http://www.youtube.com/watch?
Saturday, June 23, 2012
Wednesday, June 20, 2012
http://www.ustream.tv/recorded/23447929
http://execvid.com/marcum-
Marcum Microcap Conference
Presentation by Tom Moore, CEO of Advaxis
4pm EST, June 20th, 2012
Roosevelt Hotel, NYC
Webcast
Friday, June 15, 2012
Advaxis releases 8K June 14, 2012 -
http://www.faqs.org/sec-filings/120614/Advaxis-Inc_8-K/.
There is an informative writeup ,of the possible near future implications to ADXS from the events of this 8K, written in detail under the "nom de plume" of 'mcaeroinv'. I have taken the liberty of putting the separate writings together to make it more cohesive and reader friendly.
ADXS now appears to have:
1) Enough operating capital to pay for normal business operations through September 2012.
2) ADXS has put a plan in place as to how they will cover the rest of their trial costs for India and CIN.
3) ADXS has a minimum of 10.5M common shares left to sell by mid September, which would provide enough cash to finish 2012 covering operating costs.
4) ADXS has went away from using the rest of the Optimus funding.
5) ADXS has covered all their debt obligations through Q1 2013.
6) ADXS still has warrant conversions, tax selling and grants as options beyond selling more common shares to raise operating capital for Q1 2013.
The summary of this is that ADXS has cleared the path to get ADXS through Q1 2013. They have managed to figure out the way to do this without needing to increase common share totals beyond 500M.
Item 1.01. Entry Into
a Material Definitive Agreement.
On June 13, 2012, Advaxis, Inc. (the “
Company
”)
entered into a stock purchase agreement (the “
Stock Purchase Agreement
) with Numoda Corporation (“
Numoda
”),
pursuant to which the Company issued to Numoda 15 million shares (collectively, the “
AR Cancellation Shares
”)
at a purchase price per share of $0.15, in exchange for the immediate
cancellation
of $2,250,000 of accounts receivables owed by the Company to Numoda
pursuant to the Master Agreement, dated June 19, 2009, between
Numoda and the Company. Numoda has agreed not to sell the AR
Cancellation Shares until July 3, 2012, twenty calendar days from
the closing of the transaction on June 13, 2012 (such period, the “
Lock-Up Period
”). During the Lock-Up Period
the Company has the option, in its sole discretion, to redeem up to
100% of the AR Cancellation Shares at a purchase price per
share of $0.15. In connection with such issuance, the Company has also
agreed to register the resale by Numoda of the AR Cancellation
Shares with the Securities and Exchange Commission by July 26, 2012,
thirty business days from the closing of the transaction on
June 13, 2012.
The AR Cancellation Shares were offered
and sold to an “accredited investor” (as defined in section 501(a) of
Regulation D) pursuant to an exemption from the
registration requirements under Section 4(2) of the Securities Act and
Rule 506 of Regulation D promulgated thereunder. The AR
Cancellation Shares have not been registered under the Securities Act
and may not be offered or sold in the United States in the
absence of an effective registration statement or exemption from the
registration requirements.
The foregoing description of the Stock Purchase
Agreement does not purport to be complete and is qualified in its entirety by reference to the Stock Purchase Agreement, which
is attached hereto as Exhibit 10.1, and incorporated herein by this reference.
This is very interesting news on several fronts.
Part 1:
Let's break this down further starting with where this leaves us financially;
ADXS has run up a bill with Numoda for $3,632,127. This transaction reduces this bill to $1,382,127 thereby, freeing up an additional $2,250,000 for continued on-going trial expenses. Now, in a statement issued by ADXS on Feb 23, 2012, ADXS had already paid a total of $7.2M to Numoda of the contractual $12.2M. This means that as of June 13, 2012, ADXS has already used $10,832,127 of the originally contracted $12.2M of Numoda services that began in the 3 year contract signed on June 19, 2009. The 3 year contract would have been up on June 20, 2012. This means, ADXS is essentially $1.4M behind in the planned expenditures (or in other words not as far along in the running of the trials probably due to the slowing of patient enrollment in the India trials).
