On October 4, 2016 Five Prime Therapeutics, Inc. (Nasdaq:FPRX) a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it has initiated the Phase 1b portion of the clinical trial evaluating the immunotherapy combination of cabiralizumab (FPA008), Five Prime’s investigational monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R), with OPDIVO (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, in multiple tumor types (Press release, Five Prime Therapeutics, OCT 4, 2016, View Source [SID:SID1234515585]). Schedule your 30 min Free 1stOncology Demo! "We are very pleased to progress to the Phase 1b portion of this trial evaluating cabiralizumab in combination with nivolumab as a treatment for patients with multiple types of tumors, many of whom currently have no effective treatment options," said Robert Sikorski, M.D., Ph.D., Chief Medical Officer, at Five Prime. "Our goal is to develop new therapeutics that unleash the immune system’s natural anti-cancer activity. Based on the science, we believe that targeting both the CSF1R and PD-1 pathways has the potential to produce a synergistic treatment effect."
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Five Prime initiated the Phase 1a/1b trial, which is expected to enroll approximately 280 patients, in September 2015. During Phase 1a, Five Prime evaluated the safety, pharmacokinetics and biomarkers of escalating doses of cabiralizumab as a monotherapy, as well as in combination with the approved 3 mg/kg dose of nivolumab.
Five Prime will continue to run the Phase 1b portion of the trial and will evaluate the safety, tolerability and preliminary efficacy of the selected dose of cabiralizumab in combination with nivolumab for the treatment of advanced solid tumors, including but not limited to non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer.
About Cabiralizumab (FPA008)
Cabiralizumab is an investigational antibody that inhibits the CSF-1 receptor and has been shown in preclinical models to block the activation and survival of monocytes and macrophages. Inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment, thereby facilitating an immune response against tumors. Cabiralizumab is currently in a Phase 2 clinical trial in pigmented villonodular synovitis (PVNS) and a Phase 1 clinical trial in oncology indications. Cabiralizumab is being developed under an exclusive worldwide license and collaboration agreement entered into with BMS in October 2015.
Month: October 2016
EXCLUSIVE LICENSING AGREEMENT FOR IN-HOUSE DEVELOPED MONOCLONAL ANTIBODY FARLETUZUMAB IN LATIN AMERICA CONCLUDED WITH EUROFARMA LABORATÓRIOS S.A.
On October 4, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that its research subsidiary Morphotek, Inc. (Headquarters: Pennsylvania, United States, President and CEO: Nicholas Nicolaides, "Morphotek") has signed an exclusive licensing agreement with Eurofarma Laboratórios S.A. (Headquarters: São Paulo, Brazil, President: Maurizio Billi, "Eurofarma") to develop and commercialize the monoclonal antibody farletuzumab (development code: MORAb-003) as a potential anticancer agent in Latin America (Press release, Eisai, OCT 4, 2016, View Source [SID:SID1234515584]). Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, Morphotek will receive from Eurofarma an upfront payment as well as scheduled development and sales milestone payments. Additionally, Morphotek will receive royalties from commercial sales of farletuzumab in Latin America. Morphotek will supply Eurofarma with clinical and commercial materials while Eurofarma has the option to assume responsibility for filling and packaging farletuzumab vials. Morphotek retains all rights to develop and commercialize farletuzumab in regions outside of Latin America.
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Discovered by Morphotek, farletuzumab is an investigational, humanized, monoclonal antibody that binds to folate receptor alpha (FRA), which is reported to be highly expressed on ovarian and several other epithelial cancer cells, but mostly absent from normal tissue. Farletuzumab is currently being studied in a randomized, placebo-controlled, double-blind Phase II clinical study in first-relapsed, platinum-sensitive ovarian cancer patients with low levels of the CA-125 tumor antigen, a biomarker for ovarian cancer. The study is designed to investigate the efficacy and safety of farletuzumab in combination with standard chemotherapy.
Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Through this collaboration, Eisai hopes to accelerate development and maximize the value of farletuzumab as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.
US FDA grants Breakthrough Therapy Designation for Roche’s Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC
On October 4, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has received a second Breakthrough Therapy Designation (BTD) from the United States Food and Drug Administration (FDA) for its ALK inhibitor, Alecensa (alectinib) (Press release, Hoffmann-La Roche , OCT 4, 2016, View Source [SID:SID1234515583]). The latest BTD was granted for the treatment of adult patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.
