Valeant has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 9, 2017 Elasmogen Ltd, focused on the development of next generation biologics, and Feldan Therapeutics, focused on intracellular delivery of proteins, reported a research collaboration with Amgen, to develop and deliver novel intracellular biologics (Press release, Elasmogen, MAY 9, 2017, View Source [SID1234637762]). The collaboration combines the unique capabilities of Feldan’s Shuttle platform and Elasmogen’s soloMER technology to develop the delivery system and binding domains to two undisclosed intracellular targets for Amgen.

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The Feldan Shuttle technology is a novel peptide-based delivery method that enables the highly efficient introduction of foreign proteins into cells. Elasmogen’s soloMER’s are the smallest naturally occurring binding domains. Their small size and robust nature, particularly the resistance to changes in pH and ability to bind in intracellular conditions makes them the perfect complement to Feldan’s technology.

"Currently all approved biologic antibody therapeutics act on extracellular targets but intracellular delivery enables access to a much greater number of targets," said François-Thomas Michaud, CEO, Feldan Therapeutics. "Intracellular delivery and binding of biologics can bridge the gap between small molecules and biologics."

"This is an exciting opportunity to demonstrate the performance and capabilities of the combined Shuttle-soloMER technology. The expertise provided by Amgen will significantly accelerate the development of this potential new class of therapeutics," said Caroline Barelle, CEO, Elasmogen.

In 2016, Feldan and Elasmogen established an exclusive partnership for the development of intracellular biologics. Working together, their research teams have demonstrated both intracellular and intranuclear delivery of soloMER binding domains.

On May 8, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the first quarter ended March 31, 2017. Loss from operations for the three months ended March 31, 2017 was $9.4 million (Press release, Sunesis, MAY 8, 2017, View Source;p=RssLanding&cat=news&id=2270692 [SID1234519080]). As of March 31, 2017, cash, cash equivalents and marketable securities totaled $35.2 million.

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"Following recent regulatory developments, our reversible non-covalent BTK inhibitor, SNS-062, is the central focus of our development efforts and resources," said Daniel Swisher, President and Chief Executive Officer of Sunesis. "Data from SNS-062’s preclinical and healthy volunteer studies suggest a unique drug profile for this next-generation BTK inhibitor and the potential to overcome the key resistance mechanism of ibrutinib. SNS-062 has the potential to address this increasingly well-defined and prevalent unmet need in CLL and other B-cell malignancy patients with C481S mutations, and we look forward to dosing the first patient in our Phase 1B/2 study this quarter."

Mr. Swisher continued, "With regard to vosaroxin, we plan to continue to advance its development through investigator-sponsored group trials, and will carefully assess business development alternatives to support any future registration-directed studies. We expect that our current cash resources are sufficient to fund the company into June 2018."

First Quarter 2017 and Recent Highlights

Announced Withdrawal of Marketing Authorization Application (MAA) for Vosaroxin in Europe and Shifted Primary Development Focus to Non-Covalent Reversible BTK Inhibitor SNS-062. On May 1st, Sunesis announced the withdrawal of its European Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. The decision followed recent interactions with the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP), during which the Company made an assessment based on feedback from its rapporteurs and input from its regulatory consultants that the committee was likely to formally adopt a negative opinion and a withdrawal of its application was the best option at this time. The Company also announced its plans to reduce its investment in its AML program and shift an increasing portion of resources to the Company’s kinase inhibitor pipeline, with an emphasis on timely prosecution of SNS-062.

Progress Toward Initiation of a Phase 1b/2 Trial of Non-Covalent Reversible BTK Inhibitor SNS-062 in Patients with B-Cell Malignancies. Sunesis continues to make progress toward the initiation of treatment in a Phase 1b/2 Trial evaluating its unique, proprietary, non-covalent reversible BTK-inhibitor SNS-062 in patients with B-cell malignancies. The Company has activated multiple clinical sites across the U.S., including at U.C. Irvine Cancer Center and The Ohio State University Comprehensive Cancer Center. These sites are beginning to actively identify patients. An additional three top U.S. centers, Dana-Faber Cancer Institute, MD Anderson Cancer Center and Weill Cornell Cancer Center, expected to be initiated this quarter. Sunesis expects to announce the dosing of the first patient this quarter.

Announced Poster Presentation on BTK Inhibitor SNS-062 at the AACR (Free AACR Whitepaper) Annual Meeting. In March, Sunesis announced a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting. The poster, titled "SNS-062 demonstrates efficacy in chronic lymphocytic leukemia in vitro and inhibits C481S mutated Bruton tyrosine kinase" detailed results from The Ohio State University-sponsored preclinical study, conducted in collaboration with Sunesis, that examined the potency of SNS-062 versus ibrutinib and acalabrutinib, specifically relating to the C481S mutation.

