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As we plunge into the abyss, here's a list of partnerships, collaborations and licenses I could find, some of which I had forgotten about. I've included any pertinent financial details, if possible. Does anyone know what happened with the earlier agreements? Many seem to be dead in the water. Ah, what could have been...
Here are Advaxis collaborations and licensing agreements that I know of. Some of whom, I have no idea if they're stll active:
Amgen: "Under the terms of the agreement, Amgen receives exclusive worldwide rights to develop and commercialize ADXS-NEO. Amgen will make an upfront payment to Advaxis of $40 million and purchase $25 million of Advaxis common stock. Amgen will be fully responsible for funding clinical and commercial activities. Advaxis will lead the clinical development of ADXS-NEO through proof-of-concept, retain manufacturing responsibilities, and receive development, regulatory and sales milestone payments of up to $475 million and potential high single digit to mid-double digit royalty payments based on worldwide sales"
Aratana: "Under the agreement, Aratana made a one-time upfront payment to Advaxis of $1 million and an additional $1.5 million equity investment in Advaxis common stock and warrants. Aratana agreed to pay up to an additional $6 million in clinical and regulatory milestones for each of the four products, assuming approvals in both cats and dogs in both United States and the European Union. In addition, Aratana agreed to pay up to $28.5 million in commercial milestones. Upon regulatory approval and commercialization of the immunotherapies, Aratana agreed to pay Advaxis a tiered royalty ranging from mid-single digit to 10% on net sales."
AstraZeneca: "As part of the agreement, Advaxis will fund and lead the clinical trials to assess the efficacy and safety of the combination. MedImmune holds a non-exclusive relationship with the company regarding HPV-driven tumors types. MedImune will have the first right of negotiation for further development of the combination therapy. Results from the study will guide decisions for the combination therapy’s potential for future clinical development."
Biocon: "Under the accord, financial terms of which were not revealed, Biocon will also have access to Advaxis’ innovative and proprietary immunotherapy technology that can be leveraged for the development of other novel therapeutics for various unmet medical needs."
BMY: "Under the terms of the agreement, each party will bear their own internal costs and provide its immunotherapy agents. Advaxis will sponsor the study and pay third-party costs."
Especificos Stendhal SA de CV: "Under the terms of the Agreement, Stendhal will pay $10 million toward the expenses of AIM2CERV, a planned global Phase 3 clinical trial in women with high-risk, locally advanced cervical cancer. This payment covers a significant portion of the total planned study costs. Stendhal will also work with Advaxis to complete the clinical trial of axalimogene filolisbac in Mexico, Brazil, Colombia, and other investigational sites in Latin American countries. Additionally, Stendhal will manage the regulatory approval process, promotion, commercialization and market access for axalimogene filolisbac in these markets. Advaxis and Stendhal will share profits on a pre-determined basis."
FusionVax: "Advaxis has exclusively licensed its lead clinical-stage product candidate, ADXS-HPV, to FusionVax. Under the terms of the agreement, Advaxis will license the rights to ADXS-HPV for the Asia territory, exclusive of India, for all indications. In exchange, FusionVax will pay Advaxis an up-front payment, certain event-based financial milestones, an annual exclusive licensing fee, and an annual net sales royalty in countries with issued patents. In exchange for the up-front payment, Advaxis will provide FusionVax an equal amount of Advaxis common stock. FusionVax will be responsible for conducting clinical trials and pursuing commercialization of ADXS-HPV in Asia and, in exchange, Advaxis will pay FusionVax net sales annual royalty on ADXS-HPV in the U.S. of less than 1%. The companies will share all data generated from their respective clinical trials. Advaxis and FusionVax will work together over the next six months to enter into a definitive exclusive licensing agreement based upon these terms. FusionVax has agreed to place into escrow a portion of the first event-based milestone pending the execution of a definitive licensing agreement."
