Month: March 2017

Sunesis Pharmaceuticals Announces Submission of Responses to the EMA Day 180 List of Outstanding Issues for Marketing Authorization Application for Vosaroxin

On March 22, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that it has submitted its responses to the European Medicine Agency (EMA) Day 180 List of Outstanding Issues issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older (Press release, Sunesis, MAR 22, 2017, View Source [SID1234518235]).

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"Our team has provided detailed answers to the EMA in response to the Day 180 List of Outstanding Issues," said Daniel Swisher, President and Chief Executive Officer of Sunesis. "We are preparing to go before the Scientific Advisory Group’s Oncology Division (SAG-O) in April, which will assist the CHMP in its evaluation of our application. As we approach this final phase of the European approval process, anticipating a CHMP decision by mid-year, we continue to work in parallel to qualify the best pharma partner to work with us on a European market launch of vosaroxin in the second half of 2017."

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed/refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

Vosaroxin’s Marketing Authorization Application for relapsed refractory AML is currently under review by the European Medicines Agency, and a regulatory decision regarding approval is expected in 2017.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

AVEO Announces First Patient Dosed in Phase 1/2 TiNivo Trial of Tivozanib and Opdivo® (nivolumab) in Advanced RCC

On March 22, 2017 AVEO Oncology (NASDAQ:AVEO) reported that the first patient has been dosed in the Phase 1/2 AVEO-sponsored TiNivo trial evaluating tivozanib in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in advanced renal cell carcinoma (RCC) (Press release, AVEO, MAR 22, 2017, View Source [SID1234518233]). The study, which will be led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 trial will evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib and, assuming favorable results, is expected to be followed by an expansion Phase 2 cohort at the established combination dose.

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"There is compelling scientific rationale for combining the antiangiogenic activity of VEGF inhibition with the immunologic activity of PD-1 inhibitors. Yet, to date, the tolerability of these combinations have been a challenge with currently approved VEGF TKIs and PD-1s," said Professor Escudier. "Tivozanib has been demonstrated to be the most selective VEGF inhibitor, delivering a uniquely favorable tolerability profile in past single agent and combination studies, and has the potential for minimal overlapping toxicities with immunotherapies. I look forward to understanding the clinical potential of combining tivozanib and nivolumab in the TiNivo study, and to the prospect of further improving outcomes in this very dynamic treatment area."

"VEGF-PD-1 combinations have yielded promising tumor response outcomes in renal cell cancer, yet the data presented to date point to challenging or prohibitive toxicity," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib offers a unique opportunity to potentially overcome this barrier, and look forward to initial results from the Phase 1 portion of the TiNivo trial in the first half of 2017."

About Tivozanib

Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

OXIS BIOTECH SCIENTIFIC ADVISORY BOARD MEMBER TO ADDRESS CANCER IMMUNOTHERAPY CONFERENCE IN CHINA

On March 21, 2017 Oxis International Inc. (OTCQB: OXIS) (Euronext Paris OXI.PA) reported that Dr. Daniel Vallera, a member of the Scientific Advisory Board of its wholly owned subsidiary, Oxis Biotech Inc., has been invited to speak at the 15th National Conference of Tumor Immunotherapy on June 22, 2017, in Hefei, China (Press release, OXIS International, MAR 21, 2017, View Source [SID1234539556]).

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Dr. Vallera, Director of the section on Molecular Cancer Therapeutics at the University of Minnesota Masonic Cancer Center, said he will discuss two immunotherapy cancer treatments that he helped develop — Trispecific Killer Engager (TriKE) and Bispecific Killer Engager (BiKE). Both platforms have been licensed by Oxis.

The treatments empower the body’s immune system to identify and selectively kill cancer cells, while leaving healthy cells alone.

Dr. Vallera was instrumental in the development of Oxis’ promising cancer therapy, OXS-1550, which is currently in an FDA Phase 1/Phase 2 clinical trial in Minnesota.

The National Conference of Tumor Immunotherapy focuses on research, technology, clinical practice and government policy related to tumor immunology and immunotherapy. About 500 people are expected to attend.

Anthony Cataldo, Chairman and Chief Executive Officer of Oxis, said Dr. Vallera’s invitation is an indication that his work is widely recognized by his peers.

"We have received many requests for more information about the BiKE and TriKE platforms we have licensed from the University Of Minnesota," Mr. Cataldo said. "The biotech community realizes the potential for this technology and how it addresses the future of ‘Targeted Immunotherapy.’"

Dr. Vallera has spent 35 years with the University of Minnesota’s cancer center, where he oversees a laboratory specializing in the development of biological recombinant drugs focusing on bispecific antibody therapies that directly deliver toxic signals to cancer cells.

