Health Canada issued a Notice of Compliance with Conditions for Imbruvica (ibrutinib) an oral, once-daily single-agent therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma.
The approval with conditions is based on phase II clinical trial data that were published in the New England Journal of Medicine, showing an overall response rate of nearly 68 percent based on investigator assessment.
Imbruvica is co-developed by Cilag GmbH International, a member of the Janssen Pharmaceutical Companies, and Pharmacyclics LLC, an AbbVie company. Janssen Inc. markets Imbruvica in Canada.
Imbruvica was first approved in Canada in November 2014 for the treatment of patients with the blood cancer chronic lymphocytic leukemia, including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL with 17p deletion. For this clinical use, Imbruvica was issued marketing authorization without conditions.
The European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, granted orphan drug designation to synthetic hypericin, the active pharmaceutical ingredient in SGX301, for the treatment of cutaneous T-cell lymphoma, a rare disease and a class of non-Hodgkin’s lymphoma.
SGX301 has previously been granted both orphan drug and fast track designations from the FDA for the first-line treatment of CTCL.
Soligenix Inc., the drug’s sponsor, is currently working with leading CTCL centers, as well as with the National Organization for Rare Disorders and the Cutaneous Lymphoma Foundation to begin a 120 subject pivotal phase III clinical trial with SGX301 in the second half of 2015.
SGX301 is a novel, first-in-class, photodynamic therapy utilizing visible light for activation. Synthetic hypericin is a potent photosensitizer which is topically applied to skin lesions and activated by visible fluorescent light.
In a phase II, double-blind, placebo-controlled clinical study in CTCL patients, the drug was safe and well tolerated, with 58.3 percent of the CTCL patients responding to SGX301 treatment compared to only 8.3 percent receiving placebo (p <= 0.04).
AstraZeneca and Heptares Therapeutics entered into a licensing agreement under which AstraZeneca will acquire exclusive global rights to develop, manufacture and commercialize the adenosine A2A receptor antagonist HTL-1071, a small molecule immuno-oncology candidate.
AstraZeneca will focus on exploring HTL-1071 and any additional compounds across a range of cancers, including in combination with its existing portfolio of immunotherapies.
The companies will also collaborate to discover further A2A receptor-blocking compounds for development in cancer immunotherapy.
Heptares will receive an upfront payment of $10 million and is eligible to receive additional milestone payments based on agreed pre-clinical and clinical events. Subject to successful completion of development and commercialization milestones, Heptares is also eligible to receive more than $500 million as well as royalty payments.
Mirati Therapeutics Inc. and MedImmune, the global biologics research and development arm of AstraZeneca, announced they have entered into an exclusive clinical trial collaboration.
The phase I/II study will evaluate the safety and efficacy of Mirati’s investigational spectrum-selective histone deacetylase inhibitor, mocetinostat, in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736).
This novel combination will initially be evaluated in patients with non-small cell lung cancer with the potential to explore additional indications in the future.
Mocetinostat selectively inhibits class I HDAC enzymes, which has the potential to enhance the positive effect of checkpoint inhibitors, such as durvalumab, on tumor immunity, while durvalumab is designed to counter the tumor’s immune-evading tactics by blocking a signal that helps tumors avoid detection.
Under the terms of the agreement, Mirati will conduct and fund the initial phase I/II clinical trial, which is expected to start in 2016, and MedImmune will supply durvalumab for the trial.
In the event that the initial clinical trial demonstrates positive results, MedImmune will have an exclusive period of time in which to negotiate a commercial license for the combination in this indication.