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"The J-ALEX study that supports the second Breakthrough Designation for Alecensa showed superior efficacy versus the standard of care, crizotinib, in Japanese people with advanced ALK-positive disease," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "The decision by the FDA to grant a second breakthrough therapy designation is recognition of the clinically meaningful improvement in efficacy and safety that Alecensa brings to the care of people with advanced ALK-positive lung cancer who have not received prior treatment with an ALK inhibitor."
This second breakthrough therapy designation is based on the results of the open-label, randomised phase III J-ALEX study, which were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting in June. J-ALEX compared the efficacy and safety of Alecensa with crizotinib in 207 Japanese people with ALK-positive, advanced or recurrent NSCLC who either had not been treated with chemotherapy or had received one prior line of chemotherapy. Results from the study demonstrated that Alecensa reduced the risk of disease worsening or death (progression-free survival, PFS) by 66% compared to crizotinib, whilst maintaining a favourable tolerability and safety profile consistent with that observed in previous studies.
The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. Alecensa received its first FDA BTD in June 2013 for people with ALK-positive NSCLC whose disease progressed on treatment with crizotinib.
Alecensa is currently available in the US and Israel to ALK-positive metastatic NSCLC patients who have progressed on or are intolerant to crizotinib, and in Japan to ALK-positive unresectable, recurrent or advanced NSCLC patients. In addition, an ongoing global, randomised phase III trial called ALEX is comparing Alecensa to Xalkori as an initial (first-line) treatment for people with advanced ALK-positive NSCLC.
About J-ALEX
The J-ALEX study conducted by Chugai is an open-label, randomised Phase III study that compared the efficacy and safety of Alecensa to crizotinib in Japanese people. The J-ALEX study enrolled 207 people with ALK-positive, advanced or recurrent NSCLC who had not been previously treated with an ALK inhibitor. People were randomised to the Alecensa group or the crizotinib group in a one-to-one ratio. Results include:
Alecensa reduced the risk of disease worsening or death (PFS) by 66 percent compared to crizotinib (HR=0.34, 99 percent CI: 0.17-0.70, p<0.0001).
Median PFS was not reached in the Alecensa arm (95 percent CI: 20.3 months-not estimated) versus 10.2 months in the crizotinib arm (95 percent CI: 8.2-12.0).
Grade 3-4 adverse events (AE) occurred with lesser frequency in the Alecensa arm compared to the crizotinib arm (27 percent vs. 51 percent).
The most common AE occurring with > 30 percent frequency with Alecensa was constipation (36 percent). The most common AEs for crizotinib were nausea (74 percent), diarrhoea (73 percent), vomiting (59 percent), visual disturbance (55 percent), alteration in taste (dysgeusia, 52 percent), constipation (46 percent), and an elevation in liver enzymes called alanine transaminase (ALT, 32 percent) and aspartate transaminase (AST, 31 percent).
About Alecensa
Alecensa (RG7853/AF-802/CH5424802) is an oral medicine created at Chugai Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history. It is almost always found in people with a specific type of NSCLC called adenocarcinoma. Alecensa is currently approved in the United States for the treatment of people with advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib.
In two key phase II studies, NP28761 and NP28673, Alecensa shrank tumours in up to 44% of people with ALK-positive NSCLC who progressed on crizotinib. Alecensa also demonstrated activity in brain metastases, indicating that the drug may be taken up in the brain. The brain is protected by the Blood-Brain
Barrier, a network of tightly joined cells that line the inside of the blood vessels in the brain and spinal cord.
One of the ways the Blood-Brain Barrier prevents molecules from affecting the brain is to actively eject them from the barrier through a process known as ‘active efflux’. The active efflux system does not recognise
Alecensa, which means that it may travel into and throughout brain tissue.
The global phase III studies of Alecensa include a companion test developed by Roche Diagnostics. Alecensa is marketed in Japan by Chugai Pharmaceutical, a member of the Roche Group.
About ALK-positive non-small cell lung cancer
Lung cancer is the biggest cancer killer, causing 1.59 million deaths globally each year. NSCLC is the most common type of lung cancer, and is the leading cause of cancer-related deaths in Europe and across the world, accounting for approximately 85% of lung cancer cases. ALK-positive NSCLC occurs in approximately 5% of patients with advanced NSCLC, translating to about 75,000 patients being diagnosed with the disease annually. It is almost always found in people with a specific type of NSCLC called adenocarcinoma, and is more common in light or non-smokers.