Final Results for the year ended 30 September 2016

On March 21, 2017 Redx (AIM: REDX) reported its results for the year ended 30 September 2016 (Press release, Redx Pharma, MAR 21, 2017, View Source [SID1234524746]):

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Discovery engine delivers two assets to progress into clinical stage from extensive pipeline
Strategic refocus — Redx restructures to become a research and development focused company
£12 million gross raised post the period end and £10 million gross raised in March 2016
Pipeline produces first development assets
RXC004 — our best-in-class Porcupine inhibitor
Development candidate nominated for pancreatic, biliary and gastric cancer
Shown to have the potential to be used in combination with other immune-oncology products such as immune checkpoint inhibitors (anti-PD-1), with data presented at EORTC-AACR meeting in November 2016
Scheduled to enter first-in-human studies post clinical trial application (CTA) submission in Q2
Potential to treat fibrotic disease being investigated
RXC005 — our best-in-class reversible BTK inhibitor
In vivo proof of concept achieved for the reversible BTK program
Development candidate nominated for drug resistant chronic lymphocytic leukaemia (CLL) post -period
Pre-clinical profile presented at ASH (Free ASH Whitepaper) meeting in December 2016
Investigational new drug (IND) application and CTA to be filed around the end of 2017
Strategic Refocus
Redx will refocus its business to concentrate on its key assets in oncology and immunology, namely Porcupine and BTK
Anti-infectives research proposed to continue only under external collaborations
Redx remains committed to discovery research, but at a reduced investment level
Head count will be significantly reduced by around 86 positions. This equates to an approximately 60% reduction in staff
Key Financials
Net cash at 30 September 2016: £5.8m (2015: £9.4m)
Other operating income: £2.4m (2015: £2.6m)
Changes to the Board of Redx Pharma
The Board has received notifications from two directors, Dr Frank M. Armstrong, Chairman of the Board of Directors and Mr Peter McPartland, Non-Executive Director, have decided not to stand for re-election at the upcoming Annual General Meeting for shareholders. Dr Peter Jackson, Non-Executive Director, co-founder of Redx and Executive Chairman up to August 2014, will be stepping down from the Board on 31 March 2017.

Neil Murray, Chief Executive of Redx Pharma Plc, commented, Redx has created a world-class capability in small molecule drug discovery in oncology and immunology. We have a strong research engine that continues to deliver an innovative pipeline, but we must now shift our focus towards developing our key portfolio assets, specifically our Porcupine and BTK programs for hard to treat diseases. To reflect this new focus, we are reorganizing our business, including plans to reduce headcount.

On behalf of the Board of Redx I would like to thank Dr Frank M. Armstrong, Dr Peter Jackson and Mr Peter McPartland for their immense contributions to the success of Redx, both as a private and as a public company. Dr Peter Jackson has worked tirelessly for Redx since he helped found the business. I would also like to extend my personal thanks to Frank, Pete and Peter for the support they have given me and for the highly professional way in which they have carried out their roles.

Dr Frank M. Armstrong, Chairman of Redx Pharma Plc, added, I am pleased to have been a part of Redx, guiding the Company through the transition from private to public markets. Redx has made substantial progress with the portfolio since the IPO and I look forward to the Company’s continued progress as it makes this critical transition to clinical development and wish the Management, staff and shareholders every success for the future.

Lin BioScience Licenses Novel Therapeutic Program for Brain Cancer from the University of Sydney

On March 21, 2017 Lin BioScience, a drug development company specializing in innovative therapies for oncology, ophthalmology, and cardiology, reported an exclusive licensing agreement with the University of Sydney for a microtubule-targeting agent to treat brain cancers (Press release, Lin Bioscience, MAR 21, 2017, View Source [SID1234520604]).

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The therapeutic candidate, LBS-002, is a small molecule that disrupts the division of cancer cells by preventing the formation of microtubules (the cell structures responsible for the segregation of chromosomes in cell division).

LBS-002’s ability to cross the blood-brain barrier shows promise for treating both primary and metastatic brain cancers

"To date, treating primary glioblastomas and metastatic brain cancers has been challenging because the blood-brain barrier prevents effective drugs from reaching their targets," stated Dr. Tom Lin, CEO of Lin Bioscience. "LBS-002’s ability to cross the blood-brain barrier enables it to overcome the permeability limitations experienced by traditional treatments, making it a promising therapeutic candidate. We’re excited to work with the expertise of Dr. Munoz, Dr. Kassiou and their teams at the University of Sydney to bring new cancer therapies to the clinic."

Under the terms of the agreement, Lin BioScience will gain exclusive global rights to the development and commercialization of intellectual property developed at University of Sydney by Drs. Lenka Munoz and Michael Kassiou. Further terms of the agreement are not disclosed.

"Our research has passed the discovery stage and now our goal is to progress into clinical testing," stated Drs. Munoz and Kassiou. "LBS-002 provides an exciting basis for a program that will lead to new treatments for brain tumors and we are very excited to be working with an innovative biotech like Lin BioScience in translating our fundamental research into clinical studies," said Drs. Munoz and Kassiou.