On March 2, 2017 Foundation Medicine, Inc. (NASDAQ:FMI) reported that it has received payment from Palmetto GBA, the Company’s Medicare Administrative Contractor (MAC) in North Carolina, for its FoundationOne comprehensive genomic profiling assay when used in the clinical course of care for individuals in the United States with Stage IIIB/IV non-small cell lung cancer (NSCLC) who meet the eligibility requirements under Palmetto GBA’s Local Coverage Determination L36143 (LCD) (Press release, Foundation Medicine, MAR 2, 2017, View Source [SID1234517962]). The LCD was most recently updated on December 22, 2016. Foundation Medicine began submitting an initial set of claims to Palmetto GBA in January 2017 for FoundationOne, and received its first payments for claims under this LCD on March 1, 2017.

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"Coverage and payment for FoundationOne under Palmetto GBA’s LCD is a positive step toward advancing access to precision medicines for individuals living with non-small cell lung cancer," said Troy Cox, chief executive officer for Foundation Medicine. "We look forward to continuing to work with Palmetto GBA as we gain additional payment experience under this LCD for non-small cell lung cancer. We will continue to work with FDA and CMS as they review our universal companion diagnostic test through the Parallel Review process with the goal of being the first pan-cancer, universal companion diagnostic test to receive FDA approval and a National Coverage Determination from CMS."

On March 2, 2017 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported full-year 2016 financial results (Press release, CytomX Therapeutics, MAR 2, 2017, View Source [SID1234517961]).

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As of December 31, 2016, CytomX had cash and cash equivalents and short-term investments of $181.9 million. Based upon its current operating plan, the Company expects its existing capital resources will be sufficient to fund operations into 2019.

"Over the past year, CytomX has transformed from a research organization to a clinical-stage company, bringing us one step closer to realizing our vision of transforming lives with safer and more effective therapies," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "With our lead program, CX-072, in the clinic and CX-2009 closely behind, together with our world-class pharmaceutical partnerships, we are advancing a broad and deep pipeline of differentiated Probody therapeutics that are focused on some of the most compelling targets for the treatment of cancer."

2016 Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody) Program

Enrollment is underway in the PROCLAIM clinical study of CX-072, a PD-L1-targeting Probody therapeutic for the treatment of cancer patients.
Clinical data is expected to begin to emerge in late 2017, and throughout 2018.
CX-2009 (CD166 Probody Drug Conjugate) Program

Following completion of GMP manufacturing and GLP toxicity studies in 2016, the IND filing for CX-2009 remains on track for the first half of 2017.
CX-2009 is a first-in-class Probody drug conjugate targeting the highly expressed tumor antigen, CD166.
Clinical data is expected to begin to emerge in late 2017, and throughout 2018.
Partnerships

CytomX continues to forge biopharmaceutical partnerships that retain meaningful downstream rights to extend the reach of our technology and in order to fund its wholly-owned programs.
As part of our ongoing collaboration, Bristol-Myers Squibb selected the third and fourth targets and selected a CTLA-4 clinical candidate for a total of $25 million in payments to CytomX in 2016.
In April 2016, CytomX entered into a collaboration with AbbVie to co-develop and co-commercialize Probody Drug Conjugates against CD71 and up to two additional targets to be selected by AbbVie. CytomX received an upfront payment of $30 million.
Full-Year Financial Results
Cash, cash equivalents and investments totaled $181.9 million as of December 31, 2016, compared to $186.7 million as of December 31, 2015. The decrease reflects cash used in operations, partially offset by a $30 million upfront payment received from AbbVie in connection with the development and collaboration agreements entered into in April 2016, and $25 million in milestone payments received from Bristol-Myers Squibb in connection with its third target selection in January 2016, and fourth target selection in December 2016.

Research and development expenses were $54.8 million for the year ended December 31, 2016, compared to $28.4 million for the year ended December 31, 2015. The increase was primarily attributable to $9.6 million in manufacturing costs for the Company’s CX-072, CX-2009 and CX-2029 programs, $4.5 million in laboratory and professional services and supplies, $3.1 million in personnel-related expenses due to an increase in headcount, $3.1 million in non-cash stock-based compensation due to higher stock valuation, $2.4 million to advance CX-072 into Phase 1/2 clinical development, $1.7 million in royalty payments triggered by the payments from Bristol-Myers Squibb’s third and fourth target selections, clinical candidate selection, as well as upfront payments from AbbVie, and $1.6 million in facilities-related expenses due to a move to a larger facility in October 2016.

