Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — CTOS Annual Meeting 2022
17 slides from Intensity Therapeutics's conference presentation, Nov 18, 2022
Slide 1: INT230-6 Alone or With Ipilimumab Prolonged Survival in Refractory Sarcomas
INTRATUMORAL INT230-6 (CISPLATIN, VINBLASTINE, SHAO) ALONE OR WITH IPILIMUMAB PROLONGED SURVIVAL WITH FAVORABLE SAFETY IN ADULTS WITH REFRACTORY SARCOMAS (NCT 03058289) Christian Meyer, MD PhD Presented by: 2022 Content of this presentation is the property of the author, ANNUAL MEETING Content of th
Slide 2: INT230-6 is a Novel Intratumoral Agent Consisting of Cisplatin, Vinblastine and SHAO
INT230-6 is a Novel Intratumoral Agent Consisting of Cisplatin, Vinblastine and SHAO Cisplatin Cisplatin & Vinblastine • Direct killing: Binds to are co-formulated in a DNA to cause apoptotic cell death fixed ratio with SHAO, a • Immune effects: Attracts tissue dispersion and and binds T-Cells via c
Slide 3: Intratumoral INT230-6 Diffuses in and is Absorbed in Tumors
Intratumoral INT230-6 Diffuses in and is Absorbed in Tumors CYTOTOXICS + dye in H2O INT230-6 + dye in H2O Tumor dose is set Control by the longest Human pancreatic diameter or volume cancer in mouse INT230-6: model Drug NOT absorbed: from 3 dimensions significant leakage Fully absorbed Injections ma
Slide 4: INT230-6 Achieves Significant Cancer Killing With One or Two Doses in Multiple Types of Cancer
INT230-6 Achieves Significant Cancer Killing With One or Two Doses in Multiple Types of Cancer Breast Cancer tumors fully resected 3.9 cm invasive ductal cancer: Grade 3 4.4 cm invasive lobular cancer: Grade 2 May 6 May 13 May 20 May 27 June 16 Injection #1: Injection #2: Surgery Injection #1 (only)
Slide 5: IT-01: A Phase 1/2 Study of Intratumoral INT230-6 in Advanced Refractory Cancers
IT-01: A Phase 1/2 Study of Intratumoral (IT) INT230-6 in Adult Subjects with Advanced Refractory Cancers, incl. Soft Tissue Sarcomas Study Enrollment Completed INT230-6 monotherapy dose escalation by increasing the frequency, dose volume, number of tumors, and concentration of • INT230-6 IT is drug
Slide 6: Demographics of Sarcoma Patients as of 9/1/2022
Demographics of Sarcoma Patients as of 9/1/2022 DEMOGRAPHICS INT230-6 INT230-6 + IPI Median Age 64 (42-76) 63 (33-82) Gender 11 male, 4 female 7 male, 7 female 13.3% ECOG 0 13.3% ECOG 0 ECOG 80.0% ECOG 1 80.0% ECOG 1 6.7% ECOG 2 6.7% ECOG 2 Median number of prior 3 (0-8) 4 (0-9) therapies (range) #
Slide 7: Pharmacokinetics Primary Ingredients of INT230-6
Pharmacokinetics 3 Primary Ingredients of INT230-6 Sarcoma (29 samples) PK of platinum metal first 24 hours PK of SHAO first 24 hours PK of vinblastine first 24 hours following the first INT230-6 dose. following the first INT230-6 dose. following the first INT230-6 dose. >95% of the active agents re
Slide 8: Treatment-Related AEs in Sarcoma of INT230-6 Alone or With IPI
Treatment-Related AEs in Sarcoma of INT230-6 Alone or With IPI Monotherapy INT230-6 NCI-CTCAE Toxicity Grade n (%) (N = 15) Combination with IPI NCI-CTCAE Toxicity Grade n (%) (N = 14) MedDRA Coded MedDRA Coded 1 2 3 Total 1 2 3 Total Preferred Term Preferred Term Any 3(20.0%) 8(53.3%) 3(20.0%) 14(9
Slide 9: In Metastatic Disease Injected Tumors Shrink Over Time
In Metastatic Disease Injected Tumors Shrink Over Time 55.65 mm x 32.48 mm A scan of a chordoma treated with monotherapy highlights tumor 47.5 mm x 18.78 mm regression. Longest diameter declines 15%, whereas 2nd longest diameter declines 42% 9/22/2021 Pre dose scan 3/08/2022 Scan at 6 months Using W
Slide 10: Use of RECIST in Sarcoma May Not Capture Efficacy
Use of RECIST in Sarcoma May Not Capture Efficacy Change in Longest Diameter Change in Volume (using 3 dimensions) % change in diameter % change in volume The lack of correlation between diameter Days Days and volume indicates that RECIST may be unreliable for IT INT230-6 as a metric of efficacy Pre
Slide 11: Multiplex IHC from Matched Pair Biopsies Reveals Immune Activation
Multiplex IHC from Matched Pair Biopsies Using INT230-6 Monotherapy Reveals Immune Activation in Non-Immunogenic Cancers Day 0 Day 28 cancer Ovarian cancer 2 doses increase CD3, CD4, CD4 and CD8 Day 0 Day 28 T-cells within the cancer tumor (DAPI) Liposarcoma Presented by: 2022 Content of this presen
Slide 12: Overall Survival Increased Compared to Historical Results in Sarcoma
Overall Survival Increased Compared to Historical Results INT230-6 Alone or with Ipilimumab in Sarcoma Kaplan Meier estimates sarcoma patients 1 INT230-6 + Ipi combo Dose relative to incoming total 0.9 INT230-6 >40% of TTB 0.8 tumor burden (TTB) show 0.7 increased survival with higher drug ratio 0.6
Slide 13: Phase 3 Trial Design for INT230-6 in Soft Tissue Sarcoma
Phase 3 Trial Design for INT230-6 in Soft Tissue Sarcoma (STS) Schema 2 or 3 Line nd rd HR: 0.65 Overall survival: INT230-6 14.0 months Control 21.5 months INT230-6 Must have had doxorubicin SOC Data readout at 80% of events Two interim looks at 50% and 75% of events: test for futility and endpoint
Slide 14: Conclusions
Conclusions • INT230-6 is well tolerated with favorable safety as monotherapy and in combination with Ipilimumab • PK data indicates drug stays in the tumor • INT230-6 demonstrates direct tumor killing. • Biopsies and resected tumors indicate substantial tumor necrosis can be achieved • Data shows i
Slide 15: Conclusions (Acknowledgments)
Conclusions • The study teams would like to thank the patients and their families who participated in the trial • The study teams coordinators and nurses Le-Anne Stayner Lorraine Martinez Ashley Robichaud Lira C. Roman Tasnia Hasan Xiomara Menendez Ravi Louis Dawn Pepka-Jones Maryia Yanekina Negeen
Slide 16: ANNUAL MEETING Insert Speaker Name and Title
Presented by: 2022 Content of this presentation is the property of the author, ANNUAL MEETING Insert Speaker Name and Title licensed by CTOS. Permission is required to reuse.
Slide 17: ANNUAL MEETING Insert Speaker Name and Title
Presented by: 2022 Content of this presentation is the property of the author, ANNUAL MEETING Insert Speaker Name and Title licensed by CTOS. Permission is required to reuse.