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Yep, exactly--that's the bottom line. I am wondering how much of afactor those patent approvals have upon the partnering process.
You know me HC, I'm still here and gonna wait for it!
I do know Pfizer has electroporation with a vaccine platform, and they have a PD-L1.
11/21/2016: The Zacks: Brokerages Set $7.50 Target Price for OncoSec Medical Inc. $ONCS
I mentioned that point regard patents earlier, I think this could be an important factor in obtaining an exit opportunity. However, I did just read an article that points out some helpful 2016 details of M&A, and R&D stage out-licensing.
This has been the Worst Financial Year for Biotech in a Decade
Finance
Evelyn Warner Evelyn Warner on 10/11/2016
A presentation on the financial state of biotech kicked off BIO-Europe in Cologne this week. The hostile American political climate has done some damage.
There’s a political storm brewing across the Atlantic that has everyone in biotech worried: what does the American political climate mean for the future of the industry? The numbers already look worrying.
David Thomas, the director of Industry, Research and Analysis at the Biotechnology Innovation Organization, presented a preliminary financial report on biotech’s performance in 2016. This year has been the worst for biotech in a decade, including 2008 which was marred by the financial crisis; but this year, there was no macroeconomic cause, but rather a generally politically hostile environment.
http://labiotech.eu/wp-content/uploads/2016/11/IMG_4208-copy.jpg
Thomas showed that this year’s economic effect on biotech was industry-specific, indicating the poor performance was a direct result of policy. Overall, those that suffered the most from this poor performance were smaller, emerging biotechs instead of big pharma.
For obvious reasons, American companies suffered most from policies in the country, but the war on prices has led to fallout in Europe as well. The US dipped 39% and dragged Europe down along with it by 27%.
http://labiotech.eu/wp-content/uploads/2016/11/IMG_4210-copy.jpg
Smaller-time biotech companies were hit harder than big pharma. While the political storm is confined to the US, it has sent shockwaves across the Atlantic to Europe.
This decline reflects that fundraising has generally suffered this year. CRISPR Therapeutics finally went for an IPO but came up with half the revenue of its competitors, Intellia and Editas. But some companies, like ADC Therapeutics, have held their own in Series fundraising roudns.
While there have been fewer IPO’s this year and valuations are down, Thomas said there has been “a respectable amount of activity” regarding dealmaking. Pfizer’s jaw-dropping acquisition of Medivation seems to be carrying the field, but there have been some smaller but still impressive deals: Ganymed was recently acquired by Astellas for a German record of €1.3B, for instance. However, as Merger Markets reported, the sector has been suffering since Brexit.
http://labiotech.eu/wp-content/uploads/2016/11/IMG_4213-copy.jpg
“There is still a respectable amount of deal making,” reports David, as exemplified by acquisitions.
However, out-licensing has dropped dramatically in almost all areas, but especially neurology, endocrine disease and oncology. Notable exceptions are in ophthalmology and metabolic diseases, as well as “other,” which covers Genmab’s deal with Gilead for access its DuoBody platform as part of its efforts towards an HIV cure.
http://labiotech.eu/wp-content/uploads/2016/11/IMG_4215-copy.jpg
Neurology, Endocrine Diseases and Oncology are areas that have been particularly hard hit in terms of licensing deals.
These decreases are mostly accounted for a drop in clinical-stage upfront payments, as their preclinical counterparts are holding steady. In fact, 2016 may yet be a record year for preclinical deals. A large part of it may be credited to Allergan, which has been on a deal shopping spree.
http://labiotech.eu/wp-content/uploads/2016/11/IMG_4216-copy.jpg
Preclinical out-licensing upfront payments have held steady this year.
