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Catalysts Galore For 4SC AG

4sc oct09 lt

Shares of Germany-based 4SC AG (VSE.F), which trade on the Frankfurt Stock Exchange, have gained 7 percent over the last seven trading days.

4SC AG is a clinical-stage biopharmaceutical company developing drugs for the treatment of cancer. The Company has two drugs in clinical development - Resminostat and Domatinostat - and a third compound, 4SC-208, that is in the pre-clinical stage.

Resminostat and Domatinostat are oral histone-deacetylase (HDAC) inhibitors. The HDAC inhibitors modify the DNA structure of tumor cells to cause their differentiation and programmed cell death (apoptosis), with the potential to halt tumor progression and induce tumor regression.

4SC-208 specifically targets two kinases that play a key role in Hedgehog/GLI signaling - a signaling pathway that is critical for tumor development, proliferation, and survival.

Resminostat is currently under a pivotal phase II study as a maintenance therapy in cutaneous T-cell lymphoma, dubbed RESMAIN.

Initiated in November 2016, this study has enrolled over 140 patients with advanced-stage Mycosis Fungoides (MF) or Sézary Syndrome, the most common subtypes of cutaneous T cell lymphoma. The study is expected to be fully enrolled this year, with top-line results anticipated towards the middle of 2020.

If all goes well as planned, the Company plans to seek approval of Resminostat for cutaneous T-cell lymphoma in Europe and in the U.S. and its partner Yakult Honsha will file for approval in Japan.

Another ongoing trial with Resminostat is a phase II study in the indication of biliary tract cancer. This study, which is being conducted by 4SC AG's partner Yakult Honsha, is expected to be completed next year.

Next up in the pipeline is Domatinostat.

Domatinostat in under a phase Ib/II study in combination with Merck's Keytruda (Pembrolizumab) in adult patients with advanced (unresectable or metastatic) cutaneous melanoma primary refractory or non-responding to anti-PD-1 therapy, dubbed SENSITIZE.

Initiated in September 2017, the SENSITIZE study is designed to enroll 40 patients.

Data from the first part of the phase Ib/II SENSITIZE study were presented at the European Society for Medical Oncology Congress last month.

According to the Company, Domatinostat in combination with Keytruda was safe and well tolerated and signs of efficacy were observed, including one patient with a confirmed partial response and 7 patients with stable disease.

Domatinostat is also being studied in a phase II trial in combination with the anti-PD-L1 antibody avelumab (Bavencio) in patients suffering from microsatellite-stable esophago-gastric and colorectal (MSS-GI) cancer, dubbed EMERGE.

This investigator-sponsored study is designed to enroll 75 patients and is expected to be completed in 2020.

In the coming months, the Company is planning to initiate the following trials with Domatinostat.

-- phase II study of Domatinostat in combination with a checkpoint inhibitor in second-line Merkel cell carcinoma, dubbed MERKLIN 2, is expected to start in late-2019, with initial topline data anticipated in the first half of 2021.
-- phase II study of Domatinostat in combination with a checkpoint inhibitor as first-line therapy in advanced-stage Merkel cell carcinoma, dubbed MERKLIN 1, is expected to start in early-2020.
-- phase I proof-of-concept study of Domatinostat in combination with a checkpoint inhibitor in the neo-adjuvant setting in melanoma, dubbed DONIMI, is expected to start in late-2019, with top-line data expected to be available as early as the second half of 2020.
-- phase II study of Domatinostat in combination with two checkpoint inhibitors in advanced-stage melanoma.

Partners & Licensees:

In April 2011, 4SC AG granted an exclusive license to Yakult Honsha for the development and commercialization of Resminostat in Japan.

In May 2016, the Company granted Link Health Group, also known as Guangzhou LingSheng Pharma Tech Co. Ltd., licensing rights for the development and marketing of a cancer compound 4SC-205 in China, Hong Kong, Taiwan, and Macao.

In July 2017, 4SC granted an exclusive worldwide license to Maruho Co., Ltd. for a preclinical compound class inhibiting the ion channel Kv1.3.

Financial Numbers

The Company has no marketed products but generates revenue mainly from milestone payments received from its cooperation partners Maruho Co., Ltd. and Guangzhou LingSheng Pharma Tech Co., Ltd.

In the second quarter of 2019, revenue increased by 14% to €1,209 thousand compared to €1,064 thousand in the year-ago quarter. The net loss for the period narrowed by 49% to €2,082 thousand from €4,113 thousand in the year-ago period.

4SC ended June 30, 2019 with cash and cash equivalents of €17,751 thousand.

The Company is slated to report third-quarter financial results on October 17, 2019.

VSC.F has traded in a range of 1.83 EUR to 3.57 EUR in the last 1 year. The stock is trading at EUR 2.05, unchanged from the previous day's close.

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