General and administrative expenses were $19.9 million for the year ended December 31, 2016, compared to $12.6 million for the year ended December 31, 2015. The increase was predominantly due to $3.2 million in non-cash stock based compensation due to higher stock valuation, $2 million in professional service and outside service expenses, $1.8 million in personnel-related expenses due to an increase in headcount and $0.4 million in facilities-related expense due to a move to a larger facility in October 2016.

On March 2, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported that the Canadian Cancer Trials Group (CCTG, formerly known as the National Cancer Institute of Canada) will present clinical trial data evaluating the Company’s investigational immuno-oncology viral-agent, REOLYSIN, during the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 1-5, in Washington, DC (Filing, 6-K, Oncolytics Biotech, MAR 2, 2017, View Source [SID1234517948]).

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"We’re very pleased that CCTG has this opportunity to present final data from the metastatic breast cancer study to the international scientific community," said Dr. Matt Coffey, President & CEO of Oncolytics.

The abstract, authored by Bernstein et al, "A randomized (RCT) phase II study of oncolytic reovirus (pelareorep) plus standard weekly paclitaxel (P) as therapy for metastatic breast cancer (mBC)" will be available on the AACR (Free AACR Whitepaper) website on March 31, 2017. Submitted by the CCTG, the abstract covers final results from IND 213, an open-label, randomized, non-blinded Phase 2 study to assess the therapeutic combination of intravenously-administered REOLYSIN given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer.

Oncolytics would like to thank the patients that participated in this study, the CCTG and all the physicians and nurses involved.

About Breast Cancer
The American Cancer Society estimates there will be 255,180 new cases of breast cancer diagnosed in the United States and 41,070 deaths from the disease in 2017.

On March 2, 2017 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, reported that it will present a poster on its ComPACT platform technology at the AACR (Free AACR Whitepaper) Annual Meeting being held on April 1-5, 2017 in Washington, DC (Press release, Heat Biologics, MAR 2, 2017, View Source [SID1234517943]).

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The details for the poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting are as follows:

Title: Potency of Gp96-Ig/Fc-OX40L cell-based combination vaccine in cancer immunotherapy
Date and Time: April 2, 2017 at 1:00 p.m. – 5:00 p.m. ET
Location: Convention Center, Halls A-C, Poster Section 26
Session Title: T-cell Immunity to Cancer: New Progress
Poster Board Number: 9
Abstract Number: 605

Copies of the abstract are available and can be viewed online through the AACR (Free AACR Whitepaper) website at www.aacr.org. The poster will be uploaded to the Publications section of Heat’s corporate website in line with the conference’s embargo policy.

On March 2, 2017 Incyte Corporation (Nasdaq:INCY) announces that 20 abstracts from its research and development portfolio will be presented at the upcoming 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Washington, D.C. from April 1-5, 2017. These abstracts include a clinical data presentation from the dose-escalation phase of the Company’s ongoing trial of its selective FGFR 1/2/3 inhibitor (INCB54828), and well as preclinical data from its small molecule inhibitor programs targeting PI3Kδ (INCB50465), LSD1 (INCB59872), JAK1 (INCB52793), BRD/BET (INCB54329 and INCB57643) and FGFR4 (INCB62079) and from its epacadostat, OX40 (INCAGN1949) and GITR (INCAGN1876) immuno-oncology programs.

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"The 20 abstracts to be presented at the upcoming AACR (Free AACR Whitepaper) annual meeting underscore the breadth and potential of our innovative pipeline of oncology product candidates," stated Reid Huber, Ph.D., Chief Scientific Officer, Incyte. "We are pleased to share these new data with the scientific community, and look forward to progressing these and the other clinical programs in our growing portfolio."

