On August 02, 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 second quarter ended June 30, 2016 (Press release, Idera Pharmaceuticals, AUG 2, 2016, View Source;p=RssLanding&cat=news&id=2191763 [SID:1234514185]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter of this year represented a period of solid execution throughout the organization," stated Vincent Milano, Idera’s Chief Executive Officer. "As a result of the efforts of the team to continue driving our programs forward, we are rapidly approaching critical data readouts for Idera. During the second half of this year, we expect to be in position to share important data from our melanoma trial with IMO-2125, as well as the next steps in the program. We also expect to be in a position to select a recommended Phase 2 dose for our B-cell lymphoma program with IMO-8400. Lastly, we plan to begin elucidating the path forward for the 3GA (third generation antisense) platform, which we believe represents a pillar in the foundation of the company we are building."

Continued Milano, "I’m very proud of the team’s focus and determination as they continued to advance our research and development programs. We certainly have much more work ahead of us to arrive at our ultimate goal of delivering solutions to patients; however, we are energized knowing that we will soon be in possession of critical information to further understand the potential of these opportunities."

Research and Development Program Updates
IMO-2125 and IMO-8400 are the Company’s lead clinical development drug candidates. IMO-2125 is an oligonucleotide-based agonist of Toll-like receptor (TLR) 9. IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and 9. 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 continues to evaluate these and other potential targets for clinical proof of concept. 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 the rationale that intra-tumoral injections of IMO-2125, a TLR9 agonist, will activate dendritic cells and modulate the tumor microenvironment to potentiate the anti-tumor activity of checkpoint inhibitors. This rationale is supported by pre-clinical data in multiple tumor types. These studies have led Idera into a strategic alliance with the University of Texas MD Anderson Cancer Center to evaluate the combination of intra-tumoral IMO-2125 with 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, a CTLA4 antibody being conducted at the University of Texas MD Anderson Cancer Center. This study is in patients with relapsed or refractory Metastatic Melanoma who have failed prior PD-1 therapy. The trial continues to accrue patients according to plan and the Company intends to present the first clinical immune response translational data from this trial, addressing the mechanism of action, during the second half of 2016 at a select immuno-oncology conference, with clinical results expected in 2017.

The study has recently been amended to include the exploration of the combination of IMO-2125 with pembrolizumab, an anti-PD1 antibody.

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 that, 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 dose escalation of IMO-8400 in the ongoing trials in Waldenstrom’s Macroglobulinemia and Diffuse Large B-cell Lymphoma to explore the full potential of IMO-8400 based on the safety profile and efficacy signals seen to date. The Company plans to be in position to select a recommended Phase 2 dose by year end 2016.

Idera previously announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for IMO-8400 for the treatment of Waldenstrom’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, a rare auto-immune condition, which negatively affects skin and may result in debilitating muscle weakness. TLRs have been reported to play a role in the pathogenesis of the disease. This randomized, double-blind, placebo controlled Phase 2 trial is expected to enroll 36 patients and is being conducted at approximately 20 clinical sites worldwide. The Company plans to complete enrollment of this trial by the end of 2017.

Third Generation Antisense Platform (3GA)
Idera’s proprietary third-generation antisense (3GA) platform technology is focused on silencing the mRNA associated with disease causing genes. Idera has designed 3GA oligonucleotides to overcome specific challenges associated with earlier generation antisense technologies and RNAi technologies.

In late 2015, Idera announced the identification 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 related to these targets include, but are not limited to, interstitial cystitis, lupus nephritis, uveitis and facioscapulohumeral muscular dystrophy (FSHD). The Company is currently conducting clinical, regulatory and commercial analysis activities and conducting IND-enabling studies with the plan to enter the clinic in 2017 for the first clinical development program. In addition to these activities, over the first half of 2016, Idera generated 3GA compounds for a series of additional gene targets. These will enable the Company to continue to expand its future pipeline opportunities for both internal development as well as partnerships in areas outside of Idera’s focus. Idera plans to present pre-clinical data at several conferences in the second half of 2016.

In late 2015, Idera entered into a collaboration and license agreement with GSK to research, develop and commercialize compounds from its 3GA technology for the treatment of undisclosed, selected renal targets. As per the terms of the agreement, Idera received an upfront payment of $2.5 million and is eligible to receive up to approximately $100 million in milestone payments in addition to royalties.

