On April 13, 2016 PharmaTimes reported that Rising levels of obesity among UK women have helped drive a 54 percent jump in womb cancer rates over the last two decades, according to new figures released by Cancer Research UK (Press release, PharmaTimes, APR 13, 2016, View Source [SID:1234510735]).

Back in the early 1990s around 19 women in every 100,000 developed the disease, but that has now risen to 29 women in every 100,000, with obesity being the most likely driving force behind the increase, according to the charity.
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In the UK around 9,000 women are now diagnosed with womb cancer every year, and around 2,000 die from the disease, a marked difference from the 4,800 annual new cases and 1,500 deaths recorded twenty years ago.

"It’s worrying that womb cancer cases are going up so sharply," said Professor Jonathan Ledermann, director of the Cancer Research UK and UCL Cancer Trials Centre. "We don’t know all the reasons why. But we do know that about a third of cases are linked to being overweight so it’s no surprise to see the increases in womb cancer cases echo rising obesity levels."

On the plus side, the figures also show that survival is improving. "In the 1970s, almost six in 10 women diagnosed with the disease survived for at least 10 years. Now almost eight in 10 women survive," said Prof Lederman. "But we need more research to understand the biology of the disease better and to know more about how it is caused so that we can improve the treatment of these women as well as preventing more cases."

Why extra weight can cause cancer is not entirely clear, but there is evidence to show that extra fat in the body can increase the risk by producing hormones and growth factors that promote cell division, the charity noted.

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On April 13, 2016 Celprogen reported they successfully completed their pre-clinical evaluation of CEP1430 and CEP1507 compounds as selectively targeting Pancreatic Cancer stem Cell population that contribute to treatment related resistance (Press release, Celprogen, APR 13, 2016, View Source [SID:1234510892]). Both compounds demonstrated growth inhibition of pancreatic tumors in patient derived xenograft (PDX) cancer models by 80% to 85%. The results of the study will be presented in an abstract format on Monday, April 18, 2016 at American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in New Orleans. These compounds are Celprogen’s propriety compounds for targeting Pancreatic Cancer Stem Cells (CSC) and Circulating Tumor Cells (CTC) in patients with advanced stages of pancreatic cancer.

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The present invention relates to Drug Discovery programs at Celprogen that identify potential drug candidates for the treatment of pancreatic cancer. At present Celprogen is exploring partnership with Pharmaceutical Industry to move promising drug candidates forward to the clinical development and increasing the armament of drugs against pancreatic cancer. CEP1430 is a selective inhibitor of CSC that can be administrated orally and does not exhibit sign of toxicity. The mechanism of cell death also indicates that these molecules will greatly enhance the efficacy of immune based approaches to improve outcome in pancreatic cancer patients. These pancreatic Stem Cell selective inhibitors are expected to eradicate tumors, improve quality of life and prolong and/or overall survival and patients bearing pancreatic tumors.

On April 13, 2016 Pharmatines reported that Boehringer Ingelheim’s Giotrif has beaten AstraZeneca’s Iressa on a number of clinical measures investigated in a head-to-head study involving patients with EGFR mutation-positive advanced non-small cell lung cancer (Press release, PharmaTimes, APR 13, 2016, View Source [SID:1234510736]).

The company says data from the Phase IIb LUX-Lung 7 trial, published in The Lancet, show that Giotrif (afatinib) significantly cut the risk of lung cancer progression and treatment failure, and boosted the overall response rate versus Iressa (gefitinib), "without compromising overall health-related quality of life, safety and tolerability".
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Giotrif reduced the risk of disease progression by 27 percent compared to Iressa, and, after two years’ treatment, more than twice as many patients taking the drug were alive and progression free than those taking AZ’ drug (27 percent vs 15 percent after 18 months, and 18 percent vs 8 percent after 24 months).

In addition, Giotrif-treated patients had a significantly longer time on treatment and risk of treatment failure was reduced by 27 percent, while significantly more patients had an objective tumour response compared to Iressa (70 percent vs 56 percent), with a median duration of response of 10.1 months and 8.4 months, respectively.

Both drugs showed similar improvements in patient-reported outcome measures with no significant differences in health-related quality of life. Treatment with both was generally tolerable, leading to an equal rate of treatment-related discontinuation in both arms (6 percent). The overall frequency of serious adverse events was 44.4 percent for Giotrif and 37.1 percent for Iressa.

"The totality of the efficacy data from LUX-Lung 7 clearly differentiates the second-generation inhibitor afatinib from the first-generation inhibitor gefitinib with no significant differences observed in overall safety, tolerability and health-related quality of life between the two TKIs," noted Professor Klaus Dugi, medical director and managing director, Boehringer Ingelheim UK & Ireland. "This is really good news for patients, and it will provide clinicians with further evidence to guide treatment practice in EGFR mutated NSCLC."

Data for the co-primary endpoint of overall survival are not yet mature and will be presented in the future, BI said.

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On April 13, 2016 Intrexon Corporation (NYSE: XON), a leader in synthetic biology, reported it has entered into Exclusive Channel Collaborations (ECC) with two startups backed by the Harvest Intrexon Enterprise Fund, sponsored by Harvest Capital Strategies, LLC (Press release, Intrexon, APR 19, 2016, View Source [SID:1234511218]). Through the proprietary technologies of Intrexon, these companies will pursue new approaches for unmet needs in human health:

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Relieve Genetics, Inc. will focus on a breakthrough, non-opioid gene therapy approach for neuropathic pain; and
Exotech Bio, Inc. will utilize a novel exosome-based platform for delivering therapeutic RNA to treat select cancer indications.

