On May 9, 2016 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the launch of Epi proColon, a blood-based test for colorectal cancer screening that was approved on April 13, 2016 for clinical use by the U.S. Food and Drug Administration (FDA) (Press release, LabCorp, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166378 [SID:1234512119]). Epi proColon is the first FDA-approved DNA based blood test for colorectal cancer. The test was developed by Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) and is available under a joint commercialization agreement with Polymedco, Inc. in North America. LabCorp, the world’s leading healthcare diagnostics company, is the first laboratory in the U.S. to offer this FDA-approved, blood-based colorectal cancer screening test.

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"Colorectal cancer is one of the most curable diseases when detected in its early stages and treated surgically," said Dr. Mark Brecher, chief medical officer for LabCorp Diagnostics. "Many people are not properly screened because they are reluctant to collect a stool sample or undergo a colonoscopy. Tested from a simple blood draw, Epi proColon is a convenient, accurate alternative for those patients who should be screened for colorectal cancer. LabCorp is committed to delivering world-class diagnostics, and Epi proColon will contribute to our mission to improve health and improve lives."

The Epi proColon test detects Epigenomics proprietary Septin9 DNA methylation biomarker for colorectal cancer in cell-free DNA circulating in blood, which has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of colorectal cancer. The test is available immediately from LabCorp. Epi proColon is an important addition to LabCorp’s leading menu of integrated testing that includes comprehensive colorectal cancer offerings.

According to the American Cancer Society, there are projected to be over 134,000 new diagnoses of colorectal cancer, and almost 50,000 deaths from colorectal cancer in the U.S. in 2016. Approximately 23 million people in the U.S. are identified as at-risk for colorectal cancer or meet guidelines to be screened for this cancer remain unscreened. Currently, approved screening options including stool testing and colonoscopy are often viewed as inconvenient, uncomfortable or unpleasant, and about 35% of eligible U.S. patients refuse to undergo them. For these people and their physicians, a convenient blood test that only requires a blood draw provides a powerful screening option designed to improve participation in screening and can support earlier cancer detection, resulting in improved outcomes. For patients who may be reluctant to complete stool testing or colonoscopy, Epi proColon provides an alternative that can change the way care is provided and may encourage more patients to obtain recommended screenings.

Epi proColon is a registered trademark of Epigenomics AG.

On May 09, 2016 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported financial results for the quarter ended March 31, 2016 (Press release, Inovio, MAY 9, 2016, View Source [SID:1234512118]).

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Total revenue was $8.1 million for the three months ended March 31, 2016, compared to $5.2 million for the same period in 2015. Total operating expenses were $23.6 million compared to $13.5 million.

The net loss attributable to common stockholders for the quarter ended March 31, 2016, was $8.0 million, or $0.11 per share, compared to $10.6 million, or $0.17 per share, for the quarter ended March 31, 2015.

Revenue

The increase in revenue was primarily due to an increase in development payments from our DARPA Ebola grant.

Operating Expenses

Research and development expenses for Q1 2016 were $18.2 million compared to $9.4 million for Q1 2015. The increase in R&D expenses was generally related to increased investment in all our product development programs. General and administrative expenses were $5.4 million for Q1 2016 versus $4.1 million for Q1 2015.

Capital Resources

As of March 31, 2016, cash and cash equivalents and short-term investments were $146.8 million compared with $163.0 million as of December 31, 2015. At quarter end the company had 72.3 million shares outstanding and 80.7 million fully diluted.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2016 first quarter financial report can be found at: View Source

Corporate Update

Clinical Development

Subsequent to the quarter, Inovio held constructive meetings with both FDA (end of phase II) and European Medicines Agency (EMA) providing an affirmative path forward toward an indication for VGX-3100 to treat HPV-16/18-related high grade cervical dysplasia that is consistent with our previously reported expectations to start a pivotal phase III registration study in 2016.
Interim data from the fully enrolled phase I study of INO-4212 Ebola vaccine in 75 healthy subjects showed it was safe, tolerable, and generated strong T cell and antibody responses.
Inovio and GeneOne Life Science Inc. began recruitment of the collaborative study of GLS-5300 MERS (Middle East Respiratory Syndrome) vaccine with Walter Reed Army Institute of Research.
Corporate Development

