KA2507 / Karus Therap, UT MD Anderson Cancer Center - LARVOL DELTA

[VIRTUAL] Phase I study of KA2507, a selective HDAC6 inhibitor, in patients with relapsed or refractory solid tumors (AACR-I 2020) - P1 | "Twenty pts with various tumor types commenced treatment from Aug 2017 to Aug 2019. The median age was 56 years (27-78 years) and 13 were males. The most common tumor types were adenoid cystic carcinoma (ACC, n=6) and colorectal cancer (n=4)."

Clinical • P1 data • PD-L1

[VIRTUAL] A phase II study of selective HDAC6 inhibition with KA2507 for second-line treatment of advanced biliary tract cancer (ABC-11). (ASCO 2020) - P2 | "Background: The ABC-02 trial provided Level A evidence supporting the use of cisplatin plus gemcitabine as first-line chemotherapy for advanced biliary tract cancer (ABC) [Valle, 2010]. In second line therapy oxaliplatin and 5FU and ivosedinib for IDH1 mutated cancers are options [Lamarca, 2019; Abou-Alfa, 2019] however there remains significant unmet need for patients without actionable alterations...The study received regulatory and ethical approval to proceed in January 2020 and enrolment is in progress. Research Funding: Karus Therapeutics Ltd"

Clinical • P2 data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • IDH1

Preclinical development and first in human study of KA2507, a selective and potent inhibitor of histone deacetylase 6, for patients with refractory solid tumors. (PubMed, Clin Cancer Res) - P1 | "KA2507 is a potent and selective inhibitor of HDAC6 showing anti-tumor efficacy and immune modulatory effects in preclinical models. In a phase I study, KA2507 showed selective target engagement, no significant toxicities, and prolonged disease stabilization in a subset of patients. Further clinical studies of KA2507 are warranted, as a single agent or, preferably, combined with other immune-oncology drugs."

Epigenetic controller • Journal • P1 data • Preclinical • Adenoid Cystic Carcinoma • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor

A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Karus Therapeutics Limited; N=40 ➔ 0; Active, not recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

[VIRTUAL] Characterising the role of HDAC6 in the control of human macrophage IL-10 production (ESMO-IO 2020) - "Conclusions These data highlight an emerging role for HDAC6 in modulating the activity of the innate immune system and lend supporting rationale for further study of HDAC6 inhibitors in combination with immunotherapy agents. Data relating to IL-10 expression from the recent clinical study of KA2507 are currently pending."

IO Biomarker • Oncology • IL10

Safety,Tolerability and MTD KA2507 (HDAC6 Inhibitor) in Patients With Solid Tumours (clinicaltrials.gov) - P1; N=20; Completed; Sponsor: Karus Therapeutics Limited; Recruiting ➔ Completed; N=36 ➔ 20; Trial completion date: Jan 2021 ➔ May 2020; Trial primary completion date: Jan 2021 ➔ May 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2; N=40; Active, not recruiting; Sponsor: Karus Therapeutics Limited; Not yet recruiting ➔ Active, not recruiting; Phase classification: P1/2 ➔ P2

Enrollment closed • Phase classification • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology

Safety,Tolerability and MTD KA2507 (HDAC6 Inhibitor) in Patients With Solid Tumours (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Karus Therapeutics Limited; Trial completion date: Oct 2019 ➔ Jan 2021; Trial primary completion date: Oct 2019 ➔ Jan 2021

Trial completion date • Trial primary completion date

Newly added product (clinicaltrials.gov) - P2, Oncology, Biliary Cancer

Pipeline update