Tocagen has granted ApolloBio exclusive rights to its Phase III two-part cancer immunotherapy candidate Toca 511 (vocimagene amiretrorepvec) and Toca FC in the greater China region, in a deal that could generate up to $127 million-plus for Tocagen.

Under the companies’ license agreement, ApolloBio has agreed to develop and commercialize biologic Toca 511 and small-molecule Toca FC in China as well as Hong Kong, Macao, and Taiwan.

Toca 511 is a retroviral replicating vector designed to selectively infect cancer cells and deliver a gene for the enzyme cytosine deaminase (CD). The infected cancer cells then carry the CD gene and produce CD.

Toca FC is an oral extended-release formulation of the prodrug 5-fluorocytosine (5-FC), which is converted into an anticancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU is designed to kill cancer cells and immune-suppressive myeloid cells in the tumor microenvironment, which according to Tocagen results in anticancer immune activation and subsequent tumor killing.

Toca 511 and Toca FC are under study in the global Phase III Toca 5 trial (NCT02414165) in patients with recurrent high-grade glioma. The study is estimated to enroll 380 participants and has an estimated primary completion date of December 2019.

The two-part cancer immunotherapy has received the FDA’s Breakthrough Therapy designation and the European Medicines Agency’s PRIority MEdicines (PRIME) designation.

ApolloBio has agreed to pay Tocagen $16 million upfront, and up to $111 million in payments tied to achieving development and commercial milestones—including a $4 million payment for “near-term” milestones that include completion of the clinical trial. Tocagen is also eligible to receive low double-digit tiered royalty payments based on net sales.

Regulatory Changes

“ApolloBio brings valuable regional expertise in product development, regulation, and healthcare access, positioning our lead product to advance toward patients in the greater China region as quickly and efficiently as possible,” Tocagen CEO Marty Duvall said in a statement. “As an innovative biopharmaceutical company in China, ApolloBio is well positioned to leverage China's recent regulatory changes supporting the development of new medicines.”

China’s FDA last year began carrying out reforms designed to shorten reviews and approval timeframes for new drugs and devices. The reforms include acceptance of data from clinical trials conducted outside China, quicker reviews of drugs and devices intended to address life-threatening diseases or critical unmet medical needs, and conditional approvals for new rare disease drugs that already have approvals elsewhere in the world.

Last month, China’s State Council proposed creation of a new State Drug Administration that would oversee reviews and approvals of drugs and medical technologies, supplanting the China FDA—in the latest move to align China’s drug regulation with global standards, also reflected in China joining the International Council for Harmonization.

The companies said the number of projected new diagnoses of high-grade glioma this year were about 47,000 in greater China and 180,000 worldwide. Standard treatment includes surgery, radiation therapy, and chemotherapy.

“Toca 511 and Toca FC is a highly promising, best-in-class cancer-selective immunotherapy, and we look forward to working with Tocagen to advance this innovative late-stage product toward commercialization,” added ApolloBio CEO Weiping Yang, Ph.D.

ApolloBio’s license is subject to satisfaction of customary conditions, and is expected to become effective in the second quarter, the companies said.

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