"We are excited to enter into these new collaborations within Intrexon’s Health Sector to advance medicine on multiple fronts," said Samuel Broder, M.D., Senior Vice President, Head of Intrexon’s Health Sector. "Neuropathic pain is a tremendous unmet need in healthcare today. The collaboration with Relieve Genetics offers a significant opportunity to materially impact the lives of many patients who are in desperate need of relief from pain refractory to other therapies including opiates."

Neuropathic pain is a common, chronic complication caused by a number of different medical conditions. Current standard of care focuses mainly on easing discomfort as treatments are limited by incomplete efficacy and dose-limiting side-effects. Relieve Genetics, Inc. will instead center its therapeutic efforts on the underlying pathophysiology of neuropathic pain through gene therapy. With a designed viral vector delivery system, the collaboration will target delivery of an immunomodulatory protein alone or in combination with multiple therapeutic effectors under the control of the RheoSwitch Therapeutic System, providing localized, persistent, and regulatable drug delivery for pain management.

Dr. Broder continued, "Intrexon’s work in engineering complex miRNAs holds particular promise for an exosome-based platform to address certain cancers, for which conventional approaches have failed. In addition to the significant progress underway with our partner ZIOPHARM Oncology in the utilization of gene and adoptive cellular therapies against numerous cancer types, we look forward to introducing a new and important modality with Exotech Bio to treat cancer patients who have limited options under current treatment approaches."

Exosomes are micro-vesicles that naturally contain RNA, proteins and small molecule metabolites and are transmitted between the body’s cells to facilitate intercellular communication, immune modulation and developmental cell differentiation. A growing body of research supports the re-engineering of exosomes to transport drugs, including various RNA classes, as cell-specific cargoes that can mediate therapeutic responses to a variety of cancer cell types for which conventional treatments have been unsuccessful at effectively addressing.

Intrexon’s unique expertise in the design of subcellular localization motifs, unique protein-protein interaction motifs, multimeric miRNAs, and other RNA-based modalities can be applied in a coordinated fashion for the purpose of increasing anti-cancer therapy efficacy while reducing side effects. The collaboration with Exotech Bio, Inc. is focused on developing engineered cell lines for production of tumor-targeted allogeneic exosomes carrying bioactive RNAs to act directly on intracellular cancer pathways to suppress or eliminate specific tumor cells.

Under the terms of the ECC agreements for both collaborations, Intrexon will receive a technology access fee in the form of equity equating to 25% of each startup, reimbursement for all research and development costs, as well as potential milestones and backend economics in the form of royalties.

On April 13, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and the Sarcoma Foundation of America, reported that Advaxis has been awarded the 2016 Vision of Hope Award for their efforts to advance an immunotherapy platform to fight osteosarcoma in patients (Press release, Advaxis, APR 13, 2016, View Source [SID:1234510743]).

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"The Sarcoma Foundation of America is proud to present the Vision of Hope Award to Advaxis Immunotherapies, a trailblazer in the osteosarcoma space," said Bert Thomas IV, Ph.D., Chief Executive Officer of the Sarcoma Foundation of America. "Their innovative technology gives hope to sarcoma patients in critical need of new treatments and paves the way for additional immunotherapies to offer patients a brighter future."

Advaxis is the first biotechnology company to ever receive the award for their work in the development of ADXS-HER2, an Lm Technology that has received an orphan drug designation from the FDA and EMA for treatment of osteosarcoma. In a study examining canine osteosarcoma, 18 dogs received either 2×108, 5×108, 1×109 or 3.3×109 CFU of ADXS–HER2 post-completion of surgery and adjuvant chemotherapy with 15 dogs showing an induced antigen-specific response within 6 months of immunotherapy administration. Additionally, treatment with ADXS-HER2 reduced the incidence of metastatic disease and prolonged survival relative to a historical control group with only low-grade, transient side-effects.

Osteosarcoma is the most common primary bone tumor in dogs, with more than 10,000 dogs annually diagnosed, and the most common bone cancer in children and teens. It is the third most common cancer in teens after lymphomas and brain tumors. HER2 is expressed in approximately 40 to 60 percent of pediatric and canine osteosarcomas and in pulmonary metastatic disease, providing a strong rationale for HER2 targeted immunotherapy in these cancers.

"We are honored to be chosen as a recipient of this prestigious Award from the Sarcoma Foundation of America," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "We recognize the serious unmet need to treat children and young adults battling this life-threatening disease and are proud to work towards developing immunotherapies that may help change the course of osteosarcoma patients’ lives."

Advaxis will receive the Vision of Hope Award at the Sarcoma Foundation of America 14th Annual Fundraising Event, "A Celebration of Life," on Thursday, May 12, 2016 at 6:00 PM EDT in New York City. For further information and to register, visit the Sarcoma Foundation of America’s website.

About Sarcoma

Sarcoma is a rare cancer in adults, accounting for 1 percent of all adult cancers, but rather prevalent in children, accounting for about 15 percent of all childhood cancers. At any one time, 50,000 patients and their families are struggling with sarcoma. Every year, nearly 15,000 new cases are diagnosed and about 6,000 people die from the disease.

About the Sarcoma Foundation of America

The Sarcoma Foundation of America (SFA), a 501(c)(3) nonprofit charitable organization, is an advocate for increased research to find new and better therapies with which to treat patients with sarcoma. The organization raises money to privately fund grants for sarcoma researchers and conducts education and advocacy efforts on behalf of sarcoma patients. For more information, please visit www.curesarcoma.org.

About ADXS-HER2

ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 to Aratana Therapeutics, Inc. for animal health therapeutics. Aratana expects to receive a conditional USDA license by the end of 2016 to market and sell ADXS-HER2 for dogs with canine osteosarcoma.