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Indian FDA Approves the First Autologous Dendritic Cell-based Immuno-oncology Product, APCEDEN®

On April 5, 2017 APAC Biotech, reported that it was granted with a commercial license by Indian FDA (CDSCO – Central Drugs Standard Control Organization) to market product, APCEDEN, a Dendritic cell-based autologous Immuno-oncology product for four cancer indication namely Prostate, Ovarian, Colo-rectal and Non Small Cell Lung carcinoma (Press release, APAC Biotech, APR 5, 2017, View Source [SID1234562370]).

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The Indian Food and Drug Administration authorities, after their stringent review of the application, have issued the commercial license (Form 46) to conduct a post marketing surveillance on statistically significant number of patients for each indication.

Other products namely STEMPEUCEL, an allogeneic-cultured mesenchymal cells from Stempeutics and OSSORON, an autologous-cultured adult osteoblast and CHONDRON, an autologous-cultured adult chondrocyte from Regenerative Medical Services, Mumbai, also received the marketing license at the same time.

"The past decades have seen revolutionary progress in the development and application of cell and genetic engineering in an effort to personalize the treatment of cancer. We are now confident that it is possible to treat cancer patients using this approach as observed during clinical trials across India. The results are encouraging and mark a potential new paradigm in treating these solid tumors that do not respond to standard therapies," said a leading oncologist, Dr. Ashok Vaid.

APCEDEN, an autologous monocyte-derived mature Dendritic cell when loaded with tumor antigen have the ability to generate an effective immune response against the tumor. In the year 2011, an ATTEST trial was conducted where refractory solid tumor with multiple chemo failure patients were enrolled and administered with APCEDEN. The results were published in International Journal of Cytotherapy in the year 2014. ATTEST study included a stringent logistics management and was uniquely, effectively, conducted under the leadership of Principal investigator, Medical oncologist, Dr. P P Bapsy.

The trial was designed to understand the potential benefits and risk of the therapy. In the trial 28.9% of cases showed stability of disease with good quality of life. A retrospective study was also conducted on the advice of CBBTDEC (Cell Biology Based Therapeutic Drug Evaluation Committee), ICMR (Indian Council of Medical Research) where more than 200 days’ of survival benefit was observed as compared to the retrospective control group.

Alligator presents at DNB Small and Medium Enterprises (SME) Conference in Oslo

On April 5, 2017 Alligator presented at DNB Small and Medium Enterprises (SME) Conference in Oslo (Presentation, Alligator Bioscience, APR 5, 2017, View Source [SID1234538701]).

Promising New Cancer Therapy developed via Michigan State University and Venn Therapeutics Partnership

On April 4, 2017 Michigan State University (MSU) researchers presented promising cancer therapy results at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) International Meeting in Washington, DC. This novel technology, AdVCA0848, activates the stimulator of interferon genes (STING) pathway to delay tumor growth in a B16 melanoma model, promoting beneficial anti-tumor responses (Press release, Venn Therapeutics, APR 5, 2017, View Source [SID1234519737]).

Supported by the immuno-oncology company Venn Therapeutics, this research (session MS.CL06.01 and abstract number 2994) is led by Dr. Andrea Amalfitano, Ph.D., D.O., Osteopathic Heritage Foundation Endowed Professor of Pediatrics, Microbiology and Molecular Genetics at MSU, and Dr. Chris Waters, Associate Professor of Microbiology and Molecular Genetics at MSU.

Data showed that a single intra-tumoral treatment with AdVCA0848 rapidly inhibited tumor growth and significantly improved animal survival when compared to repeat dosing of an anti-PD1 checkpoint inhibitor. AdVCA0848 also generated high intracellular concentrations of STING agonists that were sustained over several days, reducing the need for multiple treatments. Previously published studies demonstrated that AdVCA0848 induces the production of multiple inflammatory cytokines, likely supporting the reported anti-tumor responses while showing little to no evidence of systemic toxicity.

"This research begins to demonstrate that AdVCA0848 is both a safe and potent stimulator of the STING pathway, and this unique combination promotes safe induction of impressive anti-tumor responses in vivo," said Dr. Amalfitano. "We are excited to further develop this novel immunotherapy and advance it rapidly to human clinical trials."

In general, these results provide evidence that AdVCA0848 is a novel, off the shelf STING agonist that can potentially improve anti-tumor responses in melanoma patients, either as a standalone therapeutic or in combination with currently approved therapies.