Based on this, lets assume that the contract with Numoda has a natural and sensible clause in it that takes care of trials being drawn out longer than originally intended. This is sensible and would suggest that ADXS most likely has another $1.4M plus an additional additive cost (due to trial time being extended wich is probably around $800k). Therefore, based upon the $2.25M agreement reached yesterday, this means ADXS has just ensured that they have covered the rest of their trial costs for the India test. In other words, at the end of the India trial ADXS may owe Numoda approximately $3.6M, but will have finished the India trial without additional "cash out" by this time. This is based upon ADXS' already proven ability to carry a $3.6M credit with Numoda once already.
This is means, trial expenses should now be off the table as far as a concern for finishing India and the CIN trials. This is big! The next financial concern is daily operating cash, which we know ADXS should have enough to get through September of this year.
For opreating capital, ADXS has a few tricks up their sleeves yet:
1) Further warrant conversions;
2) Tax loss selling;
3) Grants;
4) Common Share Selling (which I will get to in a moment)
The bottom line is ADXS just did another fantastic financial manuever to get them time to complete their trials. The management is doing their jobs in the BEST INTEREST OF THE SHAREHOLDERS.....
Part 2:
How does ADXS have the common shares left to sell?
The simple answer is that they are recycling shares. In an earlier SEC filing, ADXS mentioned (in small print) that ADXS had "unreserved common shares on Dec 2011 that related to the 25,560,000 warrants in the Optimus deal. This would mean that if ADXS does not have these shares in their control, they will not be able to force Optimus to purchase the rest of the 284 preferred shares for $2.84M because the warrants go with them.
Also recall, all these shares were set for $0.15 for the common shares used for converting the preferreds and for the warrants. They also had an anti-dillutive clause attached meaning that ADXS did not really want to invoke forcing Optimus to buy the preferreds with the share price being under $0.15.
This means that since the financial transactions made by ADXS to date, would not have required breaking into these 25,560,000 shares, this is the first time ADXS has used any of them. It also means that ADXS now has 10,560,000 shares still available to get operating capital. At $0.15 per share this could mean $1,584,000. This amount could be enough to get ADXS through the rest of 2012 now that their trial costs are sorted out!
Obviously, since ADXS currently has enough money to get through September, it would not make sense for ADXS to rush into a deal on these shares in the hopes they could do it for a higher share price.
Part 3:
Why would Numoda accept $0.15 per share taking an initial hair cut on the monies owed to them by ADXS?
This is more of a business and risk assessment question and will not make sense from a common shareholder viewpoint.
In other words: If you think like a business, at least a sucessful one, you should be making a profit on ANYTHING you do when you are a service provider, or you will not stay in buisness too long.
This means that Numoda most likely is making a profit mark up of 25% - 35% on their trial management. This would be a typical markup for a service based industry similar to what Numoda is providing. This means that out of the $12.2M original three year contract (using 30% mark up as an average), Numoda would stand to make $3,660,000 in profit. Another way to look at this is that Numoda's cost to manage the trials is $12.2M - $3.66M = $8,540,000.
Given this and the Feb 23 ADXS statement that ADXS had already paid Numoda $7.2M, we can figure this out:
By Feb 23, 2012 - ADXS had paid Numoda $7.2M
On Jun 13, 2012 - ADXS owed Numoda $3,632,127
On Jun 13, 2012 - ADXS agreed a share trade for $2,250,000
This means that ADXS would have paid $7.2M already and will pay $1.38M still after the June 13 agreement for a total cash payment of $8.58M.
This means that Numoda's business decision was ro invest their PROFITS on ADXS after they were ensured that their operating costs were covered. This also means that given the current economy and the fact that having money in a bank earning 1.1% is not really your best option, it makes sense to find suitable investment opportunities for your capital. What better opportunities than the ones you have some control in, such as ones that involve your maaging the trials.
