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that would be amazing
Am I crazy in thinking PDS or one of its bigger, better funded partners like the NCI, GlaxoSmithKline or Merck KGaA could be having discussions right now with FDA and other regulatory bodies about modifying the current P2 and having it changed to an Accelerated Approval Trial? I think all agree that the preliminary results were nothing short of amazing with an overall response rate of 71% in an indication that current Standard of Care (SoC) runs only about 20% response rate, at best.
To my knowledge, accelerated approval is warranted when an experimental treatment demonstrates positive results where either no current SoC exists or where the treatment is clearly better than SoC in an underserved population. Approval also needs to be based on an acceptable safety profile. Assuming the data at ASCO build upon the early results, why would they not modify the trial so approval could come as early as next year?
For reference, I have been invested in SGEN for about 10 years. From memory, I believe their first drug, Adcentris, was approved based on an accelerated trial with only 100 patients. After approval, they needed to perform follow up P3 trials to confirm the P2 trial. What would be stopping the NCI from following the same path?
I understand it will take time to get through the red tape, but after the data are presented at ASCO, think/dream about where the market cap would be if in 3 months PDS announced the current trial was changed to an Accelerated Approval trial. I believe the market cap would easily be in the $3-5 billion range shortly after such an announcement. Upon approval, which could come as early as late 2022 or early 2023, that could easily double the market cap.
While some may think I am certifiable suggesting a possible triple digit price this year, remember there are currently only 23 million shares outstanding. The above scenario easily translates into triple digits and possibly mid triple digits in just a few short years. Obviously, all predicated on an accelerated approval, but I do not see why this is not just possible but likely if ASCO shows the same or better results.
I know I have been predicting triple digit prices for PDS for the past few months. What would a reasonable market cap be for a company that could be in the middle of a registrational trial with an addressable market of tens or possibly hundreds of thousands of patients? I know I am dreaming that it’s possible, but with results seen to date, can anyone tell me why PDS, Glaxo, Merk KGaA, or the NCI would not be trying to get this combo trial to market much sooner under accelerated status?
Comments and corrections are welcome.
No trust me I was thinking it before you said it. I invest only in bio stocks and not to toot my own horn but I’m pretty good at it. I will be buying more again but moved money around a little.
This is a long hold. I’m glad I got in a few weeks back thanks to your DD.
Lol, my price target is about $60. 2/3 years from now or less.
I have to watch what I say on this board, ppl hear the word correction and they hit the panic button
((CORRECTION IS NOT BAD!))
No agree but I always de risk now I’ve had hard lessons. Sold a little playing with mostly house money now.
Every investor has their own time horizons and risk tolerances. Taking profits isn't a bad thing but the thing you don't want to do is sell too soon with a company that has so much explosive growth potential IF THE DATA continues to show proof of concept.
For me, last week's unbelievably impressive results removed a lot of risk as I believe it demonstrates Proof of Concept. Assuming it shows similar or better results in 2 weeks, followed later this year with Keytruda combo and MD Anderson trials, today's price could be the buy of the decade.
IF, and I say IF, the data demonstrates PoC with the other 2 trials, there is no reason a $5 billion and higher market cap isn't possible and is likely imo. Throw in possible Covid approval and a $5 billion market cap will be small in 6-12 months. I know a lot has to go PDS way, but last week's data was huge. With current share count less than 23 million, dream about what a $5 billion market cap translates to, sounds CRAZY, but it is possible.
My question as well ? Was going to sell some buy it’s showing no sign of a correct yet.
My question Whats your price target after the data.
Have to de risk soon here since I’m almost up 100 percent.
Agree, don’t get me wrong. I wasn’t insinuating a dump or any kind of crash. Just a little correction.
Pressure we’re going to get some juicy data that was held back
No stock can go straight up but even after the great run, PDS market cap is still only about $175 million, extremely small given its potential. This could double from here and still be low valued.