Announced Progress in Ongoing Investigator-Sponsored Studies Evaluating Vosaroxin in Patients with Acute Myeloid Leukemia (AML). Sunesis announced today that the Vanderbilt University sponsored VITAL (Vosaroxin and Infusional Cytarabine for Frontline Treatment of Acute Myeloid Leukemia) study of vosaroxin in combination with cytarabine in patients with previously untreated AML has progressed from Stage 1 to Stage 2. The single-arm, open-label trial enrolled 17 patients in Stage 1 and, following a one-time interim analysis by the Data Safety Monitoring Board of responses exceeding a pre-defined efficacy threshold, is now proceeding to enrollment in Stage 2. In this stage, the trial will enroll at least 24 additional patients. The study is being expanded to four additional sites including Yale University, UCLA, Medical University of South Carolina and University of Alabama.

Sunesis also announced today that vosaroxin has been selected as a treatment arm in the Phase 2/3 BIG-1 (Backbone InterGroup-1) trial. BIG-1 is an open label, multicenter phase 2/3 study with multiple randomization phases at different stages of AML treatment that is designed to improve overall survival in younger patients (18 to 60 years). The vosaroxin portion of the trial, which is expected to begin dosing imminently, will enroll up to 200 patients with favorable or intermediate risk AML, who will receive consolidation therapy of intermediate dose cytarabine with vosaroxin. The study is being conducted at multiple French centers, led by the University Hospital of Angers under the direction of Professor Norbert Ifrah, and the University Institute of Hematology at the Hôpital Saint-Louis under the direction of Professor Hervé Dombret.

Announced Organizational Updates. In March, Sunesis announced two management additions: Judy Fox Ph.D. to the position of Chief Scientific Officer and Pietro Taverna, Ph.D. to Executive Director, Translational Medicine. In April, Eric Bjerkholt resigned from his position of Chief Financial Officer. Dan Swisher, our Chief Executive Officer, has assumed the CFO responsibilities on an interim basis.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $35.2 million as of March 31, 2017, as compared to $42.6 million as of December 31, 2016. The decrease of $7.4 million was primarily due to $9.7 million of net cash used in operating activities offset by $2.2 million from sales of common stock through the company’s at the market facility. The Company expects that its current cash resources are sufficient to fund the company into June 2018.

Revenue for the three months ended March 31, 2017 was $0.7 million, as compared to $0.6 million for the same period on 2016. Revenue in each period was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.

Research and development expense was $6.2 million for the three months ended March 31, 2017 and for the same period in 2016, primarily relating to the vosaroxin development program in each period.

General and administrative expense was $3.9 million for the three months ended March 31, 2017 as compared to $4.3 million for the same period in 2016. The decrease of $0.4 million in 2016 was primarily due to decrease in personnel expenses and commercial expenses.

Interest expense was $0.5 million for the three months ended March 31, 2017 as compared to $0.3 million and for the same period in 2016. The increase in the 2017 period was primarily due to the increase in the notes payable.

Net other income was $0.1 million for the three months ended March 31, 2017 and for the same period in 2016. The other income was primarily comprised of interest income from the short-term investments.

Cash used in operating activities was $9.7 million for the three months ended March 31, 2017, as compared to $10.7 million for the same period in 2016. Net cash used in the 2017 period resulted primarily from the net loss of $9.8 million and changes in operating assets and liabilities of $0.9 million, partially offset by net adjustments for non-cash items of $1.0 million.

Sunesis reported loss from operations of $9.4 million for the three months ended March 31, 2017, as compared to $9.9 million for the same period in 2016. Net loss was $9.8 million for the three months ended March 31, 2017, as compared to $10.1 million for the same period in 2016.
Conference Call Information

On May 8, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) reported a clinical study agreement for a phase 1b/2a immuno-oncology trial (Press release, Inovio, MAY 8, 2017, View Source;Regeneron-Enter-Immuno-Oncology-Clinical-Study-Agreement-for-Glioblastoma-Combination-Therapy/default.aspx [SID1234518911]). The study will be conducted by Inovio in patients with newly diagnosed glioblastoma multiforme (GBM) and will evaluate Regeneron’s PD-1 inhibitor, REGN2810, in combination with Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12.

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The open-label trial, which is expected to begin later this year, is designed to evaluate the safety and efficacy of the combination therapy in approximately 50 patients. The study will be conducted at 30 U.S. sites and the primary endpoints are safety and tolerability. The study will also evaluate immunological impact, progression-free survival and overall survival.

GBM is a devastating disease for both patients and caregivers. It is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last ten years. The median overall survival for patients receiving standard of care therapy is approximately 15 months and the average five-year survival rate is less than three percent.

"Regeneron’s approach to oncology includes evaluating the combination of innovative therapies that act on diverse pathways and targets," said Israel Lowy, MD, PhD, Vice President of Translation Sciences and Oncology, Regeneron. "Using our PD-1 inhibitor as a therapeutic backbone alongside Inovio’s T cell-generating therapies offers a new path for exploration and heightens the potential to develop new, desperately-needed treatment options for patients."

"The unmet need for effective therapies in GBM remains extremely high. Certain immune checkpoint inhibitors have shown efficacy in certain cancers, but evidence increasingly suggests that the benefit of checkpoint inhibitors can be enhanced when used in combination with therapies that generate T cells," said David Reardon, MD, Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "Inovio has an innovative immunotherapy platform which has shown the ability to generate antigen-specific T cells in disease areas including cancer. We look forward to exploring the potential of combining a T cell generating immunotherapy encoding multiple antigens with REGN2810, a PD-1 checkpoint inhibitor."

