CSN Login
Members Online: 23

What’s Coming Down the Pike

BDS's picture
BDS
Posts: 90
Joined: Aug 2012

There are many new treatments for RCC currently in Clinical Trials around the world. Below is my compilation of what I believe are the most promising treatments that are on the horizon for RCC. Hopefully, these new drugs/treatments will receive FDA approval within the next 1-3 years. Each drug I mention contains snippets of information that I have copied from the Internet. - BDS      

 

 

Tivozanib (Aveo Pharmaceuticals) is a potent pan-VEGF receptor tyrosine kinase inhibitor. The biological activity of tivozanib seems to outstand that of other VEGF tyrosine kinase inhibitors. In Phase I studies, observed side effects are generally mild, with hypertension being the most common adverse event. In single-agent Phase II and III studies in patients with advanced or metastatic renal cell carcinoma, tivozanib has demonstrated convincing clinical activity.

In a statement, Aveo said that the FDA has accepted the company’s NDA, submitted in September, for tivozanib as a treatment for advanced renal cell carcinoma (RCC), or kidney cancer. The FDA’s review of the candidate is expected to be completed by July 28, 2013, the company said. The NDA includes results of the global Phase 3 trial, TIVO-1, of 517 patients with advanced RCC. The study showed that tivozanib was the first product to demonstrate more than one year of progression-free survival for patients who had never taken medication for the disease before. In a head-to-head comparison, AVEO’s drug candidate bested Nexavar, the current standard of care, made by Onyx Pharmaceuticals.

 

AVEO Oncology  Astellas Pharma Inc. today announced that new clinical data on tivozanib, an investigational agent for the treatment of metastatic renal cell carcinoma (mRCC), will be presented at the 2013 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 14-16 2013 in Orlando, Florida Presenter: Robert Motzer, M.D.   Date & Time: Saturday, February 16, 2013; 6:45-7:55am

WebLink:http://www.aveooncology.com/our-product-candidates/tivozanib/renal-cell-carcinoma/

Search Youtube for Videos:

 

BMS-936558/Nivolumab (Bristol-Myers Squibb):  It is proposed that the anti-PD-1 treatments currently being investigated work against the cancer cells by blocking them from binding to and activating PD-1. This helps the body reactivate the immune response and fight back against the cancer.

Web Links: http://www.bmsanti-pd-1drugresearchstudies.com/index.aspx

Search Youtube for Videos:

 

BNC-105P: There is an Australian company called Bionomics that is conducting clinical trials of a new promising drug called BNC105 or BNC105P.  BNC105 is a vascular disrupting agent that shuts down the blood supply to solid tumors.

Web Link: http://www.bionomics.com.au/index.php )

Search Youtube for Videos:

 

IMA901 vaccine: Completed a European multi-centerphase 2 clinical trial in renal cell carcinoma in Q4 2009. 68 patients with advanced renal cell carcinoma were treated and highly encouraging overall survival rates were observed in the treated patients, significantly improving on the data seen from market-leading drugs in previous studies. Furthermore, IMA901 showed an excellent safety profile. Based on these very encouraging results and on discussions with regulatory bodies in the US (FDA) and Europe (EMA), immatics initiated a pivotal, randomized, controlled phase 3 study that, presenting positive outcomes could soon lead to the market approval of IMA901.

 

Web Links: http://www.immatics.com/index.php

                    http://www.immatics.com/index.php?action=download&id=571

Search Youtube for Videos:

 

TVAX Biomedical is a clinical stage drug development company advancing its novel targeted cell-based immunotherapy for the treatment of cancer.

TVI-Kidney-1 is being evaluated for the treatment of kidney cancer and targets stage IV renal cell carcinoma.As with TVI-Brain-1, this drug candidate is supported by positive Phase 2 clinical data, as well as extensive preclinical and Phase 1 safety studies.  Based on these supportive data, TVAX has been authorized by the United States Food and Drug Administration (FDA) to conduct pivotal Phase 3 trials for TVI-Kidney-1 to support the therapy’s potential FDA approval.  The company has prioritized the TVI-Brain-1 program at this time, but intends to initiate the TVI-Kidney-1 pivotal Phase 3 trial in the near future.