Of the biggest deals this year, 11 out of 12 were in the preclinical stage. Moreover, 7 of 12 belonged to immuno-oncology, suggesting the field isn’t in as much trouble as the overall decrease above suggests. One such examplar was a recent deal between Medigene and bluebird bio for its TCR platform, followed by another deal between the upstart Crescendo and Takeda.
http://labiotech.eu/wp-content/uploads/2016/11/IMG_4219-copy.jpg
Most of the biggest deals this year were in the preclinical stage.
While the numbers came as a bad review of the biotech industry, the winds are changing with the result of the American election yesterday. Since it was announced that Donald Trump will be the next President of the United States, biotech stocks have climbed back up. Thomas also noted that we may yet see a spike in acquisitions if last year was any indication. However, there probably isn’t enough time for the industry to recover and score a positive end-of-year report, but 2017 looks like a more favorable year already.
Lasers, based on your past experience do you see any potential buyout opportunity to occur in the next 12 to 16 months? Providing that data continues to prove things out?
But I would agree with PD's cash upfront + $Billion in milestone incentives as a bench mark. Personally, I believe MRK will take the deal, but PD has to play it like he's open to the "Pepsi/Coke" idea, just to not look needy--You know, the business negotiation side of it to gain the biggest buck.
Thanks for the clarification on the patents. I did here Gargosky say she would prefer to stay with the data accumulation with Merck's PD-1, since the others (I think) bring too many new and potentially confounding issues regarding safety and efficacy.
You know lasers, I was just talking about this with my wife this morning. There are several things on the table for consideration here along with the companies you mentioned and to me the first is the challenge with the patents for their technology still in the application process. To me that would delay the consideration of a partnering or licensing deal except on an investigator sponsored basis. I mean, who wants to get involved with intellectual property that hasn't been approved of yet for patent.
Secondly, I think PD is in a bind regarding funding. I know he doesn't want to dilute, and at the same time he doesn't have a firm offer to partner or license. However, I do think lastly here, that was some heavy marketing regarding their new technology, that they can get the interest of big Pharma in a decent bidding war in the not-too-distant future.
I remember Dr. Gargorsky, When asked regarding the amended profile, that no matter what happened they will be prepared to go forward alone whether Mark was involved or not– – They want a buyer for their product, I don't think they care if it is "Pepsi or Cola". PD was clear that they do not have the infrastructure nor desire to build and sell their devices. What they're really are trying to offer here I believe is the development and advancement of their intellectual property and any company will highly benefit.
If they can stabilize those patents, and demonstrate entering data from a registration trial early on – – I think that's when we see big Pharma begin to feel the M&A pressure, and begin the bidding process.
We'll get a much better picture about when that will happen based on what is done with the revised or amended protocol for this trial and whether it is becoming the registration trial, will be transitioned into a registeration trial, Or will the registration trial overlap with the P2B as we begin the new year – – I don't know how it must work yet.
I think it's going to be a tough sell in the short term for PD to garner a partnership deal that would resemble one of those European bio dollar deals he mentioned at the investors/analyst presentation. It really did sound like PD believed that we are comparable with those two European companies that are using similar approaches or platforms, and all those were cash upfront plus milestone incentives totaling anywhere between one to $2 billion deals. That's a pretty steep hill to climb between now and a must have delusion in May of this coming year.
Why OncoSec Medical Inc (NASDAQ:ONCS) Shares Will Rebound Soon
By
Yashu Gola -
November 18, 2016
OncoSec Medical Inc (NASDAQ:ONCS) shares were down 5.63% on Thursday to $1.52 but recovered 7.28% in after-hours trading to $1.62. The company has a market cap of $29.48 million at 19.16 million shares outstanding. Share prices have been trading in a 52-week range of $1.36 to $3.49.
In a press release yesterday, OnoSec Medical Inc announced key corporate initiatives during the inaugural Investor and Analyst Day in San Diego. These updates included plans for a melanoma combination directed-registration study of OncoSec’s lead product candidate in combination with anti-PD-1 therapy. Aside from that, the company shared details on its preclinical multi-gene plasmid constructs, Tissue-based Real-time Adaptive Controlled Electroporation and its Technology Access Program.
