On May 24, 2016 In a presentation to the investment community today, Eli Lilly and Company (NYSE: LLY) reported it has the potential to launch 20 new products in the 10 years beginning in 2014 and extending through 2023 (Press release, Eli Lilly, MAY 24, 2016, View Source [SID:1234512717]). In addition, Lilly could launch an average of two new indications or line extensions for already-approved products per year during that same time period.

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"We’re pleased to share with investors the breadth and depth of the Lilly pipeline, which showcases our progress across our key therapeutic areas. This includes recent launches as well as a robust lineup of assets in late-stage development or already under regulatory review," said John C. Lechleiter, Ph.D., Lilly’s chairman, president and chief executive officer. "There are no guarantees given the nature of science and of our business; however, in looking at our recent launches and current pipeline, we believe we are in the midst of the most prolific period of new launches in our company’s 140-year history."

Lilly’s R&D efforts focus on five therapeutic areas where the company has assets and capabilities that enable it to compete successfully. These include four core areas—diabetes, oncology, immunology and neurodegeneration—and one emerging area—pain. Building upon a similar investment community meeting in December 2015 focused on neurodegeneration – specifically Alzheimer’s disease – as well as animal health, today’s presentation highlighted the company’s R&D strategy and progress in diabetes, oncology, immunology and pain.

"We have improved the productivity and success of our pipeline through discrete actions aimed at enhancing focus, quality and speed, and by positioning ourselves as an attractive partner for external innovation opportunities," said Jan Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories. "These improvements have led to the potential for unprecedented R&D output."

Diabetes
Lilly’s long-standing commitment to diabetes care dates to 1923, when it was the first company to bring insulin to patients. Today, the company has the broadest range of diabetes therapies in the industry. Lilly’s R&D efforts in diabetes focus on differentiated therapeutics and delivery devices within three key areas of unmet need: glucose control, metabolic control and end-organ protection. The company aims to combine its strong in-house diabetes R&D capabilities with a comprehensive external network to deliver continued innovation in this important area of therapy.

Oncology
Lilly has a long history of leadership in oncology. The company has a balanced R&D approach across three key areas of disease modification: tumor cell signaling, tumor microenvironment and immuno-oncology. This approach allows for testing of combinations of internally-derived agents to address tumor heterogeneity and drug resistance. Lilly has a portfolio of differentiated assets across these approaches, including Cyramza (ramucirumab), Portrazza (necitumumab), olaratumab and abemaciclib. Lilly’s immuno-oncology portfolio will have five differentiated molecules in clinical testing by the end of 2016, and as many as 11 by the end of 2018.

Immunology
With the recent launch of Taltz (ixekizumab) and the submission of baricitinib for regulatory review, Lilly has designated immunology as the company’s newest core therapeutic area. While these assets represent the foundational first wave of innovation, Lilly has built a robust emerging pipeline of both internal assets and partnered molecules focusing on key pathways and interventions in multiple autoimmune diseases.

Neurodegeneration
Lilly’s commitment to Alzheimer’s disease is demonstrated by its more than 25 years of research and development in the field. As a result of this sustained effort and deep understanding of the disease, Lilly today has one of the industry’s most comprehensive Alzheimer’s portfolios, with seven molecules already in human testing. The company’s Alzheimer’s research includes disease prevention, detection and treatment.

Pain
Pain is an emerging research area for Lilly, focusing on non-opioid treatment for chronic pain. The two late-stage innovative medicines currently in development are galcanezumab (CGRP Ab), being studied for cluster headache and migraine, and tanezumab, being studied for osteoarthritis pain, chronic lower back pain and cancer pain in partnership with Pfizer.

A live audio webcast of today’s presentation is available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay will be available for approximately 90 days.

On May 24, 2016 Sandoz, a Novartis division and the global leader in biosimilars, reported that the European Medicines Agency has accepted their Marketing Authorization Application for a biosimilar to Roche’s EU-licensed MabThera (rituximab) (Press release, Novartis, MAY 24, 2016, View Source [SID:1234512719]). Rituximab is a monoclonal antibody that is used to treat non-Hodgkin’s lymphoma, which includes follicular lymphoma and diffuse large B-cell lymphoma, chronic lymphocytic leukemia and autoimmune diseases such as rheumatoid arthritis. Sandoz is seeking approval for the same indications as the reference product.

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"Patients with hematologic or blood cancers and rheumatoid arthritis, as well as their doctors, often have few treatment options and have long relied on rituximab as a vital part of their treatment," said Richard Francis, Division Head and CEO of Sandoz. "If approved, we believe our biosimilar rituximab will help broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines."

Sandoz believes that the totality of data in its submission will demonstrate that our biosimilar rituximab has essentially the same biological substance as, and the final drug product is highly similar to, the reference product. In addition to analytical, functional and pre-clinical data, the submission includes data from two pivotal confirmatory safety, PK/PD and efficacy studies that involved 629 follicular lymphoma and 173 rheumatoid arthritis patients.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars. Biosimilar rituximab is part of Sandoz’ growing oncology and immunology portfolios. The oncology portfolio includes two marketed products (filgrastim and epoetin-alfa) and biosimilar candidate pegfilgrastim, which is under regulatory review in the US and EU. Today’s announcement marks the sixth of 10 regulatory filings that the company plans to submit over a three-year period (2015-2017). As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

On May 24, 2016 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported an update on its ongoing OVATION study, a Phase Ib dose escalating clinical trial combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery (Press release, Celsion, MAY 24, 2016, View Source [SID:1234512740]). GEN-1 is an IL-12 DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site.

