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Two points, In regards to MC/Valuation...TPIV may be entering unchartered territory when it comes to Immunology, as everyone seeks/covets “The Holy Grail” in regards to controlling disease recurrence/suppression and/or Metastasis.
Tapimmune is working on TNBC/Ovarian and HER2Nue but as they have hinted at their vaccine may be applicable to many types of cancers, and who knows it since it has been hinted that they may have broken the code at a “cellular” level.
What would be unrealistic? What other types of Cancer’s/Diseases would their Vaccine conjugate be applicable too?
Tapimmune just mentioned Alligator Bioscience and their relationship with JJ pegged at $700 mill and if you go to their site they only have 1 drug in Phase 1 and some in preclinical.
Not as far along as TPIV and not as compelling science/results.
Would be nice to hear/see results of the grant they requested towards the first half of 2016, that may have some effect on vanquishing those remaining warrants.
Or the partnership it’s self may cause Dart/Tapimmune to re think/remove/restructure the remaining warrants. As there most likely would be upfront and/or milestone payments.
Tapimmune really may be in uncharted waters here [only time will tell] so what may have been perceived as realistic/unrealistic in the past may not apply to the future of Cancer.
Depends on whether Tapimmune sticks to their guns and strikes a deal in the partnership from a position of strength or do they just want to get a partnership done. [Hope it is the former]
If grant and /or partnership deal is announced within first Q/half then for everyone involved to cancel those remaining warrants would make sense.
Once again if they truly are the only company [still] that has the simplest, lowest cost, least toxic solution in the game right now and into the future, what would a realistic scenario be?
We can all speculate, but only time is going to answer what may be the billion [s] dollar question.
And as john has said “all our ducks must be in line” before we must up-list, and as we have all seen, it would be a worthless scenario to do it at this point...once they have both Phase 11’s up and running, and all of the catalyst’s in first half of 2016 in play then the up-list will be successful, as TP mentioned late 2016.
At that point we should see the stock move quickly upward, for then Tapimmune should be quite coveted by funds and their willingness to buy it.
One real question is, will there be enough catalysts in the near term to allow them to up-list without the company doing one last R/S.
Right now we are still speculators, 2016 will answer most of our concerns, window IMHO will still be as I have mentioned 2016/2017 all these questions and more will be answered.
Hope that everyone had a great Christmas and best wishes for 2016
GLTA
BLU
Happy Birthday to you, Happy Birthday to you,
Happy birthday “Tommy p” Happy Birthday from BLU
May you and yours have a safe and wondrous Holiday season.
BLU
MERRY CHRISTMAS AND A SAFE AND HAPPY NEW YEAR TOO EVRYONE, THANK YOU FOR THE GOOD WISHES.
See you in 2016 have many stockings to fill, and many notes to write for Christmas hunts.
GOD BLESS ALL THOSE THAT TAPIMMUNE'S VACCINE/SCIENCE MAY HELP.
BLU
One of my favorite sayings when any of my adopted brood wants to borrow money [weekly occurrence LOL] is "Money is only something I need if I don't die tomorrow"
Once got a call early morning [pre 7AM] heard a tiny little voice on the other end crying "Papa are you okay"? asked Makayla one of my adopted girls [7 years old].
My daughter got on the line and said that she [Makayla] had overheard me say that jokingly to my daughters husband when I gave him the money.
Turns out she couldn't sleep all night crying and scared...
...the beauty of children.
GLTA
BLU
Alligator Bioscience granted exclusive rights to "1" drug to Janssen Biotech for $700 million, only drug in clinical at the point of sale.
We are further along than Gator, have more drugs in clinical and validation by both the DoD and Mayo...hence why I have had a buyout price for TPIV at a billion minimum.
2016 could very well see a bidding war for their technology, not out of the question at all.
Wondering if they are holding off on finalizing/announcing the partnership deal because of potential offers already in the wind.
BLU
Me too, no access to Tapimmune site last 2 days
BLU
PRESS: TapImmune's Phase II Trials for Breast Cancer to be Initiated at the Mayo Clinic
Mayo Clinic Report shows 90% of patients generating T-cells that recognized naturally processed antigens, a clear improvement over previous vaccines with more limited utility of patients in Phase I; Researcher believe the drugs could prevent disease recurrence; A potent new treatment for breast cancer gets closer to reality; Immunology is TapImmune's core therapy, highly effective in early clinical trials; Risks involve early-stage clinical results translating to later stage; Government money lends credence to TapImmune's science
NEW YORK, NY / ACCESSWIRE / December 21, 2015 / Technology is ready to prove cancer can be managed as a chronic disease. The science of immunotherapy would make this possible, and one particular company stands out - TapImmune, Inc. (TPIV), whose Phase I data in breast and ovarian cancer proving its drugs both safe and effective were done at the world-renowned Mayo Clinic, not accepting just anyone with an idea and a dream.
Lead drug TPIV 100/TPIV 110 is indicated for breast cancer, a highly dangerous disease that strikes women at almost any age. Doctors are quick to cut out offending tissue, leaving patients depressed, feeling that vital parts of womanhood have been taken away. With TapImmune's medical solutions, hope can bloom for those left with only the choice of chemotherapy and invasive surgery.
Importantly, TapImmune's therapy is not autologous, where a patient's own cells must be withdrawn and processed before reentering the body, making for a more efficient treatment that need not be done in the intensive care unit ((ICU)) of the hospital. Many competitors in cancer immunotherapy must deliver their drugs in the ICU setting, increasing time and expense. Also, TapImmune's drugs can be used with other treatment methods, including checkpoint inhibitors, or as a stand-alone therapy.
TPIV 100/TPIV 110 is based on a unique blend of peptides (short chains of amino acids, the building blocks of proteins) and gene-based immunotherapies, also known as DNA vaccines; these compounds encode proteins from disease-making body infiltrators, including tumors, and can be used prophylactically and therapeutically - before disease occurs or after. TapImmune's drugs upregulate T-cells CD4 and CD8; T-cells are a type of white blood cell vital to human immune response. CD4 and CD8 are a combination of proteins and carbohydrates found on T-cells and 'help' trigger response to what the body views as a foreign substance, like cancer, and make 'killer' cells that produce antibodies to ward off disease.
