Post by selluwud on Sept 22, 2014 13:00:02 GMT
Sounds like there may be more deals coming..................
www.thechairmansblog.com/advaxis/gregory-mayes/changing-seasons-direction-wheres-advaxis-headed-summer-becomes-fall/
Changing Seasons – but not direction. Where’s Advaxis headed as summer becomes fall?
Posted on Monday, September 22nd, 2014 at 7:30 am
2 0 0 Google +0
At 10:29 p.m. this evening it will officially be fall in Princeton, NJ, the home of Advaxis. The formal passage of summer into the fall season provides an excellent time to look back on the past summer season and think about the possibility of business development initiatives that lie on the horizon.
While the business development activity of most bio-pharmaceuticals (large and small) grinds to a near halt during the summer months with the traditional worldwide vacation period in high gear, Advaxis skipped the beach and closed two major collaborative deals with two separate major pharmas (AstraZeneca/MedImmune and Merck) with two different types of checkpoint inhibitors, (PD-1 (Keytruda®) and PD-L1 (MEDI-4736)). Each therapy is individually forecasted to reach peak year sales of approximately $6.5 billion dollars.
Let’s take a closer look at how these deals came together and where we plan to go from here:
First, like with all things, we start any business development activity based on a strong scientific rationale for the dialogue being initiated. With respect to combining the Advaxis Lm-LLO technology with the checkpoint inhibitors, Dr. Samir Khleif, an expert on immunotherapy and cancer vaccine, conducted a pre-clinical study that showed the combined treatment led to significant inhibition of tumor growth and prolonged survival/complete regression of tumors in treated animals, a result that was not achievable by either treatment alone. These findings showed that the Advaxis Lm-LLO technology and the checkpoint inhibitors have complementary mechanisms of action and the results were ultimately published in the Journal of ImmunoTherapy by Mkrtichyan, et al. (Journal for ImmunoTherapy of Cancer 2013, 1:15).
The next step was to engage potential partners in the scientific concept and then run the due diligence gauntlet. In this case, partner engagement was an absolute requirement. Without a bona fide, high flying checkpoint inhibitor in our hands, there could be no collaboration, no evaluation of the combination and ultimately no data — a necessity to drive the Advaxis value proposition. Initially, our internal goal was to actually secure one checkpoint combination deal. However, with interest from multiple parties, we believed that combination deals with two different types of checkpoint inhibitors (PD-1 and PD-L1) in three different tumor types (cervical, head and neck and prostate) would provide us the greatest opportunity to fully exploit our potential in this soon to be blockbuster space. In terms of due diligence, suffice it to say, Advaxis and the Advaxis Lm-LLO technology received high marks andvalidation from two of the leaders in the big pharma cancer immunology arms race.
From there, you begin to value and size up the deal. In order to properly forecast and receive significant value from a licensing transaction, you need data. Both the buyer and the seller need to know if there is a reasonable likelihood of success. While Dr. Khleif’s pre-clinical data is interesting, how the animal models translate to the human experience is the key unknown. If it works, any near term licensing deal that would have been executed this summer would have surely undervalued the ultimate value of combining a checkpoint inhibitor with the Advaxis Lm-LLO technology. The market segment for combination therapy exceeds the peak market value of previous mega-blockbuster classes, such as cholesterol-lowering statins. Our preference was to set valuation terms when we arrive at that market segment and not at the beginning of our journey to get there.
So, where do we go from here? The AstraZeneca/MedImmune and Merck collaborations are going to provide us with an excellent view into the ability of the Advaxis Lm-LLO technology to successfully combine with checkpoint inhibitors. Do we need to seek out more checkpoint deals? Probably not. What we will do now is seek to identify and secure other collaboration deals with other novel agents, such as IDO inhibitors, OX 40 and GITRs, for which a strong scientific rationale for combining modalities exists. Remember, no one agent is expected to cure cancer alone – it will be the successful combination of novel cancer immunotherapies that has the best likelihood of giving patients a chance to win their war against cancer and we are now right there in that game.
So as the calendar turns to fall, we anticipate more of the same – more novel, combination deals based on sound scientific and/or pre-clinical rationale that validate and build upon the ultimate value of the Advaxis Lm-LLO platform technology.
