Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — Investor Presentation (March 2022)
21 slides from Intensity Therapeutics's investor presentation, Mar 15, 2022
Slide 1: A New Weapon in the War on Cancer
A NEW WEAPON IN THE WAR ON CANCER Directly killing tumors to activate a patient-specific immune response Treating all stages of cancer October 2021 Q1 2022
Slide 2: Management Team: Extensive Oncology and Drug Development Experience
MANAGEMENT TEAM: EXTENSIVE ONCOLOGY AND DRUG DEVELOPMENT EXPERIENCE Chief Chief Founder, Medical Financial CEO Officer Officer Lewis H. Bender, MIT ChE, MS, MA, MBA Ian B. Walters, MD, MBA James M. Ahlers • CEO, CTO, VP, BD & Manufacturing: Emisphere • Clinical Development 30+ compounds: BMS, • Danf
Slide 3: Corporate Highlights
CORPORATE HIGHLIGHTS Localized Cancer Kill Leading to Immune Activation and Extended Survival • Novel product candidate (INT230-6) containing cytotoxic agents with a diffusion enhancing molecule • Favorable safety with efficacy; 139 patients treated through December 31, 2021, with >95% of drug remai
Slide 4: Multiple Late-Stage Pipeline Programs
MULTIPLE LATE-STAGE PIPELINE PROGRAMS CLINICAL PROGRAMS ACROSS “COLD” AND “HOT” CANCERS, METASTATIC AND PRESURGICAL SETTINGS Multiple Ongoing Phase 2 Studies or Cohorts; Phase 3 Programs Designed and Discussed with FDA INT230-6 PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Advanced Soft Tissue Sarcoma INT230-
Slide 5: DfuseRx Proprietary Drug Discovery Platform; Product Candidate INT230-6
DFUSERXSM PROPRIETARY DRUG DISCOVERY PLATFORM PRODUCT CANDIDATE: INT230-6 – CONTAINS PROVEN ANTI-CANCER AGENTS INT230-6: designed for intratumoral (IT) CISPLATIN use; scaled-up, stable, reproducible • Direct killing: Binds to DNA to cause apoptotic cell death • Immune effects: Attracts and binds INT
Slide 6: INT230-6: A Unique, Anti-Cancer Therapy
INT230-6: A UNIQUE, ANTI-CANCER THERAPY 100% WATER SOLUTION THAT DISPERSES, DIFFUSES AND IS HIGHLY RETAINED IN TUMORS – DOES NOT HARM HEALTHY TISSUE Human pancreatic *Tumors contain high percentages of fat and are under high pressure cancer in mouse model Human pancreatic INT230-6 CYTOTOXICS DRUG ca
Slide 7: Our Delivery Technology Is Based on a Proven Science
OUR DELIVERY TECHNOLOGY IS BASED ON A PROVEN SCIENCE Image from January 2018 Tuberculosis and Respiratory Diseases 81(1):29. EMISPHERE WAS ACQUIRED BY NOVO NORDISK FOR $1.8 BILLION Technology First Developed for Oral Semaglutide Tablets (Rybelsus) Systemic therapies: • Drugs do not reach hypoxic are
Slide 8: Clinical Studies Enrollment as of December 31, 2021
CLINICAL STUDIES ENROLLMENT AS OF DECEMBER 31, 2021 Attacking the Tumors – Sparing the Patient RESULTS AS OF 12/31/2021: 139 PATIENTS • STUDY IT-01: Metastatic, refractory cancer: 98 patients treated (+2 repeats) INT230-6 alone (N=62); 17 different cancer types With pembro: Pancreatic, Bile duct, CR
Slide 9: Pharmacokinetic Analysis 0-24 Hours
PHARMACOKINETIC ANALYSIS 0-24 HOURS DRUG STAYS IN TUMOR: LOW GRADE ADVERSE EVENTS Pharmacokinetics • Mean VIN plasma levels one INT230-6 injection 12.00 Dose 1 Vinblastine at 0,1,3,6 and 24 hours (89 samples) • Dose dependent response from 2 to 118 mL • Peak VIN 10.00 2 mL N=8 <5% of drug enters pla
Slide 10: Data Shows Extended Median Overall Survival
DATA SHOWS EXTENDED MEDIAN OVERALL SURVIVAL IN PATIENTS WITH PROGRESSIVE CANCER FOLLOWING ALL APPROVED TREATMENTS FOR EACH PATIENT’S TYPE OF CANCER mOS Kaplan Meier estimates of INT230-6 monotherapy patients All Subjects dosed INT230-6 alone* 360 to 410 days (n=56) 100% mOS in typical Phase 1 / 2 tr
