On December 14, 2020 ADC Therapeutics SA (NYSE:ADCT) and Overland Pharmaceuticals, a fully integrated biopharmaceutical company backed by Hillhouse Capital, reported that they have jointly formed a new company, Overland ADCT BioPharma (CY) Limited, to develop and commercialize four of ADC Therapeutics’ antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – loncastuximab tesirine (Lonca), ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore (Press release, ADC Therapeutics, DEC 14, 2020, View Source [SID1234572795]). Overland Pharmaceuticals has invested $50 million in Overland ADCT BioPharma to fund operations, including development plans for approval of Lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the licensed territory.
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"ADC Therapeutics’ Biologics License Application for Lonca, which was recently granted priority review status, is currently under review with the U.S. Food and Drug Administration," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "As we prepare for the potential U.S. launch of Lonca in 2021, we are delighted that Overland ADCT BioPharma will expand access to the therapy, as well as three of our other pyrrolobenzodiazepine-based ADCs, to address patient needs in greater China."
Under the terms of the agreement, ADC Therapeutics licensed exclusive development and commercialization rights to Lonca, ADCT-602, ADCT-601 and ADCT-901 for greater China and Singapore to Overland ADCT BioPharma. Overland Pharmaceuticals has invested $50 million in Overland ADCT BioPharma and Overland Pharmaceuticals will have a 51% stake and ADC Therapeutics a 49% stake. As part of the strategic business plan, Overland ADCT BioPharma may consider additional private investors and/or a potential public offering in the future. Both parties will appoint an equal number of nominees to the Board of Directors and a search is underway for a Chief Executive Officer for Overland ADCT BioPharma. ADC Therapeutics can also earn milestone payments and royalties from the regional license agreement with Overland ADCT BioPharma.
"We are pleased to work with ADC Therapeutics, a pioneer in the field of ADCs, on this strategic venture to enable the development and commercialization of multiple targeted therapies for the treatment of patients with difficult-to-treat hematological and solid tumor cancers in greater China and Singapore," said Hua Mu, MD, PhD, Co-founder of Overland Pharmaceuticals. Ed Zhang, MBA, Co-founder of Overland Pharmaceuticals, added, "Overland is committed to developing breakthrough medicines with a mission to bring innovative medicines to patients in Asia. We are excited to bring these first four candidates into the Overland ADCT BioPharma portfolio and look forward to developing this new company into a leading oncology player in greater China."
The Overland ADCT BioPharma pipeline is led by Lonca, an ADC composed of a humanized monoclonal antibody directed against human CD19. Lonca has been evaluated by ADC Therapeutics in a pivotal Phase 2 clinical trial in patients with relapsed or refractory DLBCL and is in two ongoing trials – a Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma and a Phase 3 confirmatory trial in combination with rituximab in patients with relapsed or refractory DLBCL. The Overland ADCT BioPharma portfolio also includes the clinical-stage candidates ADCT-602 targeting CD22, which is currently in a Phase 1/2 clinical trial in patients with relapsed or refractory acute lymphoblastic leukemia, and ADCT-601 targeting AXL, which is currently in a Phase 1 clinical trial in patients with selected advanced solid tumors. ADCT-901 targeting KAAG1 is in preclinical development for the treatment of advanced solid tumors with high unmet medical needs.
MSQ Ventures served as an advisor to ADC Therapeutics on the China strategy and business development process.