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$HEPA: Good NEWS on CRV431 in a Nonclinical Liver-Cancer-Study
Hepion Pharmaceuticals and FibroFind Announce Anti-Cancer Activity of CRV431 in a Nonclinical Liver Cancer Study
8:45 AM ET 11/16/21 | GlobeNewswire
Hepion Pharmaceuticals and FibroFind Announce Anti-Cancer Activity of CRV431 in a Nonclinical Liver Cancer Study
EDISON, N.J., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and other liver diseases, today announced the results of a nonclinical research study showing that CRV431 significantly decreased the growth of liver tumors in a mouse model of liver cancer. Additionally, CRV431 was as effective at decreasing tumor burden as an anti-PD1 antibody immune checkpoint inhibitor, PD1 antibody, and produced more beneficial changes in tumor infiltrating cells compared to anti-PD1 antibody treatment.
The study was conducted by FibroFind Ltd. (Newcastle, UK) in collaboration with Professor Derek Mann, Dean of Research and Innovation at Newcastle University. In this study, mouse hepatocellular cancer ("HCC") cells (hep53.4 cells) were surgically implanted into livers of recipient mice. In the absence of drug treatment, large tumors developed over a period of 28 days.
Drug treatments began in the treatment groups on Day 14 after HCC hep53.4 cell implantation, when the tumors had reached approximately 15% of their final size. Mice received either once-daily CRV431, administered orally, or a single dose anti-PD1 antibody, administered intraperitoneally. An additional treatment arm examined a CRV431/anti-PD1 antibody combination treatment. Drug dosing continued for a total of two weeks (Days 14 to 28 post-HCC implant) and the changes in tumor volumes were measured from the initiation of drug treatment to the end of the experiment. Treatment with CRV431 or an anti-PD1 antibody each decreased tumor size by 76%, while the CRV431/anti-PDI antibody combination treatment decreased tumor size by 83%, compared to the vehicle treatment (no drug).
Microscopic examination of the tumors showed that CRV431 beneficially doubled the number of tumor-infiltrating CD4 and CD8 lymphocytes. This same finding was observed with anti-PD1 treatment, suggesting that both treatments stimulated immunity against the tumors. Furthermore, CRV431 decreased the number of neutrophils in the tumors by 55%, which was not observed with anti-PD1 antibody treatment. Because neutrophil-mediated inflammation frequently promotes tumor growth, CRV431's demonstrated reduction in neutrophils represents an additional anti-tumor effect. Finally, a marker of cell proliferation indicated that both CRV431 and the anti-PD1 antibody decreased tumor cell proliferation to similar degrees. These results complement previously published findings of CRV431's anti-tumor activity in a different HCC model in which liver tumors developed spontaneously in mice with long-term, diabetes-associated, NASH-like disease.(1)
"CRV431 significantly decreased tumor burden in two distinct liver cancer models, suggesting that it exhibits anti-cancer activity across a range of HCC tumor subtypes and mutations," said Daren Ure, PhD, Hepion's Chief Scientific Officer. "It was also very encouraging to see that CRV431 positively altered inflammatory and immune cell populations in the tumors, which is a cornerstone of modern cancer therapy."
FibroFind CEO, Prof Jelena Mann, PhD, commented, "FibroFind is delighted with the outcome of this study, which indicates potential for CRV431 to bring about a reduction in tumour burden in what is an aggressive orthotopic model of liver cancer. The observation that CRV431 brings about a change in the neutrophil component of the tumour is particularly fascinating given the emerging role of this immune cell in many different cancers."