Slide 11: INT230-6 Causes Tumors to Become Highly Necrotic
INT230-6 CAUSES TUMORS TO BECOME HIGHLY NECROTIC A CASE FROM OUR METASTATIC STUDY PATIENT: Multiple surgeries, radiation, chemotherapy Necrosis and response seen in • (Jan ’18), Two 10 cm3 deep nodules appear in upper arm several cancers • MD’s Recommendation: Total arm and shoulder amputation • Adr
Slide 12: Phase 2 INVINCIBLE Study: Necrosis Achieved in Early Breast Cancer
PHASE 2 INVINCIBLE STUDY: NECROSIS ACHIEVED IN PROLIFERATING EARLY, INVASIVE BREAST CANCER (WHOLE TUMOR RESECTIONS) DOSE DEPENDENT DIFFUSION AND HIGH PERCENTAGE OF TUMOR KILLING OBSERVED Patient #14: Patient #20: 3.9 cm invasive ductal cancer: Grade 3 (high grade): 4.4 cm invasive lobular cancer: Gr
Slide 13: Immune Activation Observed in Multiple Cancer Types at 28 Days
IMMUNE ACTIVATION OBSERVED IN MULTIPLE CANCER TYPES AT 28 DAYS MODIFICATION OF THE TUMOR MICROENVIRONMENT OBSERVED Biopsies taken on day 0 and 28 INT230-6 dosed twice: Day 0 and Day 14 • Blue color indicates live cancer, DAPI; Green & yellow indicates immune cells Pre-dose (Day 0) 28 days after firs
Slide 14: Potential Treatment of Advanced Sarcoma
POTENTIAL TREATMENT OF ADVANCED SARCOMA HIGH UNMET MEDICAL NEED – SIGNIFICANT MARKET POTENTIAL 22 metastatic sarcoma subjects treated as of December 31, 2021 • Sarcomas are cancers of soft tissues such as fat, Demographic Value Median muscle, nerves, (STS) and bone (osteosarcoma) number of prior the
Slide 15: Decreased Tumor Volume Seen Post-Treatment Despite Increase in Diameter
DECREASED TUMOR VOLUME SEEN POST-TREATMENT DESPITE INCREASE IN DIAMETER RECIST/iRECIST MAY NOT BE A GOOD METRIC FOR EFFICACY USING OUR TECHNOLOGY: TUMOR DIAMETERS INCREASE WHILE VOLUME DECREASES A highly absorbable drug fluid potentially inducing immune Change in diameter of 6 sarcoma subjects' inje
Slide 16: INT230-6 Extends Survival Compared to Historical Phase 1/2 Results
IT INT230-6 EXTENDS SURVIVAL COMPARED TO HISTORICAL PHASE 1/2 RESULTS ADVANCED SOFT TISSUE SARCOMAS (aSTS) – KAPLAN MEIER (KM) ESTIMATES KM estimate of % alive at 1 year Kaplan Meier estimates aSTS patients • All STS (blue) (n=19) 52% • INT230-6 mono (Y) (n=7) *60% 100% • All >40%TTB (n=15) 62% 80%
Slide 17: Phase 3 Trial Design for INT230-6 in Soft Tissue Sarcoma
PHASE 3 TRIAL DESIGN FOR INT230-6 IN SOFT TISSUE SARCOMA (STS) EXPECTED TO OFFER SURVIVAL IMPROVEMENT VS CURRENT 2ND AND 3RD LINE SOC • Intent to treat (ITT) population: all STS Median OS Curve for STS standard of care drugs and projected INT230-6 in Phase 3 100% • Size: N=331 90% INT230-6 curve fro
Slide 18: Platform Validated by World Leading Partnerships
PLATFORM VALIDATED BY WORLD LEADING PARTNERSHIPS RESEARCH CLINICAL TRIAL SITES 24
Slide 19: Multiple Upcoming Milestones: Next 24 Months
MULTIPLE UPCOMING MILESTONES Next 24 months MILESTONES TIMING Multiple data presentations made in Q4 2021; SITC (2) (immunotherapy), CTOS (sarcoma Oral Podium) SABCS (breast cancer) Q4 2021 Reported safety and efficacy data of monotherapy and both I/O combinations Report Phase 2 INVINCIBLE Study dat
Slide 20: INTS Investment Summary
INTS INVESTMENT SUMMARY Experienced Oncology Drug Development Management Team Novel Technology to Kill Cancer and Activate the Immune System; Extended Patient Survival Favorable safety; 139 patients as of 12/31/2021 On-going Phase 2 Studies; Phase 3 Registration Study Designed in Sarcomas with FDA A
Slide 21: Intensity Therapeutics: A New Weapon to Treat Cancer
INTENSITY THERAPEUTICS A NEW WEAPON TO TREAT CANCER 30
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