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Celldex Therapeutics Completes Acquisition of Kolltan Pharmaceuticals

On November 29, 2016 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported it has completed its previously announced acquisition of Kolltan Pharmaceuticals, Inc., a privately held company focused on the discovery and development of novel, antibody-based drugs targeting receptor tyrosine kinases (RTKs) (Press release, Celldex Therapeutics, NOV 29, 2016, View Source [SID1234516835]).

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"Celldex has added a unique platform of antibodies targeting receptor tyrosine kinases, which are validated targets in oncology, to our pipeline. Clinical and preclinical data suggest these candidates can help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who have failed other cancer therapies," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. "We believe these programs are highly compatible with our scientific approach and can be developed independently and in combination with Celldex’s existing product candidates. We are finalizing our integrated clinical development strategy and look forward to outlining these plans in the coming weeks."

The following programs have been added to the Celldex pipeline:

CDX-0158 (formerly KTN0158) — a humanized monoclonal antibody that is a potent inhibitor of KIT activation and receptor dimerization in tumor cells and mast cells, which is currently in a Phase 1 dose escalation study in refractory gastrointestinal stromal tumors (GIST).

CDX-3379 (formerly KTN3379) — a human monoclonal antibody designed to block the activity of ErbB3 (HER3), which recently completed a Phase 1b study with combination cohorts where meaningful responses and stable disease were observed in cetuximab (Erbitux) refractory patients in head and neck squamous cell carcinoma and in BRAF-mutant non-small cell lung cancer (NSCLC).

A multi-faceted TAM program — a broad antibody discovery effort underway to generate antibodies that modulate the TAM family of RTKs, comprised of Tyro3, AXL and MerTK, which are expressed on tumor-infiltrating macrophages, dendritic cells and some tumors. Research supports TAMs having broad application and potential across immuno-oncology and inflammatory diseases.

PharmaCyte Biotech Granted FDA Pre-IND Meeting for Pancreatic Cancer Therapy

On November 29, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that a Pre-Investigational New Drug (Pre-IND) meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA (Press release, PharmaCyte Biotech, NOV 29, 2016, View Source [SID1234516834]). During the meeting with representatives from CBER, they will respond to PharmaCyte’s previously submitted questions to the FDA as part of a Pre-IND information package related to PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

PharmaCyte will be submitting a full Pre-IND package of information to the FDA that describes what PharmaCyte intends on submitting in its Investigational New Drug (IND) application. The FDA will review PharmaCyte’s manufacturing, preclinical pharmacology and toxicology and clinical trial plans for the company’s therapy to treat LAPC. After the FDA has responded to the questions and issued comments, PharmaCyte will undertake steps to address them to the FDA’s satisfaction which will lead directly to the preparation of the IND application itself. Once the IND application is found to be acceptable to the FDA, patients can be enrolled in PharmaCyte’s clinical trial.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented about the Pre-IND meeting saying, "We are pleased that the FDA has granted us a Pre-IND meeting in connection with our planned clinical trial for LAPC patients whose disease has already received maximum response from the gold standard of care – the combination therapy of Abraxane plus gemcitabine. Our Pre-IND meeting is the next step in getting our pancreatic cancer therapy into a clinical trial and approved by the FDA. We believe PharmaCyte is well on its way to accomplishing this goal."

PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they may become operable.

Seattle Genetics to Webcast Investor and Analyst Event at American Society of Hematology Annual Meeting

On November 29, 2016 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that the company will webcast an investor and analyst event on Monday, December 5, 2016 during the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, CA (Press release, Seattle Genetics, NOV 29, 2016, View Source;p=RssLanding&cat=news&id=2226084 [SID1234516833]). Members of the Seattle Genetics management team and industry experts will discuss data being presented at the conference, including from the ADCETRIS (brentuximab vedotin) and vadastuximab talirine (SGN-CD33A) programs.

The event will take place from approximately 8:15 p.m. to 9:15 p.m. Pacific Time. The webcast will be available live and for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors and News section.

Ignyta to Debut Preclinical Data on RXDX-106 at the 2016 EORTC-NCI-AACR Annual Meeting

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.

"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.

Celsion Corporation Announces Presentation of Results from Independent NIH Analysis of ThermoDox® plus Optimized RFA for the Treatment of Primary Liver Cancer at the 2016 RSNA Annual Meeting

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]).

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).