On March 19, 2020 Tarveda Therapeutics, Inc. ("Tarveda"), a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, for the treatment of patients with various solid tumor malignancies, and SciClone Pharmaceuticals International Ltd., ("SciClone") reported that they have entered into a licensing agreement for PEN-866, the initial clinical program from Tarveda’s HSP90 binding miniature drug conjugate platform, which is designed to bind to the activated form of Heat Shock Protein 90 (HSP90) to accumulate and release its potent topoisomerase 1 inhibitor (SN-38) payload in solid tumors (Press release, Tarveda Therapeutics, MAR 19, 2020, View Source [SID1234555737]).
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Under the terms of the agreement, SciClone will obtain exclusive licensing rights to co-develop and commercialize PEN-866 in the Greater China territory, including mainland China, Hong Kong, Macau and Taiwan. SciClone will be responsible for development, product registration and commercialization in these territories. Per the agreement, SciClone will pay Tarveda an upfront payment of U.S. $4 million with the right to make a future equity investment in Tarveda of up to U.S. $5 million. Tarveda will be eligible to receive up to $75 million in aggregate development, approval and commercial sales milestone payments. Tarveda is also eligible to receive royalties based on sales in the Greater China territory. Shanghai Yafo Capital Asset Management Co., Ltd acted as banking and financial advisor on this transaction for Tarveda.
"We are excited to partner with SciClone, a leading specialty pharmaceutical company with valuable experience developing and commercializing oncology and infectious disease products in Greater China that shares our dedication to advancing PEN-866," said Drew Fromkin, President and Chief Executive Officer of Tarveda. "We have completed Phase 1 clinical trials for PEN-866 and look forward to working closely with SciClone as PEN-866 moves into the later phases of its development. With SciClone’s experienced team and broad knowledge related to bringing drugs to commercialization in the Greater China region, we are confident that we have found an excellent partner to help advance PEN-866 in China."
"Tarveda’s HSP90 binding miniature drug conjugate platform offers a promising approach to the development of precision oncology medicines," said Hong Zhao, President and Chief Executive Officer of SciClone. "We are pleased to partner with the Tarveda team to develop and commercialize PEN-866, the first clinical program from Tarveda’s HSP90 binding miniature drug conjugate platform, in the Greater China region."
PEN-866 is a miniature drug conjugate that preferentially binds to the activated form of HSP90 in solid tumors and is linked to the topoisomerase 1 inhibitor (SN-38), a potent anti-cancer payload. PEN-866 is designed to accumulate and be retained in tumors. As the SN-38 payload is cleaved in the tumor over time, the sustained release of SN-38 in the tumor results in prolonged DNA damage and tumor regressions as demonstrated in multiple patient-derived and other xenograft tumor models. PEN-866 has recently completed the Phase 1, all-comers, dose escalation and safety portion of its Phase 1/2a clinical trial. PEN-866 is the first miniature drug conjugate from Tarveda’s HSP90 binding drug conjugate platform.
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This communication may be deemed to be solicitation material in respect of the proposed transaction between Organovo Holdings, Inc. ("Organovo") and Tarveda. In connection with the proposed transaction, Organovo has filed relevant materials with the SEC, including a registration statement on Form S-4 that contains a proxy statement/prospectus/information statement, which was declared effective on February 24, 2020. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Stockholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by Organovo with the SEC in connection with the proposed transactions at the SEC’s website (View Source) and at Organovo’s website (www.organovo.com).
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