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There is only one combo trial going forward not two. The new combo trial will enroll patients who are progressing on either pembrolizumab or nivolumab.
Any data updates on the TNBC trial would serve us well right now. I believe Gargosky mentioned the TNBC trial a while back in a positive light. Seemed to get the feeling that Oncosec is seeing positive results with that. Can't wait to see some data on it soon.
Monday we probably get a PR about upcoming events or some type of news for May. I hope you are right about TNBC trial collaboration possibility with Roche. That would be awesome. Interest from another major pharma company other than Merck would definitely help investor confidence. Fingers crossed as usual and plan on adding to my share count next week while price is still way undervalued.
Good to hear the study will begin shorty. Anything to get the ball rolling again here because the latsest Maxim report states that Maxim expects to receive payment for services from Oncosec within the next three months. This leads me to believe an offering is coming within the next three months so hopefully we get news of drug partnership or anything else meaningful to get the share price up before an offering comes.
FULL MAXIM REPORT for April 2017:
OncoSec Medical Inc Buy
Next-Gen DNA-Based IL-12- Positive Preclinical Data
Presented at AACR
Summary
• Oncosec presented positive preclinical data for a next-gen DNA-based IL-12
at the ongoing AACR meeting (American Association of Cancer Research)
demonstrating improved systemic anti-tumor responses.
• The data were presented as an abstract titled "Intratumoral delivery of a P2Alinked
bicistronic IL-12 construct leads to high intratumoral expression and
systemic anti-tumor responses." (ABSTRACT LINK).
• Recall that "first-gen" Immunopulse IL-12 (pIL-12-EP), which is the subject of
the upcoming registration trial (PISCES) in melanoma, has demonstrated high
levels of IL-12 and systemic CD8 responses (i.e. intratumoral delivery induced
killing of distal tumors). The next-gen plasmid incorporates modifications that
improve IL-12 protein expression, driving more enhanced tumor-specific CD8
T cell responses.
• Conclusion. The next-gen plasmid will become the backbone for Oncosec's
pipeline combination molecules, which we expect to be announced in 2017.
The focus for us remains on the first-gen IL-12 and the upcoming PISCES
study, which should initiate soon. Positive data could support registration,
potentially in late 2019.
Details
Phase 2b Study in Melanoma. The PISCES Study (Anti-PD-1 IL-12 Stage III/IV
Combination Electroporation Study) is an open-label study in patients with stage III/
IV metastatic melanoma evaluating Immunopulse IL-12 + Keytruda or Opdivo. The
study will enroll 48 patients that have progressed or are progressing within 24 weeks
of receiving available checkpoint therapies. The primary endpoint of the study will
be overall response rate (ORR) after 24 weeks, with secondary endpoints of best
overall response rate (BORR), duration of response (DOR), progression free survival
(PFS) and overall survival (OS). The study should start in 2Q17. Oncosec is targeting
completion of enrollment by YE17 and top-line data in early 2019. If positive Oncosec
could file for approval in 2019.
Targeting the non-responders. Over 60% of cancer patients are not responsive
to checkpoint therapy (Keytruda, Opdivo),Oncsec has demonstrated that DNAbased
IL-12 turns cold tumors (non-immunogenic) hot (immunogenic) to drive tumor
targeting T cells into tumors. This provides the rationale for combination therapy with
a checkpoint (PD-1/PD-L1). In addition, the company recently published a study, led
by Dr. Adil Daud, demonstrating that a novel biomarker assay may predict likely nonresponders
from responders by measuring the amount of T cells in the tumors that
are "high expressors" of both PD1 and CTLA-4 (Dr. Daud also developed an assay
for monitoring PD-L1 expression). The threshold for a responder is ~30% of T cells
expressing high levels of PD-1/CTLA-4; non-responders are defined as having 22%
or less. The ongoing phase II study in melanoma used this assay to enroll 22 patients
(25% or less expression), including six patients that were exposed to up to 30 cycles
of either Keytruda, Opdivo, Yervoy, or combinations of them. Of the responders, five
had TIL high expressers less than 20%, and two had ~21%. The ORR response rate
in the study was 43% (9/21), including patients in the checkpoint failure population.