TapImmune's technology revolves around a vaccine to address HER2/neu, an enzyme with an 'on' and 'off' switch to regulate cellular functions via epidermal growth factor receptors involved in normal cell growth, and intimately involved in immune response. Phase I trials in breast cancer revealed an abundant generation of T-cells, armed to arrest tumor development. TapImmune's folate receptor alpha (FRA) vaccine, addressing a protein found on the surface of malignant breast cancer cells, also showed good efficacy in Phase I. These results have been supported by other studies, upholding proof TapImmune's solutions work.
Recently, TapImmune displayed new data authored by Mayo Clinic researchers, supporting strong generation of T-cell immunity at higher levels than seen with other drugs for breast cancer and prompting initiation of a Phase II clinical study at Mayo for TPIV 100/TPIV 110. An astonishing 90% of patients in Phase I led to belief the drugs could prevent disease recurrence, control metastases, and, possibly, regress tumors which would allow TPIV 100/TPIV 110 to manage breast cancer as a chronic disease. If later studies show similar results, TapImmune's therapy would outpace competitors in the cancer immunotherapy arena and create a new age for breast cancer survivors.
TapImmune has shown breast cancer data at the American Society of Clinical Oncology (ASCO), proving its drugs motivate human immune cells to biologically stimulate other cells to effectively treat disease. Their vaccines are clearly creating a robust T-cell response. Use of TapImmune's technology in combination with checkpoint inhibitors and antibodies creates a multi-billion market opportunity. Partners like Mayo, unsurpassed in clinical talent and, recently, the Vaccine & Gene Therapy Institute of Florida, a nonprofit research institution committed to the study of the human immune system, will be valuable to TapImmune's future goals.
In September 2015, TapImmune released good news from Phase I studies in triple negative breast cancer (TNBC) that led to the Department of Defense's (DOD) $13.3 million grant to fund a 280 patient Phase II to be done at Mayo. TNBC occurs in 20% of all breast cancers that lack important hormones found in breast ducts that would otherwise thwart abnormal cell growth. Fatality is high - a 53% risk of death if chemotherapy is not undertaken very soon after diagnosis.
When told the of the grant, I expressed disbelief but was corrected by Glynn Wilson, Ph.D., chairman and CEO, that DOD is very active in this particular disease. End to breast cancer is its goal, with efforts to facilitate research and innovative therapies. TapImmune's solution, as a targeted therapy, fits perfectly.
Another Phase II trial using TPIV 200, a vaccine with similar characteristics to its other drugs, should commence shortly for TNBC, this one to be done by the company, with the potential to move along faster than the Mayo trial. TapImmune is planning a Phase II with TPIV 200 in ovarian cancer who's Phase I done at Mayo had statistically significant results showing strong efficacy compared to placebo; these results were displayed at ASCO. A pharmaceutical partner with a checkpoint inhibitor will be sought for the second phase; my understanding is talks are ongoing. TPIV 200 has been granted coveted Orphan Drug designation by the FDA with tax credits and seven-year exclusivity from competition on approval.
Drugs under preclinicals include Polystart, an antigen for HER2/neu breast cancer; FRA antigens for TNBC and ovarian cancer; and a study with FRA combined with PD-1 checkpoint inhibitors for testing against ovarian cancer.
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View photo
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Breast cancer dramatically alters a woman's life; TPIV 100/TPIV 110 has the capacity to change this. The large base of HER2+ breast cancer patients could benefit immensely from TapImmune's HER2/neu antigens whose vaccines pump up T-cell immunity and, in early results, show 'memory' immunity, allowing longer term effects, something not seen with current immunotherapy treatments.
An astounding 12% of women in the US contracts breast cancer each year; death rates hover around 3%, not as fatal as other malignancies, but the psychological impact can be immense. Costs to treat breast cancer are huge - estimates are upwards of $100,000 per year, including mastectomy. Treatment for ovarian cancer is larger - $200,000 with hospital, pharmacy and physician charges taken into account.
Most popular among therapies for breast cancer is Herceptin, approved long ago for metastatic, and more recently, early stage disease. Problem - Herceptin use may result in cardiac failure, lung toxicity, and death. Women who desire to become pregnant are warned that Herceptin could cause low amniotic fluid, vital to a developing fetus, in addition to skeletal abnormalities in utero, and fetal death. Still, chemotherapy and radiation are not ideal alternatives. TapImmune's breast cancer drugs provide a much better answer, proving safe and effective in Phase I, with a strong immune response.
It's interesting to note in August, a little-known clinical stage cancer immunotherapy firm, Sweden-based Alligator Bioscience AB, struck a deal with Johnson & Johnson (JNJ) to the tune of $700 million for its monoclonal antibody targeting certain cancers, using immune-response cell receptor CD40 to effect a big increase in T-cells to attack tumors. Alligator found in its Phase I trial establishment of a tumor-specific memory leading to lengthier times to cancer reoccurrence. Its clinical efficacy and trial progress mirrors TapImmune's, who may be slightly ahead, yet TapImmune's market capitalization at $41.3 million is severely undervalued considering its potential.
In its latest quarter ended September 30, 2015, TapImmune swung to net profit, but due only to changes in fair value of derivative liabilities. Operating costs grew, not surprising as research and development ramps up, although general and administrative expense dropped as the company conservatively manages its cash.
The usual risks, common to any emerging biotechnology firm, apply to TapImmune as well: late stage clinical trials may not show efficacy; larger numbers of patients may exhibit adverse effects not seen in smaller groups; drug dosages may need to be adjusted, leading to more, expensive studies. Despite a recent money raise of over $4.9 million, funds may not meet the runway needed to bring clinical trials to completion; however, Mayo Clinic financing should shore up any capital deficits.
