Saltar para: Posts [1], Pesquisa e Arquivos [2]

http://cyto.blogs.sapo.pt

Espaço de publicação e discussão sobre oncologia. GBM IMMUNOTHERAPY ONCO-VIRUS ONCOLOGY CANCER CHEMOTHERAPY RADIOTHERAPY


Quarta-feira, 19.08.15

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

Published on August 17, 2015 at 7:21 AM ·

United Therapeutics Corporation (NASDAQ: UTHR) announced today that the European Commission (EC) has granted Marketing Authorisation for Unituxin™ (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). Unituxin is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.

Neuroblastoma is the most common extracranial solid cancer in childhood and the most common cancer in infancy, with an annual incidence in the European Union of approximately 1500 patients, of whom 50% are diagnosed as having high-risk disease.

The European approval was based on demonstration of improved event-free survival (EFS) and overall survival (OS) in a multicenter, open-label, randomized trial (ANBL0032) sponsored by the US National Cancer Institute under a Cooperative Research and Development Agreement with United Therapeutics and conducted by the Children's Oncology Group (COG).

Trial design and results

The trial randomized (1:1) 226 patients to either the Unituxin/13-cis-retinoic acid (RA) arm or the RA alone arm. Patients in each arm received six cycles of treatment. The Unituxin/RA arm consisted of Unituxin in combination with granulocyte macrophage-colony stimulating factor and RA (cycles 1, 3, and 5), Unituxin in combination with interleukin-2 and RA (cycles 2 and 4), and RA (cycle 6). Patients were 11 months to 15 years of age (median age 3.8 years).

The major efficacy outcome measure was investigator-assessed EFS, defined as the time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy or death. The primary intent-to-treat analysis found an improvement in EFS associated with dinutuximab immunotherapy plus isotretinoin as compared to isotretinoin alone. The two-year estimates of EFS were 66% among subjects receiving dinutuximab immunotherapy plus isotretinoin as compared with 48% in subjects receiving isotretinoin alone (log-rank test p = 0.033) although this difference did not reach formal statistical significance according to the pre-specified plan for interim analyses. In addition, OS was evaluated with 3 years of follow-up after the EFS analysis as a secondary endpoint with a significant improvement observed among ITT subjects randomly allocated to receive dinutuximab immunotherapy plus isotretinoin as compared with isotretinoin alone. The three-year estimates of OS were 80% compared with 67% among subjects receiving dinutuximab immunotherapy plus isotretinoin and isotretinoin alone, respectively (log-rank test p = 0.0165). Long-term overall survival was evaluated with five years of follow up after the EFS analysis and continued to demonstrate a survival advantage for patients who received dinutuximab immunotherapy compared to those who received isotretinoin alone. The five-year estimates of OS were 74% for dinutuximab immunotherapy compared to 57% for isotretinoin alone (log-rank test p = 0.030).

Frequently occurring adverse reactions

The most frequently occurring (more than 30% of patients) adverse reactions reported during the neuroblastoma studies were hypotension (67%), pain (66%), hypersensitivity (56%), pyrexia (53%), urticaria (49%), capillary leak syndrome (45%), anaemia (45%), hypokalaemia (41%), platelet count decreased (40%), hyponatraemia (37%), alanine aminotransferase increased (35%), decreased lymphocyte count (34%) and decreased neutrophil count (31%). Additional adverse reactions characteristic of an allergic response were also reported – including anaphylactic reaction (18%) and bronchospasm (4%).

Posology and method of administration

Unituxin is to be administered by intravenous infusion over five courses at a daily dose of 17.5 mg/m2. It is administered on days 4-7 during courses 1, 3 and 5 (each course lasting approximately 24 days) and on days 8-11 during courses 2 and 4 (each course lasting approximately 28 days).

The treatment regimen consists of Unituxin, GM-CSF, IL-2, and isotretinoin, administered over six consecutive courses.

