On March 16, 2016 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) reported that it will present new data related to its clinical and preclinical anti-cancer stem cell and immuno-oncology therapeutic candidates in a total of five presentations at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Meeting to be held April 16-20, 2016 in New Orleans, LA (Press release, OncoMed, MAR 16, 2016, View Source [SID:1234509590]).

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Among the presentations will be multiple abstracts related to the company’s novel GITRL-Fc immuno-oncology therapeutic candidate, biomarker research associated with its vantictumab (anti-FZD7, OMP-18R5) and anti-RSPO3 (OMP-131R10) clinical programs, and xenograft data for demcizumab (anti-DLL4, OMP-21M18) in non-small cell lung cancer.

The following abstracts have been selected for presentation by OncoMed scientists:

Sunday, April 17, 2016 1:00 PM — 5:00 PM

1. "Development of a RSPO3 CLIA-validated assay as a predictive biomarker for response to anti-RSPO3 antibody treatment in patients with solid tumors"
Abstract Number: 404
Presenting author: Chun Zhang, Ph.D., Associate Director, Translational Medicine
Session: Biomarkers

Monday, April 18, 2016 1:00 PM — 5:00 PM

2. "GITR ligand fusion protein (GITRL-Fc) induces T cell mediated anti-tumor immune response and can combine with anti-PDL1 to enhance anti-tumor immunity and long-term immune memory"
Abstract Number: 2214
Presenting author: Minu Srivastava, Ph.D., Senior Scientist
Session: Adoptive Cell Therapy, Immune Checkpoints and Vaccines

Tuesday, April 19, 2016 8:00 AM — 12:00 PM

3. "GITRL-Fc can significantly reduce tumor growth by stimulating innate and adaptive immunity"
Abstract number: 3215
Presenting author: Hyun-Bae Jie, Ph.D., Scientist
Session: Immune Checkpoints 2

4. "Predictive biomarker identification for response to vantictumab (OMP-18R5; anti-Frizzled) using primary patient-derived human pancreatic tumor xenografts"
Abstract Number: 3129
Presenting author: Chun Zhang, Ph.D., Associate Director, Translational Medicine
Session: Biomarkers for Gastrointestinal, Hematologic, and Uncommon Cancers

Wednesday, April 20, 2016 8:00 AM — 12:00 PM

5. "Effects of anti-DLL4 treatment on non-small cell lung cancer (NSCLC) human xenograft tumors"
Abstract number: 4652
Presenting author: Alayne Brunner, Ph.D., Senior Scientist
Session: Cellular Responses to Anticancer Drugs

On March 16, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that it will present preclinical and clinical data on its extensive oncology pipeline at the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 16-20, 2016 at the Ernest N. Morial Convention Center, New Orleans, Louisiana (Press release, Merrimack, MAR 16, 2016, View Source [SID:1234509589]). Of particular focus will be preclinical data on the latest novel therapeutic developed from Merrimack’s nanoliposome platform and systems biology approach – MM-310, an ephrin receptor A2 (EphA2)-targeted nanoliposome delivering docetaxel.

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EphA2 is a key receptor associated with poor prognosis and is shown to be overexpressed in several solid tumors including prostate, ovarian, gastric and lung cancer. In preclinical models, MM-310 has demonstrated that Merrimack’s proprietary delivery platform provides controlled biodistribution and sustained exposure of the drug at the site of the tumor. This design has shown improvement in antitumor activity while avoiding the hematologic toxicities common with docetaxel or the bleeding associated with a traditional antibody drug conjugate (ADC) format in preclinical models.

Merrimack will also present a late-breaking abstract describing in vitro and in vivo targeting effects of MM-302 in HER2 intermediate cancer cells as well as research on ONIVYDE (irinotecan liposome injection) and other targeted therapies currently in development.