Investors have not yet grasped the value of TapImmune's vaccine technology. Trials show an overwhelming biological response in humans: activation of T-cells inside the body using an easily-administered vaccine that stimulates immune response cells to attack cancer. Past data is conclusive for efficacy and upcoming results from larger trials could prove TapImmune'’s therapy for breast cancer works, giving women a better and gentler medical solution in the future.
About Small Cap Forecasting, Inc.
Sharon di Stefano has spent 20 years as an analyst, beginning her career at Smith Barney, Harris Upham & Co. specializing in medical devices, pharmaceuticals, healthcare information technology, and bio-pharmacology. Ms. di Stefano had also served as Senior Venture Officer for the Edison Innovation Fund, implemented through the New Jersey Economic Development Authority that provided funding for early-stage life sciences companies. Industry experience includes laboratory research for Johns Hopkins Hospital and the Department of Defense. Ms. di Stefano received a Master's of Science degree, in Business, from Johns Hopkins University in 1986, and a Bachelor of Arts from the University of Delaware in 1984 with a minor in biology.
Media contact:
Jackie Rodriguez
646-430-578
SOURCE: Small Cap Forecasting, Inc.
BLU
Best to wait till new year to address any new news, any press within the next 2 weeks would only be wasted with Holiday frenzy.
Would like to see initiation of [Mayo] Phase 2 [Folate] and Partnership news released in synergy with each other, we have waited this long best to start the year fresh.
Open the New year with a bang, and follow up with news on possible grant, in house Phase 2 trial, and would love to see/hear breakdown of SABCS abstract.
Don't really understand why Phase 2 initiation of Her2Nue has been pushed back till 3Q 2016, are they not expecting the stock price to extend past $1.25 by 2016 3Q. To fill up the coffers with .50/.75/1.25 warrant cash.
Can't think of another reason they would be so delayed on that start other than cash allocation, many companies work on multiple trials in conjunction with each other.
They say a greater need for the TNBC/Ovarian which is true, but best to have to many irons in the fire opposed to too little.
GLTA
BLU
I posted a few weeks ago a list of NY Cancer centers, and possible collaborators...Sloan was my pick also, seemingly the best fit.
Time will tell.
GLTA
BLU
That's simply not true, you know the science and management is very sound, they did what they needed to do to keep the company and science afloat [warrants].
Whatever misdirection you spew, you cannot change the facts the science is sound, bio techs are always a long term hold. They will prevail...you will not!
Fairly simple when I spell it out isn't it?
And once again many of us still hold a good profit even at these prices...so just who are the bag holders?
I will wish you a Merry Christmas now, cause you'll be gone in 2016, those of us holding TPIV will simply be richer.
BLU
Hope no one in your family or friends get Cancer...what kind of a "jerk" berates people that are trying to save lives, pain and suffering?
Try to look past the monetary gain, and appreciate what they are trying to accomplish.
We all know this is going much higher in the early new year, I as many others hold a substantial position, I have no worries as to the eventual outcome.
If it drops much lower will add once again.
P.S your ridiculous rants are "baseless", like others have stated in early 2016 you will simply be a memory.
GLTA
BLU
I would like to thank you for your most amusing rants, as making money for most of us on this board is relatively easy, most of us have already banked or hold significant profit in TPIV.
Our DD has already proved out to this point so higher highs, or lower lows are of no consequence.
Those of us that have done our DD already hold the keys to most of your questions, we thank you for most of us may have forgotten or became complacent just how “brilliant” we were in discovering Tapimmune in its infancy stage [personal pre.30]
Sometimes one should remain silent and appear to be somewhat less than intelligent, as opposed to not being silent and therefore removing all doubt.
Investing is a gamble at the best of times, we have taken that gamble and most are sitting pretty. I along with most on this board do not gratuitously answer questions that have already been addressed.
For in life there truly are no free rides.
You are/will become an investor in Tapimmune or as time progresses we will see/hear less of you as the SP increases...after all “life is a beach”.
I am very comfortable in my position in TPIV, as a am surrounded by intellect not only on this board but by many scientific minds that are diligent in their quest to making this world a much better environment.
Some of us are not entirely vested for the monetary gain, but choose to support Cancer victims to eliminate/eradicate it in any form possible.
Tapimmune is shaping up to be a world class Onco-immunology company as most if not all their data is/has been peer reviewed by minds much more intelligent than you or I.
Best of luck to you in life’s endeavors...I live life with a glass have full, and on the occasion the glass becomes less than that...I Buy/Average more “TAPIMMUNE”
If you truly wish to have the answers to your questions get to work...either way one of us in time will prevail, I'm betting on me!
GLTA
BLU
Thank you very much for clarifying that point much appreciated as I found it somewhat confusing, Investor_cmz thank you very much also.
BLU
Can anyone give some clarity on this line from todays press "Antibody immunity to HER2 was modestly increased in vaccinated patients".
Not a science guy but doesn't sound too impressive.
Thanks
BLU
Greenman: First and foremost the stock is, and has been quite undervalued to peers in the Immunology space.
A year even six months ago one might have made the argument that the company was just too speculative.
In the past six months they have accomplished or exceeded all the goals that they set for themselves.
As others say these are truly exciting times, first and foremost for those that have been so unfortunate to have Cancer decimate their lives, no one should lose sight of what the science is all about...saving lives.
In regards to investors, I have heard on each step forward about resistance .40/.50/.60 and most recently .75 which we just blew through.
It seems that we are just now on the cusp of really taking off, we have several catalysts that the investment community will not be able to dispute, most recently today’s late announcement.
Most have waited so long that the small increment moves upward are making us giddy, when in reality as many have eluded to the SP should be more in tune with $2/$3 at this point, and with the impending milestones should get more in line with those predictions.
I don’t believe the price is baked into the market, I believe that the market is just now beginning to “fully” grasp the enormous potential of Tapimmunes science, tomorrow and the following days we will get a lot more color.
This move upwards from .50/.60 has been a lot more deliberate [than the move to $1.71] and looks like many have positioned themselves, the partnership news should include milestone payments, and I believe that we will receive the applied for grant.
