On August 28 2015 Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) reported that it has received its BLA Filing Notification for MCNA from the U.S. Food and Drug Administration (FDA). This formal letter communicates that the FDA has completed its initial review of Telesta’s Biologics License Application (BLA) submitted on June 29, 2015 and has accepted it for filing (Press release, Telesta Therapeutics, AUG 28, 2015, View Source [SID:1234507865]). In the same letter, the FDA communicated that it has designated the file for 6 month Priority Review and has set February 27, 2016 as the review goal date for MCNA. The FDA has also advised that it will be organizing an advisory committee to discuss the BLA application.

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Commenting on the FDA letter, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted: "Today is a historic day for Telesta Therapeutics and for all of our staff and collaborators who have worked so diligently to advance our new treatment for non-muscle invasive bladder cancer towards potential regulatory approval early next year. While we recognize that the FDA must complete its full review of our BLA filing before rendering its ultimate decision, we are working extremely hard, at all levels, to prepare for commercial launch in the United States."

About MCNA

MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy with a therapeutic alternative to surgery. MCNA is derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line bacillus Calmette-Guérin (BCG) therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA’s pivotal Phase 3 trial was recently published in The Journal of Urology. The FDA has set February 27, 2016 as its review goal date for MCNA’s potential approval.

About Telesta Therapeutics Inc.

Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global health market. The Company’s primary goal is to develop and commercialize products that advance human health and increase shareholder value. For more information, please visit www.telestatherapeutics.com

On August 27, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it will release its year-end financial results for the fiscal year ending June 30, 2015 on Friday, September 4, 2015 (Press release, DelMar Pharmaceuticals, AUG 27, 2015, View Source [SID:1234507346]).

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DelMar’s management team will host a business update conference call and live webcast for investors, analysts and other interested parties on Friday, September 4, 2015, at 11:00 a.m. EDT / 8:00 a.m. PDT.

During the business update call, management will discuss recent corporate highlights including the Company’s progress of its Phase II clinical trial of VAL-083 (dianhydrogalactitol) for the treatment of refractory glioblastoma multiforme (GBM) and corporate goals for the upcoming year including plans to advance VAL-083 into registration-directed Phase II/III clinical trials in refractory GBM as well as initiate new clinical trials with VAL-083 as a potential treatment for non-small cell lung cancer (NSCLC) and other solid tumors.

On August 27, 2015 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC) (NASDAQ:ONCY) reported that Dr. Miguel A. Villalona-Calero will make an oral presentation at International Association for the Study of Lung Cancer (IASLC) 16th World Conference on Lung Cancer on September 9, 2015 (Press release, Oncolytics Biotech, AUG 27, 2015, View Source [SID:1234507352]). The presentation, titled "Oncolytic Reovirus in Combination with Paclitaxel/Carboplatin in NSCLC Patients with Ras Activated Malignancies, Long Term Results," covers updated results, including longer-term survival data, from the Company’s REO 016 Phase 2 study in Non-Small Cell Lung Cancer (NSCLC).

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"Our research collaborators are noting the two-year survival data from this study, which is high for later-stage patients with recurrent or metastatic disease," said Dr. Matt Coffey, COO of Oncolytics. "As with our REO 017 clinical study that treated pancreatic cancer patients with gemcitabine and REOLYSIN, there was a clear overall survival benefit with apparent limited impact on progression free survival, which is generally characteristic of immune involvement in outcomes."

Highlights of the data to be presented include:

A survival analysis for 37 Stage IV patients showing a median progression free survival (PFS) of four months and median overall survival (OS) of 13.1 months;
One- and two-year survival rates of 57% and 30%, respectively, with the authors concluding that the survival of 11 patients longer than two years was substantial; and
Seven patients remaining alive after a median follow up of 34.2 months (range 26.9-71.5 months), with two patients showing no evidence of disease progression to date (50 and 37 months).
For comparison, the Company is referring to historical control data as per Schiller et al., 2002, which reported a median PFS of 3.1 months, median OS of 8.1 months, one-year survival rates of 34%, and two-year survival rates of 11%. There were 290 patients treated with carboplatin and paclitaxel, 86% of which were Stage IV and 14% Stage IIIB.

Of the 35 patients evaluable for clinical response in the REO 016 study, 11 patients (5 Kras mutant) had a partial response (PR), 20 had stable disease (SD) and four had progressive disease by RECIST for an objective response rate (ORR) of 31%. Four patients with SD had a >40% PET standardized update value reduction after two cycles, yielding an ORR considering PET of 43%.

REO 016 is a U.S. single arm, two-stage, open-label, Phase 2 study of REOLYSIN given intravenously with paclitaxel and carboplatin every three weeks. Patients received four to six cycles of paclitaxel and carboplatin in conjunction with REOLYSIN, at which time REOLYSIN may have been continued as a monotherapy. As previously disclosed, the primary objectives of the trial were to determine the ORR of REOLYSIN in combination with paclitaxel and carboplatin in patients with metastatic or recurrent NSCLC with Kras or EGFR-activated tumours, and to measure PFS at six months. The secondary objectives were to determine the median survival and duration of PFS in patients, and to evaluate the safety and tolerability of REOLYSIN in combination with paclitaxel and carboplatin in this patient population.

A copy of the abstract will be available on the Oncolytics website at: View Source and is also available on the conference website at: View Source

(Filing, 10-K, ImmunoGen, AUG 27, 2015, View Source [SID:1234507356])

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On August 27, 2015 OncoMed reported New biomarker data related to OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) Phase 1b/2 PINNACLE clinical trial of tarextumab (Anti-Notch 2/3, OMP-59R5) in small cell lung cancer (SCLC) will be presented by academic collaborator, Anne Chiang M.D., Ph.D., of the Yale School of Medicine, during a mini oral discussion session at the upcoming 16th World Conference on Lung Cancer taking place September 6-9 in Denver, CO (Press release, OncoMed, AUG 27, 2015, View Source [SID:1234507353]). Details for the presentation are provided below.

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Wednesday, September 9, 2015

Mini27.08: NOTCH3 Protein Expression and Outcome in Small Cell Lung Cancer (SCLC) and Therapeutic Targeting with Tarextumab (Anti-Notch 2/3)

Lead author: Anne Chiang, M.D., Ph.D., Yale School of Medicine

Session: Mini Oral 27: Biology and Other Issues in SCLC

Location: Colorado Convention Center, Room 605+607

ID: 2999