Global BioPharma: "As part of the agreement, Advaxis will exclusively license to GBP the rights to ADXS-HPV for Asia, Africa, and former USSR territory, exclusive of India and certain other countries. Advaxis will receive event-based financial milestones, an annual development fee, and annual net sales royalty payments from GBP. Additionally, as an upfront payment, GBP will make an investment in Advaxis by purchasing shares of the company’s stock at market price. An option to purchase additional shares at a 150% premium to the stock price will also be available to GBP on the effective date of the agreement. GBP will be responsible for all clinical development and commercialization costs in the GBP territory and pay the clinical trial costs for up to 150 patients with cervical cancer for enrollment in Advaxis’ U.S. and GBP’s Asia registrational programs for cervical cancer."
Knight Therapeutics Inc: "In connection with the licensing agreement, Knight is purchasing directly from Advaxis 359,454 shares at $13.91 per share, which represents a 7 percent premium to the price of Advaxis's common stock at market close on August 25, 2015. In addition, Sectoral Asset Management, a leading Canadian-based global healthcare investment advisor, is purchasing 1,437,815 shares at $13.91 per share directly from Advaxis on behalf of its clients. The combined gross proceeds to Advaxis from these direct investments is $25 million. Under the terms of the licensing agreement, Knight will be responsible for all commercial activities related to Advaxis current and future products, including axalimogene filolisbac, ADXS-PSA and ADXS-HER2, in Canada. Advaxis is eligible to receive double digit royalty as well as sales milestones."
Merck: "... company will bear most costs of the study, which is slated to begin in early 2015 and probably be conducted by a contract research organization. Merck will provide the pembrolizumab, an injectable monoclonal antibody, to be used in the trial."
OS Therapies: "Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG) [1] , will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. Advaxis will receive an upfront payment, reimbursement for product supply and other support, clinical, regulatory, and sales-based milestone payments, and royalties on future product sales. Additional details of the financial terms have not been disclosed."
Sellas: " Advaxis will conduct all preclinical activities required for an IND filing, with Sellas agreeing to oversee all clinical development and commercial activities. In return for the license, Sellas has agreed to pay Advaxis up to $358 million tied to achieving development, regulatory, and commercial milestones. Should the cancer immunotherapy candidate receive regulatory approval, Sellas has agreed to pay Advaxis single-digit to low double-digit royalties based on worldwide net sales upon commercialization."
So, AH is as bad as it gets? Bloodbath tomorrow? Any possible positive development?
I'd like to see one more (AXAL/cervical) deal before the next conference call. If the deal is not weak, that would send a strong message to the markets.
At this point, I was happy to see ANY deal announced. I am particularly happy with this one as I think there is nothing worse than seeing a child with cancer. I can't imagine the upfront payment is very much due to the nature of OS Therapies and how they receive funding but there are milestone payments. Still, OS will be responsible for the conduct and funding of a clinical study. So, to paraphrase Mark Twain, "The reports of ADXS-HER2 death have been greatly exaggerated”
Both bladder and breast cancers have elevated HER2 expression so, if the next HOT candidate is either one of those, it could indicate HER is still on the company's mind.
If ADXS-HER2 shows as much efficacy in humans as canines, we have a winner. It's probably even more efficacious combined with a CI.
On an older slide, there had been an IST for Locally Advanced HPV+ Head & Neck Cancer beginning 1st half 2018. I'm assuming this is trial to which they refer.
https://gciggroup.com/system/files/19%20Duke%20SLIDES%20Advaxis.pdf
Didn't Ken talk about shelving this trial?
Metastatic Cervical Combo with durvalumab
Much truth in what you say, Easy. My hope is Ken strikes a good enough deal(s) to boost SP and get us through our own trials (pun intended). The addition to slide 22, as pointed out by JS, makes me wonder if they anticipate enough cash to fund a HOT trial on their own.
I think that might be new.
The ADXS pipeline is now much smaller than before now that Axal is basically worthless.
I choose to be positive. I have skin in the game and I try to remain optimistic that this investment will pay off. I have, on occasions, expressed disappointment with management. I think they've made MANY mistakes. I just don't dwell on negativity. And, my peke is just tired (they're not Jack Russells, after all). I'm not referring to his backyard activities.
Question: Are they a creation of some (the same) supreme power?
Good catch!
They have a joint steering committee so there should be a bit of interaction there. They should jump the gun and buy us now (yes, a dream at the moment...I know).