Oral presentation
MM-310: a novel EphA2 targeted nanoliposome for delivery of docetaxel

Session Title: Antibody-targeted Therapy
Nanoliposomal targeting of Ephrin receptor A2 (EphA2): Preclinical in vitro and in vivo rationale (Abstract #871)
Sunday, April 17, 2016, 4:15 PM – 6:15 PM ET

Poster Sessions
MM-310: a novel EphA2 targeted nanoliposome for delivery of docetaxel

Session Title: Targeting the Microenvironment
Nanoliposomal targeting of Ephrin receptor A2 (EphA2): Clinical Translation (Abstract #750, Poster Section 33)
Sunday, April 17, 2016, 1:00 PM – 5:00 PM ET

Session Title: Drug Delivery
Activity of an EphA2-targeted docetaxel nanoliposome in pancreatic patient-derived models as monotherapy and in combination with gemcitabine (Abstract #2069, Poster Section 15)
Monday, April 18, 2016, 1:00 PM – 5:00 PM ET

Session Title: Therapeutics
MM-310, a novel EphA2-targeted docetaxel nanoliposome (Abstract #3912, Poster Section 21)
Tuesday, April 19, 2016, 1:00 PM – 5:00 PM ET
MM-398 (ONIVYDE (irinotecan liposome injection) or "Nal-IRI"): a novel encapsulation of irinotecan in a liposomal formulation

Session Title: Drug Delivery
Differential tissue clearance results in improved therapeutic index for irinotecan liposome injection (ONIVYDE) when combined with the PARP inhibitor veliparib in preclinical cervical tumors (Abstract #2075, Poster Section 15)
Monday, April 18, 2016, 1:00 PM – 5:00 PM ET

Session Title: Targeted Therapy
Preclinical anti-tumor activity of nanoliposomal irinotecan (Nal-IRI, MM-398) + 5-FU + oxaliplatin in pancreatic cancer (Abstract #4830, Poster Section 20)
Wednesday, April 20, 2016, 8:00 AM – 12:00 PM ET
MM-302: a novel HER2 targeted liposomal doxorubicin

Session Title: Late-Breaking Research: Cancer Chemistry
HER2-targeted PEGylated liposomal doxorubicin (MM-302) efficiently targets the HER2 intermediate cell population in vitro and in vivo (Abstract #LB-061, Poster Section 12)
Sunday, April 17, 2016, 1:00 PM – 5:00 PM ET
MM-141 (istiratumab): a monoclonal antibody that acts as a tetravalent inhibitor of PI3K/AKT/mTOR

Session Title: Growth Factor Receptors and Surface Antigens as Therapeutic Targets
Istiratumab (MM-141), a bispecific antibody targeting IGF-1R and ErbB3, inhibits pro-survival signaling in vitro and potentiates the activity of standard of care chemotherapy in vivo in ovarian cancer models (Abstract #1209, Poster Section 15)
Monday, April 18, 2016, 8:00 AM – 12:00 PM ET
MM-151: an oligoclonal therapeutic consisting of a mixture of 3 fully human monoclonal antibodies designed to bind and inhibit signaling of the epidermal growth factor receptor (EGFR)

Session Title: New Drugs, Therapeutic Targets, and Treatment Approaches
MM-151 elicits broad and unique inhibition of cells harboring EGFR extracellular domain mutations —results of multiscale experiments with genome-edited cell lines (Abstract #2148, Poster Section 18)
Monday, April 18, 2016, 1:00 PM – 5:00 PM ET
Companion Therapeutics:

Session Title: Growth Factor Receptors and Surface Antigens as Therapeutic Targets
A network biology screen reveals ligand-receptor pathway connections and resistance mechanisms to RTK-directed therapies in cancer cells (Abstract #1199, Poster Section 15)
Monday, April 18, 2016, 8:00 AM – 12:00 PM ET
Preclinical Research:

Session Title: Targeting Protein Kinases, Death Pathways, and the Tumor Microenvironment
Design and engineering of TRAIL fusion proteins for cancer therapy (Abstract #3842, Poster Section 19)
Tuesday, April 19, 2016, 1:00 PM – 5:00 PM ET

On March 16, 2016 Incyte Corporation (Nasdaq: INCY) reported that ten abstracts featuring data from its emerging development portfolio will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans, Louisiana from April 16–20, 2016 (Press release, Incyte, MAR 16, 2016, View Source;p=RssLanding&cat=news&id=2149072 [SID:1234509588]). These abstracts include data from the Company’s monoclonal antibody agonist programs targeting GITR and OX40 as well as its small molecule inhibitor programs targeting LSD1, BRD (BET), PI3Kδ and JAK1.

