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Post by JHam on Aug 25, 2014 9:33:28 GMT
Well, now we know what was happening. Big news. Congrats guys! Jckrdu, it looks like ADVX beat ONCS to the punch in a collaboration trial with a PD-1 checkpoint inhibitor. This one with Merck (not sure if that means Merck is out of the running for ONCS' trial): Advaxis, Merck to test immune therapies against prostate cancer www.reuters.com/article/2014/08/25/advaxis-merck-co-cancer-idUSL2N0QS27G20140825
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Post by JHam on Aug 25, 2014 9:38:59 GMT
Advaxis, Merck to test immune therapies against prostate cancer
BY RANSDELL PIERSON Mon Aug 25, 2014 12:01am EDT
Aug 25 (Reuters) - Advaxis Inc on Monday said it will test an experimental immuno-oncology drug in combination with a high-profile immunotherapy from Merck & Co Inc as a treatment for patients with advanced prostate cancer.
The tiny U.S. biotechnology company, in its second cancer collaboration with a large drugmaker in the past month, said it would evaluate the use of its ADXS-PSA as a standalone treatment and also study it in combination with Merck's pembrolizumab in the Phase I/Phase II trial.
Merck's drug is a member of an exciting new class of medicines called "PD-1 inhibitors" that work by blocking the PD-1 protein, thereby taking the brakes off immune system cells and prodding them to attack tumors.
The Advaxis drug consists of a modified form of the Listeria bacterium fused to a protein called PSA that is shed by prostate tumors. It is meant to spur creation of immune system soldiers, called T-cells, that are primed to recognize and kill prostate cancer cells.
By using different approaches, the drugmakers hope the two drugs have a better chance of knocking down the prostate cancer than either could achieve on its own.
"If the combination of drugs shows an added effect, the companies would likely continue their collaboration," perhaps under a licensing deal, said Daniel O'Connor, chief executive officer of Advaxis.
Prostate cancer is the most common cancer among men, other than skin cancer. One man in six will get prostate cancer during his lifetime, and about 3 percent of men die from the disease, according to Advaxis.
O'Connor, in an interview, said his 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.
PD-1 inhibitors and other immuno-oncology drugs have already shown promise against other types of cancer, including melanoma, but have not yet been tested to any great extent against prostate cancer, according to David Mauro, executive director of oncology at Merck.
"We think this combination gives us the opportunity to do early exploration in prostate cancer and bring immuno-oncology into this space," Mauro said in an interview.
Merck previously announced collaborations with several other drugmakers on combined uses of pembrolizumab with their medicines, including British drugmaker GlaxoSmithKline, Pfizer Inc, Amgen Inc and Incyte Corp.
Advaxis last month announced a collaboration with British drugmaker AstraZeneca to test immunotherapy drugs from both companies in combination.
Under that deal, AstraZeneca's drug MEDI4736 will be evaluated in a Phase I/II clinical study together with the U.S. company's cancer vaccine ADXS-HPV. The AstraZeneca drug blocks PD-L1, a protein similar to PD-1.
The combination will be tested in patients with cervical cancer and head and neck cancer, tumors that are closely linked to infection with the human papillomavirus.
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Post by JHam on Aug 25, 2014 9:39:35 GMT
Advaxis is footing the bill for this one as well.
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Post by selluwud on Aug 25, 2014 11:57:04 GMT
Sell into the news today??