“By focusing our clinical programs on patients who do not respond to anti-PD-1 therapy, we are committed to developing therapies for those in critical need of alternative treatments,” said Punit Dhillon, President and CEO of OncoSec medical inc. “We are pleased to be focused on a registration-directed clinical program with a regulatory path that we hope will lead to a potential FDA approval for our first commercial product in 2019.”
Dhillon added that the favorable anti-tumor activity and safety data garnered from the Investigator Sponsored Trial (IST) Phase II clinical trial combining ImmunoPulse IL-12 and KEYTRUDA provided them with additional confidence to move forward with key regulatory, clinical and commercial efforts aimed at achieving marketing approval for ImmunoPulse IL-12 in anti-PD-1 non-responder advanced melanoma.
“We are changing the way clinicians and scientists think about the use of technology to manipulate cellular activity with the power of DNA construct delivery and activation through our innovative, easy to use, next-generation gene electro-transfer devices,” continued Mr. Dhillon.
He also explained that their development strategy for ImmunoPulse IL-12 will lead to a large market opportunity, and can generate significant value for shareholders. It will also provide a strong foundationfor advancing the company’s next clinical candidate in first-in-human studies in 2018.
The company also highlighted the new Phase II melanoma data that was recently presented at the Society for Immunotherapy of Cancer Annual Meeting. This single-arm, open-label trial assessed the combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse IL-12, and Merck’s KEYTRUDA in patients with unresectable metastatic melanoma. A predictive biomarker was used to enroll patients that have a low likelihood of response to an anti-PD1 agent alone, and the purpose of the trial is to assess whether the addition of ImmunoPulse IL-12 can increase response rates in these patients.
OnoSec Medical Inc is a biotechnology company that is focused on designing, developing and commercializing gene therapies, therapeutics and medical approaches to stimulate an anti-tumor immune response for the treatment of cancer. Its lead product candidate, ImmunoPulse IL-12, consists of a plasmid construct encoding the proinflammatory cytokine, IL-12, which is delivered into the tumor through in vivo electroporation.
The company has been pursuing two clinical trials: ImmunoPulse IL-12 monotherapy in patients with metastatic melanoma and ImmunoPulse IL-12 plus pembrolizumab in patients with advanced, metastatic melanoma. Aside from that, OnoSec Medical Inc is pursuing ImmunoPulse IL-12 monotherapy in patients with triple negative breast cancer.
www.forexminute.com/why-oncosec-medical-inc-nasdaqoncs-shares-will-rebound-soon/
I didn't hear anything about a catheter per se, but they did mention the device that will be able to reach multiple indications. If you remember the part where the device can actually secure it self to the internal tumor? That is when they were discussing the catheter device.
On another note, I noticed the recist outcome measurements we're described as being and older assessment system based on chemotherapy as to how patients are progressing or not. And they discussed that immunotherapy needs to be assessed for progression differently.
This is because when a tumor becomes inflamed and becomes more aggressive that's also a part of the process of teaching the systemic immuno system on how to spot and kill tumors throughout the body. Many of those patients that showed progression Will simply receive more treatment until the immune system is properly trained and then go into remissions .
The present recist assessment doesn't account for this. That's why having five out of six patients showing progression is not a problem for them, that simply means they need further treatment that would move towards inducing remission. If it were chemotherapy that type of progression would mean forcing an individual through more chemotherapy and potentially inducing death.
They have to develop a whole new recist measurement for immunotherapy.
This is so cutting edge, and becoming so highly individualized in its treatment – – I'm amazed at watching the birth of the potential technological breakthrough… Which if you remember no one else is targeting this population in this way
Much appreciated Titan!
That's why I put CST for those of us here in Chicago
Me too, I'm setting aside 11-1pm.(CST) to watch.