Above and beyond this, the fact that the trials are going to take longer than originally planned (for whatever reason) means, Numoda will make even more money from ADXS (recall the additional $800k I was estimating which includes an additional 30% markup in this!).
The argument between $0.15 versus a lower price is actually not that relevant from the perspective described above. In fact, I would argue it was more important to ADXS to achieve the $0.15 price target because these shares were historically tied to the $0.15 value and on the books as such. This would save a year end adjustment on their value.
The 20 day "no-sell" and "repurchase" period is actually not a big deal. It most likely is to eliminate any immediate sale. Maybe it is because there are high hopes from the June 20 presentation. Maybe it was because the ADXS shares were having a 5M trading volume day while this deal was being put together.
Summary:
ADXS now appears to have:
1) Enough operating capital to pay for normal business operations through September 2012.
2) ADXS has put a plan in place as to how they will cover the rest of their trial costs for India and CIN.
3) ADXS has a minimum of 10.5M common shares left to sell by mid September, which would provide enough cash to finish 2012 covering operating costs.
4) ADXS has went away from using the rest of the Optimus funding.
5) ADXS has covered all their debt obligations through Q1 2013.
6) ADXS still has warrant conversions, tax selling and grants as options beyond selling more common shares to raise operating capital for Q1 2013.
The summary of this is that ADXS has cleared the path to get ADXS through Q1 2013. They have managed to figure out the way to do this without needing to increase common share totals beyond 500M.
The unanswered question is what happens at the end of Q1 2013?
1) Is it the selling of a construct?
2) Is it the selling of all of ADXS?
3) Is it going for FDA approval on their own for a construct?
Part 1:
Let's break this down further starting with where this leaves us financially;
ADXS has run up a bill with Numoda for $3,632,127. This transaction reduces this bill to $1,382,127 thereby, freeing up an additional $2,250,000 for continued on-going trial expenses. Now, in a statement issued by ADXS on Feb 23, 2012, ADXS had already paid a total of $7.2M to Numoda of the contractual $12.2M. This means that as of June 13, 2012, ADXS has already used $10,832,127 of the originally contracted $12.2M of Numoda services that began in the 3 year contract signed on June 19, 2009. The 3 year contract would have been up on June 20, 2012. This means, ADXS is essentially $1.4M behind in the planned expenditures (or in other words not as far along in the running of the trials probably due to the slowing of patient enrollment in the India trials).
Based on this, lets assume that the contract with Numoda has a natural and sensible clause in it that takes care of trials being drawn out longer than originally intended. This is sensible and would suggest that ADXS most likely has another $1.4M plus an additional additive cost (due to trial time being extended wich is probably around $800k). Therefore, based upon the $2.25M agreement reached yesterday, this means ADXS has just ensured that they have covered the rest of their trial costs for the India test. In other words, at the end of the India trial ADXS may owe Numoda approximately $3.6M, but will have finished the India trial without additional "cash out" by this time. This is based upon ADXS' already proven ability to carry a $3.6M credit with Numoda once already.
This is means, trial expenses should now be off the table as far as a concern for finishing India and the CIN trials. This is big! The next financial concern is daily operating cash, which we know ADXS should have enough to get through September of this year.
For opreating capital, ADXS has a few tricks up their sleeves yet:
1) Further warrant conversions;
2) Tax loss selling;
3) Grants;
4) Common Share Selling (which I will get to in a moment)
The bottom line is ADXS just did another fantastic financial manuever to get them time to complete their trials. The management is doing their jobs in the BEST INTEREST OF THE SHAREHOLDERS.....
Part 2:
How does ADXS have the common shares left to sell?
The simple answer is that they are recycling shares. In an earlier SEC filing, ADXS mentioned (in small print) that ADXS had "unreserved common shares on Dec 2011 that related to the 25,560,000 warrants in the Optimus deal. This would mean that if ADXS does not have these shares in their control, they will not be able to force Optimus to purchase the rest of the 284 preferred shares for $2.84M because the warrants go with them.
