1stOncology™: Cancer Intelligence Service – Page 18196 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Cancer Research UK, Cancer Research Technology And Asterias Biotherapeutics Partner To Trial Immunotherapy Vaccine For Lung Cancer

On September 11, 2014 CANCER RESEARCH UK and Cancer Research Technology (CRT), the charity’s development and commercialisation arm, have reached an agreement with Asterias Biotherapeutics, Inc. (OTCBB: ASTY), a biotechnology company in the emerging field of regenerative medicine, to take forward Asterias’ novel immunotherapy treatment AST-VAC2 into clinical trials in subjects with non-small cell lung cancer (Press release BioTime, SEP 11, 2014, View Source;p=RssLanding&cat=news&id=1966042 [SID:1234500740]).

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!

AST-VAC2 represents the tenth treatment to enter Cancer Research UK’s Clinical Development Partnerships* (CDP) scheme, with six having progressed into the clinic to date. CDP is a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and Cancer Research Technology, to develop promising anti-cancer agents which pharmaceutical companies do not have the resources to progress through early phase clinical trials.

AST-VAC2 is a non-patient specific (allogeneic) cancer vaccine designed to stimulate patients’ immune systems to attack telomerase, a protein that is expressed in over 95 percent of cancers but is rarely expressed in normal adult cells.

The vaccine was developed following successful early phase clinical trials of a similar, patient specific (autologous) Asterias vaccine, called AST-VAC1, which was derived from patients’ blood cells and tested in prostate cancer and acute myeloid leukemia.

Unlike AST-VAC1, and other autologous (patient specific) vaccines that are developed from a patient’s own cells, AST-VAC2 is derived from human embryonic stem cells (hESCs), meaning it can be produced on a large scale and stored ready for use, rather than having to produce a specific version of the drug for each patient.

The trial of AST-VAC2 will evaluate the safety and toxicity of the vaccine, feasibility, stimulation of patient immune responses to telomerase and AST-VAC2, and clinical outcome after AST-VAC2 administration in patients with resected early-stage lung cancer and in patients with advanced forms of the disease.

Pedro Lichtinger, Asterias’ chief executive officer, said: "The Asterias collaboration with Cancer Research UK’s Drug Development Office and CRT represents a major step in advancing our proprietary dendritic cell platform for the potential benefit of patients.

"AST-VAC2 is based on a specific mode of action that is complementary and potentially synergistic to other immune therapies. We are delighted to partner with Cancer Research UK to advance this important platform through Phase 1/2 clinical trials. Cancer Research UK’s Drug Development Office has the global recognition of having the quality, capability and track record of successfully advancing development programs. We are excited about the possibility of favorably impacting the lives of patients across multiple cancers and are proud to be working with Cancer Research UK."

Under the agreement, Asterias will complete development of the manufacturing process for AST-VAC2. Cancer Research UK will then produce the vaccine and conduct the phase 1/2 clinical trial in the UK. On completion of the clinical trial, Asterias will have an exclusive first option to acquire a license to the data from the trial on pre-agreed terms including an upfront payment, milestones and royalties on sales of products. If Asterias declines this option, CRT will then have an option to obtain a license to Asterias’ intellectual property to continue the development and commercialisation of AST-VAC2 and related products in exchange for a revenue share to Asterias of development and partnering proceeds.

Dr. Jane Lebkowski, president of research and development at Asterias, said: "The use of human embryonic stem cells to derive allogeneic dendritic cells for cancer immunotherapy has the potential to dramatically improve the scalability, consistency, and feasibility of cellular cancer vaccines. We believe this collaboration will enable the acceleration of clinical studies of AST-VAC2 and the collection of important proof-of-concept data for the entire human embryonic stem cell-derived dendritic cell immunotherapy platform."

Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: "Recent advances in cancer immunotherapy have demonstrated the exciting potential of these treatments to improve outcomes in devastating diseases such as lung cancer. Better treatment options for lung cancer are badly needed and it is through collaborations such as this that we can save more lives sooner."

Cancer Research UK, Cancer Research Technology and Asterias Biotherapeutics partner to trial immunotherapy vaccine for lung cancer

On September 11, 2014 Cancer Research UK and Cancer Research Technology (CRT), the charity’s development and commercialisation arm, reported an agreement with Asterias Biotherapeutics, Inc. (OTCBB: ASTY), a biotechnology company in the emerging field of regenerative medicine and a subsidiary of BioTime, Inc. (NYSE MKT: BTX), to take forward their novel immunotherapy treatment AST-VAC2 into clinical trials with non small cell lung cancer patients (Press release, Cancer Research Technology, SEP 11, 2014, View Source [SID1234523224]).