"HCC is the most common primary liver cancer, is often related to NASH, and is a leading cause of death worldwide," commented Robert Foster, PharmD, PhD, Hepion's CEO. "There is a constant and urgent need for new drug development to augment surgical interventions, including liver transplantation, when treating patients with HCC. The findings from this study bode well for the continued development of CRV431 as a drug candidate for treating liver diseases, including HCC and NASH. CRV431 targets the liver, and its anti-inflammatory and anti-fibrotic effects have been demonstrated in many liver disease models. More recently, CRV431 has shown positive changes in ALT and Pro-C3 in a 28-day NASH Phase 2a clinical trial, indicating its anti-inflammatory and antifibrotic effects. Having a single drug candidate with demonstrated beneficial activity in both NASH and HCC is quite remarkable and represents an opportunity for Hepion to further explore CRV431's potential in HCC while continuing to advance its clinical program in NASH."
Reference
(1) Kuo et al. A Pan-Cyclophilin Inhibitor, CRV431, Decreases Fibrosis and Tumor Development in Chronic Liver Disease Models, J. Pharmacol. Exp. Therap. (2019) 371(2):231-241; doi:10.1124/jpet.119.261099.
About Hepion Pharmaceuticals
The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform, called AI-POWR(TM), which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR(TM) to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR(TM) to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Stephen Kilmer
Hepion Pharmaceuticals Investor Relations
Direct: (646) 274-3580
skilmer@hepionpharma.com
> Dow Jones Newswires
November 16, 2021 08:45 ET (13:45 GMT)
Lol 1.40. What a shitshow haha prs only drop this
Nice to see. This is going to be a long drag ‘‘em out journey. Hopefully the end result is all worth it.
Yes still here. Diamond hands
$1.36 cash + $0.11 science = $1.47 stock price
Market putting a big valuation on the science.
Still with us? 10q released today. 90 plus million in cash. Company and big hedgies playing games. Interesting times.
Shares selling for cash on B/S
Any decent pumpndump ought to be able to jack this to $2.50.
Business is for free, with solid data.
Cabal needs to get to work.
Have heard that before. Too many games being played by mgmt right now.
$HEPA: Our SAVA moment is COMING.
And then watch what happens when we are trading well over $50/sh
ITS COMING !!!!!!!
You will be BLOWN AWAY
GO $HEPA
Buyout at $3 a share would work for me.
Major suppression going on here. Some believe a buyout deal has been made already. Trying to rob the shareholders out of a fair shake.
Last 10Q, $1.44 in cash per share
Now trading at less than cash, $1.43.
Insane.
The rumor was they are. It’s hard to get any truth out of this company right now while the syndicate is controlling the action.
When? November is a big NASH meeting. ST has some good info.
Any specifics on this meeting and if HEPA is presenting?
Hopefully he still holds this GEM. I hope for him. We will make money , just be patience. I added more today now my avg. is $1.99
Them lasers might need some alignment
Did the girlfriend axe you? The silence is defining.
BOMC, The company in the past has had a reverse stock split. Investors
fear management will do this again. Company will eventually need a
Phase 3 clinical trial so it is estimated results from such may not be
out until 2025-2026. If all goes well and substantial dilution is
avoided this stock could be a 100X gainer. The best way to play this
is to simply buy some stock and then sell call options until it is
called away. Might not get a 100X but could get you a double sooner
or later. Their only drug looks to be a winner if they can get it
through the gauntlet and perhaps reap the rewards of a BO.
298 share circus premarket
pure manipulation
As soon as the crime syndicate lets it go. November is a big NASH meeting. ST has some good info.
Chart looks to be at bottom...
when will it rise again?
Can anyone provide a short history of what is happening with this company?
Seems extremely undervalued and the science seems to work as far as I can tell.
Why are so many people voting against management? Is management OK?
Looking to buy 20K shares but don't understand why this company is so cheap and relations with management so bad.
This outcome should start the ball rolling. If the syndicate wants to make any money now they need that price higher. Failed 3 times trying to steal from us retail holders.
“Enough cash on hand to cover all costs of programs through end of Phase 2b (about 3 years in cash), assuming no expansion into other areas/projects”
Their words not mine
I don't know what happens here, we are at liquidation value right now. Incoming events, coming tuesday just a simple convention, and in November a full data readout.