"These data are very encouraging. This research highlights a strong STING asset, as the characteristics of AdVCA084 overcome many hurdles that STING-targeting small molecules currently face," said Dr. Edith Janssen, Associate Professor, Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, and Chair of the Scientific Advisory Board for Venn Therapeutics. "We are excited to take this asset into clinical trials for further development and improve therapeutic outcomes for cancer patients."

This research is made possible in part through sponsored research and licensed technology partnerships with Michigan State University.

"Partnerships with companies like Venn Therapeutics allow us to work together to move bright ideas to the marketplace and therapies to patients even faster," said Anne C. DiSante, CLP, Associate Director of MSU Technologies. "That’s why translational research is remarkable: we can work collaboratively nationally, even internationally, to enhance human health and well-being."

To learn more about research underway at the MSU Department of Microbiology and Molecular Genetics, visit View Source

Venn Therapeutics is an immuno-oncology company focused on developing novel, best-in-class drugs that transform tumor-resident innate immune cells to an anti-tumor phenotype reversing the immunosuppressive microenvironment found within tumors. Venn believes this approach will expand the number of patients who can be effectively treated with immuno-oncology modalities. For more information visit www.VennTherapeutics.com

The MSU Innovation Center combines innovation, technology transfer, start-up support, and a portfolio of dedicated business and community partnerships to bring cutting-edge ideas to the marketplace. Composed of Business-CONNECT, MSU Technologies and Spartan Innovations, the MSU Innovation Center stewards ideas from concept to product, launching more than 150 discoveries into patented products and start-up businesses annually. Learn more at View Source

OSE Immunotherapeutics Presented New Data at AACR Annual Meeting 2017 on OSE-172 (Effi-DEM), Company’s Checkpoint Inhibitor Blocking Suppressive Myeloid Cells and Inducing Anti-tumoral Potent T Memory Response

On April 05, 2017 (GLOBE NEWSWIRE) — OSE Immunotherapeutics SA (ISIN: FR0012127173) (Mnémo:OSE) reported that the Company presented significant results at the AACR (Free AACR Whitepaper)* meeting in the very promising field of myeloid/macrophage suppressive cells, an abundant immune cell type infiltrating many tumors and often associated with a poor prognosis.

OSE-172 (Effi-DEM) is a first-in-class checkpoint inhibitor that blocks these suppressive cells, allowing parallel mobilization of T cells and produces dramatic anti-tumorigenic results in monotherapy and in combination with other immunotherapies as T checkpoint inhibitors.

OSE-172 is a selective SIRP-alpha antagonist monoclonal antibody. SIRP-alpha is expressed on myeloid suppressive cells (primarily on Myeloid Derived Suppressor Cells (MDSC) and Tumor Associated Macrophages (TAM)). The main ligand of SIRP-alpha is CD47, which is ubiquitously expressed in various cells and overexpressed in tumors.

The preclinical safety of OSE-172 was first established without any binding to or potential interaction with human red blood cells and platelets while CD47 is expressed on these hematological cells. Furthermore, CD47 interacts with several other ligands and physiological functions, such as the CD47/SIRP-gamma axis, another member of the SIRP family, which has been observed to play a role in human T cell proliferation. OSE-172, as selective antagonist of SIRP-alpha, is not a binder of SIRP-gamma, thus avoiding a deleterious impact on T cell immune response and allowing for a strong human effector T cell proliferation, a key advantage of this mechanism of action.

Furthermore, the efficacy of this myeloid checkpoint inhibitor has been established alone and in combination with immunotherapies as T checkpoint inhibitors. OSE-172 has demonstrated its impact on the Tumor Micro-Environment by switching M2 pro-tumorigenic macrophages into M1 anti-tumorigenic macrophages whilst increasing effector memory CD8 T cells.

When OSE-172 was combined with other immunotherapies, T memory cells transmitted efficacy against a new tumor re-challenge.

"These new data demonstrate OSE-172 as having a differentiated safety and selective pharmacological profile which provides us with the opportunity to open various potential indications in the immuno-oncology field for our new myeloid checkpoint inhibitor. We are currently actively preparing the next steps of its development towards clinical stage," said Bernard Vanhove, Chief Operating Officer of OSE Immunotherapeutics, in charge of R&D and International Scientific Collaborations.

