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BioGenerator Invests in New Immunotherapy Company, Unleash. Company will open operations in St. Louis.

On February 18, 2016 BioGenerator, an evergreen investor that creates, grows and invests in promising companies and entrepreneurs, reported that it has made an investment from its Concept Fund into Unleash Immuno Oncolytics, a company focused on treatments of cancer (Press release, Unleash Immuno Oncolytics, FEB 18, 2016, View Source [SID1234540112]). Unleash is an immune-oncology company developing virus immunotherapy products to treat cancer. The company was developed based on collaborations between Dr. David Curiel, Director, Biologic Therapeutics Center at Washington University School of Medicine and Dr. Osvaldo Podhajcer, Director of the Argentinian Consortium of Genomic Technology and is licensing technology from Leloir Institute. As part of the funding, Unleash will set up headquarters in St. Louis and operate from CIC in the @4240 building.

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BioGenerator is the investment arm of BioSTL, a nonprofit civic organization building St. Louis’ innovation ecosystem and which in the last two years has added a focus of recruiting international companies to the region. "Through our GlobalSTL initiative we are leveraging St. Louis’ scientific and business strengths to attract cutting-edge technologies and talent that enrich our region," explained Donn Rubin, president and CEO of BioSTL. "Unleash’s decision to locate in St. Louis is a testament to our world-class strengths in medicine and human health." "Unleash is based on technology from two leaders in the field of oncology and has promising applications," said Charlie Bolten, vice president of BioGenerator. "Immunotherapy is a quickly evolving area of human health and BioGenerator is pleased to be one of the first investors in a company at the cutting edge of research."

Other investors in the round include Axia Ventures, a Latin American investment and support organization. Unleash will use the initial investment to fund IND-enabling tasks including cGMP manufacturing, toxicology and bio-distribution studies for its oncolytic immunotherapy product.

¨We are pleased with BioGenerator’s role as lead investor in this round and establishing Unleash in Saint Louis," said Daniel Katzman, CEO of Unleash. "We are now eager to advance Unleash’s virus immunotherapy products to the clinic."

Unleash Immuno Oncolytics Enters License Agreement with Leloir Institute to Develop Immuno-Oncology Products for Cancer Treatment, Gets Established in Saint Louis

On February 18, 2016 Unleash Immuno Oncolytics, an immune-oncology company developing oncolytic virus immunotherapy products to treat cancer, reported that the company has entered a license agreement with INIS Biotech, the tech transfer arm of Fundación Instituto Leloir, and has established operations in Saint Louis, Missouri, USA (Press release, Unleash Immuno Oncolytics, FEB 18, 2016, View Source [SID1234540111]).

"Immuno-oncology is a very promising field and we are excited to enter this space that could potentially bring truly breakthrough therapies for cancer treatment. Unleash is privileged to license this technology from the Leloir Institute, to leverage this outstanding science to develop innovative immune-oncology therapies" said Unleash’s CEO, Daniel Katzman.

The research work of Dr. Osvaldo Podhajcer´s group led to the development of Unleash’s leading product – UIO-512, an oncolytic virus designed to target both malignant cells and tumor-associated stroma cells. "The stroma, composed by non-malignant cancer-associated fibroblasts, endothelial and immune cells, provides nutrients, structure and helps the malignant cells to grow and disseminate. Cancer-associated stroma cells may account for up to 90% of the tumor mass and are not being specifically and are not targeted by any other current therapies. Thus, targeting the stroma cells is a significant paradigm shift over existing cancer treatments" explained Dr. Podhjacer – Chief, Laboratory of Molecular and Cellular Therapy (Fundación Instituto Leloir, Buenos Aires), Superior Researcher (CONICET) ), Director of the Argentinian Consortium of Genomic Technology.

"UIO-512’s viral replication is triggered by a triple hybrid promoter that combines the stroma-associated SPARC gene promoter and motifs responsive to tumor microenvironment conditions such as inflammation and hypoxia. Unleash’s patented technology is unique in that it attacks the entire tumor mass, not only the malignant cells themselves but also the stromal cells that support cancer dissemination" said Dr. David T. Curiel – Unleash’s Scientific Advisory Board Chairman and Director of the Biologic Therapeutics Center, Washington University School of Medicine.

Unleash was formed by Axia Ventures Company Builder. ¨We are proud to have created an exciting biotechnology start-up company born with the vision of a global world-class scale¨, said Lisandro Bril, Managing Partner of Axia Ventures.

Unleash will establish its operations in Saint Louis. ¨Saint Louis’ growing biotechnology ecosystem is happy to welcome Unleash. We are excited to be the lead investor in Unleash’s seed round of financing", said Charles Bolten, Vice President of BioGenerator, a biotechnology fund and incubator based in Saint Louis, Missouri.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On February 18, 2016 Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostic testing services, conditional approval status for RosettaGX Reveal, its novel microRNA classifier for the diagnosis of indeterminate thyroid Fine Needle Aspirate (FNA) smears from the New York State Department of Health (NYSDOH) under the Company’s Molecular Oncology permit (Filing, 6-K, Rosetta Genomics, FEB 18, 2016, View Source [SID:1234509216]). RosettaGX Reveal is the only molecular test in the thyroid market that has been validated in a multicenter, international, blinded study using convenient, routinely prepared cytology slides.

The assay is CLIA certified, but New York requires an additional license from the NYSDOH for CLIA-certified tests to be offered to patients in the state. With this conditional approval, RosettaGX Reveal is now available in all 50 states. In making the assay available pending final approval, the NYSDOH requires the Company to provide any additional information that it may request within 60 business days.