Maybe M&A will happen, maybe not, we just don't know. Just stick to the potential of the science, that's it guys.
There is not a big risk of dilution, certainly not after the result of the vote.
It's clear that their initial target was to have 400m shares issuable, so they could issue the 320m shares on the shelf for the maximum of 350 million dollar they were cleared to. Let's say $1.10
Next play was the 240m shares issuable, so they had 160m shares to offer for the max of 350m dollar. Let's say $2.20
Now they have only 40m shares left to offer, for the max of 350m dollar. Let's say $9 bucks.
Conclusion, I don't know whether M&A will happen, maybe the ''Change of Control'' thing has to do with something else. Fact is, the potential here is HUGE, and the risk is LOW.
Low Risk, High Reward, as Warren likes 'em.
$HEPA
Vote for increased shares defeated. One for the good guys. Time to go higher.
No no.. still Holding almost 5k shares @ 2.09 avg.
Funny how shit coins have 3-32 billion dollar market caps vs hepion with all its research and scientists only has a 125 million mc at best lolololol and dilution coming short the shit out this fucker
Guess you sold and moved on as well?
Good news and more manipulation. Oh well we wait.
Additional Phase IIa Data Confirms Hepion's CRV431 As A Very Promising NASH Candidate Drug
Sep. 21, 2021 4:19 PM ET Hepion Pharmaceuticals, Inc. (HEPA)
https://seekingalpha.com/article/4456410-additional-phase-iia-data-confirms-hepions-crv431-as-a-very-promising-nash-candidate-drug?mail_subject=francisco-javier-garcia-additional-phase-iia-data-confirms-hepion-s-crv431-as-a-very-promising-nash-candidate-drug&utm_campaign=rta-author-article&utm_content=link-0&utm_medium=email&utm_source=seeking_alpha
Given the direct relationship that the level of the Pro-C3 biomarker has with liver fibrosis, we are going to compare the behavior of the Pro-C3 biomarker in different trials carried out by companies with candidate drugs for NASH and thus be able to determine if the data provided by Hepion is promising.
Hepa is a empty shell with a notorious scammer CEO. They have paid tacto to pump their empty shell how they burn up the cash they made with dilution with salaries and bonuses. they do not even have a "0ffice" they contract out a investor relations firm. P.o boxes and cell phones is their over head!
“The decline in Pro-C3 that was observed in the AMBITION trial puts us well within the range of NASH data published by other companies with later-stage NASH drug candidates,” said Hepion’s Chief Medical Officer, Todd Hobbs MD.
“But notably, these declines in Pro-C3 with CRV431 occurred in only 4 weeks, compared to declines with other agents, where the changes occurred over several months.”
What is the significance of only 4 weeks?Sentence has a negative undertone.
I think the reason for all the delays and cancellations of the board meeting is because they didn’t have the votes to do it.
Guess we just vote NO ?
I could wait out the seller. But now their going to vote on adding 200 mil. Shares. What the hell is the CFO thinking?!
Diluted. I’ve been watching the seller holding it down.
I posted it last weekend
$HEPA: $110Milly Cash, No Debt, 76Milly OS
We doing just fine here.
Ambition looked good.
Party is only genna get much much better here.
A steal here at $1.54
GO $HEPA
Apparently just our hopes got shattered here...but at least we know this low floater will move
All that volume today for a damn penny. What the hell happened???? What's the short data like someone?
Filled gap.. now we can rise :)
Back to where we started…..
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Hepion Pharmaceuticals (Nasdaq: $HEPA) is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV).
Hepion announced top line data from the low dose cohort in the Company's Phase 2a ‘AMBITION' clinical trial of CRV431, an oral, once daily novel cyclophilin inhibitor. This Phase 2a study is continuing with the higher dose of 225 mg CRV431, with NASH patient dosing expected to be completed in Q1-2021.In 2021, of the more than 300 million people living with HBV infection, 10.5% (27 million) were aware of their infection. Non-alcoholic Fatty Liver Disease (NAFLD) affects up to 25% of people in the United States. There are currently no medicines that can cure non-alcoholic Fatty Liver Disease effectively. The same can be said with HBV. With the momentum growing around hepatitis B drug discovery research, we are closer than ever to a cure.