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"We are pleased to present the latest scientific data that underlie the potential of our emerging development portfolio at the upcoming AACR (Free AACR Whitepaper) annual meeting," stated Reid Huber, PhD, Chief Scientific Officer, Incyte. "This collection of abstracts exemplifies our discovery team’s innovative approach to cancer research, and reinforces Incyte’s commitment to the advancement of novel therapeutics which have the potential to improve and extend the lives of patients living with cancer."

In addition to these presentations, Incyte has been invited to present "IDO1 Inhibition as a Modifier of the Immune Composition of the Tumor Microenvironment and a Component of Combination Immunotherapy for Cancer," as part of an AACR (Free AACR Whitepaper) Major Symposia entitled, "Cancer Immunotherapy: Small Molecule Approaches" scheduled for Wednesday, April 20, 2016 from 10:15 a.m.–12:00 p.m., Ernest N. Morial Convention Center, Theater C, New Orleans, La.

Key abstract presentations, including Incyte-sponsored and independent investigator studies, include:

Effects of INCB052793, a Selective JAK1 Inhibitor, in Combination with Standard of Care Agents in Human Multiple Myeloma (MM) Cell Lines and Xenograft Models (Abstract #1339)
Monday April 18, 8:00 a.m.–12:00 p.m., Halls G-J, Poster Section 19

Preliminary safety, efficacy, and pharmacodynamics of a highly selective PI3Kδ inhibitor, INCB050465, in patients with previously treated B-cell malignancies (Abstract #CT056)
Monday Apr 18, 2016 1:00–5:00 p.m., Halls G-J, Poster Section 13

INCAGN01949: An anti-OX40 agonist antibody with the potential to enhance tumor specific T cell responsiveness, while selectively depleting intratumoral regulatory T cells (Abstract #3204)
Tuesday, April 19, 2016, 8:00 a.m.–12:00 p.m., Halls G-J, Poster Section 25

A novel agonist antibody (INCAGN01876) that targets the co-stimulatory receptor GITR (Abstract #3220)
Tuesday, April 19, 2016, 8:00 a.m. –12:00 p.m., Halls G-J, Poster Section 25

Activity of the BET Inhibitor INCB054329 in models of lymphoma (Abstract #3780)
Tuesday, April 19, 2016, 1:00–5:00 p.m., Halls G-J, Poster Section 16

The LSD1 inhibitor INCB059872 is synergistic with ATRA in models of non-APL acute myelogenous leukemia (Abstract #4696)
Wednesday, April 20, 2016, 8:00 a.m.–12:00 p.m., Halls G-J, Poster Section 16

Combination of BET inhibitor INCB054329 and LSD1 inhibitor INCB059872 is synergistic for the treatment of AML in vitro and in vivo (Abstract #4702)
Wednesday, April 20, 2016, 8:00 a.m.–12:00 p.m., Halls G-J, Poster Section 16

The evaluation of INCB059872, an FAD-directed Inhibitor of LSD1, in preclinical models of human small cell lung cancer (Abstract #4704)
Wednesday, April 20, 2016, 8:00 a.m.–12:00 p.m., Halls G-J, Poster Section 16

Discovery of INCB059872, a novel FAD-directed LSD1 inhibitor that is effective in preclinical models of human and murine AML (Abstract #4712)
Wednesday, April 20, 2016, 8:00 a.m.–12:00 p.m., Halls G-J, Poster Section 16

The BET inhibitor INCB054329 enhances the activity of checkpoint modulation in syngeneic tumor models (Abstract #4904)
Wednesday, April 20, 2016, 8:00 a.m.–12:00 p.m., Halls G-J, Poster Section 23

Full session details for AACR (Free AACR Whitepaper) 2016 can be found here.

On March 16, 2016 GlobeImmune, Inc. (NASDAQ: GBIM) today provided an update on the Company’s business and clinical programs and announced financial results for the full year ended December 31, 2015 (Filing, Annual, GlobeImmune, 2015, MAR 16, 2016, View Source [SID:1234509586]).