Web Links: http://www.tvaxbiomedical.com/index.shtml

 

Argos Therapeutics

AGS-003 is an investigational, fully personalized, cancer immunotherapy being evaluated in a phase 3 clinical study in combination with targeted drug therapy for the treatment of metastatic renal cell carcinoma (mRCC).

To make AGS-003, a small tumor sample is obtained during the initial, standard surgery (nephrectomy). Following recovery from surgery, a blood donation procedure (leukapheresis) is performed to collect a certain type of blood cell which is required to make powerful dendritic cells. Once these elements are combined, up to 5 years of treatment is made for each patient.

Where AGS-003 Fits:

Adding AGS-003 to targeted drug therapy may represent an important advancement in the treatment of advanced kidney cancer. In a previous clinical trial, AGS-003 was safely added to a commonly used targeted therapy and appeared to trigger an immune response which helped patients fight their cancer.

Web Link: http://adaptkidneycancer.com/

 

AGS-16C3F

Not Sure Who Makes this Drug: AGS-16C3F is an antibody-drug conjugate. It is composed of an antibody which binds to a specific receptor on cancer cells. Once there, a chemotherapy drug that is bound to the antibody can kill the cancer cell. AGS-16C3F is given intravenously (by vein).

Weblink: http://www.mskcc.org/cancer-care/trial/12-162

 

 

 

Exelixis Inc

 

Cabozantinib (Exelixis Inc.) is an inhibitor of both VEGFR2 and c-Met, both of which promote angiogenesis. 25 patients were evaluated, all of whom had prior therapies for kidney cancer, mostly VEGF or mTOR inhibitors. This was an experienced group as close to half of the patients had three or more prior therapies. For example, 14 of the 25 had previously taken sunitnib (Sutent). The dosage was 140 mg/daily, which was previously determined to be the maximum tolerated dose (MTD). Other studies have used 40 mg to 140 mg, with the lower dose showing efficacy in prostate cancer. Exelixis, the biotech company that developed the drug, will consider dose reduction in the future for RCC. 

 

Response


The progression-free survival (pfs) for the 25 patients was 14.7 months. With respect to tumor shrinkage, 21 patients were evaluated, and, based on RECIST criteria, of those, 7 had a partial response (>30% shrinkage), 13 had stable disease, and one had progression. In total, 19 of the 21 evaluated patients had some shrinkage, although one had progressive disease due to new lesions.  

 

Based on prostate trial data, cabozantinib has demonstrated significant efficacy in reducing or eliminating bone lesions. There were four rcc patients with bone lesions at baseline, two with pain. The pain resolved for both and one has continued to be pain-free for 73 weeks. One patient did develop new bone lesions. According to Exelixis, in addition to cabozantinib’s effect on osteoblasts and osteoclasts, an anti-tumor effect was also noticed in the bone lesions. It will be interesting to see further elucidation of this since, as compared with Zometa, which is an agent that has been used successfully to treat bone metastases, it is still unclear if there is an anti-tumor effect. 

 

What stands out in this trial is the response rate, specifically the pfs of 14.7 months and some tumor shrinkage in 19 of the 21 evaluated patients for a patient mix that was heavily pre-treated. For example, of the 7 patients who showed partial tumor response (> 30% shrinkage), 4 of them had four or more prior treatments. The best pfs in current therapies is about a year, and this is mostly for treatment-naïve patients. The axitinib-sorafenib second-line trial (with one prior therapy) yielded a pfs of 6.7 months and 4.7 months for axitinib and sorafenib, respectively. Additionally, the patients on this trial were all in the intermediate and poor risk categories. Most trials have patients who have good and intermediate risk for recurrence. Cabozantinib also demonstrated efficacy against bone lesions, following its similar history with prostate cancer. The drug also seems to be well-tolerated without the significant hypertension and possibly concomitant heart issues found in other tyrosine kinase inhibitors.  

Although the numbers are small, there doesn’t seem to be a relationship between number of prior therapies and response to cabozantinib. In other words, it doesn’t matter how many priors you’ve had, you still have a possibility of tumor response to cabozantinib.