Once again go through all the up-coming catalysts, and there are many, then ask yourself if .90/$1.00 is a fair valuation with all they will accomplish in the next 3/6 months.
It seems as if now we have got the attention/validation of Government agencies...despite our penny status I would believe that it would be hard for any BP in this space to not be looking at us seriously at this point.
If any stock is poised to explode it would be Tapimmune...do any of us really get it, Tapimmune may be able to control many forms of Cancer, 2 examples of our future KITE, JUNO. Long term holders will be the real beneficiaries...as someone eluded to, there are future millionaires holding this stock.
Don’t lose sight of the big picture here, these prices are bargains.
Sorry sounding repetitive, the story really speaks for itself, and it truly is a great story.
GLTA
BLU
Goines: It looks like there are others in that 7:30-9:00 timeslot Poster Session 2 "Treatment Immunotherapy", so don't know their allotted amt of time to present.
Got this off the SABCS abstract for Tapimmune, not sure if has been previously posted.
[P2-11-02] Robust generation of T cell immunity to HER2 in HER2+ breast cancer patients with a degenerate subdominant HLA-DR epitope vaccine
Knutson KL, Kalli KR, Block MS, Hobday TJ, Padley DJ, Erskine CL, Dockter T, Suman VJ, Wilson G, Degnim AC. Mayo Clinic, Jacksonville, FL; Mayo Clinic, Rochester, MN; TapImmune, Inc., Seattle, WA
Background: Recent studies have indicated that vaccination can protect against cancer development. One key aspect of developing vaccines is circumventing peripheral tolerance by identifying subdominant epitopes that are unique to the deregulated tumor microenvironment.
While existing subdominant epitope vaccines are showing efficacy in preventing cancer, these vaccines are applicable only for subsets of patients with specific HLA subtypes.
Therefore, we recently developed a degenerate HER2 subdominant epitope-based vaccine that should be useful in approximately 85% of all patients.
The vaccine consists of a pool of four HLA-DR-restricted 15-amino acid epitopes (p59, p88, p422, and p885) that are naturally processed and are designed to elicit helper T cell immunity, the cornerstone of immune surveillance. Here we present Phase I trial results of this multi-peptide HER2 vaccine.
Methods: Eligible women had HER2+ breast cancer (Stages II-III) and had completed standard treatment (i.e. surgery, chemotherapy, and trastuzumab) at least 90 days prior to enrollment and were rendered disease free.
Vaccine included the above epitope pool along with adjuvant GM-CSF. Patients were vaccinated six times over six months and were monitored for toxicity at each visit.
Peripheral blood samples were collected for immune responses evaluating for T cell and antibody immunity. Endpoints were safety and immunogenicity leading to the development CD4 helper T cells that recognized naturally-processed HER2.
Results: Twenty-two subjects (age 33 to 69 years) were enrolled. At the present analysis, 21 have completed all 6 vaccination cycles; one patient withdrew after developing a grade 1 injection site reaction during the first vaccination cycle.
Twenty patients have had LVEF measured after vaccination; only 2 patients had an LVEF drop of 10% or more but remained in the normal LEVF range.
One severe toxicity was reported: a grade 3 INR increase considered unrelated to treatment. Mild to moderate (grade 1-2) toxicities included injection site reactions, fatigue, and white blood cell count decreases.
All patients were alive at analysis and only one experienced a recurrence (median follow-up 507 days, range 22 – 844).
Twenty patients have had immune response assessments. Vaccine induced T cell immunity was observed in 94% of patients to p59, in 94% of patients to p88, in 82% of patients to p422, and in 74% of patients to p885.
Importantly, T cell immunity to naturally processed HER2 proteins occurred in 94% of patients. The mean number of T cells specific for each peptide, post vaccination, ranged from 349–528 T cells per million peripheral blood mononuclear cells (PBMCs).
The mean number of T cells specific for whole HER2 protein was 783 T cells per million PBMCs compared to a mean of 898 T cells/million PBMCs specific for the foreign tetanus toxin.
In contrast to T cell responses, modestly increased antibody immunity to HER2 occurred in 35% of patients, consistent with the T cell-inducing design of the vaccine.
Conclusion: Our results show that it is possible to develop vaccines with broad HLA coverage that circumvent natural tolerance and induce tumor antigen-specific immunity in the vast majority of patients.
Thursday, December 10, 2015 7:30 AM
GLTA
BLU
Catalyst's in place to do just that "as Jackie Gleason" would say "to the moon Alice".
BLU
Yes this is the first time I can remember that they do not present at the end of the day [7:30-9:00].
Also the fact that they are allowed 1 1/2 hours to present should give a lot of color, hopefully we are close to partnership news.
Up front or milestone payments certainly a possibility here...and as others have stated we may be close to finding out about applied grant.
Expect a CC from company after SABCS to further augment presentation findings or simply to give clarity not allowed at SABCS.
Each dime upwards reduces worst case scenario another substantial R/S...from our mouths to company's ears "let the data speak for it's self" as Glynn has already stated, and the stock should move accordingly.
Still looking for serious buyout offers in 2016, could be Pharma partner [Roche my pick], Dart? or anyone looking to compliment their technologies.
Hope that last 6 months data has held firm, remember Phase 1 data not complete vaccine formulation, and still "unheard of data" as John stated. Commercial vaccine formulation now finished potentially much stronger.
Another cash infusion if we hold over .75.
GLTA
BLU
Nice to see you back tootall.
BLU
Lately they have been doing a CC after important presentations,I like the fact that their poster presentation is going to be 1½ hours opposed to the usual rushed 15 minutes, seems like the presentation will be very in-depth.
June 1st was the final submission date for SABACS [6 months ago] and the last line “still” says “we are excited” which leads me to believe that the new data may be even better than previous data.
They have stated that they are moving forward with TNBC and Ovarian first, so good news that they are once again excited with the Her 2Nue platform, as Glynn stated that they were putting it on the back burner till 3rd/4th quarter of 2016.