This is the tenth treatment to enter Cancer Research UK’s Clinical Development Partnerships* (CDP) scheme, with six having progressed into the clinic to date. CDP is a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and Cancer Research Technology, to develop promising anti-cancer agents which pharmaceutical companies do not have the resources to progress through early phase clinical trials.

The vaccine was developed following successful early phase trials of a similar Asterias drug, called AST-VAC1, which was designed to treat acute myeloid leukemia and derived from patients’ blood cells.

The trial of AST-VAC2 will evaluate the safety and toxicity of the vaccine, feasibility, stimulation of patient immune responses to telomerase and AST-VAC2, and clinical outcome after AST-VAC2 administration in patients with either resected early-stage, or advanced forms of lung cancer.

Pedro Lichtinger, Asterias’ chief executive officer, said: "The Asterias collaboration with Cancer Research UK’s Drug Development Office represents a major step in advancing our proprietary dendritic cell platform for the potential benefit of patients.

"AST-VAC2 is at the forefront of cell-based immune therapies. It is based on a unique mode of action that is complementary and potentially synergistic to other immune therapies. We are delighted to partner with Cancer Research UK to advance this important platform through Phase 1/2 clinical trials. Cancer Research UK’s Drug Development Office has the global recognition of having the quality, capability and track record of successfully advancing development programs. We are excited about the possibility of favorably impacting the lives of patients across multiple cancers and are proud to be working with Cancer Research UK."

Under the agreement, Asterias will complete development of the manufacturing process for AST-VAC2. Cancer Research UK will then produce the vaccine and conduct the phase 1/2 clinical trial. On completion of the clinical trial, Asterias will have an exclusive first option to acquire the data from the trial. If Asterias declines this, CRT will then have an option to obtain a license to Asterias’ intellectual property to continue the development and commercialisation of AST-VAC2 and related products in exchange for a revenue share to Asterias of development and partnering proceeds.

Dr Jane Lebkowski, president of R&D at Asterias, said: "The use of human embryonic stem cells to derive allogeneic dendritic cells for cancer immunotherapy has the potential to dramatically improve the scalability, consistency, and feasibility of cellular cancer vaccines. We believe this collaboration will enable the acceleration of clinical studies of AST-VAC2 and the collection of important proof-of-concept data for the entire hESC-DC immunotherapy platform."

Eleison Announces Completion of Enrollment in Stage 1 of its Phase II Trial of ILC (Inhaled Lipid-complexed Cisplatin) for Pediatric Bone Cancer

On October 9, 2014 Eleison Pharmaceuticals LLC, a specialty pharmaceutical company developing life-saving therapeutics for rare cancers, reported that it has completed enrollment in the first stage of its ongoing Phase II study of ILC (Inhaled Lipid-complexed Cisplatin), for the treatment of patients with pediatric osteosarcoma (bone cancer) (Press release, Eleison Pharmaceuticals, SEP 10, 2014, View Source [SID1234517399]). The single-arm trial employs a Simon two-stage design and is evaluating the safety and efficacy of ILC. The Company has commenced enrollment in the second stage of the ongoing study and is enrolling patients at 15 of the leading U.S. hospitals and medical centers.

MabVax Therapeutics Enters Agreements with Memorial Sloan Kettering Cancer Center and Juno Therapeutics for Development of Anti-Cancer Therapeutics

On September 10, 2014 MabVax Therapeutics reported it has entered into agreements with Memorial Sloan Kettering Cancer Center (MSK) and Juno Therapeutics (Juno) for the development of novel therapeutic products using antibody targeting sequences derived from the fully-human antibodies discovered using the Company’s internally developed antibody discovery platform (Press release MabVax, SEP 10, 2014, View Source [SID:1234500743]).

Under the agreements, MabVax will supply unique targeting sequences from the fully-human antibodies to MSK. Pursuant to the agreement with MSK, researchers at MSK will conduct the early stage research and development of Chimeric Antigen Receptor (CAR) T-cell therapeutics using the MabVax antibody sequences and then test them both in vitro and in animal models with the objective of producing anti-cancer therapeutics targeting certain solid tumors.