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Post by jckrdu on Aug 25, 2014 11:58:57 GMT
Advaxis is fitting the bill for this one as well. Jham, Sell, All - My thoughts below.... All, PR out this morning (which explains last week's run-up was due to a news leak) on a collaboration with Merck to evaluate Advaxis' immunotherapy alone and in combination with Merck's PD-1 inhibitor. The good news - Advaxis on the map with another partnership with big pharma. If the results of this Phase 1/2 study (starts early 2015) are good, Advaxis will be able to command signifcant $$$ for licensing. The bad news - Like the recent Astrazeneca deal on HPV, Advaxis is funding these prostate trials. With an approximate $20 million annual burn rate and $25 million of cash on the balance sheet, the market is going to start to wonder where the cash is coming from to fund all these trials. Aduro was able to strike a $365 million pre-clinical deal with J&J on their listeria based immunotherapy targeting prostate cancer, so why couldn't Advaxis get similar terms? The answer is one of 2 things; 1) The CEO of Advaxis just can't seem to negotiate and strike deals on decent terms, or 2) Advaxis is very confident their therapy will work, and they don't want to strike a weak deal at the preclinical stage. Honestly, I'm not sure which one it is. How will the market react? I'm not sure. My best guess is that there will be an initial move higher as Advaxis will be in the limelight with Merck, but then a gradual pullback as funding/capital requirements to fund this deal come more into focus. My thoughts for the remainder of 2014? Advaxis can still land partners and funding for their planned Phase 3 trial in the US for HPV, and perhaps announce a pre-clinical deal for breast cancer. However, with another weak deal (IMO) announced today for prostate, I'm less bullish for Advaxis prospects for the remainder of 2014. Given the way Advaxis is structuring these recent deals, significant value creation for shareholders may only come after the results are announced for the Astrazeneca (HPV) and Merck (prostate) deals, farther down the road. Value creation in 2014 is still possible if Advaxis can do one of the following: 1) Biocon secures approval to commercialize HPV in India on the strength of the Phase 2 results in hand, 2) partnership with upfront cash announced for breast or HPV Phase 3. Disclosure: I hold no shares of Advaxis at this time. If I did, I'd take the opportunity to take some profits on any move higher today on the Merck deal. Jim finance.yahoo.com/news/advaxis-merck-form-collaboration-evaluate-040100840.html
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Post by selluwud on Aug 25, 2014 12:02:50 GMT
My thoughts as well, get out while the getting is good, and get back in after the finances are disclosed and executed.
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Post by jckrdu on Aug 25, 2014 12:08:15 GMT
My thoughts as well, get out while the getting is good, and get back in after the finances are disclosed and executed. The wildcard is Biocon's efforts to secure approval to commercialize HPV in India based on the completed Phase 2 trial. Advaxis has been silent on this topic. If Biocon is successful (and perhaps Advaxis knows they will be so they're in no rush to strike weak preclinical licensing deals with Merck and Astrazeneca?) Advaxis could start seeing licensing revenue in 2014/2015 from Biocon to help fund these trials. If Biocon isn't successful, Advaxis is on the hook to fund a Phase 3 HPV trial in India, and more dilution will be coming.
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Post by selluwud on Aug 25, 2014 13:54:27 GMT
Sold at 3.45, I should have been more patient as the volume is still there.
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Post by iamaverb on Aug 25, 2014 14:18:04 GMT
My thoughts as well, get out while the getting is good, and get back in after the finances are disclosed and executed. The wildcard is Biocon's efforts to secure approval to commercialize HPV in India based on the completed Phase 2 trial. Advaxis has been silent on this topic.If Biocon is successful (and perhaps Advaxis knows they will be so they're in no rush to strike weak preclinical licensing deals with Merck and Astrazeneca?) Advaxis could start seeing licensing revenue in 2014/2015 from Biocon to help fund these trials. If Biocon isn't successful, Advaxis is on the hook to fund a Phase 3 HPV trial in India, and more dilution will be coming. My thoughts as well, Advaxis has been very, very quite in regards to the trials in India after indicating initial promising results. Additional collaborations with other BP could be in the future for this company. I intend to hold long.
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Post by jckrdu on Aug 26, 2014 2:20:41 GMT
The wildcard is Biocon's efforts to secure approval to commercialize HPV in India based on the completed Phase 2 trial. Advaxis has been silent on this topic.If Biocon is successful (and perhaps Advaxis knows they will be so they're in no rush to strike weak preclinical licensing deals with Merck and Astrazeneca?) Advaxis could start seeing licensing revenue in 2014/2015 from Biocon to help fund these trials. If Biocon isn't successful, Advaxis is on the hook to fund a Phase 3 HPV trial in India, and more dilution will be coming. My thoughts as well, Advaxis has been very, very quite in regards to the trials in India after indicating initial promising results. Additional collaborations with other BP could be in the future for this company. I intend to hold long. Impressive move up today on incredible volume. Over 3.4 million shares traded, which is over 17% of the outstanding shares. Good luck to all ADXS holders.
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