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Daiichi Sankyo Initiates Phase 1/2 Study of Novel Antibody Drug Conjugate U3-1402 in Patients with HER3-Positive Metastatic or Unresectable Breast Cancer

On January 18, 2017 Daiichi Sankyo Company reported the initiation of a three-part open-label phase 1/2 study in Japan with U3-1402, a novel HER3-targeting antibody drug conjugate, in patients with HER3-positive metastatic or unresectable breast cancer who are refractory or intolerant to standard treatment, or for whom no standard treatment is available (Press release, Daiichi Sankyo, JAN 18, 2017, View Source [SID1234517450]).

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U3-1402, the second clinical-stage investigational antibody drug conjugate in the Daiichi Sankyo Cancer Enterprise pipeline, comprises a humanized anti-HER3 antibody attached by a peptide linker to a novel topoisomerase I inhibitor (DXd) payload, utilizing Daiichi Sankyo’s proprietary payload and linker-payload technologies. U3-1402 achieves a Drug-Antibody Ratio (DAR) near 8, meaning nearly eight molecules of DXd are attached per antibody.

"While treatment for patients with metastatic HER2-negative breast cancer has gradually improved over the past several years, there is still need for improvement, particularly by developing targeted therapies," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "The purpose of this study is to determine whether delivering a cytotoxic agent via a HER3 monoclonal antibody could be an effective and safe approach to treating patients with HER3-overexpressing breast cancer."

About the Study
In this three-part open-label phase 1/2 study, U3-1402 will be given as an intravenous infusion every three weeks. The first part of the study (dose escalation) will assess the safety, tolerability and maximum tolerated dose of U3-1402 in HER3-positive metastatic breast cancer patients who are refractory or intolerant to standard treatment, or for whom no standard treatment is available. The second part of the study (dose-finding) will assess the safety and efficacy of U3-1402 and determine the recommended phase 2 dose in HER3-positive metastatic breast cancer patients who have received six or fewer prior chemotherapy regimens. The third part of the study (phase 2) will assess the safety and efficacy of the recommended dose of U3-1402 in HER3-positive metastatic breast cancer patients who have received six or fewer prior chemotherapy regimens. Additional trial information is available at ClinicalTrials.gov.

About HER3-Positive Metastatic Breast Cancer
Breast cancer is typically classified and treated based on one of three types of biomarker status classifications: hormone-receptor positive (HR+), where the tumor cells contain either estrogen receptors (ER) or progesterone receptors (PR); HER2-positive (HER2+), where the tumor cells overexpress HER2; and triple negative, where the tumor cells do not have estrogen or progesterone receptors and are HER2-negative.1However, human epidermal growth factor receptor 3 (known as HER3 or ERBB3) is a tyrosine kinase receptor that is increasingly being recognized as important to tumor growth in certain cancers including breast cancer.2 Patients living with invasive breast cancer with high levels of HER3 face a significantly worse prognosis and decreased survival, and to date there is no approved HER3 directed precision medicine therapy option.3

OXIS BIOTECH ANNOUNCES ENROLLMENT OF 2 NEW PATIENTS IN FDA CLINICAL TRIAL OF PROMISING CANCER DRUG OXS-1550

On January 17, 2017 Oxis International Inc. [OTCQB: OXIS and OXI.PA], a biotechnology company focused on immunotherapies for the treatment of cancer, reported that it has enrolled two additional patients in a Phase 1/Phase 2 trial of its most promising cancer drug, OXS-1550 (Press release, OXIS International, JAN 17, 2017, View Source [SID1234539554]).

The FDA-approved clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center under the watch of Clinical Investigator Dr. Veronika Bachanova and research scientist Dr. Daniel Vallera. Dr. Vallera developed OXS-1550 and is a member of the Oxis Biotech Scientific Advisory Board.

"This is another very important milestone for Oxis," said Anthony Cataldo, Chairman and Chief Executive Officer of Oxis. "Moving forward with the enrollment of these two patients will allow us to complete the phase 1 portion of the Oxis OXS-1550 Phase 1/Phase 2 FDA trial."

OXS-1550 (DT2219ARL) is designed to target cancer cells and destroy them, while leaving healthy cells alone. When OXS-1550 binds to cancer cells, the cancer cells internalize the drug and are killed.

"We are very optimistic about OXS-1550 and believe it has the potential to be an important therapy in the treatment of cancer," Mr. Cataldo said.

"What sets OXS-1550 apart from other cancer treatments is its ability to target cancer cells without damaging healthy cells," Dr. Vallera said. "As a result, the treatment has lower occurrences of side effects than more common cancer treatments. Additionally, the FDA has allowed these new patients to receive a much higher dosage and regimen."

"We believe OXS-1550 to be a powerful alternative to existing chemotherapies, since many patients fail chemotherapy or reach the toxic limits of their therapy. I am looking forward to helping guide Oxis into the future of targeted immunotherapy."

Dr. Vallera, who earned a Ph.D. in immunotherapy from Ohio State University, has spent 35 years with the University of Minnesota’s cancer center, where he is director of a laboratory specializing in translational molecular cancer research.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Generex, JAN 17, 2017, View Source [SID1234517456])

Takara Bio USA Holdings, Inc. completes acquisition of Rubicon Genomics, Inc.