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The Company continues to seek potential strategic transactions and, after a thorough process, has not identified a potential transaction to date. Cantor Fitzgerald & Co. has been retained by the Company to assist in reviewing ways to maximize stockholder value. There is not a defined timeline for the strategic review process and the review may not result in any specific action or transaction.

The Company has three ongoing clinical trials being conducted by the Company’s corporate collaborators, Gilead Sciences, Inc. and Celgene Corporation. GS-US-330-1401, the GS-4774 Phase 2 clinical trial in patients with chronic HBV infection who are currently not receiving treatment, is fully enrolled and the 24-week results are projected to be available in the second quarter of 2016. The results from a GI-6207 Phase 2 trial in subjects with medullary thyroid cancer are projected to be available in the second half of 2016. A Phase 2 clinical trial designed to investigate the safety and efficacy of evaluating GI-6301 in combination with radiation therapy in patients with chordoma is still enrolling patients.

Financial Results – Fiscal Year 2015

For the full year ended December 31, 2015, GlobeImmune reported a net loss of $2.8 million compared to $16.3 million in 2014. The decrease in net loss for 2015 was due to $1.8 million of revenue from the license of the GI-6200 program to Celgene, lower research and development expenses due to lower compensation expense, as well as no interest expense, early retirement expense associated with convertible notes and no fair-value adjustments of warrants as these costs terminated upon the closing of the Company’s initial public offering in July 2014. GlobeImmune reported a loss applicable to common stockholders of $2.8 million, or $0.48 per share, for the year ended December 31, 2015 compared to loss applicable to common stockholders of $23.4 million, or $8.04 per share, in 2014.

Research and development for proprietary programs expense for the year ended December 31, 2015 was $1.8 million compared to $2.2 million for the year ended December 31, 2014, a decrease of $0.4 million. The decrease was primarily due to a reduction in expenses related to the GI-4000 program and a decrease in salary expense due to layoffs during the third quarter. Costs of manufacturing services for 2015 were $0.3 million compared to $1.5 million in 2014. The decrease was primarily due to a decrease in expenses relating to manufacturing services for Gilead for the Phase 2 HBV trial. Costs of collaboration license and services for the year ended December 31, 2015 was $2.4 million compared to $3.5 million for the year ended December 31, 2014, a decrease of $1.1 million. The decrease was primarily due to a decrease in expenses related to the Phase 1 clinical trial for GS-4774 and reduction in salary expense due to layoffs during the third quarter. General and administrative expense for the year ended December 31, 2015 was $4.6 million compared to $4.3 million for the year ended December 31, 2014, an increase of $0.3 million. The increase was related to expenses associated with being a public company for a full year ended December 31, 2015 offset by lower travel expenses and gain on sale of property and equipment.

At December 31, 2015, GlobeImmune had cash and equivalents of $9.9 million. The Company’s major financial obligation is the remaining balance on its lease. Net of the total payments due over the remaining 36 months of the lease obligation, the Company believes it has sufficient cash to operate the company through the end of 2016 as it continues to evaluate strategic alternatives.

On March 16, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) and its collaborators reported new data in a variety of tumor types at the 2016 United States and Canadian Academy of Pathology (USCAP) Annual Meeting taking place March 12-18 in Seattle (Press release, Foundation Medicine, MAR 16, 2016, View Source [SID:1234509585]). The data further strengthens the growing body of evidence across various cancers in support of integrating comprehensive genomic profiling with FoundationOne into the clinical pathology assessments of cancer patients to help inform targeted therapy utilization and improve patient care. The data presented underscore an urgent need for innovative solutions capable of accurately informing therapeutic options based on unique genomic alterations found within each patient’s tumor. Oncology case reports and series have indicated positive responses to targeted therapies for certain rare tumor types, and additional evidence supporting clinical utility is evolving to support payor coverage.

