On November 9, 2017 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the highlights of numerous advances in understanding immune response and cancer immunotherapy using the nCounter platform that will be presented at the 32nd Annual Meeting of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Ligand, NOV 9, 2017, View Source [SID1234521879]).

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"The scope of nCounter-based research being presented at this year’s SITC (Free SITC Whitepaper) conference demonstrates our scientific and commercial momentum in immuno-oncology," said Alessandra Cesano, chief medical officer of NanoString. "In addition, several abstracts outline the unique capabilities of our Digital Spatial Profiling technology to characterize the tumor and its microenvironment to inform cancer research and drug development."

At least 45 abstracts using NanoString’s nCounter platform will be presented at the SITC (Free SITC Whitepaper) Annual Meeting, being held in National Harbor, Maryland, Nov. 8-12, 2017. The research being presented spans a wide breadth of applications including biomarker development, assessing the biology of immune responsiveness and resistance, and digital pathology. They include biomarker studies covering 21therapeutic agents, as single agents or in combination.

Nineteen studies used NanoString’s PanCancer Series of panels to explore biomarkers associated with response to immunotherapy. Fourteen of these studies incorporate NanoString’s best-selling PanCancer Immune Profiling Panel. An additional five studies incorporating both early access and commercial versions of NanoString’s new PanCancer IO 360 Panel. The PanCancer IO 360 Panel assays key pathways from the tumor, the microenvironment and the immune system and includes more than 20 signatures that are potentially associated with therapeutic response to novel therapeutic agents with "matched" mechanisms of action. Three additional studies incorporate the nCounter Hallmarks of Cancer suite of gene expression panels, which includes three panels covering Cancer Immune Profiling, Cancer Pathways, and Cancer Progression.

The PanCancer IO 360 Panel studies provide initial evidence of positive association between the Tumor Inflammation Signature scores and clinical response to different immuno-oncology agents including nivolumab, ipilimumab, pembrolizumab and entinostat. NanoString’s Tumor Inflammation Signature (TIS) was recently described by Ayers, et al. (View Source) and is included in the PanCancer IO360 panel. The Tumor Inflammation Signature measures the presence or absence of a peripherally suppressed adaptive immune response within the tumor.

Five studies cover the use of NanoString’s Digital Spatial Profiling (DSP) platform in immuno-oncology research. DSP allows for digital quantification of protein from discrete regions of FFPE tissue in an automated and multiplex format. DSP will become widely available with the launch of a new instrument planned for late 2018, and in the meantime is available under a Technology Access Program.

Two studies cover the use of 3D Biology panels and demonstrate the utility of the nCounter platform. NanoString’s 3-D Flow technology provides detailed molecular profiles of T cell populations, and enables unique, simultaneous analysis of high-plex protein and RNA data. 3D Biology and 3D Flow approaches can be used to characterize baseline immunological state and response to stimulation, which may be useful for profiling mechanisms of action or therapeutic response.

At the 2017 SITC (Free SITC Whitepaper) Annual Meeting, NanoString will showcase its nCounter platform, IO360 Data Analysis, Digital Spatial Profiling and 3D Biology capabilities at booth #605.

NanoString will host a Digital Spatial Profiling Educational Session on Nov. 11, 2017, 12:45 – 1:45 p.m.

Below is a summary of abstracts co-authored by NanoString employees:

Abstract # Title Hyperlink
05 A dendritic cell targeting NY-ESO-1 vaccine significantly augments early and durable immune responses in melanoma patients pretreated with human Flt-3 Ligand View Source

019 ENCORE-601: Phase 1b/2 study of entinostat (ENT) in combination with pembrolizumab (PEMBRO) in patients with non-small cell lung cancer (NSCLC) View Source

P40 Deep proteomic and transcriptomic analysis of sorted T cells with a simple, integrated workflow View Source

P43 Assessment of Pharmacodynamic Effects of Immuno-Oncology Agents in Cynomolgus Monkeys using High-Content Gene Expression Profiling View Source

P64 Analytical Validation of Digital Spatial Profiling – a novel approach for multiplexed characterization of protein distribution and abundance in FFPE tissue sections View Source

P65 Spatially-resolved, multiplexed digital characterization of protein abundance in FFPE tissue sections: application in preclinical mouse models View Source

P66 Digital spatial profiling platform allows both spatially-resolved, multiplexed measurement of solid tumor and immune-associated protein distribution and abundance using a single FFPE tissue section View Source

P72 Analysis of biomarkers from a cohort of advanced melanoma patients previously exposed to immune checkpoint inhibition treated with entinostat (ENT) and pembrolizumab (PEMBRO).

