What’s Coming Down the Pike
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Immunicum AB - INTUVAX™ cancer vaccine
Promising data for cancer vaccine INTUVAX™ in the treatment of kidney cancer
Immunicum AB (publ) presents a status update with promising data from an ongoing clinical phase I/II-study of the cancer vaccine INTUVAX™ in the treatment of metastatic renal cell carcinoma. Two patients with poor prognosis have thus far shown an average survival of about 11 months, which can be compared to the expected median survival of 5 months.
Immunicum AB (publ), a Swedish listed company developing therapeutic cancer vaccines, initiated a clinical phase I/II-study in renal cell carcinoma with its leading cancer vaccine INTUVAX™ in February 2012. On May 21, Immunicum’s CEO gives an update of clinical data at Avanza Bank's Stock Exchange Day.
The clinical trial will include a total of 12 patients with metastatic renal cell carcinoma of which 9 have been treated to date. The treatment consists of two intratumoral injections/vaccinations with INTUVAX™ every two weeks, after which the cancerous kidney is surgically removed.
All treated patients are still alive and injection of INTUVAX™ has not had a negative impact on patients' general condition and no serious side effects have been reported. No patients have so far been considered in need of additional treatment with established kidney cancer drugs.
One of the patients belonging to the subgroup with poor prognosis has so far demonstrated a progression-free survival exceeding 8 months, compared with an expected progression-free survival of approximately 2.5 months in untreated patients in a comparable prognosis group.
- Although we still cannot be sure of the vaccine efficacy, the data that has been gathered so far is looking promising", says CEO Jamal El-Mosleh. INTUVAX™ also seems to be free from the troublesome side effects such as extreme fatigue, nausea, vomiting, painful mouth ulcers and hypertension, which are frequent in the treatment with established drugs for kidney cancer.
For the four patients treated with a higher dose of INTUVAX™, a statistically significant (P <0.01) immunological effect, associated with vaccination, has been observed in the form of a transient decrease in the number of "natural killer cells" (NK cells) in the blood. This suggests that NK cells are recruited to the vaccination site. Furthermore, immunohistological studies revealed a massive infiltration of potentially cytotoxic T cells (CD8 + T cells) in 3 out of 7 treated renal tumors (surgically removed in connection with nephrectomy). However, no increased infiltration of CD8 + cells were observed in the surrounding healthy kidney tissue, indicating that infiltration, and the immune response, is tumor-specific. The infiltration of CD8 + T cells in a resected metastasis has also been studied where a significant infiltration of these cells in the tumor tissue has been noted, indicating that the immune response has effect throughout the entire body and not just locally in vaccinated tumors.
- These immunological findings correspond well with the expected mechanism of action, says Immunicum’s Chief Scientific Officer and founder, Associate Professor Alex Karlsson-Parra.
Immunicum’s patented vaccine is based on over 30 years of research in the field of transplantation immunology and activates the body's own immune system to attack harmful substances like tumor cells.Web Link
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CD47
Anti-CD47 antibody may offer new route to successful cancer vaccination
May 21, 2013 by Christopher Vaughan in Cancer
(Medical Xpress)—Scientists at the School of Medicine have shown that their previously identified therapeutic approach to fight cancer via immune cells called macrophages also prompts the disease-fighting killer T cells to attack the cancer.
The research, published online May 20 in the Proceedings of the National Academy of Sciences, demonstrates that the approach may be a promising strategy for creating custom cancer vaccines.
Various researchers have been working over the years to create vaccines against cancer, but the resulting vaccines have not been highly effective. Current approaches to developing the vaccines rely on using immune cells called dendritic cells to introduce cancer protein fragments to T cells—a process known as antigen presentation. The hope has been that the process would stimulate the body's T cells to identify cancer cells as diseased or damaged and target them for elimination. However, this process often only modestly activates the most potent cancer-fighting kind of T cell, called killer T cells or CD8+ T cells.
The Stanford team discovered that there was another viable vaccine approach, using the macrophage pathway to program killer T cells against cancer. Irving Weissman, MD, professor of pathology and of developmental biology, and his team previously showed that nearly all cancers use the molecule CD47 as a "don't-eat-me" signal to escape from being eaten and eliminated by macrophages. The researchers found that anti-CD47 antibodies, which can block the "don't-eat-me" signal and enable macrophages to engulf cancer cells, eliminated or inhibited the growth of various blood cancers and solid tumors.