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "I am a strong believer in this combination regimen approach in immuno-oncology: use Inovio immunotherapies to generate killer T cells to turn ‘cold’ tumors into ‘hot’ tumors, then block T cell suppression via checkpoint inhibition. This step with INO-5401 is very important for us in 2017, as we believe INO-5401 has the potential to be a powerful cancer immunotherapeutic in combination with promising checkpoint inhibitors such as Regeneron’s REGN2810, and we look forward to investigating its potential for GBM and multiple other challenging cancers."

Under the terms of the agreement, the trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon study design, and Regeneron will supply REGN2810. Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, in collaboration with Sanofi, is developing REGN2810 both alone and in combination with other therapies for the treatment of various cancers.

About Glioblastoma

Glioblastoma, also known as glioblastoma multiforme (GBM), is the most common and aggressive type of brain cancer. GBM is usually found in the area of the brain which controls some of the most advanced processes, such as speech and emotions. GBM treatment is often limited by the tumor location and ability of a patient to tolerate surgery. Consequently, it is a particularly difficult cancer to treat. Worldwide there are an estimated 240,000 cases of brain and nervous system tumors per year; GBM is the most common and most lethal of these tumors.

About INO-5401

INO-5401 includes Inovio’s SynCon antigens for WT1, hTERT and PSMA and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development. WT1 was at the top of the list. The hTERT antigen relates to 85 percent of cancers, and WT1 and PSMA antigens are also widely prevalent in many cancers.

On May 8, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported a clinical study agreement for a Phase 1b/2a immuno-oncology trial (Press release, Regeneron, MAY 8, 2017, View Source [SID1234518958]). The study will be conducted by Inovio in patients with newly-diagnosed glioblastoma multiforme (GBM) and will evaluate Regeneron’s PD-1 inhibitor, REGN2810, in combination with Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12.

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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

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The open-label trial, which is expected to begin later this year, is designed to evaluate the safety and efficacy of the combination therapy in approximately 50 patients. The study will be conducted at 30 U.S. sites and the primary endpoints are safety and tolerability. The study will also evaluate immunological impact, progression-free survival and overall survival.

GBM is a devastating disease for both patients and caregivers. It is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last ten years. The median overall survival for patients receiving standard of care therapy is approximately 15 months and the average five-year survival rate is less than three percent.

"The unmet need for effective therapies in GBM remains extremely high. Certain immune checkpoint inhibitors have shown efficacy in certain cancers, but evidence increasingly suggests that the benefit of checkpoint inhibitors can be enhanced when used in combination with therapies that generate T cells," said David Reardon, MD, Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "Inovio has an innovative immunotherapy platform which has shown the ability to generate antigen-specific T cells in disease areas including cancer. We look forward to exploring the potential of combining a T cell generating immunotherapy encoding multiple antigens with REGN2810, a PD-1 checkpoint inhibitor."

Under the terms of the agreement, the trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon study design, and Regeneron will supply REGN2810. Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, in collaboration with Sanofi, is developing REGN2810 both alone and in combination with other therapies for the treatment of various cancers.

"Regeneron’s approach to oncology includes evaluating the combination of innovative therapies that act on diverse pathways and targets," said Israel Lowy, MD, PhD, Vice President of Translation Sciences and Oncology, Regeneron. "Using our PD-1 inhibitor as a therapeutic backbone alongside Inovio’s T cell-generating therapies offers a new path for exploration and heightens the potential to develop new, desperately-needed treatment options for patients."

"I am a strong believer in this combination regimen approach in immuno-oncology: use Inovio immunotherapies to generate killer T-cells to turn ‘cold’ tumors into ‘hot’ tumors, then block T cell suppression via checkpoint inhibition," said J. Joseph Kim, PhD, Inovio’s President and Chief Executive Officer. "This step with INO-5401 is very important for us in 2017, as we believe INO-5401 has the potential to be a powerful cancer immunotherapeutic in combination with promising checkpoint inhibitors such as Regeneron’s REGN2810, and we look forward to investigating its potential for GBM and multiple other challenging cancers."

About Glioblastoma
Glioblastoma, also known as glioblastoma multiforme (GBM), is the most common and aggressive type of brain cancer. GBM is usually found in the area of the brain which controls some of the most advanced processes such as speech and emotions. GBM treatment is often limited by the tumor location and ability of a patient to tolerate surgery. Consequently, it is a particularly difficult cancer to treat. Worldwide there are an estimated 240,000 cases of brain and nervous system tumors per year; GBM is the most common and most lethal of these tumors.

About INO-5401
INO-5401 includes Inovio’s SynCon antigens for WT1, hTERT and PSMA and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development. WT1 was at the top of the list. The hTERT antigen relates to 85 percent of cancers, and WT1 and PSMA antigens are also widely prevalent in many cancers.