On April 18, 2016 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, reported that the Company, and its collaborating investigators at Leiden University Medical Center (LUMC), have been selected for a late-breaking poster presentation of a T cell receptor (TCR) product candidate containing the proprietary MyD88/CD40 activation switch (Go-TCR) at the AACR (Free AACR Whitepaper) 2016 Annual Meeting (Press release, Bellicum Pharmaceuticals, APR 18, 2016, View Source;p=RssLanding&cat=news&id=2157773 [SID:1234510961]). The conference will take place in New Orleans from April 16-20, 2016.

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The presentation, titled "Go-TCR: Inducible MyD88/CD40 (iMC) Enhances Proliferation and Survival of Tumor-Specific TCR-Modified T Cells, Increasing Anti-Tumor Efficacy" will highlight preclinical data demonstrating that its novel "go" switch can augment activation and expansion of TCR-engineered T cells while sensitizing tumors to T cells via cytokine-induced MHC class I upregulation.

The poster will be available in the Events & Presentations section of the Bellicum website at the time of the presentation.

Presentation Details

Abstract Number: LB-084
Presentation Title: "Go-TCR: Inducible MyD88/CD40 (iMC) Enhances Proliferation and Survival of Tumor-Specific TCR-Modified T cells, Increasing Anti-Tumor Efficacy"
Presentation Date: Monday, April 18, 2016
Presentation Time: 8:00 a.m. -12:00 p.m. CDT

On April 18, 2016 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company developing checkpoint modulator antibodies and cancer vaccines, reported that three abstracts on the Company’s checkpoint modulator product candidates were accepted for poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2016 Annual Meeting (Press release, Agenus, APR 18, 2016, View Source [SID:1234510982]). The conference is taking place in New Orleans from April 16-20, 2016.

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Poster Details:

OX40
Poster Title: INCAGN01949: A Novel Anti-OX40 Agonist Antibody with the Potential to Enhance Tumor Specific T-cell Responsiveness, while Selectively Depleting Intratumoral Regulatory T Cells
Poster Number: #3204
Session Date: Tuesday, April 19, 2016
Session Time: 8:00 AM -12:00 PM CDT

GITR
Poster Title: A Novel Agonist Antibody (INCAGN01876) that Targets the Costimulatory Receptor GITR
Poster Number: #3220
Session Date: Tuesday, April 19, 2016
Session Time: 8:00 AM -12:00 PM CDT

CTLA-4
Poster Title: AGEN1884 and AGEN2041: Two Functionally Distinct Anti-CTLA-4 Antagonist Antibodies
Poster Number: #5005
Session Date: Wednesday, April 20, 2016
Session Time: 7:30 AM -11:00 AM CDT

Agenus is partnered with Incyte Corporation for the development of INCAGN1949 and INCAGN1876, and is partnered with Recepta Biopharma SA for certain South American rights for AGEN1884 and AGEN2041. Abstracts and posters will become available on the Company’s website at View Source following the poster sessions.

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Glioblastoma multiforme (GBM) is the most common brain and central nervous system (CNS) cancer, accounting for 15.1% of all primary brain tumors, and 55.1% of all gliomas. There are an estimated 12,120 new glioblastoma cases predicted in 2016 in the U.S. Malignant brain tumors are the most common cause of cancer-related deaths in adolescents and young adults aged 15-39 and the most common cancer occurring among 15-19 year olds in the U.S. While GBM is a rare disease (2-3 cases per 100,000 person life years in U.S. and E.U.), it is quite lethal with 5-year survival rates historically less than 10%. Chemotherapy with temozolomide and radiation are shown to extend mean overall survival from 4.5 to 15 months, while surgery remains the standard of care. GBM remains difficult to treat due to the inherent resistance of the tumor to conventional therapies.

Immunotherapy approaches targeting brain tumors offer promise over conventional treatments. IL13Rα2 is an attractive target for CAR-T therapy as it has limited expression in normal tissue but is over-expressed on the surface of greater than 50% of GBM’s. CAR-T cells are designed to express membrane-tethered IL-13 receptor ligand (IL-13) with high affinity for IL13Rα2 and reduced binding to IL13Rα1 in order to reduce healthy tissue targeting.

We are developing an optimized CAR-T product incorporating enhancements in CAR design and T-cell engineering to improve antitumor potency and T-cell persistence. We include a second generation hinge optimized CAR containing mutations in the IgG4 linker to reduce off target Fc interactions as well as the 41BB (CD137) co-stimulatory signaling domain for improved survival and maintenance of memory T-cells as well as extracellular domain of CD20 as a selection/safety marker. In order to further improve persistence, central memory T-cells (TCM) are isolated and enriched. The manufacturing process limits ex vivo expansion in order to reduce T-cell exhaustion and maintain a TCM phenotype.

In collaboration with the COH, we have an on-going phase I clinical study to assess the feasibility and safety of using TCM enriched IL13Rα2-specific CAR engineered T-cells and are currently treating patients with recurrent/refractory GBM. We will assess the T-cell persistence and determine the potential immunogenicity of the cells to determine a recommended phase II dose.

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, InfiMed, APR 18, 2016, View Source [SID:1234510962]).

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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."

Learn more about the Stablemates Trial at View Source

Lenalidomide and bevacizumab have antitumor activity in various tumor types. We conducted a phase I study of this combination in patients with advanced cancer.
A "3 + 3" study design was used. Lenalidomide 10 or 20 mg (orally, days 1-21) and bevacizumab 5, 7.5, or 10 mg/kg, (intravenously, every 2 weeks) were given at four escalating dose levels, followed by an expansion phase at the highest maximum tolerated dose (MTD) (1 cycle = 4 weeks). Dose-limiting toxicity (DLT), MTD, adverse events, and clinical outcomes were assessed.
Thirty-one patients were enrolled (median age, 60 years; men, 52 %). The most common tumor types were colorectal carcinoma (n = 11) and melanoma (n = 5). Overall, 105 cycles (median, 2) were administered. No DLTs were observed. The maximum tested dose (level 4) was used in the expansion phase. The most common toxicities were fatigue (n = 7, 23 %) and skin rash (n = 4, 13 %). One patient developed a transient ischemic attack (3.2 %); prophylactic anticoagulation became mandatory in the subsequent 17 treated patients. Of 31 patients, 27 were evaluable for response. Stable disease (SD) was noted in 10 (37 %) patients, including five patients with SD for ≥6 months (tumor types: clear cell sarcoma, germ cell tumor, colorectal carcinoma, and melanoma). The median progression-free survival and overall survival were 2.8 and 5.5 months, respectively.
The combination of lenalidomide with bevacizumab in patients with advanced solid tumors was safe. Prolonged stable disease was noted in selected tumor types, warranting further clinical evaluation.

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