In the new study, the Stanford team showed that after engulfing the cancer cells, the macrophages presented pieces of the cancer to CD8+ T cells, which, in addition to attacking cancer, are also potent attackers of virally infected or damaged cells. As a result, the CD8+ T cells were activated to attack the cancer cells on their own. "It was completely unexpected that CD8+ T cells would be mobilized when macrophages engulfed the cancer cells in the presence of CD47-blocking antibodies," said MD/PhD student Diane Tseng, the lead author of the study. Following engulfment of cancer cells, macrophages activate T cells to mobilize their own immune attack against cancer, she said.
The Stanford group plans to start human clinical trials of the anti-CD47 cancer therapy in 2014. The new research provides hope that the therapy will cause the immune system to wage a two-pronged attack on cancer—through both macrophages and T cells. The approach may also give physicians early indicators of how the treatment is working in patients. "Monitoring T-cell parameters in patients receiving anti-CD47 antibody may help us identify the immunological signatures that tell us whether patients are responding to therapy," said co-author Jens Volkmer, MD, an instructor at the Stanford Institute for Stem Cell Biology and Regenerative Medicine.
The research revives interest in an aspect of macrophages that has been neglected for decades: their role in presenting antigens to T cells. For many years, researchers have focused on the dendritic cell as the main antigen-presenting cell, and have generally believed that macrophages specialize in degrading antigens rather presenting them. This research shows that macrophages can be effective at antigen presentation and are powerful initiators of the CD8+T cell response.
The fact that T cells become involved in fighting cancer as a result of CD47-blocking antibody therapy could have important clinical implications. The antibody might be used as a personalized cancer vaccine allowing T cells to recognize the unique molecular markers on an individual patient's cancer. "Because T cells are sensitized to attack a patient's particular cancer, the administration of CD47-blocking antibodies in a sense could act as a personalized vaccination against that cancer," Tseng added.
Below is a link to the Stanford School of Medicine website containing a webpage and video about CD47. BDS
http://stemcell.stanford.edu/CD47/
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Immunotherapy Promising for Kidney Cancer
Orlando, Fla.—In patients with aggressive metastatic renal cell carcinoma (RCC), combining the standard therapy of sunitinib (Sutent, Pfizer) with an experimental fully personalized immunotherapy called AGS-003 (Argos Therapeutics) can double expected progression-free survival (PFS) and overall survival. These results come from a Phase II trial presented at the 2013 ASCO Genitourinary Cancers Symposium (abstract 348).
“We have encouraging clinical and immunologic responses that have been observed and correlated with prolonged overall survival,” said Robert Figlin, MD, the director of the Division of Hematology/Oncology at Cedars-Sinai’s Samuel Oschin Comprehensive Cancer Institute in Los Angeles, who presented the study.
To produce AGS-003, monocytes are isolated from RCC patients during a single leukapheresis procedure and differentiated into dendritic cells. These cells are loaded with antigen-encoding RNA amplified from the patient’s tumor and injected into the patient. Each production run of AGS-003 generates up to five years of treatment for each patient. The immunotherapy stimulates the proliferation of central and effector memory cytotoxic T lymphocytes for a durable immune response.
In the study, 21 patients with newly diagnosed, advanced-stage, unfavorable-risk RCC received one cycle of sunitinib and then five doses of AGS-003 three weeks apart and AGS-003 quarterly until disease progression. Sunitinib also was given until disease progression. The only adverse events (AEs) that were attributed to AGS-003 were injection-site erythema, which occurred in 33.3% of patients, and injection-site induration, which occurred in 23.8% of patients. No grade 3/4 AEs were related to the immunotherapy, and there was no evidence of emergent autoimmune disease.
The median PFS was 11.2 months, and Dr. Figlin pointed out that the median PFS for patients in a similar population who received sunitinib monotherapy would be approximately six months. The median overall survival of the study patients is 30.2 months, roughly twice that expected in a similar population of patients receiving sunitinib monotherapy.
