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Author Topic: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos  (Read 5295 times)

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Offline leit

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This immunotherapy is based on the properties of dendritic cells, whose role is to present specific proteins from infectious organisms at their surface, thereby alerting the rest of the immune system. In collaboration with Argos Therapeutics, the researchers designed a study in which the dendritic cells of nine study patients were multiplied in vitro and then treated with the RNA (ribonucleic acid) from the virus that had infected each patient. A virus sample was taken before the administration of any antiretroviral treatment.

The surfaces of these manipulated dendritic cells present an increased number of HIV proteins, which allows them to stimulate the cytotoxic response of a certain type of immune cell called CD8+ lymphocytes. After receiving multiple subcutaneous injections of these dendritic cells, eight of the nine patients involved experienced a significant increase in CD8+ lymphocyte activity.

“At this stage, we have shown that the technique doesn’t cause side effects or an undesirable auto-immune response,” said Dr. Routy [from the Research Institute of the McGill University Health Centre (MUHC)]. “Health Canada has approved a multicentre clinical trial across the country that will let us further assess the technique's effectiveness at controlling HIV reproduction. We’re hoping that the FDA in the United States will also give us the go-ahead soon so that our pharmaceutical partner, Argos Therapeutics, can begin testing in the United States.”


Quote from: McGill University Health Centre (MUHC) - News Centre

Media Clip: Interview with Dr. Routy
Abstract: XVII IAC - Mexico City 2008
Poster: XVII IAC - Mexico City 2008

« Last Edit: August 18, 2008, 06:13:53 AM by leit »

Offline Inchlingblue

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #1 on: October 14, 2009, 01:08:15 AM »
Argos Therapeutics to Present Positive Immune Response and Viral Load Data for Arcelis™ HIV Program at the AIDS Vaccine 2009 Conference

AIDS Vaccine 2009 Conference
 

DURHAM, N.C.--(BUSINESS WIRE)--Argos Therapeutics today announced the presentation of two abstracts at the AIDS Vaccine 2009 conference, being held October 19-22 in Paris, France. Favorable immune response, viral load and safety data from the ongoing Phase 2a proof-of-concept trial of AGS-004 therapy for the treatment of HIV will be discussed. AGS-004 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden. The target population for the trial is HIV-1-infected patients with durable viral suppression from antiretroviral therapy (ART).

More information on the presentations:

Abstract Title: “Safety and Viral Load Changes in HIV-1 Infected Subjects Treated with Autologous Dendritic Immune Therapy Following ART Discontinuation”
Abstract #: 164340
Presentation Type: Oral presentation
Date/Time: October 21, 2009, 12:00PM
Presenter: Jean-Pierre Routy, M.D., of McGill University Health Centre, Montreal, Canada

Abstract Title: “Immunogenicity of an Autologous Dendritic Cell Anti-HIV Therapy in HIV-1 Infected Individuals”
Abstract #: 173838
Presentation Type: Poster presentation
Date/Time: October 21, 2009, 12:30-2:00PM
Presenter: Bader Yassine-Diab, Ph.D., of University of Montreal Research Center, Montreal, Canada


Does anybody know more about this? Is it necessary to take blood samples before initiating HAART, while there is still a viral load? If so then it seems it would not work on those who are already on meds and undetectable? I guess they will be presenting more info. during the conference in Paris in the next few days.

LINK:

http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20091013005109&newsLang=en
« Last Edit: October 14, 2009, 01:21:41 AM by Inchlingblue »

Offline veritas

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #2 on: October 14, 2009, 09:33:06 AM »
Inch,

I don't believe one has to have a measurable viral load since "the target population for the trial is HIV-1 infected patients with durable viral suppression from antiretroviral therapy (ART)". From your link, unless I'm missing something. This therapy sounds promising. However, it also sounds very expensive to tailor make these cells for each individual. Maybe they can come up with a less expensive way.

v
« Last Edit: October 14, 2009, 09:38:58 AM by veritas »

Offline Inchlingblue

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #3 on: October 14, 2009, 10:56:25 AM »

I don't believe one has to have a measurable viral load since "the target population for the trial is HIV-1 infected patients with durable viral suppression from antiretroviral therapy (ART)".

The thing is in the original post, above, it says:

A virus sample was taken before the administration of any antiretroviral treatment.

Also, I found a link to a clinical trial and it says one of the criteria for being in the study is:

Availability of ≥ 1.2 mL of continually frozen plasma (may have been thawed and refrozen only once) drawn no more than 90 days before starting ART and preferably within 30 days.

It seems they need this in order to "customize" the therapy for each individual's virus?