Source:

United Therapeutics Corporation

Autoria e outros dados (tags, etc)

por cyto às 12:08

Quarta-feira, 19.08.15

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

GLIOBASTOMA GBM

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

Published on August 13, 2015 at 8:32 AM ·

ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) announced today that it has reached agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the phase 3 registrational trial of its cancer immunotherapy ICT-107 to treat patients with newly diagnosed glioblastoma.

The phase 3 trial is designed as a randomized, double-blind, placebo-controlled study of about 400 HLA-A2 positive subjects, which will be conducted at about 120 sites in the US, Canada and the EU. The primary endpoint in the trial is overall survival, which the FDA and EU regulators have stated is the appropriate endpoint for registrational clinical studies in glioblastoma. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups. Patient enrollment is anticipated to begin in the late third quarter or early fourth quarter of 2015.

A Special Protocol Assessment is a written agreement between the sponsor company and the FDA on the design, clinical endpoints, size and statistical design of a clinical trial intended to form the primary basis of an efficacy claim in the marketing application, such as a biologic licensing application (BLA) or a new drug application (NDA). Final marketing approval depends upon the safety and efficacy results demonstrated in the phase 3 clinical program.

Andrew Gengos, ImmunoCellular's Chief Executive Officer Commented: "We are pleased to have achieved this important milestone, and think that successful completion of the SPA process adds meaningful validation to the ICT-107 phase 3 program and design, especially the use of the gold standard primary endpoint of overall survival. With this SPA in place, we think that ICT-107 is uniquely positioned in the field of immuno-oncology approaches being tested in glioblastoma. We are making significant progress toward establishing our clinical site network and obtaining the necessary institutional review board approvals. We are confident that we are on track to begin patient enrollment in the late third quarter or early fourth quarter of this year."

Source:

ImmunoCellular Therapeutics, Ltd.

Autoria e outros dados (tags, etc)

por cyto às 11:37

Quinta-feira, 23.07.15

Magnetic nanoparticles may hold key to bringing immunotherapy into successful clinical use

 

Magnetic nanoparticles may hold key to bringing immunotherapy into successful clinical use

Published on July 16, 2015 at 1:54 AM

In recent years, researchers have hotly pursued immunotherapy, a promising form of treatment that relies on harnessing and training the body's own immune system to better fight cancer and infection. Now, results of a study led by Johns Hopkins investigators suggests that a device composed of a magnetic column paired with custom-made magnetic nanoparticles may hold a key to bringing immunotherapy into widespread and successful clinical use. A summary of the research, conducted in mouse and human cells, appears online July 14 in the journal ACS Nano.

The Johns Hopkins team focused on training and rapidly multiplying immune system white blood cells known as T cells because of their potential as an effective weapon against cancer, according to Jonathan Schneck, M.D., Ph.D., a professor of pathology, medicine and oncology at the Johns Hopkins University School of Medicine's Institute for Cell Engineering. "The challenge has been to train these cells efficiently enough, and get them to divide fast enough, that we could use them as the basis of a therapy for cancer patients. We've taken a big step toward solving that problem," he says.

In a bid to simplify and streamline immune cellular therapies, Schneck, Karlo Perica, a recent M.D./Ph.D. graduate who worked in Schneck's lab, and others worked with artificial white blood cells. These so-called artificial antigen-presenting cells (aAPCs) were pioneered by Schneck's lab and have shown promise in activating laboratory animals' immune systems to attack cancer cells.

To do that, Perica explains, the aAPCs must interact with naive T cells already present in the body, awaiting instructions about which specific invader to target and battle. The aAPCs bind to specialized receptors on the T cells' surfaces and "present" them with distinctive proteins called antigens. This process activates the T cells to ward off a virus, bacteria or tumor, as well as to make more T cells.

In a previous study in mice, Schneck's team found that naive T-cells activated more effectively when multiple aAPCs bound to different receptors on the cells, and then were exposed to a magnetic field. The magnets brought the aAPCs and their receptors closer together, priming the T cells both to battle the target cancer and divide to form more activated cells.

