Intensity Therapeutics, Inc. · NASDAQ:INTS
Intensity Therapeutics — CTOS 2021
14 slides from Intensity Therapeutics's conference presentation, Oct 15, 2021
Slide 1: Safety and Efficacy from a Phase 1/2 Study of Intratumoral INT230-6 in Metastatic Sarcomas
SAFETY AND EFFICACY FROM A PHASE 1/2 STUDY OF INTRATUMORAL INT230-6 ALONE OR IN COMBINATION WITH IPILIMUMAB [INTENSITY# IT-01; BMS# CA184-592] IN ADULT SUBJECTS WITH METASTATIC SARCOMAS (NCT 03058289) Matthew Ingham, James S. Hu, Giles Whalen, Jacob Thomas, Anthony El-Khoueiry, Diana Hanna, Anthony
Slide 2: INT230-6 is a novel intratumoral agent of cisplatin, vinblastine and SHAO
INT230-6 is a novel intratumoral agent consisting of cisplatin, vinblastine and SHAO Cisplatin & Vinblastine is Cisplatin co-formulated in a fixed • Direct killing: Binds to DNA to cause apoptotic cell ratio with SHAO, a death tissue dispersion and • Immune effects: Attracts cell penetration and bin
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 Human pancreatic Injections made to center cancer in mouse model of tumor over 90 sec Drug NOT absorbed: INT230-6: significant leakage Fully absorbed TUMOR TUMOR TUMOR cut in half Drug leaks int
Slide 4: INT230-6 overcomes problems of current therapies to treat cancer and alter tumors
INT230-6 overcomes problems of current therapies to treat cancer and alter tumors Intratumoral INT230-6 dose Cold Hot T Cell T Cell Tumor microenvironment is unfavorable to treatment Post-INT2306 Injection: Necrotic tumor • Systemic delivered drugs can not reach hypoxic • INT230-6 saturates tumor wi
Slide 5: IT-01: A Phase 1/2 Study of Intratumoral INT230-6 in Adult Subjects
IT-01: A Phase 1/2 Study of Intratumoral INT230-6 in Adult Subjects with Advanced Refractory Cancers, incl. Soft Tissue Sarcomas Phase 1 Completed • INT230-6 dosing is proportional to the Phase 1 INT230-6 monotherapy dose escalation by increasing the frequency, dose volume, number of tumors, and con
Slide 6: Demographics as of July 31, 2021
Demographics as of July 31, 2021 DEMOGRAPHICS • 19 soft tissue sarcoma (STS) subjects (10 Age Median 64 (33-82) monotherapy, 8 combination with ipilimumab, and Gender 11 male, 8 female 1 other checkpoint combination). ECOG 32% ECOG 0 • Demographics were similar in subjects enrolled in 63% ECOG 1 mon
Slide 7: Pharmacokinetics
Pharmacokinetics Pharmacokinetic profiles for Pharmacokinetic profiles for Pharmacokinetic profiles for retained platinum for the first 24 SHAO for the first 24 hours vinblastine for the first 24 hours hours following the first INT230-6 following the first INT230-6 dose following the first INT230-6
Slide 8: Related AEs in INT230-6 alone or checkpoint inhibitor combination
Related AEs in INT230-6 alone or checkpoint inhibitor combination by max severity in >1 STS subject (n=19) Grades Preferred Term 1 2 3 4 5 Total No. of subjects with least 1 AE 4 (21.1%) 10 (52.6%) 4 (21.1%) 0 0 18 (94.7%) Localized tumor-related pain 6 (31.6%) 6 (31.6%) 1 ( 5.3%) 0 0 13 (68.4%) Nau
Slide 9: H&E from matched pair biopsies pre and post two INT230-6 injections
Hematoxylin and Eosin (H&E) from matched pair biopsies from a STS subject pre and post two INT230-6 injections • H&E assessments demonstrated substantial reductions of cancer cells in biopsies from INT230- 6 monotherapy subjects after two injections of INT230-6, when compared to baseline. Image A: P
Slide 10: Multiplex IHC staining from matched pair biopsies
Multiplex IHC staining from matched pair biopsies from an INT230-6 monotherapy STS subject pre and post two INT230-6 injections Image A: Pre-dose Day 0 Image B: Post 2 doses Day 28 Post dose, there is a decrease in Treg cells (red), and an increased presence of T-cells, representing an influx of CD4
Slide 11: Immunohistochemistry & Immunofluorescence Biomarker analysis of tumor and microenvironment
Immunohistochemistry & Immunofluorescence Biomarker analysis of tumor and microenvironment from STS subjects Immunohistochemistry Immunofluorescence analysis of immune cells biomarkers analysis of paired (pre- conducted from biopsies of 9 sarcoma subjects (5 INT230-6 and 28 days post-dose) monothera
Slide 12: Spider plot showing long term stabilization of individual lesions
Spider plot showing long term stabilization of individual lesions in 8 INT230-6 monotherapy STS subjects • Abscopal effects were seen in visceral lesions in 2 INT230-6 monotherapy STS subjects. 12
Slide 13: Overall Survival for STS subjects
Overall Survival for STS subjects • For all sarcoma subjects enrolled in IT-01 study, Kaplan Meier estimates of sarcoma subjects, exploratory ~50% of subjects will be alive at 1 year. Blue analysis by dose, for INT230-6 monotherapy patients dosed to curve (n=19) >40% TTB • In a retrospective explora
Slide 14: Conclusions
Conclusions • INT230-6 is well tolerated as monotherapy and preliminary data suggests that INT230-6 is well tolerated in combination with ipilimumab in a heterogenous group of soft tissue sarcoma subjects. • INT230-6 demonstrates direct tumor killing and abscopal effects. • Biopsies showed substanti