Investigators are planning the Phase III ADAPT trial to compare AGS-003 plus standard therapy with standard therapy alone in newly diagnosed, advanced RCC.
Leonard Gomella, MD, the chair of the Department of Urology at Jefferson University Hospitals in Philadelphia, said the data on AGS-003 was “very encouraging and will need to be confirmed in a larger number of patients.”
—Kate O’Rourke
Web Article:
http://www.clinicaloncology.com/ViewArticle.aspx?d=Solid+Tumors&d_id=148&i=May+2013&i_id=960&a_id=23268
You know it is hard to keep up with all the new developments in renal cell carcinoma but I am trying. - BDS
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Immunotherapy Promising for Kidney CancerBDS said:Immunotherapy Promising for Kidney Cancer
Orlando, Fla.—In patients with aggressive metastatic renal cell carcinoma (RCC), combining the standard therapy of sunitinib (Sutent, Pfizer) with an experimental fully personalized immunotherapy called AGS-003 (Argos Therapeutics) can double expected progression-free survival (PFS) and overall survival. These results come from a Phase II trial presented at the 2013 ASCO Genitourinary Cancers Symposium (abstract 348).
“We have encouraging clinical and immunologic responses that have been observed and correlated with prolonged overall survival,” said Robert Figlin, MD, the director of the Division of Hematology/Oncology at Cedars-Sinai’s Samuel Oschin Comprehensive Cancer Institute in Los Angeles, who presented the study.
To produce AGS-003, monocytes are isolated from RCC patients during a single leukapheresis procedure and differentiated into dendritic cells. These cells are loaded with antigen-encoding RNA amplified from the patient’s tumor and injected into the patient. Each production run of AGS-003 generates up to five years of treatment for each patient. The immunotherapy stimulates the proliferation of central and effector memory cytotoxic T lymphocytes for a durable immune response.
In the study, 21 patients with newly diagnosed, advanced-stage, unfavorable-risk RCC received one cycle of sunitinib and then five doses of AGS-003 three weeks apart and AGS-003 quarterly until disease progression. Sunitinib also was given until disease progression. The only adverse events (AEs) that were attributed to AGS-003 were injection-site erythema, which occurred in 33.3% of patients, and injection-site induration, which occurred in 23.8% of patients. No grade 3/4 AEs were related to the immunotherapy, and there was no evidence of emergent autoimmune disease.
The median PFS was 11.2 months, and Dr. Figlin pointed out that the median PFS for patients in a similar population who received sunitinib monotherapy would be approximately six months. The median overall survival of the study patients is 30.2 months, roughly twice that expected in a similar population of patients receiving sunitinib monotherapy.
Investigators are planning the Phase III ADAPT trial to compare AGS-003 plus standard therapy with standard therapy alone in newly diagnosed, advanced RCC.
Leonard Gomella, MD, the chair of the Department of Urology at Jefferson University Hospitals in Philadelphia, said the data on AGS-003 was “very encouraging and will need to be confirmed in a larger number of patients.”
—Kate O’Rourke
Web Article:
http://www.clinicaloncology.com/ViewArticle.aspx?d=Solid+Tumors&d_id=148&i=May+2013&i_id=960&a_id=23268
You know it is hard to keep up with all the new developments in renal cell carcinoma but I am trying. - BDS
You know it is hard to keep up with all the new developments in renal cell carcinoma but I am trying. - BDS
And a damned fine job you're making of it, BDS, for which we're all greatly indebted to you!!!
Apart from the actual content itself, the sheer fact that so much promising work is being carried out is a huge boost to the morale for everyone here.
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updatesBDS said:Immunotherapy Promising for Kidney Cancer
Orlando, Fla.—In patients with aggressive metastatic renal cell carcinoma (RCC), combining the standard therapy of sunitinib (Sutent, Pfizer) with an experimental fully personalized immunotherapy called AGS-003 (Argos Therapeutics) can double expected progression-free survival (PFS) and overall survival. These results come from a Phase II trial presented at the 2013 ASCO Genitourinary Cancers Symposium (abstract 348).