What is important to note, in addition to the ORR of 43%, is that converting checkpoint
failures to CR and PR is significant. Patients that fail checkpoints are not retreated,
there is no point, thus they are definitive "non-responders."
Valuation Methods
ONCS: We provide detailed models for the opportunity in melanoma, merkle cell, and breast cancer. Our current assumption is for commercialization
beginning in 2022. Using these metrics, we model the market potential and discount back using a 30% rate in our FCF, discounted-EPS, and sumof-
the-parts models, which are equally weighted and averaged to arrive at our price target; these metrics are dependent on our clinical assumptions.
Price Target and Investment Risks
ONCS: Aside from general market and other economic risks, risks particular to our price target and rating for OncoSec Medical include: (1) clinical
data (will it work?); (2) the execution of the clinical trial; (3) regulatory interactions; and (4) the ability to raise capital and commercialize products.
RISK RATINGS
Risk ratings take into account both fundamental criteria and price volatility.
Speculative – Fundamental Criteria: This is a risk rating assigned to early-stage companies with minimal to no revenues, lack of earnings, balance
sheet concerns, and/or a short operating history. Accordingly, fundamental risk is expected to be significantly above the industry. Price Volatility:
Because of the inherent fundamental criteria of the companies falling within this risk category, the price volatility is expected to be significant with the
possibility that the investment could eventually be worthless. Speculative stocks may not be suitable for a significant class of individual investors.
High – Fundamental Criteria: This is a risk rating assigned to companies having below-average revenue and earnings visibility, negative cash
flow, and low market cap or public float. Accordingly, fundamental risk is expected to be above the industry. Price Volatility: The price volatility of
companies falling within this category is expected to be above the industry. High-risk stocks may not be suitable for a significant class of individual
investors.
Medium – Fundamental Criteria: This is a risk rating assigned to companies that may have average revenue and earnings visibility, positive cash
flow, and is fairly liquid. Accordingly, both price volatility and fundamental risk are expected to approximate the industry average.
Low – Fundamental Criteria: This is a risk rating assigned to companies that may have above-average revenue and earnings visibility, positive
cash flow, and is fairly liquid. Accordingly, both price volatility and fundamental risk are expected to be below the industry.
Maxim Report for April answered the question that Oncosec IR did not:
Phase 2b Study in Melanoma. The PISCES Study (Anti-PD-1 IL-12 Stage III/IV
Combination Electroporation Study) is an open-label study in patients with stage III/
IV metastatic melanoma evaluating Immunopulse IL-12 + Keytruda or Opdivo. The
study will enroll 48 patients that have progressed or are progressing within 24 weeks
of receiving available checkpoint therapies. The primary endpoint of the study will
be overall response rate (ORR) after 24 weeks, with secondary endpoints of best
overall response rate (BORR), duration of response (DOR), progression free survival
(PFS) and overall survival (OS). The study should start in 2Q17. Oncosec is targeting
completion of enrollment by YE17 and top-line data in early 2019. If positive Oncosec
could file for approval in 2019.
Targeting the non-responders. Over 60% of cancer patients are not responsive
to checkpoint therapy (Keytruda, Opdivo),Oncsec has demonstrated that DNAbased
IL-12 turns cold tumors (non-immunogenic) hot (immunogenic) to drive tumor
targeting T cells into tumors. This provides the rationale for combination therapy with
a checkpoint (PD-1/PD-L1). In addition, the company recently published a study, led
by Dr. Adil Daud, demonstrating that a novel biomarker assay may predict likely nonresponders
from responders by measuring the amount of T cells in the tumors that
are "high expressors" of both PD1 and CTLA-4 (Dr. Daud also developed an assay
for monitoring PD-L1 expression). The threshold for a responder is ~30% of T cells
expressing high levels of PD-1/CTLA-4; non-responders are defined as having 22%
or less. The ongoing phase II study in melanoma used this assay to enroll 22 patients
(25% or less expression), including six patients that were exposed to up to 30 cycles
of either Keytruda, Opdivo, Yervoy, or combinations of them. Of the responders, five
had TIL high expressers less than 20%, and two had ~21%. The ORR response rate
in the study was 43% (9/21), including patients in the checkpoint failure population.
What is important to note, in addition to the ORR of 43%, is that converting checkpoint
failures to CR and PR is significant. Patients that fail checkpoints are not retreated,
there is no point, thus they are definitive "non-responders."