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The Company announced that an abstract detailing the trial design of the OVATION Study has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place from June 3-7 in Chicago. The abstract, entitled "Phase 1 study of the safety and biological activity of intraperitoneal IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer administered in combination with standard neoadjuvant chemotherapy (NAC) in patients with newly diagnosed ovarian cancer," will be presented in a poster session on Monday, June 6th from 1:00 PM to 4:00 PM.

The Company also announced today that it has completed enrollment of the second cohort of the OVATION Study and expects to report clinical data from that cohort mid-year. Celsion has previously reported highly encouraging data from the first cohort of the OVATION Study. In the first three patients dosed, GEN-1 plus standard chemotherapy produced excellent results, with no dose limiting toxicities and highly promising efficacy signals leading to successful surgical outcomes as summarized below:

Of the three patients treated in the first cohort, two patients demonstrated stable disease (SD) and one patient demonstrated a complete response (CR), as measured by RECIST criteria.
All patients had successful resections of their tumors, with two patients having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and one patient with Stage IV ovarian cancer having an optimal R1 resection.
One patient demonstrated a pathological complete response (pCR). pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection, and have been associated with a median overall survival (OS) of 72 months, which is more than three years longer than those who do not experience a pCR.
All patients experienced a dramatic > 96% drop in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells. A 50% reduction in CA-125 levels is considered meaningful. All patients’ CA-125 levels were below the standard cutoff level of 35 U/mL.
Celsion also expects to report translational data from the first two cohorts of the OVATION Study early in the third quarter of 2016. The translational data will provide further insight into GEN-1’s mechanism of action through the evaluation of dose-related changes in the tumor and peritoneal immune cell population, as well as through the peritoneal cytokine levels. Moreover, immune cell density, a common indicator of survival in ovarian cancer patients, will be explored to further demonstrate the therapy’s efficacy in these patients.

"We continue to successfully execute our OVATION Study in newly diagnosed ovarian cancer patients, and are pleased to report that our second cohort is now fully enrolled," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "The translational and clinical data seen to date underscore the potential efficacy and safety profile of GEN-1, and we look forward to learning more about the utility of our gene-based immunotherapy approach as our data set matures."

OVATION Study Design

The Phase Ib trial will evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m², 79mg/m², and up to 103mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.

On May 24, 2016 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported the publication of an abstract for a poster session at the 2016 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois (Press release, Ignyta, MAY 24, 2016, View Source [SID:1234512753]). The abstract relates to the results of the Phase 1 clinical trial of RXDX-105, the company’s orally available, small molecule multikinase inhibitor with potent activity against such targets as RET and BRAF. The poster session will be held on Sunday, June 5, 2016.

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"We are honored that the ASCO (Free ASCO Whitepaper) Scientific Program Committee has selected the abstract describing exciting data from our Phase 1 clinical trial of RXDX-105 for a poster presentation," said Pratik Multani, M.D., Chief Medical Officer of Ignyta. "We are looking forward to sharing updated data from this clinical trial in this prestigious scientific forum."

Details of the presentation are as follows:

Title:
A phase 1 dose escalation study of RXDX-105, an oral RET and BRAF inhibitor, in patients with advanced solid tumors. (Abstract number 2574, Poster number 274)
Date/time: Sunday, June 5, 2016, 8:00 AM – 11:30 AM, Central time

On May 24, 2016 Benitec Biopharma Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) reported its Interim Report for the nine months ended March 31, 2016. The report includes the financial results and a review of operations for the period (Press release, Benitec Biopharma, MAY 24, 2016, View Source [SID:1234512755]).

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Summary of the key points from the Interim Report:
• The net loss for the nine months was $A18.5 million and included research and development spending of AU$11.1 million. Benitec’s current assets at March 31, 2016 were A$26.5 million.

• In March 2016 Benitec announced encouraging results of its recent in vivo efficacy study of BBHB-331. Key findings indicate that a single BB-HB-331 treatment in the PhoenixBio mouse model can result in suppression of hepatitis B (HBV). These results demonstrate the potential utility of an approach that combines RNAi with gene therapy to treat HBV, and the Company intends to advance the HBV program towards the clinic.

• On February 26, 2016 Benitec announced that it would wind-down its hepatitis C program and terminate the program upon completion of patients in Cohort 4 in its Phase I/IIa clinical trial for TT-034.

• In December 2015, Benitec announced positive in vitro data demonstrating the efficacy of BBHB-331 and supporting the progression of BB-HB-331 into in vivo preclinical testing. The data was presented at the HEPDART 2015 conference in the US in December 2015.

• In August 2015, Benitec completed a NASDAQ listing raising A$18.8 million (US$13.8 million) before costs.

• In July 2015, Benitec announced it acquired full rights to its preclinical DNA-directed RNA interference based hepatitis B therapeutic program for $2.5 million. The program was previously a joint development collaboration between Benitec and Biomics.

• Benitec anticipates completing in vivo preclinical proof of concept studies for age-related macular degeneration (‘AMD’) and oculopharyngeal muscular dystrophy (‘OPMD’) by the end of calendar year 2016