“The cancer cells in a patient’s body don’t all express the same number or kinds of antigens,” said Roger Sidhu, a global product general manager at Amgen who chairs the Amgen-Advaxis Joint Steering Committee. “This new approach could generate antitumor T cells that target a broad spectrum of the cells present in a tumor. We see that as an exciting potential advantage.”
Amgen reference now gone.
I tried calling Ranya about slide 14 but her mailbox is full. I'm sure other people are calling about the same thing.
New opening, not sure if this was previously posted:
Associate Director of Clinical Operations
Job Locations US-Princeton
Posted Date 18 hours ago(18 hours ago)
ID
2018-1128
Overview
Responsible for appropriate execution and oversight of clinical operational development for several Phase 1-2 clinical trials across various cancer indications and tumor types. Accountable for all activities associated, directly or indirectly with trial execution and clinical development, reporting and submission activities of the compound, as appropriate. As applicable, this position is responsible for the coordination of all activities performed by Study Team Members assigned to her/his program/project of responsibility. As needed, responsibilities may include involvement in / leadership of INDs and other regulatory filings. As applicable, is responsible for the line management and development of all manager(s) assigned to her/his program/project. Supports the development of Human Resources programs which may include performance review and talent management and training requirements. Must have demonstrated capacity to lead with minimal supervision, communicate effectively, think strategically, and drive for results.
Absolutely! Here's hoping for good news!
It is possible to see results that early, I believe. I would like to see an update on overall enrollment for the trial. If more than one patient is showing improvement, they could possibly share some info at a conference.
I believe it did. It involved patents and marketability, I believe. That's what I said "if" he can turn this around.
As has been mentioned here before, if Ken can pull off a good deal(s) and get the share price up he can write his own ticket. Many struggling bios will want him.
He's made some tough, and I think right calls, so far. Now, as they've announced they are in multiple partnership talks, I want him to show us the money!
Well said, Dawson.
I lifted this from the CVM letter to shareholders I found on SA today. I did not investigate the veracity of the quote or the nanes of the companies that were sold but, if true, may bode well for any negotiations Advaxis is conducting:
"In the past 18 months, several successful Phase 3 cancer immunotherapy companies were sold for $7 billion to almost $12 billion. They had positive survival data from their pivotal studies, but had not yet received FDA approval. In addition, recently one cancer immunotherapy company with Phase 3 studies that were not yet complete was sold for about $1.6 billion."
This guy didn't know what he was talking about.
I believe he wrote a rebuttal to a Pearson article once on SA. It was clear, concise and convincing.
totally unproved ADXS LM Technology
I would have hoped they would allow the treatments for those with no other recourse.
When these geniuses finally realized that AXAL & the LM technology was a dud, they unloaded.
Can't argue with your points. I believe (may be wrong) that Dan stated the EMA had encouraged the company to apply. Hard to believe if it was turned down for more data. That should have come up in early discussions.
If the company picks HER2 for it's next ADXS-HOT construct, we could still get breast cancer in the clinic. If a BP steps up, maybe they get it in the clinic sooner.
He pulled it out of somewhere...
Wouldn't these qualify?
https://clinicaltrials.gov/ct2/show/NCT02164461?term=advaxis&draw=2&rank=8
https://clinicaltrials.gov/ct2/show/NCT01266460?term=advaxis&draw=1&rank=11
I don't know if they're late stage but they have persistent or recurrent cervical cancer.
Easy, I'm sure many here echo your sentiments. It's a sad fact, cash is king. If funding can't be found then the company could curtail AXAL development. The PIII has been ongoing and I hope they would continue, at least, with this. Patients have been enrolled and recruitment continues (unless the clinical trials gov't page has not been updated, something the company has been lapse in). We'll know soon enough.
https://www.focr.org/fda-expedited-review-programs
We should be working towards these.
What does that have to do with what she told me?
My recollection, per Noelle, was Advaxis was making changes (upgrades?) to the process and Amgen was onboard with the changes which caused the delay.
Why don't you post who bought?
I doubt all of them hold shares. No rational investor would cry doom and gloom consistently and then claim to still be in. It defies logic.
If his posts bother you so much, why do you read them?