Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
This is very true. While there is cause for optimism there are no guarantees in life. Especially in biotech.
The combo trial with Keytruda has yet to be proven. That is what the P2b trial is all about. It could fail, or it could be a smashing success. No one knows at this point.
For the hope of cancer patients and investors (me, selfishly included), I'm betting on the latter outcome. Keeping fingers crossed.
Excellent. Did you read the article that Titan V posted?
Not publicly traded companies, but there are some examples of extreme multiples being paid for early stage biotechs in that article.
A buyout of ONCS is possible at some point, but it is pure conjecture at this point as you well know. Nothing along those lines will happen unless the P2b interim results (known only by Merck, ONCS, and few others) is positive.
We should see some positive results "sometime" in 2015.
I believe the original point (by a separate poster) was that ONCS "could" eventually be acquired for 4-5x their CURRENT market cap. NOT the market cap at the time of acquisition.
And that is what I based my follow-up post on.
Perhaps it was not worded explicitly enough. Sorry for the misunderstanding.
Read through the posts again. Does this give you a better understanding?
That would translate to about $2.50/share at the high end.
But remember timing is everything. The earlier the buyout, the cheaper the buyout price because the buyer then starts to assume more of the risk. The longer big pharma waits, however, the higher the buyout price becomes. A classic case of weighing risk vs. reward.
IF a buyout were to occur by Merck, I'd suggest it "could" happen in Q3 or Q4 of 2015. Other suitors might be lining up in parallel, or afterwards.
But again, all of this is conjecture until proven as fact.
A continuation of this thought from a very informed opinion:
Read http://seekingalpha.com/article/2355835-amgen-amgn-ceo-bob-bradway-on-q2-2014-results-earnings-call-transcript
You will see Amgen is taking Tvec very seriously.
With similar/superior efficacy/toxicity profile to Tvec, this should be a giant clue that Immunopulse+PD1 is going to blow it out of the water. Note the 50% ORR that Tvec achieved was with Yervoy, not PD1.
Tvec+PD1 should even be better than 50% ORR (based on Yervoy monotherapy 10% vs PD1 20-30%). We could see ORRs approaching 80%, with CRs approaching 50%. The key point is you can take these numbers and reasonably extrapolate them to Immunopulse.
Furthermore, I suspect Immunopulse+PD1 efficacy will be be slightly better than Tvec (given the intrinsic advantages of the electroporation/DNA plasmid approach)
1) constant, continuous secretion IL12
2) acute inflammation / danger signals
3) direct tumor kill and mechanical compromising of tumor defenses
If this proves out, then it is just a matter of time. Merck will need Immunopulse to position against Amgen's Tvec. 80% response rates is what CAR-Ts can offer for CD19+ blood cancers. Look at how excited that's got the industry. Blood cancers are "easier" to treat than solid tumors. So, achieving 80% ORRs for solid tumors will be nothing short of revolutionary.
The important advantage Immunopulse + PD1 has is it will be much safer than CAR-T. CAR-T has a big problem where patients have died violent deaths (when the CAR-Ts attack healthy cells that express the intended target in small amounts).
Secondly advantage: Immunopulse + PD1 is much much cheaper and logistically much easier to administer than CAR-T. CAR-T requires collection of white cells, complex genetic engineering, culturing, shipping cells etc etc. Much more expensive than simple antibody infusions of PD1 + roll-into office device (Immunopulse). DNA plasmids Immunopulse uses are also very cheap and easy to make in comparison to genetic engineering of CAR-Ts.
Witness the hysteria around CAR-T companies now. KITE market cap at $2B. Juno ipo said to be coming out at $3B. But there are already 8 of more players in the space. There is risk of investors losing a lot of money in that space if CAR-Ts do not work for solid tumors. Like the early dot com days. In the beginning, web mail portals attracted huge, huge valuation. After a very short time, every company had it's own web mail portal. Similar thing will happen to CAR-T space. The general approach is public domain knowledge as it was discovered by NIH and other country/government scientists.
ONCS has seen the light. They have made a course adjustment to go after head & neck cancer. I see this as a sign they need to push hard and fast to position themselves for other solid tumor indications, not just the crowded melanoma space.
I suspect worst case scenario is we get bought by Merck for 4-5x today's market cap. Best case, we get to chart our own future and grow into a multi-billion platform standalone company.
The relationship with Plexxikon opens the door for potential meetings with Daiichi Sankyo. Plexxikon is owned by Daiichi. Did you see the buyout number for Plexxikon?
This is not to say that Punit is currently meeting with Daiichi in Singapore. That is pure conjecture and nothing more was intended by my post.
Cheers.
Perhaps those meetings bore some eventual fruit?