But naive T cells are as rare in the blood as a "needle in a haystack," Perica says. Because the ultimate goal is to harvest a patient's T cells from a blood sample, then train them and expand their numbers before putting them back into the patient, Schneck's research team looked to magnets as a potential way to separate the naive T cells from others in the blood.

The team mixed blood plasma from mice and, separately, humans with magnetic aAPCs bearing antigens from tumors. They then ran the plasma through a magnetic column. The tumor-fighting T cells bound to aAPCs and stuck to the sides of the column, while other cells washed straight through and were discarded. The magnetic field of the column activated the T cells, which were then washed off into a nourishing broth, or culture, to grow and divide. After one week, their numbers had expanded by an estimated 5,000 to 10,000 times. Because numbers of these cells could be expanded quickly enough to be therapeutically useful, the approach could open the door to individualized immunotherapy treatments that rely on a patient's own cells, says Perica.

Schneck says that the use of naive T cells could make the new technique useful for more patients than another immunotherapy now being tested, which relies on other white blood cells called tumor-infiltrating lymphocytes. Those cells are already "trained" to fight cancer, and researchers have shown some success isolating some of the cells from tumors, inducing them to divide, and then transferring them back into patients. But, Schneck says, not all patients are eligible for this therapy, because not all have tumor-infiltrating lymphocytes. By contrast, all people have naive T cells, so patients with cancer could potentially benefit from the new approach whether or not they have tumor-infiltrating lymphocytes.

"The aAPCs and magnetic column together provide the foundation for simplifying and streamlining the process of generating tumor-specific T cells for use in immunotherapy," says Juan Carlos Varela, M.D., Ph.D., a former member of Schneck's laboratory who is now an assistant professor at the Medical University of South Carolina.

The researchers found that the technique also worked with a mixture of aAPCs bearing multiple antigens, which they say could help combat the problem of tumors mutating to evade the body's defenses. "We get multiple shots on the goal," Schneck says.

While the team initially tested the new method only on cancer antigens, Schneck says it could also potentially work for therapies against chronic infectious diseases, such as HIV. He says that if further testing goes well, clinical trials of the technique could begin within a year and a half.

Source:

Johns Hopkins Medicine

Autoria e outros dados (tags, etc)

por cyto às 22:49

Terça-feira, 21.07.15

TSRI study reveals alternative approach to current anti-HIV strategies

 

TSRI study reveals alternative approach to current anti-HIV strategies

Published on July 9, 2015 at 8:49 AM 

AIDS Study Points to ‘Functional Cure’

HIV-infected patients remain on antiretroviral therapy for life because the virus survives over the long-term in infected dormant cells. Interruption of current types of antiretroviral therapy results in a rebound of the virus and clinical progression to AIDS.

But now, scientists from the Florida campus of The Scripps Research Institute (TSRI) have shown that, unlike other antiretroviral therapies, a natural compound called Cortistatin A reduces residual levels of virus from these infected dormant cells, establishing a near-permanent state of latency and greatly diminishing the virus' capacity for reactivation.

"Our results highlight an alternative approach to current anti-HIV strategies," said Susana Valente, a TSRI associate professor who led the study. "Prior treatment with Cortistatin A significantly inhibits and delays viral rebound in the absence of any drug. Our results suggest current antiretroviral regimens could be supplemented with a Tat inhibitor such as Cortistatin A to achieve a functional HIV-1 cure, reducing levels of the virus and preventing reactivation from latent reservoirs."

The study was published this week in the journal mBio.

Cortistatin A was isolated from a marine sponge, Corticium simplex, in 2006, and in 2008, TSRI chemist Phil Baran won the global race to synthesize the compound. A configuration of the compound, didehydro-Cortistatin A, was shown in earlier studies to target the protein Tat, which exponentially increases viral production.