Webcast today at Stifel 2016 Healthcare Conference: 11 AM EST today for a webcast of OncoSec's CEO presentation at:
https://goo.gl/8SIJoj
PD's focus appears to be looking past oral/written post tomorrow & Saturday respectfully, and past Stifel conf., and has his business eyes set on the I&A Day. I wonder if any info they plan to share during the 3hrs. on the 17th will be present in the Stifel webcast presentation on the 15th (which is usually 15-20 min.)-- at least there will be slides.
Not sure Deluge Capital if this is what your looking for:
OncoSec Collaborators Present Results of Novel T-Cell Exhaustion Marker to Predict Response to Anti-PD-1 Monotherapy
June 06, 2016
The combination of OncoSec's ImmunoPulse™ IL-12 and pembrolizumab is the first clinical trial to use this assay to select specific patients, who are unlikely to respond to monotherapy with anti-PD-1 agents
SAN DIEGO, June 6, 2016 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced that its collaborators at the University of California San Francisco (UCSF) presented results at the American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating the utility of a T-cell exhaustion marker to predict response to anti-PD-1 monotherapies. Authors of this poster discussion session from UCSF include Adil Daud, MD, Alain Algazi, MD, and Michael Rosenblum, MD, PhD. This "low-tumor infiltrating lymphocyte" (TIL) marker is currently being used to select patients for the ongoing Phase II investigator-sponsored clinical trial evaluating the combination of OncoSec's investigational therapy, ImmunoPulse™ IL-12, and the approved anti-PD-1 therapy, pembrolizumab, in patients with unresectable metastatic melanoma.
Using samples from prior trials, authors presented results from a total of 53 patients evaluable for both response and the T-cell exhaustion marker (TEx). Fifteen patients were treated with a combination of ipilimumab and nivolumab, and 38 with monotherapy anti-PD-1. Patients determined to be "low-TIL" (TEx ≤20%) had 0/12 (0%) responses to anti-PD-1 therapy, while patients who were "high-TIL" (TEx >20%) had 21/26 (81%) responses. Median TEx was 40.3% for responders and 16% for non-responders. Using a threshold of TEx at 20%, the negative predictive value for response was 100% and the positive predictive value was 81%. For patients treated with the combination of ipilimumab and nivolumab, the TEx threshold predictive of response was much lower. The authors concluded that this novel T-cell exhaustion marker (% TEx) is an accurate predictor of response to monotherapy, but not response to combination therapy with ipilimumab and nivolumab.
OncoSec is currently enrolling patients into the Phase II clinical trial led by UCSF to assess the anti-tumor activity, safety, and tolerability of the combination of ImmunoPulse™ IL-12 and pembrolizumab. This multi-center, open-label, single-arm trial is the first study to select patients for "low-TIL" status using UCSF's T-cell exhaustion marker assay. The study will test the hypothesis as to whether the addition of ImmunoPulse™ IL-12 to pembrolizumab can increase the response rate in low-TIL melanoma patients, who have a low likelihood of responding to monotherapy with anti-PD-1 blockade. The key endpoints of the study include: best overall response rate (BORR) by RECIST v1.1 and immune-related Response Criteria (irRC); safety and tolerability; duration of response; 24-week landmark progression-free survival; median progression-free survival; and overall survival.
"We are delighted that our collaborators are presenting data at ASCO demonstrating the utility of the flow cytometric TIL assay," said Robert H. Pierce, MD, Chief Scientific Officer at OncoSec. "Our ongoing investigator-sponsored combination trial of ImmunoPulse™ IL-12 and pembrolizumab hinges on the strong predictive value for poor treatment outcomes from this assay. Given these data, we are confident that we will be able to robustly identify a combination efficacy signal in our ongoing single-arm trial."