Plexxikon is a wholly owned subsidiary of Daiichi Sankyo.
http://finance.yahoo.com/news/oncosec-medical-plexxikon-collaborate-explore-110300462.html
And Daiichi Sankyo is the 2nd largest pharma in Japan.
ImmunoPulse, Keytruda, and T-Vec. A perfect combinatorial trifecta?
For those who are familiar with these drugs and technologies, please weigh in with your thoughts.
As for Punit being in Singapore? He could be visiting relatives or he could be meeting with Daiichi Sankyo. Or something completely different. Who knows?
This is just an opinion, but an informed one:
The presence of PD1/PDL1 expression in the tumor has been shown to be NOT a reliable indicator of efficacy (of the PD/L1 checkpoint blockade antibodies).
In the EARLY days of the trials, investigators *thought* it was potentially a reliable marker. Then, they started noticing patients were responding to the checkpoint blockade antibodies even though the biopsied tumors did NOT contain PD1/PDL1.
Basically, the immune system is highly complex. PD1/PDL1 expression can come and go. It depends when you one is actually measuring expression on the tumor.
The $1m question is whether or not combining Immunopulse + PD1 will result in significant synergies. My bet is yes.
I dug around Stanford University's research website and found the following:
http://www.nejm.org/doi/full/10.1056/NEJMc1203984
As you can see, just introducing radiation therapy to a single tumor can make checkpoint blockade suddenly work (where it was not working before). They got so excited that they even started a clinical trial combining the two:
http://clinicaltrials.gov/ct2/show/NCT01769222
Now, take this observation one step further. Go ask all the radiation oncologists how many times they have seen the "immunopulse effect" where zapping just one or two tumors can cause systemic antitumor effect. Very very few, if any will tell you they've seen it. The point here is that if simple radiation can cause dramatic response to checkpoint blockade, it is a reasonable, if not a strong bet, that combining Immunopulse with checkpoint blockade will result in this combination synergy, perhaps more apparent, at higher rates.
The scientific rationale is all there -- zapping a tumor with immunopulse causes immediate attraction of Tcells. Tcells attack the tumor, leading to an "in situ vaccine effect". These Tcells go on to attack other tumors throughout the body. However, tumors have highly immunosuppressive defensive mechanisms. That's where the PD1 checkpoint blockade comes in -- to remove these defenses.
My bet is we truly will see a shockingly high synergistic rate of responses to PD1 with Immunopulse. Furthermore, other alternatives such as radiation, vaccines may not be as good as Immunopulse because of the following:
1) Immunopulse DNA plasmids result in *constant* secretion of IL12 -- this creates a "constant vaccine" like effect. Imaging if you have to vaccinate a person (or irradiate) every minute. 24x7.
2) Electroporation causes transient intense inflammation. This is highly beneficial in generating the needed immune response. You can research something called cryo-ablation (or cryoablation). Many investigators have observed a transient systemic anti-cancer effect -- just like immunopulse -- from cryo-ablation. However, this effect is very temporary and nowhere as apparent as Immunopulse. The point is that the transient inflammation is very beneficial.
3) IL12 has been tried in the past (systemic infusions). However, it failed. Why? One reason posited was IL12 causes upregulation of "Bad stuff" like Tregs. You see, the immune system is highly complex will all sorts of checks & balances. These checks exist to prevent bad stuff from happening like auto-immune diseases (where your own Tcells attack your healthy tissue). IL12 has been shown to cause Tregs to initially decrease increase. This promotes the beneficial antitumor effects. However, after some time, Tregs may re-increase to prevent autoimmune type symptoms. This is one explanation for the countless "failed" immunotherapies from the 80s, 90s, and even today. This is where checkpoint blockade comes in. Checkpoint blockade (PD1) prevents Tregs from eventually stopping the anti-tumor effects of IL-12.
None of us know Dr. Pierce personally.
(If you do, raise your hand in chime in to this discussion.)
No hands raised in all likelihood.
As such, NONE of us know what his true motivations are. He is where he is by his choice and due to the fact that he's uniquely positioned his career to help beat cancer in his own way.
Trying to decipher his personal motivations is extra-topical, boring, and frankly provides zero value. Just my opinion. You may have yours.
Can we move past Dr. Pierce? We're beating a dead horse that was buried a long time ago.
The main focus should be ONCS' technology and their business model, IN MY OPINION.
Non-profits typically don't produce breakthrough drug combinations.
There may be exceptions, but they are just that. Exceptions.
This is his best opportunity to do what he believes will help the world in the shortest period of time.
I personally believe Dr. Pierce wants to cure melanoma.
