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Now hopefully Oncosec has learned from previous mistakes and the registration trial gets underway without the delays of the current phase II trial which seriously hurt investor sentiment and sunk the stock price since uplifting to the Nasdaq. Good combo results in the next few months + swift enrollment in the registration trial will lead to an early approval and commercialization. Go Oncosec! Make it happen!
I was under the impression this is the final registration trial for the combo study because the title states "accelerated approval trial design" and it is 6 month duration.
I think Titan should apply for a job at Oncosec in the PR department because we got no PR's for October but their are things scheduled and we have heard nothing. What's up with that?
Catalyst Pharmaceuticals Inc. was the BIGGEST GAINER on the NASDAQ today: (CPRX) up +$0.340 (+30.36%) higher to $1.460
TIME TO GET ON BOARD THIS TRAIN BECAUSE IT IS LEAVING THE STATION. TOO MUCH POTENTIAL (FIRDAPSE, CPP-115), THE DROP IN PRICE THIS YEAR WAS A MASSIVE BUYING OPPORTUNITY. STILL NOT TOO LATE TO GET IN.
Firdapse will be CPRX bread and butter. CPP-115 will be icing on the cake. Recent study of CPP-115 was very promising; they just need a partner to push development along. Very promising Orphan drug.
Takeda was looking to buy Valeant Pharmaceuticals earlier this year, so they are in the hunt for big deals. Oncosec might be too small to interest them but you never know. I see that Daiichi Sankyo who owns Plexxicon (Oncosec collaborator) will be attending the Japan Biopharma Partnering Conference. Would be nice to see some out of the blue unexpected partnership happen soon. Combo results coming soon should help us out. Then we can see some massive volume come into Oncosec stock.
Oncosec is wise to keep options open. Maybe Takeda would like to spread some of that 14 billion dollars our way.
Nasdaq compliance+price target upgrade to $4+ Orphan Drug Designation of Firdapse for the Treatment of Myasthenia Gravis+positive data recently released on cpp-115=safe to invest again in CPRX. Incredible volume here.
Oncosec mentioned on Investopedia.com:
http://www.investopedia.com/news/oncosec-sets-fourthquarter-conference-call-oncs-0/
The part of this interview I like the most is when Dr. Pierce notes at the end about how under appreciated combination immunotherapy is by the market. That will change soon enough.
REV 1 ON ONCOSEC:
REV·1 developed multiple design solutions addressing how to access the tumors, stabilize them, and deliver OncoSec's proprietary Genetic Payload, followed by electroporating the tumors.
REV·1 designed a simple hand-held unit that can be introduced in a minimally invasive out-patient setting to access tumors deep in the body. Currently in pre-clinical trials, this device, combined with OncoSec's proprietary gene therapy, will radically change the treatment of these deep-in-the-body, life-threatening tumors.
Oncosec will be a part of the immunotherapy revolution friends. Count on it.
Accelerated Approval Trial Design of ImmunoPulse® IL-12 and Keytruda in Stage III/IV Melanoma
Multicenter Phase II Trial of intratumoral pIL-12 + electroporation in combination with pembrolizumab (Keytruda) in patients with Stage III/IV melanoma who are refractory to pembrolizumab treatment
Patients will be given pIL-12 every 6 weeks and pembrolizumab every 3 weeks - Primary Objective
– Overall response rate (ORR) by RECIST (1.1) during 24 weeks of treatment - Secondary Objectives
– Duration of response (DOR)
– Response rate by irRECIST V 1.1
– Median progression free survival (PFS)
– Median overall survival (OS)
This is information from Oncosec's latest investor presentation download for September.
I assume this is the registration trial.
This is a six month accelerated approval trial design so by the end of next year we could have an approval for Immunopulse IL-12 with keytruda.....maybe?
Dr. Pierce speaking at the Sachs 4th Annual CBPI Forum.
Immunotherapy & Chemotherapy: What's the Difference?
http://bit.ly/2d9YCXm
this is posted on Oncosec Facebook page. Nice animated short video on immunotherapy.
Sage Therapeutics is another example of a company gaining Breakthrough status with a small trial size.
Sage Receives FDA Breakthrough Therapy Designation for SAGE-547 for the Treatment of Postpartum Depression (enrollment estimate:32 patients)
SAGE-547 is also being developed as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE) in the global Phase 3 STATUS Trial.
Maybe Oncosec will gain a first line therapy designation for Melanoma if combo data is excellent.
Just an example of a small company gaining Breakthrough designation is all, and yes they do have to do a small additional study before they get approval for Firdapse for LEMS. Why should it matter if it is adjunct therapy or first line therapy? Why wouldn't Oncosec qualify for Breakthrough status if the combo results are great?
Catalyst Pharma received Breakthrough status for the treatment of LEMS with Firdapse. The trial enrolled less than 40 patients.
Looks like a no-brainer to me. Merck and a few other companies will be all over this when results are released.
Oh, that's good. I liked your post on Jimmy Carter and Immunotherapy. Only a matter of time before Oncosec starts making bigger headlines. Could happen overnight.
My mistake Titan, I thought it was Stanford University. Eager to hear some results on this study.
Oh, ok. But I'm glad we agree that Oncosec PPS will rise on the good news that is coming with combo results. Good to be on the same page with that. :)
With TNBC news coming soon, I wonder if Oncosec will also announce that they are using the next generation Electroporation device for deep tissue cancers in this trial. This trial is taking place at Stanford University where there is much focus on immunotherapy. Titan V most recently posted an article about Jimmy Carter and immunotherapy. This is very positive and also their was a note in there about Stanford University. Seems good things are happening there and I would have high hopes for our TNBC trial.