Since we know in exactly 2 weeks we get updated data on the unbelievably impressive results last week, I can see a situation were we continue in a very strong uptrend, possibly doubling from here. Where we go after ASCO presentation and the company's cc will depend on the data.
Will they report even more impressive data when you add another 10 or so patients? Does some respected bio journalist "find" PDS and report on the data?
So many things that could get this to a half billion and more market cap in the near term. We are just getting started imo. Fingers crossed.
PDS hosting a conference call 6/8 after oral presentation
https://finance.yahoo.com/news/pds-biotech-host-company-conference-120700156.htm
A stock shouldn’t and can’t go straight up. It’s not healthy. It needs to breathe. A little correction is good
Why you say that with so many catalysts on the horizon? Gltu
Really good article out yesterday about us from Brazil over on Stocktwits.
Expecting an update next month, yes.
Back at ya bud. Next week should be interesting. A full week before the presentation
Not sure. I think the focus for now is the cancer technology and the rest of the data. And what comes next.
Thanks...you too
Have a good weekend
Aren’t we expecting news out of Brazil shortly as well?
PDS is the talk of the town. In both the market world and the medical community. this will be building mo mo for the next 2 weeks. Then the oral presentation. Everyone should keep in mind we were just given a taste of the data. There's going to be more imo
Whoever was putting up the hidden bid all morning really got them on that opening dip. Think we could see $10 Monday
yes they are. 14 million short volume yesterday. lol
Yep, and still 2 weeks till oral presentation
Looks good today
Volume. Double digits on the horizon.
Woh!!! What just happened! Kaboom!
Nice day so far. Great DD
Is PDS Biotech Stock a Buy Right Now? This Is What You Need to Know
Momentum has been driving PDS Biotech (PDSB) stock forward in 2021 and the latest developments have put more fuel in the tank for this micro-cap biotech.
Shares were trending higher in Thursday’s session following the publication of interim data from the NCI-led Phase 2 study of PDS0101 for the treatment of HPV-related cancers. The company is working on novel cancer therapies based on its proprietary Versamune T-cell activating technology.
The trial is looking into a triple combination of PDS0101 with a pair of investigational immunomodulating agents - bintrafusp alfa (M7824), a TGF-ß trap/anti-PD-L1 bifunctional fusion protein, and NHSIL12 (M9241), a DNA-targeted immunocytokine.
The data from 14 patients showed tumor reductions in 83% of HPV16-positive relapsed or refractory checkpoint inhibitor naïve patients (5 of 6) and 63% of HPV16-positive relapsed or refractory advanced cancer patients who also failed to respond to checkpoint inhibitor therapy (5 of 8).
Overall, the objective response rate was 71% (10/14), amongst them 1 complete response (anal cancer) and 9 partial responses (3 cervical cancer, 2 vulvar/vaginal cancer, 2 anal cancer, 2 oropharyngeal cancer). After a median 5 months of follow up, 90% (9 out of 10) of these responses are ongoing.
“We believe these results represent an important validation of Versamune's ability to elicit anti-tumor responses in patients that have received multiple lines of therapy and may present a weakened and unresponsive immune system,” said H.C. Wainwright’s Joseph Pantginis. “On an important note, these results reflect those seen in preclinical studies with the triple combination, therefore adding confidence the positive outcome of these studies.”
Pantginis also make a point of reminding investors that all three PDS0101 “important” Phase 2 studies are now in process with readouts anticipated this year or at the start of 2022.
“We believe the potential news flow from these studies to be meaningful during 2021, and should lead to multiple catalysts representing important drivers for the shares,” the 5-star analyst further noted.
Given the strong data, Pantginis says it is no wonder the company will make an oral presentation – including results from a larger sample base - at the 2021 ASCO Annual Meeting on June 7.
