Menarini Group will receive exclusive licensing rights for the development and marketing of 4SC’s lead cancer compound resminostat in the Asia-Pacific region, except Japan, through a regional subsidiary. The deal could generate more than €95 million (about $101.4 million) for 4SC, the companies said today.

Menarini Asia-Pacific Holdings (Menarini AP) will control licensing and development rights to reminostat in countries that include China, South Korea, Australia, Thailand, Philippines, Indonesia, and Vietnam.

Menarini AP will oversee clinical development, regulatory approval and commercialization of resminostat in China, and other territories included in the agreement, in all oncological indications, especially hepatocellular carcinoma (HCC).

4SC considers Asia-Pacific and China in particular to be key strategic markets for resminostat, since more than 75% of all HCC cases occur in the region—largely in association with chronic hepatitis B virus (HBV) infection—while about half of HCC cases globally occur in China alone.

“We are convinced that Menarini AP, with its vast commercial experience in Asia and broad capabilities in clinical development and regulatory processes, is a perfect partner for us – and an ideal complement to our existing resminostat partner Yakult Honsha in Japan,” Enno Spillner, 4SC’s CEO, said in a statement.

Yakult Honsha is currently developing resminiostat through two randomized clinical Phase II trials in Japanese and Korean patients in HCC and non-small cell lung cancer (NSCLC).

John Graham, CEO of Menarini AP, noted that oncology represents a strategic area of focus for the Menarini Group. Cancer—especially solid tumors, blood cancer, and support therapies—is among key therapeutic areas for the Italian-based drug developer, along with analgesia, gastro-intestinial disorders, and osteoarthritis.

Menarini AP agreed to pay 4SC upfront cash and payments tied to achieving regulatory and commercialization milestones. 4SC is also eligible for double-digit royalties on sales of resminostat.

Resminostat is an oral histone-deacetylase (HDAC) inhibitor designed to fight cancer by modifying the three-dimensional chromatin DNA structure of tumor cells and trigger cell differentiation, which can ultimately result in apoptosis. The compound is being developed for a broad spectrum of cancer indications, both as a monotherapy and in combination with other oncology drugs.

Last month at the European Cancer Organisation’s 2nd Immunotherapy of Cancer Conference (ECCO ITOC-2) in Munich, 4SC presented new preclinical data of resminostat’s immunomodulating effects, including re-programming cancer cells and enhancing the immune system's defense mechanism against them.

4SC also said the data showed that resminostat strongly reduced the expression of immunosuppression mediating enzymes IDO1 and ARG1; and led to upregulation of NK cell ligands and a strong boost of NK cells while also significantly enhancing expression of several cancer antigens and MHC class I molecules on several tumor cell lines—thus making tumor cells more visible for recognition by the T cells of the immune system, leading to more effective elimination of the tumor cells, the company stated.

According to 4SC, resminostat holds potential to significantly improve the effect of checkpoint inhibitors (PD1/PDL1) and other immunotherapeutic approaches in oncology—from antibodies such as rituximab, to immunostimulating agents such as TLR ligands—when applied in combination therapy with these drugs in clinical settings.








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