 

Weblink: http://www.exelixis.com/

 

Note – (I could be wrong on this But…) Only a Phase 1 trial has been completed with Cabozantinib for RCC.   From what I can currently determine the company (Exelixis) is not vigorously pursuing a Phase 2 clinical trial.  I cannot find any mention of it on ClinicalTrials.gov only on Exelixis website where it is in a status of “Not Yet Recruiting”.  - BDS

 

 

Acceleron Pharma

Dalantercept: February 5, 2013 – Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, announced the initiation of a phase 2 study of dalantercept, a novel angiogenesis inhibitor that targets the activin receptor-like kinase 1 (ALK1) pathway.  The phase 2 study is a two-part, randomized study of dalantercept in combination with axitinib (Inlyta®, Pfizer), a vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor, to treat patients with metastatic renal cell carcinoma (RCC).  Acceleron, its partners, and collaborators have now initiated seven phase 2 studies across three of Acceleron’s programs – dalantercept (ACE-041), sotatercept (ACE-011), and ACE-536 – since November of 2012.

“Many patients with renal cell carcinoma respond to treatment with a VEGF inhibitor yet their disease subsequently progresses,” said Michael B. Atkins, M.D., Deputy Director, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center. “We are optimistic that combining two therapies with distinct anti-angiogenesis mechanisms, a VEGF inhibitor and dalantercept, an ALK1 signaling inhibitor, can provide a more effective and durable antitumor response in these patients.”

Weblink: http://www.acceleronpharma.com/

 

Interesting Articles:

 

Rice-Cell Cocktail Tough on Cancer Cells, Nice to Normal Cells

Weblink: http://www.newswise.com/articles/rice-cell-cocktail-tough-on-cancer-cells-nice-to-normal-cells

 

Marijuana and Cancer: Scientists Find Cannabis Compound Stops Metastasis In Aggressive Cancers

 

Weblink:  http://www.huffingtonpost.com/2012/09/19/marijuana-and-cancer_n_1898208.html?icid=maing-grid10%7Chtmlws-main-bb%7Cdl1%7Csec3_lnk1%26pLid%3D207936

 

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Taken along with Chuck's excellent response in the nivo/ipi trial, the future looks increasingly rosy for anti PD1 treatments, doesn't it?

foxhd's picture
foxhd
Posts: 1868
Joined: Oct 2011

to have been part of a study that has helped so many. Including me. I wish I was still on it. Go Chuck and everyone else!

angec's picture
angec
Posts: 621
Joined: Mar 2012

So how much marijuana do you have to ingest to stop canvcer?  Arent' there many tokers with cancer?  Good question.

BDS's picture
BDS
Posts: 90
Joined: Aug 2012

 

Billionaire-backed immatics bags $46M to wrap cancer vaccine PhIII

 

October 15, 2013 | By Damian Garde

 

Armed with promising data and the support of biotech billionaire Dietmar Hopp, Germany's immatics now has the cash to get its cancer vaccine past the goal line, closing a $46 million Series D that will carry it through Phase III.

 

Immatics, a 2007 Fierce 15 alum, is in the midst of a Phase III study of IMA901, the company's cancer vaccine derived from 10 different tumor-associated peptides that are commonly over-expressed in renal cell carcinoma. The latest funding--courtesy of dievini Hopp Biotech, Wellington Partners and others--will bankroll that trial and carry immatics all the way to regulatory submissions in the U.S. and Europe.

 

The company is studying whether IMA901 paired with Pfizer's ($PFE) sunitinib can boost overall survival in patients with metastatic or locally advanced kidney cancer. Immatics hauled in a $70 million round in 2010 to get the 339-patient study rolling, and the company expects to have interim results ready next year with final OS figures coming in 2015.

 

In Phase II data published last year, patients who responded to two or more of IMA901's tumor-associated peptides had significantly longer rates of survival, and immatics CEO Paul Higham said the latest funding round is an affirmation of the vaccine's promise.

 

"There is a clear need for novel cancer therapies that can deliver prolonged survival while maintaining a good quality of life," Higham said in a statement. "We remain hopeful that IMA901 will deliver a significant improvement for patients with renal cell cancer."

 

http://www.fiercebiotech.com/story/billionaire-backed-immatics-bags-46m-wrap-cancer-vaccine-phiii/2013-10-15?utm_source=rss&utm_medium=rss

 

BDS's picture
BDS
Posts: 90
Joined: Aug 2012

Combinability of CRLX101 and Avastin® Established in Clinical Trial in Renal Cell Carcinoma

“We have established that the recommended dose of CRLX101 can be used in combination with the standard RCC dosing of bevacizumab,” said the study’s principal investigator, Stephen Keefe, M.D., of Penn’s Abramson Cancer Center. “We’ve also observed that patients with both clear cell and non-clear cell disease appear to be deriving clinical benefit, beyond what would have been predicted with a single drug alone.” 