Maybe someone in his family has died of it. Who knows. He was definitely motivated enough to leave Merck to pursue this in a more focused way.
The stock options and financial rewards go with being a person of his importance to his company and the field of oncology and immunology.
Yes, Dr. Pierce would be interested in stock options.
We live in a capitalistic society.
I've always enjoyed them whenever I have worked at start-ups. It's one of the carrots that companies of that size offer employees.
I agree. Dr. Pierce has more knowledge about Keytruda and ImmunoPulse (together) than anyone in the world.
So, yes, he is well positioned to have a better opinion of this than anyone in the world. Certainly more than all of us here.
Dr. Pierce will know if it works in 2015 and I believe that we will too.
If you disagree, fine. We can agree to disagree.
We will know sometime in 2015 whether it works.
Merck and ONCS will know before we know.
Dr. Pierce has a better idea of this than anyone.
Preliminary data in related previous studies is good.
But the P2b trial is where the rubber meets the road.
Different drugs and different FDA protocols.
Apples and oranges comparison.
Valuable data will be available in early-to-mid 2015.
Merck will have access to the P2b data before anyone else except for ONCS.
We will agree to disagree.
Thanks Jeff. This is how it works.
That is incorrect. They are interested in both.
Data is all that matters.
Everything else is irrelevant and simply noise. Ignore it.
Patience is needed. Wait for the data in 2015. "Build it, and they will come."
That assumes that one has access to perfect information.
No one on this board has access to perfect information.
Therefore, it's presumptuous to take either side of the question being discussed. It's all conjecture.
There is no evidence to support the contrary, either. Thanks.
We will need to agree to disagree on that. Thanks.
Hang in there, David.
All of us have felt the same emotions either with ONCS or other biotechs we have owned at some point in time.
Patience, grasshopper. :)
Just be patient. Build it, and good things will come.
Even if all of us were to whine about it, nothing will change.
Patience.
David--none of us have any control on that.
If you believe in the science, be patient. That's the biggest problem biotech investors face.
This will run when you least expect it.
We're done with 2014. All milestones were met.
Let's again look to 2015 and see what the future brings.
Again, some of us disagree on enrollment data and the time it will take to partially enroll for P2b. It's fine to disagree.
We just need to find the facts and share them here.
Actually, all three at different times during the presentation.
My takeaway is that everything is proceeding according to plan.
Let's focus on 2015 and P2b trials.
Partner specific details are "off limits" during conference calls.
Especially when negotiations may be fluid.
It is understandable why he didn't answer the question. He delivered all that he said he would deliver in 2014.
Let's focus on 2015 and P2b trials.
Agreed. Those are typically the kinds of incentives which get thrown to folks joining small start-up organizations.
Dr. Pierce is not leaving.
I'm not sure how you could infer that from the text of my post.
To be more clear, Dr. Pierce is not leaving.
Can we also please leave this stale topic behind? Please?
Gentlemen and Ladies: No one is irreplaceable.
Not me, not you, not "dr_lowenstein", not Dr. Pierce, not Mr. Dhillon, not the president of Merck, not president Obama, and on and on. We can ALL be replaced.
Having said that, it is VERY unlikely that Dr. Pierce will be leaving ONCS anytime soon. He had a great job at Merck, but wanted to join a start-up which allowed him the freedom to achieve his goal turning non-responders into responders and creating combinatorial immunological approaches to defeat cancer via ImmunoPulse electroporation.
Can we please leave this topic behind. It's getting pretty stale and boring. Please?
Yes, they are in a very good position.
We will likely see additional competent professionals join ONCS' team as the company continues to grow and build out its capabilities.
Agreed. Who did you have in mind?
"Mai Le and Robert both sounded experienced and confident. Mai Le may be the smartest one there."
Agreed. Robert's wife is extremely smart.
Not that Dr. Pierce is a slouch in any way.
Both are indispensable to ONCS.
Well said. It's my understanding that Dr. Pierce is still very highly regarded at Merck. He helped them quite a bit with MK-3475 (Keytruda) and in other ways.
Larger players will come onboard once P2b interim results are in.
Patience is needed. One must not set expectations beyond what is rational.
They are where they are. Great progress is being made. We'll get more guidance from them in January.
NDA and/or relationship with Merck might preclude Punit talking about partnerships. In fact, I see Merck potentially buying ONCS at some point, depending how the P2b results are.
I'll reserve judgement until we start to see some P2b data. Until then, I'm perfectly happy being long in ONCS and other biotechs in my portfolio. It's a great space to be in oncology, with room for quite a few companies, including ONCS.
Folks, at this point it's all about the P2b data, and little else. Build it, and they will come.
Heading to an important set of meetings.
Will be offline until later today.