I have a thought on the struggling biotech sector. There's kind of a global hold on its performance and I think it's related to the presidential race. I know Clinton has advocated for regulating pharmaceutical prices down which would impact big Pharma dramatically. I think it's in a stall in anticipation of November 8. And I would expect with a trump victory that we would see the market respond favorably with the biotech especially with the new immunotherapy drugs coming onto the market.
I'm speaking solely on how the market will react not who should be voted in – – what are your thoughts?
Hey there HC, not that I disagree with you but and accompanying thought is that the file tech sector in the market as a whole is still taking it on the chin. Even the global market – – everything is hesitating or declining in anticipation of the election. The global market is unclear about whether the election will be honored by either party which can after medical facts in the long run about policy and what will happen if interest rates and so forth. I think that's just another contributing factor anyway.
Once again, Jckrdu offers some good partnership-food-for-thought:
That's only speaking of the heart, toxicities are high with yervoy-opdivo, and have had patients die from many other of their side effects.
http://www.opdivoyervoy.com/servlet/servlet.FileDownload?file=00Pi000000frv0pEAA
"Very Excited" the very words Dr. Sharon Gargosky used to discribe how they (OncoSec team) how they felt about the interim Data on 15 of the 42 patients.
And by the way, Moderns is a good example, it doesn't even have a phase 1 trial begun everything is in pre-clinical
The six-month point for the phase 2B trial was October, so if they're approved for the amendment by say, January February time, we're looking at at least an extension of four months or whatever the amount of time is between October and FDA approval. I agree implementation and enrollment should happen very quickly. This is the fun stuff are going to get to hear about November 17…
That is the best understanding I have heard regarding that emendation ONCS is seeking from the FDA--And I bet they get it. I appreciate you bringing that over here to IHUB. I would assume that if the protocol is amended, final data release would be pushed back as well.
Dirk, I like the way you roll ;o)
I hope so for your sake Titan– – This is what we've been waiting for the last four years. I'm all in with 25k shares and holding out for a buyout...
At a $1.85 I'm guessing this is going to be the last opportunity to get in before people start situating for the run up to the news.
Nice dreams of his eh Twiz? I've been pondering the value of Dr. Gargosky's quote where she said,
Clinicaltrials.gov shows Active, Not Recruiting for IL-12/MK3475--So They have completed enrollment (provided no loss of patients from illness).
I like this post from board moderator JCKRDU over at the biotech investor:
I get the idea that we're not gonna hear anything about the oral presentation until after the oral presentation.
You got that right, check out their advisory boards – – the doctors are actually world renowned in melanoma. Dr. Hauschild's a stud.
From the SITC 2016 site re: abstract embargoes
So when I listen to Dr. Gargosky speak of amending the phase 2B trial, it sounds as though the protocol she was looking to amend would be to include information from patients who had prior failed chemo, immuno, or radiation therapy. And that they were going to enter into discussions to see if that were possible for the remaining months of this trial. It can't relate to patient recruitment because they believe the clinical trial will be fully enrolled by end of calendar year this year. Is that an adequate take away from your comments?
I am also assuming by the way she is impressed with the data – – that it appears these nonresponders are generating a favorable remission to the tumors regardless of the type of prior treatment they have had.
Here is the "amend" quote:
Lasers, do you remember from the Q&A portion of the last quarterly call when Gargroky spoke of amending the trial to include addition Patient type inclusion believing it would generate more information with their data?
From the good spirit of debate...I think the difference here is,that the assay can predict with certainty that Patients with a TIL environment below <25%, will not, can not, could not, won't respond to PD-1 therapy. The on responders are selected from two groups of patient population...Those accurately assessed by the assay to have too low a TIL count; and, those who may have had prior treatment with PD-1 and did not respond, for whatever reason, then assayed to be positively determined to have a deficient amount of TIL's.
I listened again to Dr. Sharon Gargosky's statement of just how impressed with the data they are--You know people have to making some powerful progress. And if I remember right, are these late stage tumors non-resectable? So this is there last shot at life?