Evotec and Carrick Therapeutics build strategic alliance
On October 4, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported that in line with its strategy to participate in promising corporate formations it will deepen its already existing relationship with Carrick (Press release, Evotec, OCT 4, 2016, View Source [SID:SID1234515582]). Evotec will invest up to $ 6 m towards Carrick’s latest funding round. The total $ 95 m round was led by ARCH Venture Partners and Woodford Investment Management with participation from Cambridge Enterprise Seed Funds, Cambridge Innovation Capital, Google Ventures (GV), Lightstone Ventures, and Evotec AG. Schedule your 30 min Free 1stOncology Demo! Carrick, headquartered in Dublin with R&D located in Oxford and Dublin has a clear vision for cancer patients: Its mission is to target the molecular pathways that drive the most aggressive and resistant forms of cancer in order to have a major impact on the lives of patients. Instead of banking on a single compound or biological mechanism, Carrick is building an innovative portfolio of first-in-class treatments that target multiple mechanisms of the most aggressive forms of cancer, and which will be tailored to an individual patient’s tumour. To support this mission Evotec will provide its full range of discovery and oncology services, through its discovery and pre-clinical platform. Carrick will progress multiple programmes through hit-to-lead and lead optimisation with the goal of delivering multiple development candidates.
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Dr Werner Lanthaler, Chief Executive Officer of Evotec commented: "We are very excited to be part of creating and co-owning a next generation leading oncology company. Putting all Evotec’s tools that support innovation and capital efficiency at work will allow Carrick to very rapidly progress a first-in-class oncology pipeline."
Chief Executive of Carrick Therapeutics, Dr Elaine Sullivan, said: "This is a unique new venture in cancer treatment, backed by some of the highest quality investors in the field. There is a significant unmet need in cancer treatment, and targeting aggressive and resistant disease is an area where we can make a real difference to patients’ lives. Working with Evotec has allowed us to build a pipeline with optimal speed and highest quality."
No further financial details are disclosed.
Evotec’s financial guidance for 2016, also with regard to liquidity, remains unchanged, despite the recent investment in Topas Therapeutics and now Carrick Therapeutics.
PEGPH20 Selected For Inclusion In Groundbreaking Clinical Trial Initiative Designed To Transform Outcomes For Pancreatic Cancer Patients
On October 4, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO), an oncology biotech developing novel oncology and drug-delivery therapies, reported that its investigational drug, PEGPH20, and a companion diagnostic assay for assessment of hyaluronan (HA) under development by Ventana Medical Systems, Inc. will be included in a groundbreaking pancreatic cancer clinical trial initiative called Precision Promise (Press release, Halozyme, OCT 4, 2016, View Source [SID:SID1234515575]). Schedule your 30 min Free 1stOncology Demo! The Precision Promise initiative aims to change the current treatment approach to pancreatic cancer, offering options to patients based on the molecular profile of their tumor. This is being accomplished through the Pancreatic Cancer Action Network leading an unprecedented collaboration that brings together clinicians, researchers, and drug developers. Precision Promise plans to enroll patients at 12 initial consortium sites in Spring 2017.
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President and CEO Dr. Helen Torley said: "Halozyme is proud to be participating in this important initiative that has the potential to change how pancreas cancer is treated and improve outcome for patients. I want to recognize The Pancreatic Cancer Action Network for their visionary leadership in bringing the community together. The selection of PEGPH20 and incorporation of HA testing into the trial supports the science and promise of our targeted therapy."
Pancreatic cancer is the third-leading cause of cancer related death in the United States and is anticipated to become the second around 2020. Nationally, only 4 percent of pancreatic cancer patients enroll in clinical trials.
"Precision Promise is an unprecedented opportunity for patients and is vital to move the field forward," said Julie Fleshman, JD, MBA, president and CEO of the Pancreatic Cancer Action Network. "Instead of looking for the right patient for a clinical trial, we are designing the right clinical trial for each patient."
Halozyme’s PEGPH20 is an enzyme that targets and degrades HA in the tumor microenvironment. HA is a glycosaminoglycan – a chain of natural sugars distributed throughout human tissue – that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies. Patients with high levels of HA will receive PEGPH20 in combination with other therapies. In preclinical models, this approach has enabled higher concentrations of the therapeutic agent or the body’s natural immune cells to reach the targeted tumor.
More information on Halozyme’s phase 3 clinical trial of PEGPH20, HALO-301, may be found at www.halo301.com and additional background and vision of Precision Promise may be found at www.pancan.org/precision-promise.