Maybe we will see them have that Phase 2 trial up and running by end of 2nd Quarter 2016.
Hopefully the 1 ½ presentation will encompass news/data on both trials, either way the wording of this press leads one to believe that it is going to be very positive for the company.
End of this week will give us a lot of color it seems.
Like the fact too that their presentation is at 7:30-9:00 [early] as most if not all previous presentations have been stuck late afternoons when everyone is already tired/disinterested or have left for the day.
GLTA
BLU
unobaja, here is the trial and contact info, and I think I may speak for everyone on this board that our prayers are with you and you wife/family.
I lost my mother to Cancer, a young grandchild and many friends as they say everyone has lost someone to Cancer it truly is a disease that does not discriminate.
STUDY DIRECTOR: Patrick would be able to refer you to exact person if not him, as there are Mayo and Tapimmune's in house trial, either way he will be able to direct you.
Contact: Patrick D Yeramian, MD 904 677 3597 pyeramian@tapimmune.com
Contact: Ana Aleman, MD 904 533 6012 aaleman@tapimmune.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT02593227
OR
CLINICAL TRIALS REFERRAL COORDINATOR
CONTACT: TONI KAY MANGSKAU
855 776 0015
Tapimmune trial info:
Not yet recruiting Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
Condition:
Breast Cancer
Interventions:
Biological: Low dose FRa vaccine; Drug: Cyclophosphamide; Biological: High dose FRa vaccine
Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2015 by Tapimmune Inc.
Sponsor:
Tapimmune Inc.
Information provided by (Responsible Party):
Tapimmune Inc.
ClinicalTrials.gov Identifier:
NCT02593227
First received: October 27, 2015
Last updated: October 30, 2015
Last verified: October 2015
History of Changes
Full Text View
Tabular View
No Study Results Posted
Disclaimer
How to Read a Study Record
Purpose
This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRa) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).
Condition
Intervention
Phase
Breast Cancer
Biological: Low dose FRa vaccine
Drug: Cyclophosphamide
Biological: High dose FRa vaccine
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination With Folate Receptor Alpha Peptides With GM-CSF in Patients With Triple Negative Breast Cancer
Resource links provided by NLM:
Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: B Vitamins Breast Cancer
Drug Information available for: Cyclophosphamide
U.S. FDA Resources
Further study details as provided by Tapimmune Inc.:
Primary Outcome Measures: •Immune response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Emergence of B and T cell immunity targeting the folate receptor alpha
Secondary Outcome Measures: •Folate receptor alpha expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
To determine FRa expression status of primary tumors
•Relapse Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
RFS in relation to FR specific immune response
•Objective response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
ORR in the subset of patients with residual disease
•Safety and tolerability (treatment emergent adverse events and injection site reactions) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Incidence of treatment emergent adverse events and injection site reactions
Estimated Enrollment: 80
Study Start Date: December 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: Low dose FRa vaccine
FRa peptide vaccine with GM-CSF adjuvant - single ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Biological: Low dose FRa vaccine
165ug per peptide ID injection
Other Name: TPIV200
Experimental: High dose FRa vaccine
FRa peptide vaccine with GM-CSF adjuvant - triple ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Biological: High dose FRa vaccine
500ug per peptide ID injection
Other Name: TPIV200
Experimental: Low dose FRa vaccine + cyclophosphamide
Cyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRa peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Biological: Low dose FRa vaccine
165ug per peptide ID injection
Other Name: TPIV200
Drug: Cyclophosphamide
IV infusion over 1 hour
Other Name: Cytoxan
Experimental: High dose FRa vaccine + cyclophosphamide
Cyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRa peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence
Drug: Cyclophosphamide
IV infusion over 1 hour
Other Name: Cytoxan
Biological: High dose FRa vaccine
500ug per peptide ID injection
Other Name: TPIV200
Detailed Description:
Triple negative breast cancers (TNBCs) occur in approximately 20-25% of all patients with breast cancer and are associated with a poor prognosis. Patients with TNBCs derive no benefit from targeted therapies. Excluding those patients who demonstrate a pathologic complete response following neoadjuvant chemotherapy, which is a minor fraction (i.e. 15%), overall survival is only 45% at 7 years.
Following standard of care, there are windows of opportunity to further and safely treat patients to prevent recurrence. Stimulating the immune system to produce T cells immunity specific for tumor antigens may significantly delay recurrence and cure patients.
The proposed vaccine is intended to induce T cells to survey for the reemergence of TNBCs and to prevent recurrence in the adjuvant setting. The vaccine strategy is antigen-specific and targets the Folate Receptor Alpha (FRa). FRa is an ideal target because of its limited expression in the healthy tissues and it high expression in 86% of TNBCs. Studies have shown that it is a biologically important marker that is associated with poorer clinical outcome and is retained in metastatic lesions.
The FRa vaccine include a pool of 5 peptides that are immunogenic epitopes and safely generate tissue-surveying CD4 T cell immune responses in patients tested in a recently completed phase I clinical trial.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
•Female patient, Age 18 years or older;
•Written informed consent;
•Negative for ER, PR and negative for Her2-neu (0 or 1+ on immunohistochemistry and/or normal gene copy number by fluorescence in-situ hybridization);
•Completed surgery and radio/chemotherapy in adjuvant or neo-adjuvant setting.
•Completed last cycle of chemotherapy or radiation > 60 days prior to consent
•Unilateral or bilateral primary carcinoma of the breast with tumor Stage II-III according to AJCC 7th edition, and one of the following:
a.For patient treated in the neoadjuvant setting: Histologically detectable tumor residuals (ypT0/is ypN0), M0 and no evidence of gross tumor or gross residual adenopathy.
b.For patients treated in the adjuvant setting: pN2-3 and M0. No evidence of gross tumor or gross residual adenopathy
c.Patient with residual clinical disease after neoadjuvant or adjuvant therapy, M0
•Adequate Blood, renal and hepatic function, as determined within 28 days from enrollment:
Exclusion Criteria:
•Clinical evidence of distant metastases per practice guidelines for breast cancer;
•Inflammatory breast cancer or tumor with deep adherence or cutaneous invasion;
•Known hypersensitivity reaction to the GM-CSF adjuvant; Any known contra-indication to GM-CSF or Cyclophosphamide treatment;
•Pregnant or lactating patients.