LINK:

http://clinicaltrials.gov/ct2/show/NCT00672191?term=argos+hiv&rank=2

« Last Edit: October 14, 2009, 10:59:35 AM by Inchlingblue »

Offline xman

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #4 on: October 14, 2009, 01:06:13 PM »
correct me if i missed something but the trial page states it is in phase II.
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline xman

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #5 on: October 14, 2009, 01:22:20 PM »
It is currently in phase II. See below

Human Immunodeficiency Virus (HIV)
Argos is currently conducting a Phase 2 trial of its Arcelis immunotherapy targeted to HIV. This trial is measuring the safety and efficacy, in terms of viral load control, of the therapy. An investigator-sponsored Phase 1 trial measuring safety and immunogenicity has been completed and was being conducted at McGill University Health Center in Montreal under the direction of Jean-Pierre Routy, M.D., associate professor and principal clinical investigator of the Division of Hematology and Immunodeficiency Service. Results from this Phase 1 trial, presented at the 2008 International AIDS conference, demonstrated that the candidate AGS-004 achieved the trial´s primary endpoint of induction of T cells response to patient-specific HIV antigens. The novel Argos RNA-loaded DC therapy for HIV utilizes small plasma samples from infected patients to amplify large quantities of viral RNA encoding selected antigens, resulting in a personalized treatment to the patient’s own strain of virus. For further information see the following site at http://www.clinicaltrials.gov/ct2/show/NCT00672191?term=argos&rank=7


http://www.argostherapeutics.com/current_trials.html
http://www.argostherapeutics.com/product_pipeline.html
« Last Edit: October 14, 2009, 01:35:40 PM by xman »
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline Inchlingblue

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #6 on: October 14, 2009, 01:33:33 PM »
correct me if i missed something but the trial page states it is in phase II.

The original post is dated August 2008, maybe that's why the tittle of the thread says Phase I. Does that mean it moved from Phase I to Phase II in one year or less? Or maybe the Op just made a mistake.

It does appear to be in Phase IIa now.

I don't think this one was on the list in the recent thread started by xman. There is one for dendritic cells but it was a different one.
« Last Edit: October 14, 2009, 02:27:41 PM by Inchlingblue »

Offline Inchlingblue

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #7 on: October 21, 2009, 12:49:31 PM »
They announced more specific data and it looks pretty good. Apparently it kept people off of ART for 3 months  which doesn't sound all that impressive to me but they feel they can do better and they say,

"Although still preliminary, we are impressed with the diversity and strength of the immune responses observed so far. Importantly, the immune responses were composed of the same types of T cells observed in long-term non-progressors, which are individuals who are infected with HIV, but whose infection does not rapidly progress to AIDS,"

They are planning a Phase IIb in first half of 2010. One of the researchers here is R. Sekaly, who recently received a prestigious grant and has been doing important research on the reservoirs and viral latency (LINKS: http://forums.poz.com/index.php?topic=27666.0 & http://www.natap.org/2009/ResisWksp/ResisWksp_44.htm)

Argos Therapeutics Presents Positive Phase 2 Viral Load and Immune Response Data for Arcelis HIV Program at the AIDS Vaccine 2009 Conference

Wed Oct 21, 2009 8:00am EDT

Personalized Immunotherapy Candidate Demonstrates:

* Viral Load Control in Absence of Antiretroviral Therapy
* Robust Immune Response to a Diverse Set of HIV Antigens
* Potential to Offer Independence from Antiretroviral Therapy

DURHAM, N.C. and PARIS--(Business Wire)--

Argos Therapeutics today announced two presentations at the AIDS Vaccine 2009
conference, detailing positive viral load, immune response and safety data from
an ongoing Phase 2a trial of AGS-004, its personalized immunotherapy candidate.
AGS-004 is a product of the Company`s Arcelis technology, and is a personalized,
RNA-loaded, dendritic cell-based immunotherapy that is perfectly matched to each
patient`s unique HIV viral burden. The presentations contained important
results, including a favorable safety profile for AGS-004, the ability to induce
partial to complete viral load control in the absence of antiretroviral therapy
(ART) during a 12-week structured treatment interruption (STI), and a potent and
diverse immune response to AGS-004 treatment. These AGS-004 results are
unprecedented for an immunotherapeutic candidate in HIV and, if confirmed in an
upcoming randomized study, could lead to a new treatment paradigm for HIV.

"The Arcelis approach to immunotherapy has broad potential as a new therapeutic
strategy to combat HIV," said Jean-Pierre Routy, M.D., from McGill University
Health Centre in Montreal. "The level of viral load control in response to
AGS-004 has been unexpectedly strong compared to what has been reported for
other immunotherapies tested in similar patient populations. Additionally,
because this approach uses patient-specific HIV antigens, it may overcome the
extreme genetic heterogeneity of HIV from patient to patient, which has been one
of the reasons for the failure of prior HIV immunotherapies."


