4SC AG: FDA approves IND application for domatinostat (4SC-202) in melanoma

IND approval paves the way for U.S. clinical trials with domatinostat


Planegg-Martinsried, Germany, 15 August 2018 – 4SC AG (4SC, FSE Prime Standard: VSC) today announced that it has received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for domatinostat (4SC-202) in melanoma.

Jason Loveridge, Ph.D., CEO of 4SC, said: “The FDA’s approval of our IND application in melanoma is a major milestone for the clinical development of domatinostat in melanoma, and will also facilitate future IND applications of domatinostat in other indications. We are currently enrolling advanced-stage melanoma patients in the Phase Ib/II SENSITIZE study in Germany, but will look to expand the study into the U.S. in 2019.”

Related press releases

31 July 2018, First patient enrolled in 2nd dose cohort of Phase Ib/II study SENSITIZE of domatinostat (4SC-202) + pembrolizumab in melanoma

3 July 2018, Positive safety review of 4SC’s Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma

17 April 2018, 4SC at AACR: Broadened clinical options for 4SC-202

About domatinostat (4SC-202)

Domatinostat is an orally administered small molecule Class I selective HDAC inhibitor with a unique mode of action designed to strengthen the body’s own anti-tumor immune response. Domatinostat also influences the tumor microenvironment facilitating infiltration of immune cells into the tumor and making it more visible to the immune system.

Domatinostat has been investigated in a Phase I study with 24 heavily pretreated patients with several types of advanced hematologic cancers and was well tolerated. Positive signs of anti-tumor efficacy were also observed; with one complete remission (28 months) and one partial responder (8 months).

In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating domatinostat in combination therapies. 4SC initiated a Phase Ib/II study of domatinostat in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma. A second Phase II study of domatinostat in combination with the anti-PD-L1 checkpoint inhibitor avelumab, conducted by an academic partner in gastrointestinal cancers, is expected to start soon.

As soon as results from the aforementioned trials will be available, 4SC plans to advance domatinostat into a pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory patients with advanced Merkel cell carcinoma (MCC).

 About the SENSITIZE study – Domatinostat (4SC-202) + pembrolizumab for the treatment of melanoma

The SENSITIZE Phase Ib/II study (ClinicalTrials.gov identifier: NCT03278665) was opened for recruitment in September 2017, and is conducted at 6 certified skin cancer centers in Germany. It will enroll up to 40 patients with unresectable advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies (checkpoint inhibitors). In the first part of the study, 3 cohorts will be treated at different dose levels of domatinostat in combination with pembrolizumab. In the second part, additional patients will be treated with the recommended dosing regimen defined in the first part of the study.

The primary goal of the study is to determine the safety and tolerability of domatinostat in combination with pembrolizumab and key secondary endpoints aim to assess the anti-tumor activity of the combination treatment. Additionally, the study will investigate changes in key immunological biomarkers to better understand how domatinostat renders patients more susceptible to treatment with checkpoint inhibitors. 4SC anticipates top-line data to be available in H1 2019.

About 4SC

4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs. 4SC’s pipeline is protected by a comprehensive portfolio of patents and currently comprises three key drug candidates in various stages of preclinical and clinical development: resminostat, domatinostat (4SC-202) and 4SC-208.

4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 47 employees as of 31 March 2018 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond 4SC’s control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

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