The new study shows that didehydro-Cortistatin A inhibits replication in HIV-infected cells by significantly reducing levels of viral messenger RNA - the blueprints for producing proteins and more infection.

"In latently infected primary T cells isolated from nine HIV-infected subjects being treated with antiretroviral drugs, didehydro-Cortistatin A reduced viral reactivation by an average of 92.3 percent," said Guillaume Mousseau, the first author of the study and a member of the Valente lab.

The results suggest an alternative to a widely studied strategy for latent HIV eradication known as "kick and kill," which tries to purge viral reservoirs by "kicking" them out of their latency with reversing agents and stopping new rounds of infection with an immunotherapy agent to boost the body's own immune system response while on antiretroviral treatment.

"In our proposed model, didehydro-Cortistatin A inhibits the viral transcriptional activator, Tat, far more completely, delaying or even halting viral replication, reactivation and replenishment of the latent viral reservoir," said Valente.

Autoria e outros dados (tags, etc)

por cyto às 18:25

Terça-feira, 21.07.15

Scientists elucidate which mechanisms block natural killer cells and how this could be lifted

 

Scientists elucidate which mechanisms block natural killer cells and how this could be lifted

Published on July 8, 2015 at 12:00 PM 

Natural killer cells of the immune system can fend off malignant lymphoma cells and thus are considered a promising therapeutic approach. However, in the direct vicinity of the tumor they lose their effect. Scientists of Helmholtz Zentrum München have now elucidated which mechanisms block the natural killer cells and how this blockade could be lifted. The results were recently published in the European Journal of Immunology.

Natural killer cells (NK cells) are part of the immune system and provide an innate immunity against exogenous and altered endogenous structures. This also appears to apply to tumor cells, against which the body could develop immunity as it does against pathogens, e.g. against viruses. Tumors of the lymph nodes, called lymphomas, are malignant neoplasms that originate from the B cells or T cells of the lymphatic system. B cell lymphomas are very difficult to treat - which is why innovative approaches to therapy are needed. Earlier studies have shown that NK cells have the potential to attack B lymphoma cells and are therefore considered a possible approach to new treatment strategies. In the living organism, however, tumor control by NK cells has been found to be clearly limited.

NK cells become functionally impaired in the tumor microenvironment

In their experiments, the team led by Prof. Dr. Ralph Mocikat of the Institute of Molecular Immunology (IMI) at Helmholtz Zentrum München, found that the NK cells in the immediate vicinity of the tumor showed reduced function. If the cells were placed in a normal environment, their function could be restored within a few hours. This suggests that the factors responsible for the inactivation of the NK cells derive from the tumor itself.

An inflammatory cytokine inactivates NK cells - altered surface molecules block immune activation

The scientists engaged in the research project identified two important tumor-specific factors that are associated with impaired NK cell function. First, a specific inflammatory cytokine (IL-10) is indirectly involved in the inactivation of NK cells. Second, the tumor cells develop protective mechanisms against the NK cells. Thus, the research group showed that specific surface molecules of the tumor cells (NKG2D ligands) which NK cells could bind are down-regulated. Consequently, the NK cells lack an important activation mechanism and are no longer able to carry out cytotoxic activity. Despite the inhibitory strategies of the tumor cells, at an early stage the NK cells produce the cytokine interferon-gamma (IFN-γ), the scientists reported. IFN-γ is essential to activate further immune responses that support the fight against the tumor.

Immunotherapy possible using NK cells - with optimization potential

"Our results show that the transfer of NK cells is a possible strategic option to treat B cell lymphoma. According to our findings, this therapeutic approach can be optimized when transferred NK cells are already activated in vitro prior to their injection, thus bypassing the missing activation potential in the tumor microenvironment. An additional injection of IFN-γ or of antibodies against IL-10 could further support the immune activity," said study leader Mocikat.

