On April 17, 2016 Precision Biologics, a NantWorks affiliated clinical stage biotechnology company focused on developing therapeutic and diagnostic products for the early detection and treatment of cancer and a participant in the Cancer MoonShot 2020 program, reported it will present a poster titled, "Identification of target and cytotoxicity of novel monoclonal antibody NEO-201 in ovarian and uterine cancer subtypes" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 (Press release, Precision Biologics, APR 18, 2016, View Source [SID:1234511010]).

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"With better identification of cancer subtypes that express the NEO201 target, we are taking a step closer to personalized medicine for women diagnosed with ovarian and uterine cancer," said Philip M. Arlen, M.D., President & Chief Executive Officer of Precision Biologics, Inc. of Rockville, MD. "Without the visionary support of NantWorks and Dr. Patrick Soon-Shiong, tumor-specific and neo-epitope cytotoxicity research would face a much slower development path, potentially impacting cancer morbidity and mortality rates."

At AACR (Free AACR Whitepaper), Precision Biologics will present preclinical data on the cytotoxic effects of NEO-201 in uterine and ovarian cancers. NEO-201 is an investigational, humanized monoclonal antibody that targets a novel neo-antigen with sequence homology to the tumor-associated antigens (TAA) CEACAM-5 and CEACAM-6, but highly sensitive to epithelial tumors with little cross reactivity to normal tissue. It is being explored as a potential therapy for epithelial malignancies. NEO-201 demonstrates antibody-dependent cellular cytotoxicity and specifically targets cancer tissues with minimal reactivity in normal tissues.

"Accelerating clinical development of neo-epitopes is a key focus of our immunotherapy initiative. Given the complexity of ovarian and uterine cancer and the great unmet need to overcome these cancers which strike women in the prime of their lives, the work that Precision Biologics is doing with NEO-201 to drive combination immunotherapy reinforces why NantWorks and Cancer MoonShot 2020 supports this program," said Patrick Soon-Shiong, M.D., founder of NantWorks and leader of the Cancer MoonShot 2020 program.

Results from in vitro cytotoxicity assays and inhibition of tumor growth in nude mice will be reported, both as single agents and in combination with a Natural Killer cell line. The preclinical data indicate that NEO-201 demonstrates tumor-specific cytotoxicity and provides promise for the development of TAA-directed therapy for ovarian and uterine malignancies.

Presentation Information: Identification of target and cytotoxicity of novel monoclonal antibody NEO-201 in ovarian and uterine cancer subtypes

Monday, April 18, 2016 at 8:00am-12:00pm in Section 25, Poster Board 27, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, Ernest N. Morial Convention Center, New Orleans, LA.

Abstract Title: # 1496

Author: M. K. Neuman1, L. Hernandez1, X. P. Wang2, O. Saric2, A. Dubeykovskiy2, P. Arlen1,2 and C. M. Annunziata1,1 National Cancer Institute, Bethesda, MD, 2Precision Biologics, Rockville, MD

About Cancer MoonShot 2020
The Cancer MoonShot 2020 Program is one of the most comprehensive cancer collaborative initiative launched to date, seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. This initiative aims to explore a new paradigm in cancer care by initiating randomized Phase II trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and the aspirational MoonShot to develop an effective vaccine-based immunotherapy to combat cancer by 2020.

On April 18, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported that they presented the first proof-of-concept data from its novel multiplexed digital immunohistochemistry (IHC) technology at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in New Orleans, Louisiana (Press release, NanoString Technologies, APR 18, 2016, View Source [SID:1234511006]). Using a prototype device together with an nCounter Analysis System, the company and its collaborators demonstrated simultaneous counting of 30 different protein targets across a fixed, slide-mounted slice of tumor tissue. The technology demonstrated a dynamic range exceeding five logs and neared single-cell spatial resolution.

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The new approach is described on AACR (Free AACR Whitepaper) poster #1372, "Spatially resolved, multiplexed digital characterization of protein distribution and abundance in FFPE tissue sections." Gordon B. Mills, M.D., Ph.D., Professor and Chair of the Department of Systems Biology at MD Anderson Cancer Center, is co-author of the poster. Dr. Mills commented, "The expansion of NanoString technology to the spatial context of protein concentration is an exciting advance that holds much promise for biomarker discovery and implementation into patient management. We are excited by the actionable data generated by the prototype and look forward to future developments and exploring the utility of the platform in improving patient outcomes."