“We have encouraging clinical and immunologic responses that have been observed and correlated with prolonged overall survival,” said Robert Figlin, MD, the director of the Division of Hematology/Oncology at Cedars-Sinai’s Samuel Oschin Comprehensive Cancer Institute in Los Angeles, who presented the study.
To produce AGS-003, monocytes are isolated from RCC patients during a single leukapheresis procedure and differentiated into dendritic cells. These cells are loaded with antigen-encoding RNA amplified from the patient’s tumor and injected into the patient. Each production run of AGS-003 generates up to five years of treatment for each patient. The immunotherapy stimulates the proliferation of central and effector memory cytotoxic T lymphocytes for a durable immune response.
In the study, 21 patients with newly diagnosed, advanced-stage, unfavorable-risk RCC received one cycle of sunitinib and then five doses of AGS-003 three weeks apart and AGS-003 quarterly until disease progression. Sunitinib also was given until disease progression. The only adverse events (AEs) that were attributed to AGS-003 were injection-site erythema, which occurred in 33.3% of patients, and injection-site induration, which occurred in 23.8% of patients. No grade 3/4 AEs were related to the immunotherapy, and there was no evidence of emergent autoimmune disease.
The median PFS was 11.2 months, and Dr. Figlin pointed out that the median PFS for patients in a similar population who received sunitinib monotherapy would be approximately six months. The median overall survival of the study patients is 30.2 months, roughly twice that expected in a similar population of patients receiving sunitinib monotherapy.
Investigators are planning the Phase III ADAPT trial to compare AGS-003 plus standard therapy with standard therapy alone in newly diagnosed, advanced RCC.
Leonard Gomella, MD, the chair of the Department of Urology at Jefferson University Hospitals in Philadelphia, said the data on AGS-003 was “very encouraging and will need to be confirmed in a larger number of patients.”
—Kate O’Rourke
Web Article:
http://www.clinicaloncology.com/ViewArticle.aspx?d=Solid+Tumors&d_id=148&i=May+2013&i_id=960&a_id=23268
You know it is hard to keep up with all the new developments in renal cell carcinoma but I am trying. - BDS
BDS Thanks for keeping all of us updated. It gives all of us great hope for the future.
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U.S. drugmakers cheer 'speed lane' for breakthrough therapies
U.S. drugmakers cheer 'speed lane' for breakthrough therapies
By Toni Clarke | Reuters
WASHINGTON (Reuters) - A new regulatory pathway could shave years off the traditional drug approval process in the United States, according to some companies whose drugs have been given "breakthrough therapy" designation by the U.S. Food and Drug Administration.
Speaking at a briefing in Washington to raise awareness of the drug review process, Dr. Jay Siegel, head of global regulatory affairs at Johnson & Johnson, said he expects two years to be knocked off the time it would typically take the FDA to review ibrutinib, the company's experimental cancer drug.
To be granted breakthrough designation, an experimental drug must show early indication of clinical improvement over existing therapies, even if the clinical trial is small. It might apply, for example, to a new type of cancer drug that shows strong early promise.
J&J's ibrutinib, which it is developing with Pharmacyclics Inc, would be the first in a class of oral medicines that block a protein known as Bruton's tyrosine kinase. It is being developed for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and for patients with mantle cell lymphoma, both cancers of the blood.
Dr. Jeffrey Leiden, the chief executive of Vertex Pharmaceuticals Inc, who also spoke at the briefing and whose cystic fibrosis drug Kalydeco was approved under the designation, said his company's experience working with the FDA was dramatically different from the normal drug approval process.
Under breakthrough designation, he said, "everything is on the table" for discussion in order to move the process along as quickly as possible. Communications that might typically take weeks and months, under the breakthrough pathway take minutes.
"We pick up the phone and talk in real time," Leiden said. "It makes the process immeasurably smoother."
The breakthrough pathway was spearheaded by Friends of Cancer Research, a patient advocacy organization. It received bipartisan support in Congress and was signed into law in July 2012. As of July 12, the FDA had received 67 requests for breakthrough designation. It had granted 24 and denied 18.
Dr. Janet Woodcock, director of the FDA's drugs division, said during the discussion that the breakthrough pathway was designed to accommodate new science, particularly targeted therapies that may work in people with certain genetic mutations. She noted that just because the review process is speeded up there is no guarantee of approval.
