1stOncology™: Cancer Intelligence Service – Page 15806 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CRT Pioneer Fund, Cancer Research UK and NCI collaborate to boost research against the ‘undruggable’ RAS

On April 19, 2017 Cancer Research UK and the Cancer Research Technology Pioneer Fund (CPF)* reported that they have committed £2.5 million in collaboration with the National Cancer Institute (NCI) in the US to tackle one of the toughest challenges in cancer that has thwarted researchers for more than 30 years (Press release, Cancer Research Technology, 19 19, 2017, View Source [SID1234523166]).

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!

Scientists will develop and test promising new molecules for targeting RAS, one of the most common driving mutations in aggressive, hard to treat cancers including pancreatic and lung cancer.

Scientists at the NCI in Frederick, Maryland, USA will work with the Drug Discovery Unit at the Cancer Research UK Beatson Institute** in Glasgow, Scotland to develop gold standard tests to analyse these novel RAS inhibitors.

This new collaboration links up with the NCI’s RAS Initiative*** which brings scientists together from around the globe to help develop drugs targeting the faulty protein. Launched in 2013, the initiative has established a hub of expertise that supports the international community in developments that could have huge clinical benefit.

The CRT Pioneer Fund, managed by Sixth Element Capital, will be responsible for the commercial exploitation of compounds that arise from the collaboration.

For decades, scientists have been attempting to target RAS,**** but with little success. This is because RAS lacks an obvious site on its surface for potential drug molecules to fit into and inhibit its signalling.

Dr Martin Drysdale, head of the Drug Discovery Unit at the Cancer Research UK Beatson Institute, said: "Our team is determined to challenge the dogma that RAS is ‘undruggable.’ This collaboration is our biggest yet and will double our resource targeting RAS. We are excited to be joining forces with the NCI in their pioneering RAS Initiative."

"Instead of scientists working and thinking in isolation, the NCI has created a research hub to pull together all the best science and expertise. My team is looking forward to contributing and working with Dr Frank McCormick, who leads the RAS Initiative and who has been at the forefront of cancer science for many years."

Dr Frank McCormick, who directs the research efforts of the RAS Initiative at the Frederick National Laboratory for Cancer Research, sponsored by the NCI, said: "We’re making progress in our understanding of how RAS proteins function at the molecular level and how they form signalling complexes in membranes. New technologies and tools mean we can now analyse these proteins in ways that were not possible a few years ago, and can now test new ways of blocking RAS function."

Dr Iain Foulkes, chief executive officer of Cancer Research Technology and executive director of research and innovation at Cancer Research UK, said: "It’s crucial that we unite the brightest minds across the globe. This international collaboration and investment could herald a new era in targeting RAS.

"We hope to develop these small molecules to pave the way for potential drugs in the future. Our aim is to work alongside industry to ensure any progress makes its way into clinical trials."

Dr Robert James, Managing Partner at Sixth Element Capital, said: "The CRT Pioneer Fund was established to invest in outstanding science that has the potential to benefit patients on a global scale. We are delighted to have catalysed this relationship which has created an opportunity to make real progress in discovering drugs against RAS, one of the most important oncogenes in cancer."

VLP Therapeutics Receives Notice of Allowance of Key U.S. composition of matter Patent for immune checkpoint PD-1/PD-L1/PD-L2 inserted alphavirus VLP

On April 19, 2017 VLP Therapeutics, LLC. ("VLP"), a biotechnology company focusing on the research and development of therapeutic and preventative vaccines and antibody agents, reported that it successfully received a notice of allowance from the U.S. Patent and Trademark Office for the composition of matter patent to cover immune checkpoint PD-1/PD-L1/PD-L2 inserted alphavirus VLP (Press release, VLP Therapeutics, APR 19, 2017, View Source [SID1234519826]). The patent will be issued on May 2nd. The patent protects key composition of matter of VLP’s proprietary i-α virus like particles platform technology, and the pharmaceutical composition and vaccine for use in the treatment of cancer. Utilizing the platform technology covered by this patent and other patent estates, VLP is currently focused on developing preventative and therapeutic cancer vaccines as well as next generation of targeted antibody agents.