*American Association for Cancer Research, Washington April -1-5th, 2017
The poster presented was entitled: "Selective targeting of SIRP alpha induces potent memory anti-tumor immune responses without presenting hematological toxicity" and is available on the AACR (Free AACR Whitepaper) website.

ABOUT OSE IMMUNOTHERAPEUTICS
Our ambition is to become a world leader in activation and regulation immunotherapies
OSE Immunotherapeutics is a biotechnology company focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology, auto-immune diseases and transplantation. The company has a balanced portfolio of first-in-class products with a diversified risk profile ranging from clinical phase 3 registration trials to R&D:

In immuno-oncology:

Tedopi (OSE-2101), a combination of 10 optimized neo-epitopes to induce specific T activation in immuno-oncology – Currently in registration Phase 3 trial advanced NSCLC HLA A2+ patients EU /US – Orphan Status in the US – Registration expected in 2019 – A Phase 2 with Tedopi in combination with a checkpoint inhibitor in NSCLC is considered in 2017.
OSE-172 (Effi-DEM), new generation checkpoint inhibitor targeting the SIRP-α receptor – In preclinical development for several cancer models.

In auto-immune diseases and transplantation:

FR104, CD28-antagonist in immunotherapy – Phase 1 trial completed – For the treatment of autoimmune diseases and for use with transplantation – Licensed to Janssen Biotech Inc. to pursue clinical development.
OSE-127 (Effi-7), interleukin receptor-7 antagonist – In preclinical development for inflammatory bowel diseases and other autoimmune diseases. License option agreement with Servier for the development and commercialization.

The portfolio’s blockbuster potential gives OSE Immunotherapeutics the ability to enter global agreements at different stages of development with major pharmaceutical players.

Immunotherapy is a highly promising and growing market. By 2023 Immunotherapy of cancer could represent nearly 60% of treatments against less than 3% at present * and the projected market is estimated at $67 billion in 2018 **.

There are more than 80 autoimmune diseases that represent a significant market including major players in the pharmaceutical industry with sales towards $10 billion for the main products. The medical need is largely unmet and requires the provision of new innovative products involved in the regulation of the immune system.

MEDIGENE PRESENTED PRECLINICAL DATA ON ITS PRAME-SPECIFIC TCR AT AACR CONFERENCE

On April 5, 2017 Medigene AG (FSE: MDG1, Prime Standard, TecDAX) reported that preclinical data on the T-cell receptor (TCR) T4.8-1-29 was presented during an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Washington, D.C., USA (Press release, MediGene, APR 5, 2017, View Source [SID1234518506]). This PRAME-specific TCR will be used in Medigene’s first TCR immunotherapy "MDG1011" which will be tested in a clinical phase I/II trial scheduled to be started by the end of 2017.

Dr. Manon Weis, Scientist at Medigene, held an oral presentation on the "Isolation and Characterization of a PRAME-specific TCR for Immunotherapy", describing the target antigen PRAME, the procedures to identify and select the TCR candidate and data that showed its safety and efficacy.

Medigene selected PRAME (PReferentially expressed Antigen in MElanoma) as antigen target for its first clinical TCR therapy MDG1011, as it 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. This makes it an attractive target for adoptive T-cell therapy.

Medigene used blood from a healthy donor and a rapid in vitro process to isolate CD8-positive T cells specific for PRAME. T cells and PRAME expressing dendritic cells (DCs) from the same donor were co-cultured to activate antigen specific T cells, which were isolated using FACS technology and re-tested for specific recognition of PRAME after expansion. The TCR-sequences of antigen-specific clones were identified by Next Generation Sequencing and the TCRs further characterized in terms of safety and efficacy.

This characterization revealed that the TCR clone T4.8-1-29 is highly specific for the target antigen and leads to a recognition and lysis of PRAME-expressing tumor cells. To assess its safety profile, the potential recognition of healthy tissues derived from different organs from HLA-A*02:01-positive donors was investigated. Multiple normal tissue cells were neither recognized nor lysed by TCR expressing T cells, underpinning the very favorable safety profile of this TCR.

Dr. Markus Dangl, Senior Vice President Research & Preclinical Development of Medigene, said: "Effector cells with our TCR against PRAME show a high natural avidity for the target epitope without the need of further manipulation, e.g. functional efficacy enhancement by affinity maturation. In addition, the toxicity assessment using various in vitro and in silico tools revealed a favorable preclinical safety profile for this TCR."

To view the abstract(1) of the presentation please visit: bit.ly/2nExnY

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.