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"We are encouraged by the latest data presented amongst the global leaders and top minds in the pathology field at USCAP," said Jeffrey S. Ross M.D., medical director of Foundation Medicine, chair of pathology at the Albany Medical Center and lead author of two of the studies. "The pathology community is essential to advancing the next generation of novel therapies and personalized treatment for cancer patients worldwide. We are honored to provide an evidence-based platform to help the oncology community identify clinically relevant genomic alterations that hold the potential to influence patient treatment options, both for therapies that are FDA approved and therapies that are being investigated in clinical trials."

Three of the posters presented at the event focused on cancers with diverse, clinically relevant alterations, many of which are undetectable with standard screening, and represent indications with unmet clinical need, including refractory and metastatic breast cancer, triple negative breast cancer (TNBC) and adult and pediatric brain tumors. Results from all three data sets point to the importance of comprehensive genomic profiling to potentially influence and personalize treatment and guide the selection of approved targeted therapies or access to novel therapies that are being investigated in clinical trials.

Key Data Highlights:

The poster presentation titled, "Pangenomic Analysis of BRAF Genomic Alterations Across All Types of Brain Tumors Reveals Expanded Opportunities for Targeted Therapies," by Zachary R. Chalmers, lead researcher, senior research associate with Foundation Medicine, and presented by Dr. Ross demonstrates the need for additional basket-type clinical trials aimed to identify BRAF genomic alterations in various types of non-melanoma cancers to further understand targeted therapy choice and efficacy. Comprehensive genomic profiling using FoundationOne was performed to search for all classes of BRAF alterations in a large series of intracranial neoplasms including adult and pediatric brain tumors, and key findings include:

142 (4.8 percent) brain tumors featured BRAF alterations including base substitutions (70 percent), fusions (25 percent) and rare amplifications and other alterations types (5 percent). Genomic alterations in BRAF are widely distributed in brain tumors with base substitutions primarily seen in high-grade gliomas and BRAF fusions in low grade gliomas

The presentation demonstrated that BRAF base substitutions and fusions can be successfully targeted with anti-BRAF and anti-MEK targeted therapies

Preliminary findings outlined in the poster presentation titled, "Genomic Alterations of MCL1 is a Predictive Biomarker of Triple Negative Status and Therapy Response in Breast Cancer," led and presented by Dr. Ross, draw attention to the vital need for comprehensive analysis of breast cancer genes and the inherent limitations of hotspot testing in uncovering potential therapy options. Two hundred patients with breast cancer underwent comprehensive genomic profiling using FoundationOne, and key findings include:

MCL1 amplification is a frequent feature in advanced stage and high grade breast cancer, and MCL1 amplified breast cancer is very seldom ERBB2 co-amplified

Of the MCL1 amplified breast cancer cases, 88 percent were high grade and 98 percent were stage IV at the time of sequencing

Of the 200 MCL1 amplified breast cancer patients, 12 (6 percent) were ERBB2 (HER2) amplified

Clinical observation across several case studies suggest that treatment with targeted therapies including sorafenib and vorinostat in heavily pre-treated MCL1 amplified breast cancer may be correlated with clinical benefit

These preliminary findings suggest that MCL1 amplified TNBC may benefit from combination targeted therapy, and warrant further investigation in a prospective clinical trial

Consistent with the other two data sets, the findings in the poster presentation titled, "The Detection of IHC-/FISH- ERBB2 Non-Amplification Mutations in 5,606 Cases of Refractory and Metastatic Breast Cancer: an Emerging Opportunity for anti-HER2 Targeted Therapies," led by Siddhartha Dalvi, MBBS, lead researcher, Albany Medical College, and presented by Dr. Ross, demonstrate the potential for missing critical information with routine hotspot sequencing tests and thus the need for comprehensive profiling with FoundationOne. Comprehensive genomic profiling was performed on 5,606 metastatic breast cancer patients, and key findings include:

ERBB2mut are responsible for nearly 20 percent of ERBB2 alterations in metastatic breast cancer, though such mutations are not detectable by routine IHC and FISH slide-based HER2 tests

698 (12.5 percent) featured ERBB2 alterations, 596 (10.6 percent) featured ERBB2 amplifications (ERBB2amp) and 137 (2.4 percent) featured ERBB2mut

Evidence that ERBB2mut driven mBC are responsive to anti-HER2 targeted therapies is steadily accumulating