On January 18, 2017 Takara Bio USA Holdings, Inc. ("TBUSH") reported that it has completed the acquisition of Rubicon Genomics, Inc. ("Rubicon"), Rubicon has become a wholly-owned subsidiary of TBUSH as of January 17, 2017 (US local time) (Press release, Takara Bio, JAN 17, 2017, View Source [SID1234517461]).

Under the merger agreement executed with Rubicon, TBUSH paid 75 million US dollars to acquire 100% of the equity in Rubicon. TBUSH is a wholly owned subsidiary of Takara Bio Inc. ("Takara Bio"), a leading global biotechnology and life science company headquartered in Shiga, Japan. Takara Bio USA, Inc. ("TBUSA", formerly known as Clontech Laboratories, Inc.) is a wholly owned subsidiary of TBUSH, and both TBUSA and TBUSH are part of the global Takara Bio Group. The impact of the acquisition on Takara Bio Inc.’s financial results in 2017 will be immaterial.

The Takara Bio Group provides a wide range of life science products and services under the Takara, Clontech, and Cellartis brands that assist discovery, translational, and clinical scientists in the advancement of their work. The Rubicon acquisition will allow the Takara Bio Group to augment and expand its worldwide commercial offerings in next generation sequencing (NGS) sample preparation and expand into new markets.

"We are pleased to announce the completion of this transaction and officially welcome Rubicon to the Takara Bio Group," said Carol Lou, President, TBUSA. "We are excited about the synergy between Rubicon’s technologies and products and our own longstanding expertise and SMART-based portfolio of cDNA synthesis, low-input, and single cell RNA-seq products. We now have an expanded NGS and genetic analysis capabilities that strengthen our product portfolio and allow us to better serve the life science research market, as well as creating new opportunities for us to serve customers in IVF and other clinical markets. We are excited to move forward as one organization positioned for growth."

As previously communicated, Rubicon’s technology is also complementary with the WaferGen Bio-systems, Inc. instrument platforms and technologies. TBUSH announced plans to acquire WaferGen in 2016, and anticipates that the merger will close in March 2017. The combined acquisitions are synergistic and will allow the Takara Bio Group to provide the exciting benefits of the combined portfolios to the life science community.

ERYTECH Presents New Preclinical Data on ERY-MET at the 2017 ASCO GI Symposium

On January 17, 2017 ERYTECH Pharma (Euronext Paris – ERYP), the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs (the "Company"), reported new data supporting the second Company’s product candidate ERY-MET will be presented at the 2017 Gastrointestinal Cancers Symposium co-sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO GI), being held January 19 – 21, 2017 in San Francisco, California (Press release, ERYtech Pharma, JAN 17, 2017, View Source [SID1234517431]).

The research will be presented during the poster session of the symposium by the first author of the abstract, Dr. Vanessa Bourgeaux, the Company’s R&D Project Leader. The abstract will be available online starting on January 20, 2017 on ERYTECH’s website via View Source

The findings from the preclinical studies demonstrate that ERY-MET, which is methionine gamma-lyaseencapsulated in red blood cells (RBC) developed using the Company’s proprietary ERYCAPS encapsulation platform technology, can inhibit tumor growth in a murine model of human gastric adenocarcinoma. This effect can be regulated by Vitamin B6 supplementation.

Abstract #78: Methionine gamma-lyase-encapsulated into red blood cells (ERY-MET) shows profound antitumor activity in gastric carcinoma
Author: Vanessa Bourgeaux
Date: Thursday, January 19, 2017
Time: 12:30 – 2:00 p.m. PST 5:30 – 7:00 p.m. PST
Location: Board G12, Moscone West Building Poster
Session: A: Cancers of the Esophagus and Stomach

Methionine is an essential amino acid, which all cells need to grow and multiply. More particularly, fastgrowing tumor cells exhibit very high requirements of methionine to proliferate. The enzyme methionine gamma-lyase (MGL) mediates tumor starvation via systemic lowering of methionine levels. MGL is an enzyme with a short half-life and is dependent on a co-factor, a Vitamin B6 derivative, to function. Encapsulating MGL in RBCs extends the half-life significantly and the conversion of Vitamin B6 to the co-factor happens naturally inside the RBC.

The Company’s research team determined the plasma methionine level reduction as a pharmacodynamics biomarker and analyzed the anti-tumor activity of weekly ERY-MET injections in mice. The study found that ERY-MET, in combination with daily Vitamin B6 supplementation, increased active MGL half-life in vivo, from less than 24 hours to 8-9 days. The combined ERY-MET and Vitamin B6 treatment exhibited anti-tumor activity in 100% of treated mice, with tumor growth inhibitions varying from 91% to 100% by the end of the study.

Dr. Bourgeaux stated, "We had already identified the potential of ERY-MET as a tumor starvation agent in a mouse model of glioblastoma. This work, demonstrating that ERY-MET can also induce tumor growth inhibition in mice with human gastric adenocarcinoma and achieving an almost complete regression, strengthens the Company’s current strategy to develop product candidates based upon its proprietary ERYCAPS platform as potential treatments for various oncology indications in addition to blood cancers. We believe ERY-MET shows significant promise as a new anti-tumor drug to treat gastric and other recalcitrant cancers."