Subsequent to the quarter, Inovio completed the acquisition of all of Bioject Medical Technologies Inc.’s assets, including pioneering needle-free jet injection technology, devices, and intellectual property, for $5.5 million in cash and stock.
Received $500,000 grant from the U.S. Army’s Small Business Innovation Research program to advance Inovio’s next generation delivery device capable of administering vaccines via skin-surface, needle-free electroporation delivery.
Signed collaborative research agreements with the Wistar Institute for therapeutic and preventive DNA-based immunotherapy applications and products for cancers and infectious diseases developed by David B. Weiner, Ph.D., and his Wistar laboratory. Inovio will have the exclusive right to in-license new intellectual property developed in this collaboration.
VGX-3100 HPV cervical dysplasia immunotherapy recognized as "Best Therapeutic Vaccine" by World Vaccine Congress for fourth consecutive year.
Preclinical Development

The Journal of Infectious Diseases published the paper, "Rapid and long-term immunity elicited by DNA encoded antibody prophylaxis and DNA vaccination against Chikungunya virus," highlighting Inovio’s DNA-based monoclonal antibody technology.
Preclinical testing of Zika virus synthetic vaccine induced robust and durable immune responses. The first clinical study of Inovio’s Zika vaccine is on track to start in 2016.

On May 09, 2016 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, reported its financial and operational results for the first quarter ended March 31, 2016 (Press release, Idera Pharmaceuticals, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166519 [SID:1234512117]).

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"Idera continued to make strong progress across all of our areas of focus during the first period of 2016," stated Vincent Milano, Idera’s Chief Executive Officer. "Our clinical development teams have transformed our programs into executable registration strategies and the research group continues to advance the 3GA platform to put us into position to enter human proof of concept trials in 2017."

Continued Milano, "The amount of strategic consideration and effort that has taken place over the past year and the related execution should provide us with critical catalysts beginning in the second half of this year and right through the course of 2017 across all aspects of our business. We’re currently conducting four separate clinical trials and we expect data from all four of these studies over the course of the next six to 18 months. This is an exciting time for Idera and we look forward to a very bright future for the patients we aim to serve as well as our investors, who support these bold endeavors."

Research and Development Program Updates
IMO-8400 and IMO-2125 are our lead clinical development drug candidates. IMO-8400 is an oligonucleotide-based antagonist of Toll-like receptors (TLRs) 7, 8, and 9. IMO-2125 is an oligonucleotide-based agonist of TLR9. The company also announced during the fourth quarter of 2015, the first two development targets from its proprietary 3GA Technology platform: NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4). The company plans to take the first 3GA candidate into human proof of concept studies in 2017.

Toll-like Receptor (TLR) Agonism

Immuno-Oncology Program
Idera’s development program in immuno-oncology is based on pre-clinical studies that demonstrated through the mechanism of intra-tumoral injections of the TLR9 agonist, IMO-2125, the tumor microenvironment could be impacted in a manner which positively increases the efficacy of check-point inhibition. These studies have led Idera into a strategic research alliance with the University of Texas MD Anderson Cancer Center to clinically explore the combination of checkpoint inhibitors.

In December 2015, Idera announced the initiation of a Phase 1/2 clinical trial of intra-tumoral IMO-2125 in combination with Ipilimumab in patients with relapsed or refractory Metastatic Melanoma being conducted at the University of Texas MD Anderson Cancer Center. The study will also include an arm exploring the combination of IMO-2125 with a PD1 inhibitor. The company expects to present the first translational data from the trial during the second half of 2016, with clinical results expected in 2017.