Edward Garmey, M.D, chief medical officer of Cerulean, commented: “CRLX101 is designed to concentrate in tumors and release its payload over an extended period of time in order to maximize the drug’s effect. That sustained release allows for a durable inhibition of HIF-1a, which could be the reason for the encouraging progression free survival and tumor shrinkages we have seen in a patient population where neither is expected.”

http://ceruleanrx.com/

This clinical trial, which is being conducted at the University of Pennsylvania Abramson Cancer Center, will now expand to enroll a total of 22 mRCC patients.

 

TillieSOK's picture
TillieSOK
Posts: 232
Joined: Jul 2013

This may duplicate other postings, but a dr friend sent this to me...

http://www.cancer.gov/clinicaltrials/search/results?protocolsearchid=6461052&vers=2

BDS's picture
BDS
Posts: 90
Joined: Aug 2012

 

Drug Combination Therapy Causes Cancer Cells to 'Eat Themselves'

 

Nov. 5, 2013 — Results from a recent preclinical study have shown that a new drug combination therapy being developed at Virginia Commonwealth University Massey Cancer Center effectively killed colon, liver, lung, kidney, breast and brain cancer cells while having little effect on noncancerous cells. The results lay the foundation for researchers to plan a future phase 1 clinical trial to test the safety of the therapy in a small group of patients.

 

"It is still too premature to estimate when a clinical trial will open to further test this drug combination therapy, but we are now in the planning phase and encouraged by the results of these laboratory experiments," says Andrew Poklepovic, M.D., oncologist and member of the Developmental Therapeutics research program at VCU Massey Cancer Center and assistant professor in the Division of Hematology, Oncology and Palliative Care at VCU School of Medicine. "We are also encouraged by the fact that the drugs used in this therapy are either already approved by the FDA to treat certain cancers or are currently being investigated in other clinical trials."

 

Featured in the journal Molecular Pharmacology, the study led by Paul Dent, Ph.D., demonstrated that the drugs sorafenib and regorafenib synergize with a class of drugs known as PI3K/AKT inhibitors to kill a variety of cancers. Sorafenib and regorafenib work by blocking the production of enzymes called kinases, which are vital to the growth and survival of cancer cells. Sorafenib is currently approved by the FDA to treat kidney and liver cancers, and regorafenib is currently approved for the treatment of colorectal cancer. However, sorafenib and regorafenib do not directly affect PI3K and AKT kinases, which are also very active in promoting cancer cell survival. The addition of a PI3K/AKT inhibitor to the combination of sorafenib and regorafenib dramatically increased cell death and was even effective against cells with certain mutations that make one or the other drug less effective.

 

"We know that there are certain cellular processes that are frequently dysregulated in cancers and important to cell proliferation and survival, but if you shut down one, then cells can often compensate by relying on another," says Dent, Universal Corporation Distinguished Professor for Cancer Cell Signaling and member of the Developmental Therapeutics research program at VCU Massey Cancer Center as well as vice chair of the Department of Neurosurgery at VCU School of Medicine. "We are blocking several of these survival pathways, and the cancer cells are literally digesting themselves in an effort to stay alive."

 

Results of the study showed that the combination therapy killed the cells by physically interacting with molecules to block the survival pathways and induce a toxic effect known as autophagy. Autophagy is a protective process where cells metabolize themselves when starved of the resources needed to survive.

 

"Many groups are trying the approach of inhibiting two survival signaling pathways, but our approach takes this further by blocking significantly more of these pathways," says Dent. "Our findings could benefit many different cancer patients based on the broad range of effects seen in multiple cancer types."

 

Web address:
http://www.sciencedaily.com/releases/2013/11/

131105103631.htm

 

 

BDS's picture
BDS
Posts: 90
Joined: Aug 2012

 

Promising Immune Activation Found in mRCC for AGS-003

Author: Silas Inman

The investigational autologous dendritic cell vaccine AGS-003 successfully activated a cytotoxic T cell response that correlates with a prolongation in survival for patients with metastatic renal cell carcinoma (mRCC), according to an analysis presented at the 2013 Annual Meeting of the Society for Immunotherapy of Cancer.