In the 1990s, she said, the agency was not seeing drugs whose promise could be detected in early clinical trials.
"We didn't see these therapies in Phase I or II where you said 'bingo,' you've got a likely winner," she said.
Still, there are challenges associated with speeding up a drug's development timeline. For one thing, other nations might not be willing to approve the products based on the FDA's more flexible clinical trial standards under the breakthrough designation.
"Our hope is that foreign regulators will catch up," Siegel said.
Moreover, he said, it is not clear that insurers will pay for drugs if the data do not show improved survival or other clear benefit they are used to seeing when drugs are approved. One task, he said is to figure out "how to bring payors on board."
The panelists did not discuss what happens once a drug reaches the market under the breakthrough designation.
Under a separate pathway known as "accelerated approval" drugs may be approved based on a so-called surrogate endpoint - a measure, such as tumor shrinkage - that might reasonably be expected to confer a clinical benefit such as improved survival.
Companies that win approval for a product under the accelerated approval process are required subsequently to prove through further clinical trials that the surrogate measure does in fact correlate with improved survival or a reduction in disease symptoms.
"A discussion on this topic is reckless if it doesn't discuss the next stage after the drug reaches the market," said Sidney Wolfe, co-founder and senior adviser to Public Citizen's Health Research Group, a watchdog organization that has frequently criticized the FDA for approving, or failing to withdraw, drugs it considers unsafe.
Woodcock said the FDA is now working to develop a mechanism to speed the development of breakthrough diagnostics that can be used in conjunction with new drugs to help identify which patients will respond to a particular therapy.
(Reporting by Toni Clarke; Editing by Ros Krasny and Lisa Shumaker)
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another interesting article
http://shearlingsplowed.blogspot.com/2013/04/merck-oncology-candidate-granted.html
This drug is also granted as "breakthrough" and it is now chasing Nivolumab. Will patients benefit from the catching up game? I hope so!!!!
Here are some other clinical trials I've been watching, BDS.
1. Dovitinib is against FGFR pathway, and the clinical results show its effectiveness in heavily pretreated patients. Since it targets a differernt pathway, I am hoping that it can extend life in the true sense.The article below tells us sth about FGFR pathway.2. Another one is Gemcitabine + Capecitabine，the article below summarizes several experiments that have been conducted. These two drugs are already FDA approved, right?0 -
Immunicum AB cancer vaccine
Faster Pace Than Expected, Immunicum Completes Treatment of the Last Patient in Its Kidney Cancer Vaccine Phase I/II-Study Already in August
Category: Vaccines
Published on Monday, 19 August 2013 12:34
GOTHENBURG, Sweden I August 19, 2013 I Immunicum AB (publ) today announced that the last scheduled patient in the Company's phase I/II study in metastatic renal cancer has received the concluding dose of the cancer vaccine INTUVAX(R).
The study is conducted at the University Hospital in Uppsala and at Norrland University Hospital. A total of 12 patients with metastatic renal cancer have been treated with the cancer vaccine INTUVAX(R) and the results have so far shown promise.
On May 20, Immunicum reported a status update where the Company concluded that no serious vaccine-related adverse events have been recorded and that the immune system appears to be activated specifically against cancer. In addition, immunological findings suggest that the immune system also has an effect on metastases and not only in the primary tumor where the vaccine was administered. No patients have yet passed away and survival data for patients with poor prognosis already looks promising. Two patients in this subgroup have thus far shown an average survival of about 14 months, which may be compared to the expected median survival of 5 months for untreated patients and about 8 months for patients treated with existing therapies, such as Sutent, that are also associated with adverse effects.
- The patients were included faster than expected and we now plan to complete the final study report at the beginning of next year. We are obviously very pleased with the promising survival data we have seen so far but it is not until we have completed the final report that we can better determine their validity and other efficacy parameters we study, says Jamal El-Mosleh, CEO of Immunicum.
In parallel with the completion of the phase I/II-study in renal cancer, Immunicum will intensify its work in the fall with planning the upcoming phase II-trial in renal cancer and focus on the initiation of the Company's newly approved phase I/II-trial in liver cancer. The first patient in the liver cancer study is expected to be treated around the turn of the year.