•History of auto-immune diseases;
•Other uncontrolled illness or medical condition , such as active infection, symptomatic heart failure, unstable angina pectoris, myocardial infarction or stroke within last 6 months, psychiatric illness that may limit compliance with study requirement or interfere with the understanding and giving of informed consent;
•Prior active secondary malignancy < 5 years prior to consent (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix) or currently receiving other specific treatment for this cancer (including monoclonal antibody or pathway inhibitor);
•Completed treatment with systemic corticosteroid or immune-modulators > 30 days prior to registration;
•Planned treatment with other experimental drugs or any other anti-cancer therapy;
•Immunocompromised patients including patients with known HIV infection;
•Currently receiving thyroid replacement therapy.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02593227
Contacts
Contact: Patrick D Yeramian, MD 904 677 3597 pyeramian@tapimmune.com
Contact: Ana Aleman, MD 904 533 6012 aaleman@tapimmune.com
Sponsors and Collaborators
Tapimmune Inc.
Investigators
Study Director: Patrick D Yeramian, MD Tapimmune Inc.
More Information
Additional Information:
Corporate website This link exits the ClinicalTrials.gov site
No publications provided
Responsible Party: Tapimmune Inc.
ClinicalTrials.gov Identifier: NCT02593227 History of Changes
Other Study ID Numbers: FRV-002
Study First Received: October 27, 2015
Last Updated: October 30, 2015
Health Authority: United States: Food and Drug Administration
Keywords provided by Tapimmune Inc.:
TNBC
Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
ClinicalTrials.gov processed this record on December 04, 2015
My family's prayers are with you.
GLTA
BLU
Is that just a guess?
As you have not contributed to the board till now...do you have a factual reason to make such a bold statement?
Do you know the 1 catalyst coming up in 2 trading days, and the possibility of major news at any moment?
Who are the sellers you speak of, other than just warrant holders.
With the near term catalyst in play would not make much sense for their to be lots of sellers...75 cents is an exercise of warrants is that your concern?
At .75 the stock is still very undervalued, not much profit and to much upside, news should eat up the resistance soon.
Not to worry.
BLU
JOF, not so much this Webcast, but the culmination of a series of prior catalyst's...and the imminent catalyst's at hand.
We all know that this had/has to break out at some point, it has been so undervalued for so long, even these prices are an insult to the science/data so far and world class scientist involved.
BLU
John mentioned their partnership with a prestigious Cancer centre in New York here is a list of all the Cancer centres in New York.
Memorial Sloan Kettering Cancer Center [2nd best Cancer hospital in the US very good chance]
The Herbert Irving Comprehensive Cancer Center [possible]
Mount Sinai Beth Israel Comprehensive Cancer Center- West Campus
New York Presbyterian Hospital : Cancer Center [1 of top ten in US possible]
Maimonides Breast Cancer Center
Maimonides Medical Center : Cancer Center [2nd centre]
Memorial Sloan Kettering: Brooklyn Infusion Center [2nd centre]
Mount Sinai Dubin Breast Center [may be this one]
Memorial Sloan Cancer Center: Glickman Michael Ste MD
Queens Hospital Cancer Center
Weill Cornell Breast Center
Memorial Sloan Kettering: D'Angelica Michael I MD [3rd centre]
NYU Clinical Cancer Center
Tisch Cancer Institute at Mount Sinai
Memorial Sloan Kettering Cancer Center Epidemiology and
Biostatistics [4th centre]
The Ralph Lauren Center for Cancer Care and Prevention
New York Eye Cancer Center [doubt this one]
Any ideas anyone?
Once again I think that a partnership with "Roche" would be a perfect fit.
GLTA
BLU
Phantom, Tapimmune has gone through too much and worked to hard to get to this point...they are in the drivers seat in regards to their next step[s]
I would be very surprised if they give away anything at this stage that is not in their best interest.
It was a great webcast, 2016 is going to be a massive year for them,$50/100 thousand dollars cost to KITE and JUNO to produce and $300/450 thousand "per patient" to sell their standard of treatment will be to pricy for market to bear.
It seems that we are going to be much sought after in 2016 by everyone.
30,000 new patients each year lets say at 15000 patients per year and a [ludicrous] lowball treatment cost $10,000 = 1.5 Billion
15000 at $50,000 = $7.5 billion...the numbers become staggering.
Partner to be announced very soon!
SABCS should really open some eyes.
Each CC they speak with more and more confidence, and I believe that he mentioned that the "commercial" vaccine formulation is now ready.
Future is bright regardless of path they choose.
GLTA
BLU
With investing, don’t lose sight of what is truly important, those with families should make their welfare first and foremost, after all we invest to better our lives and the lives of our loved ones.
Having a family, “responsibility” makes investing decisions more complicated, as there is much more at stake, individuals who are single are may be prone to a far greater level of “risk” as they have no one to answer to then themselves.
As in the buffet video, one should initially weigh the long term potential of any investment and ones long term criteria for that investment. Did you invest to simply pay down credit/mortgage or are you invested to have a retirement income.
Do not make the mistake of underscoring “Tapimmune’s” vast potential, for if the truly have broken the “Cancer code” as was indicated in the last video, Tapimmune may very well be like a Berkshire company years into the future.
Can you imagine the scenario where every individual woman/man/child in the world would be vaccinated against “getting cancer”, at this point one cannot even perceive the implications of that scenario.
But if it were to come to fruition, whoever would hold that prestigious honour would be most coveted...is it simply a dream or one day will we really be able to control cancer with a simple injection?
It is early days but in my humble opinion the rewards strongly outweigh the risks even at this very early stage, I am as you all know in for the long haul for my vision sees Tapimmunes science becoming the standard of care in the future.