Yes, it should start getting very interesting about now.
Yes, I agree that these sorts of small cap undervalued companies go way up on good news, which will likely be the case with Oncosec when they release combo data results. Glad we are on the same page here that Oncosec will be a huge winner.
I totally agree with you Titan. There is too much at stake here in the immunotherapy race. Merck would be very foolish to not do a buyout in the near future if the combo results are great.
Regardless of the small trial size I still believe the market will react positively to good results. We shall see soon enough.
I also believe in what Oncosec brings to the table with their platform. We are nearing a great inflection point in cancer treatments; you can feel it brewing in the market. Too many people are dying from cancer and there is just too much at stake to not move the cancer treatment landscape further towards combination immunotherapy as first-line treatments. Oncosec is on the cusp of something really great here. Good vibes to all!
Thanks Ahab. I appreciate that. I will continue to ignore the negativity as well. I believe in supporting companies like Oncosec that are trying to save lives where there is a great unmet need, such as cancer. Tobira and Intercept should also be commended on their trials for NASH, a great unmet need in that area as well. People need to have more human compassion in this world and I find it really discouraging when people insult your investment style if it relates to a personal reasoning for investing. Many people have lost friends and family to cancer and I think that is an excellent reason and tribute to investing in cancer immunotherapy companies. Just my personal thoughts about this. Good vibes to all!
Tobira stock rocketed yesterday on a buyout from Allergen. This sub $5 stock goes up to $39 overnight.....phase 2b trials. If big pharma wants it they will shell out the bucks. We are not dreaming when it comes to Oncosec valuation and buyout potential here. Tobira will release phase 2 results one year from now and it gets bought out. We will release results in less than 3 months. I suggest buying shares of Oncosec now rather than chasing it later. Good vibes to all.
Oncosec has Great Potential! It is a fact that Biotech stocks are extremely risky but we all know that here. Stocks blow up every day. Avoid the negativity and focus on the positive information posted here. I appreciate all the good information anybody is able to dig up and I will continue to post anything I come across of interest related to Oncosec and immunotherapy. Good vibes to all. Let's keep the positivity going on this board.
Liam Ratcliffe, MD, PhD, Managing Director, New Leaf Venture Partners will be involved in this. I like that. Would be nice to see an investment from New Leaf in Oncosec.
According to Adil Daud this is a big deal even though we are talking 20 people. I would tend to believe a well respected Professor of Medicine when he gets excited over these results.
Adil Daud quote:
"These findings represent an advance in the field of cancer immunotherapy," said Adil Daud, MD, director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center. "Many tests examining PD-L1 levels in tumor tissue can only modestly discriminate between responders and non-responders. This analysis accurately predicts response to anti-PD-1 therapy and can be utilized in the clinic to appropriately select patients with a high likelihood of achieving a clinical response to PD-1 pathway inhibition."
Sweet! Icing on the cake!
I never believed that Dr. Pierce was exiting Oncosec. Dr. Pierce has always seemed very passionate about his belief in what Oncosec had to offer. We are getting closer to achieving his goal, and he is definitely still a part of the Oncosec team. So far results have been very promising so why on Earth would he bail now, right? Go Oncosec!
Absolutely......and I am ready to add more shares at this point. Only a matter of time before liftoff.
More info about speaker sessions: Our man Pierce will be there too.
Biomarkers and Precision Medicine USA Congress Day 2 – 4th October 2016
14.00 – 14.30
Biomarker Development for Intratumoral Gene Therapy with DNA-encoded IL-12
Patient selection biomarkers for low TIL/low anti-PD1 responder population
Pharmacodynamic (PD) biomarkers of effective in-situ vaccination
Robert Pierce, Chief Scientific Strategist, OncoSec Medical
15.30 – 16.00
Panel Discussion- Immuno-oncology Biomarker Development
Challenges in Precision medicine
Status of PDL1 assay and biomarker development and other pathways
Non Respondence of PDL1
Lessons learnt
Chair: Adil Daud, Professor of Medicine, University of California, San Francisco
Panellists:
Robert Pierce, Chief Scientific Strategist, OncoSec Medical Chan Whiting, Associate Director, Aduro Biotech
http://www.biomarkersusa-congress.com/wordpress/wp-content/uploads/2016/09/BF-Biomarkers-and-Precision-Medicine-USA-090916.pdf
NICE!
With every new article about Immunotherapy and the role Biomarkers will play in this game of combo-therapy we get closer to liftoff.....when we release the combo data, the market should start to wake up to Oncosec and give us some respect.
It seem that yes, Adil Daud will be a speaker at:
Biomarkers & Precision Medicine USA Congress 2016
http://www.biomarkersusa-congress.com/2016-speaker-line-up/
What we need now is great combo data results to capitalize on these Scientific articles. We need the word to get out in bold headlines that, hey, Oncosec has a solution here......then we can join the popular group and become a must-own stock on Wallstreet. Pray for great results soon. We get that and we will be in great shape going forward.
I do believe that with good combo results we will see a rise in share price. We need sustainable momentum and partnership money will give us that. I think the market is in fear mode with companies like Novavax collapsing every other day on bad news. Holding tight and still believe in Oncosec. GLTA!