1stOncology™: Cancer Intelligence Service – Page 16428 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

PharmaCyte Biotech Retains Facet Life Sciences to Guide Pancreatic Cancer Therapy Development Lifecycle with FDA

On January 30, 2017 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, officially reported that PharmaCyte has retained Facet Life Sciences, Inc. (Facet) to guide PharmaCyte through its pancreatic cancer therapy development lifecycle with the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JAN 30, 2017, View Source [SID1234517605]). Facet has been working with PharmaCyte and Translational Drug Development (TD2) since September 2016 and was instrumental in expediting PharmaCyte’s pre-IND meeting with the FDA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The Chief Executive Officer of PharmaCyte explained retention of Facet, "After we completed much of the Chemistry, Manufacturing and Control (CMC) work for PharmaCyte’s pre-IND submission to the FDA, we decided that PharmaCyte needed to retain a life sciences consulting firm that could guide it in a broad spectrum of areas that will be required for the successful development of PharmaCyte’s therapy for pancreatic cancer.

"Facet’s initial efforts to date have included assembling all of the preclinical and clinical data available on PharmaCyte’s therapy for pancreatic cancer and submission to the FDA as a ‘pre-IND package.’ Subsequently, Facet made arrangements with the FDA for the pre-IND meeting with the FDA and played a significant role in the meeting. We are extremely pleased with Facet’s performance and are convinced, based upon the results of the FDA meeting, that we made the right selection in retaining Facet."

The Facet Life Sciences team is comprised of drug development, regulatory affairs and regulatory writing experts who have scientific degrees and over 100 years of combined experience in the pharmaceutical, biologics, biopharmaceutical and medical device industry. The services offered by Facet span the full spectrum of services that PharmaCyte will need for regulatory approval of its therapy for pancreatic cancer. Facet is the U.S. Agent for PharmaCyte before the FDA and will assist with regulatory and clinical strategy, preparation and support for regulatory meetings, regulatory submission leadership, gap analyses, product labeling, risk management and medical writing in a number of areas.

The President and CEO of Facet, Ken VanLuvanee, commented on Facet’s retention by PharmaCyte saying, "We are extremely pleased to have been selected to work with PharmaCyte on its novel live-cell encapsulation therapy for pancreatic cancer. This is cutting edge technology that presents one of the most complex regulatory product candidates on which we have ever worked. In spite of its complexity, when compared to a single chemotherapy drug for example, we believe that successful development of PharmaCyte’s therapy may change the way tumors of the pancreas and other solid tumors are treated in the future. It’s truly an exciting time for us and PharmaCyte alike."

Facet development experts work closely with client teams to successfully reach their corporate and product goals. Facet has created and managed critical development aspects for some of the industry’s fastest growing life sciences companies. Its specialists deliver expert services and cutting-edge technologies that are designed to help small life science companies with big goals optimize their product research and development efforts.

TEMPUS AND UNIVERSITY OF MICHIGAN ANNOUNCE PANCREATIC CANCER COLLABORATION

On January 30, 2017 Tempus, a technology company focused on helping doctors personalize cancer care, and the University of Michigan are partnering to help researchers and physicians to identify customized treatment opportunities for pancreatic cancer patients (Press release, Tempus, JAN 30, 2017, View Source [SID1234517597]).

As part of the new collaboration, Tempus will provide genomic and transcriptomic sequencing and analysis for pancreatic cancer patients being treated at the University of Michigan. Utilizing bioinformatics and its machine learning platform, Tempus will help physicians analyze these data sets to identify patterns and potentially actionable treatments.

Pancreatic cancer is the third leading cause of cancer-related death in the United States and anticipated to become the second by around 2020. The disease kills more people than breast cancer and has a five-year survival rate of just nine percent.

"Though pancreatic cancer patients face some of the toughest odds, they do not yet have access to a host of targeted therapies with proven effectiveness in the same way that other diseases have, in part because there isn’t enough patient, treatment and outcome data to identify patterns that might lead to actionable treatments," said Eric Lefkofsky, Co-founder and CEO of Tempus. "At Tempus, we are proud to be leading an effort to make that data available to researchers and physicians on the frontlines of care."

The University of Michigan Comprehensive Cancer Center is one of 47 Comprehensive Cancer Centers in the U.S. designated by the National Cancer Institute, and has been a leader in pancreatic cancer, from both a clinical and research perspective, for the past several decades.

"The University of Michigan Comprehensive Cancer Center is committed to providing researchers and physicians with the tools and resources they need to battle pancreatic cancer," said Diane Simeone, Director of the Gastrointestinal Oncology Program. "We are pleased to partner with Tempus, a company that shares our commitment to innovation and collaboration in the pursuit of better treatment options for patients battling this disease."

