S YSTEMATICALLY T RANSFORMING C ANCER I MMUNOTHERAPY
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Company Snapshot Company: ImmunSYS, Inc. is a clinical stage immunotherapeutic development company focusing on 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. 3 www.immunsys.com
YourVaccx ™ : Customized Cancer Therapy 4 www.immunsys.com
YourVaccx ™ Advantages Over Current Therapies 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 own tumors, thereby eliciting immune responses that are tailored to each patient’s unique cancer. 5 www.immunsys.com
CLINICAL DATA 6 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. o Each patient was incurable with available therapies. 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. 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 *Dr. Onik is the Executive Vice President, Chief Medical Officer, a director and an indirect stockholder of ImmunSYS, Inc. 7 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 8 www.immunsys.com
PoC Prostate Cancer Patient Efficacy Data (range: 5 to 49 months) 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% 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. 9 www.immunsys.com
PoC Prostate Cancer Patient Safety Data (range: 5 to 49 months) Adverse Events # Patients = 13 Hyperkalemia 1/13 (8%) 3 patients had SAEs, including nausea and vomiting (prolonged Hypothyroidism 1/13 (8%) hospitalization); prostate abscess; and Elevated BUN and creatinine 1/13 (8%) left perinephric abscess Urinary retention 1/13 (8%) 1 unrelated death 19 months post Elevated ALT and AST 1/13 (8%) treatment due to complications of subsequent hiatal hernia surgery SIAHS 1/13 (8%) Short term memory loss 1/13 (8%) Chest pain 1/13 (8%) 10 www.immunsys.com
Gary Onik, M.D. – Inventor, Physician & Patient Dr. Onik was diagnosed with a very aggressive metastatic prostate cancer in October 2018. o Metastasized to bone, pelvis and distant areas o PSA of 137 He underwent the YourVaccx ™ therapy, receiving the standard 2 treatments (one in early December 2018 and one in late December 2018). His first follow-up was February 1 st , 2019 11 www.immunsys.com
Dr. Onik’s Initial Results After Before 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 12 www.immunsys.com
CRF #7 - Representative Patient Case Study CRF #7 75 yr old male with bladder and Before After rectal invasion, obstruction of both ureters and a suprapubic tube and nodal metastases Previous surgical procedures and therapies: o Radical prostatectomy (failed) o Radiation therapy (failed) o 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 13 www.immunsys.com
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