Source:

Helmholtz Zentrum München - German Research Center for Environmental Health

Autoria e outros dados (tags, etc)

por cyto às 18:20

Terça-feira, 21.07.15

Ludwig, CRI launch clinical trials to evaluate immunotherapies for treatment of GBM and solid tumors

 

Ludwig, CRI launch clinical trials to evaluate immunotherapies for treatment of GBM and solid tumors

Published on July 8, 2015 at 11:50 PM 

Ludwig Cancer Research (Ludwig) and the Cancer Research Institute (CRI) have launched clinical trials evaluating an immunotherapy for the treatment of the brain cancer glioblastoma multiforme (GBM), and a combination of immunotherapies for a variety of solid tumors.

The trials are being conducted through the CVC Clinical Trials Network in collaboration with MedImmune, the global biologics research and development arm of AstraZeneca. The CVC Clinical Trials Network -- jointly managed by Ludwig and CRI -- is a coordinated global network of basic and clinical immunologists with expertise in devising and developing immunotherapies for the treatment of cancer. The CVC Clinical Trials Network is led by Jedd Wolchok, Ludwig member and director of the Ludwig Collaborative Laboratory at Memorial Sloan Kettering Cancer Center, as well as associate director of the CRI Scientific Advisory Council.

The GBM trial is a nonrandomized, multicenter Phase 2 trial testing the effects of MedImmune's checkpoint blockade antibody durvalumab (MEDI4736) in patients with GBM, which is the most aggressive and deadly type of adult brain cancer. The study will be conducted using three cohorts of patients - newly diagnosed, recurrent patients and those with tumors which have become unresponsive to standard treatment of care.

"GBM is an inevitably lethal cancer that has so far eluded every therapy in the pharmaceutical arsenal," said Jonathan Skipper, Ludwig's executive director of technology development. "We are hopeful that adding a promising immunotherapy to the treatment regimen for this brain cancer will yield significant benefits for patients who today have a median life expectancy of roughly 15 months, even with the best treatment available."

Durvalumab is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. Durvalumab blocks these signals, countering the tumor's immune-evading tactics. The antibody belongs to an emerging class of immunotherapies commonly referred to as checkpoint inhibitors because they remove checks the body places on immune activation.

"Checkpoint inhibitors have deservedly stirred considerable excitement in the oncology community as their application yields notable results against a growing variety of cancers," said Adam Kolom, managing director of CRI's venture fund and Clinical Accelerator, which organizes and provides philanthropic funding and clinical resources for this and other promising immunotherapy trials. "This will be the first time the immunotherapeutic agent will be tested against this difficult-to-treat cancer, and its outcomes are eagerly anticipated by the GBM patient community."

The other trial, which Ludwig and CRI launched in 2013, is a Phase 1 nonrandomized multicenter trial evaluating the combination of durvalumab with another checkpoint blockade therapy (tremelimumab, anti-CTLA-4) for the treatment of a variety of advanced solid tumors including ovarian cancer, non-small cell lung cancer, colorectal cancer, head and neck cancer, cervical cancer and kidney cancer.

Both clinical trials, which are now under way, are part of a larger clinical research program supported by Ludwig and CRI to speed the evaluation of novel cancer immunotherapies, alone or in combination with other cancer drugs. All of the studies will include collection of genetic and immunologic data derived from clinical samples obtained from patients. Such information will provide clues to the impact of the evaluated therapies and suggest refined or new strategies for treating cancer.

Source:

Ludwig Institute for Cancer Research

Autoria e outros dados (tags, etc)

por cyto às 18:12

Terça-feira, 21.07.15

Patients' own genetically engineered immune cells show significant success against multiple myeloma

 

Patients' own genetically engineered immune cells show significant success against multiple myeloma

Published on July 21, 2015 at 2:37 AM 

In recent years, immunotherapy has emerged as a promising treatment for certain cancers. Now this strategy, which uses patients' own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable. The results appeared in a study published online today in Nature Medicine.