To this end, Pantginis rates PDSB a Buy while his $8 price target suggests 12-month upside of 10%. (To watch Pantginis’ track record, click here)
Pantginis’ colleagues agree. All 4 recent reviews say Buy, naturally culminating in a Strong Buy consensus rating. The average price target clocks in at $9.40, suggesting further upside of 29%.
https://finance.yahoo.com/news/pds-biotech-stock-buy-now-225536278.html
PDS Biotech Announces Release of Abstract for PDS0101 in NCI-Led Phase 2 Clinical Study for Oral Presentation at 2021 ASCO Meeting
Great day here today gang
Objective responses (tumor reduction) observed in 83% (5 of 6) of HPV16-positive relapsed or refractory checkpoint inhibitor naïve patients and 63% (5 of 8) of HPV16-positive relapsed or refractory advanced cancer patients who have also failed checkpoint inhibitor therapy
FLORHAM PARK, N.J., May 20, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced publication of abstract #2501 by the American Society of Clinical Oncology (ASCO). The abstract summarizing interim data from the National Cancer Institute (NCI)-led phase 2 trial has been accepted for oral presentation at the 2021 ASCO Annual Meeting taking place June 4-8. The presentation, scheduled for June 7, is expected to include results from a larger sample than the 14 patients included in the abstract.
Additional data highlights from abstract #2501 include:
An overall objective response rate of 71% (10/14) in patients with refractory HPV16-associated cancers
1 complete response (anal cancer)
9 partial responses (3 cervical cancer, 2 vulvar/vaginal cancer, 2 anal cancer, 2 oropharyngeal cancer)
90% of these of these responses are ongoing after a median 5 months of follow up (9/10)
The NCI Center for Cancer Research’s Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial (NCT04287868), which studies PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional “trap” fusion protein targeting TGF-ß and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. Bintrafusp alfa is being jointly developed by Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA, Darmstadt, Germany.
The trial is evaluating the treatment combination in both checkpoint inhibitor naïve and refractory patients with advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment. Objective response is measured by radiographic tumor responses according to RECIST 1.1. These reported data validate the preclinical studies published by the NCI demonstrating that the complementary mechanisms of action of the three immunotherapies which involve potent in-vivo HPV16-specific killer and helper T-cell induction with effective T-cell tumor infiltration, blocking of immune checkpoints as well as targeting of TGF-ß resulted in superior tumor regression.
“The achievement of a 71% objective response rate in a difficult to treat patient population continues to strengthen the evidence of our novel Versamune® platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer resulting in strong synergy with Bintrafusp alfa and NHS-IL12, thus leading to effective tumor regression,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “The initial data solidifies our belief that PDS0101’s published preclinical efficacy, when combined with these two immune-modulating agents, demonstrates the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV-associated cancers who have limited treatment options.”
There are more than 630,000 cases of HPV-associated malignancies including cervical, oropharyngeal and anal cancer worldwide annually. HPV 16 is responsible for most of these cases. About 15-20% of HPV-associated malignancies respond to PD-(L)1 inhibitors. However, for the overwhelming majority of patients who progress on these immunotherapies there is no effective standard of care therapy.
The abstract is now available online on the ASCO conference website: https://am.asco.org/.
Abstract Number: 2501
Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.
Presenting Author: Julius Strauss, MD, National Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Date: June 7, 2021
Time: 3:00 PM-6:00 PM EDT
Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the Principal Investigator of this phase 2 clinical trial in advanced HPV-associated cancers. For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website: https://trials.cancer.gov.
https://finance.yahoo.com/news/pds-biotech-announces-release-abstract-120000501.html
* * $PDSB Video Chart 05-20-2021 * *
Link to Video - click here to watch the technical chart video
Definitely a good day. Still waiting for so much more Brazil and a host of other things. Glta
Fress my friend thanks for the tip. Happy that I’ve been holding. Double digits is so close now!!!
Close HOD.. Next week double digit. Diamond hands.
$PDSB I just want to remind everyone why we are holding this stock going into the ASCO data presentation.
1. Immunotherapy for cancer patients is the hottest are of research currently with Biden promising to focus on a cancer cure.
