On November 29, 2016 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported its first disclosed preclinical data on RXDX-106—its potent, selective, type II pseudo-irreversible inhibitor of TYRO3, AXL and MER (or TAM) and c-MET—will be presented at the 2016 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Molecular Targets and Cancer Therapeutics Symposium in Munich, Germany, highlighting both the immuno-oncology and targeted therapeutic activity of this novel agent (Press release, Ignyta, NOV 29, 2016, View Source [SID1234516832]). Additionally, the company will present data on multiple compounds in clinical development from its robust pipeline of molecularly targeted oncology therapies, including entrectinib—an orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions—and RXDX-105—a VEGFR-sparing, potent RET inhibitor.

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"We are pleased to introduce preclinical data on RXDX-106 at ENA alongside our promising clinical data for entrectinib and RXDX-105," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "RXDX-106 is an intriguing, novel agent that may offer a dual mechanism by potentiating the immune system, while also providing selective activity against key molecular targets involved in both primary oncogenesis and resistance."

In the presented preclinical data on RXDX-106, researchers demonstrated that the agent is a potent and selective inhibitor of TAM and c-MET, and inhibited TAM-mediated and c-MET-mediated tumor growth in vivo. Additionally, researchers demonstrated, via in vitro and in vivo studies, that RXDX-106, as a single agent, appears to release the molecular brakes on immune activation in macrophages, NK cells, and T cells, resulting in the repolarization of the immune response to elicit an anti-tumor effect. Furthermore, emerging in vivo combination data suggest that RXDX-106 potentiates the activity of anti-PD-1 and anti-CTLA-4 agents. These data further support the continued evaluation of RXDX-106 in both a preclinical and clinical setting (Abstract number 73, Poster number P044; Abstract number 65, Poster number P036).

Also presented as part of this poster session were preclinical data on RXDX-105 demonstrating significant anti-tumor activity in models harboring RET fusions (Abstract number 85, Poster number P056), as well as preclinical data on entrectinib showing potent anti-tumor activity in multiple different tumor model systems driven by NTRK1/2/3, ROS1 and ALK fusions, regardless of the fusion partners or the tumor tissue of origin (Abstract number 78, Poster number P049). Additional clinical data on RXDX-105 and entrectinib will be presented later in the week at ENA.

On November 29, 2016 Celsion Corporation (NASDAQ:CLSN) reported the presentation of results from an independent retrospective analysis conducted by the National Institutes of Health (NIH) on the intent-to-treat population of the Company’s HEAT Study, a 701-patient study of ThermoDox, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC) (Press release, Celsion, NOV 29, 2016, View Source [SID1234516829]).

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The findings of the NIH study were presented during The Interventional Oncology Series: Hepatocellular Carcinoma and Cholangiocarcinoma at the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) on Monday, November 28, 2016 from 1:00 pm to 6:00 pm CT and was moderated by Professor Riccardo Lencioni, lead European Investigator on Celsion’s HEAT Study. Celsion is currently studying the use of RFA as a heat source both for tumor ablation and to activate ThermoDox as a means of affecting the area surrounding the tumor, where later recurrence most often takes place.
The NIH analysis was conducted under the direction of Dr. Bradford Wood, MD, Director, NIH Center for Interventional Oncology and Chief, NIH Clinical Center Interventional Radiology. The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome, concluded that increased burn time per tumor volume significantly improved overall survival (OS) in patients with solitary lesions treated with RFA + ThermoDox compared to patients treated with RFA alone. More specifically, the analysis showed that a one unit increase in RFA duration per tumor volume improved OS by 20% in patients treated with optimized RFA + ThermoDox compared to RFA alone.

This novel way of assessing the impact of the drug takes into account both the size of the tumor and the time of ablation, both of which appear to be important factors. The NIH analysis included 437 patients with a single lesion from the Company’s HEAT Study, the same patient population being treated in the Company’s ongoing Phase III OPTIMA Study. These findings are consistent with Celsion’s own analysis of the HEAT Study data, which demonstrated that over a 3.5 year period, there was a statistically significant two (2) year survival benefit for patients treated with ThermoDox plus optimized RFA over the optimized RFA only group.

"There is clear evidence that the duration of the RFA regimen used in combination with ThermoDox is critical, as was demonstrated in the NIH’s independent analysis," said Riccardo Lencioni, MD, FSIR, EBIR, Professor of Interventional Radiology, Vice Chair, Clinical and Translational Research, Department of Interventional Radiology, University of Miami School of Medicine. "Findings from this analysis provide additional confirmation that increased RFA burn time improves OS in patients administered ThermoDox. For patients with intermediate HCC who are not optimal candidates for surgery, there exists a dire unmet need, and being able to offer these patients optimized RFA + ThermoDox has the potential to be a meaningful paradigm shift in the current management of this deadly disease."

