On January 18, 2017 Telix Pharmaceuticals Limited ("Telix") reported a product development partnership with Therapeia GmbH & Co KG ("Therapeia") (Press release, Telix Pharmaceuticals, JAN 18, 2017, View Source [SID1234626270]). Telix will add Therapeia’s ACD-101 theranostic program for glioblastoma to its pipeline of advanced theranostic radiopharmaceutical products. Telix also has secured the option to acquire Therapeia under pre-agreed terms. The financial terms of the transaction are not disclosed.

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ACD-101 is a synthetic amino acid that targets the L-type amino acid transporter 1 (LAT1), which is strongly over-expressed in many aggressive malignancies, including glioblastoma, multiple myeloma, melanoma, gastric, breast, prostate and primary hepatocellular carcinoma (HCC). ACD-101 has been studied clinically with both diagnostic radiolabels (for imaging with Positron Emission Tomography – PET) and therapeutic radionuclides. ACD-101 demonstrates favourable therapeutic biodistribution and kinetics, and is actively transported across the intact blood-brain-barrier into tumour cells. ACD-101 potentially offers therapeutic benefit as a monotherapy, and in conjunction with other therapeutic agents, including radiotherapies (external beam therapy, microspheres, brachytherapy, etc.), due to its radiosensitization effect.

CEO Chris Behrenbruch stated, "ACD-101 is a unique multi-action agent that has the potential to deliver something really new to the management of several very challenging malignancies, particularly glioblastoma. Early patient experience in Germany has demonstrated promising therapeutic results and we are excited to be working with the Therapeia team to take this program forward to Phase II and beyond."

Therapeia Managing Director, Dr. Andreas Kluge added, "We are delighted become part of the Telix team and to add this program to Telix’s stable of theranostic radiopharmaceuticals. The radiopharmaceutical space has lacked commercial critical mass for decades, and has only just started to gain the clinical and product development momentum it truly deserves. Only by building a portfolio of best-in-class products and financing them appropriately, can we expect to see the field deliver on its enormous clinical potential." Dr. Kluge joins Telix as a Co-Founder and Chief Medical Officer.1

About ACD-101

ACD-101 is a synthetic amino acid that targets the L-type amino acid transporter 1 (LAT1), which is over-expressed in many malignancies, including glioblastoma, multiple myeloma and primary hepatocellular carcinoma (HCC). LAT1 forms part of the tumour metabolome, harnessed by tumour cells to grow at the expense of surrounding healthy cells. LAT1 has been recently identified as promising drug target in oncology. Over a hundred patients have been successfully imaged with ACD-101 to study biodistribution and kinetics, including in patients with inoperable brain tumours. Clinical pilot studies for the therapeutic forms of ACD-101 have commenced in Europe.

In glioma, ACD-101 is actively transported over the intact blood-brain-barrier into tumour cells overexpressing LAT1, conveying a unique triple mode of action consisting of 1) a targeted radiation toxicity, when administering radiolabeled forms of ACD-101 (131I, 211At), 2) a direct cytostatic effect combined with 3) an intrinsic radiosensitizer effect, enhancing the activity of both, internal and external radiation therapy. The fact, that pathologically increased amino acid uptake is central function in any tumour disease, suggests that ACD-101 may have very broad clinical applicability.

On January 17, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, reported that the first patient of the Therapeutic Immunotherapy with NKR-2 (THINK) trial started cell processing in Belgium (Press release, Celyad, JAN 17, 2017, View Source [SID1234517421]). Blood was collected from this patient and first CAR-T NKR-2 dose level infusion (3×108 cells) is expected in January 2017.

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"We are pleased to announce that the first patient has been registered in our Belgian Phase Ib trial of CAR-T NKR-2. After witnessing evidence of activity in our initial safety studies, we are enthusiastic about reporting data from this trial in 2017,"said Christian Homsy, CEO of Celyad. "We look forward to expanding the trial to U.S.-based institutions and I would like to thank our clinical partners, and the Celyad team for enabling this milestone."

Dr. Frédéric Lehmann, VP Clinical Development & Medical Affairs at Celyad: "This is an important moment for Celyad. The THINK trial is aimed to demonstrate that CAR-T NKR-2 cells can deeply transform the way we treat cancer patients. The team keeps on showing its awe-inspiring ability to deliver in Research and Development, and the Company has now reached a cardinal inflection point to emerge as a key player in the CAR-T space."

About the THINK trial
THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase Ib study to assess the safety and clinical activity of multiple administrations of autologous CAR-T NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma).
The trial will test three dose levels adjusted to body weight: up to 3×108, 1×109 and 3×109 CAR-T NKR-2 cells. At each dose, the patients will receive three successive administrations, two weeks apart, of CAR-T NKR-2 cells. The dose escalation part of the study will enroll up to 24 patients while the extension phase would enroll 86 additional patients.

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]).

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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.

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]).

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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.

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]).

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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."