It seems as if in the last year many others hold that very same sentiment...find your tolerance to risk, examine your long term goals and the goals of the ones you love. Do not put yourself or those you love at risk then you will feel much more comfortable in how you make your investments.
Within 1 to 2 years you will know whether Tapimmune has the goods to be the Berkshire of Cancer stocks, if you have impelling obligations within that timeframe that exceed the long term potential then let those obligations come first...as any investment no matter how sound may unravel at any moment.
One should only invest with money that one can afford to lose, hence why less than 50% of the population is invested in stocks...if you do not put your family at risk, then you’re investing experience will be much less complicated and far more enjoyable.
We all invest to better our futures, but make sure that you are doing just that, continuous DD is paramount in that equation for fundamentals change by the minute for either the positive or negative.
Tapimmune seems to have/hold the promise of greatness in the future remain diligent in following the companies day to day operations, and you will be well prepared to see flaws that may occur down the road, and you will be better prepared to circumvent losses that may occur.
Why sell at $5 $10 if the potential is $100, this is not a dream for KITE, JUNO have SP’s within those parameters and if Tapimmune really has cracked the code we will see those stock prices.
Use your own discretion, know your priorities try not to exceed your limitations and you will be able to invest with confidence.
GLTA
BLU
Listening to the video...interesting how the reporter mentions the "National cancer Institute" and how 5 billion dollars may have been spent in the wrong place.
Could Tapimmune be the right place?
Coincidentally Glynn has hinted on at least 2 occasions that they were going to announce a collaboration with not only a large BP but a cancer institute as well.
Just wondering if there may be a nice grant from the Cancer Institute, when they announce who those two collaborations are with.
After all the Institute has spent 5 billion in the "wrong places" as per the video, a nice 10 million or so grant may not be out of the question at all.
Glynn mentioned in the last CC that they are expecting a grant any time soon...seems to me to be quite a coincidence.
If they get involved, would be great to see then fund the HER2Nue trial and if they do come on board, may continue to fund till end of trials if the data continues to be stellar.
Remember folks they are nearing completion of the "commercial" vaccine which is supposed to be much more effective than the Phase 1 data vaccine.
As to the suppression of SP due to the warrants, most of us know this is at least a 2 year window "patience" the momentum is swinging our way.
I will reiterate, would not be surprised at all that with 2 Phase 11 trials up and running [mid 2016], grant funding, partnership with large BP and institute possible [funding], continued non-recurrence of disease, and Polystart Phase 1 initiation, and no debt and cash in bank, fast track status etc. That we do not receive one if not multiple offers to purchase the company.
Glynn looks quite excited in the video with Figueredo, each and every step of the way so far, they have accomplished, and exceeded their goal[s] .
The Tapimmune story is substantially better than the prior 2 companies that were bought out for 1 billion plus, scenario once again, 100 mill O/S [min possibly 120 max] within the mid 2016 timeframe $10 dollars plus. There may be a very real possibility of that scenario coming to fruition.
Would be great to see those sequence of events occur without a R/S, but if R/S does occur than with the reduced amount of shares and Dart's overwhelming ownership. SP mid 2016 should after up-listing to major exchange garner a much higher SP than $10.
Is it out of the question that Dart buys the company?
Let the bidding wars begin as the announcer says "For the first time ever, a Palm Beach County doctor is on the verge of one of the biggest medical breakthroughs of the century".
GLTA
BLU
Gobble Gobble I sent CNN the video and story that just came out from WPEC-TV CBS 12 News and all the contact information.
Cant hurt, wonder hopefully someone will look into it.
GLTA
BLU
Phantom Lord, I would also like to express my Thanks to you for that excellent breakdown of the warrants as it is very confusing.
Poor Broke Bloke, thank you for the belated Thanksgiving wishes.
And from your Canadian friends "Happy Thanksgiving" to you all in the U.S, and thank you to everyone on this board who at some point in time has contributed to this board.
Have a safe and festive day of Thanks.
GLTA
BLU
ariafan, sugarshaker...ariafan sorry for your loss, unfortunately kindred spirits in that regard, sugar, appreciate those kind words.
I think we are all well aware that each day that passes, brings us 1 day closer to fulfilling our expectations, any manipulation in the meantime is just smoke and mirrors.
Many, many catalyst's in the next 3/6 months way too close to give up your shares now friends.
Patience here will be rewarded...what pride we will all have if we have helped in some small way to help save lives.
And if we have made a great investment along the way, and profit handsomely, good deeds reap rewards, we are after all investors, not saints.
Although being from Belfast Ireland...I could be Saint Patrick!
BLU [AKA Shawn]
I will not presume to speak for everyone/anyone on this board, but my investment in Tapimmune was more geared towards participating in something beneficial.
It has allowed me in some small way give something back to those in my life that I have lost to cancer most notably [Mother 1993 cervical cancer/lost a grandchild to Brain cancer and have lost many friends] in my short 57 years on this earth.
Tapimmune’s science may or may not prevent/cure some forms of Cancer, or it may simply give those individuals that have received what may be the most fearful news that anyone get, some form of relief/hope or simply more time...to spend with those they love.
Cancer has no conscience it takes those of us regardless of age, children, adults, the rich the homeless; it knows no bounds as it attacks all ethnicities.
God forbid that you, your family, anyone in your inner or outer circle “ever” get the call/news that you/they have been diagnosed with some form.
Glynn, Keith, Edith are dedicating their life’s, and may have harnessed the body’s own immune system to fight back and it seems at the very least to be able to control/suppress. And in doing so are laying the groundwork so that future generations may eradicate Cancer completely.
If they through the course of these trials, save or prolong even one life, then my small part in investing in Tapimmune, despite how small or insignificant it may be, allows them and others to move forward.
They last thing Tapimmune is is a “pump and dump” company, only those that are motivated by greed and personal gain have the ability to at this point to curtail/delay our progress.
It is a very real possibility that Tapimmune may have through perseverance and dogged determination over the past 15 years plus, developed a vaccine/cure that will truly benefit mankind now and in the future.