The open-label phase II study examined AGS-003 plus sunitinib as a treatment for 21 patients with unfavorable-risk mRCC. The final median overall survival from the trial was 30.2 months, with approximately one-third of patients alive after nearly 4 years of follow-up. Following the announcement of these promising results earlier this year, Argos Therapeutics Inc., the company developing the drug, announced the initiation of a phase III investigation.

In a secondary analysis of the study, the absolute number of a distinct AGS-003-specific cytotoxic T cell signature correlated with the improvement in survival. One patient who received long-term treatment with AGS-003 maintained multifunctional expression of the CD28 and CCR7 receptors with negative CD45RA expression for more than 3 years post-treatment. Survival for this patient exceeded the 30-month median in the trial.

"We believe that these additional findings from our phase II trial support the in vivo mechanism of action of AGS-003," said Charles Nicolette, Argos' chief scientific officer and vice president of research and development, in a statement. “We also believe this is the first demonstration in a clinical trial that the magnitude of an adaptive immune response following immunotherapy correlates with prolonged survival."

The production of AGS-003 requires initial legwork, including upfront leukapheresis to collect dendritic cells. AGS-003 is then manufactured by transfecting the autologous dendritic cells with patient-specific RCC amplified RNA and synthetic, truncated human CD40 ligand RNA that has the potential to stimulate the immune system’s antineoplastic properties. After this process, the vaccine is reintroduced into the patient as an intradermal injection, eliciting a highly specific cytotoxic T-cell response through the initiation of a signaling cascade that causes the secretion of the cytokine IL-12.

This mechanism was examined in the analysis using immune monitoring multi-color flow cytometry for patients receiving at least 5 doses of AGS-003 (n=14). These data were then analyzed using an adaptation of binary tree-structure vector quantization, which partitioned cytotoxic T cell subsets into related groups without consideration to clinical outcomes.

Through this approach, the study identified a cytotoxic T cell signature associated with AGS-003. The signature was characterized by the co-expression of the receptors CD28, CCR7, and CD27 in the absence of CD45RA, an isoform of CD45 commonly associated with naïve T lymphocyte expression. The lack of this isoform suggests activation of memory T cell lymphocytes; however, CD45RO expression was not noted.

As a result of these findings, Argos is utilizing the identified cytotoxic T cell signature as a biomarker of response to AGS-003. Moreover, the company will use the quantization platform to track immune responses for patients with mRCC enrolled in the phase III development program.

Four hundred fifty patients are expected to be enrolled in the phase III ADAPT trial, which opened in January 2013. The trial is seeking participants with newly diagnosed clear cell mRCC who are identified as having an unfavorable risk with 1-3 baseline risk factors. Additionally, patients must be candidates for nephrectomy and treatment with sunitinib.

In the trial, patients will be randomized in a 2:1 ratio to receive AGS-003 plus sunitinib or sunitinib alone following a unilateral or partial nephrectomy. In the investigational arm, patients will undergo leukapheresis before receiving treatment. Sunitinib will be administered for a 6-week cycle at 50 mg daily for 4 weeks, with a 2-week treatment holiday. Treatment with AGS-003 consists of three 0.2 mL intradermal injections administered for 5 doses over the course of 15 weeks followed by quarterly doses. Treatment in both arms will be continued until disease progression.

In September, Argos announced that it planned to move the ADAPT study beyond North America. At this point, more than 100 patients have been screened for the trial at more than 80 global sites.

“The continued expansion of the ADAPT study to key centers in Europe and Israel demonstrates the increasing excitement and support throughout the international community in advancing cancer immunotherapy research,” said Doug Plessinger, vice president of Clinical and Medical Affairs at Argos in a statement. “This progress ensures we will remain on track to complete enrollment of the trial in the second half of 2014. Furthermore, we expect to activate more European sites in the United Kingdom and Italy, as well as 15-20 more in North America later this year.”