Immunicum's patented vaccine is based on over 30 years of research in the field of transplantation immunology and activates the body's own immune system to attack harmful substances like tumor cells.
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Nivolumab Benefits Durable in Three Tumor Types
Nivolumab Benefits Durable in Three Tumor Types
Anita T. Shaffer
Published Online: Monday, August 19, 2013
Nivolumab, the most advanced agent in the rapidly developing field of PD-1-targeting cancer immunotherapy, delivered durable clinical benefits across multiple solid tumor types, according to long-term data from a phase I trial.
Benefits in overall response rates and survival were evident in patients with advanced, treatment-refractory melanoma, non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC), with the most dramatic results seen in melanoma, according to Suzanne L. Topalian, MD, who presented the findings during the 2013 American Society of Clinical Oncology Annual Meeting in Chicago in June.1
The overall response rates (ORRs), defined as complete or partial responses by standard RECIST criteria, were 31% for patients with melanoma, 29% for those with RCC, and 17% for participants with NSCLC.
The results represent long-term efficacy data involving 306 patients who received nivolumab from 2008-2012, with at least 14 months’ follow-up. The participants had a median age of 63 years and good performance status scores, and nearly half had received three or more prior therapies.
Topalian, a professor of Surgery and Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, Maryland, said overall survival results (Table) “compare favorably to published results in similar heavily pretreated patient groups with advanced metastatic disease.”Table. Nivolumab Phase I Long-Term Results1
Tumor Type
ORR
(%; no patients)Response Duration
(median; mo)OS
(median; mo)Survival (%)
1 yr
2 yr
Melanoma
31 (33/107)
24.0
16.8
62
43
NSCLC
17 (22/129)
17.0
9.6
42
14
RCC
29 (10/34)
12.9
>22
70
50
NSCLC indicates non-small cell lung cancer; ORR, overall response rate; OS, overall survival; RCC, renal cell carcinoma.
Earlier data from the trial, presented last year at ASCO’s annual meeting, have generated much excitement. The ongoing positive findings have prompted Bristol-Myers Squibb to advance development of the drug; there are now six ongoing phase III trials in the three tumor types.
Nivolumab, also known as BMS-936558, targets the PD pathway. “This is a normal turnoff mechanism that’s used by the immune system to terminate immune responses at the appropriate time,” said Topalian. “It’s a pathway that can be co-opted by cancer cells to fly below the radar of the immune system.”
A fully human monoclonal antibody, nivolumab blocks the PD-1 receptor from binding to both of its known ligands, PD-L1 (B7-H1) and PD-L2 (B7-DC), thus “rejuvenating antitumor immunity,” Topalian said.Topalian said the results suggest that “nivolumab can reset the balance between the immune system and cancer.” Of the 65 patients who responded to the drug, 65% (42 patients) had a response lasting more than a year and 54% (35 patients) had ongoing responses at the time of data analysis. “Responses are persisting in some cases for a fairly long time after the drug is stopped,” said Topalian.
The treatment consisted of four-dose cycles of intravenously administered nivolumab (0.1-10 mg/kg) every two weeks for eight-week cycles, with a maximum duration of treatment for up to two years. Among 27 responding patients who had discontinued treatment for reasons other than disease progression, 70% (19 patients) maintained responses off-drug for 16-59 weeks, including 14 patients whose response was ongoing at time of analysis, Topalian said.
In terms of adverse events (AEs), Topalian said most of the toxicities occurred within the first six months of treatment, with skin and gastrointestinal reactions most frequently reported. Drug-related AEs of all grades occurred among 75% of the patients, including 17% of patients who experienced grades 3/4 AEs. Immune-related AEs of all grades occurred in 46% of patients, including grades 3/4 AEs in 6% of participants.
There were three deaths associated with pneumonitis early in the trial, resulting in the development of treatment algorithms for early detection and management, said Topalian.0 -
Nivolumab resultsBDS said:Nivolumab Benefits Durable in Three Tumor Types
Nivolumab Benefits Durable in Three Tumor Types
Anita T. Shaffer
Published Online: Monday, August 19, 2013
Nivolumab, the most advanced agent in the rapidly developing field of PD-1-targeting cancer immunotherapy, delivered durable clinical benefits across multiple solid tumor types, according to long-term data from a phase I trial.