Also recall, all these shares were set for $0.15 for the common shares used for converting the preferreds and for the warrants. They also had an anti-dillutive clause attached meaning that ADXS did not really want to invoke forcing Optimus to buy the preferreds with the share price being under $0.15.
This means that since the financial transactions made by ADXS to date, would not have required breaking into these 25,560,000 shares, this is the first time ADXS has used any of them. It also means that ADXS now has 10,560,000 shares still available to get operating capital. At $0.15 per share this could mean $1,584,000. This amount could be enough to get ADXS through the rest of 2012 now that their trial costs are sorted out!
Obviously, since ADXS currently has enough money to get through September, it would not make sense for ADXS to rush into a deal on these shares in the hopes they could do it for a higher share price.
Part 3:
Why would Numoda accept $0.15 per share taking an initial hair cut on the monies owed to them by ADXS?
This is more of a business and risk assessment question and will not make sense from a common shareholder viewpoint.
In other words: If you think like a business, at least a sucessful one, you should be making a profit on ANYTHING you do when you are a service provider, or you will not stay in buisness too long.
This means that Numoda most likely is making a profit mark up of 25% - 35% on their trial management. This would be a typical markup for a service based industry similar to what Numoda is providing. This means that out of the $12.2M original three year contract (using 30% mark up as an average), Numoda would stand to make $3,660,000 in profit. Another way to look at this is that Numoda's cost to manage the trials is $12.2M - $3.66M = $8,540,000.
Given this and the Feb 23 ADXS statement that ADXS had already paid Numoda $7.2M, we can figure this out:
By Feb 23, 2012 - ADXS had paid Numoda $7.2M
On Jun 13, 2012 - ADXS owed Numoda $3,632,127
On Jun 13, 2012 - ADXS agreed a share trade for $2,250,000
This means that ADXS would have paid $7.2M already and will pay $1.38M still after the June 13 agreement for a total cash payment of $8.58M.
This means that Numoda's business decision was ro invest their PROFITS on ADXS after they were ensured that their operating costs were covered. This also means that given the current economy and the fact that having money in a bank earning 1.1% is not really your best option, it makes sense to find suitable investment opportunities for your capital. What better opportunities than the ones you have some control in, such as ones that involve your maaging the trials.
Above and beyond this, the fact that the trials are going to take longer than originally planned (for whatever reason) means, Numoda will make even more money from ADXS (recall the additional $800k I was estimating which includes an additional 30% markup in this!).
The argument between $0.15 versus a lower price is actually not that relevant from the perspective described above. In fact, I would argue it was more important to ADXS to achieve the $0.15 price target because these shares were historically tied to the $0.15 value and on the books as such. This would save a year end adjustment on their value.
The 20 day "no-sell" and "repurchase" period is actually not a big deal. It most likely is to eliminate any immediate sale. Maybe it is because there are high hopes from the June 20 presentation. Maybe it was because the ADXS shares were having a 5M trading volume day while this deal was being put together.
Summary:
ADXS now appears to have:
1) Enough operating capital to pay for normal business operations through September 2012.
2) ADXS has put a plan in place as to how they will cover the rest of their trial costs for India and CIN.
3) ADXS has a minimum of 10.5M common shares left to sell by mid September, which would provide enough cash to finish 2012 covering operating costs.
4) ADXS has went away from using the rest of the Optimus funding.
5) ADXS has covered all their debt obligations through Q1 2013.
6) ADXS still has warrant conversions, tax selling and grants as options beyond selling more common shares to raise operating capital for Q1 2013.
The summary of this is that ADXS has cleared the path to get ADXS through Q1 2013. They have managed to figure out the way to do this without needing to increase common share totals beyond 500M.
The unanswered question is what happens at the end of Q1 2013?
1) Is it the selling of a construct?
2) Is it the selling of all of ADXS?
3) Is it going for FDA approval on their own for a construct?