Patients received an infusion of altered immune cells known as T-cells - roughly 2.4 billion of them - after undergoing a stem cell transplantation of their own stem cells. In 16 of 20 patients with advanced disease, there was a significant clinical response. The scientists found that the T-cell therapy was generally well-tolerated and that modified immune cells traveled to the bone marrow, where myeloma tumors typically are found, and showed a long-term ability to fight the tumors. Relapse was generally associated with a loss of the engineered T-cells.

"This study suggests that treatment with engineered T-cells is not only safe but of potential clinical benefit to patients with certain types of aggressive multiple myeloma," says first author Aaron P. Rapoport, MD, the Gary Jobson Professor in Medical Oncology at the University of Maryland School of Medicine. "Our findings provide a strong foundation for further research in the field of cellular immunotherapy for myeloma to help achieve even better results for our patients."

The trial is the first published use of genetically modified T-cells for treating patients with multiple myeloma. The approach has been used to treat leukemia as well as lymphoma, according to Dr. Rapoport, who is the Director of the Blood and Marrow Transplant Program at the University of Maryland Marlene and Stewart Greenebaum Cancer Center.

More than 77,000 people in the United States have multiple myeloma, with about 24,000 new cases diagnosed each year. Patients are treated with chemotherapy and in many cases an autologous stem cell transplant, but long-term response rates are low, and median survival is three to five years.

"The majority of patients who participated in this trial had a meaningful degree of clinical benefit," Dr. Rapoport notes. "Even patients who later relapsed after achieving a complete response to treatment or didn't have a complete response had periods of disease control that I believe they would not have otherwise experienced. Some patients are still in remission after nearly three years."

The research is a collaboration between the University of Maryland School of Medicine, the Perelman School of Medicine at the University of Pennsylvania and Adaptimmune, a clinical stage biopharmaceutical company which owns the core T-cell receptor technology and funded the study. Dr. Rapoport and co-authors Edward A. Stadtmauer, MD, of the University of Pennsylvania Abramson Cancer Center, and Gwendolyn K. Binder-Scholl, PhD, of Adaptimmune, contributed equally to the research. Dr. Rapoport is the study's principal investigator.

In the clinical study, patients' T-cells were engineered to express an affinity-enhanced T-cell receptor (TCR) specific for a type of tumor antigen, or protein, known as a cancer-testis antigen (CT antigen). The target CT antigens were NY-ESO-1 and LAGE-1. Up to 60 percent of advanced myelomas have been reported to express NY-ESO-1 and/or LAGE-1, which correlates to tumor proliferation and poorer outcomes. According to Adaptimmune, the trial is the first published study of lentiviral vector mediated TCR gene expression in humans.

Of the 20 patients treated, 14 (70 percent) had a near complete or complete response three months after treatment. Median progression-free survival was 19.1 months and overall survival was 32.1 months. Two patients had a very good partial response three months post treatment. Half the patients were treated at the University of Maryland Greenebaum Cancer Center and half at the University of Pennsylvania Abramson Cancer Center. Researchers note that the response rate was better than would be expected for a standard autologous stem cell transplant. In addition, patients did not experience side effects which have been associated with another type of genetically engineered T-cells (chimeric antigen receptors, or CARS) used to treat other cancers.

The study was originally developed by Carl H. June, MD, of the University of Pennsylvania Abramson Cancer Center, and Dr. Rapoport, who have been research collaborators for 18 years.

"Multiple myeloma is a treatable but largely incurable cancer. This study reveals the promise that immunotherapy with genetically engineered T-cells holds for boosting the body's ability to attack the cancer and provide patients with better treatments and control of their disease," says E. Albert Reece, MD., PhD, MBA, vice president for medical affairs at the University of Maryland and the John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine. "This trial is also an excellent example of significant scientific advances that result from collaborations between academic medical institutions and private industry."