Maxim has pointed out that the subset of patients who had previous checkpoint therapy in recent data release were in fact checkpoint failures. Good to know that there was absolutely a response in this subset of patients and not sure why Oncosec did not answer e-mails to clarify this data.
I received a letter today from Maxim Group. Looks like they are trying to drum up business and offering Oncosec shareholders a free research report. I am happy to receive a free research report that will probably have all the same rehashed information we all know already. We are all just waiting here for any positive momentum or catalysts. Long Oncosec for however long it takes.
A mention on the Biotech Investor forum about the TNBC trial has me wondering when results will be released and if a partnership is in store for the next phase of development....phase II? On clinical trials site this is listed as a phase I trial but Oncosec has this listed as a Phase II trial on their pipeline graph and it is always mentioned in PR's as Phase II trial. I hope we get some sort of partnership for TNBC and announce some data on this soon.
I think the next current combo trial update may help the stock price if we see continued positive results. Oncosec seemed very enthusiastic about the last data release from the current combo study especially with regards to the subset of 9 patients that had previous treatment with either Opdivo or Keytruda. I e-mailed IR twice and got no response back with regards to this subset of patients. I am still wondering about the specifics of that data. Did Oncosec mean that the subset of 9 patients were absolute failures to Opdivo or Keytruda which would mean that a response to the combo therapy with IL-12 and EP would be more significant. I am still confused about that. Ever since that data release the share price has tanked so I think the market is a bit confused about this too. Any thoughts on this. I would hate to think that Oncosec was sending mixed messages about that data. In the past they have answered all questions when I e-mailed IR.
I agree Titan that something substantial will come from collaboration with MighTy Biopharmaceuticals and Kevin Hollevoet.
With the right succession of good news and results in the next year I believe we get back to the uplisting price of $5.50 and then much higher on a BO exit opportunity.....if the stars are aligned our way. Let's hope for great news in the next year!
Company shareholder e-mail today reiterates- Finalize a drug supply agreement for PISCES, as top of the list on 2017 key milestones.
News should come soon.
Titan, any idea about possible upcoming conferences or events? It is like watching paint dry right now....just waiting for something to happen.
Eventually we will get a run like AVXL and go from $1 to $10. Our time will come.
I figured we would be knocked down more to the point we are at now. I am adding to my position in the next few days. Drug supply news any time now and we start the reversal process.
I'm not outraged at all. Nobody says , "hey invest in my company that sucks and most likely will fail". Risky biotech companies need money and have to promote to get interest. When you are a microcap stock what else do you do until you get greater institutional support. It is all risky business. Fact is that if Oncosec eventually gets FDA approval for the current combo trial then it is a new ball game. It is a huge risk for an investor here....and may pay off big time....or maybe not. Everybody is free to make their own call here.
Titan, ONCS engaged in a lot of paid promotions while on the OTC market. When they uplisted to the NASDAQ I had hoped they put that behind them. Electroporation has been a hard sell for years now. What they need is FDA approval and that is it. Here we wait. Adam F. is talking about promotions from before the Nasdaq uplisting. I'm not concerned about the past. The future is what matters and that is intact I believe. Like you said, the drug supply partnership with Merck will be the validation we need to light a fire under this stock.
Oncosec has 24 mil cash and no debt. Drug supply partnership could put us back over $2 instantly.
My mistake, this is an option to purchase stock. Why don't these guys start making open market buys to get some confidence in this company?
An SEC filing showed up this morning (listed on Oncosec website under SEC filings) for Anthony Maida, a purchase of 20,000 shares at 1.34.
I only hope that other directors and board members start to kick in with purchases too. That might create some confidence here.
MAIDA ANTHONY just exercised an option to purchase 20,000 shares of Oncosec stock at 1.34.
SEC filing today, date 4-3-2017
Innovative Immunotherapies Emerging as the Cancer Treatments of the Future
http://www.aboutpharma.com/blog/2017/03/23/innovative-immunotherapies-emerging-as-the-cancer-treatments-of-the-future/
Nice to see Oncosec listed along other innovative companies in this article.