Continued. . .

LINK:

http://www.reuters.com/article/pressRelease/idUS120905+21-Oct-2009+BW20091021
« Last Edit: October 21, 2009, 12:52:05 PM by Inchlingblue »

Offline Inchlingblue

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #8 on: October 26, 2009, 06:13:57 PM »
Personalized Therapeutic Vaccine Shows Promise

October 26, 2009

An experimental treatment strategy involving a vaccine that is tailor-made from an HIV-positive person’s virus and immune system cells can reduce viral load and improve the function of the immune system, according to a presentation at the AIDS Vaccine 2009 conference in Paris on October 21 that was announced by the vaccine’s developer, Argos Therapeutics.

Preventive vaccines work by stimulating the immune system so that when it encounters an infectious pathogen, it will quickly respond and keep the infection from taking hold. A therapeutic vaccine is also designed to provoke an immune response, but in people already infected with a virus or bacteria. Its aim is to help the body better control the infection. A number of therapeutic vaccines have been tried in HIV disease, but have not proved successful until now.

AGS-004, a therapeutic vaccine being developed by North Carolina–based Argos, customizes immune system cells from each individual, using HIV fragments known as messenger RNA, to maximize an HIV-positive person’s immune response to the virus. To do this, dendtritic cells are removed from the body and combined with mRNA taken from the same individual’s HIV.


Continued. . .

LINK:

http://www.poz.com/articles/hiv_therapeutic_vaccine_761_17480.shtml

Offline GNYC09

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #9 on: October 26, 2009, 10:19:05 PM »
This is very interesting.  Forgive me for what may seem like a dumb question but since these subjects were humans, they must have first done similar tests on animals (primates)?  If so, I wonder how well those did and if the results held long-term. 

Offline tkeyspet

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #10 on: October 28, 2009, 01:29:40 PM »
this is very interesting 8) but we have to wait until all trials are completed i was excited to hear first hand information from someone who is in the study  :-[ but it will take another 4 or 5 years to work and after all that time i think it would best if they look at prolong periods  ::) like at the of 12 weeks we saw the viral load ok but what would happen after that a renewed vaccine  or what ???  :o but i think finally we r moving out of the woods into the right direction but would take ages to reach the most needy and some people are dying, im afraid that some of these things that shows good promise should be thouroghly assessed by gov agancies and move on like the other vaccinnes H!n! it did not take 3 or 5 years, the Most needy is Africa and the disease is spreading like much faster, i know the environment and as such these people should look into the feasibility even of such to the most needy but a start is better than none and who knows if these guys pu;; it off and i am alive then i can get the shots, and what the others in the business would think, these might spark like meds race, but i am opmistic, because history shows us that. thanks for the post and last word is that why is this report not on something like BBc CNN or AOL  ;D happy to be alive and read the antidote will take another decade  ::)

Offline Inchlingblue

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #11 on: November 26, 2009, 11:11:31 AM »
Tailor-made HIV/AIDS treatment closer to reality

Nov. 25, 2009

An innovative treatment for HIV/AIDS patients developed by McGill University Health Centre (MUHC) researchers has passed its first clinical trial with flying colours. The new approach is an immunotherapy customized for each individual patient, and was developed by Dr. Jean-Pierre Routy from the Research Institute of the MUHC in collaboration with Dr. Rafick Sékaly from the Université de Montréal. “This is a vaccine made for the individual patient – an “haute couture” therapy, instead of an off-the-rack treatment” said Dr Routy.

By “priming” the immune system, as with a vaccine, to fight the specific strain of HIV/AIDS infecting a given patient, the scientists believe they have developed a therapy that shows immense promise and could be an even more effective weapon against the virus than the anti-retroviral cocktails currently in use. The results of the first-stage clinical trials, which tested the therapy in conjunction with anti-retroviral drugs, were published recently in Clinical Immunology. Phase 2 of the clinical trial, which is nearly complete, is testing the therapy’s efficacy on its own at 8 different sites in Canada.


Continued . . .