"It is an honor to have confirmatory support from the NIH that the use of RFA for more than 45 minutes in patients treated with ThermoDox can have a correlative impact on reductions in tumor size and OS in patients with primary liver cancer," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "This analysis provides further validation for our ongoing global Phase III OPTIMA Study. In addition, learnings from a computational modeling study, an experimental animal study and the HEAT Study post hoc subgroup analysis, all of which are consistent with each other and which — when examined together — suggest a clearer understanding of a key ThermoDox heat-based mechanism of action: the longer the target tissue is heated, the greater the doxorubicin tissue concentration."

Presentation Details
Abstract Number: 16013790
Title: RFA Plus Lyso Thermosensitive Liposomal Doxorubicin Improves Survival Using Metric of RFA Duration per Tumor Volume: Retrospective Analysis of Prospective Randomized Controlled Trial
Session: Interventional Oncology Series: Hepatocellular Carcinoma and Cholangiocarcinoma (VSI021)
Date and Time: Monday, November 28, 2016, 1:00 pm to 6:00 pm CT
The NIH presentation will be available on Celsion’s website under "News & Investors – Scientific Presentations."

About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 75 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The primary endpoint for the trial is Overall Survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).

On November 29, 2016 Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it will host a conference call and webcast at 8:30 a.m. ET (5:30 a.m. PT) on Monday, Dec. 5, 2016, to discuss the poster presentation on its lead drug candidate, TTI-621, at the American Society of Hematology (ASH) (Free ASH Whitepaper) 58th Annual Meeting in San Diego (Filing, 6-K, Trillium Therapeutics, NOV 29, 2016, View Source [SID1234516828]). Trillium will present initial clinical data from its ongoing TTI-621 hematologic malignancy Phase 1 trial at ASH (Free ASH Whitepaper).

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The conference call may be accessed by dialing:

U.S. callers: (844) 358-6757
International callers: (216) 562-0400
Conference ID: 28772974.
The conference call will also be available via a live webcast on the investors section of Trillium’s website at www.trilliumtherapeutics.com. Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software. Following the call, an archived webcast replay will be available on the company’s website for three months.

On November 29, 2016 KaloBios Pharmaceuticals, Inc. (OTC:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, reported that Dr. Tariq Arshad, acting Chief Medical Officer, will present on the potential for lenzilumab at the 2016 Juvenile Myelomonocytic Leukemia (JMML) International Symposium in San Diego, Calif., December 1-2, 2016 (Press release, KaloBios, NOV 29, 2016, View Source [SID1234516826]).

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KaloBios plans to assess interim data from its Phase 1 study of lenzilumab in chronic myelomonocytic leukemia (CMML), a rare hematologic cancer in older adults, to determine the feasibility of commencing a Phase 1 study in JMML, a rare pediatric form of CMML with high unmet medical need and no FDA-approved therapies. In July 2016, KaloBios initiated dosing in a Phase 1 clinical trial in patients with CMML to identify the maximum tolerated or recommended Phase 2 dose and to assess its safety, pharmacokinetics, and clinical activity. More information, including medical centers conducting the trial, can be found at View Source

Details of the JMML International Symposium presentation follow:

Title: Potential Use of KB003/Lenzilumab in JMML
Presenter: Tariq Arshad, MD, MBA, KaloBios Pharmaceuticals
Date: Thursday, December 1, 2016
Time: 5:00 – 5:20 p.m. PST
Session: Update on Clinical Trials, Moderator: Charlotte Niemeyer, MD, University of Freiburg

For more information on the conference, please visit View Source

About Lenzilumab

Lenzilumab is a Humaneered recombinant monoclonal antibody that targets and is an antagonist of soluble Granulocyte Macrophage – Colony Stimulating Factor (GM-CSF), a cytokine suggested to be central to the inflammation and activation of certain immune cells. Lenzilumab has been studied for its ability to limit hypersensitivity to GM-CSF signaling, which appears to be a key feature in many CMML and JMML patients, and GM-CSF inhibition may affect the growth of leukemic cells in patients. Lenzilumab has been tested in more than 90 subjects in previous clinical trials in rheumatoid arthritis, asthma and healthy volunteers, and was found to be generally safe and well tolerated.

About KaloBios Pharmaceuticals, Inc.

On November 29, 2016 AstraZeneca and its global biologics research and development arm, MedImmune, will continue the oncology momentum built during 2016 with a strong end-of-year presence at three major congresses (Press release, AstraZeneca, NOV 29, 2016, View Source [SID1234516824]). In total, 50 abstracts – including 15 oral presentations – have been accepted across:
ASH: The 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, 3-6 December 2016, San Diego, USA
WCLC: The 17th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, 4-7 December 2016, Vienna, Austria
SABCS: The 2016 San Antonio Breast Cancer Symposium, 6-10 December 2016, San Antonio, USA
The December congresses will offer a comprehensive update on AstraZeneca’s portfolio progress and highlight the scientific strength and clinical potential of the company’s cancer medicines – in particular Iressa, Tagrisso and Faslodex – as well as the company’s emerging presence in blood cancers.

