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Health Care : Biotechnology | Mid Cap Value
Company profile

Novavax, Inc. is a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants. The Company operates through developing recombinant vaccines segment. The Company, through its recombinant nanoparticle vaccine technology, produces vaccine candidates to respond to both known and newly emerging diseases. The Company's product pipeline focuses on a range of infectious diseases with vaccine candidates in clinical development for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza and the Ebola virus (EBOV). The Company's lead adjuvant for human applications, Matrix-M, is in a Phase I/II clinical trial for pandemic influenza H7N9 vaccine candidate. It is also testing Matrix-M in conjunction with its EBOV vaccine candidate in a Phase I clinical trial. It is developing additional pre-clinical stage programs in a range of infectious diseases, including Middle East respiratory syndrome (MERS).

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OnKure and Pfizer Enter Clinical Trial Collaboration and Supply Agreement to Evaluate Combination of OKI-179 and Binimetinib

11:00 am ET September 21, 2020 (BusinessWire) Print

OnKure, Inc., a leader in discovery and development of next generation histone deacetylase (HDAC) inhibitors, entered into a clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) to support the clinical proof of concept study for MEKTOVI(R) (binimetinib) in combination with OKI-179, a highly potent and tolerable Class I HDAC inhibitor currently in Phase I for the treatment of NRAS melanoma.

Activating NRAS mutations occur in approximately 20% of melanomas, representing the second most common oncogenic driver mutation in melanoma after BRAF mutations. An unmet medical need remains for targeted therapy in metastatic patients harboring an NRAS mutation. Binimetinib, a mitogen-activated protein kinase (MEK) inhibitor that Pfizer has exclusive rights to in the U.S. and Canada, has been approved for use in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Based on a recent study by Maertens et al. reported in Cancer Discovery, as well as preclinical combination studies conducted by OnKure, the rational combination of these two agents may enhance clinical benefit of MAPK inhibition in NRAS melanomas.

OnKure and Pfizer will form a Joint Development Committee to review clinical trial results from the OnKure-sponsored study.

"We are excited to collaborate with Pfizer on this promising initiative to address unmet need in NRAS melanoma," said Tony Piscopio, Ph.D., Co-founder, President and Chief Executive Officer of OnKure. "We believe, based on the exceptional tolerability profile of OKI-179, this agent has the potential to provide clinically-meaningful impact and confer a broad therapeutic index in combination with targeted therapeutics across additional tumor types, including CREBP mutant SCLC, ER-positive breast cancer and BRAF melanoma."

"Recent translational work with my collaborators at Harvard suggests that adding an HDAC inhibitor can further augment binimetinib activity in patients suffering from NRAS melanoma," said Keith T. Flaherty, M.D., Director of Clinical Research at the Massachusetts General Hospital Cancer Center. "I look forward to this novel combination being tested in patients."

About OnKure

OnKure, Inc. is a biopharmaceutical company focused on the discovery and development of targeted small molecule drugs to improve the outcomes of patients afflicted with cancer. OnKure's drug candidates aim to treat patients by targeting malignant cells directly, by working in combination with other small molecule therapies and by priming the tumor microenvironment such that checkpoint inhibition is optimized. For more information about OnKure, please visit

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SOURCE: OnKure, Inc.

Amelia Tanttila,
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