Berlin, September 15, 2020 - Bayer has signed an exclusive global license agreement with Systems Oncology, LLC for ERSO ™, an orally administered drug in preclinical development for the treatment of metastatic estrogen receptor-positive (ER +) breast cancer. ERSO is a small molecule active ingredient that activates the so-called Unfolded Protein Response (UPR), a control mechanism in the cell, in ER + breast cancer cells. Its innovative mechanism of action offers significant potential for a novel treatment option in women with metastatic ER + breast cancer, an area in which new therapies are urgently needed.
"Despite the general advances in breast cancer treatment, there are limited treatment options for patients with advanced disease, especially those in the metastatic stage," said Robert LaCaze, member of the Executive Committee of the Pharmaceuticals Division and head of the Oncology Strategic Business Unit at Bayer. “In line with our oncology strategy of focusing on areas of high unmet medical need and innovative approaches with the potential to significantly improve treatment, we are excited to partner with Systems Oncology to develop ERSO. ERSO offers a promising innovative approach to treating many women with ER-positive breast cancer, and is expanding our portfolio so that we can offer new therapies for patients,
With over 2 million new cases worldwide in 2018, breast cancer is the most common tumor type in women and the second most common tumor type overall. The prognosis as well as the available treatment options strongly depend on the subtype and stage of the breast cancer. Around 70% of all women with breast cancer suffer from ER + disease, with the survival rate for metastatic ER + breast cancer being only 20%. Therefore, additional treatment options beyond established anti-hormonal treatment approaches are urgently needed.
In preclinical studies, ERSO showed activity in ER + breast cancer cells as well as activity in ER mutations that are resistant to standard treatments. The mode of action of ERSO to activate the unfolded protein response (UPR) in ER + breast cancer cells offers a significant differentiation from current and potential future anti-hormonal agents. In addition, the therapeutic potential of this novel mode of action is also being investigated for other types of tumors.
“Given ERSO's unique mechanism and potential to reshape cancer care, it was important for us to find a collaborative partner who would innovate. Bayer shares our vision for ERSO and has the clinical, scientific and business expertise to be successful, ”said Dr. Spyro Mousses, CEO and Co-Founder of Systems Oncology.
"With the experienced Bayer team who will lead the development program, I assume that this novel approach has the potential to bring about a real paradigm shift for breast cancer treatment," said Dr. Joyce O'Shaughnessy of Baylor University Medical Center in Texas Oncology, US Oncology.
"The collaboration with Systems Oncology combines their specialised know-how in identifying novel treatment approaches with our globally established profile of providing new treatment options for better patient outcomes," said Marianne De Backer, PhD, MBA, member of the Executive Committee of the Pharmaceuticals Division of Bayer and Head of Strategy and Business Development & Licensing. "It underlines our commitment to enter into partnerships for innovative treatment approaches at all levels."
Under the terms of the agreement, Bayer will be responsible for developing and commercialising ERSO worldwide. Systems Oncology will receive a $ 25 million upfront payment and, upon reaching certain development and commercialisation milestones totalling $ 345 million, as well as royalties for future global net sales, will receive payments from Bayer.
Bayer’s Pharmaceuticals Business Development & Licensing Team initiated the license agreement.
About ERSO ™
Systems Oncology scientists entered into a strategic research collaboration with two University of Illinois professors, Dr. David Shapiro and Dr. Paul Hergenrother, who conducted pioneering research into the biology and chemistry of the activation of UPR in breast cancer. The research resulted in proprietary novel small molecule drugs that can selectively and quantitatively kill cancer cells by hyperactivating the UPR. Inspired by a multi-scalar systems understanding of this mechanism, Systems Oncology licensed the university and invested in the advancement of preclinical studies and manufacturing development to eventually establish the ERSO program as a promising therapeutic compound with transformative potential.
A current poster describing ERSO,
https://www.systemsoncology.com/wp-content/uploads/2020/02/Quantitative-Regression-of-Estrogen-Receptor-Alpha-Positive-Breast-Cancer.pdf