"We are delighted to have achieved this milestone which provides strong protection for our immune checkpoint PD-1/PD-L1/PD-L2 inserted alphavirus VLP based on our platform technology. We strongly believe that this technology represents next generation cancer therapies that use the body’s own immune system to fight cancer with less side effects than current therapies." said Chief Executive Officer, Dr. Wataru Akahata. "Our candidate products have already been shown to be very effective in multiple cancer types in animals, which confirms my belief that this technology has the potential to treat a number of different cancers with high unmet medical needs. More people can benefit from our new cancer vaccine. This patent is another important element in our intellectual property strategy that we believe will allow us to fully exploit the fundamental value of the ongoing research and development. With this patent, as well as additional patents we are actively prosecuting, we are set to move forward with our R&D programs rapidly," he continued.

About i-α VLP Technology

The immune system is biologically designed to protect us against disease. The human immune system detects foreign objects such as viruses, bacteria or abnormal self-tissues (like cancer cells) in the body, and not only tries to eliminate these entities but also "memorizes" them so it can protect the body from these objects in the future. Vaccines utilize the immune system to protect us from various diseases.
Traditional vaccines are made using live viruses, which, though rare, can cause serious safety issues. Unlike traditional vaccines, VLP’s novel, proprietary platform technology was created by utilizing virus like particles. Virus like particles are identical to the authentic native viruses in their shapes, but do not carry the genetic material of native viruses. Without genetic material, these particles cannot replicate themselves. This means that when virus like particles are presented within our bodies, our immune system will recognize the particles as foreign objects, triggering effective immune responses, but will not cause side effects associated with the native virus due to the absence of genetic material.
Utilizing these virus like particles, VLP Therapeutics developed a proprietary, plug-and-play platform called inserted alphavirus virus-like particle (i-αVLP) using the Chikungunya virus (CHIKV) VLP. Through this adaptable platform, foreign antigens can be inserted into two specific sites of the envelope protein on the surface of i-αVLP. With 240 copies of envelope protein per CHIKV VLP, each i-αVLP can display a tremendous 480 copies of an inserted antigen. This highly symmetrical, icosahedral dense array of antigens has been shown to induce very strong immune responses, resulting in its superior efficacy. Additionally, unlike traditional vaccines, virus like particles themselves are non-replicative, as described above, because they do not carry any genetic material, and therefore are safe, having been used to make the FDA-approved vaccines for Hepatitis B virus and human papillomavirus. VLP Therapeutics has established a method to efficiently produce i-αVLPs which can be scaled for commercial production.

About VLP Therapeutics

VLP Therapeutics, LLC (VLP) was established in 2012 by seasoned biopharmaceutical veterans with the mission to develop innovative medical treatments which can transform traditional vaccines and targeted antibody therapies to address global unmet medical needs. Its vision is to combat 21st century global public health problems through its revolutionary next generation i-αVLP technology platform. VLP is currently developing preventative and therapeutic vaccines as well as next generation targeted antibody agents to treat cancer, infectious diseases, such as Malaria, Dengue Fever and Zika virus-based diseases, autoimmune and neurological diseases.

AbbVie Announces Topline Results from Two Phase 3 Studies Investigating Veliparib in Combination with Chemotherapy for the Treatment of Patients with Advanced or Metastatic Squamous Non-Small Cell Lung Cancer and Early-Stage Triple-Negative Breast Cancer

On April 19, 2017 AbbVie, a global biopharmaceutical company, reported that two Phase 3 studies evaluating veliparib, an investigational, oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor did not meet their primary endpoints (Press release, AbbVie, APR 19, 2017, View Source [SID1234518630]). The studies evaluated veliparib in combination with the chemotherapy regimen carboplatin and paclitaxel in patients with squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC). Full results will be presented at upcoming medical meetings or published in a peer-reviewed journal.

"Research shows there is a role for PARP inhibitors in cancers associated with DNA repair deficits, such as those with BRCA mutations. In these clinical trials, we wanted to explore whether a PARP inhibitor could augment chemotherapy in patients with squamous non-small cell lung cancer and triple negative breast cancer by disrupting the repair of cancer cells," said Gary Gordon, M.D., Ph.D., vice president, oncology clinical development, AbbVie. "Unfortunately, these data do not support the use of veliparib in combination with chemotherapy in these patients."