Final data from the ADAPT clinical trial are expected in December 2015. If positive, the company is expected to submit a Biologic License Application to the FDA. In April 2012, the development of the agent received a Fast Track designation from the FDA.

http://www.onclive.com/web-exclusives/Personalized-Immunotherapy-Shows-Promise-in-mRCC

 

 

 

 

 

BDS's picture
BDS
Posts: 90
Joined: Aug 2012

Immunicum reports positive phase I/II-data for the therapeutic cancer vaccine INTUVAX® in the treatment of kidney cancer

Gothenburg, Sweden, 2013-12-05 09:00 CET (GLOBE NEWSWIRE) -- Immunicum® AB (publ), a Swedish listed company on NASDAQ OMX First North, developing therapeutic cancer vaccines, today announces positive survival data from a clinical phase I/II-study with the therapeutic cancer vaccine INTUVAX ® for the treatment of metastatic renal cancer. A presentation will be held today by the Company’s Chief Scientific Officer, Associate Professor Alex Karlsson-Parra, at Informa’s Immunotherapy Conference in Brussels.

The clinical phase I/II-study, initiated in February 2012, includes a total of 12 patients, each treated with two intratumoral injections/vaccinations with INTUVAX®, two weeks apart, after which their cancer affected kidney, as part of the standard treatment, was surgically removed.

Vaccination with INTUVAX® did not have any negative impact on patients' general condition and no serious vaccine-related adverse events have been reported.

Median overall survival after vaccination for the subgroup of 5 patients with poor prognosis (subgrouping according to generally accepted so-called Heng-criteria) is currently at 8 months and has thus already exceeded the expected median overall survival of 5 months with interferon treatment and 7.8 months with modern targeted therapies.

Three of the five patients in the poor prognosis group also have an unusual tumor type, so called extensive sarcomatoid tumor transformation, which impairs the prognosis further. Median survival in these 3 patients is currently at 6 months from the time of diagnosis compared to the expected 3 months.

Noteworthy is that 2 of 5 patients (40%) in the poor prognosis group currently have survived for more than 15 months after vaccination, and both are still alive. These figures can be compared with an expected 15-month survival rate of approximately 15 % in patients with poor prognosis who are treated with interferon and about 25 % in patients treated with targeted therapies.

The observation period is still too short to draw any conclusions about how the median overall survival in the subgroup with intermediate prognosis (7 patients) stands in relation to the expected median. Two patients have already passed the expected median survival of 14 months for patients treated with interferon. The first patient treated has now survived for almost 22 months after vaccination and has not required any further treatment.

Looking at the entire patient population of 12 patients, 10 patients are still alive. The Company will continue to monitor survival data after the final study report has been submitted to the Medical Products Agency, which is expected in Q1 2014.

- The vaccine-related increases in circulating tumor-specific lymphocytes in 9 of 11 examined patients, as well as the massive intratumoral infiltration of potentially tumor killing CD8 + T-cells, noted in 5 of 12 analyzed primary tumors, also give good support to the expected mechanism of action, said Immunicum’s Chief Scientific Officer, Associate Professor Alex Karlsson-Parra. According to available scientific publications, the intratumoral infiltration of CD8 + T-cells in the 5 patients is the most massive ever reported in therapeutic cancer vaccination, in animal studies as well as in human studies. In addition, massive intratumoral infiltration of CD8 + T-cells seems to correlate with prolonged survival in our patients with sarcomatoid tumor transformation.

- Even if we have only treated a limited number of patients, with no control arm, all these results are very encouraging, especially as current therapies are often associated with severe side effects. We therefore look forward to test our vaccine in a larger phase II-study that we plan to launch during next year, says CEO, Jamal El-Mosleh.

Immunicum’s vaccine cells are comprised of so-called allogeneic dendritic cells, which through a unique processing system are developed into effective immune activating cells. Immunicum’s unique vaccine concept is based on over 30 years of research in the field of transplantation immunology and, by use of a new method, activates the body's own immune system to attack tumor cells. Immunicum’s shares have been traded since April 22, 2013 on NASDAQ OMX First North under the ticker IMMU.

 About Immunicum AB (publ):

Immunicum AB (publ) develops cancer immunotherapies. Its two main groups of therapeutic cancer vaccines, SUBCUVAX® and INTUVAX®, and the method of expansion of tumor-specific T-cells (CD70) is based on the Nobel prize awarded discovery of the dendritic cell and its central role in the activation of the specific immune response. Since the raw material consists of allogeneic dendritic cells, Immunicum’s products can be produced in large scale. The vaccines are now undergoing clinical trials in renal cell carcinoma and hepatocellular carcinoma.

www.immunicum.com

 

 

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

First this post needs to be back at / near the top.. too important.  Also please be aware of AACR.. I will post a link later..