Additionally, the company presented new preclinical data demonstrating the potentiation of anti-tumor effects through combination of IMO-2125 and indoleamine-pyrolle 2,3-dioxygenase (IDO-1) in cancer models at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Toll-like Receptor (TLR) Antagonism

Genetically Defined Forms of B-cell Lymphoma
Idera’s program in genetically defined forms of B-cell lymphoma is based on pre-clinical studies that have demonstrated in certain B-cell lymphomas driven by the oncogenic MYD88-L265P mutation, blocking TLR7 and 9 signaling can promote tumor cell death.

In December 2015, Idera presented positive clinical data from the ongoing Phase 1/2 trial of IMO-8400 in patients with Waldenstrom’s Macroglobulinemia at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, FL. The company is continuing further dose escalation of IMO-8400 in both the ongoing trials in Waldenstrom’s Macroglobulinemia and Diffuse Large B-cell Lymphoma to further explore the full potential of IMO-8400 based on the safety profile and efficacy signals seen to date. The company expects to complete the accrual of the escalated dosing for both the WM and DLBCL studies by the end of 2016, with data available in the first half of 2017.

Idera previously announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for IMO-8400 for the treatment of Waldenström’s macroglobulinemia and DLBCL.

Rare Diseases
In November 2015, Idera announced the initiation of a Phase 2 clinical trial of IMO-8400 in patients with Dermatomyositis. The company expects to have the DM Phase 2 study fully enrolled in the first half of 2017.

The company announced during the first quarter of 2016 that due to the resources required to fully commit to a Duchenne muscular dystrophy (DMD) clinical development endeavor, the company has chosen to suspend internal efforts at this time to advance IMO-8400 into clinical development for DMD.

Third Generation Antisense Platform

Throughout 2015, the company undertook an analysis and prioritization of oncology and rare disease indications for potential development of drug candidates derived from our 3GA technology platform. The key considerations in identifying disease indications from our third generation antisense program included: strong evidence that the disease is caused by a specific protein; clear criteria to identify a target patient population; biomarkers for early assessment of clinical proof-of-concept; a targeted therapeutic mechanism for action; and unmet medical need to allow for a well-defined development path to approval and commercial opportunity. As a result of this analysis, in the fourth quarter of 2015 Idera announced the selection of NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4) as initial gene targets to advance into IND-enabling activities, which will occur throughout 2016. Potential disease indications include, but are not limited to interstitial cystitis, uveitis and facioscapulohumeral muscular dystrophy (FSHD), respectively. The company is currently conducting clinical and regulatory pathway and commercial analysis activities and conducting IND-enabling studies with the plan to enter the clinic in 2017 for the first disease indication.

Financial Results

First Quarter 2016 Results

Net loss for the three months ended March 31, 2016 was $12.8 million, or $0.11 per basic and diluted share, compared to a net loss of $12.5 million, or $0.12 per basic and diluted share, for the same period in 2015. There was nominal revenue recognized in each of the first quarters of 2016 and 2015. Research and development expenses for the three months ended March 31, 2016 totaled $9.3 million compared to $8.7 million for the same period in 2015. General and administrative expense for the three months ended March 31, 2016 totaled $3.9 million compared to $3.8 million for the same period in 2015.

As of March 31, 2016, Idera’s cash, cash equivalents and investments totaled $74.1 million compared to $87.2 million as of December 31, 2015. The company expects the current cash position and investments to fund its operations into the third quarter of 2017.

Investor Event and Webcast

Idera will host a conference call and live webcast on Monday, May 9, 2016 at 5:00 P.M. EST to provide an update on the company’s progress and to provide an overview of additional clinical activity from the ongoing Phase 1/2 clinical trial of IMO-8400 in Waldenstrom’s Macroglobulinemia. To participate in the conference call, please dial (844) 882-7837 (domestic) and (574) 990-9824 (international). The webcast can be accessed live or in archived form in the "Investor’s" section of the company’s website at www.iderapharma.com.

