On November 16, 2016 Therapeutic Proteins International (TPI) reported that it will change its name to Adello Biologics, LLC, effective immediately (Press release, Therapeutic Proteins International, NOV 16, 2016, View Source;s%20Interest-,Therapeutic%20Proteins%20International%20Renames%20Company%20to%20Adello%20Biologics%2C%20LLC%3B%20Relocates,Headquarters%20to%20Piscataway%2C%20New%20Jersey&text=CHICAGO%2C%20Nov.,Biologics%2C%20LLC%2C%20effective%20immediately [SID1234563291]). The name change accompanies the move of its corporate headquarters to Piscataway, New Jersey. Along with all corporate functions, the 50,000 sq. ft. facility will house the company’s new R&D lab. The company plans to complete the move by the end of the year.

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"The new name aligns with our company’s vision; To become the trusted choice of high-quality, affordable biosimilars for patients worldwide," said Dr. Peter Moesta, Chief Executive Officer of Adello. "We are fully focused on developing a robust portfolio of biosimilars, and our move to New Jersey is an effort to further enhance our R&D bench strength, drawing on the scientific talent pool in the area."

The Chicago site will remain the company’s key manufacturing facility in the U.S. with around 100 employees supporting operations. Adello is currently actively recruiting positions for the R&D function in Piscataway. With capacity for 70 scientists, the group will continue to be led by Chief Scientific Officer, Dr. Michael Washabaugh.

On November 16, 2016 Heat Biologics, Inc. (Nasdaq:HTBX), a leader in the development of gp96-based immunotherapies that are designed activate a patient’s immune system to fight cancer, reported that it will present a poster reporting topline results, including primary endpoint data, from the Phase II trial evaluating HS-410 (vesigenurtacel-L) in combination with standard of care, Bacillus Calmette-Guérin (BCG), in the treatment of non-muscle invasive bladder cancer (NMIBC) at the Society of Urology Annual Meeting, in San Antonio, TX, on Wednesday, Nov 30th (Press release, Heat Biologics, NOV 16, 2016, View Source [SID1234516626]). The poster will be presented by study principal investigator, Gary Steinberg, MD, The Bruce and Beth White Family Professor of Surgery and Director of Urologic Oncology at The University of Chicago Medical Center.

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Poster Presentation Details:

Title: Top-Line Results from Vesigenurtacel-L (HS-410) in Combination with BCG from a Randomized, Blinded Phase 2 Trial in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)

Date and Time: November 30, 2016, 5:30-7:15PM EST (4:30-6:15PM CST)

Poster Number: 21

The abstract can be viewed in the searchable online program at: View Source

On November 15, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that new preclinical data for the company’s LOXO-292 and LOXO-195 programs will be presented at the 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics taking place November 29 – December 2, 2016 in Munich, Germany (Press release, Loxo Oncology, NOV 15, 2016, View Source [SID1234516601]).

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The details of the poster presentations are as follows:

LOXO-292

Date: December 1, 2016
Title: The development of a potent, KDR/VEGFR2-sparing RET kinase inhibitor for treating patients with RET-dependent cancers
Session: Molecular targeted agents II
Abstract Code: 441
Poster Number: 120
Location: Exhibition Hall

LOXO-195

Date: December 1, 2016
Title: The development of LOXO-195, a second generation TRK kinase inhibitor that overcomes acquired resistance to 1st generation inhibitors observed in patients with TRK-fusion cancers
Session: Molecular targeted agents II
Abstract Code: 442
Poster Number: 121
Location: Exhibition Hall

On November 15, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) announced today it will present first-in-human data from its Phase 1 clinical trials of anti-RSPO3 (OMP-131R10) and anti-DLL4/VEGF bispecific antibody (OMP-305B83) at the upcoming 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium being held November 28 — December 2, 2016 in Munich, Germany. Abstracts for the presentations have been posted to www.ecco-org.eu/ENA.

