According to a new research report “Phosphatidylinositol 3-Kinase (PI3K) Inhibitors Pipeline Analysis, 2017 – Clinical Trials & Results, Patent, Designation, Collaboration and Other Developments” published by P&S Market Research, PI3K inhibitors currently exhibits a strong pipeline with approximately 37 drug candidates.
PI3K inhibitors pipeline analysis
The PI3K inhibitors pipeline analysis report covers approximately 37 active drug candidates, of which eight drug candidates are in Phase III stage, 10 drug candidates are in Phase II stage, nine drug candidates Phase I stage, eight in Pre-Clinical stage and two drug candidates are in Discovery stage.
Phosphatidylinositol 3-kinases (PI3K) are lipid kinases that are involved in cell regulation, including cell survival, proliferation and differentiation. They act as intermediate molecules in PI3K/AKT/mTOR signaling pathway by sending chemical messengers from cell surface to cytoplasm. These signals activate multiple effector kinase pathways, resulting in survival and growth of normal cells. Phosphatidylinositol 3-kinases is categorized on the basis of classes as class I, II and III, on the basis of structure of the PI3K, based on the specificities of the substrate as well as on the basis of lipid end-product’s nature. Bases on structure, Phosphatidylinositol 3-kinases has four different forms PI3K alpha, PI3K beta, PI3K gamma and PI3K delta.
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Pipeline Insights
The pipeline for PI3K inhibitors was analyzed based on route of administration, molecule type and phase of drugs. Based on route of administration, around 57.0% active drug candidates are being developed to be administered by oral route, 8.0% by intravenous route and 5.0% to be administered by other routes, including inhalation and intravitreally or subconjunctivally. Most of the drug candidates are being developed to be administered by oral route, due to high patient compliance. Route of administration of around 30.0% active PI3K drug candidates pipeline is not disclosed.
Several companies are targeting PI3K pathways for the treatment of cancer and various other diseases in different phases. The pharmaceutical companies engaged in manufacturing of PI3K inhibitors include, but are not limited to, Novartis Pharmaceuticals, F. Hoffmann-La Roche AG, Verastem, Inc., Bayer AG, GlaxoSmithKline plc, SignalRX Pharmaceuticals Inc., Eli Lilly and Company and PIQUR Therapeutics AG. Novartis AG is developing Buparlisib and Alpelisib, which are Phase III drug candidates.
Positive clinical results from drug candidates targeting PI3K
In March 2017, Bayer AG presented clinical results of Phosphoinositide 3-kinase (PI3K)-targeting drug candidate Copanlisib in Phase II CHRONOS-1 trial, evaluating patients with relapsed or refractory indolent non-Hodgkin’s lymphoma (iNHL), trial with NCT ID 01660451. The results across all patient groups showed an objective response rate (ORR) of 59.2%, with a 12% complete response (CR) rate and a median duration of response (DOR) of more than 98 weeks, or 687 days (range 0-687). The full analysis set comprised of 142 patients, of which 141 patients had iNHL. At the time of analysis, median duration of treatment was 22 weeks and 46 patients remained on treatment. In the FL subset of CHRONOS-1 (n=104), copanlisib treatment resulted in an ORR of 58.7%, including a CR of 14.4% and a median median duration of response of more than 52 weeks, or 370 days (range 0-687), with safety being generally consistent. The most common treatment-related adverse events were transient hyperglycemia (all grades: 49%/Grade ≥3: 40%), which did not show severity above Grade 4, and hypertension (all grades: 29%/Grade ≥3: 23%), which did not show severity above Grade 3.
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Phase III – Highest stage of development in PI3K inhibitors pipeline
There are eight PI3K inhibitors in the Phase III stage of development. Among them, Alpelisib is a drug candidate of Novartis Pharmaceuticals AG for the treatment of estrogen receptor positive (ER+) breast cancer. It is in Phase II stage for adenocarcinoma lung cancer, squamous cell lung carcinoma, in Phase I/II stage for acute myeloid leukemia and myelodysplastic syndromes. It is also in Phase I stage for head and neck cancer, breast cancer, esophageal squamous cell carcinoma, colorectal cancer, pancreatic neuroendocrine neoplasms, renal cancer and ovarian cancer. The drug candidate targets PI3K alpha isoform and inhibits its action. It is being developed to be administered by oral route.
Major companies collaborate for the development of PI3K inhibitors pipeline
The research found that different companies engaged in manufacturing of PI3K inhibitors are collaborating. One of the collaborations occurred in November 2016 between Verastem, Inc. and Infinity Pharmaceuticals, Inc. Under the terms of the agreement, Verastem, Inc. licensed all exclusive worldwide rights to develop and commercialize Infinity’s oncology product candidate duvelisib. Verastem paid Infinity Pharmaceuticals, Inc. up to $28.0 million in milestones, with positive data from DUO, a Phase III, randomized monotherapy study of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia, triggering the first milestone payment, and royalties on net sales.
Some of the key players developing PI3K inhibitors pipeline include Novartis Pharmaceuticals, F. Hoffmann-La Roche AG, SignalRX Pharmaceuticals Inc., Verastem, Inc., Bayer AG, GlaxoSmithKline plc, Eli Lilly and Company and Takeda Pharmaceutical Limited.
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