Thursday, June 14, 2012
NewCo News: Advaxis Uses Listeria Bug to Launch Attack on Cancer Cells
Advaxis Inc. reported positive
preliminary results from a Phase II trial of its human papillomavirus
(HPV) immunotherapy product, ADXS-HPV, at the American Society of
Clinical Oncology meeting in Chicago this week.
In the ongoing trial at 22 sites in India, 109
patients with late-stage disease received ADXS-HPV with and without
cisplatin. Survival at nine months was 31 percent, with four complete
responses and seven partial responses.
Fifty-six percent of patients achieved disease
control, defined as complete response, partial response or stable
disease. Thirty-six percent experienced a Grade 1-2 adverse event, but
only 0.9 percent suffered a Grade 3 serious adverse event.
A safer and less toxic form of cancer treatment is the goal behind the Princeton, N.J.-based company's development program.
Patients with cancer have come to expect that
cancer treatment will be harsh and dangerous due to the necessity of
using potent drugs to stop the out-of-control growth of the cancer
cells. Advaxis is working on a new type of immunotherapy based on a
common food poisoning bug.
Advaxis, founded in 2002, is engineering the common foodborne pathogen, Listeriamonocytogenes,
to carry a modified antigen payload designed to train the immune system
to seek and destroy cancer cells with the same vigor that it attacks
its familiar enemy, Listeria.
Listeriosis is a foodborne illness that can be
serious, resulting in several hundred deaths in the U.S. each year. The
pathogen is present and common in the food supply. It is most dangerous
to people with compromised immune systems, such as pregnant women or HIV
patients. That is due to an elaborate immune response "hardwired" into
the genome, according to Advaxis.
"We take advantage of that very well-developed and elaborate immune response by bioengineering the Listeria," Advaxis CEO Tom Moore told BioWorld Today.
Two important changes are made to the Listeria
bug to transform it into a cancer therapy. First, it is attenuated to
make it safe to inject into the body. Second, it is engineered to
secrete a fusion protein consisting of listeriolysin (Lm-LLO) and a
target antigen of interest. Lm-LLO stimulates a powerful immune response
that is then redirected to the target antigen.
"Before, we've come in with a variety of poisons
or radiation to try to kill the cancer, hopefully just before we kill
the patient," Moore said. "Immunotherapy works to turn on the body's own
immune system to attack cancer."
Cancer immunotherapy is becoming one of the
hottest trends in biotech. Provenge (sipuleucel-T, Dendreon Inc.) for
prostate cancer and Yervoy (ipilimumab, Bristol-Meyers Squibb Co.) for
melanoma, have become early successes in the field, showing that
biotherapeutics can train the immune system to seek and destroy tumor
cells.
Advaxis is developing three Listeria-based
cancer therapies: ADXS-HPV for cervical and other cancers; ADXS-PSA for
prostate cancer; and ADXS-HER2 for HER2-overexpressing cancers and
canine osteosarcoma.
ADXS-HPV is Advaxis's most advanced product. It
successfully completed a Phase I trial and is being evaluated in several
Phase II trials. Two of those focus on patients with metastasized,
progressive cervical cancer that has not responded to previous
treatment. One is being carried out in India, one in the U.S. Another
trial focuses on locally advanced cervical cancer.
A fourth, UK-based Phase I/II trial will evaluate
ADXS-HPV in patients with head and neck cancer with endpoints of
safety, dose escalation and immunology.
Historically, the expected survival for that
cohort â?? those previously treated with radiation and/or chemotherapy,
with subsequent relapse â?? is only 5 percent, according to Advaxis. It
is hoping to exceed that number by a wide margin in the ongoing trial.
The U.S.-based Phase II trial of ADXS-HPV will
evaluate safety and efficacy in patients with cervical intraepithelial
neoplasia Grades 2 and 3 (CIN 2/3) by CIN remission using loop
electrosurgical excision procedure.
Advaxis completed the first three dose cohorts in
that trial, finding that 52 percent of CIN2/3 lesions regressed to CIN 1
or normal in the treatment arm, with no serious adverse events. "We've
totally eliminated all of the cervical cancer in three patients," Moore
said, pointing out that unlike typical cancer therapies, Advaxis'
immunotherapies have potential to work better over time, as they retrain
the immune system. "The immune system is often damaged because of
previous exposure to cancer treatment."