MabVax and Juno entered into an exclusive option agreement giving Juno the right to negotiate a license agreement for exclusive rights to any CAR T-cell therapeutic products using the antibody sequences provided to MSKCC.

J. David Hansen, Chief Executive Officer of MabVax, said, "We are excited that this research opportunity has come together. We think that the human targeting sequences derived from our antibody program and incorporated into the very unique and promising CAR T-cell technology developed at MSKCC holds real promise for patients suffering from certain solid tumor cancers. We are very pleased to be able to be involved with Juno, a leader in this new and important therapeutic area."

MabVax’s antibody discovery effort has resulted in a pipeline of fully human antibodies to eleven separate cancer targets consistently overexpressed on solid tumor cancers. The lead antibody 5B1 has been the subject of multiple recent press releases, including the announcement of the receipt of a $1.5 million National Institutes of Health contract to develop a radiolabeled version of the antibody as a novel PET imaging agent for pancreatic cancer.

U.S. FDA Approves New Indication for the Use of XTANDI(R) (Enzalutamide) Capsules for Patients With Metastatic Castration-Resistant Prostate Cancer

On September 10, 2014 Medivation and Astellas Pharma reported that the U.S. Food and Drug Administration (FDA) approved a new indication for the use of XTANDI (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC) (Press release Medivation, SEP 10, 2014, View Source [SID:1234500737]). This new approved use follows a priority review of the supplemental New Drug Application (sNDA) that was based on results of the Phase 3 PREVAIL trial.

The FDA initially approved XTANDI, an oral, once-daily androgen receptor inhibitor, in August 2012 for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy). The new indication approves XTANDI for use in men with metastatic CRPC who have not received chemotherapy. Metastatic CRPC is defined as a cancer that has spread beyond the prostate gland and has progressed despite treatment to lower testosterone (i.e., with a gonadotropin-releasing hormone (GnRH) therapy or with removal of the testes).

“The FDA’s priority review and approval of this new indication for XTANDI now enables the use of an important therapy by patients with metastatic castration-resistant prostate cancer at all stages of their disease,” said Sef Kurstjens, M.D., Ph.D., chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc. “We are pleased that these patients now have XTANDI available as a treatment option.”

“All of us at Medivation extend our thanks to the clinicians and patients who participated in the PREVAIL clinical trial culminating in today’s approval,” said David Hung, M.D., founder, president and chief executive officer, Medivation, Inc. “As a company dedicated to the rapid development of novel therapies to treat serious diseases, we are pleased to see XTANDI approved in this important patient population.”

In the Phase 3 PREVAIL trial, men receiving XTANDI and GnRH therapy exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo and GnRH therapy.

XTANDI significantly reduced the risk of radiographic progression or death by 83% compared with placebo (HR=0.17; p < 0.0001). XTANDI significantly reduced the risk of death by 29% compared with placebo (HR=0.71; p < 0.0001). When compared to placebo, treatment with XTANDI also delayed time to initiation of chemotherapy and time to a skeletal related event. The safety profile for XTANDI was updated to reflect data from both the AFFIRM and PREVAIL Phase 3 trials. Seizure occurred in 0.9% of patients receiving XTANDI who previously received docetaxel and 0.1% of patients who were chemotherapy-naive. The most common adverse reactions ( ≥ 10%) that occurred more commonly ( ≥ 2% over placebo) in the XTANDI-treated patients from the two randomized clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. "Enzalutamide has been studied and is approved for patients with metastatic prostate cancer that is resistant to primary hormonal therapy, a disease state we call castration-resistant prostate cancer. In this setting, enzalutamide has been shown to extend overall survival and significantly delay the progression of prostate cancer," said Tomasz M. Beer, M.D., F.A.C.P., co-principal investigator of the PREVAIL study, deputy director of the Knight Cancer Institute and professor of medicine at Oregon Health & Science University. "Furthermore, in the PREVAIL trial, the median time to initiating chemotherapy was delayed by 17 months with enzalutamide treatment as compared to placebo, so the result is a meaningful period of time during which men have their disease controlled without the need for chemotherapy." A variation application to amend the European Marketing Authorization Application based on the results of PREVAIL was validated for review by the European Medicines Agency on April 24, 2014. The approval of this new indication for XTANDI triggers $90 million in milestone payments to Medivation under its collaboration agreement with Astellas.