On May 14, 2015 Heat Biologics reported its financial results for the first quarter ended March 31, 2015.

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First Quarter 2015 Highlights & Recent Developments
· Presented positive immunological data on HS-410 (vesigenurtacel-L) in non-muscle-invasive bladder cancer (NMIBC)

o At the 7th Annual Phacilitate Immunotherapy Forum, data were presented showing a strong immune response, that correlated with a clinical response, in a HS-410 treated patient, supporting the mechanism of action of ImPACT therapy

o At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, provided an update on immune responder and non-responder phenotypes from the phase I clinical trial of HS-410 in NMIBC.

· Received US FDA "Fast-Track" designation for HS-410 in combination with BCG for the treatment of non-muscle invasive bladder cancer

· Presented preclinical data on a novel approach to combination immunotherapy at the Keystone Symposia on Tumor Immunology

o Data presented demonstrate strategy for vaccine and co-stimulation in a single-cell based product

· Announced collaboration with OncoSec Medical to evaluate
combination immunotherapy platforms

· Announced initiation of a new Phase 1b trial of Viagenpumatucel-L (HS-110) in non-small cell lung cancer (NSCLC)

oTrial will explore combination of HS-110 with various immune checkpoint agents

· Raised net proceeds of approximately $11.1 million in an underwritten public offering

"We are pleased to report continued positive momentum with our lead clinical programs in NMIBC and NSCLC," said Jeff Wolf, Heat’s CEO. "We look forward to achieving several additional clinical milestones this year, including interim immune response data from the ongoing Phase 2 trial in NSCLC and completion of enrollment in the Phase 2 trial in NMIBC. The successful public financing we completed in March of this year puts us in a stronger financial position to execute on our development activities."

Quarter Ended March 31, 2015 vs. Quarter Ended March 31, 2014
Research and development expenses for the first quarter of 2015 decreased 6% compared to the first quarter of 2014. Clinical and regulatory expenses were $2.2 million compared to $0.8 million for the first quarter of 2014. The increase was attributable to increases in clinical trial execution costs, increased investigator payments, and other costs related to the manufacturing of vaccines for clinical trials.

General and administrative expenses for the quarter were $1.3 million compared to $1.0 million for the first quarter of 2014. The increase from the first quarter of 2014 was attributable to increases related to professional services, personnel costs as well as an increase in non-cash stock compensation.

Net loss attributable to common stockholders was $3.9 million, or ($0.57) per basic and diluted share for the first quarter of 2015. This compares to a net loss of $2.3 million, or ($0.36) per basic and diluted share for the first quarter of 2014.

As of March 31, 2015, the Company had approximately $21.1 million in cash, cash equivalents, and short-term investments. This balance includes the $11.1 million net proceeds from the March 2015 offering and subsequent over-allotment option.

On May 14, 2015 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis technology platform, reported financial results for the first quarter ended March 31, 2015 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, MAY 14, 2015, View Source [SID:1234504337]).

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"We continue to make strong progress in our clinical programs," said Jeff Abbey, president and chief executive officer. "Data from the previously conducted phase 2 clinical trial of AGS-003 in metastatic renal cell carcinoma (mRCC) were recently published in the Journal for ImmunoTherapy of Cancer and showed that an increase in memory T-cells after five doses of AGS-003 was associated with prolonged survival. In addition, patients with intermediate risk mRCC experienced a median survival in excess of 5 years. Expected median survival for these patients treated with sunitinib as their first line targeted therapy is approximately 20.5 months. These and the other findings of the trial are being further evaluated in the ongoing phase 3 ADAPT trial. We look forward to an interim data analysis for this trial by the Independent Data Monitoring Committee, or IDMC, at approximately 25% of events which we expect will occur during the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting."

Mr. Abbey continued, "We are also pleased to have recently entered into an agreement with Lummy HK, under which they licensed from us the rights to manufacture, develop and commercialize AGS-003 for the treatment of cancer in China, Hong Kong, Taiwan and Macau. We believe this agreement provides further validation of AGS-003 to treat not only mRCC, but potentially others cancers as well, and look forward to the development of this promising product candidate to treat a new population of patients with high unmet medical needs."

Recent Highlights and Anticipated Milestones

Data from the previously conducted phase 2 clinical trial of AGS-003 published in the Journal for ImmunoTherapy of Cancer
The data from the trial show that treatment with AGS-003 in combination with sunitinib was safe, well tolerated and associated with immunologic responses and extended survival
Median overall survival for all patients was 30.2 months and median overall survival for intermediate risk patients was over 5 years
Observations from the trial indicate that an increase in memory T-cells after five doses of AGS-003 was associated with prolonged survival

Entered into a license agreement with Lummy HK for the development of personalized immunotherapies to treat cancer in China
Lummy HK licensed the rights to manufacture, develop and commercialize AGS-003 for the treatment of cancer in China, Hong Kong, Taiwan and Macau
Lummy HK has agreed to pay Argos a royalty on net sales of AGS-003 at a rate in the teens and up to an aggregate of $20 million for regulatory and commercial milestones
Argos sold $10 million of its common stock to an affiliate of Lummy and the China BioPharma Capital I Fund

NIH Division of Aids (DAIDS) approved $6.6 million in funding for the investigator-initiated phase 2 adult eradication study of AGS-004, the company’s investigational fully personalized immunotherapy for HIV
Allows stage two of the adult eradication trial to move forward; the trial has already been cleared for initiation by the FDA