View Source
P73 First-in-human neoadjuvant study of the immunogenomic impact of the oral IDO inhibitor epacadostat (INCB024360) on the tumor microenvironment of advanced ovarian cancer View Source

P98 Immunological profiling of baseline and resected biopsies from locally/regionally advanced/recurrent melanoma treated with neoadjuvant combination ipilimumab (3mg/kg or 10mg/kg) and high dose IFN-α2B View Source

P99 Biomarker analysis from the OpACIN trial (Neo-/adjuvant ipilimumab + nivolumab (IPI+NIVO) in palpable stage 3 melanoma) View Source

P100 Pretreatment gene expression correlation with clinical response to pembrolizumab or nivolumab in metastatic melanoma View Source

P383 Molecular and immune characterization of melanoma metastases with heterogeneous PTEN expression View Source

P485 Use of the NanoString Gene Expression Profiling Platform to Capture the Immunological Status of the Leukemia Microenvironment View Source

P512 Deep immunoprofiling of rare T-cell populations from clinical samples View Source

P524 Clinical and biomarker analyses of a phase II study of intratumoral tavokinogene telseplasmid (pIL-12) plus pembrolizumab in stage III/IV melanoma patients predicted to not respond to anti-PD-1 View Source

Ligand has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Ligand, 2017, NOV 9, 2017, View Source [SID1234521847]).

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IntelGenx has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, IntelGenx, 2017, NOV 9, 2017, View Source [SID1234521914]).

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On November 9, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that it will host a live conference call and webcast at 4:30 p.m. ET on Tuesday, November 14, 2017 to report its third quarter 2017 financial results and provide a corporate update (Press release, Eleven Biotherapeutics, NOV 9, 2017, View Source [SID1234521862]).

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To access the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) at least five minutes prior to the start time and refer to conference ID 3890769. An audio webcast of the call will also be available on the Investors & Media section of the Company’s website, www.elevenbio.com. An archived webcast will be available on the Company’s website approximately two hours after the event and will be available for 30 days.

On November 9, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported financial results for the three and nine months ended September 30, 2017 and key corporate highlights (Press release, Sophiris Bio, NOV 9, 2017, View Source [SID1234521903]).

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Key Corporate Highlights:

o
Update on Enrollment in Phase 2b Localized Prostate Cancer Study. Eight active clinical trial sites continue to schedule and dose the remaining handful of patients required to complete enrollment. The Company expects biopsy data from all patients dosed with the first administration of topsalysin to be available in the first half of 2018.

The Phase 2b study includes an option to re-treat patients with a second dose of topsalysin, with a targeted biopsy to occur 24 weeks following the second dose. The Company expects to have complete data on all patients who receive a second dose in the fourth quarter of 2018, assuming enrollment is completed as expected.

o
Loan and Security Agreement with Silicon Valley Bank. On September 8, 2017, the Company and Silicon Valley Bank ("SVB") entered into a Loan and Security Agreement pursuant to which SVB has agreed to lend the Company up to $10.0 million (subject to certain condition) in two term loans. On September 12, 2017, the Company borrowed $7.0 million from SVB under the Loan and Security Agreement.

"Execution of our Phase 2b clinical trial of topsalysin in localized prostate cancer is our priority," said Randall E. Woods, president and CEO of Sophiris. "Our clinical team together with our investigators are diligently identifying patients most likely to benefit from topsalysin."

