The fact that Morrison and Foerster LLP has represented Merck before to me is neither here nor there. They are a huge firm. BUT, the fact that every other filling by ONCS including every other share offering has been done by McDonald and Wilson LLP is except for this one is VERY VERY VERY VERY significant. There would be absolutely no other reason that ONCS would need to do this except at the request by someone else.

By the way, as the resident lawyer on this board, I found this intellectually interesting. What a nerd, I know.

What it also means for me is that this is NOT going to be an offering. This means partnership to mean.

S-3 amendment:

1. I spent some time reading this carefully. The only changes to the original S-3 filing are Exhibit's 5.2 and 23.3. Both of these exhibits are essentially the same thing: A review of the S-3 by Morrison & Foerster LLP as to the validity of the original S-3 (Exhibit 5.2) and a consent to use/rely on such opinion (Exhibit 23.3).

2. What is interesting is that ONCS already had the same legal opinion filed with the original filing by the law firm of McDONALD CARANO WILSON LLP LETTERHEAD in Exhibit 5.1. Compare Exhibits 5.2 and 23.3 with Exhibits 5.1.

3. Finally, McDonald Carano and Willson, LLP have been ONCS' legal counsel for a long time and was the law firm that wrote the consent letter in ONCS last share offering. See link: http://ir.oncosec.com/all-sec-filings?page=5#document-10064-0001104659-13-064569

I read this in only one way: I think the recipient of these shares has asked ONCS to seek a legal opinion for it. Most likely Merck. Exciting times ahead.

I don't know. It might slow down the number of requests/inquiries from many people if it was a collective thing. Further, from Punit's perspective, it would be a set time per month that he could answer several questions at once. Further, ONCS might even be willing to do a webcast for investors. Other companies do this.

Well, it was actually Z's idea. I think it is a good idea and, if we worked together, we could come up with a list of really good questions to ask each month that would not only help us but Z as well. For example, you ask great questions Bob and your input is invaluable. Why not ask your questions in an organized what directly to management?

Zoriden:

This is the kind of stuff that needs to be posted here more often. You have a great re poor with management and your reported conversations are greatly appreciated. The "golden eggs" conversation went a long way.

I think it is high time we implemented your idea of having you be the spokesman from IHUB with ONCS management and have a long conversation once a month. You would become the new Brian Nichols.

On our side, we, as a group, can come up with a mixture of scientific and investment questions to ask. We have a great group of very diligent investors who are willing to dig. Further, there are some extremely valuable scientific minds who would be able to form the correct questions.

I envision a scheduled time once a month with management where they can schedule it and know when it is coming instead of being badgered. Further, as is appropriate, we will get our answers directly from the company itself (as much as they can legally answer or course).

Then, we would truly be working as a team. What do you all think?

Best advice ever!!!

Please deflate that's guys bs !!!

No doubt. Very exciting!!

I went to Merck's website, specifically, the investor relations page. I found this:

http://www.mercknewsroom.com/news-release/corporate-news/merck-highlights-progress-its-strategic-initiative-sharpen-commercial-an

Pretty cool.

I totally agree. That is why they have to listen to real offers. I would not be surprise if Merck offers to buy it. I know partnering has been the focus but you never know.

Well, the deal could be constructed in multiple ways. The buyout could be only for melanoma alone at a set price leaving other indications in place for ONCS.

I agree with both of you that this could severely limit themselves. On the other hand, the cancer research/immunotherapy market is exploding. For example, there are have mice studies on IL-15! As many have said, that is years away but it is an example that everyone is on hot pursuit.

These are just thoughts on a boring day.

I was thinking out loud too! Time will tell.

Great post. I truly think ONCS has already received offers just not the one Punit wants. "Stay Tuned." LOL.

I posted this on the yahoo board as well but I was wondering if anyone is aware of partnership agreements where there is an option to purchase the entire at a set price at the end of the trial?

It seems that that would be a consideration here where Merck has stated that it intends to start over 10 combination trials with MK-3475 before the end of the year as well as stating that they have the intent to acquire smaller companies especially that augment MK-3475.

With all that said, it seems that Merck would have an interest to pay more up front cash to ONCS for the option of purchasing at a set share price after phase 2B is completed. Is this unheard of or a possibility?

Thoughts?

Haha. I don't think you can compare the two types of partnerships. Aegnus' was a license agreement at 100 million to make MK-3475 better but not a new standard of care. ONCS' deal I believe will be much more lucrative and has the potential to set a new standard of care and, at the same time, by-pass a phase 3 trial in at least melanoma.

I love your enthusiasm! I hope it is soon.

I know. It is like watching a soap opera. I hate them but can't stop watching this one.

Great find!!!! Best section for me:

"It is anticipated that by the end of 2014, the MK-3475 development program will grow to more than 24 clinical trials across 30 different tumor types, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide, including four new Phase 3 studies. Ongoing and planned late-stage monotherapy and combination studies include:

. . .

Ten combination studies, including advanced melanoma, advanced NSCLC, advanced renal cell carcinoma, HER2+ breast cancer and other solid tumors."

I re-read the 14.2 billion acquisition article. This is my favorite line:

"Merck said it would put the money from selling its over-the-counter business into new drugs, including the experimental MK-3475, which uses the body’s immune system to fight cancer."

Sounds good to me. $ONCS

Probably so.

I agree with you on that, Dr. Heller is presenting at a symposium. Is there anything that would prevent ONCS from issuing a PR in the morning like they did for PEGS and have a combination mouse study be part of the symposium? I'm probably barking up the wrong tree, but just curious.