On May 9, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the first quarter ended March 31, which included an increase in revenue of 128 percent from the prior-year period and a net loss of $19.8 million, or $0.16 per share, compared to a net loss in the first quarter of 2015 of $15.1 million, or $0.12 per share (Press release, Halozyme, MAY 9, 2016, View Source [SID:1234512116]).

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"During the first quarter, we continued to execute against our two-pillar strategy with ongoing clinical studies of PEGPH20 and through growing the value of our ENHANZE platform," said Dr. Helen Torley, president and chief executive officer. "We made good progress toward our goal of initiating greater than 90 percent of HALO-301 sites by the end of the year and in evaluating the recommended dose to take into the expansion phase of our lung and gastric cancer studies.

"With our ENHANZE platform, we continued to see strong growth in royalty revenue combined with progress from our partners’ programs. During the quarter, Lilly nominated its third target triggering an $8 million milestone and Pfizer nominated an additional target triggering a $1.5 million milestone. These developments highlight the great potential associated with our ENHANZE technology franchise."

First Quarter 2016 and Recent Highlights include:

Dosing of first patient in HALO-301 | Pancreatic study in March, a phase 3 study to explore PEGPH20 with gemcitabine and ABRAXANE (nab-paclitaxel) in metastatic pancreatic cancer patients. The company plans to initiate sites outside the United States beginning in the second quarter and to reach its target of greater than 90 percent of centers ready to start screening patients by the end of the year.
Approval by the Food and Drug Administration (FDA) of an investigational device exemption for the companion diagnostic test developed with Ventana to prospectively identify patients with high levels of hyaluronan, or HA, in the company’s phase 3 study.
Progressing towards dose expansion in its phase 1b/2 PRIMAL study of PEGPH20 plus docetaxel in non-small cell lung cancer patients. The company is now evaluating patients at a dose of 2.2 µg/kg and remains on track to move into the dose expansion phase of the study in the second half of 2016.
Advancing into the second dosing cohort and recently submitting a protocol amendment in its phase 1b study of PEGPH20 plus KEYTRUDA (pembrolizumab) in lung and gastric cancer patients. The company submitted the protocol amendment to the FDA based on bleeding events observed in heavily pretreated relapsed gastric cancer patients. These events were not classified as dose limiting toxicities or determined by investigators to be related to PEGPH20. Halozyme is awaiting feedback from the FDA and plans to resume enrollment in the second dosing cohort following approval of the amendment.
Eli Lilly nominating their third target to be studied with Halozyme’s ENHANZE platform, triggering an $8 million milestone payment to Halozyme which will be received in the second quarter.
Pfizer nominating an additional target to be studied with Halozyme’s ENHANZE platform, triggering a $1.5 million milestone to Halozyme.
Baxalta receiving a positive opinion for HYQVIA from the Committee for Medicinal Products for Human Use for a pediatric indication in Europe. In addition, Baxalta initiated a phase 3 trial in patients with chronic inflammatory demyelinating polyneuropathy.
Expansion of oncology pipeline and demonstration of expertise in the tumor microenvironment with two new preclinical programs, an immune checkpoint inhibitor targeting adenosine and a novel antibody-drug conjugate targeting epidermal growth factor receptor. Preclinical data for the discovery and early development of these potential drug candidates were shared during the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual conference.
First Quarter 2016 Financial Highlights

Revenue for the first quarter was $42.5 million, compared to $18.7 million for the first quarter of 2015, driven primarily by milestone payments from Lilly and AbbVie, as well as royalties from partner sales of Herceptin SC, MabThera SC and HYQVIA. Revenue for the quarter included $11.4 million in royalties, $9.0 million in sales of bulk rHuPH20 primarily for use in manufacturing collaboration products and $3.9 million in HYLENEX recombinant (hyaluronidase human injection) product sales.
Research and development expenses for the first quarter were $40.1 million, compared to $16.7 million for the first quarter of 2015. The planned increases were primarily due to expenses for preclinical and clinical support of PEGPH20 and clinical API supply to ENHANZE partners.
Selling, general and administrative expenses for the first quarter were $10.8 million, compared to $9.4 million for the first quarter of 2015. The increase was primarily due to an increase in personnel expenses, including stock compensation, for the period.
Net loss for the first quarter was $19.8 million, or $0.16 per share, compared to a net loss in the first quarter of 2015 of $15.1 million, or $0.12 per share.
Cash, cash equivalents and marketable securities were $238.6 million at Mar. 31, 2016 compared to $108.3 million at Dec. 31, 2015.
Financial Outlook for 2016