Because the Listeria system is a
platform technology, it can be used to create a virtually unlimited
number and variety of drugs. Advaxis has a large number of potential
candidates, and once it demonstrates that the basic platform is
effective, the company will take those drugs through the
proof-of-concept phase and license them out.
The company recently announced a research
collaboration with the Karolinska Institutet in Stockholm, Sweden, to
develop immunotherapies for allergic diseases.
Over the past three and a half years, Advaxis has
raised about $29 million in the form of equity offerings, convertible
debt and other financing instruments, through 11 different raises. "The
technology is pretty compelling," Moore said.
BioWorld Today - Jun. 06, 2012
BioWorld Today - Jun. 06, 2012
Advaxis Selects Russo Partners for Corporate Communication Support
Date: June 8, 2012
Russo Partners is handling message development and positioning work as well as media relations for Princeton, N.J.-based Advaxis. The biotechnology company is in late-stage Phase 2 clinical trials with next-generation of immunotherapies for cancer. Advaxis immunotherapies in development for cancer and infectious diseases are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein that redirects the powerful immune response all human beings have to the bacteria to the cancer itself.
Date: June 8, 2012
Russo Partners is handling message development and positioning work as well as media relations for Princeton, N.J.-based Advaxis. The biotechnology company is in late-stage Phase 2 clinical trials with next-generation of immunotherapies for cancer. Advaxis immunotherapies in development for cancer and infectious diseases are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein that redirects the powerful immune response all human beings have to the bacteria to the cancer itself.
Media Relations | A Brief Overview
Media Relations is the act of involvement with various media for the purpose of informing the public of an organization’s mission, policies and practices in a positive, consistent and credible manner.
Typically, media relations involve coordinating directly with
the people responsible for producing the news and features in the mass
media. The goal of media relations is to maximize positive coverage in
the mass media without paying for it directly through advertising.
Many people use the terms “public relations” and “media relations”
interchangeably; however, doing so is incorrect. The definition of media
relations is somewhat narrower. Media relations refer to the
relationship that a company or organization develops with journalists,
while public relations extend that relationship beyond the media to the
general public.
Dealing with the media presents unique challenges in that the news
media cannot be controlled – they have ultimate control over whether
news angles pitched to them are of interest to them or their audiences.
Because of this, the ongoing facilitation of communication and
relationships between an organization and the news media is vital. One
way to ensure a positive working relationship with media personnel is to
become deeply familiar with their “beats” and areas of interests. Media
relations and public relations practitioners should read as many
magazines, journals, newspapers, and blogs as possible as they relate to
one’s practice – (i.e., if you represent clients in the financial
field, it’s obvious practitioners should have a general idea as to the
types of stories being covered in this area, and they should read the
major dailies as well as The Wall Street Journal in order to develop
future strategies).
Working with the media on the behalf of an organization allows for
awareness of the entity to be raised as well as the ability to create an
impact with a chosen audience. It allows access to both large and small
target audiences and helps build public support and mobilizing public
opinion for an organization. This is all done through a wide range of
media and can be used to encourage two-way communication.
By using media relations effectively, public relations
practitioners can enhance the reputation of their respective
organizations while establishing good working relationships with
journalists that will serve them well in future endeavors.
Key elements of strategically based media relations:
- The media strategy is documented and implemented according to principles agreed between public affairs and senior management.
- A media policy is drawn up with responsibilities, profiles and positioning.
- Media activity is planned to reach target audiences in direct support of your organizational mission and goals.
- Media contact is broadly divided into proactive and reactive activities.
- Systematic use of consistent messages is made (eg. about organizational performance, issues, use of new technologies and corporate behavior including environmental policy, corporate governance and corporate social responsibility).
- Spokespersons’ roles are documented, communicated and supported.
