Oncoethix, the Swiss-based specialist in oncology drug development, reported that the first patient has been enrolled in an international, open-label, non-randomized, multicenter Phase 1b trial of OTX015 in advanced solid tumors (Press release OncoEthix, NOV 12, 2014, View Source [SID:1234501220]). The trial will be coordinated by Dr Lillian Siu, MD, of the Princess Margaret Hospital, Toronto, Canada, who is Professor of Medicine at the University of Toronto, and Director of the Phase 1 program.

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The trial seeks to enrol up to 98 patients across seven centers in five countries (Belgium, Canada, France, Spain and Switzerland), including the Institut Gustave-Roussy in Paris, where Professor Jean-Charles Soria is the Principal investigator. Three patients have already been enrolled. The trial aims to determine, in a first step, the suitability of five solid tumor indications under investigation (BRD-NUT Midline Carcinoma, Triple Negative Breast Cancer, Non-Small Cell Lung Cancer harbouring a rearrangement ALK gene/fusion protein or KRAS mutation, and Castrate-Resistant Prostate Cancer and Pancreatic Ductal Carcinoma) to be progressed into the Phase 2a part of the trial.

Dr Esteban Cvitkovic, MD, Founder and Chief Scientific Officer, Oncoethix, commented: "This multicenter Phase 1b trial is an important step for OTX015, as it will provide key safety and efficacy data in several solid tumor types, after having characterized its single agent safety and activity profile in the Acute Leukemias and Lymphomas in Phase 1 trial (OTX015_104). The solid tumor indications approach selected for OXT015 is based on compelling data from our own preclinical pharmacology program. We have also initiated a multicentric (France, Switzerland) Phase 2a trial in recurrent glioma."

OTX015 is a novel first-in-class synthetic small molecule inhibitor of BET bromodomain proteins 2/3/4. These proteins are considered potential cancer targets, as they play a pivotal role in regulating the transcription of growth-promoting and cell cycle regulators.

Coordinating investigator Dr Lillian Siu commented: "OTX015 is a promising drug that has shown outstanding early results in hematologic cancer studies and we are delighted to have commenced the solid tumor trial at the Princess Margaret Cancer Centre in Canada."

Bertrand Damour, Chief Executive Officer at Oncoethix, added "We believe that OTX015 has the potential to be an important new drug across a number of advanced solid tumors and the start of the Phase 1b is a key milestone for the Company. We are also ahead of schedule in our hematologic cancer program and will be releasing further data from this program at NCI/EORTC/AACR in November and the American Society of Hematology (ASH) (Free ASH Whitepaper) in December."

On November 12, 2014 Blueprint Medicines reported the completion of a $50 million Series C financing (Press release Blueprint Medicines, NOV 12, 2014, View Source [SID:1234500956]). Proceeds from the financing will be used to advance Blueprint Medicines’ two lead product candidates through clinical trials in 2015 and fund the continued development of Blueprint Medicines’ kinase discovery platform and pipeline.

"The proceeds from this financing provide us with the financial strength to initiate clinical trials for our FGFR4 and KIT Exon 17 inhibitors in 2015 with the goal of establishing proof of concept rapidly and ultimately improving the lives of patients," said Jeffrey Albers, chief executive officer of Blueprint Medicines. "We are incredibly pleased to welcome such highly respected public investors to our shareholder base. Their investment provides strong endorsement for the quality of the platform, pipeline and team we’ve built at Blueprint Medicines over the past three years."

Blueprint Medicines’ Series C financing was led by Partner Fund Management and included additional new investors, Wellington Management Company, RA Capital, Tavistock Life Sciences, Perceptive Advisors, Sabby Capital, Cowen Investments and Redmile Group. The Company’s existing shareholders – Biotechnology Value Fund, Casdin Capital, Fidelity Biosciences, Nextech Invest and Third Rock Ventures – also participated in the financing.
"Blueprint Medicines’ proprietary kinase platform, which combines a first-of-its-kind chemical library and a novel genomics-based target discovery engine, holds significant value creation potential," said Alex Virgilio, Ph.D. of Partner Fund Management. "The team has achieved impressive results to date by rapidly discovering and advancing two first-in-class product candidates toward clinical development. We believe the team can sustainably replicate this success based on the strength of the platform in producing exquisitely selective inhibitors to novel genomically defined kinase targets."

Blueprint Medicines expects to initiate clinical trials in 2015 with its two lead product candidates:
 BLU-285 is the first known selective inhibitor of KIT Exon 17 mutants. The Company intends to initiate two clinical studies, including one for the underserved systemic mastocytosis patient population and another for genomically defined subsets of patients with gastrointestinal stromal tumors (GIST).
 BLU-554 is the first known selective FGFR4 inhibitor. Blueprint Medicines anticipates initiating a clinical study for patients suffering from hepatocellular carcinoma with aberrant FGFR4 pathway activation.

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On November 11, 2013 Patrys reported that it is initiating an investigator-sponsored trial (IST) evaluating the effectiveness of Patrys’ lead anti-cancer drug PAT-SM6 in combination with carfilzomib, in patients with relapsed and refractory multiple myeloma (MM) (Press release Patrys, NOV 11, 2014, View Source [SID:1234500543]). The trial will be headed by Professor Dr. Hermann Einsele, Director of the Department of Medicine II, University of Würzburg, Germany, and is being funded by Onyx Pharmaceuticals, Inc., an Amgen subsidiary.
Both clinical and preclinical studies of PAT-SM6 conducted to date have shown evidence of activity in patients with relapsed and refractory MM. One of the notable features of PAT-SM6, being demonstrated in the currently-ongoing Phase I/IIa clinical trial, is the lack of serious side-effects in treated patients. This feature of PAT-SM6 may allow it to be safely administered in combination with carfilzomib and may have the potential to improve current treatments for MM. Carfilzomib is a proteasome inhibitor owned by Onyx, and is marketed in the United States (U.S.) under the brand name Kyprolis (carfilzomib) for Injection. Onyx will provide carfilzomib study drug for the trial.

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miRagen’s lead program in hematological malignancy targets miR-155, a microRNA that has key roles in the differentiation, function and proliferation of blood and lymph cells (Company Pipeline miRagen Therapeutics, NOV 10, 2014, View Source [SID:1234500949]).

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Dendreon has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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