Key abstracts, including Incyte-sponsored and independent investigator-sponsored studies, include:
Targeted therapies abstracts
Activity of the Selective FGFR 1, 2 and 3 Inhibitor INCB54828 in Genetically-Defined Models of Triple-Negative Breast Cancer (Abstract #531)
Sunday, April 2, 2017, 1:00-5:00 p.m. EDT, Poster Section 22
Preclinical Studies on Potential Therapeutic Combination Partners for the Potent and Selective PI3K Inhibitor INCB50465 in DLBCL (Abstract #143)
Sunday, April 2, 2017, 1:00-5:00 p.m. EDT, Poster Section 6
The Evaluation of INCB59872, an FAD-Directed Covalent Inhibitor of LSD1, in Preclinical Models of Ewing Sarcoma (Abstract #1162)
Monday, April 3, 2017, 8:00-12:00 p.m. EDT, Poster Section 5
The Novel FGFR4-selective Inhibitor INCB62079 is Efficacious in Models of Hepatocellular Carcinoma Harboring FGF19 Amplification (Abstract #1234)
Monday, April 3, 2017, 8:00-12:00 p.m. EDT, Poster Section 7
Mechanisms of Bromodomain and Extra-Terminal Motif Inhibitor (BETi) Sensitivity in Triple-Negative Breast Cancer (TNBC) (Abstract #1518)
Monday, April 3, 2017, 8:00-12:00 p.m. EDT, Poster Section 20
Selective Inhibition of FGFR4 by INCB62079 is Efficacious in Models of FGF19- and FGFR4-Dependent Cancers (Abstract #2100)
Monday, April 3, 2017, 1:00-5:00 p.m. EDT, Poster Section 33
Combination of Epigenetic Regulation with Targeted Therapies Significantly Enhances Anti-Tumor Effects in Hematologic Malignancy Models (Abstract #2032)
Monday, April 3, 2017, 1:00-5:00 p.m. EDT, Poster Section 4
Preliminary Results from a Phase 1/2 Study of INCB54828, a Highly Selective Fibroblast Growth Factor Receptor (FGFR) Inhibitor, in Patients (pts) with Advanced Malignancies (Abstract #CT111)
Tuesday, April 4, 2017, 8:00-12:00 p.m. EDT, Poster Section 33
INCB52793 JAK1 inhibitor synergizes with ATRA to inhibit expansion of AML (Abstract #3726)
Tuesday, April 4, 2017, 8:00-12:00 p.m. EDT, Poster Section 29
The LSD1 Specific Inhibitor INCB59872 Enhances the Activity of Immune Checkpoint Blockade by Reshaping the Myeloid Compartment in the Syngeneic 4T1 Mouse Mammary Tumor Model (Abstract #4635)
Tuesday, April 4, 2017, 1:00-5:00 p.m. EDT, Poster Section 27
The Selective Bromodomain Inhibitor, INCB54329 Targets both Cancer Cells and the Tumor Microenvironment in the KC Inflammatory Preclinical Model of Ductal Pancreatic Cancer (Abstract #5082)
Wednesday, April 5, 2017, 8:00-12:00 p.m. EDT, Poster Section 2
BET Inhibitors INCB54329 and INCB57643 Display Significant Activity in Androgen-Independent Prostate Cancer Models (Abstract #5080)
Wednesday, April 5, 2017, 8:00-12:00 p.m. EDT, Poster Section 2
Preclinical Characterization of the Potent and Selective BET Inhibitor INCB57643 in Models of Hematologic Malignancies (Abstract #5071)
Wednesday, April 5, 2017, 8:00-12:00 p.m. EDT, Poster Section 2
Immuno-oncology abstracts
Inhibition of IDO1 with Epacadostat Enhances Anti-Tumor Efficacy of PD-1 Blockade in a Syngeneic Glioblastoma (GBM) Model (Abstract #572)
• Sunday, April 2, 2017, 1:00-5:00 p.m. EDT, Poster Section 25
Agonist Antibodies Targeting OX40 and GITR Enhance the Activity of the IDO1-Selective Inhibitor Epacadostat in Preclinical Models (Abstract #2618)
• Monday, April 3, 2017, 1:00-5:00 p.m. EDT, Poster Section 25
INCAGN1876, a Unique GITR Agonist Antibody that Facilitates GITR Oligomerization (Abstract #3643)
• Tuesday, April 4, 2017, 8:00-12:00 p.m. EDT, Poster Section 26
INCAGN1949, an Anti-OX40 Antibody with an Optimal Agonistic Profile, with the Ability to Selectively Deplete Intratumoral Regulatory T Cells in a Range of Tumor Indications (Abstract #4703)
• Tuesday, April 4, 2017, 1:00-5:00 p.m. EDT, Poster Section 30
Trials-in-progress abstracts
Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of INCB54828 in Subjects with Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement (Abstract #CT057)
• Monday, April 3, 2017, 1:00-5:00 p.m. EDT, Poster Section 33
Phase 2, Open-label, Multicenter Study of the Efficacy and Safety of INCB54828 for Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring Fibroblast Growth Factor (FGF)/FGF Receptor (FGFR) Alterations (Abstract #CT059)
• Monday, April 3, 2017, 1:00-5:00 p.m. EDT, Poster Section 33
Phase 2, Open-label, Multicenter Study of the Efficacy and Safety of INCB54828 in Patients with Advanced, Metastatic, or Surgically Unresectable Cholangiocarcinoma (CCA) With Inadequate Response to Prior Therapy (Abstract #CT063)
• Monday, April 3, 2017, 1:00-5:00 p.m. EDT, Poster Section 33
Full session details and data presentations at the AACR (Free AACR Whitepaper) 2017 can be found here.