"We are very pleased to have approval to market this important cancer diagnostic for the benefit of physicians and patients in the vast New York market," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "It is estimated that nearly 550,000 FNAs are performed on thyroid nodules each year in the U.S. and that approximately 740,000 are performed annually in Europe. Interpretation of FNA samples is not always straightforward, leading to an indeterminate result in up to 30% of the samples. Many patients with indeterminate results undergo surgery as a precaution despite the fact that up to 80% of these cases are benign. This exposes patients to unnecessary surgical risk and costs the healthcare system hundreds of millions of dollars. Through an analysis of our validation study data, we believe we can help prevent up to 75% of unnecessary thyroid surgeries."

"In addition to this expanded geographic access, recent managed care contracting initiatives have resulted in covered lives for RosettaGX Reveal exceeding 150 million in the U.S. These increases in geographic and health insurance access, along with the potential health economic benefits the RosettaGX Reveal assay can bring by avoiding unnecessary surgeries, should enhance adoption into a market valued at more than $350 million annually in the U.S. alone. This market is one that continues to see accelerating penetration of molecular classifiers such as RosettaGX Reveal, which we expect to continue over the next several years," added Mr. Berlin.

AbbVie Declares Quarterly Dividend

On February 18, 2016 The board of directors of AbbVie Inc. (NYSE: ABBV) reported a quarterly cash dividend of $0.57 per share (Press release, AbbVie, FEB 18, 2016, View Source;p=RssLanding&cat=news&id=2140604 [SID:1234509123]).

The cash dividend is payable May 16, 2016 to stockholders of record at the close of business on April 15, 2016.

Since the company’s inception in 2013, AbbVie has increased its dividend by more than 42 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

Heat Biologics Reports Fiscal Year 2015 Financial Results

On February 18, 2016 (Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported financial results for the fiscal year ended December 31, 2015 (Press release, Heat Biologics, FEB 18, 2016, View Source [SID:1234509093]).

"2015 proved to be a significant year for Heat as we reported positive Phase 1 data for HS-410 in bladder cancer, as well as initiated a Phase 1b trial evaluating HS-110 in lung cancer in combination with a PD-1 checkpoint inhibitor," stated Jeff Wolf, Heat’s Founder and Chief Executive Officer. "We expect to continue the momentum into 2016 with important milestones throughout the year highlighted by topline data for our Phase 2 trial evaluating HS-410 for non-muscle invasive bladder cancer (NMIBC) anticipated in the fourth quarter."

Recent Developments & Fourth Quarter 2015 Corporate Highlights

On February 10, 2016, Heat announced that the U.S. FDA lifted the partial clinical hold on its HS-410 Phase 2 clinical trial and patient enrollment was resumed after one week; clinical timelines were materially unchanged. The partial clinical hold came after Heat concluded that the cell line on which HS-410 is based had been previously misidentified and immediately notified FDA of this conclusion. The FDA placed Heat’s HS-410 Phase 2 clinical trial on partial clinical hold while they reviewed updated documentation. The partial clinical hold did not relate to concerns regarding the safety or efficacy of HS-410.

In January 2016, Heat reported three-month interim data from the unblinded, monotherapy cohort of the company’s ongoing Phase 2 trial of HS-410 for the treatment of high-risk, NMIBC. Images of the bladder taken from patients treated with HS-410 alone (e.g., no Bacillus Calmette-Guérin (BCG)) showed changes that resemble T cell-rich structures, indicating that systemic administration with HS-410 leads to a localized immune response within the bladder that cannot be attributed to standard of care. The interim data further validated HS-410’s mechanism of action. One of the treated patients had carcinoma in situ (CIS) – the patient population believed to be least responsive to BCG – and that patient experienced complete response. Heat continues to enroll the 25-patient arm and expects to report further monotherapy HS-410 data later this year.

In November 2015, Heat announced results from its Phase 1 clinical trial, evaluating the safety and immune response of HS-410 after surgery and treatment with standard of care, BCG, in patients with NMIBC. HS-410 had a positive safety profile with no serious adverse events. HS-410 elicited a broad-based (polyclonal) expansion of patient T cells and a high level of CD8+ tumor-infiltrating lymphocytes (TILs). Additionally, based on tissue samples taken from each patient, HS-410 shared 15 or more tumor antigens with those expressed on the patients’ cancer cells.

In October 2015, Heat completed enrollment of the 75 patients in the company’s blinded, randomized, placebo-controlled arms of its Phase 2 clinical trial of HS-410 for the treatment of NMIBC. In these three arms, Heat is evaluating the ability of HS-410 in combination with BCG to prevent cancer recurrence. The company plans to report topline efficacy, immune-response and safety data in the fourth quarter of 2016.

Fiscal Year 2015 Financial Highlights

Research and development expenses decreased to $2.6 million in 2015 from $2.9 million in 2014, a decrease of $0.3 million. The decrease is attributable to a reduction in pre-manufacturing costs associated with preparing clinical trial material and professional and consulting expenses, offset by increases in compensation costs, lab supplies and other fees.

Clinical and regulatory expenses increased to $14.1 million in 2015 from $5.3 million in 2014, an increase of $8.8 million. The increase is attributable to increases in clinical trial execution expenses, personnel costs and expenses related to the production of our clinical trial material.

General and administrative expenses increased to $4.4 million in 2015 from $4.0 million in 2014, an increase of $0.4 million. The increase is attributable to increased personnel and professional service fees.

Net loss for 2015 was $20.3 million compared to a net loss of $11.8 million for 2014.

Cash, cash equivalents and short-term investments totaled approximately $11.6 million at December 31, 2015 compared to $14.4 million at December 31, 2014.