Ron

sblairc's picture
sblairc
Posts: 74
Joined: Feb 2014

Wow, this information is amazing. I am literally in tears. My hope for the future of my husband and everyone here is in these promising therapies. Thanks for bumping this post up, especially for us new to the forum. Hope. . . 

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

No thanks needed.. it is the "job" of olde farts like me to help all I can.   Keep in mind some of the info is already a bit dated.. but some of us will continue to add the new stuff we hear of...

Here is the AACR link..  http://www.aacr.org/

Be Well All..!!

Ron

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

OK, here is a bit more info on the 2014 AACR Conference.  This is a huge annual conference with a big group of the best Cancer researchers..  I will be attending as a Patient - Advocate, which means I have to give a presentation.  But I will also try to attend all related sessions and make notes to share.  Here is a link to the conference info..  http://www.aacr.org/home/scientists/meetings--workshops/aacr-annual-meeting-2014.aspx

Ron

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

A good read on.. Immune Checkpoint Inhibitors

http://www.washingtonpost.com/national/health-science/new-therapies-raise-hope-for-a-breakthrough-in-tackling-cancer/2014/02/14/b4f8e4fc-8dad-11e3-95dd-36ff657a4dae_story.html

PD-1  PDL-1...

Soon we hope..!

Ron

BDS's picture
BDS
Posts: 90
Joined: Aug 2012

Ok this has nothing to do with RCC but it's really cool - watch this - BDS

http://www.cbsnews.com/videos/are-fruit-flies-the-key-in-the-fight-against-cancer/

NanoSecond's picture
NanoSecond
Posts: 514
Joined: Oct 2012

Actually, it did have one oblique connection to the treatment of RCC.  One of the drugs that they determined would be effective against his thyroid cancer was Nexavar (Sorafenib)...

BDS's picture
BDS
Posts: 90
Joined: Aug 2012

 

Unfortunately, due to the demands of work and family I have become more of a lurker than an active member here at CSN.  Since the failure of Tivozanib to gain FDA approval it seems to me that the pharmaceutical companies have not been issuing very many press releases or news stories about the latest treatments in renal cell carcinoma. So unfortunately, I have not had much to add to the post of “What’s coming down the Pike”. However, on February 27th I had a meeting with my oncologist who has been running clinical trials with BMS-936558/Nivolumab. We had a frank and honest discussion about when the FDA would approve Nivolumab. What my oncologist has informed me is that her BMS reps do not expect Nivolumab to be FDA approved for renal cell until 2016. Many of you I am sure have read internet stories and were hoping for an  approval date as early as the end of 2014 or the beginning of 2015. However, this is probably not the case; I trust what my oncologist is telling me. Sorry, if I am the bearer of bad news. - BDS  

 

 

 

*** Now please, Oh please do not directly discuss this post with your doctors. I have a frank and honest relationship with my oncologist and I would like to keep it that way.  I would really appreciate a little bit of discretion. – Thank you        

 

sblairc's picture
sblairc
Posts: 74
Joined: Feb 2014

Are there any exceptions for getting the drug outside of clinial trials? I was just wondering if you can get experimental medication for compassionate reasons. 

Darron's picture
Darron
Posts: 218
Joined: Jun 2013

I, like many, am still taking Nivolumab after being declared cancer freeze in my Jan 2 scan. The original trial was rinstop treatment at NED. That was amended to try and establish a maintenance dosing protocol. I think it is moving quicker than originally thought, but still not quick enough!

I had asked if it is possible to get back in the drug if I went NED, was dropped, then had a recurrence. I was told that I could not go back in the trial, but I could apply to the FDA for an individual liscence vs. Under the trial licence, but it would be difficult. Also, the coat would most likely not be covered on insurance, or trial. It sounded like a dead end.

That is why you will read about dictors working the trial and keeping their patients on the drug as long as possible

i_love_my_dad
Posts: 20
Joined: Jan 2013

I think it can hardly be approved for kidney cancer soon. But can it be approved for Melanoma earlier? I think people can reach it as long as it is FDA approved, no matter for which kind of cancer.  

yoricks
Posts: 2
Joined: Feb 2014

A year after the original post, if I were to summarize where we are now:

1.      