- There are clear triggers for engagement as part of the issues management/stakeholder relations process
- Decisions are agreed beforehand on the follow-up activities after media coverage.
Advaxis Awarded Best Therapeutic Vaccine
Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has been selected as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards for its ADXS-HPV construct.
The ViE awards, sponsored by Novartis Vaccines and Diagnostics, were created to recognize the accomplishments and contributions of companies and individuals in the vaccine industry over the previous 12 months.
"We are delighted to receive recognition for our Company's achievements in developing ADXS-HPV," commented Thomas A. Moore, Chairman & CEO of Advaxis. "Our team continues to bring our proprietary platform technology from the laboratory into the clinic and meet major milestones in development in HPV caused cancers and soon in prostate and breast cancer, as well."
The ViE Awards
The ViE Award nominees were voted on by those in the global vaccine industry and also judged by a panel of representatives from pharma, biotech, academia, government, non-governmental organizations (NGOs), and public health. Winners were announced at the annual ViE Awards on April 11, 2012 during the World Vaccine Congress in Washington, D.C., produced by Terrapinn.
The criteria used to judge this category are as follows:
-Vaccine candidate addresses current unmet medical needs
-Candidate shows significant potential for vast geographical and market reach
- Candidate possesses a novel mode of action or technology
-Progress made to date through clinical trials and/or achieved milestones
- Advanced efficacy, safety, and risk management data where appropriate
Judges specific comments on the winner included:
1. Has been shown to work at a rate that is greater than or equal to any other available treatment while being a fraction of the cost with no SAE. This vaccine also has implications across a wide range of diseases.
2. Revolutionary approach yet intuitively very simple and economical, safe and easy to administer, real breakthrough potential.
3. Its also worth noting in the wider industry vote, although not decisive, this company gained 40% of the 793 votes cast for this category
Well done Advaxis: ADXS-HPV – HPV !
http://blogs.terrapinn.com/vaccinenation/2012/04/12/winner-therapeutic-vaccine-advaxis-wvcusa-vie-awards/
Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has been selected as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards for its ADXS-HPV construct.
The ViE awards, sponsored by Novartis Vaccines and Diagnostics, were created to recognize the accomplishments and contributions of companies and individuals in the vaccine industry over the previous 12 months.
"We are delighted to receive recognition for our Company's achievements in developing ADXS-HPV," commented Thomas A. Moore, Chairman & CEO of Advaxis. "Our team continues to bring our proprietary platform technology from the laboratory into the clinic and meet major milestones in development in HPV caused cancers and soon in prostate and breast cancer, as well."
The ViE Awards
The ViE Award nominees were voted on by those in the global vaccine industry and also judged by a panel of representatives from pharma, biotech, academia, government, non-governmental organizations (NGOs), and public health. Winners were announced at the annual ViE Awards on April 11, 2012 during the World Vaccine Congress in Washington, D.C., produced by Terrapinn.
The criteria used to judge this category are as follows:
-Vaccine candidate addresses current unmet medical needs
-Candidate shows significant potential for vast geographical and market reach
- Candidate possesses a novel mode of action or technology
-Progress made to date through clinical trials and/or achieved milestones
- Advanced efficacy, safety, and risk management data where appropriate
Judges specific comments on the winner included:
1. Has been shown to work at a rate that is greater than or equal to any other available treatment while being a fraction of the cost with no SAE. This vaccine also has implications across a wide range of diseases.
2. Revolutionary approach yet intuitively very simple and economical, safe and easy to administer, real breakthrough potential.
3. Its also worth noting in the wider industry vote, although not decisive, this company gained 40% of the 793 votes cast for this category
Well done Advaxis: ADXS-HPV – HPV !
http://blogs.terrapinn.com/vaccinenation/2012/04/12/winner-therapeutic-vaccine-advaxis-wvcusa-vie-awards/
Advaxis ADXS-PSA Construct Causes Significant Tumor Regression in Preclinical Prostate Cancer Study
Advaxis, Inc.,a leader in developing the next generation of immunotherapies for cancer and
infectious diseases, announced the publication of preclinical research with
ADXS-PSA (ADXS31-142), Advaxis' Lm-LLO immunotherapy
targeting the PSA antigen associated with prostate cancer.