2. Low market cap
3. Low float
4. High insider ownership
5. Lots of cash in the bank
6. Third parties funding most of their work.
7. 3 phase 2 studies with highly highly respectable partners
8. Great ties to academia
9. PDS 0101 chosen for oral presentation of interim results at ASCO
10. Triple combo at least 3 of 8 and study expanded to 40ish patients
11. Unique scalable platform developed over 10 years
12. Partnering with
$16B
/yr Keytruda with synergistic mechanisms of action
13. Patents till at least mid 2030s
14. New scientific advisory partners
15. Tarp and Muc1
16. 74 other cancer antigens
17. Adjuvant therapy w low toxicity
18. Frank and Lauren’s enthusiasm and grin when they present
19. Please feel free to add...I have to go to work now!
Source @ Llamalamb2921
We have more data in June sit tight.
It’s nice price action should have a strong close.
Looks like tmw will be the same. I also hope it’s a leg up and we are above a level of support so far not sure but not selling anything today.
Strong hands from my side.
Double digits within 1month IMO.
Disappointing start here. Oh well wasn’t selling regardless. Glta
StockTwits pretty active on this
Surprised this board is so quiet. We need this news picked up by some major outlets. Hopefully all the weak hands get out this morning. Upwards
With a steep quick rise comes the shorts, hoping for this leg up to become support, no selling til double digits, this is a winner jmo
Looking for a nice day here today. Too many penny profit pinchers taking us lower this PM. Wake up whales opportunity knocks.
Definitely glad I got In a few weeks ago. Appreciate everyone’s post.
PDS should start moving early if we get some press coverage about today's impressive results. The company will most likely issue a PR early and hopefully that gets it to catch fire and start moving towards double digits where we belong.
I sent an email to Allison Gatlin at IBD telling her about today's abstract and suggesting she right a story about PDS. She and I had exchanged emails in the past concerning my current #1 investment, UniQure after she wrote a story about them. I don't expect UniQure to hold that position for much longer as I expect PDS to rise significantly over the coming days and weeks. I am still very optimistic about qure long term but I think pds moves much more rapidly. I am hoping she looks into PDS and writes an article to gain some momentum.
The company should get positive press from the abstract if the journalists are aware of it. Since it is such a small company that is not followed by many analysts, I wouldn't be surprised to see this go under the radar until ASCO presentation. Hope it catches fire tomorrow and Friday as my options need a run over $7.50 to be in the money :^) Can't believe it didn't close over that price in AH's today.
Congrats to all. PDS will be one of the best investments of 2021 imo.
Looks like were done at $6.83 and about 2.7 million in volume
wondering what time it will start to move tomorrow
Yep. but i think all that after close volume we had it will attract some big money investors. Bazinga was on it earlier
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https://pdsbiotech.com/images/pdf/presentation/2021/march/PDSB_Corporate_Overview_-_March_11_2021_FINAL_1.pdf ![]() |
DEVELOPING POWERFUL, SAFE, VERSATILE IMMUNOTHERAPIES |
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PDSB Versamune® T cell Platform. Our Versamune® platform trains the immune system to unleash a powerful targeted T-cell attack and could dramatically improve treatment and patient outcomes across the cancer spectrum. |
PDSB analyst coverage: |
SECOND GENERATION COVID-19 VACCINE PHASE 3 Q4 2021 PDSB $100.00 PRICE PER SHARE =2.2 BILLION MARKET CAP |
PDSB biz presentation 2021: PDSB White Paper: https://pdsbiotech.com/images/pdf/presentation/2021/Whitepaper-2021_v6.pdf PDSB Biotech preparing to initiate 3 CANCER Phase 2 clinical studies for lead candidate PDS0101: https://www.youtube.com/watch?v=iYZRmRmRtUI&t=2s OPPENHEIMER Annual Healthcare Conference MARCH 16TH 2021 https://wsw.com/webcast/oppenheimer9/register.aspx?conf=oppenheimer9&page=pdsb&url=https://wsw.com/webcast/oppenheimer9/pdsb/2708189 PDSB website: |
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