No new treatments were approved or a positive Phase III trial completed.

2.      

Tivozanib and Dovitinib, which were in final stages, failed.

3.      

We still have 4 new treatments in Phase III clinical trials:

A.     

Cabozantinib – Exelixis.

B.     

Nivolumab  -BMS

C.     

IMA901 -  Immatics

D.     

AGS 003 – Argos

 

We have of course dozens of phase I and II trials which need a separate cover.

Did I get it right?

yoricks
Posts: 2
Joined: Feb 2014

Novel treatments in Phase II:

 

1.     

RO 4929097

Roche

 

2.     

BEZ 235

Novartis

 

3.     

MK 2206

Merck

 

4.     

Pidilizumab/ CT 011

CureTech

 

5.     

Anlotinib

Jiangsu Chia-tai Tianqing Pharmaceutica

 

6.     

Carfilzomib

Onyx Therapeutics, Inc.

 

7.     

Bortezomib/ Velcade

Millennium Pharmaceuticals

 

8.     

ASONEP

Lpath, Inc.

 

9.     

TH 302

Threshold Pharmaceuticals

 

10. 

TRC 105

TRACON Pharmaceuticals 

 

11. 

Trebananib/ AMG 386

Amgen

 

12. 

Famitinib

China

 

13. 

Lipotecan/TLC388

Taiwan Liposome Company 

 

14. 

Dalantercept

Acceleron Pharma, Inc.

 

15. 

AZD 2014

AstraZeneca

 

16. 

LY2510924

Eli Lilly

 

17. 

MPDL3280A

La Roche

 

18. 

GDC 0980

La Roche/Genentech

 

19. 

Tasquinimod/ ABR-215050, CID 54682876

Ipsen

 

20. 

INC280

Novartis/Incyte

 

21. 

MK 3475

Merck

 

22. 

RX 0201

 

Rexahn

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

Immunotherapy...   Check out this video.. it is an hour long.. pull up a chair..

 

https://www.youtube.com/watch?v=XGeqAEr1RnE&list=UUIRzxohZ6SbwsPqHFQGMJ7A

 

Ron

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

Bump..!

Galrim's picture
Galrim
Posts: 270
Joined: Apr 2013

But I have mailed the moderators about this to no avail...

/G

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

I agree.. a sticky on this one would be a good thing... in the mean time.. have to "bump" it every now and then...

Ron

CSN_Rowan's picture
CSN_Rowan
Posts: 49
Joined: Nov 2013

Hi Galrim,

I'm actually looking in to creating a sticky for this right now, and if there is a reason that we can't easily put a sticky on this board we'll let you know. Thank you for your continuing support of new members!

Rowan

CSN Support Team

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

Awesome..!

Thanks..!

Ron

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

Here are two links.. one is an early report on a new combo drug trial..  But a 79% plus response rate is amazing..!!

http://ecancer.org/news/5738-asco-2014--ipilimumab-with-nivolumab-achieves-long-term-survival-in-advanced-melanoma.php

And some interesting RCC news..

http://ireport.cnn.com/docs/DOC-1147923

Ron

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

Here is another link from the recent ASCO Conference.  This video tells a broader tale on the Ipi combo with Nivo.  You Southern California people, may want to check out when this combo may show up at City of Hope..  Looks like there may be some difficult side effects, but the rewards should be well worth it..  You know I will be watching this combo..

http://cancergrace.org/kidney-cancer/2014/07/02/asco_2014_hottest_thing_late_stage_kidney/

Ron

GSRon's picture
GSRon
Posts: 1160
Joined: Jan 2013

Hi All.. in case you did not see this... soon we may have another weapon...  Nivolumab..!!

http://news.bms.com/press-release/rd-news/bristol-myers-squibb-announces-plans-third-quarter-submission-biologics-licens&t=635405948819403627

Be Well All..!!

Ron

Subscribe with RSS
About Cancer Society

The content on this site is for informational purposes only. It is not a substitute for professional medical advice. Do not use this information to diagnose or treat a health problem or disease without consulting with a qualified healthcare provider. Please consult your healthcare provider with any questions or concerns you may have regarding your condition. Use of this online service is subject to the disclaimer and the terms and conditions.

Copyright 2000-2014 © Cancer Survivors Network