Financial Results:

At September 30, 2017, the Company had cash, cash equivalents and securities available-for-sale of $28.5 million and working capital of $27.5 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations to the middle of 2019. The Company is currently not planning on pursuing a second Phase 3 trial in benign prostatic hyperplasia, (BPH), unless the Company can secure a development partner to fund a new clinical trial or the Company obtains other financing.

For the three months ended September 30, 2017

The Company reported a net loss of $2.7 million or $(0.09) per share for the three months ended September 30, 2017 compared to a net loss of $4.3 million or $(0.17) per share for the three months ended September 30, 2016.

Research and development expenses

Research and development expenses were $1.6 million for the three months ended September 30, 2017 compared to $0.6 million for the three months ended September 30, 2016. The increase in research and development costs is primarily attributable to increases in the costs associated with the Company’s Phase 2b clinical trial for the focal treatment of localized prostate cancer, costs associated with manufacturing activities for topsalysin and, to a lesser extent, an increase in non-cash stock-based compensation expense. These increases are partially offset by decreases in personnel related costs.

General and administrative expenses

General and administrative expenses were $1.7 million for the three months ended September 30, 2017 compared to $3.0 million for the three months ended September 30, 2016. The decrease in general and administrative expense is primarily due to the inclusion of $1.4 million in offering costs which were allocated to warrants issued in our public offering completed in 2016. Also contributing to the decrease in general and administrative expense were decreases in costs associated with professional services and personnel related costs. These decreases are partially offset by increases in non-cash stock-based compensation and market research activities.

Gain (loss) on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $0.7 million for the three months ended September 30, 2017 compared to a loss of $0.4 million for the three months ended September 30, 2016. Because these warrants may require the Company to pay the warrant holder cash under certain provisions of the warrant, the Company accounts for these warrants as a liability and the Company is required to calculate the fair value of these warrants each reporting date. The non-cash gain reported for this three months ended September 30, 2017 is associated with a reduction in the fair value of the Company’s warrant liability from June 30, 2017 to September 30, 2017 which is calculated using a Black-Scholes pricing model. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in a material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.

For the nine months ended September 30, 2017

The Company reported a net loss of $4.7 million or $(0.15) per share for the nine months ended September 30, 2017 compared to a net loss of $10.6 million or $(0.51) per share for the nine months ended September 30, 2016.

Research and development expenses

Research and development expenses were $4.2 million for the nine months ended September 30, 2017 compared to $2.5 million for the nine months ended September 30, 2016. The increase in research and development costs is primarily attributable to increases in the costs associated with the Company’s Phase 2b for the focal treatment of localized prostate cancer, costs associated with the manufacturing activities for topsalysin and, to a lesser extent, an increase in the non-cash stock-based compensation expense. These increases are partially offset by decreases in costs associated with the Company’s completed Phase 2a proof of concept clinical trial for low to intermediate risk prostate cancer and personnel related costs primarily related to our completed reduction in work force in 2016.

General and administrative expenses

General and administrative expenses were $4.4 million for the nine months ended September 30, 2017 compared to $5.6 million for the nine months ended September 30, 2016. The decrease in general and administrative expense is primarily due to the inclusion of $1.6 million in offering costs which were allocated to warrants issued in the Company’s public offering completed in 2016. Also contributing to the decrease in general and administrative expense were decreases in costs associated with professional services and personnel related costs. These decreases are partially offset by increases in non-cash stock-based compensation, market research activities and consulting expenses.

Gain (loss) on revaluation of the warrant liability

Gain on revaluation of the warrant liability was $3.9 million for the nine months ended September 30, 2017 as compared to a loss of $2.0 million for the nine months ended September 30, 2016. Because these warrants may require the Company to pay the warrant holder cash under certain provisions of the warrant, the Company accounts for these warrants as a liability and the Company is required to calculate the fair value of these warrants each reporting date. The non-cash gain reported for this nine months ended September 30, 2017 is associated with a reduction in the fair value of the Company’s warrant liability from December 31, 2016 to September 30, 2017 which is calculated using a Black-Scholes pricing model. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in a material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.