LINK:

http://www.muhc.ca/media/news/item/?item_id=112535

Offline ronaldinho

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #12 on: November 27, 2009, 11:06:55 AM »
This approach has already been tried, with no success:

http://forums.poz.com/index.php?topic=18582.0

http://forums.poz.com/index.php?topic=15847.0

http://forums.poz.com/index.php?topic=2370.0

So, I wonder  how exactly this new trial differs from the preceding one.
« Last Edit: November 27, 2009, 11:09:07 AM by ronaldinho »

Offline Inchlingblue

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Re: Another phase I: "Arcelis", a "personalized immunotherapy" by MUHC/Argos
« Reply #13 on: November 27, 2009, 11:27:02 AM »
Ronaldhino:

There is another clinical trial, currently in Phase I that also uses dendritic cells (from Baylor). I believe the MOA for that one is the same as the one you cite from a few years ago done in Brazil.

The one discussed in this thread is from Argos and is in Phase IIa. They both use dendritic cells but they have different approaches.

LINK TO INFORMATION ABOUT THE OTHER DENDRITIC CELL VACCINE (BAYLOR):

http://forums.poz.com/index.php?topic=29576.0
« Last Edit: November 27, 2009, 11:38:02 AM by Inchlingblue »

Offline Inchlingblue

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Argos Therapeutics Publishes Positive Immune Response, Safety and Manufacturing Data for its Arcelis™ HIV Program in Clinical Immunology

DURHAM, N.C. - (Business Wire) Argos Therapeutics today announced the publication of a manuscript in the February edition of Clinical Immunology, detailing positive immune response, safety and manufacturing data for its AGS-004 immunotherapy for HIV. AGS-004 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden. The manuscript details a clinical study in which AGS-004 was evaluated in type-1 HIV-infected adults who were being treated with antiretroviral therapy (ART). The study demonstrated that AGS-004 is capable of producing a proliferative T cell response to HIV-1 antigens in patients, with full or partial HIV-specific proliferative immune responses occurring in 78% of evaluable subjects.


Continued . . .

LINK:

 http://www.earthtimes.org/articles/show/argos-therapeutics-publishes-positive-immune,1191104.shtml#ixzz0hJZWmKLc

Offline Inchlingblue

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I guess this therapy's MOA entails some Viral Decay Acceleration.

Argos Therapeutics Presents New Phase 2a Data on the Impact of Arcelis™ HIV Program on Viral Genetic Diversity
 
Argos Therapeutics today announced the presentation of data from the Phase 2a trial of AGS-004, providing information on rebound viral genetic diversity in HIV patients treated with the personalized immunotherapy following antiretroviral therapy (ART) interruption. The data were discussed in a poster session at the Keystone Symposia Global Health Series HIV Vaccines meeting, held March 21-26, 2010 in Banff, Canada. AGS-004 is a product of the Company’s Arcelis™ technology, and it is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden. Argos recently reported interim data from the Phase 2a trial, demonstrating viral load control in the absence of antiretroviral therapy and robust immune responses to a diverse set of HIV antigens. Argos plans to initiate a Phase 2b trial in the first half of 2010.

AGS-004 utilizes autologous RNA encoding HIV antigens Gag, Vpr, Rev and Nef (GVRN). Argos’ RNA technology is designed to amplify a complex mixture of autologous mutated HIV quasispecies, specific to each patient, from plasma collected prior to ART initiation. In the Phase 2a trial, patients received four doses of AGS-004 during ART treatment, followed by two doses after ART interruption. Samples of post-AGS-004 plasma were then collected during the ART interruption from subjects with detectable viral load. Genetic evolution of the virus was analyzed through sequencing at least 10 individual clones of each GVRN gene following AGS-004 treatment, and comparing to those isolated from the pre-treatment sample. As expected, in some subjects, the post-AGS-004 samples revealed a shift in viral diversity, indicating that the remaining virus did mutate over the course of treatment.

Charles Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development of Argos Therapeutics, said: “We believe that one component of the method-of-action for AGS-004 is that it forces the virus to mutate in response to immune pressure. The more the virus mutates, the less able to replicate and weaker it becomes. Additionally, the diversity of the mutations is generally much narrower following AGS-004 treatment. We believe that this less robust residual virus is a direct result of the broad immune response induced by AGS-004. These observations may explain the low viral load levels reported for patients enrolled in the Phase 2a trial of AGS-004. We are excited to generate controlled data for AGS-004 in the Phase 2b trial, which we anticipate will commence soon.”


LINK:

http://www.genengnews.com/news/bnitem.aspx?name=78646379

Offline bmancanfly

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Interesting stuff.

They keep refering to "low viral load" but I can't see what they mean by that.  Does anyone know?  Low is a relative term.  And what percentage of the people in the study responded with a low viral load?
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline Inchlingblue

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Argos Therapeutics Presents Phase 2a Data For Arcelis? HIV Program Demonstrating Positive Impact On Viral Diversity And Viral Load


LINKS:

http://www.medicalnewstoday.com/articles/189108.php

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100517005256&newsLang=en

 


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