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Galectin Therapeutics Inc. (GALT)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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1.9300-0.0900 (-4.46%)
At close: 04:00PM EST
1.9200 -0.01 (-0.52%)
After hours: 04:00PM EST
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  • S
    ScorpionLeather
    There is an interesting new article by CMO Pol Boudes entitled "GALECTIN INHIBITORS – Is a Galectin-3 Inhibitor the Answer for Millions of Patients With Cirrhosis & Cancer?" It provides a nice top level summary on GALT drug development. Here's an excerpt,

    "IN SILICO MODELING

    Much of the initial search for suitable molecules was done using state-of-the-art in silico methods, where computer models were used to screen drug candidates for their physical and chemical properties to interact with galectin-3 and the carbohydrate recognition domain. Galectin Therapeutics began with existing molecules but soon went on to design de novo new molecule structures that weren’t yet known.

    Because of the poor druggability of the galectin-3 CBD site, Galectin Therapeutics believed that carbohydrate chemistry held the answer to creating a different type of galectin-3 inhibitor. Galectin-3 is a large molecule itself and offers other options for binding sites in addition to the single CBD. The flexibility of a complex polycarbohydrate structure meant such a molecule might have greater interaction with multiple binding sites on the galectin-3 molecule.

    Galectin Therapeutics set out to create such flexible molecules that would bind to galectin-3 and thereby prevent the development of scar tissue and the other deleterious effects. Computer models were used to predict the chemical interactions of candidate molecules with the galectin receptor itself.

    The predictions of the in silico modeling were confirmed with in vitro testing, the results of which were used to refine the computer models.

    This was not a trivial effort. Nearly 1,000 molecules were examined, not only for their galectin-3 binding abilities but also for affinity to other galectins. Extensive studies were required to characterize the physical, chemical, and biological properties of potential drug candidates utilizing state-of-the-art analytical techniques and methodologies, some of which were developed in collaboration with leading scientists in the academic field of carbohydrate research. Galectin Therapeutics has patented many of these new molecules. The first molecules, such as belapectin, will be delivered as infusions, and oral follow-up compounds are currently early in the development process."
    Bullish
  • k
    karl
    Jan/Feb 2022. Pol f Boudes in ‘drug developmemt ent and delivery ‘GALECTIN INHIBITORS – Is a Galectin-3 Inhibitor the Answer for Millions of Patients With Cirrhosis & Cancer?"

    I found this very interesting …

    The ongoing work at the Providence Cancer Institute likewise shows the impact a galectin-3 inhibitor might have in modifying the body’s immune response to cancer when used in combination with a check-point inhibitor.13

    There is also a suggestion that the combination of belapectin and keytruda could reduce the incidence of auto-immune reactions, a well known and sometimes problematic side effect.12 These results are encouraging, and additional data are expected soon.
  • S
    ScorpionLeather
    Comprehensive new review article (15 Jan 2022) explains why galectins are going to be important targets for cancer immunotherapy, and references GALT belapectin studies.

    "The engagement of galectin-3 and PD-1 leads to tumor-induced immune suppression, and both PD-L1 and galectin-3 have been implicated in M2 macrophage polarization and reduced CD8+ T cell recruitment to the tumor site. Blockade of galectin-3 enhanced the antitumor efficacy of checkpoint inhibitors and T cell agonists by restoring the function of tumor-reactive T cells, including restored cytokine production and cytolytic activity."