- See more at: www.thechairmansblog.com/advaxis/gregory-mayes/changing-seasons-direction-wheres-advaxis-headed-summer-becomes-fall/#sthash.L94DC2fj.dpuf
www.thechairmansblog.com/advaxis/gregory-mayes/changing-seasons-direction-wheres-advaxis-headed-summer-becomes-fall/
Changing Seasons – but not direction. Where’s Advaxis headed as summer becomes fall?
Posted on Monday, September 22nd, 2014 at 7:30 am
2 0 0 Google +0
At 10:29 p.m. this evening it will officially be fall in Princeton, NJ, the home of Advaxis. The formal passage of summer into the fall season provides an excellent time to look back on the past summer season and think about the possibility of business development initiatives that lie on the horizon.
While the business development activity of most bio-pharmaceuticals (large and small) grinds to a near halt during the summer months with the traditional worldwide vacation period in high gear, Advaxis skipped the beach and closed two major collaborative deals with two separate major pharmas (AstraZeneca/MedImmune and Merck) with two different types of checkpoint inhibitors, (PD-1 (Keytruda®) and PD-L1 (MEDI-4736)). Each therapy is individually forecasted to reach peak year sales of approximately $6.5 billion dollars.
Let’s take a closer look at how these deals came together and where we plan to go from here:
First, like with all things, we start any business development activity based on a strong scientific rationale for the dialogue being initiated. With respect to combining the Advaxis Lm-LLO technology with the checkpoint inhibitors, Dr. Samir Khleif, an expert on immunotherapy and cancer vaccine, conducted a pre-clinical study that showed the combined treatment led to significant inhibition of tumor growth and prolonged survival/complete regression of tumors in treated animals, a result that was not achievable by either treatment alone. These findings showed that the Advaxis Lm-LLO technology and the checkpoint inhibitors have complementary mechanisms of action and the results were ultimately published in the Journal of ImmunoTherapy by Mkrtichyan, et al. (Journal for ImmunoTherapy of Cancer 2013, 1:15).
The next step was to engage potential partners in the scientific concept and then run the due diligence gauntlet. In this case, partner engagement was an absolute requirement. Without a bona fide, high flying checkpoint inhibitor in our hands, there could be no collaboration, no evaluation of the combination and ultimately no data — a necessity to drive the Advaxis value proposition. Initially, our internal goal was to actually secure one checkpoint combination deal. However, with interest from multiple parties, we believed that combination deals with two different types of checkpoint inhibitors (PD-1 and PD-L1) in three different tumor types (cervical, head and neck and prostate) would provide us the greatest opportunity to fully exploit our potential in this soon to be blockbuster space. In terms of due diligence, suffice it to say, Advaxis and the Advaxis Lm-LLO technology received high marks andvalidation from two of the leaders in the big pharma cancer immunology arms race.
From there, you begin to value and size up the deal. In order to properly forecast and receive significant value from a licensing transaction, you need data. Both the buyer and the seller need to know if there is a reasonable likelihood of success. While Dr. Khleif’s pre-clinical data is interesting, how the animal models translate to the human experience is the key unknown. If it works, any near term licensing deal that would have been executed this summer would have surely undervalued the ultimate value of combining a checkpoint inhibitor with the Advaxis Lm-LLO technology. The market segment for combination therapy exceeds the peak market value of previous mega-blockbuster classes, such as cholesterol-lowering statins. Our preference was to set valuation terms when we arrive at that market segment and not at the beginning of our journey to get there.
So, where do we go from here? The AstraZeneca/MedImmune and Merck collaborations are going to provide us with an excellent view into the ability of the Advaxis Lm-LLO technology to successfully combine with checkpoint inhibitors. Do we need to seek out more checkpoint deals? Probably not. What we will do now is seek to identify and secure other collaboration deals with other novel agents, such as IDO inhibitors, OX 40 and GITRs, for which a strong scientific rationale for combining modalities exists. Remember, no one agent is expected to cure cancer alone – it will be the successful combination of novel cancer immunotherapies that has the best likelihood of giving patients a chance to win their war against cancer and we are now right there in that game.
So as the calendar turns to fall, we anticipate more of the same – more novel, combination deals based on sound scientific and/or pre-clinical rationale that validate and build upon the ultimate value of the Advaxis Lm-LLO platform technology.
- See more at: www.thechairmansblog.com/advaxis/gregory-mayes/changing-seasons-direction-wheres-advaxis-headed-summer-becomes-fall/#sthash.L94DC2fj.dpuf