Monday morning. The firm issued a buy rating and a $18.00 price target on the stock.
Their solutions are very similar in mechanism of action.
a.Both employ genetic engineering. Both result in continuous emission of "come kill me signals" to the immune system.
b.For Immunopulse this is done by incorporating DNA fragments into tumor cells. The DNA fragments cause tumor cells to emit a continuous stream of IL-12 (a cytokine).
c.For Tvec, this is done by injecting a genetically modified live virus. The virus infects and kills some cancer cells. The virus is modified to emit a continuous stream of GmCSF (another cytokine).
2.Oncosec's Phase 2 data is virtually neck-and-neck with Tvec's Phase 3 data
a.Here is a comparison table of efficacy
14% CR (all tumors disappear)
31% ORR (at least some tumors respond)
c.Tvec monotherapy had 11% CR and 26% ORR (see wikipedia for more on Tvec)
Even though Immunopulse seems slightly better than Tvec, Tvec results were Phase 3 with larger sample size (n=295).
That said, Immunopulse Phase 2 had 29 patients. ORR and CR were generally consistent with their earlier Phase 1. Despite the smaller numbers, this is an important clue that their results are reproducible.
e.It is no surprise Immunopulse phase 2 results are about the same as Tvec.
Their mechanisms of action are so similar -- both are novel methods of creating a constant stream of "come get me" signals at the site of the injected tumor.
3.Both have an extremely low toxicity, with Oncosec's slightly superior
a.Oncosec's main toxicity - if you can even call it that - is temporary pain and inflammation at the injection site. This typically lasts 1 minute.
b.Tvec uses live, genetically modified virus. Causes fatigue, chills and fevers. Even so, these are temporary and nowhere near the toxicity from chemo and targeted agents. Given a choice, some patients may prefer not to go through fever/chills. They may prefer to grit their teeth, endure 1 minute of pain (Grade 1-2 level pain).
4.Both result in systemic anti-tumor effect
a.In both Tvec & Immunopulse, patients experienced shrinkage of tumors that were NOT injected. The virtually identical data affirms this. Both can cause complete regression of systemic disease. In theory, this can only happen via creation of Tcells that "recognize" the tumor as enemy.
b.Throughout history, systemic anti-tumor effect has been observed when tumors are damaged. Doctors have observed this during surgery or even biopsy (but rare). It has also been seen after radiation, thermal ablation, cryo-therapy. The likely explanation for this is the local damage led to creation of some Tcells that recognize the tumor. In all of these cases, the systemic anti-tumor effect was minor and transient. It certainly did not result in dramatic or prolonged shrinkage of all tumors. Otherwise, we would have seen dramatic increase in survival rates.
c.Recently, researchers at Stanford University and Memorial Sloan Kettering documented how radiation "rescued" Yervoy. In other words, Yervoy was not working by itself. But when suddenly combined with a local "intra-tumoral" therapy (radiation), all of the patient's tumors dramatically shrank. This is not surprising. Yervoy and other checkpoint blockers simply "take the brakes off" the immune system. However, the "car is not going to move" if you don't have an accelerator pedal. Having Tcells that recognize the tumor is that accelerator pedal. In this case, local Radiation therapy to a single tumor likely caused creation of those Tcells (accelerator pedal).
d.The key advantage of Tvec and Immunopulse - they cause a constant 24x7 stream of "come kill me" signals to the immune system. It is as if one performed repeated radiation to a single tumor every minute, over and over. The embedding of this homing signal by Tvec / Immunopulse is an extremely elegant approach, resulting in 24x7 creation of Tcells.
e.Furthermore, both IL-12 (Immunopulse) and GmCSF (Tvec) help to modify the defenses around the tumor to allow incoming immune cells to penetrate. In response to the immune assault, tumors upregulate certain defenses (such as PD1 and CTLA4). Tumors do this by taking advantage of the body's natural tendency to prevent autoimmune diseases and allergies. Without PD1, CTLA4 and other pathways, we might all be dead from all sorts of allergies (think Peanut allergies, asthma).
f.PD1 and CTLA4 blockers are able to "take the brakes off" by temporarily shutting down the human body's natural anti-allergy mechanism. This is done for a short window of time during PD1 infusion. During that window, antigen presenting cells are empowered to penetrate, kill, and go on to educate Tcells to recognize tumor. This process should take a few days/week (think of how long it takes for your body to generate Tcells to fend of a flu)
g.Once Tcell education is achieved, you may not need PD1 any longer. You can allow the body's anti-allergy mechanisms to resume. How do we know this? There are patients who took Yervoy and PD1 years ago, during the early trials - yet are still alive with no tumors today. They only had a few infusions years ago, with zero therapy thereafter. Yet their tumors kept on shrinking, and stayed away with no other therapy.
h.In summary, Immunopulse & Tvec greatly facilitate the training process for Tcells right inside the body. This is not just theory. Tvec's combination trial with Yervoy proved this (increasing ORRs from 26%- 56% … discussed further below)
Sentiment: Strong Buy
PLYMOUTH MEETING, Pa. – December 17, 2014 – Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today the appointment of Zane Yang, M.D. as Vice President, Clinical Development, Oncology. In this position, he will be responsible for advancing Inovio’s oncology portfolio of DNA immunotherapies through clinical trials to commercialization. He will report to Dr. Mark Bagarazzi, Inovio’s Chief Medical Officer.
Inovio is planning a phase III trial for its immunotherapy for a pre-cancer, known as cervical dysplasia, which met its endpoints in a recent phase II trial. The company is in or about to move into phase I trials for numerous cancers including prostate, cervical, breast, lung, head and neck and pancreatic cancers.
Dr. Yang joins Inovio from Janssen Pharmaceuticals, a unit of Johnson & Johnson, where he was Director, Oncology Medical Affairs in the U.S. Dr. Yang led the prostate cancer and solid tumor therapeutic area including development and commercialization of Zytiga®, for the treatment of metastatic castration-resistant prostate cancer. Prior to Janssen, he was Director of Global Medical Affairs and Clinical Development at Novartis Oncology, and Director of Clinical Development at Merck & Co.
Dr. J. Joseph Kim, President & CEO of Inovio, said, “Zane is a highly regarded and accomplished executive and clinical researcher whose experience in the global cancer market makes him exceptionally qualified to lead clinical development in oncology at Inovio. There’s a new wave of cancer therapeutics coming, products that enhance the body’s immune system to fight and prevent cancer. Inovio is proud to be a leader in this new paradigm of products and Dr. Yang’s leadership will play a critical role as we move forward.”
Dr. Yang, who earned his M.D. at Beijing Medical University, was a Fellow at Emory University’s Winship Cancer Institute and the Wistar Institute. Before transitioning to the pharmaceutical industry he was an associate professor at the University of Virginia Medical Center.
So ,would you like to pay 8.50 for this potential,or would you like to show your stupidity buy typing here..
Sentiment: Strong Buy
PART of todays 'email from INOVIO.It reads...
Looking forward we plan to publish our phase II data in a peer reviewed journal; we have the potential for data from our phase I hepatitis C, cervical cancer and head & neck cancer studies; and we plan to initiate multiple other clinical trials targeting prostate cancer, breast, lung, and pancreatic cancer displaying the antigen hTERT, hepatitis B, HIV, and Ebola. The initiation of the hepatitis B trial will trigger a milestone payment from Roche.
Sentiment: Strong Buy
are we going to have our low hanging fruit ripped off!! 16 days of mistery...(like the 12 days of Christmass)Happy holidays to all....even the bashers..
Sentiment: Strong Buy