AbbVie has a robust pipeline in hematologic oncology and in solid tumors with more than 200 clinical trials in over 20 different tumor types. AbbVie’s oncology portfolio consists of three medicines currently approved for use in multiple markets, three investigational treatments in late-stage clinical development and more than 20 programs in Phase 1 and pre-clinical development.

"We have a comprehensive and innovative oncology pipeline that will help bring to market meaningful therapies for hematologic malignancies and solid tumors, especially where there continues to be a significant unmet need," said Michael Severino, M.D., executive vice president, research and development, and chief scientific officer, AbbVie.

About the Phase 3 NSCLC Study
The randomized, double-blind, multicenter, Phase 3 clinical trial was designed to evaluate the efficacy and safety of veliparib combined with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in patients with previously untreated metastatic or advanced squamous non-small cell lung cancer. Patients were evaluated based on their smoking status. The intent-to-treat population of 970 patients was stratified by smoking history: those who had smoked within the past 12 months and had more than 100 smoking events in their lifetime; those who had more than 100 smoking events in their lifetime with at least 12 months since the last event; and those who had 100 or fewer smoking events in their lifetime. The primary endpoint was improvement in overall survival in the group of patients who had smoked within the past 12 months and had more than 100 smoking events in their lifetime. Secondary endpoints included improvement in overall survival in the intent-to-treat population, as well as progression-free survival and overall response in the primary endpoint subgroup and in the intent-to-treat population.

About the Phase 3 TNBC Study
The randomized, double-blind, multicenter, Phase 3 study of 312 patients was designed to evaluate the efficacy and safety of the addition of veliparib to carboplatin and standard neoadjuvant chemotherapy (paclitaxel) for the treatment of patients with early-stage triple-negative breast cancer. Patients were randomized to three arms, and treated with either a regimen of veliparib combined with carboplatin and paclitaxel, placebo combined with carboplatin and paclitaxel, or placebo combined only with paclitaxel, all followed by doxorubicin plus cyclophosphamide. The primary endpoint was complete pathologic response. Secondary endpoints included breast conservation rate, overall survival and event-free survival.

About Veliparib
Veliparib is an investigational oral PARP inhibitor being evaluated in multiple tumor types. PARP is a naturally-occurring enzyme in the body involved in the repair of DNA damage. Discovered by AbbVie researchers, veliparib is being investigated in combination with chemotherapy. Ongoing Phase 3 studies include non-squamous non-small cell lung cancer, BRCA1/2 breast cancer and ovarian cancer. Veliparib is an investigational compound, and its efficacy and safety have not been established by the U.S. Food and Drug Administration (FDA) or any other health authority.

LION BIOTECHNOLOGIES ANNOUNCES STRATEGIC ALLIANCE WITH MD ANDERSON CANCER CENTER TO CONDUCT CLINICAL TRIALS OF TILS IN MULTIPLE SOLID TUMORS

On April 19, 2017 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology and The University of Texas MD Anderson Cancer Center, reported a multi-year strategic alliance agreement involving multi-arm clinical trials to evaluate the safety and efficacy of TIL therapy in ovarian cancer, various sarcomas, and pancreatic cancer (Press release, Lion Biotechnologies, APR 19, 2017, View Source [SID1234518624]). In addition, preclinical research will explore the expansion of TIL in other rare tumor types.

In the clinical trials, TIL therapy will be evaluated in multiple solid tumor cancers using two different TIL manufacturing processes. The trials will be designed by the Lion and MD Anderson joint steering committee and conducted at MD Anderson. A related preclinical research collaboration will focus on the expansion of TIL from additional tumor types to identify new indications for future clinical research. Lion and MD Anderson will both have manufacturing responsibilities for production of TILs used in the planned cellular therapy trials.

"We are excited to form this strategic alliance with MD Anderson. Together, we expect to generate data that will support the pursuit of additional pipeline indications to complement our ongoing Lion-sponsored TIL clinical programs in metastatic melanoma, head and neck and cervical cancers," said Maria Fardis, PhD, MBA, Lion Biotechnologies’ President and Chief Executive Officer. "This collaboration leverages Lion’s strong expertise in TIL therapy and our expanding TIL manufacturing capacity, with MD Anderson’s deep experience in developing novel methods for generating TIL and innovative clinical care in treating oncology patients with unmet needs."