Tempus provides molecular sequencing and clinical analytic solutions for top academic centers, hospital systems, associations, and healthcare providers.

ALCMI – Scancell Collaboration in Lung Cancer

On January 30, 2017) The Addario Lung Cancer Medical Institute ("ALCMI"), the Bonnie J. Addario Lung Cancer Foundation ("ALCF") and Scancell Holdings PLC ("Scancell") reported a collaboration to evaluate the use of Scancell’s second innovative cancer vaccine, SCIB2, from its ImmunoBody platform to treat non-small cell lung cancer ("NSCLC") (Press release, Scancell, JAN 30, 2017, View Source [SID1234517594]).

Scancell’s ImmunoBody cancer vaccine platform is a novel immunotherapy treatment under development that stimulates the immune system to potentially treat and prevent cancer. The Company
recently successfully completed a Phase 1/2 clinical trial with SCIB1 in patients with melanoma.

The Addario Advanced Collaboration Program brings patients into clinical trials from ALCMI’s extensive research consortium of international researchers and member institutions and ALCF’s patient support programs. ALCMI plans to assist Scancell in the design and development of a Phase 1/2 clinical trial with SCIB2 in patients with NSCLC which is planned to begin in 2018 and complete approximately 18 months later.

"This partnership enables us to access an important clinical program that could also accelerate the development of this groundbreaking immunotherapy technology," said ALCMI President and COO
Steven Young. "Combining our two foundations’ unique resources will increase patient engagement with the goal to bring new treatment options to non-small cell lung cancer patients," added Bonnie J. Addario, a 12-year lung cancer survivor and founder and chair of ALCF and founder of ALCMI.

According to the Centers for Disease Control and Prevention, lung cancer accounts for 27 percent of all cancer deaths, more than breast, prostate and colon cancer combined. More than 228,000 people receive a cancer diagnosis in the United States alone and more than 160,000 will not survive. It remains one of the most difficult cancers to treat.

"Immunotherapy has dramatically improved many patients’ outcomes across various cancer types. One of the next steps is how we can further enhance the immune response to cancer. Early clinical data on ImmunoBody suggests it is extremely well tolerated and may significantly improve outcomes, which would be ideal. I’m excited to work with Scancell and hopeful that we will take another important step in the fight against lung cancer," said Jacob M. Sands, MD, assistant
professor, medical oncology, Lahey Hospital & Medical Center in Burlington, Massachusetts.

SCIB2 has the potential to complement existing treatments and has potential value where current treatments either do not work or are not available. By stimulating immune responses to specific lung
cancer antigens, SCIB2 should assist the body in targeting and fighting NSCLC, leading to longer survival rates.

"We have generated preclinical data that suggests that SCIB2 could be the ideal complement to existing and emerging checkpoint inhibitor therapies to treat NSCLC and so provide an effective new potential treatment option for patients with this devastating disease," said Scancell CEO Richard
Goodfellow.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

Valo Therapeutics closes seed fundraising round to develop a novel oncolytic virus-based cancer immunotherapy

On January 30, 2017 Valo Therapeutics reported it had closed a seed fundraising round to develop a novel oncolytic virus-based cancer immunotherapy (Press release, Valo Therapeutics, JAN 30, 2017, View Source [SID1234518750]).

It is a spin-out from the University of Helsinki, Valo Therapeutics is developing novel oncolytic viral vaccines for the treatment of multiple forms of cancer. The therapeutic platform is projected to target cancer by recruiting the body’s own defence mechanisms to clear the cancer and subsequently to give patients a lasting resistance to recurring disease (vaccination). Valo Therapeutics recently closed its seed funding round, establishing strategic partnerships with world class investors in this rapidly growing scientific space.

The funding will take the company through pre-clinical development of a proprietary and genetically modified adenovirus coupled with tumor-specific peptides, that can both directly target cancer cells as well as elicit a strong and lasting specific anti-tumor immune response. A highly experienced team with deep experience of oncolytic viruses and clinical trials is driving development.

Current oncolytic viral therapies mostly focus on direct tumor cell lysis and typically generate a strong anti-viral immune response plus a weaker anti-tumor effect. Valo Therapeutics has disguised its viral particles using tumor-specific antigens (peptides), which can provide the information necessary to direct the immune response toward the patient’s tumor. This patented technology was developed by Scientific Founder Professor Vincenzo Cerullo, Head of the Drug Research Program at the University of Helsinki in the Faculty of Pharmacy, and a leader in his field: “Our approach seeks to revolutionise the way oncolytic virotherapies will be used in the future” said Prof. Cerullo, adding, “this technology is applicable to nearly all viruses being used at the moment”.