Source:

University of Maryland Medical Center

Autoria e outros dados (tags, etc)

por cyto às 18:10

Terça-feira, 21.07.15

clinical study data on ImmunTraCkeR assay in the Journal for ImmunoTherapy of Cancer

 

ImmunID announces publication of clinical study data on ImmunTraCkeR assay in the Journal for ImmunoTherapy of Cancer

Published on July 8, 2015 at 10:02 AM 

ImmunID today announced the publication of a short report in the Journal for ImmunoTherapy of Cancer (JITC) showing that the analysis of peripheral T cell receptor diversity using the company's ImmunTraCkeR® assay is associated with clinical outcomes following Ipilimumab treatment in metastatic melanoma. Results from the study, conducted at Memorial Sloan Kettering Cancer Center, were first presented at the SITC 2014 Annual Meeting.

Study results suggest that ImmunTraCkeR® may ultimately be used as a companion diagnostic for immune checkpoint agents, to determine eligibility to the treatment.

"We are delighted to have been selected by the JITC editorial board for publication. ImmunID's mission is to add precision to the immuno-oncology revolution by personalizing immunotherapy. A large multicenter study is currently underway (Predict-ID Melanoma, France) with the aim to validate prediction capabilities of ImmunTraCkeR® for response to immune checkpoint inhibitors. This is an area of high unmet medical need and could be game-changing for patients," said Bernhard Sixt, ImmunID's Chairman and Chief Executive Officer.

Autoria e outros dados (tags, etc)

por cyto às 18:06

Terça-feira, 21.07.15

Isis Innovation, Ludwig Cancer Research announce launch of new cancer immunotherapy spinout

 

Isis Innovation, Ludwig Cancer Research announce launch of new cancer immunotherapy spinout

Published on July 9, 2015 at 7:30 AM 

Isis Innovation, the University of Oxford's technology commercialisation company, and Ludwig Cancer Research are proud to announce the launch of a new spinout company, iOx Therapeutics. iOx Therapeutics will develop a novel cancer immunotherapy discovered through a collaboration between Ludwig Cancer Research and Professor Vincenzo Cerundolo, the director of the MRC Human Immunology Unit within the University of Oxford's Weatherall Institute of Molecular Medicine.

Since 2003, Professor Cerundolo, supported by funding from Ludwig Cancer Research, has led a research team working in collaboration with Professor Gurdyal Besra and Dr. Liam Cox of the University of Birmingham and Professor Richard Schmidt of the University of Konstanz. This team discovered multiple synthetic lipid compounds, now under development by iOx, which activate iNKT cells. A large body of evidence suggests that iNKT cells play an important role in anti-tumour immune responses and could prove highly effective in combination with other immunotherapies.

"Preclinical studies of our iNKT-activating compounds have been extremely promising," said Professor Cerundolo. "We've been able to show that these molecules can halt the progression of tumours in animal models. I am very excited to see them moving toward the clinic, and gratified that our research could prove to be of benefit to cancer patients."

"The new immune checkpoint inhibitors recently approved by regulatory agencies, such as anti-PD-1 antibodies, sabotage the strategies used by tumour cells to suppress the immune system and so induce potent anti-tumour immune responses in many patients," said Dr. Jonathan Skipper, Ludwig's executive director of technology development. "There is good reason to expect that iOX's iNKT agonists could significantly improve these responses, and we look forward to seeing the results of their clinical evaluation."

The company has discussed plans for a first human trial with the UK Medicines and Healthcare products Regulatory Agency. The trial will be run by Professor Mark Middleton, director of the Oxford Experimental Cancer Medicine Centre at Oxford University Hospitals NHS Trust.

Jim Mellon, an Oxford alumnus, has invested in the company through SalvaRx, an oncology-focused investment vehicle that provides capital and drug development expertise to support emerging technologies and companies.

Isis Innovation Head of Technology Transfer, Life Sciences Dr. Adam Stoten said, "The field of cancer immunotherapy is moving forward with unprecedented momentum and we're delighted to support Professor Cerundolo and his team in their goal of finding new and better cancer treatments."