If that makes me or any other individuals that have invested in Tapimmune, regardless of the price "suckers" in anyone’s eyes, then I can only pray that those individuals thinking so, never have cancer touch them or someone they love.
Sometimes it is not about the reward, but simply getting involved; despite ones financial status for a greater good...I have seen in the course of my life family, friends loved ones, healthy one day then devastated the next as they received the news.
How does one put a price on something like that? .20 cents, $1 buck, a thousand a share? Whilst I sat at my loved ones death bed $1000 a share would have been cheap.
I am fortunate enough to have been able to contribute “like all the others on this board”, [notably RKmatters, I am sure all others would agree]
There will be no greater gift than to have been a participant if Tapimmune really does have the science/vaccine that curtails/postpones/eradicates Cancer as we know it.
And as for your .45 buys...most of us on this board have a much lower entry point, so even there you will be paying up.
We have believed from the beginning and will not be swayed to give away our shares until Tapimmune’s science prevails...God bless each and everyone here that shares my sentiments.
GLTA
BLU
Appreciate that Phantom, as I am completely committed to helping those that are embarking on this journey with Tapimmune, I only try to state the facts [company wise] as they present themselves.
"Grain of salt" is all I'm saying to investors that may be swayed by someone that E-mail's out their picks. We all know that it is rampant in investing, anyone doing that does not wait until they have posted their picks to acquire their own position.
Kudos to him/her for what they have achieved, I'm much more transparent more of a giver than taker in life...as can be proven by the 6 children and "now" 25 grandchildren I have adopted.
Like they say Money is only something you need if you don't die tomorrow...LOL.
GLTA
BLU
Compensation for services rendered most likely [warrants in previous possibly]...or incentives either way good for company not negative.
Keep the cash, like I mentioned before the O/S will most likely be closer to 70 mill out other than 64, maybe more if warrants have been exercised, just the course of business.
BLU
Deadline for Q3 Nov 16 [Mon] maybe bring out over weekend, otherwise should see Mon unless they file late...which is a possibility.
BLU
tmeier: They stated in the last CC that they have min of 6 possibly 7/8 mill cash. the 13.3 mill grant applied to the mayo will cover all cost incurred by the Phase 11 Folate Receptor trial in TNBC/Ovarian.
They should have plenty of cash to fund their own in house Phase 11 trial[s] well into 2016, once the stock hits $1 I believe there is another min $5 mill of warrants.
The impending news of the major BP partnership should be announced within the next 3/6 months will most likely entail milestone payments possibly upfront. Eliminating the need for drastic dilution in 2016.
I would think that they have gotten this far on their own merits, and if the partnership is announced in conjunction with the initiation of 1 possibly 2 Phase 11 trials up and running. Their bargaining position would be very strong, in regards to an upfront cash infusion.
John said in the last CC that they are negotiating the terms at this point, waiting till both trials are up and running would be prudent in my opinion 3/6 months. Great if all comes together sooner!
They have navigated through a lot of adversity over the past two years and have weathered the storm well, I can't believe that they would give up too much when the seem to be on the verge of something great near term.
Once again another R/S in my opinion would send a signal to the market that they do not have enough faith in their science, I personally would rather wait another year or even two and let the science and catalyst's get the share price in line with up-list requirements.
Then see what we have just seen in AVXL, if they try to up-list without 1 or both Phase 11's up and running then the share price will be vulnerable to heavy short trading, and will get decimated.
Hopefully they are on the same page.
GLTAS
BLU
SABCS: Only 4 weeks away Dec 8-12 and counting!
I am not here to make you or anyone feel better about making an investment in Tapimmune I have spent 6 years doing my DD.
I leave the science to scientist, I am an investor, have done my DD as far back as Wilfred Jefferies from UBC in 1993.
That is where you want to start if you truly wish to understand Tapimmune's proprietary TAP technology, as he is the inventor.
As the years have progressed they have added and refined the science to a point where now it is believed to be a viable option to existing therapies/treatments.
Investing is like a giant puzzle, many pieces but you won't know till the end if you are successful, or if all the time spent has been futile. I have assembled all my pieces, gone over them a thousand times, and feel confident in my investment.
Hope your own DD leads you to the same conclusions as the rest of us, Edith Perez, or Keith Knutson or John may be able to help you get a grasp of the internal workings of the science.
We are mid puzzle at this point, Like I said investing in even the most promising companies, can lead to failure.
GLTY
BLU
Every stock on every market is speculative! Obtaining a 13.3 mill dollar [mayo] grant from the DoD has given substantial validity.
Listen to the latest CC, they now have 4 full time employees, and recruiting for more that fit their long term plans.
Holding the “bag”, yes a bag of cash. [long term] average .29 cents [190,000 shares] Trade at your leisure everyone's agenda is different. Most of us here believe in the science and will not trade for pennies when the potential near term outcome far out ways a small gain here and there.
It certainly sounds like you have not done your DD, or you would understand the science.
Good luck in your trading
BLU
Why does the 20% move have to be associated with impending news?
The stock has been grossly undervalued for the past year, do your DD where can you find another Bio tech stock that has the potential science of Tapimmune, and is trading below $1?.
Not to mention the 13.3 mill grant Mayo just obtained on Tapimmune's behalf, and impending news of a major BP partnership plus initiation of Phase 11 in multiple billion dollar markets on at least two fronts.
.70 is still a joke the stock should be well over $1 in contrast to all others in our space.
BLU
Expect Q3 out next week [usually file/release around 14th of Nov], looking for some good color on upcoming catalyst's.
Any other news will be a bonus, remember that we are still ridiculously undervalued at anything under $1.
Think of it, possibly best science in the space [low low cost to produce will bring in many bidders if recurrence has held up] no debt. And on the verge of announcing major BP partner, and within 3/6 months two Phase 11 high profile trials in multi billion dollar markets.
Would be quite surprised if BP partnership did not include serious milestone payments in early stage.
GLTA
BLU