Based on NanoString’s proprietary barcoding technology, the multiplexed digital IHC approach measures local protein levels within heterogeneous tissue samples. The prototype includes imaging and fluidic components to capture spatial context, and existing nCounter instruments provide the quantification. Current multi-target IHC techniques involve sequential processing steps; therefore, each target addition increases the overall handling time and workload. In contrast, NanoString’s novel technology samples all analytes simultaneously to shorten experiments and simplify data analysis while preserving a higher multiplexing capacity and a wider detection range. The technology is expected to be compatible with current and upcoming nCounter Vantage products for 3D Biology analysis.

"NanoString’s new digital IHC technology combines the high multiplexing and digital quantification of single-molecule optical barcodes with the biological insights provided by protein localization," stated Joseph Beechem, Ph.D., Senior Vice President of R&D at NanoString. "Over the remainder of this year, our plan includes increasing the number of targets in our assays, enhancing the imaging resolution and exploring use with other 3D Biology applications."

Dr. Beechem will present the initial results at the AACR (Free AACR Whitepaper) meeting in Spotlight Theater B, Hall J on Tuesday, April 19th from 12:30 – 1:30 pm Central Time. His presentation is titled "New Optical Barcode Chemistries for Digital, Multiplexed Immunohistochemistry: Power of 3D Biology Enhanced by Spatially Resolved Multiplexed Protein Quantitation on FFPE."

On Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) today presented data demonstrating enhanced anti-tumor efficacy and survival by combining anti-NKG2A with PD-1/PD-L1 pathway inhibitors in murine models at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans, Louisiana, USA (Press release, Innate Pharma, APR 18, 2016, View Source [SID:1234511005]).

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The NKG2A checkpoint receptor is expressed on a subset of NK cells. Similar to the PD-1 receptors, NKG2A can also be induced on tumor-infiltrating CD8 T cells. Therefore, PD-1 and NKG2A may both inhibit anti-tumor immune responses in situations where cancers express the ligands of both these checkpoint receptors. Conversely, anti-tumor immune responses might be enhanced by combined NKG2A and PD-1 pathway blockade.

Poster #2342 reports preclinical data based on an in vivo model of PD-L1 expressing solid tumors. In this model, treatment with either an antibody blocking PD-1 or NKG2A as single agents resulted in modest anti-tumor efficacy. The frequency of tumor-infiltrating NKG2A+ CD8 T cells was increased in anti-PD-1 resistant mice, suggesting that NKG2A is a pathway involved in adaptive PD-1 resistance. Treatment with combination of NKG2A and PD-1 checkpoint inhibitors resulted in significantly enhanced anti-tumor responses. Nearly twice as many mice achieved complete tumor cell regression compared to treatment with anti PD-1 alone.

Nicolai Wagtmann, CSO of Innate Pharma, said: "We are very excited by these data showing that the NKG2A pathway acts as a major mechanism of tumor escape in this model. Considering the high frequency of patients who respond inadequately to PD-1 pathway blockade, we are intrigued by the observations that NKG2A expression on CD8 T cells was increased in PD-1 resistant mice". He added: "These data and the striking efficacy of the combination treatment in this model provide strong support for the clinical trial that was just initiated, testing the combination of monalizumab, Innate’s first-in-class NKG2A checkpoint inhibitor, and durvalumab, AstraZeneca/Medimmune’s investigational PD-L1 checkpoint inhibitor".

On April 18, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, reported results from two programs will be presented in oral sessions at the upcoming 19th Annual American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Meeting (Press release, Ziopharm, APR 18, 2016, View Source [SID:1234511002]). The first presentation highlights preclinical data from the Company’s novel viral gene therapy candidate for the controlled expression of IL-12 in combination with inhibition of programmed cell death protein 1 (PD-1) in a mouse model of glioma. The second presentation highlights preclinical data from the Company’s evolution of the Sleeping Beauty (SB) non-viral transposon-transposase system in a mouse model of leukemia. The ASGCT (Free ASGCT Whitepaper) meeting will take place May 4-7 at the Marriott Wardman Park Hotel in Washington, D.C.