Fact: The inflows have been massive the last 2 weeks. Reason why In just 28 days at the low dose, HEPA CRV431 results were as good as what Madrigal's P3 lead NASH drug took 12 weeks to accomplish.
Bottom line The FDA looks for safety first we have the safest NASH drug our efficacy data is better than MDGL & AKRO. there market caps our almost 10x HEPA. Smart savvy biotech investors with deep pockets know this and are accumulating all they can of HEPA at these levels.
One morning we can wake up and see the price has tripled from its 160 market cap. Also they have 120 million in cash burning under 5 million a quarter. Lots of moving parts here. Gilead & Novo in the mix we will see? A new molecule being added to the pipeline. This management team is experienced 100 years total and world renown experts on cyclophilin inhibitors. They brought a FDA approved blockbuster drug to market already.
June 2021 Hepa Biz Presentation
https://hepionpharma.com/wp-content/uploads/2021/06/Corporate-deck-June-2021-FINAL.pdf
HEPA AI-POWR
https://hepionpharma.com/ai-powr/
HEPA Tackling Chronic Liver Disease - CRV431 Mechanism of Action
https://www.youtube.com/watch?v=CE7es4l1avM
HEPA GLOBAL NASH CONFERENCE PRESENTATION:
https://12ewye24eigk3g5kwa2dxjzm-wpengine.netdna-ssl.com/wp-content/uploads/2021/04/4thGlobal_NASH_Congress_Draft_20Apr2021_FINAL-1.pdf
HEPA website
https://hepionpharma.com
Chairman of the Board, Gary Jacob, is not just a business guy, he's one hell of a biochemist, and you can bet he has a solid grasp of everything that's going on with Hepion.
He's a key player here!
His background goes way beyond what you ordinarily see on the BOD of little R&D biotechs. You might see those with his research background on Scientific Advisory Boards, but they wouldn't have a fraction of the business expertise he's got.
Hepion has the whole package, with this guy!!
Hepion Pharmaceuticals Welcomes Dr. Stephen Harrison to its Scientific Advisory Board
https://www.globenewswire.com/news-release/2019/08/07/1898563/0/en/Hepion-Pharmaceuticals-Welcomes-Dr-Stephen-Harrison-to-its-Scientific-Advisory-Board.html
Former Novo Nordisk Executive, Dr. Todd M. Hobbs, Joins Hepion Pharmaceuticals as Chief Medical Officer
Todd Hobbs coming to Hepion. It was published in December. Hobbs' primary focus has always been on diabetes, and I have said many times that there's a blockbuster reason for him leaving his position as Vice President, Chief Medical Officer at Novo Nordisk, a USD 190B global pharmaceutical behemoth, after nearly 17 years there, to come to tiny Hepion.
I believe we'll be hearing about CRV431 in the treatment of diabetes, as it has the highest known potency of any reported cyclophilin inhibitor known, by a wide margin...
https://www.biospace.com/article/releases/former-novo-nordisk-executive-dr-todd-m-hobbs-joins-hepion-pharmaceuticals-as-chief-medical-officer/
Nash Phase 2 & 3 Trials by companies in the space:
AKRO Akero Therapeutics 1.1 Billion Marketcap 240 Million in cash
MDGL Madrigal Pharmaceutical 1.7 Billion Marketcap 300 Million in cash
HEPA Hepion Pharmaceuticals 160 Million market cap 120 million in cash
Currently trading at $2.2 due to a public offering of 44.000.000 shares $2
According to analysts' consensus price target of $80.00, Hepion Pharmaceuticals has a forecasted upside of 3,503.6% from its current price of $2.22.
$HEPA
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