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Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "At the end of a memorable year for AstraZeneca in oncology, we will reinforce our leadership in lung and breast cancer research and our growing late-stage pipeline of potential medicines for life-threatening blood cancers. Our data will confirm the superiority of Tagrisso over standard of care chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer and of Faslodex over Arimidex as 1st-line treatment in advanced breast cancer. New data will add to the emerging safety and efficacy profile of acalabrutinib, our potential best-in-class investigational therapy for the treatment of a range of B-cell malignancies."

At ASH (Free ASH Whitepaper): Rapid progress in haematology research
Less than a year after announcing a majority investment in Acerta Pharma, which is becoming AstraZeneca’s haematology Centre of Excellence, the Company will demonstrate momentum in blood cancers with new clinical data on acalabrutinib, its investigational, highly selective, potent Bruton tyrosine-kinase (BTK) inhibitor in Phase III development for B-cell malignancies. The 2016 ASH (Free ASH Whitepaper) Annual Meeting will feature two oral presentations on acalabrutinib:

Acalabrutinib monotherapy in patients with Richter transformation from the Phase I/II ACE-CL-001 clinical study (Oral presentation, Abstract #60, 3 December 2016, 08:45 PST, Room 6AB)
Acalabrutinib monotherapy in patients with ibrutinib intolerance: results from the Phase I/II ACE-CL-001 clinical study (Oral presentation, Abstract #638, 5 December 2016, 07:15 PST, Room 5AB)
The Company will also report new pre-clinical data on a range of investigational treatment mechanisms with potential to address unmet medical needs in blood cancers.

At WCLC: Tagrisso data show clinical benefit in EGFR T790M-positive NSCLC in confirmatory Phase III trial
With 26 abstracts and nine oral presentations – including a presentation on AURA3 which will be part of the Presidential Symposium – AstraZeneca will showcase the breadth and potential of its lung cancer portfolio. Tagrisso will be a particularly strong focus, with detailed data from the positive AURA3 trial in patients with EGFR T790M mutation-positive NSCLC who have progressed after EGFR tyrosine kinase inhibitor treatment. This is the first randomised, controlled Phase III trial for Tagrisso against standard-of-care chemotherapy, and includes results from plasma ctDNA testing. Analyses will also be presented on Phase II data in patients with CNS metastases:

Randomised Phase III study of osimertinib vs platinum-pemetrexed for EGFR T790M-positive advanced NSCLC (AURA3) (Oral presentation, Abstract PL03.03, 6 December 2016, 09:05 CET, Hall D)
Osimertinib vs platinum-pemetrexed for T790M-positive advanced NSCLC (AURA3): plasma ctDNA analysis (Mini-oral presentation, Abstract MA08.03, 6 December 2016, 11:12 CET, Lehar 3-4)
CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two Phase II trials (Mini-oral presentation, Abstract MA16.11, 7 December 2016, 15:32 CET, Strauss 2)
Iressa presentations at WCLC include an oral ‘late breaker’ report of over 10 years experience with the US Iressa Clinical Access Program (ICAP):

Analysis of Outcomes in US IRESSA Clinical Access Program (ICAP) Patients on Gefitinib for More Than 10 Years (Oral presentation, Abstract OA23.07, 7 December 2016, 15:25 CET, Stolz 2)
In addition, data from the Phase II ATLANTIC trial of durvalumab in ≥3rd-line treatment of locally advanced or metastatic, EGFR/ALK wild type NSCLC will also be presented.

At SABCS: Phase III Faslodex data extend understanding in advanced breast cancer
Latest data from the Phase III FALCON trial to be presented at the SABCS 2016 congress will build on previous findings demonstrating superior progression-free survival (PFS) with Faslodex over Arimidex in the 1st-line treatment of women with advanced hormone receptor positive (HR+) breast cancer, including an analysis in women with and without metastases that have spread to the liver and/or lung, so-called visceral disease.

Key presentations among the 14 abstracts at SABCS include:

Progression-free survival results in postmenopausal Asian women: subgroup analysis from a Phase III randomised trial of fulvestrant 500mg vs anastrozole for hormone receptor-positive advanced breast cancer (FALCON) (Poster presentation number: P2-08-09, Poster Session 2, 8 December 2016, 07:30-09:00 CST, Hall 1)
A real-world evidence study to define the prevalence of endocrine therapy-naïve hormone receptor-positive locally advanced or metastatic breast cancer in the US (Poster presentation number: P5-08-20, Poster Session 5, 9 December 2016, 17:00-19:00 CST, Hall 1)