For the full year 2016, the company is updating its previously announced guidance. Halozyme now expects:

Net revenues to be in the range of $130 million to $145 million, an increase from the prior range of $110 million to $125 million, driven by unplanned ENHANZE milestones and an increase in bulk product sales to ENHANZE partners;
Operating expenses to be in the range of $245 million to $260 million, a narrowing of the bottom end of the prior range of $240 million to $260 million as a result of the increase in product sales to ENHANZE partners;
Cash flow to be in the range of $45 million to $65 million, an increase from the prior range of $35 million to $55 million; and
Year-end cash balance to be in the range of $150 million to $170 million, an increase from the prior range of $140 million to $160 million.

On May 9, 2016 GTx, Inc. (Nasdaq: GTXI) reported the first public presentation of preclinical data from the Company’s selective androgen receptor degrader (SARD) program (Press release, GTx, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166265 [SID:1234512115]). The results demonstrate that the Company’s highly potent SARDs selectively bind to the ligand binding domain (LBD) and interact with the N-terminal domain (NTD) of the androgen receptor (AR) and inhibit and degrade the AR at very low concentrations. These preclinical results suggest that the Company’s SARDs may be the first-in-class dual-interacting AR antagonists and degraders.

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The preclinical data are being presented at the 2016 American Urological Association (AUA) Annual Meeting taking place May 6-10, 2016, in San Diego, California.

Poster: Novel Dual-Binding Selective Degraders of Full Length and Splice Variant Androgen Receptors for the Treatment of Castration-Resistant Prostate Cancer

Presenter: Ramesh Narayanan, Ph.D., Director, Center for Cancer Drug Discovery and Associate Professor, Department of Medicine, University of Tennessee and Consultant for GTx, Inc.

Date:
Saturday, May 7 at 10:30 am until Tuesday, May 10 at 1:00 pm

According to Dr. Narayanan, "One of the limitations of current prostate cancer therapy is that some men with castration-resistant prostate cancer do not respond or eventually develop resistance to the therapy. These preclinical results suggest that novel SARD compounds may degrade and inhibit multiple forms of the androgen receptor, including AR splice variants, and may therefore potentially treat CRPC in men who are non-responsive to androgen therapy."

The Company’s lead SARD compounds are currently being evaluated in preclinical studies in order to select the best SARD compounds for continued development, with a goal of initiating first human clinical trials in 2017.

About SARDs

Selective Androgen Receptor Degrader (SARD) technology is being evaluated as a potentially novel treatment for men with castration-resistant prostate cancer (CRPC), including those who do not respond or are resistant to currently approved therapies. GTx believes that its novel SARD compounds will degrade multiple forms of the androgen receptor, including AR splice variants, such as AR-V7. GTx licensed the SARD technology from the University of Tennessee Research Foundation in 2015 with the goal of expanding its portfolio of product candidates targeting hormonal receptors.

About Prostate Cancer

Prostate cancer that is localized to the prostate can be effectively treated with surgery, radiation, brachytherapy and other modalities in an effort to eradicate all of the disease and cure the patient. In some cases, the tumor advances locally or metastasizes; these are examples of advanced prostate cancer. The goal of treatment for advanced prostate cancer is to control the tumor and keep the patient alive for as long as possible.

In advanced prostate cancer, a number of treatments with hormone blocking therapies or chemotherapy are used to slow the spread of metastases, shrink existing tumors, reduce symptoms and improve quality of life. Although most men with advanced prostate cancer are not cured of their disease, they can live a normal life for many years.