Benefits in overall response rates and survival were evident in patients with advanced, treatment-refractory melanoma, non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC), with the most dramatic results seen in melanoma, according to Suzanne L. Topalian, MD, who presented the findings during the 2013 American Society of Clinical Oncology Annual Meeting in Chicago in June.1
The overall response rates (ORRs), defined as complete or partial responses by standard RECIST criteria, were 31% for patients with melanoma, 29% for those with RCC, and 17% for participants with NSCLC.
The results represent long-term efficacy data involving 306 patients who received nivolumab from 2008-2012, with at least 14 months’ follow-up. The participants had a median age of 63 years and good performance status scores, and nearly half had received three or more prior therapies.
Topalian, a professor of Surgery and Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore, Maryland, said overall survival results (Table) “compare favorably to published results in similar heavily pretreated patient groups with advanced metastatic disease.”Table. Nivolumab Phase I Long-Term Results1
Tumor Type
ORR
(%; no patients)Response Duration
(median; mo)OS
(median; mo)Survival (%)
1 yr
2 yr
Melanoma
31 (33/107)
24.0
16.8
62
43
NSCLC
17 (22/129)
17.0
9.6
42
14
RCC
29 (10/34)
12.9
>22
70
50
NSCLC indicates non-small cell lung cancer; ORR, overall response rate; OS, overall survival; RCC, renal cell carcinoma.
Earlier data from the trial, presented last year at ASCO’s annual meeting, have generated much excitement. The ongoing positive findings have prompted Bristol-Myers Squibb to advance development of the drug; there are now six ongoing phase III trials in the three tumor types.
Nivolumab, also known as BMS-936558, targets the PD pathway. “This is a normal turnoff mechanism that’s used by the immune system to terminate immune responses at the appropriate time,” said Topalian. “It’s a pathway that can be co-opted by cancer cells to fly below the radar of the immune system.”
A fully human monoclonal antibody, nivolumab blocks the PD-1 receptor from binding to both of its known ligands, PD-L1 (B7-H1) and PD-L2 (B7-DC), thus “rejuvenating antitumor immunity,” Topalian said.Topalian said the results suggest that “nivolumab can reset the balance between the immune system and cancer.” Of the 65 patients who responded to the drug, 65% (42 patients) had a response lasting more than a year and 54% (35 patients) had ongoing responses at the time of data analysis. “Responses are persisting in some cases for a fairly long time after the drug is stopped,” said Topalian.
The treatment consisted of four-dose cycles of intravenously administered nivolumab (0.1-10 mg/kg) every two weeks for eight-week cycles, with a maximum duration of treatment for up to two years. Among 27 responding patients who had discontinued treatment for reasons other than disease progression, 70% (19 patients) maintained responses off-drug for 16-59 weeks, including 14 patients whose response was ongoing at time of analysis, Topalian said.
In terms of adverse events (AEs), Topalian said most of the toxicities occurred within the first six months of treatment, with skin and gastrointestinal reactions most frequently reported. Drug-related AEs of all grades occurred among 75% of the patients, including 17% of patients who experienced grades 3/4 AEs. Immune-related AEs of all grades occurred in 46% of patients, including grades 3/4 AEs in 6% of participants.
There were three deaths associated with pneumonitis early in the trial, resulting in the development of treatment algorithms for early detection and management, said Topalian.Taken along with Chuck's excellent response in the nivo/ipi trial, the future looks increasingly rosy for anti PD1 treatments, doesn't it?
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I'm proudTexas_wedge said:Nivolumab results
Taken along with Chuck's excellent response in the nivo/ipi trial, the future looks increasingly rosy for anti PD1 treatments, doesn't it?
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!
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Update. sort ofBDS said:CD47
Anti-CD47 antibody may offer new route to successful cancer vaccination
May 21, 2013 by Christopher Vaughan in Cancer
(Medical Xpress)—Scientists at the School of Medicine have shown that their previously identified therapeutic approach to fight cancer via immune cells called macrophages also prompts the disease-fighting killer T cells to attack the cancer.