This research was conducted in collaboration with Dr. Chandan Guha and his
laboratory at Montefiore Medical Center, Bronx, NY. The paper titled
"Combined immunotherapy with Listeria
monocytogenes-based PSA vaccine and radiation therapy leads to a therapeutic
response in a murine model of prostate cancer" by
Hannan R, Zhang H, Wallecha A, Singh R, Liu L, Cohen P, Alfieri A, Rothman J,
and Guha C., has been e-published ahead of print in the journal Cancer
Immunology Immunotherapy.
The objective of the study was to determine if the combination of ADXS-PSA
immunotherapy and radiation therapy could improve upon the efficacy of either
immunotherapy alone or radiation therapy alone in the treatment of mice bearing
PSA-expressing TPSA23 tumors, a preclinical model of prostate cancer.
The study showed:
-- The combination of ADXS-PSA immunotherapy and radiation therapy resulted in
complete regression of established tumors in 60% of mice compared to less-than
or equal to 10% complete regression in either of the treatments alone.
-- In mice that completely regressed after combination therapy, tumors did not
develop upon re-challenge with tumor cells, suggesting the induction of systemic
and protective immune memory.
-- In addition, combination therapy resulted in increased induction of
PSA-specific T cells in the periphery and an increased infiltration of these
cells in the tumor microenvironment.
"ADXS-PSA continues to demonstrate activity in models
of prostate cancer, confirming our decision to move this construct into clinical
development. The potential synergy of ADXS-PSA and radiotherapy observed in this
study suggests that ADXS-PSA might be combined with other therapies that show
efficacy in this type of tumor," commented Dr. John
Rothman, EVP of Science and Operations at Advaxis.
The abstract is available online.
http://ir.issuerdirect.com/adxs/read_press_release/2600
Advaxis, Inc.,a leader in developing the next generation of immunotherapies for cancer and
infectious diseases, announced the publication of preclinical research with
ADXS-PSA (ADXS31-142), Advaxis' Lm-LLO immunotherapy
targeting the PSA antigen associated with prostate cancer.
This research was conducted in collaboration with Dr. Chandan Guha and his
laboratory at Montefiore Medical Center, Bronx, NY. The paper titled
"Combined immunotherapy with Listeria
monocytogenes-based PSA vaccine and radiation therapy leads to a therapeutic
response in a murine model of prostate cancer" by
Hannan R, Zhang H, Wallecha A, Singh R, Liu L, Cohen P, Alfieri A, Rothman J,
and Guha C., has been e-published ahead of print in the journal Cancer
Immunology Immunotherapy.
The objective of the study was to determine if the combination of ADXS-PSA
immunotherapy and radiation therapy could improve upon the efficacy of either
immunotherapy alone or radiation therapy alone in the treatment of mice bearing
PSA-expressing TPSA23 tumors, a preclinical model of prostate cancer.
The study showed:
-- The combination of ADXS-PSA immunotherapy and radiation therapy resulted in
complete regression of established tumors in 60% of mice compared to less-than
or equal to 10% complete regression in either of the treatments alone.
-- In mice that completely regressed after combination therapy, tumors did not
develop upon re-challenge with tumor cells, suggesting the induction of systemic
and protective immune memory.
-- In addition, combination therapy resulted in increased induction of
PSA-specific T cells in the periphery and an increased infiltration of these
cells in the tumor microenvironment.
"ADXS-PSA continues to demonstrate activity in models
of prostate cancer, confirming our decision to move this construct into clinical
development. The potential synergy of ADXS-PSA and radiotherapy observed in this
study suggests that ADXS-PSA might be combined with other therapies that show
efficacy in this type of tumor," commented Dr. John
Rothman, EVP of Science and Operations at Advaxis.
The abstract is available online.
http://ir.issuerdirect.com/adxs/read_press_release/2600
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