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May 06, 2015 11:40 PM ET

Biotechnology

Company Overview of ProNAi Therapeutics, Inc.

Company Overview

ProNAi Therapeutics, Inc., a biopharmaceutical company, develops and commercializes therapies that target DNA to treat patients with cancer and other diseases. The company applies its nucleic acid-based DNA interference technology (DNAi) to create and develop novel therapeutics for cancer and other diseases. Its lead drug, PNT2258, is a 24-base, single-stranded, chemically-unmodified DNA oligonucleotide designed to treat cancers that overexpress BCL2. The company’s DNAi uses single-stranded, unmodified, phosphodiester DNA sequences designed against genomic DNA to modulate gene transcription. ProNAi Therapeutics, Inc. was incorporated in 2003 and is based in Plymouth, Michigan.

46701 Commerce Center Drive

Michigan Life Science and Innovation Center

Plymouth, MI 48170

United States

Founded in 2003

Phone:

734-233-3967

Key Executives for ProNAi Therapeutics, Inc.

Chief Executive Officer, President and Director
Age: 45
Chief Financial Officer
Chief Scientific Officer and Vice President of Product Development
Age: 48
Chief Business & Strategy Officer and Head of Commercial
Chief Medical Officer
Age: 58
Compensation as of Fiscal Year 2014.

ProNAi Therapeutics, Inc. Key Developments

ProNAi Therapeutics, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-15-2015 11:30 AM

ProNAi Therapeutics, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-15-2015 11:30 AM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Nicholas R. Glover, Chief Executive Officer, President and Director.

ProNAi Therapeutics Inc. Initiates Phase II Trial of PNT2258 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

ProNAi Therapeutics Inc. reported that the first patient with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) has enrolled in the 'Wolverine' Phase II study and been treated with PNT2258. The patient was treated by Dr. Wael Harb, Founder of the Horizon Oncology Center in Lafayette, Indiana. Study Design: The multi-center, single-agent, open-label, Phase II investigation of PNT2258 (ClinicalTrials.gov identifier: NCT02226965) will characterize anti-tumor activity and collect safety data on approximately 60 patients with relapsed or refractory DLBCL. The primary endpoint is overall response rate, assessed by FDG-Positron Emission Tomography (PET) scan and compared to relevant historical controls. Secondary outcome measures include disease control rate, progression-free survival, overall survival, and exploratory predictors of outcome assessed by tumor biopsy and pharmacodynamics sample analysis. PNT2258 will be administered at 120 mg/m2 as an intravenous (IV) treatment on days 1-5 of a 21-day cycle during the induction phase. Treatment may continue for a total of eight cycles of therapy, unless disease progression or the occurrence of unacceptable toxicity occurs. Patients who benefit from PNT2258 can continue treatment (100 mg/m2 administered as a 2-hour IV on days 1-4 of a 28-day cycle) until disease progression. The study was designed on the basis of interim results from an ongoing pilot Phase II trial of PNT2258, which were reported recently at the 56th Annual Meeting of the American Society of Hematology (ASH). The investigators for that study concluded that: PNT2258 treatment results in significant, durable responses in patients with relapsed or refractory non-Hodgkin's lymphoma (r/r NHL) with eleven of the thirteen (11/13) patients treated achieving clinical benefit, with ongoing Progression Free Survival (PFS) extending to 18 months and beyond. In particular, all four of the patients (4/4) with DLBCL responded to PNT2258, with three patients achieving complete responses (CR) and one patient achieving a partial response (PR), with durations extending to greater than 500 days. Durable and clinically meaningful CR's and PR's were achieved in subjects with aggressive disease, such as Richter's transformation and Burkitt's-like DLBCL. PNT2258 therapy is safe and very well tolerated with dosing periods up to and exceeding 18 months.

Marina Biotech Reports and ProNAi Therapeutics Present Interim Phase 2 Data on Its BCL2-Targeting DNAi(R) Therapeutic

Marina Biotech, Inc. announced that its licensee, ProNAi Therapeutics, reported that a number of patients with relapsed or refractory Non-Hodgkin's Lymphoma treated with its first DNAi®-based therapeutic, PNT2258, achieved meaningful therapeutic outcomes and continue to exhibit durable clinical responses. PNT2258 is one of two nucleic acid-based therapeutics in clinical development which are formulated with Marina Biotech's proprietary SMARTICLES® delivery technology. The investigators for the study concluded that: PNT2258 treatment results in significant, durable responses in patients with relapsed or refractory non-Hodgkin's Lymphoma (r/r NHL); Eleven of the thirteen (11/13) patients treated achieved clinical benefit, with ongoing Progression Free Survival (PFS) extending to 18 months and beyond; PNT2258 is demonstrably active in patients with diffuse large B-cell lymphoma (DLBCL). All four of the patients (4/4) with DLBCL responded to PNT2258, with three patients achieving complete responses (CR) and one patient achieving a partial response (PR), with durations extending to greater than 500 days; Durable and clinically meaningful CR's and PR's were achieved in subjects with aggressive disease, such as Richter's transformation and Burkitt's-like DLBCL; Noteworthy durable CR's and PR's were also observed in subjects with advanced stage follicular lymphoma (FL); and PNT2258 therapy is safe and very well-tolerated with dosing periods up to and exceeding 18 months.

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