cisplatin/vinblastine/SHAO-FA (INT230-6)

P2, N=54, Not yet recruiting, Swiss Group for Clinical Cancer Research

P3, N=333, Not yet recruiting, Intensity Therapeutics, Inc.

Preliminary evidence shows that a single dose of INT230-6 can cause significant intratumoral necrosis compared to saline especially in tumors >2. cm. INT230-6 stimulates an immune response in breast cancers prior to surgery with minimal adverse effects and good tolerability.

INT230-6 use was associated with immune infiltration and a clinically relevant mOS particularly when ≥40% of the TTB was injected. Uninjected tumors shrank in a high percentage of monotherapy subjects. INT230-6 dosed IT alone or with IPI had favorable safety in diverse sarcomas.

P1/2, N=110, Completed, Intensity Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> Feb 2023 | Trial primary completion date: Jul 2022 --> Feb 2023

P1/2, N=110, Active, not recruiting, Intensity Therapeutics, Inc. | Recruiting --> Active, not recruiting | N=180 --> 110

Intratumoral INT230-6 appears well-tolerated in this heterogenous soft tissue sarcoma population, and early safety with the IPI combination appears favorable. INT230-6 monotherapy treatment resulted in encouraging signs of tumor burden reduction in injected and non-injected lesions, and immune activation. Given the poor cor- 93 relation of RECIST responses and OS in this population, preliminary analysis of OS from this study compares favorably to historical results from a P1/2 basket sarcoma study with a similar, heavily pretreated, heterogeneous sarcoma population balanced for three prognostic health criteria: albumin and lactase dehydrogenase levels and a subject’s number of metastatic sites.

P2, N=90, Recruiting, Ottawa Hospital Research Institute | N=60 --> 90

This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents.

P2, N=60, Recruiting, Ottawa Hospital Research Institute | Not yet recruiting --> Recruiting

P2, N=60, Not yet recruiting, Ottawa Hospital Research Institute

Background: INT230-6 is comprised of cisplatin (CIS), vinblastine (VIN) and an amphiphilic penetration enhancer which facilitates dispersion throughout tumors and diffusion into cancer cells when given IT. Proof of concept was demonstrated that INT230-6 delivers high drug doses into the tumor without systemic exposure and typical cytotoxic AEs. Systemic and local immune activation was observed. INT230-6 was safe and well tolerated in > 175 deep tumor injections with tumor burden reduction in injected and non-injected tumors (an abscopal effect).