BOARD
Gary Onik, M.D.YourVaccx™ Inventor, Lead Scientific Advisor Considered a world-leader in prostate cancer, Dr.
Onik is the pioneer of focal prostate cancer therapy and inventor of the male lumpectomy.
Neal Shore, M.D.Advisor Director, CPI, Carolina Urologic Research Center CPI who has numerous publications in peer-
reviewed journals and has lectured extensively on the treatment of prostate cancer
E. David Crawford, M.D.Advisor Head of the Section of Urologic Oncology,
University of Colorado Anschutz Medical Campus Internationally renowned urologist and prostate
cancer expert
Steven J. O’Day, M.D.Advisor Executive Director of John Wayne Cancer Institute and
Cancer Clinic at Providence Saint John's Health Center
Recognized as one of the world’s preeminent thought leaders in immune-based therapies across many cancer types.
Donald L. Trump, M.D.Advisor Recently Retired CEO and Executive Director,
Inova Schar Cancer Institute Medical oncologist who specializes in the
treatment of patients with genitourinary cancers, especially prostate and bladder cancer
Timothy P. Murphy, M.D.Advisor 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.
2011 President of Society of Interventional Radiology
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MULTI-MODALITY IMMUNE THERAPY WITH ENCOURAGING PoC DATA
Experienced Senior Executive and Clinical Development teams with an expert scientific advisory board
YourVaccx™ Therapy combines local controlled cellular lysis to release tumor antigen, checkpoint blockade and immune stimulation
Initial proof of concept data demonstrated a 47% Complete Response rate in patients with metastatic prostate cancer
Initial proof of concept data demonstrated that 62% of patients had a greater than 50% decrease in PSA
Initial proof of concept data suggests that YourVaccx™ therapy is well tolerated with relatively low rates of autoimmune side effects compared to combination systemic therapy with anti-PD-1 and anti-CTLA4 Abs
Phase I/II trial development underway
Planned presentation of detailed clinical proof of concept data at upcoming Scientific Meeting
ImmunSYS currently conducting an expanded private financing round
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