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Title: Regulated Expression of IL-12 as Gene Therapy Concomitant with Blockade of PD-1 for Treatment of Glioma
Session Title: Cancer-Immunotherapy, Cancer Vaccines II
Date and Time: Friday, May 6, 2016 4:00 PM – 6:00 PM ET
Abstract Number: 509
Room: Washington 1-2
Summary: The utility of clinically-feasible immunotherapy in the investigational treatment of glioma may be improved through combination therapies that enhance cytotoxic immune-activation while concomitantly reducing immunosuppression. ZIOPHARM and Intrexon evaluated the combination of controlled local interleukin 12 (IL-12) administration using a virus (Ad-RTS-IL-12) activated by an oral ligand (veledimex) (Ad +V) and blockade of PD-1 using a checkpoint inhibitor:

Results demonstrated that survival of mice treated with Ad +V and anti-PD-1 therapy was superior to either treatment alone;
Combination showed 100% survival;
Because Ad-RTS-IL-12 and anti-PD-1 are clinically available, these data provide impetus for evaluating this combination immunotherapy in humans;
ZIOPHARM plans to initiate a combination study in 2016 and is currently in discussion with partners to provide anti PD-1 therapy.
"The use of PD-1 checkpoint inhibitors in solid tumors has yielded impressive clinical outcomes, yet these results have not yet translated to gliomas, due in part to the immunologic privilege of the central nervous system," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "By combining PD-1 inhibitors, which release a brake on the immune system, with the controlled tumor-directed release of IL-12, which steps on the immune system’s accelerator, we see significant anti-tumor activity. These data provide a strong rationale for studying Ad-RTS-IL-12 + veledimex in combination with anti-PD-1 in the clinic, a trial we look forward to initiating later this year."

Title: Next-Generation Non-Viral Gene Transfer to Redirect T-Cell Specificity
Session Title: Cancer-Immunotherapy, Cancer Vaccines I
Date and Time: Thursday, May 5, 2016 4:00 PM – 5:45 PM ET
Abstract Number: 278
Room: Washington 5-6
Summary: Non-viral gene transfer using the SB transposon/transposase system has been successfully tested in humans to express a chimeric antigen receptor (CAR) to redirect T-cell specificity to CD19. A next-generation SB system has been modified by MD Anderson Cancer Center researchers to improve the design of a CD19-specific CAR as well as reduce the time to manufacture:

Changing the "stalk" of the CAR improved the anti-tumor activity of SB-modified T cells;
These data support the use of new CAR in an ongoing clinical trial (IND#16474).
Decreasing the time the SB-modified T cells were in culture improved the anti-tumor effect;
These data provide support for ZIOPHARM’s efforts to address the challenges of cost and time of bioprocessing cell therapies;
"Targeting CD19 with CAR-modified T cells is an effective approach to treating CD19-expressing leukemias and lymphomas, as demonstrated by current clinical studies," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "Fundamental to advancing this approach, and any modified cell-based therapy, into a broadly deployed treatment option is a streamlined and simplified manufacturing process, with a reduction in the associated cost. These data demonstrate our ability to address these challenges by leveraging the less costly, non-viral Sleeping Beauty system and reducing cell culture time, all while improving the effectiveness of the CD19-specific CAR. We look forward to understanding how these next-generation ideas translate into outcomes in an ongoing Phase 1 study and future clinical studies."

On April 18, 2016 Varian Medical Systems (NYSE: VAR) reported it is supporting a phase III trial comparing outcomes of radiosurgery versus surgical resection for the treatment of early-stage, high-risk, operable non-small cell lung cancer (NSCLC) (Press release, Varian Medical Systems, APR 18, 2016, View Source [SID:1234511001]).

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Known as the "Stablemates Trial," the randomized study will test the hypothesis that the 3-year overall survival in high risk operable patients with stage I NSCLC is equivalent or greater in patients who undergo stereotactic ablative radiotherapy (SAbR) as compared with conventional sublobar resection (SR) surgery. Led by co-chairs Hiran Fernando, MD, Boston Medical Center, and Robert Timmerman, MD, University of Texas Southwestern Medical Center, the study currently involves 34 institutions and 258 patients.

"In addition to a potentially longer survival rate, SAbR may benefit some lung cancer patients by offering them a noninvasive, outpatient treatment option that is easier to tolerate and that doesn’t interfere greatly with their normal, everyday living activities," said Dr. Timmerman.

Sponsored by the Joint Lung Cancer Trialist’s Coalition, the study is being administered by the Department of Radiation Oncology at the University of Texas Southwestern Medical Center. Over the next five years, the study will examine patients’ overall, disease-free, and regional recurrence-free survival rates three years after treatment, as well as adverse events and post-treatment quality of life measures.

"Varian believes in supporting high quality clinical research," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "This clinical trial presents the opportunity to advance radiation oncology and enhance the standard of patient care by giving clinicians a noninvasive treatment option in determining the appropriate therapy for patients."