Dr. Michael Stein is the incoming Chairman of Valo Tx (currently Chairman and CEO of OxStem, the award winning spin-out from the University of Oxford). Dr Stein observed: “I was struck by the quality of the company’s very promising pre-clinical data. In addition, the team is equipped with all the expertise necessary to accelerate this treatment to market, providing patients with a potentially transformational therapy”. Dr. Stein continued, “Valo Tx is fortunate to have the strategic backing of some highly experienced investors including the University of Helsinki, as well as the resources of the University of Helsinki Innovation Services” (HIS).

HIS supported the company in preparing the initial spin-out and will continue to provide support for full commercialisation of the technology. Jari Strandman, CEO of Helsinki Innovation Services: “We are incredibly excited about the potential of this new technology and delighted to see the rapid progress already being made”.

Freeman Road is a family consortium with deep experience in the healthcare technology space, and a primary Investor in Valo Therapeutics. Director and Physician Dr. Paul Porter said: “We invested into Valo Tx because the business concept is novel, with potential for enormous impact; and it is backed by a highly experienced team”.

Valo Therapeutics will fund the progression of its new therapy through clinical trials in humans in 2018 – each with a focus on a different cancer indication with large unmet therapeutic need. The team will focus initially on two cancer indications as a proof of concept, with a view to expanding to other cancer types over time.

Aeterna Zentaris Announces Completion of Zoptrex™ Pivotal Phase 3 Clinical Trial in Advanced Endometrial Cancer; Expects to Report Top-Line Results in April 2017

On January 30, 2017 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") reported the occurrence of the 384th death in the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with Zoptrex (zoptarelin doxorubicin) in women with advanced, recurrent or metastatic endometrial cancer, representing the clinical endpoint of the study (Press release, AEterna Zentaris, JAN 30, 2017, View Source [SID1234517598]). The Company currently expects to lock the clinical database and to report top-line results in April 2017. Zoptrex is the Company’s proposed tradename for zoptarelin doxorubicin. The proposed tradename is subject to approval by the United States Food and Drug Administration (the "FDA").

Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, "We are pleased to announce the completion of the clinical phase of our pivotal Phase 3 clinical study of Zoptrex, which was conducted under a Special Protocol Assessment with the FDA. Reaching this important milestone took longer than we anticipated because the rate of events slowed significantly during the past year. As previously reported, the study was fully enrolled in June 2015 and the final dosing occurred in January 2016. Therefore, a significant number of patients survived more than 18 months since enrollment in the study. We are thankful that these patients continued to survive a devastating disease and are hopeful that their lives are continuing successfully. We are close to locking the clinical database and are focused on producing the top-line results of the study. Currently, we expect to release top-line results in April 2017."

David A. Dodd, President and Chief Executive Officer of the Company stated, "With the completion of the clinical portion of this trial, we will now focus on analyzing the data and, if warranted by the results, submitting a new drug application later this year. There is a significant unmet medical need for a treatment for women with advanced, recurrent or metastatic endometrial cancer and we are hopeful that Zoptrex will provide clinicians and their patients with an effective therapy for treating the disease. We are indebted to all 512 patients who participated in this important clinical program and, hopefully, we will advance to providing a very important new therapy for this devastating cancer."

About the ZoptEC Pivotal Phase 3 Trial

The ZoptEC pivotal Phase 3 trial was a fully-recruited (over 500 patients), open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin, to doxorubicin alone. Patients were centrally randomized in a 1:1 ratio and received either Zoptrex (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every three weeks and for up to nine cycles. Response was evaluated every three cycles during treatment, and thereafter, every 12 weeks until progression. All patients were followed for survival as the primary efficacy endpoint ("EP"). Secondary EPs include progression-free survival, objective response-rate, and clinical benefit rate. The trial is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration ("FDA"). For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).

About Zoptarelin Doxorubicin

Zoptrex (zoptarelin doxorubicin), a novel synthetic peptide carrier linked to doxorubicin as a New Chemical Entity (NCE), is the Company’s lead oncology compound. Zoptrex is the first targeted oncological therapy using a peptide as the targeting agent and, therefore, it represents potentially a new tool in the treatment of cancer tumors that overexpress the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumors, typically found in gynecological cancers, prostate cancer and some forms of breast cancer. Potential benefits of this targeted approach may include enhanced efficacy and a more favorable safety profile with lower incidence and severity of adverse events, as compared to doxorubicin. Based on the results of Phase 2 studies, the Company believes it may be efficacious for the treatment of ovarian and prostate cancer. If Zoptrex is approved as a therapy for endometrial cancer, the Company intends to develop it for these additional indications. The Company has licensed marketing rights to Zoptrex to Sinopharm A-Think for China, Hong Kong and Macau; to Orient EuroPharma for Taiwan and Southeast Asia; to Rafa Labs for Israel and the Palestinian territories and to Specialised Therapeutics for Australia and New Zealand.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be approximately 50,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.