The research, published online May 20 in the Proceedings of the National Academy of Sciences, demonstrates that the approach may be a promising strategy for creating custom cancer vaccines.
Various researchers have been working over the years to create vaccines against cancer, but the resulting vaccines have not been highly effective. Current approaches to developing the vaccines rely on using immune cells called dendritic cells to introduce cancer protein fragments to T cells—a process known as antigen presentation. The hope has been that the process would stimulate the body's T cells to identify cancer cells as diseased or damaged and target them for elimination. However, this process often only modestly activates the most potent cancer-fighting kind of T cell, called killer T cells or CD8+ T cells.
The Stanford team discovered that there was another viable vaccine approach, using the macrophage pathway to program killer T cells against cancer. Irving Weissman, MD, professor of pathology and of developmental biology, and his team previously showed that nearly all cancers use the molecule CD47 as a "don't-eat-me" signal to escape from being eaten and eliminated by macrophages. The researchers found that anti-CD47 antibodies, which can block the "don't-eat-me" signal and enable macrophages to engulf cancer cells, eliminated or inhibited the growth of various blood cancers and solid tumors.
In the new study, the Stanford team showed that after engulfing the cancer cells, the macrophages presented pieces of the cancer to CD8+ T cells, which, in addition to attacking cancer, are also potent attackers of virally infected or damaged cells. As a result, the CD8+ T cells were activated to attack the cancer cells on their own. "It was completely unexpected that CD8+ T cells would be mobilized when macrophages engulfed the cancer cells in the presence of CD47-blocking antibodies," said MD/PhD student Diane Tseng, the lead author of the study. Following engulfment of cancer cells, macrophages activate T cells to mobilize their own immune attack against cancer, she said.
The Stanford group plans to start human clinical trials of the anti-CD47 cancer therapy in 2014. The new research provides hope that the therapy will cause the immune system to wage a two-pronged attack on cancer—through both macrophages and T cells. The approach may also give physicians early indicators of how the treatment is working in patients. "Monitoring T-cell parameters in patients receiving anti-CD47 antibody may help us identify the immunological signatures that tell us whether patients are responding to therapy," said co-author Jens Volkmer, MD, an instructor at the Stanford Institute for Stem Cell Biology and Regenerative Medicine.
The research revives interest in an aspect of macrophages that has been neglected for decades: their role in presenting antigens to T cells. For many years, researchers have focused on the dendritic cell as the main antigen-presenting cell, and have generally believed that macrophages specialize in degrading antigens rather presenting them. This research shows that macrophages can be effective at antigen presentation and are powerful initiators of the CD8+T cell response.
The fact that T cells become involved in fighting cancer as a result of CD47-blocking antibody therapy could have important clinical implications. The antibody might be used as a personalized cancer vaccine allowing T cells to recognize the unique molecular markers on an individual patient's cancer. "Because T cells are sensitized to attack a patient's particular cancer, the administration of CD47-blocking antibodies in a sense could act as a personalized vaccination against that cancer," Tseng added.
Below is a link to the Stanford School of Medicine website containing a webpage and video about CD47. BDS
http://stemcell.stanford.edu/CD47/
Hi All..!! I was at Stanford on 9-5-13 and asked about CD47 again. Yes looks like the date for the 1st trial has been moved to mid-2014. But it also states there may be a trial in the U.K. So my U.K. pals please note..! The link seems to have the best info, thanks BDS..! I will continue to ask about it.. as this really sounds promising..! Oh yes, and just me asking about it, got several smiles.. All the people I see at Stanford are very pleased about the possibility... Hang on folks..!! Please be able to hang on... Ron Oh yes, go to the link below, then watch the video.. I think it is very impressive..!
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Immatics - IMA901
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
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CRLX101
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.”
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.
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This may duplicate otherBDS said:CRLX101
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.”
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.
This may duplicate other postings, but a dr friend sent this to me...
http://www.cancer.gov/clinicaltrials/search/results?protocolsearchid=6461052&vers=2
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Interesting
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.htm0 -
Promising Immune Activation Found in mRCC for AGS-003
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
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Immunicum reports positive phase I/II-data
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.
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First this post needs to beBDS said:Immunicum reports positive phase I/II-data
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.
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
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