Context Therapeutics and Tyligand Bioscience Reach ONA-XR Manufacturing Optimization Milestone

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PHILADELPHIA, PA — Context Therapeutics Inc. and Tyligand Bioscience, Ltd. announced the successful completion of ONA-XR (onapristone extended release) manufacturing process optimization pursuant to the collaboration agreement entered into between the parties in March 2020.

ONA-XR is an orally administered, potent and specific antagonist of the progesterone receptor (PR) being evaluated in the clinic for PR-positive (PR+) breast, ovarian and endometrial cancers.

In connection with this successful optimization, Context and Tyligand entered into a license agreement whereby Tyligand was granted the exclusive right and sole responsibility for the development and commercialization of ONA-XR in China, Hong Kong and Macau (the “Territory”), and Context is eligible to receive royalties on net sales of ONA-XR in the Territory. Context retains rest of world rights to commercialize ONA-XR.

“We are thrilled to announce this successful optimization work completed for ONA-XR and the execution of the license agreement with Tyligand,” said Martin Lehr, CEO of Context. “This work represents another major step forward for Context’s ability to efficiently scale our manufacturing and clinical capacity to support the development and future commercialization of ONA-XR to address the unmet need in treating women with PR+ cancers.”

“Onapristone has an intriguing molecular structure, and it is no small feat to achieve such a significant improvement in its manufacturing process,” said Peter Wuts, PhD, a pharmaceutical veteran and Senior Advisor to Context. “It is a testament to the drive and creativity of the Tyligand team of molecule builders and the power of chemistry in making better medicines.”

“Tyligand and Context share the commitment of providing effective and affordable treatment options for cancer patients globally and this milestone brings us closer to realizing our goal,” said Tony Zhang, PhD, CEO of Tyligand. “ONA-XR has the potential to be the first-in-class therapeutic agent specifically targeting progesterone receptors and we look forward to working with Context in further developing and commercializing this excellent molecule.”

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