One more thing about the potential combination mouse study:

Do you think its possible that Dr. Heller might be presenting the results of a combination mouse trial at the ASGCT? It might make sense for the following reasons:

1. Dr. Heller is presenting at ASGCT and he is in charge of the Old Dominion research project that has conducted the mouse studies.

2. The topic, which is quoted below, is specifically focused on results from Phase I and II Clinical Trials to "provide the rationale for an expanded study."

3. The only expanded trial is a Phase 2B combination trial involving anti-PD-1.

I'd love all you guys' thoughts on this. This might be another place for data to be released that could show immense possibilities for the combination study.

Richard Heller, PhD
Non-Viral Gene Transfer of pIL-12 for the Treatment of Melanoma: Results from Phase I and II Clinical Trials
Electrotransfer of plasmids encoding cytokines directly to tumors has been shown to generate a local and systemic anti-tumor effect in both preclinical and clinical studies. In the clinical studies, patients with in-transit cutaneous melanoma received at least one treatment cycle (days 1, 5, 8) of intratumor pIL-12 delivered by electrotransfer in up to four lesions per cycle. In both the Phase I and II trials increases in IL-12 levels and enhanced immune activity were observed and the therapy was well tolerated. Intratumor treatment with pIL-12 electro transfer exhibited a systemic antitumor immune response with activity in both treated and non-treated sites of disease and objective response to treatment. These positive results provide the rationale for an expanded study.

I thought it might be a good idea to re-read the combination study at Old Dominion presented last year. To be fair, even though this study used a combination approach with 100% results, it didn't measure systemic results because it was focused on one tumor. The quote below seems to indicate that there might be some results coming using mice in a combination study. See quote below:

“Results are encouraging and indicate that using gene electrotransfer to deliver plasmid IL-12 into tumors can be an effective and safe delivery tool. Additional studies are being conducted to demonstrate that the combination may lead to immune responses against distant untreated lesions in mice. We will investigate the anti-tumor response and plan to present these findings in the near future,” commented Dr. Heller.

1. Is there a study being conducted right now that has immunopulse combined with an anti-PD-1? If so, where could we find that it is registered?

2. I know that I agreed with erostratus about the fact that we didn't think there would be further study on mice with this combination, but the above quote leaves open that combination.

3. I can't find what anti-PD-1 was used. Was it Merck's?

http://oncosec.com/oncosec-medical-announces-positive-preliminary-safety-data-in-combination-study/

I used to be a prosecutor and in the jury selection portion of the trial I would always try to weed out conspiracy theorists that would not follow the facts and law presented to them.

I would ask them if they truly believed that we actually went to the moon. At least one person is virtually every trial would raise their hand and say: "You know, I've always wondered about that. I'm just not sure." Whoever said that would be the first person I'd kick off the panel. I believe you are one of those people.

If you have facts that point to your position, state them. That is what this board is for. However, your statement about a unknown partnership being built into the price is pure non-sense. If your position is based on fact, state it and we will listen. Otherwise, don't waste everyone's time.

copycat. :)

Nope.

They really need to get a room and get this done. It's like watching a soap opera. Jeez!!!

In the same group as mk-3475. Nice

Back to boredom.

Haha. We can only dream.

Zoridan: how did the beer fest go with the good doctor? :)

I agree. Do you think that Dr. Heller will doing any more mouse trials to flesh out this systemic effect even more fully or do you think this is the "scientific green light" that pierce was referring to?

Thanks. So, what do you think of my next question of whether ONCS is going to conduct a combination anti-PD-1 trial BEFORE the human trial? It seems to me that would be a huge PPS mover if so. Further, such a study could be conducted quickly. My feeling is that they are not going to do that but you never know. Thoughts?

How do you think these results will be used? Are they going to expand this mouse trial or is the trial simply to validate their decision to conduct a combination trial with PD-1?

Do you think they are now going to do an expansion trial with mice using PD-1? The reason I ask is that this might be a huge PPS mover BEFORE the results of the human combination trial starting later this year. I am trying to identify another cataylist. Thoughts?

Ok. LOL!!! We are overlapping on both sites. Bob, is my summary correct? You have been very helpful.

So, if I understand what your saying:

They had noticed a systemic effect on untreated tumors in human trials where the point of that trial was not necessarily to study the systemic effects of untreated lesions. In this study, they have taken these observations and created a mouse trial to specifically measure the systemic effect on untreated lesions.

In other words, unanticipated results (the side effect) of the human trials are being isolated as the focus in the new mouse trial to confirm the observations in the previous human trials? Is so, I get it.

So, how is that different with the human trials? The systemic effects have always been a noted side effect of the trials. I especially don't understand the significance of this study when ONCS has already announced that it plans on doing a combination study with PD-1's. I probably sound dumb here, but I still don't understand why this study matters. I thought they were going to do a combination with anti PD-1 and report results. Am I totally out to lunch here?

So, you science guys:

I've read the PR this morning about 4 times. Obviously, it is great news. However, I need a little help understanding its significance.
My understanding is that this mouse study confirms IL-12's systemic ability to fight untreated tumors. What I don't understand is the significance of this study on ONCS. Two points I'd like help with:

1. Its seems like we have have results that show systemic responses in human trials in both Phase 1 and 2 throughout multiple studies. Therefore, I read this study as confirming in mice what we already know in humans.

2. I thought the Old Dominion Study with Heller was to explore results with mice using combination therapies such as anti-PD-1. I didn't see anything related to combination therapy at all.

I know this is a limited reading of the results today, so if someone could help me understand the significance of this study it would be greatly appreciated.

Here it goes. Hell ya!!