Financial Results

Second Quarter 2016 Results

Net loss for the three months ended June 30, 2016 was $13.5 million, or $0.11 per basic and diluted share, compared to a net loss of $12.7 million, or $0.11 per basic and diluted share, for the same period in 2015. Revenue totaled $0.3 million and $0.6 million during the three and six months ended June 30, 2016, respectively. There was nominal revenue recognized during the corresponding 2015 periods. For the six month period ended June 30, 2016, the Company’s net loss was $26.3 million, or $0.22 per basic and diluted share, compared to a net loss of $25.2 million, or $0.23 per diluted share, for the same period in 2015.

Research and development expenses for the three months ended June 30, 2016 totaled $10.1 million compared to $9.0 million for the same period in 2015. For the six month period ended June 30, 2016, research and development expenses totaled $19.4 million compared to $17.7 million for the same period in 2015.

General and administrative expense for the three months ended June 30, 2016 and June 30, 2015 totaled $3.8 million, respectively. For the six month period ended June 30, 2016 and June 30, 2015, general and administrative expenses totaled $7.7 million, respectively.

As of June 30, 2016, Idera’s cash, cash equivalents and investments totaled $64.1 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.

On August 2, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported financial and operating results for its second quarter ended June 30, 2016 (Press release, Foundation Medicine, AUG 2, 2016, View Source [SID:1234514184]). Highlights for the quarter included:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Achieved second quarter revenue of $28.2 million, 26% year-over-year growth;
Reported 10,286 clinical tests in the second quarter, 16% year-over-year growth;
Grew FoundationCORE, the company’s molecular information knowledgebase, to nearly 90,000 patient cases;
Commercially launched FoundationACT, the company’s circulating tumor DNA (ctDNA) assay;
Presented new data at the 2016 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) demonstrating that tumor mutational burden as measured by FoundationOne may predict response to cancer immunotherapies in a broad range of solid tumors;
Published 23 manuscripts in high-quality, peer-reviewed journals and delivered 30 podium and poster talks at various medical and scientific meetings.
Foundation Medicine reported total revenue of $28.2 million in the second quarter of 2016, compared to $22.5 million in the second quarter of 2015. Revenue from biopharmaceutical partners grew 88% to $18.8 million in the second quarter of 2016, compared to $10.0 million in the second quarter of 2015. The increase in revenue demonstrates the company’s leading role as an important partner in drug development for oncology-focused biopharmaceutical companies.

Revenue from clinical testing in the second quarter of 2016 was $9.4 million, compared to $12.4 million in the second quarter of 2015. The decrease in clinical revenue was driven in part by moving in-network with a large national payor for stage IV Non-Small Cell Lung Cancer (NSCLC) testing, which resulted in no longer receiving payments for other indications and also resulted in payment delays for the covered indication.

The company reported 10,286 clinical tests in the second quarter of 2016, a 16% increase from the same quarter last year. This reported volume number includes 8,864 FoundationOne tests and 1,248 FoundationOne Heme tests.

"Foundation Medicine reported a strong second quarter highlighted by continued growth in our biopharma business and robust clinical volume growth," said Michael Pellini, M.D., chief executive officer of Foundation Medicine. "We believe that our recent accomplishments, which also include our participating in both the Expedited Access Pathway with FDA and Parallel Review with FDA and CMS for FoundationOne, position our company for continued growth and further competitive differentiation, and place us at the leading edge of transforming cancer care."

The company’s molecular information knowledgebase, FoundationCORE, grew to nearly 90,000 patient cases. FoundationCORE is a unique asset and critical component of the value that Foundation Medicine delivers to its biopharmaceutical and physician customers. The increasing scale and breadth of this high quality, clinically relevant oncology data set derived from the company’s testing platform continues to enhance clinical practice and help enable improved outcomes for patients.

Total operating expenses for the second quarter of 2016 were approximately $45.5 million compared with $46.6 million for the second quarter of 2015, which included a one-time expense in April 2015 of $14.4 million in advisor fees related to the closing of the company’s strategic collaboration with Roche. Net loss was approximately $29.0 million in the second quarter of 2016, or a $0.84 loss per share. At June 30, 2016, the company held approximately $190.4 million in cash, cash equivalents and marketable securities.

Today, Foundation Medicine also secured a $100 million credit facility from Roche Finance. The facility represents a three-year line of credit, after which any outstanding balance will convert to a term loan payable over the following five years. No funds were drawn under the credit facility upon the closing. The company intends to use the proceeds for product development and commercialization, corporate development and working capital management.

