Kazia Therapeutics Ltd (ASX:KZA) (NASDAQ:KZIA) (FRA:NV9) has entered an exclusive worldwide licensing agreement with Oasmia Pharmaceutical AB (STO:OASM) (OTCMKTS:OASMY) for Cantrixil (TRX-E-002-1), a clinical-stage, first-in-class drug candidate under development for the treatment of ovarian cancer.
The agreement will see Sweden-based Oasmia, an innovation-focused specialty pharmaceutical company, assume worldwide exclusive rights to develop and commercialise Cantrixil for all indications, with an initial focus on ovarian cancer.
Oasmia's lead product, Apealea® (paclitaxel micellar), is approved in Europe for adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer, and is in late-stage clinical development in the US.
It expects to commence a Phase II study of Cantrixil in ovarian cancer in 2022.
“Passing the baton”
Kazia CEO Dr James Garner said: “Oasmia possesses deep expertise in the field of ovarian cancer, and also brings to Cantrixil a highly commercial focus, world-class formulation capabilities, and an extensive network of clinician relationships in Europe and the US.
"This transaction follows the release of very encouraging top-line data from the phase I study of Cantrixil late last year.
"Our strategy has been to seek a partner for Cantrixil’s further development, and we are delighted to now pass the baton to the Oasmia team.”
Under the terms of the agreement, Oasmia will make an upfront payment of US$4 million to Kazia, with contingent milestone payments of up to US$42 million and double-digit royalties on commercial sales.
“Exciting addition”
Oasmia CEO Dr François Martelet said: “Cantrixil is an exciting addition to Oasmia’s oncology pipeline and builds on our development expertise in ovarian cancer.
“Expanding Oasmia’s portfolio of therapies and technologies is a key pillar of our transformation strategy.
“Acquiring rights to Cantrixil, which has established clinical proof of concept, is a major step forward in executing this strategy, and we will continue to leverage our development and partnering expertise to build our oncology pipeline.”
Cantrixil (TRX-E-002-1)
Cantrixil is a proprietary formulation of the potent and selective third-generation benzopyran, TRX-E-002-1, that targets the entire spectrum of cancer cells, including chemotherapy-resistant tumour-initiating cells (cancer stem cells) thought to be responsible for disease relapse.
In December 2020, Kazia announced top-line results of a Phase I open-label study (NCT02903771) conducted at sites in the US and Australia, covering both monotherapy and combination therapy in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer.
The Phase I study met its primary endpoints and full data are expected to be published in a peer-reviewed scientific journal during 2021.
Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015.
Kazia’s lead program is paxalisib (formerly GDC-0084), a small molecule inhibitor of the PI3K/AKT/mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults.