Difference between revisions of "Cancer Vaccines - Clinical Trial Analysis"
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Contents
Cancer Incidence
The following interactive chart gives the global cancer incidence, Cancer incidence by countries, Cancer incidence in USA (for every type of cancer) and agewise cancer incidence (Breakup for male and female is also depicted).
Click on the tabs to view the required information
Market Overview - Cancer Vaccines
The following interactive chart gives the market overview for Cancer Vaccines
Click on the relevant tab for more information
Market Size
- The global market size of Cancer vaccines has increased from $1500 Mn in 2007 to $1657 Mn in 2010
- Till 2009, the Cancer Vaccine market was dominated by Cervical Cancer Vaccines, occupying more than 99% market share
- The major Cervical cancer vaccines in the cancer vaccines market were Gardasil (by Merck) and Cervarix (by Glaxo Smith Kline)
- These vaccines prevent the occurrence of human papillomavirus (HPV), the most common sexually transmitted infection (STI) in the United States, with about 6.2 million cases diagnosed annually
- Gardasil prevents infection of four strains of HPV—two strains (16, 18) that cause 70% of cervical cancer cases and two strains (6, 11) that cause 90% of genital warts cases
- The Cervarix vaccine, which is used more broadly in several countries outside the U.S., protects only against HPV strains 16 and 18
- Only after the launch of Provenge, a prostate cancer vaccine by Dendreon in April 2010, Prostate cancer vaccine market gained a market share of 10% in 2010
- The CAGR of Cancer Vaccines Market during the period 2007-2010 was 3.4%
Market Segmentation
By Vaccine Type
The Cancer Vaccines market can be segmented based on the when a particular vaccine is to be administered. Based on the Vaccine type, cancer vaccines are segmented into 2 segments:
- Therapeutic Cancer Vaccines - Therapeutic cancer vaccines are designed to treat existing cancers. They are given to cancer patients to stimulate the immune system into recognizing and destroying their existing cancer
- Prophylactic Cancer Vaccines - Prophylactic cancer vaccines are designed to prevent the development of cancer. They are given to healthy subjects to prevent infection with cancer-causing viruses
By Cancer Type
Cancer Vaccine market can also be segmented based which type of cancer, the vaccine caters to. According to this classification, cancer vaccine market has 7 major segments:
- Prostate Cancer Vaccine
- Renal Cancer Vaccine
- Bladder Cancer Vaccine
- Cervical Cancer Vaccine
- Colon/Rectal/Colorectal Cancer Vaccine
- Lymphoma Cancer Vaccine
- Melanoma Cancer Vaccine
Other minor segments in the cancer vaccine market are almost non existent. But there are many clinical trials going on in these segments by various companies and universities. These segments include Lung Cancer, Breast Cancer, Pancreatic Cancer, Ovarian Cancer, Brain Cancer, Metastate Cancer etc
Market Forecast
- The Cancer Vaccine market is forecasted to generate a revenue of $2198 Mn in 2011
- It is expected to grow at a CAGR of 35.9% and reach the market size of $7690 Mn by 2015
- Therapeutic cancer vaccines are expected to occupy a market share of 76.1% whereas Prophylactic cancer vaccines occupy only 23.9% of the market
- Prostate cancer is expected to gain 58.39% of the cancer vaccines market by 2015 and Cervical Cancer Vaccines are expected to occupy 25.49% of the market
- The other types of cancer vaccines, mainly being Renal, Bladder, Colon/Rectal, Lymphoma and Melanoma, are expected to occupy 15.67% of the market share
Market Analysis
Prostate Cancer
- The Prostate Vaccine Segment is expected to be the most lucrative in the cancer vaccine market by 2015
- Provenge, the only prostate cancer vaccine, is expected to generate a lot of revenue for Dendreon
- Within 9 months of its launch, Provenge generated a revenue of $48Mn in 2010 (Source: Dendreon Annual Report 2010)
- Provenge is expected to generate revenues of $350-400 Mn in 2011 (Source:WSJ)
- Prostate Cancer vaccine market is expected to grow with a CAGR of 90.3% by 2015 (The CAGR calculated is for the period 2010 - 2015)
- Prostate Cancer is seeing high activity with 21 clinical trials in this segment
Prostate Cancer - Incidence Rate
The following chart illustrates Delay-adjusted SEER Incidence Rates by Year, for Prostate Cancer:
Source: SEER
To know more about Prostate Cancer, click here
Cervical Cancer
- Cervical cancer is expected to be the second most lucrative segment in the cancer vaccines market by 2015
- Cervical cancer vaccines Gardasil and Cervaix will be among the top three bestselling vaccines
- Cervical Cancer vaccine market is expected to grow with a CAGR of 5.8% by 2015 (The CAGR calculated is for the period 2010 - 2015)
Apart from the cervical cancer segment - Melanoma and Lung Lymphoma cancer vaccine segments are also seeing high activity with a number of products in late stage of development (Source)
Significant Cancer Vaccine Approvals
In April 2010, the cancer vaccine market experienced one of the biggest achievements in the therapeutic vaccine treatment of cancer-the approval of the prostate cancer vaccine PROVENGE (TM). This, in addition to the success of cervical cancer vaccine products, has created a viable market for what was merely a speculative area just one decade ago. Even with achievements for some companies, numerous vaccines with apparently strong prospects have been hit by developmental delays and failures. These include CancerVax's Canvaxin, Aphton's Insegia, Progenics' GMK vaccine, and Biomira's Theratope. Despite setbacks many developers are hopeful of a turnaround. With a couple prophylactic vaccines for cervical cancer on the market, a few select therapeutic vaccine approvals and several therapeutic vaccines on a promising path to commercialization, the market could see a surge of regulatory activity and an influx of market opportunities.
The following table lists down the significant Cancer Vaccines that have been approved in 2000-2010
Product Approved | Company | Region | Approval Year | Cancer Type Treated | Vaccine Type |
Cervarix | GlaxoSmithKline | European Union | 2007 | Cervical | Prophylactic |
Cervarix | GlaxoSmithKline | United States | 2009 (October) | Cervical | Prophylactic |
DCVax-Brain | Northwest Biotherapeutics | Switzerland | 2007 (November) | Brain | Therapeutic |
Gardasil | Merck | United States | 2006 (June) | Cervical | Prophylactic |
Gardasil | Merck | European Union | 2006 (September) | Cervical | Prophylactic |
Melacine (disc.) | Corixa Corp | Canada | 2001 | Melanoma | Therapeutic |
MVAX | AVAX Technologies | Switzerland | 2005 | Melanoma | Therapeutic |
MVAX (disc.) | AVAX Technologies | Australia | 2000 | Melanoma | Therapeutic |
Oncophage | Antigenics | Russia | 2008 (April) | Renal | Therapeutic |
Onco VAX | Vaccinogen | Netherlands | 2008 (May) | Colon | Therapeutic |
Provenge | Dendreon | United States | 2010 (April) | Prostate | Therapeutic |
Clinical Trials - Cancer Vaccines
This section presents detailed information on all the clinical trials, by companies and universities, that are going on in the Cancer Vaccines area.
Number of Clinical Trials
By Cancer Type and Trial Phase
Click on the cells below to get the corresponding number of clinical trials in that area, by companies/universities
By Company/University conducting the trial and Trial Phase
Click on the cells below to get the corresponding number of clinical trials in that area, by cancer type
Possible Cancer Vaccine Launches
Number of Cancer Vaccines in each area
There are 28 clinical trials going on in Phase III in the cancer vaccines area, which could be a potential launch in the next 5 years.
The following table shows the number of clinical trials, in Phase III, going on in each cancer area
Cancer Type | No. of Vaccines under Clinical Trial |
Prostate | 6 |
Lung | 4 |
Melanoma | 3 |
Renal | 3 |
Cervical | 2 |
Breast | 1 |
Colon/Rectal | 1 |
Genital Warts | 1 |
Lymphoma | 1 |
Vaginal | 1 |
Vulvar | 1 |
Drug Details
The areas expected to display the highest competition include melanoma, lymphoma, cervical, renal and prostate cancer. These areas have a wide range of research and development activities brewing from preclinical trials to Phase III. Many of the products already in Phase III development have orphan drug status, SPA status, or Fast Track status. This provides a promising future for many of these products.
The following Cancer Vaccines are in their last stages of the clinical trials (Phase III). The table gives details of every possible Cancer Vaccine, to be launched by 2013-2015.
S.No. | Cancer Vaccine Type | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | Breast | - | Stimuvax | Oncothyreon | III | Suspended | - | - | - |
2 | Cervical | - | HPV-16/18 vaccine (Cervarix) Aimmugen™ |
GlaxoSmithKline | III | Approval in more than 70 countries including European Union countries, Mexico, Singapore, Australia; Received approval in the U.S. in October 2009 | 2006 | 2009 | Source |
3 | Cervical | - | V503 | Merck | III | Expected results in late 2011 | 2010 | 2011 | Source |
4 | Colon/Rectal | - | OncoVAX autologous vaccine |
Vaccinogen | III | Available in Netherlands/Switzerland Possible U.S. and E.U. approvals in 2014 | - | - | - |
5 | Genital Warts | - | V503 | Merck | III | Expected results in late 2011 | 2010 | 2011 | Source |
6 | Lung | - | Lucanix | NovaRx | III | Earliest approval - late 2013 | 2008 | 2012 | Source |
7 | Lung | - | Stimuvax, Placebo | EMD Serono, Merck KGaA | III | Active: The purpose of this study is to determine whether the cancer vaccine Stimuvax in addition to best supportive care is effective in prolonging the lives of patients with unresectable stage III non-small cell lung cancer, compared to best supportive care alone. | 2006 | 2014 | Source |
8 | Lung | - | TG 4010 | Transgene | II/III | TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen. | 2011 | 2016 | Source |
9 | Lung | - | L-BLP25 or BLP25 liposome vaccine (Stimuvax), Placebo | Merck KGaA | III | Darmstadt, Germany, June 17 2010 - Merck Serono, a division of Merck KGaA, and its U.S. affiliate, EMD Serono, Inc. today announced that they are resuming their Stimuvax® (BLP25 liposome vaccine)* clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, START and INSPIRE. | 2009 | 2018 | Source |
10 | Lung | - | MAGE-A3 | GlaxoSmithKline | III | Beyond 2015 | - | - | - |
11 | Lung | - | EGF Cancer Vaccine/ TGF Cancer Vaccine |
Biovest International | II/III | - | - | - | - |
12 | Lymphoma | - | tumor specific immune response, control vaccine | Biovest International | III | Fast-Track Phase III completed; Pending U.S. and European regulatory applications |
2000 | 2009 | Source |
13 | Lymphoma | - | MyVax | Genitope Corporation | II/III | This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. | 2006 | Ongoing | Source |
14 | Melanoma | - | MDX-010 (anti-CTLA4) monoclonal antibody | Bristol-Myers | III | Fastrack Approval possibly by 2013 |
2004 | 2009 | Source |
15 | Melanoma | - | Dacarbazine (DTIC), Temozolomide (TMZ) | Vical/AnGes | III | Approval possibly by 2013 | 2006 | 2012 | Source |
16 | Melanoma | - | MVax autologous cell vaccine | AVAX Technologies | III | Study suspended pending capitalization in US | - | - | - |
17 | Ovarian | - | Abagovomab | Menarini Group | II/III | The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy. | 2006 | 2015 | Source |
18 | Prostate | - | sipuleucel-T, APC-Placebo | Dendreon | III | Completed. This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer. |
2000 | 2005 | Source |
19 | Prostate | - | Provenge | Dendreon | III | The Protect-Provenge Treatment and Early Cancer Treatment trial is a Phase IIIB trial for patients with hormone sensitive prostate cancer. | 2001 | 2006 | Source |
20 | Prostate | - | Provenge | Dendreon | III | The PROTECT-PROvenge Treatment and Early Cancer Treatment trial is a Phase IIIB trial for patients with hormone sensitive prostate cancer | 2001 | 2006 | Source |
21 | Prostate | Provenge | Sipuleucel-T, APC-Placebo | Dendreon | III | Provenge is an investigational product designed to activate a man’s own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them. Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study. | 2003 | 2010 | Source |
22 | Prostate | ProstAtak | AdV-tk + valacyclovir; Placebo + valacyclovir | Advantagene | III | This is a double-blinded, randomized, placebo-controlled Phase 3 trial of ProstAtak™(AdV-tk + valacyclovir) in combination with standard external beam radiation therapy with or without androgen deprivation therapy (ADT) for intermediate-high risk localized prostate cancer. ProstAtak™ is an investigational product that kills tumor cells and elicits an anti-tumor vaccine effect. The hypothesis is that this combination therapy can lead to improvement in the clinical outcome for patients with newly diagnosed prostate cancer. Patients will be randomized to the ProstAtak™ or control arm at a 2:1 ratio. | 2011 | 2015 | Source |
23 | Prostate | - | DCVax-Prostate | Northwest Biotherapeutics | III | Earliest Approval -2011 | - | - | - |
24 | Renal | Sunitinib, Cyclophosphamide | IMA901 plus GM-CSF | Immatics Biotechnologies GmbH | III | The primary objective of the phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with sunitinib. Secondary objectives include a subgroup analysis of overall survival in patients defined by a certain biomarker signature, the investigation of progression-free survival, best tumor response, safety, and immunological parameters | 2010 | 2011 | Source |
25 | Renal | - | - | Antigenics | III | Terminated due to lack of enrollment | 2002 | - | Source |
26 | Renal | - | Reniale | FBM-Pharma | III | Approval in select regions outside the U.S. by 2013 | - | - | - |
27 | Vaginal | - | V503 | Merck | III | Expected results in late 2011 | 2010 | 2011 | Source |
28 | Vulvar | - | V503 | Merck | III | Expected results in late 2011 | 2010 | 2011 | - |
Clinical Trial Details - by Cancer Type
Lung Cancer
There are 44 clinical trials for cancer vaccines going on in the Lung Cancer area.
The following table gives all the details on clinical trials going on in the field of Lung Cancer for Vaccines
S.No | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | - | AVX701 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
2 | - | V934/V935 | Merck | I | Completed. This is a two-part study to test the safety, tolerability, and immune response for V934/V935 vaccine using a new prime-boost regimen in participants with selected solid tumors. |
2008 | 2011 | Source |
3 | - | Lucanix | NovaRx | III | Earliest approval - late 2013 | 2008 | 2012 | Source |
4 | - | MAGE-A3 | GlaxoSmithKline | III | Beyond 2015 | - | - | - |
5 | - | BLP25 Liposome Vaccine plus best supportive care | Oncothyreon/ Merck | II | NDA submission 2011-2012 | 2000 | 2006 | Source |
6 | - | EGF Cancer Vaccine/ TGF Cancer Vaccine |
Biovest International | II/III | - | - | - | - |
7 | - | GI-4000 Vaccine + Activated T Cells, Surgical Evaluation after Vaccine 4 | University of Pennsylvania | I | The purpose of this study is to determine if it is safe to add multiple immunotherapies to standard chemotherapy and radiation for treating pancreatic cancer tumors that cannot be completely removed by surgery | 2008 | 2009 | Source |
8 | - | HyperAcute-Lung Cancer Vaccine | NewLink Genetics | II | Terminated. Purpose was: To determine the response rate of the administration of HyperAcute-Lung Cancer Vaccine for subjects with stage IIIB or stage IV non-small cell lung cancer who have been treated with first line platinum-doublet therapy and have responded or are considered to have stable disease. |
2007 | 2011 | Source |
9 | - | TG 4010 | Transgene | II/III | TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen. | 2011 | 2016 | Source |
10 | - | LungVax | AVAX Technologies | II | - | - | - | - |
For more clinical trials in the Lung Cancer area, click here
Prostate Cancer
There are 21 clinical trials for cancer vaccines going on in the Prostate Cancer area.
The following table gives all the details on clinical trials going on in the field of Prostate Cancer for Vaccines
S.No. | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | GVAX Pancreas, Cyclophosphamide and CRS-207 | - | Aduro BioTech | I | This clinical trial will evaluate the safety, immune response and overall survival of the sequential administration of two cancer vaccines, GVAX Pancreas Vaccine and CRS-207. GVAX vaccines are composed of cancer cells that have been genetically-modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to stimulate the immune system and that have been irradiated to prevent further cell division. GVAX Pancreas is administered with cyclophosphamide, which has been shown to increase effectiveness of GVAX by inhibiting T regulatory cells | 2011 | 2014 | Source |
2 | GVAX Pancreas, Cyclophosphamide and CRS-207 | - | Aduro BioTech | II | This clinical trial will evaluate the safety, immune response and overall survival of the sequential administration of two cancer vaccines, GVAX Pancreas Vaccine and CRS-207. GVAX vaccines are composed of cancer cells that have been genetically-modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to stimulate the immune system and that have been irradiated to prevent further cell division. GVAX Pancreas is administered with cyclophosphamide. | 2011 | 2014 | Source |
3 | - | AVX701 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
4 | - | AVX704 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
5 | - | OncoVEX GM-CSF modified herpes-simplex 1 virus | BioVex | I | The purpose of the study is to assess the safety of injections of OncoVEX GM-CSF into patients with pancreatic cancer that cannot be removed by surgery. The study will also test whether the injections are effective in treating the tumor. | 2006 | 2010 | Source |
6 | - | CDX-1309 | Celldex Therapeutics | I | Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine) to see if it can be used to make the immune system attack the cancer | 2006 | 2009 | Source |
7 | - | carcinoembryonic antigen RNA-pulsed DC cancer vaccine | Duke University, National Cancer Institute (NCI) | I | Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment. | 2000 | 2009 | Source |
8 | - | QS22 | Fox Chase Cancer Center, National Cancer Institute (NCI) | I | Phase I trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have advanced pancreatic or colorectal cancer. | - | - | - |
9 | - | PSMA/PRAME | MannKind Corporation | I | Completed The present clinical trial is a dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on a large number of solid cancers. |
2007 | 2009 | Source |
10 | - | Interleukin-2 | National Cancer Institute (NCI) | II | Phase II trial to study the effectiveness of a vaccine made with the patients’ white blood cells mixed with tumor proteins in treating patients who have advanced cancer. | - | - | - |
For more clinical trials in the Prostate Cancer area, click here
Colon/Rectal Cancer
There are 31 clinical trials for cancer vaccines going on in the Colon/Rectal Cancer area.
The following table gives all the details on clinical trials going on in the field of Colon/Rectal Cancer for Vaccines
S.No | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | GVAX Pancreas, Cyclophosphamide and CRS-207 | - | Aduro Biotech | I | Terminated This clinical trial will evaluate the safety, immune response and overall survival of the sequential administration of two cancer vaccines, GVAX Pancreas Vaccine and CRS-207 |
2011 | 2014 | Source |
2 | - | AVX705 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
3 | - | AVX701 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
4 | - | AVX702 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
5 | - | Oncophage | Antigenics | Preclinical | - | - | - | - |
6 | - | GVAX | BioSante Pharmaceuticals |
I | The present clinical trial is a dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on a large number of solid cancers. | 2007 | 2009 | - |
7 | - | CDX-1308 | Celldex Therapeutics | I | Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine) to see if it can be used to make the immune system attack the cancer | 2006 | 2009 | Source |
8 | - | CDX-307 | Celldex Therapeutics | II | - | - | - | - |
9 | - | CA-9 | Dendreon | Preclinical | - | - | - | - |
10 | - | Lapuleucel-T | Dendreon | Preclinical | - | - | - | - |
For more clinical trials in the Colon/Rectal Cancer area, click here
Breast Cancer
There are 28 clinical trials for cancer vaccines going on in the Breast Cancer area.
The following table gives all the details on clinical trials going on in the field of Breast Cancer for Vaccines
S.No | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | - | ADXS31-164 | Advaxis | I | - | - | - | - |
2 | - | AVX701 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
3 | - | AVX701 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
4 | - | NeuVax | Apthera | II | - | - | - | - |
5 | - | MVA-BN HER2 vaccine | Bavarian Nordic ImmunoTherapeutics | I/II | To evaluate the safety of MVA-BN-HER2 in women with HER-2-positive breast cancer. | 2010 | 2011 | Source |
6 | - | GVAX | BioSante Pharmaceuticals | II | - | - | - | - |
7 | - | CDX-1307 | Celldex Therapeutics | I | Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine) to see if it can be used to make the immune system attack the cancer | 2006 | 2009 | Source |
8 | - | CEA | Dendreon | Preclinical | - | - | - | - |
9 | - | Lapuleucel-T | Dendreon | I | - | - | - | - |
10 | Lapatinib | dHER2 + AS15 ASCI | Duke University, GlaxoSmithKline | I/II | This is a phase I/II study to determine the safety and gain insight into the immune response of the immunologic agent dHER2+AS15 ASCI when administered in combination with lapatinib. This study is for patients with metastatic breast cancer (invasive breast cancer with stage IV disease) that overexpresses HER2 and is resistant to trastuzumab (Herceptin). | 2009 | 2011 | Source |
For more clinical trials in the Breast Cancer area, click here
Pancreatic Cancer
There are 21 clinical trials for cancer vaccines going on in the Pancreatic Cancer area.
The following table gives all the details on clinical trials going on in the field of Pancreatic Cancer for Vaccines
S.No. | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | GVAX Pancreas, Cyclophosphamide and CRS-207 | - | Aduro BioTech | I | This clinical trial will evaluate the safety, immune response and overall survival of the sequential administration of two cancer vaccines, GVAX Pancreas Vaccine and CRS-207. GVAX vaccines are composed of cancer cells that have been genetically-modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to stimulate the immune system and that have been irradiated to prevent further cell division. GVAX Pancreas is administered with cyclophosphamide, which has been shown to increase effectiveness of GVAX by inhibiting T regulatory cells | 2011 | 2014 | Source |
2 | GVAX Pancreas, Cyclophosphamide and CRS-207 | - | Aduro BioTech | II | This clinical trial will evaluate the safety, immune response and overall survival of the sequential administration of two cancer vaccines, GVAX Pancreas Vaccine and CRS-207. GVAX vaccines are composed of cancer cells that have been genetically-modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to stimulate the immune system and that have been irradiated to prevent further cell division. GVAX Pancreas is administered with cyclophosphamide. | 2011 | 2014 | Source |
3 | - | AVX701 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
4 | - | AVX704 | AlphaVax | I/II | The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. | 2007 | 2010 | Source |
5 | - | OncoVEX GM-CSF modified herpes-simplex 1 virus | BioVex | I | The purpose of the study is to assess the safety of injections of OncoVEX GM-CSF into patients with pancreatic cancer that cannot be removed by surgery. The study will also test whether the injections are effective in treating the tumor. | 2006 | 2010 | Source |
6 | - | CDX-1309 | Celldex Therapeutics | I | Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine) to see if it can be used to make the immune system attack the cancer | 2006 | 2009 | Source |
7 | - | carcinoembryonic antigen RNA-pulsed DC cancer vaccine | Duke University, National Cancer Institute (NCI) | I | Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment. | 2000 | 2009 | Source |
8 | - | QS22 | Fox Chase Cancer Center, National Cancer Institute (NCI) | I | Phase I trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have advanced pancreatic or colorectal cancer. | - | - | - |
9 | - | PSMA/PRAME | MannKind Corporation | I | Completed The present clinical trial is a dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on a large number of solid cancers. |
2007 | 2009 | Source |
10 | - | Interleukin-2 | National Cancer Institute (NCI) | II | Phase II trial to study the effectiveness of a vaccine made with the patients’ white blood cells mixed with tumor proteins in treating patients who have advanced cancer. | - | - | - |
For more clinical trials in the Pancreatic Cancer area, click here
Melanoma Cancer
There are 20 clinical trials for cancer vaccines going on in the Melanoma Cancer area.
The following table gives all the details on clinical trials going on in the field of Melanoma Cancer for Vaccines
S.No. | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | - | aldesleukin, incomplete Freund’s adjuvant, recombinant tyrosinase-related protein-2 | Alphavax | II | To compare the effectiveness of vaccine therapy plus interleukin-2 to that of vaccine therapy alone in treating patients who have metastatic melanoma that has not responded to previous treatment. | 2001 | Ongoing | Source |
2 | - | MVax autologous cell vaccine | AVAX Technologies | III | Study suspended pending capitalization in US | - | - | - |
3 | - | GVAX | BioSante Pharmaceuticals | I | - | - | - | - |
4 | - | MDX-010 (anti-CTLA4) monoclonal antibody | Bristol-Myers | III | Fastrack Approval possibly by 2013 |
2004 | 2009 | Source |
5 | - | BMS-936558 (MDX-1106) | Bristol-Myers Squibb | I | The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. | 2008 | 2015 | Source |
6 | - | CDX-1401 | Celldex Therapeutics | I/II | The main purpose of this study is to examine the safety and tolerability of CDX-1401 when given in combination with an immune stimulant (resiquimod) to patients with advanced cancers that are known to express the NY-ESO-1 protein. | 2009 | 2013 | Source |
7 | - | 2401502 (domain antibody targeted multicomponent vaccine) |
GlaxoSmithKline | I | - | - | - | - |
8 | - | PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes, Aldesleukin, Cyclophosphamide, Fludarabine | GlaxoSmithKline/NCI | II | To evaluate the safety and effectiveness of anti-MAGE-A3/12 lymphocytes as a treatment for metastatic cancers that have not responded to standard treatment | 2010 | 2012 | Source |
9 | - | Melaxin (autologous dendritoma vaccine) and BCG | Greenville Hospital System University Medical Center, Oncolix | I/II | The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage IV malignant melanoma. | 2008 | 2009 | Source |
10 | - | TDS/DNA Cancer Vaccine |
Ichor Medical Systems | I | - | - | - | - |
For more clinical trials in the Melanoma Cancer area, click here
Ovarian Cancer
There are 19 clinical trials for cancer vaccines going on in the Ovarian Cancer area.
The following table gives all the details on clinical trials going on in the field of Ovarian Cancer for Vaccines
S.No. | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | - | OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine | AVAX Technologies | I/II | To determine if a vaccine made from the patient’s own tumor tissue can stimulate an immune response against the patient’s tumor cells. To determine the safety of the vaccine. | 2008 | 2011 | Source |
2 | - | OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine | Avax Technologies | I/II | To determine if a vaccine made from the patient’s own tumor tissue can stimulate an immune response against the patient’s tumor cells. To determine the safety of the vaccine. | 2008 | 2012 | Source |
3 | - | CDX-1311 | Celldex Therapeutics | I | Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine) to see if it can be used to make the immune system attack the cancer | 2006 | 2009 | Source |
4 | - | Lapuleucel-T | Dendreon | I | completed | - | - | - |
5 | - | carcinoembryonic antigen RNA-pulsed DC cancer vaccine | Duke University, National Cancer Institute (NCI) | I | Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment. | 2000 | 2009 | Source |
6 | standard of care observational follow-up | FANG | Gradalis, Inc. | II | This is a Phase II 2:1 randomized study of adjuvant intradermal autologous FANG™ cancer vaccine (1.0 x 10^7 cells/injection; maximum of 12 vaccinations) in women with stage IIIC epithelial ovarian cancer who attain a clinical or pathologic complete response (including a post-treatment, prevaccination baseline serum CA-125 level of ≤ 20 units/ml) after primary surgical cytoreduction and a total of six courses of front-line (pre- and post- or post-surgical) chemotherapy. | 2011 | 2015 | Source |
7 | - | oregovomab; cyclophosphamide | Gynecologic Oncology Group, NCI | I/II | This randomized clinical trial is studying the side effects of oregovomab and to see how well it works with or without cyclophosphamide in treating patients with stage III or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that responded to second-line chemotherapy. | - | - | - |
8 | carboplatin, cisplatin, cyclophosphamide, paclitaxel, dinitrophenyl | BCG vaccine, autologous tumor cell vaccine | Gynecologic Oncology Group, NCI | II | Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV ovarian epithelial cancer. | 1999 | 2009 | Source |
9 | - | Allogeneic whole epithelial tumor cells, DNP-conjugated and irradiated | Hadassah Medical Organization | I/II | This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with colorectal, gastric, ovarian, breast or lung epithelial cancer | - | - | Source |
10 | low dose cyclophosphamide (oral) | DPX-Survivac with low dose cyclophosphamide |
ImmunoVaccine Technologies, Inc. | I/II | This is a phase 1-2 study to determine the safety and immunogenicity profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose oral cyclophosphamide. DPX-Survivac is for the treatment of ovarian, fallopian tube, and peritoneal cancers. | - | - | Source |
For more clinical trials in the Ovarian Cancer area, click here
Renal Cancer
There are 17 clinical trials for cancer vaccines going on in the Renal Cancer area.