If the IL-12 with Pembro is too toxic or not effective, then maybe they would pursue the use of EP-IL12 in solid tumors as the next resort. Oncosec's next generation electroporation device is meant to do exactly this....go after deep tissue solid tumors. Oncosec does list solid tumors in their pipeline on their website.
Maybe this NCI trial will lead to Merck licensing Oncosec tech for solid tumors.
Wondering what a $500 million licensing deal with Merck would boost Oncosec share price? I bet that would boost us a bit. That could be us next year. Not crazy but we could be looking at a share price above $20. Fingers crossed that we get that kind of support eventually.
Good news, Heat and Oncosec are in collaboration which looks likely to continue. More eyes on Heat means more eyes on Oncosec.
No kidding, but it is obvious.....sheeezzzz! 'Nuff said!
My opinion, but we will find this out very shortly. According to recent Heat PR it seems likely because the combo with Oncosec sounds like it is yielding positive results.
Re-read again if you missed it.
OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its ImmunoPulse® IL-12, a potentially first-in-class, Intratumoral anti-cancer gene therapy that expresses interleukin-12 (IL-12) for the treatment of metastatic melanoma, following progression on pembrolizumab or nivolumab.
This means the 9 patients had either Opdivo or Pembro and progressed on it.....they were anti-pd1 failures. The data does not say that it was inconclusive, it says they progressed on it.
'Nuff said.
Cash Positive Tap license deal will be announced with Heat Biologics soon.
OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its ImmunoPulse® IL-12, a potentially first-in-class, Intratumoral anti-cancer gene therapy that expresses interleukin-12 (IL-12) for the treatment of metastatic melanoma, following progression on pembrolizumab or nivolumab.
Apparently the FDA deems the data on the 9 patients worthy enough to grant fast track designation.
Now it is up to Oncosec to prove it out in the registration trial.
'Nuff said...time will tell.
Obviously it is significant enough to grant fast track designation to their therapy and move them onto a registration trial.
The combination therapy continued to demonstrate a favorable safety profile and was well tolerated. Importantly, of the 22 patients enrolled, nine had previous checkpoint inhibitor therapy; ORR for this subset of patients was 33% (3/9).
If the 9 patient subset did not previously fail monotherapy I don't know why they would have pointed these patients out as significant data simply because they had previous checkpoint inhibitor therapy. It would only be significant if they were failures to monotherapy.
IR has always responded to any questions I have. Not sure why you would think that is laughable. I will post any response they give to this question. If the 9 patients were not complete failures to monotherapy investors need to know this. If they are not willing to disclose this information I would be disappointed and I would question the motive for that. Until I hear a response I will give them the benefit of the doubt.
I just e-mailed IR to get some clarity on this. I assumed the 9 patients were complete monotherapy failures and that they mentioned this in the conference call. If they didn't this should be stated one way or they other to get this point straight.
Are you saying the subset of 9 patients in Oncosec's recent study were not previously failed anti-pd1 patients? I thought they said these patients absolutely failed monotherapy and the other patients were predicted non-responders? Elaborate please if you can.
Actually Oncosec's recent data is about equal to this combo you refer to but Oncosec data includes failed anti-pd1 patient data and this other combo study does not seem to refer to any subset of patients targeting this patient population.
link to this other combo study if anybody wants to compare:
http://oncologypro.esmo.org/Meeting-Resources/ESMO-2016/Epacadostat-plus-pembrolizumab-in-patients-with-advanced-melanoma-and-select-solid-tumors-Updated-phase-1-results-from-ECHO-202-KEYNOTE-037
There are quite a few successful companies that trade on the Nasdaq as well as failures.
Oncosec Medical is a real Nasdaq traded company with real science and real scientists. They consist of
caring employees and a caring CEO. Punit Dillon is also the founder of BeCancerPositive.org
The goal of Oncosec and Punit Dillon is to continue to support the ongoing fight against cancer.
BeCancerPositive.orgis a support website for cancer patients. Check it out. Most of us have been touched by cancer in some way and this is a very uplifting site.
There is no fraud here.
There is risk, but there is no fraud in terms of fake science here.
Might really be a grand attempt to stand out in the crowd. I hope we succeed is all I can say. Fact is that the stock market is a popularity contest and we need to finally join the cool crowd.....and get a transformative cancer treatment to market to save lives.