Source:

Ludwig Institute for Cancer Research

Autoria e outros dados (tags, etc)

por cyto às 18:00

Sábado, 04.07.15

new immunotherapy treatment for cancer patients

 

CTCA at Western begins Phase Ib/II trial of new immunotherapy treatment for cancer patients

Published on June 27, 2015 at 2:15 AM · 

Cancer Treatment Centers of America® (CTCA) at Western Regional Medical Center (Western) in Goodyear, Arizona, has begun a new Phase Ib/II clinical trial using a new immunotherapy treatment for patients with advanced kidney, non-small cell lung cancer, pancreatic cancer and colorectal carcinoma.

This "NivoPlus" clinical trial combines an immunotherapy drug (nivolumab) with already FDA-approved chemotherapy drugs (temsirolimus, irinotecan, and a combination of irinotecan and capecitabine).

The addition of nivolumab is intended to activate the body's own immune system to improve on the results that otherwise might not be achieved from chemotherapy alone. This combination of chemotherapy and immunotherapy drugs is investigational in this study and is the third such combination clinical trial launched in the past year by CTCA® at Western.

There are anticipated to be up to 49 patients enrolled on the multi-arm NivoPlus study. The first patient received treatment on this study earlier this month.

"Some of these drug combinations are not available elsewhere, giving CTCA patients additional treatment options," said Dr. Glen Weiss, Director of Clinical Research and Medical Oncologist, CTCA at Western. "Our ultimate goal is to evaluate if these combinations yield improved results for our patients."

Nivolumab works by inhibiting a protein called PD-1, which otherwise blocks the body's immune system from attacking cancerous cells.

Nivolumab was approved by the Food and Drug Administration in December 2014 for the treatment of advanced melanoma and on March 4, 2015, for patients with previously treated metastatic squamous non-small cell lung cancer.

"Patients with these types of advanced-stage cancers have tumors that may be challenging to treat," said Dr. Vivek Khemka, Medical Oncologist, CTCA Western and NivoPlus Principal Investigator. "We are investigating whether combining nivolumab with these chemotherapy drugs will be a more powerful approach against their disease."

Recent data reported in the New England Journal of Medicine and Lancet demonstrates promising results with antibody-based immunostimulatory therapy in treating melanoma, renal cell carcinoma, non-small cell lung cancer and colorectal cancer. Data has also shown synergetic effects of utilizing cytotoxic chemotherapy in combination with immunostimulatory therapy. NivoPlus will build upon this data, extending treatment options to additional cancer types.

CTCA investigators have been actively researching the impact of immunotherapy, a topic prominently highlighted this year at the annual conferences of both the American Association for Cancer Research (AACR) and the American Society of Clinical Oncologists (ASCO).

At AACR, physicians described immunotherapy as now being considered an integral part of cancer biology and cancer treatment, and recent clinical successes were described as "stunning" and "unprecedented" in their ability to improve the care of cancer patients.

At ASCO, a full press briefing was devoted to the subject of immunotherapy, which was described by doctors as "one of the most exciting advances in oncology," enabling the body's own immune system to target cancer tumors and key to helping accelerate the pace of progress "and ultimately achieve cures for cancer."

Additionally, in 2013, Science magazine named cancer immunotherapy the scientific breakthrough of the year.

CTCA physicians are committed to bringing the latest technologies and advanced treatment options to their patients as quickly as possible. At the same time, CTCA patients are supported with therapies to reduce side effects, boost energy levels and keep them strong during treatment.

Source:

Cancer Treatment Centers of America

Autoria e outros dados (tags, etc)

por cyto às 11:18


Mais sobre mim

foto do autor


Subscrever por e-mail

A subscrição é anónima e gera, no máximo, um e-mail por dia.

Pesquisar

Pesquisar no Blog  

calendário

Fevereiro 2016

D S T Q Q S S
123456
78910111213
14151617181920
21222324252627
2829