(Filing, Annual, Cellectis, 2016, MAR 23, 2017, View Source [SID1234518254])

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On March 23, 2017 Medigene AG (FSE: MDG1, Prime Standard, TecDAX), reported details on the Company’s first clinical trial with T-cell receptor-modified T cells, planned to start in late 2017 (Press release, MediGene, MAR 23, 2017, View Source [SID1234518258]). Medigene will use an HLA-A2:01-restricted T-cell receptor (TCR) that targets PRAME, a well characterized tumor antigen. Medigene identified a TCR candidate for this target that demonstrates favorable safety and efficacy in extensive preclinical studies. Data on Medigene’s selected TCR candidate will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 1-5, in Washington, D.C., USA.

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Subject to regulatory approval, Medigene intends to start a combined Phase I/II safety and feasibility trial of its TCR targeting PRAME, named MDG1011, in patients with advanced hematological diseases, namely acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). The Phase I part of this First-in-Man trial is designed as a dose escalation, testing up to 4 dose cohorts in a 3+3 design. The chosen dose will then be further tested in the Phase II part which will include a prospective control group and might potentially be extended into further malignancies. Final details, including trial size, study sites and timelines will become available after clinical trial approval by the competent authority.

Prof. Dolores Schendel, CEO and CSO of Medigene, commented: "Based on extensive preclinical assessment, we are convinced that our TCR specific for the PRAME antigen with high avidity, potent antitumor efficacy and a favorable safety profile will enable us to execute a unique clinical program. This particular trial design examining various indications in parallel allows for faster decisions about future clinical development options based on multiple clinical data sets."

The antigen PRAME (Preferentially Expressed Antigen in Melanoma) was first discovered in melanoma and is overexpressed in a variety of solid cancer indications and several hematological malignancies, while its expression pattern in normal tissue is mainly limited to testis, making it an attractive target for adoptive T cell therapy. As this antigen is expressed intracellularly, it is an ideal candidate for a TCR approach, which otherwise could not be targeted with chimeric antigen receptor (CAR) T cells. Medigene already uses PRAME as a target in its ongoing DC-vaccine trial in AML, where the favorable safety profile of this vaccine allowed the trial to advance into Phase II in April 2016 (Phase I/II final data expected for late 2019).

To view the abstract of the upcoming AACR (Free AACR Whitepaper) presentation please visit: bit.ly/2nnExnY

About Medigene’s TCR technology: The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient’s T cells outside the body (ex vivo).

TCR therapy is developed to utilize a higher number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR T) therapy. Medigene is preparing the clinical development of its first TCR candidates and is establishing a pipeline of recombinant T-cell receptors, and has established Good Manufacturing Practice (GMP)-compliant processes for their combination with patient-derived T cells.

Medigene’s TCR technology for adoptive T-cell therapy is one of the company’s three highly innovative and complementary immunotherapy platforms in immuno-oncology.

On March 23, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris OXI.PA) reported that it has entered into a sponsored research agreement with the University of Minnesota to conduct a toxicity study of its TriKE cancer treatment (OXS-3550), a required step before researchers can apply for a Phase 1 clinical trial with the Food and Drug Administration (Press release, OXIS International, MAR 23, 2017, View Source [SID1234539507]).

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Under the agreement, Oxis will pay for the university to conduct a study that will determine the optimal dose for OXS-3550. The research will be led by Dr. Daniel Vallera, Director of the section on Molecular Cancer Therapeutics at the University of Minnesota Masonic Cancer Center. He is a member of the Scientific Advisory Board of Oxis’ wholly owned subsidiary, Oxis Biotech Inc.

Oxis and the University of Minnesota have reached a licensing agreement under which Oxis holds the worldwide rights to commercialize the TriKE therapy, once it receives regulatory approval.

"The agreement will support the TriKE toxicology studies that are needed for an FDA submission, which we expect to file soon," said Dr. Jeffrey Miller, Deputy Director of the University of Minnesota Masonic Cancer Center. "We are excited to see this drug development move forward."

Dr. Vallera and Dr. Miller were instrumental in developing Trispecific Killer Engager (TriKE) cancer therapy and Bispecific Killer Engager (BiKE). Both platforms have been licensed by Oxis. The BiKE therapy, OXS-1550, is currently in an FDA Phase 1/Phase 2 clinical trial in Minnesota.

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

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.

On March 23, 2017 Alligator reported that the phase I trial, which began in April 2015, is a dose-escalation study involving intratumoral and intravenous administration of ADC-1013 at five clinical sites in Sweden, Denmark and the UK (ClinicalTrials.gov: NCT02379741). The study is sponsored by Alligator and includes 24 patients and ten different tumor types (Press release, Alligator Bioscience, MAR 23, 2017, View Source [SID1234538688]).

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The data will now be analyzed, focusing on safety and tolerability, pharmacokinetics, immunogenicity, biomarker response and clinical response evaluation. The aim is to present the results during the fourth quarter of 2017 at a scientific meeting, followed by a publication in a scientific journal.

"The study has progressed very well and we look forward to evaluating the data," said Per Norlén, CEO at Alligator Bioscience. "I would like to extend my warmest gratitude to all the patients and their families, as well as the investigators and clinical study staff who enabled this study to be successfully completed ahead of time."

In August 2015, Alligator entered a collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, which has the global development rights to ADC-1013.

In October 2016, Janssen Biotech Inc. started a second phase I clinical study (ClinicalTrials: NCT02829099). This study is an intravenous dose escalation study with ADC-1013 (JNJ-64457107).

Webcast
The webcast can be accessed live on the link below and will be available on the company website 30 minutes after the broadcast.

View Source

Phone numbers for participants from:
UK: +44 2030089806
SE: +46856642669
US: +18558315944

For further information, please contact:
Per Norlén, CEO
Telephone: + 46 46 286 42 80 (switchboard)
E-mail: [email protected]

Rein Piir, VP Investor Relations
Telephone: +46 708 537292
E-mail: [email protected]

Per-Olof Schrewelius, CFO
Telephone: +46 46 286 42 85
E-mail: [email protected]

The information in the press release is such that Alligator Bioscience AB is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08.00 CET on 23 March, 2017.

On March 23, 2017 Ethicon* reported the completion of its acquisition of Torax Medical, Inc., a privately held medical device company that manufactures and markets the LINX Reflux Management System for the surgical treatment of Gastroesophageal Reflux Disease (GERD) (Press release, Johnson & Johnson, MAR 23, 2017, View Source [SID1234518409]). This acquisition is aligned with Ethicon’s strategy of expanding its portfolio of minimally invasive options for patients suffering from prevalent and serious medical conditions. Financial terms of the transaction have not been disclosed.

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"Millions of patients continue to suffer from GERD symptoms even when taking high dosages of medication to treat the acid reflux and are left with limited choices to improve their symptoms," said Michael del Prado, Group Company Chair of Ethicon. "This novel technology offers patients an attractive minimally invasive surgical alternative, that preserves gastric anatomy, establishes normal physiological function, and is reversible."

GERD can have a significant impact on a patients’ quality of life. For those patients with symptoms that are not well controlled by lifestyle or medical management, anti-reflux surgery is an option. The LINX Reflux Management System offers patients a clinically proven, safe, effective and durable alternative to the anatomy-altering Laparoscopic Nissen Fundoplication (LNF).i, ii The LINX Reflux Management System is a small implant comprised of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads augments the esophageal sphincter’s barrier function to prevent reflux.

"Torax and Ethicon share a vision for the transformational role that our products can have in advancing patient care," said Todd Berg, CEO and President of Torax Medical. "We are excited to join together to expand patient access to the clinical benefits of LINX."