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Data will be presented on Tuesday, November 29, 2016:

Poster #P039; Abstract #68: Initial results from a Phase 1a/b study of OMP-131R10, a first-in-class anti-RSPO3 antibody, in advanced solid tumors and previously treated metastatic colorectal cancer (CRC)
Session: Molecular targeted agents I
Presenting author: Johanna Bendell, M.D., Sarah Cannon Research Institute

Poster #P057; Abstract #87: A first-in-man Phase 1a study of the bispecific anti-DLL4/anti-VEGF antibody OMP-305B83 in patients with previously treated solid tumors
Session: Molecular targeted agents I
Presenting author: Kathleen Moore, M.D., University of Oklahoma Stephenson Cancer Center

The posters will be available on OncoMed’s website following the presentation at www.oncomed.com.

About Anti-RSPO3
OncoMed is currently enrolling patients in an ongoing Phase 1a/b clinical trial of anti-RSPO3 that was started in July 2015. The Phase 1a/b trial initially enrolled patients with advanced refractory solid tumors and includes an expansion arm for biomarker-selected patients to receive single-agent therapy. The Phase 1b portion, which began enrollment in January 2016, is testing anti-RSPO3 with FOLFIRI in patients with second-line metastatic colorectal cancer. Anti-RSPO3 is believed to be the first drug candidate in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers.

About Anti-DLL4/VEGF
OncoMed initiated a single-agent study of its anti-DLL4/VEGF bispecific in January 2015 in patients with advanced refractory solid tumors. Dose escalation is completed in the Phase 1a trial and enrollment in an expansion cohort is ongoing. The anti-DLL4/VEGF bispecific antibody is designed to combine the anti-cancer stem cell, dysangiogenic and immunotherapy mechanisms of anti-DLL4 with the anti-angiogenic activity of an anti-VEGF agent. The bispecific antibody was discovered using OncoMed’s proprietary MAbTrap antibody display technology, which enables the rapid identification of monoclonal antibodies that bind targets with high affinity and specificity. The antibody is the first program based on OncoMed’s BiMAb bispecific platform technology to enter clinical testing.

On November 15, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported the publication of data demonstrating enhanced persistence of genetically modified T cells targeting leukemia through utilization of its non-viral Sleeping Beauty (SB) system to co-express membrane-bound IL-15 (mbIL15) and a CD19-specific chimeric antigen receptor (CAR) (Press release, Ziopharm, NOV 15, 2016, View Source [SID1234516794]). The article, titled "Tethered IL-15 augments antitumor activity and promotes a stem-cell memory subset in tumor-specific T cells," was published in the Proceedings of the National Academy of Sciences (PNAS) and is available online here.

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Using the SB system, researchers generated genetically modified T cells that preserved stem-cell memory (TSCM) by co-expressing the CAR with a fusion variant of IL-15. These engineered T cells were effective in treating established CD19+ leukemia in mice by facilitating the long-term persistence of TSCM cells sustained by signaling through mbIL15. These findings provide for a translational pipeline of immunotherapies with improved potential by combining mbIL15 and T cells with diverse specificities.

"The ability to generate CAR-T cells with preserved stem-cell memory is a novel strategy for promoting long-lived persistence and effectiveness of immunotherapies for the treatment of patients with cancers. Producing this rare, but highly desirable, T-cell subset has historically been a challenge," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM and an author of the publication.

"We have demonstrated the ability to incorporate membrane-bound IL-15 via the non-viral Sleeping Beauty platform, thereby enhancing T-cell survival and raising our expectations for corresponding therapeutic benefit. The fundamental role that IL-15 plays in T-cell activation and propagation makes it an attractive candidate to incorporate into engineered immunotherapies, and we are advancing CAR-modified T cells co-expressing mbIL15 to testing in humans," added Dr. Cooper.

The SB transposon-transposase is a unique non-viral system for introducing genes into cells and is exclusively licensed by Intrexon Corporation (NYSE:XON) through The University of Texas MD Anderson Cancer Center and accessed as part of ZIOPHARM’s collaboration with Intrexon.