The following table gives all the details on clinical trials going on in the field of Renal Cancer for Vaccines
S.No | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | - | Cancer vaccine | Advantagene | Preclinical | - | - | - | - |
2 | - | HSPPC-96 | Antigenics | I/II | Renal cell carcinoma patients’ blood will be monitored over a period of 15 weeks to evaluate their level of immune response to multiple administration of HSPPC-96 | 2010 | 2012 | Source |
3 | - | - | Antigenics | III | Terminated due to lack of enrollment | 2002 | - | Source |
4 | - | Dendritic cell vaccine | Argos Therapeutics | I/II | The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma. | 2004 | 2008 | Source |
5 | - | AGS-003+sunitinib | Argos Therapeutics/ Kirin Brewery |
II | Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC. | 2008 | 2011 | Source |
6 | - | BMS-936558 (MDX-1106) | Bristol-Myers Squibb | I | The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. | 2008 | 2015 | Source |
7 | - | Serum and urinary CA9 level | Centre Hospitalier Universitaire de Saint Etienne | Preclinical | It was demonstrated that the level of expression of CA9 in tumor tissue can be used as a predictive marker of response to immunotherapy. | 2009 | 2013 | Source |
8 | - | Reniale | FBM-Pharma | III | Approval in select regions outside the U.S. by 2013 | - | - | - |
9 | - | PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes, Aldesleukin, Cyclophosphamide, Fludarabine | GlaxoSmithKline/NCI | II | To evaluate the safety and effectiveness of anti-MAGE-A3/12 lymphocytes as a treatment for metastatic cancers that have not responded to standard treatment | 2010 | 2012 | Source |
10 | Endoxana, IMA901, Leukine | - | Immatics Biotechnologies GmbH | II | This study was conducted in order to evaluate the efficacy and safety of the cancer vaccine IMA901 and GM-CSF as adjuvant in the treatment of advanced renal cell carcinoma. | 2007 | 2009 | Source |
For more clinical trials in the Renal Cancer area, click here
Cervical Cancer
There are 13 clinical trials for cancer vaccines going on in the Cervical Cancer area.
The following table gives all the details on clinical trials going on in the field of Cervical Cancer for Vaccines
S.No. | Drug Name | Biological Name | Developer | Current Development Phase | Additional Information | Start Date | Completion Date | Source |
1 | - | Lorvaxin C | Advaxis | I | completed | - | - | - |
2 | - | CA-9 | Dendreon | Preclinical | - | - | - | - |
3 | - | HPV-16/18 vaccine (Cervarix) Aimmugen™ |
GlaxoSmithKline | III | Approval in more than 70 countries including European Union countries, Mexico, Singapore, Australia; Received approval in the U.S. in October 2009 | 2006 | 2009 | Source |
4 | - | Listeria monocytogenes cancer vaccine ADXS11-001 | Gynecologic Oncology Group, NCI | II | This phase II clinical trial is studying the side effects and how well vaccine therapy works in treating patients with persistent or recurrent cervical cancer. | 2010 | 2011 | Source |
5 | - | VGX-3100 | Inovio Pharmaceuticals | I | The investigators have developed a DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18 | 2010 | Ongoing | Source |
6 | - | PSMA/PRAME | MannKind Corporation | I | Completed The present clinical trial is a dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on a large number of solid cancers. |
2007 | 2009 | Source |
7 | - | Gardasil, Placebo | Merck | Approved | Approved more than 100 countries including U.S., European Union, Mexico and others | 2005 | 2006 | Source |
8 | - | V503 | Merck | III | Expected results in late 2011 | 2010 | 2011 | Source |
9 | - | - | National Cancer Institute (NCI) | II | PV701 may be able to kill tumor cells while leaving normal cells undamaged. | 2003 | Ongoing | Source |
10 | - | Interleukin-2 | National Cancer Institute (NCI) | II | Phase II trial to study the effectiveness of a vaccine made with the patients’ white blood cells mixed with tumor proteins in treating patients who have advanced cancer. | - | - | - |
For more clinical trials in the Cervical Cancer area, click here
All other Cancer types
There are 80 clinical trials for cancer vaccines going on in all other areas of Cancer.
For complete information on other clinical trials, click here
Challenges in Cancer vaccine development
Cancer vaccines are promising, emerging therapeutic options. The global cancer vaccine market is faced with numerous challenges.
Cancer Vaccine market is subjected to the following roadblocks:
- Clarity on how best to use cancer vaccines with respect to disease stage and in combination with other therapies
- Regulatory hurdles
- High cost involved in producing an oncology product
- Government cost containment measures
- Fear over the efficacy and side effects of cancer vaccine
- The expected cost of cancer vaccines would be around $15,000 to $20,000 per patient per year.
- This augments the reimbursement issues and it is likely to reduce the penetration rate of cancer vaccines
But it is a timely reminder for developers that the path to market for therapeutic cancer vaccines is not going to be an easy one. Companies must focus on conducting well-designed trials with achievable but robust endpoints in suitable patient populations, and perhaps even consider combination trials with other therapies.