In The NEWS
Mirati Therapeutics (MRTX) is an oncology company focusing on genetic and epigenetic drivers of cancer. The firm’s clinical stage product candidates include MGCD265, a multi-targeted kinase inhibitor that is in Phase 1b clinical development trials for the treatment of solid tumors, including lung, head and neck, and gastric cancers; MGCD516, a kinase inhibitor, which is in Phase 1 clinical development for non-small cell lung cancer and solid tumors; and Mocetinostat, an orally,bio-available histone deacetylase inhibitor that is in Phase 2 clinical trial for bladder cancer, myelodysplastic syndrome, and non-hodgkins lymphoma, principally diffuse large B-cell lymphoma and follicular lymphoma. Mirati Therapeutics, Inc. is headquartered in San Diego, California.
AstraZeneca Partner With Mirati On Immunotherapy For Lung Cancer
AstraZeneca (AZN) announced that MedImmune, its global biologics research and development arm, has entered into an exclusive clinical trial collaboration with Mirati Therapeutics. The Phase 1/2 study will evaluate the safety and efficacy of MedImmune’s investigational anti-PDL1 immune checkpoint inhibitor, durvalumab (MEDI4736), in combination with Mocetinostat, Mirati’s investigational spectrum-selective histone deacetylase (HDAC) inhibitor.
This novel combination will first be evaluated in patients with non-small cell lung cancer (NSCLC), with the potential to explore additional indications in the future.
Durvalumab (anti PD-L1) is designed to counter the tumor’s immune-evading tactics by blocking a signal that helps tumors avoid detection, while Mocetinostat selectively inhibits Class I HDAC enzymes. It is said that Mirati drug Mocetinostat has the potential to enhance the positive effect of checkpoint inhibitors, such as durvalumab, on tumor immunity.
David Berman, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune, said: “The collaboration with Mirati is yet another example of our combination-focused immuno-oncology strategy and our comprehensive approach in lung cancer as a key disease area. We continue to follow the scientific evidence to explore novel combination treatments to meet unmet patient need, with durvalumab as the cornerstone.”
Charles M. Baum, President and CEO, Mirati, said: “There is a growing body of evidence that mocetinostat may enhance the efficacy of immune check-point inhibitors such as PD-L1 antibodies. Mocetinostat selectively targets specific HDACs that may increase the efficacy of durvalumab in patients with non-small cell lung cancer, as well as other tumor types. We look forward to working with MedImmune on this combination to potentially improve future outcomes for patients.”
Under The Terms Of the Agreement
Mirati will conduct and fund the initial Phase 1/2 clinical trial, which is expected to start in 2016. MedImmune will supply durvalumab for the trial. The parties have established a Joint Steering Committee to oversee 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.
Immunotherapy is the novel successful revolution in the treatment of cancer. Immune checkpoint protein inhibitors are currently the most advanced and most active immunotherapy approach. The oncology community is thrilled about immunotherapy. Oncologists realized, though, that combination treatments might enhance the checkpoint protein inhibitors’ efficacy. AstraZeneca selected a drug that belongs to Mirati therapeutics for its Immunotherapy combination.
This very good news for Mirati, the small development-stage oncology firms whose market cap is less than $500 million.
The stock is trades now at $28.49 Up $0.37.
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Theravance Biopharma (TBPH)
The FDA Granted Fast Track Designation to the Firm’s Drug TD-8954 for Short-Term use with Enteral Feeding To Achieve Early Nutritional Adequacy in Critically ill Patients At High Nutritional Risk.
TD-8954 is a selective 5-HT4 receptor agonist. It is being evaluated for potential use in the treatment of gastrointestinal motility disorders, including enteral feeding intolerance (EFI). There are currently no FDA-approved therapies for EFI, leaving the approximately one million Americans who suffer from the disorder without adequate treatment options.
TD-8954 is in Phase 2 clinical development having completed a study in critically ill patients with EFI. The study was to evaluate the safety, tolerability and pharmacodynamics of a single dose of TD-8954 administered intravenously compared to metoclopramide.
Theravance Biopharma seems to be ready to discuss with FDA potential designs for the next TD-8954 study in EFI patients. It will continue to assess accelerated development pathways for this program through conversations with FDA and potential collaboration with prospective partners.
FDA’s Fast Track might expedite the review of drugs that have potential to treat serious conditions and unmet medical needs. Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met.
The firms are allowed to submit completed sections of their New Drug Application (NDA) for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.
VIBATIV® (telavancin): The firm’s first and only approved once-daily dual-mechanism antibiotic. The drug is approved in the U.S., Europe and certain other countries for difficult-to-treat infections.
TD-4208 is an investigational long-acting muscarinic antagonist (LAMA) intended for once-daily, nebulized treatment for COPD.
Axelopran (TD-1211) — an oral investigational potential once-daily for opioid-induced constipation (OIC).
Additionally, future payments may be made by GlaxoSmithKline plc pursuant to its agreements with Theravance, Inc. relating to certain drug development programs, including the combination of fluticasone furoate, umeclidinium and vilanterol (the “Closed Triple”).
One step forward is good news.
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