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Lilly Announces CYRAMZA™ Phase III Second-Line Colorectal Cancer Trial Meets Primary Endpoint of Overall Survival

On September 12, 2014 Eli Lilly reported that the RAISE trial, a Phase III study of ramucirumab (CYRAMZA) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival (Press release Eli Lilly, SEP 12, 2014, View Source [SID:1234500738]). The global, randomized, double-blind study compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin and a fluoropyrimidine in the first-line setting.

RAISE showed a statistically significant improvement in overall survival in patients treated with ramucirumab plus FOLFIRI compared to placebo plus FOLFIRI. The study also showed a statistically significant improvement in progression-free survival in the ramucirumab-plus-FOLFIRI arm compared to the placebo-plus-FOLFIRI arm. The most common ( > 5% incidence) grade > /=3 adverse events occurring at a higher rate on the ramucirumab-plus-FOLFIRI arm compared to the control arm were neutropenia, fatigue, hypertension, and diarrhea.

Despite advances in treating colorectal cancer in recent years, the mortality rate remains significant. It is the fourth leading cause of cancer death worldwide and the second leading cause of cancer death in the U.S.

“Patients with metastatic colorectal cancer – particularly those in the second-line setting – continue to need new treatment options that improve survival,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. “We are pleased that the RAISE study demonstrated a survival benefit and are hopeful that ramucirumab will become a new anti-angiogenic treatment option after first-line bevacizumab-containing therapy for metastatic colorectal cancer patients.”

Lilly plans to present data from the RAISE trial at a scientific meeting in 2015 and expects to initiate regulatory submissions in the first half of 2015.

Dr. Gaynor added, “We now have four Phase III ramucirumab trials that improved survival in three of the world’s most common and deadly cancers–gastric, lung, and colorectal–supporting global regulatory submissions in multiple indications. The RAISE data also build on Lilly’s growing presence in gastrointestinal cancer therapy.”

Ramucirumab is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds VEGF Receptor 2 and blocks binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. VEGF Receptor 2 is an important mediator in the VEGF pathway.i,ii In an in vivo animal model, ramucirumab inhibited angiogenesis. Angiogenesis is a process by which new blood vessels form to supply blood to normal healthy tissues as well as tumors, enabling the cancer to grow.

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]).

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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.