DGAP-News: 4SC AG: Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma

4SC AG: Positive safety review of Phase Ib/II SENSITIZE study of domatinostat + pembrolizumab in melanoma

• Safety Review Committee examined data from third dose cohort
• Combination treatment of domatinostat + pembrolizumab well tolerated and safe
• Data set to be presented at upcoming scientific conference
• A further two cohorts to be initiated

Planegg-Martinsried, Germany, 11 July 2019 - 4SC AG (4SC, FSE Prime Standard: VSC) today announced, that the Safety Review Committee (SRC) consisting of clinical and drug safety experts evaluated the safety data from the third dose cohort in the Phase Ib/II SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665).

The SENSITIZE study is a dose escalation study of domatinostat in combination with the checkpoint inhibitor pembrolizumab - an anti-PD-1 antibody approved in the US and the EU as a cancer immunotherapy - to evaluate the safety and tolerability of the combination treatment. The study is being conducted in patients with advanced-stage melanoma who are non-responding or refractory to prior treatment with checkpoint inhibitors.

The combination of domatinostat and pembrolizumab was confirmed as safe and well tolerated by the SRC at this, the third and highest predefined dose cohort.

Frank Hermann, M.D., Chief Development Officer of 4SC, said: "The SENSITIZE study is a key study to evaluate the safety and tolerability of domatinostat in combination with checkpoint inhibitors such as pembrolizumab. We are pleased to see that the highest predefined dose of domatinostat in combination with checkpoint blockade was safe and well tolerated.

In addition, from the sequential biopsies taken in SENSITIZE, we will be able to generate important biological data on the patient's tumor microenvironment to investigate and support our preclinical data and proposed immuno-modulatory mechanism of action for domatinostat. Data analysis is ongoing, and we intend to publish the clinical and translational data set at an upcoming scientific conference."

Jason Loveridge, Ph.D., CEO of 4SC, added: "Based on the positive safety and tolerability outcome of the first three dose cohorts we will expand the SENSITIZE study and initiate further two cohorts. Taken together, the data from all cohorts will give us important information on how to optimally combine domatinostat with checkpoint blockade and inform our planned clinical studies of domatinostat in other indications.

We plan to initiate several clinical trials of domatinostat in combination with checkpoint inhibitors both in melanoma and Merkel cell carcinoma (MCC) in late 2019 and early 2020 with the intention that one of the MCC studies would be potentially sufficient for registration purposes."

- Press release ends -

Related articles

8 April 2019, Domatinostat's mode of action in Merkel cell carcinoma

6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer

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

Further information

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 two drug candidates in clinical development: resminostat and domatinostat.

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 2019 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

About domatinostat

Domatinostat is an orally administered small molecule class I selective HDAC inhibitor. It strengthens the body's own anti-tumor immune response, influences the tumor and tumor microenvironment, making the tumor more visible to the immune system and facilitates the infiltration of immune cells into the tumor.

Domatinostat has been investigated in a Phase I study in 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's capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 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 in patients with advanced-stage microsatellite-stable gastrointestinal cancer is conducted by Prof. David Cunningham of The Royal Marsden NHS Foundation Trust (London, UK).

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

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.

Contact

4SC
Anna Niedl, Ph.D., CIRO
Corporate Communications & Investor Relations
anna.niedl@4sc.com
+49 89 700763-66

LifeSci Advisors
Hans Herklots
Managing Director
hherklots@lifesciadvisors.com
+41 79 598 7149