Received the Economic Development Award at the 17th annual Triangle Commercial Real Estate Women (Triangle CREW)
Champion Awards

Argos recognized for its plans to expand into a new 100,000 square foot manufacturing facility currently under construction and create nearly 250 jobs in Durham, NC

Initiation of an investigator-initiated phase 2 pediatric trial of AGS-004 planned for second half of 2015

Continue the build-out and equipping of Argos’ automated commercial manufacturing facility

Full enrollment of the phase 3 ADAPT trial for AGS-003 in mRCC expected by the end of second quarter 2015

Interim data analysis from the ADAPT trial by the IDMC at approximately 25% of events expected during the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Dr. Robert Figlin, Principal Investigator, will present an update from the ADAPT trial at ASCO (Free ASCO Whitepaper) during the Genitourinary (Nonprostate) Cancer poster session on Monday, June 1st from 1:15-4:45pm CT
Poster titled "Patient identification and eligibility insights in the synchronous metastatic RCC population: An update from the ongoing ADAPT phase 3 study experience" (abstract TPS4582)

Selected First Quarter 2015 Financial Results

Revenue for the three months ended March 31, 2015 totaled $0.2 million compared to $0.8 million for the same period in 2014. Net loss attributable to common stockholders for the three months ended March 31, 2015 was $17.5 million, or $0.89 per share, compared to a net loss attributable to common stockholders of $10.9 million, or $1.05 per share, for the same period in 2014. Research and development expense for the three months ended March 31, 2015 totaled $14.8 million compared to $8.5 million for the same period in 2014. General and administrative expense for the three months ended March 31, 2015 totaled $2.4 million compared to $1.9 million for the same period in 2014.

As of March 31, 2015, Argos’ cash, cash equivalents and short-term investments totaled $39.2 million compared to $56.2 million as of December 31, 2014.

Five Prime Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Five Prime Therapeutics, MAY 14, 2015, View Source [SID1234504283]).

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Kura Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Kura Oncology, MAY 13, 2015, View Source [SID1234504332]).

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On May 13, 2015 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported interim results from a global, randomized Phase II study (POPLAR) in people with previously treated non-small cell lung cancer (NSCLC) (Press release, Genentech, MAY 13, 2015, View Source [SID:1234506565]). The study showed the investigational cancer immunotherapy MPDL3280A (anti-PDL1) reduced the risk of death by half (53%) (overall survival [OS]; hazard ratio [HR]=0.47) in people whose cancer expressed the highest levels of PD-L1 (programmed death ligand-1) compared with docetaxel chemotherapy. An improvement in survival was also observed in people who had medium and high (HR=0.56) or any level of PD-L1 expression (HR=0.63), as characterized by a test being developed by Roche. MPDL3280A was generally well tolerated and adverse events were consistent with what has been previously reported for MPDL3280A in NSCLC. Updated results will be presented in an oral session at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

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In our study of MPDL3280A in previously treated lung cancer, the amount of PD-L1 expressed by a person’s cancer correlated with improvement in survival," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "The goal of PD-L1 as a biomarker is to identify people most likely to experience improved overall survival with MPDL3280A alone, and which people may be appropriate candidates for a combination of medicines."

In February 2015, MPDL3280A received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people whose NSCLC expresses PD-L1 and who progressed during or after standard treatments (e.g., platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease). Genentech is discussing the interim data from POPLAR with the FDA as part of Breakthrough Therapy Designation in lung cancer. Genentech currently has three Phase II and six Phase III studies of MPDL3280A ongoing in various kinds of lung cancer.

About the POPLAR Study

Interim results of the POPLAR study will be presented by Dr. Alexander I. Spira, Virginia Cancer Specialists Research Institute, U.S. Oncology Research (Abstract #8010, Sunday, May 31, 4:42-4:54 P.M. CDT): Efficacy, safety and predictive biomarker results from a randomized Phase II study comparing MPDL3280A vs docetaxel in 2L/3L NSCLC (POPLAR).

The Phase II study enrolled 287 people with previously treated, advanced NSCLC. The primary endpoint was OS; secondary endpoints included progression-free survival (PFS), overall response rate (ORR) and safety. People were stratified by PD-L1 expression on tumor-infiltrating immune cells (IC), histology and prior lines of therapy. PD-L1 expression was assessed on both tumor cells (TC) and IC; and people were scored as TC 0, 1, 2 or 3 and IC 0, 1, 2 or 3 with an immunohistochemistry (IHC) test.

Fewer people receiving MPDL3280A experienced Grade 3 to 5 adverse events compared to docetaxel (44% vs. 56%). More respiratory events were reported for MPDL3280A. The median length of treatment with MPDL3280A was 3.7 months compared to 2.1 months for chemotherapy. Other immune-related adverse events in the MPDL3280A arm included increase of enzyme levels in the blood (aspartate and alanine aminotransferase; 4% each), inflammation in the lining of the colon (colitis; 1%), inflammation of the liver (hepatitis; 1%) and lung tissue (pneumonitis; 2%).

About MPDL3280A

MPDL3280A (also known as anti-PDL1 and RG7446) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. MPDL3280A is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells.

About Lung Cancer

According to the American Cancer Society, it is estimated that more than 221,000 Americans will be diagnosed with lung cancer in 2015, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.