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news.US-based clinical stage biopharmaceutical firm AADi has entered into an inlicensing agreement with Celgene for ABI-009, a nanoparticle albumin-bound (nab) version of the mTOR inhibitor sirolimus or rapamycin.
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The company said that ABI-009 leverages the same technology of the nab platform that is behind the success of ABRAXANE (paclitaxel protein-bound particles for injectable suspension).
Under the deal, AADi will develop ABI-009 initially in oncology and cardiovascular indications.
A Phase I trial for ABI-009 has already been completed in patients with advanced non-hematologic malignancies in which the drug was well tolerated with evidence of activity in heavily pretreated patients.
As part of the agreement, Celgene has the option to reacquire ABI-009 at various stages in development.
AADi has also enrolled first three patients in its new multi-center Phase I/II clinical trial of ABI-009 to treat non-muscle invasive bladder cancer.
The Phase I/II trial is funded in-part through a Fast-Track STTR grant awarded to AADi from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).
Columbia University, which has expertise in bladder cancer, is a consortium partner for AADi as part of the awarded grant and will be the primary clinical trial site.
The company said that Vanderbilt University will also be involved in the clinical trial.
AADi founder, president and chief executive officer Neil Desai said, "The NIH trial funding is a testament to the strong scientific and biological rationale for the use of ABI-009 in bladder cancer where the mTOR activation plays a key role in progression of the disease."
Columbia University Medical Center principal investigator and interim chairman of the department of Urology James McKiernan said, "It is important that we continue to search for new treatments for bladder cancer patients who are all too often faced with surgical removal of their bladder as their only option."
AADi also intends to start clinical trials with ABI-009 in the treatment of peripheral artery disease and pulmonary arterial hypertension, as part of its focus in cardiovascular disease.