Recent Enterprise Highlights

Announced acceptance of FoundationOne for review as part of the Expedited Access Pathway program with FDA and Parallel Review through FDA and CMS. If approved, FoundationOne could be the first FDA-approved comprehensive genomic profiling (CGP) assay to incorporate multiple companion diagnostics to support precision medicine in oncology and would be offered as a covered benefit to Medicare beneficiaries nationwide. View Source
Announced the first strategic initiative under a master collaboration agreement with AstraZeneca to develop a novel companion diagnostic assay for Lynparza to support its global development program.
Announced the release of a broad set of genomic profiles of adult cancers from FoundationCORE to the National Cancer Institute in support of the National Cancer Moonshot and Precision Medicine initiatives.
2016 Outlook

Foundation Medicine’s business and financial outlook for 2016 is the following:

The company expects 2016 revenue will be in the range of $110 to $120 million.
The company is increasing clinical volume guidance and now expects to deliver between 39,000 and 41,000 FoundationOne and FoundationOne Heme clinical tests in 2016.
The company expects operating expenses will be in the range of $175 and $185 million.
The company intends to expand upon reimbursement progress and work to drive additional coverage decisions.

On August 2, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported financial results for the second quarter ending June 30, 2016 (Filing, Q2, Compugen, 2016, AUG 2, 2016, View Source [SID:1234514182]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Anat Cohen-Dayag, Ph.D., Compugen’s President and Chief Executive Officer, stated, "Our broad portfolio of novel targets for immuno-oncology is comprised of two key categories – T cell-based and myeloid cell-based immune checkpoint target candidates, with candidates in both categories identified within the tumor microenvironment of multiple types of cancers. These discoveries provide Compugen with the potential for the development of multiple transformational, first-in-class, antibody drugs for immuno-oncology. In this respect, during the past quarter we selected a lead therapeutic antibody for CGEN-15029, named COM701, which is now undergoing preclinical development activities in preparation for advancement to clinical trials, with an anticipated IND filing next year."

Dr. Cohen-Dayag continued, "In parallel with our therapeutic development activities, we are also pursuing a significant, previously undisclosed research activity, under which we have established a comprehensive in vivo validation system, based on knockout mice, where the target of interest has been genetically removed. This activity was initiated in early 2015 and was applied to the majority of the Company’s immuno-oncology target candidates, in order to further evaluate in vivo their likely clinical relevance, identify effective drug combinations, and assess the mechanisms-of-action by which our targets suppress immune response. Similar evaluations in knockout mice were a major factor driving the development of approved immuno-oncology therapies such as PD-1 and CTLA-4 inhibitors, and have been shown to be predictive of the ultimate clinical relevance of their respective target proteins."

Dr. Cohen-Dayag concluded, "Now, with our immuno-oncology target pipeline consisting of both T cell-based and myeloid cell-based immune checkpoint target candidates, we are focusing on target candidates that have the potential to complement each other, and that are expected to substantially enhance the overall value of our pipeline, particularly when taking into consideration the need for combination therapies."

Revenues for the second quarter of 2016 and six months ending June 30, 2016 were $0.5 million and $0.6 million respectively, compared with $0.2 million and $0.7 million for the comparable periods in 2015, reflecting primarily the milestone in the amount of $0.4 million achieved in the second quarter of 2016 and the non-cash amortization during these periods of the upfront payment, in both cases related to the August 2013 collaboration and license agreement with Bayer.

R&D expenses for the second quarter of 2016 and six months ending June 30, 2016 were $5.5 million and $12.2 million respectively, compared with $5.2 million and $10.1 million in the comparable periods in 2015. The increase primarily reflects expanded activities involving our pipeline program candidates, including the hiring of additional professional employees and manufacturing and regulatory consultants to support pre-clinical activities.

Net loss for the second quarter of 2016 was $6.6 million, or $0.13 per diluted share, compared with a net loss of $6.8 million, or $0.14 per diluted share, for the comparable period in 2015. Net loss for the six months ending June 30, 2016 was $15.2 million, or $0.30 per diluted share, compared with a net loss of $13.0 million, or $0.26 per diluted share, for the comparable period in 2015.

As of June 30, 2016, cash and cash related accounts totaled $74.1 million, compared with $81.4 million as of December 31, 2015. The Company has no debt.