"This TIL-based technology is yet another tool in MD Anderson’s ongoing efforts to provide new therapies for our patients," said Amir Jazaeri, M.D., associate professor of Gyn/Onc and Reproductive Medicine at MD Anderson. "It is our hope that this area of study will further treatment options for multiple types of cancer."

Bavarian Nordic Announces Initiation of Phase 2 Combination Trial of PROSTVAC, Ipilimumab and Nivolumab in Patients with Localized Prostate Cancer

On April 19, 2017 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported the initiation of a Phase 2 clinical trial of its prostate cancer immunotherapy candidate, PROSTVAC (rilimogene), in combination treatment with YERVOY (ipilimumab) and/or OPDIVO (nivolumab), both of which are immune checkpoint inhibitors from Bristol-Myers Squibb, as neoadjuvant therapy in patients with localized prostate cancer (Press release, Bavarian Nordic, APR 19, 2017, View Source [SID1234518623]).

A lead-in stage will evaluate the safety of the combination of all three drugs in 10 patients with castration-resistant prostate cancer, followed by enrollment of up to 55 patients with localized prostate cancer in three cohorts, who will receive PROSTVAC in combination with either ipilimumab or nivolumab, or a combination of all three drugs prior to undergoing radical prostatectomy. The primary endpoint of the study is to evaluate and compare changes in T cell infiltration in the tumor after neoadjuvant treatment across the three different cohorts. The principal investigator of the study is James L. Gulley, MD, Senior Investigator, Center for Cancer Research, part of the National Cancer Institute (NCI), and the sponsor of the study. Detailed information on the trial can be found at View Source

"There are now eleven ongoing studies of PROSTVAC across various stages of prostate cancer. In recent years, there has been a growing interest in the evaluation of the immunotherapy candidate in earlier disease stages, where the cancer has not yet spread beyond the prostate. We are excited to learn more about the potential of PROSTVAC for treating this population, and to evaluate the potential synergistic effects of combining the vaccine with checkpoint inhibitors, as we believe PROSTVAC may enhance the clinical activity of these drugs," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

This is the second trial conducted in collaboration with Bristol-Myers Squibb. The first trial was initiated in October 2016, and is investigating the combination treatment of PROSTVAC and ipilimumab at the University of California, San Francisco (UCSF), also in a neoadjuvant setting.

For patients interested in enrolling in this clinical trial, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or see the website: View Source and search for NCT02933255.

About PROSTVAC
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec or "rilimogene") is a prostate specific antigen (PSA)-targeted immunotherapy candidate designed to enhance or stimulate the body’s immune response, specifically T cells that will target and kill prostate cancer cells, altering the course of the disease and improving overall survival (OS) of patients with prostate cancer. A robust data package has been established that includes 19 ongoing or completed clinical studies, comprising more than 2,000 patients of which more than 1,100 patients have been actively treated with PROSTVAC, which has been generally well-tolerated. A pivotal Phase 3 clinical trial in 1,297 patients, designed to determine if PROSTVAC extends the overall survival for patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) has completed enrollment and top-line data are anticipated in 2017.

The combination of PROSTVAC and ipilimumab was previously investigated in an NCI-sponsored Phase 1 trial in mCRPC patients, indicating improved survival for the treatment regimen when compared to the predicted survival (J Clin Oncol 33, 2015 (suppl 7; abstr 172)). This improved effect is believed to be due to PROSTVAC’s ability to stimulate an anti-prostate cancer immune response combined with the ability of checkpoint inhibitors to make the anti-cancer immune response more effective.

PROSTVAC is being developed in collaboration with the Center for Cancer Research, part of the intramural research program of the National Cancer Institute under a Cooperative Research and Development Agreement.

More information available at /pipeline/prostvac.aspx.

About ipilimumab and nivolumab
Ipilimumab and nivolumab are immune checkpoint inhibitors developed and marketed by Bristol-Myers Squibb. Ipilimumab is a CTLA-4 antibody, which is approved by the FDA for the treatment of melanoma. Nivolumab is a PD-1 antibody, which is approved for the treatment of patients with NSCLC in the second line setting, among other indications. These immune checkpoint inhibitors work by targeting molecules that serve as checks and balances in the regulation of immune responses. By blocking inhibitory molecules or, alternatively, activating stimulatory molecules, these treatments are designed to unleash and/or enhance pre-existing anti-cancer immune responses.