    https://www.jimmunol.org/content/208/2/278
    Despite tremendous success against hematological malignancies, the performance of chimeric Ag receptor T cells against solid tumors remains poor. In such settings, the lack of success of this groundbreaking immunotherapy is in part mediated by ligand
    Despite tremendous success against hematological malignancies, the performance of chimeric Ag receptor T cells against solid tumors remains poor. In such settings, the lack of success of this groundbreaking immunotherapy is in part mediated by ligand
    www.jimmunol.org
    Bullish
  • M
    Moe
    Got more and will be adding more sub 2
  • E
    ExPharmaGuy
    So I watched the presentation by Joel Lewis and Pol Boudes on GALT's website. Very encouraged by what they are attempting to do in NASH cirrhosis, a previously neglected area of clinical research. Said this many times, they are doing everything right in terms of the Phase III NAVIGATE trial. The adaptive design, the right KOLs, and the right CRO. Having worked in Hepatology, there is no question that the Hepatologists have embraced participating in this trial. So it boils down to the first major catalyst which is the interim analysis 1st qtr of 2024. Supposing, that Belapectin reproduces the efficacy signal in an overwhelming way that the trial has to be stopped in order to put the placebo patients on, it will gain immediate acceptance in the U.S., and globally as well. Unless something very unforseen occurs, cannot imagine the share price being $2.00 two years from now. With respect to cancer, the good news is that they will sponsor the trial in advanced HNSCC, and agree that a focus on this, will help them with a label. However, Dr. Boudes still was explaining that they were fine tuning the protocol with a registration path in mind-hope he has a sense of urgency to get that trial initiated and recruiting. Finally, its not clear what is happening with Dr. Curti.Hopefully the relationship is not strained, and they can continue to investigate the combination; while their studies will not be used for registrational purposes, it helps to publicize the POF within the Oncology community.
  • S
    SpaceFlower
    Why are there so many people on this board from competitor Madrigal pharma??? (B the Bozo, Fred, trey, BioMan and several others??)
    Bullish
  • S
    ScorpionLeather
    Two new papers published this week which mention GALT GR-MD-02 (belapectin). The interest in galectin-3 inhibitors is growing at a rapid pace in the research community.

    Prevalence, Risk Factors, and Pathophysiology of Nonalcoholic Fatty Liver Disease (NAFLD) in Women with Polycystic Ovary Syndrome (PCOS)

    Galectin-3 as a Novel Multifaceted and Not Only Cardiovascular Biomarker in Patients with Psoriasis with Regard to Systemic Treatment—Preliminary Data
    Bullish
  • S
    ScorpionLeather
    11 Jan 2022 - A common aspect of fibrotic disease is the production of galectin-3 by macrophages:

    "While the prevailing school of thought is that PF arises from ineffective repair of airway epithelium following repetitive injury, there is now compelling evidence that macrophages contribute to PF pathology and that targeting macrophages could be beneficial in human disease. First, there is vast macrophage accumulation in the lung parenchyma during PF and experimental fibrosis where they co-localise with collagen-producing myofibroblasts and support their proliferation and function through production of PDGFα, PDGFβ, TGFβ1 and Galectin-3."

    The impact of the lung environment on macrophage development, activation and function: diversity in the face of adversity

    https://www.nature.com/articles/s41385-021-00480-w
    Mucosal Immunology - The impact of the lung environment on macrophage development, activation and...
    Mucosal Immunology - <ArticleTitle Language="En" xml:lang="en">The impact of the lung environment on macrophage development, activation and...
    www.nature.com
    Bullish
  • B
    B
    Hello 1's...good time to buy.
  • S
    ScorpionLeather
    In today’s presentation, two things stood out,

    1. CEO Joel Lewis reiterated at the beginning that the expanded team has significant experience with due diligence. The terminology “due diligence” is typically used in the context of partnership and M&A talks.

    2. CMO Pol Boudes outliner the clinical trial strategy for both NASH and cancer in a very clear way. He explains the previous p2 data and why it is so exciting. The company strategy is to get to registration/commercialization fast.

    I added more shares in recent days. The company is extremely undervalued at this price level.
    Bullish
  • S
    ScorpionLeather
    New findings January 6, 2022

    Elevated plasma Galectin-3 is associated with major adverse kidney events and death after ICU admission

    “Recent studies explored the impact of Gal-3 inhibitors to prevent kidney injury or improve post-AKI outcomes [8, 25, 34, 35]. Prud’homme et al. showed that experimental AKI increased both renal and cardiac expression of Gal-3 originating from bone-marrow-derived cells and promoted cardiac injury after AKI [8]. Genetic or pharmacological inhibition of Gal-3 prevented AKI-induced cardiac injury, inflammation, fibrosis, and cardiac dysfunction [8]. More recently, Gal-3 expression was highly increased in septic AKI and the use of Gal-3 inhibitors in a septic model reduced mortality in rats [9].”

    “In our opinion, these data provide a strong argument for testing the impact of Gal-3 inhibition on outcomes in critically ill patients and elevated plasma Gal-3 levels.”

    Boutin, L., Legrand, M., Sadoune, M. et al. Crit Care 26, 13 (2022).
    Bullish
  • X
    X
    Who makes these decisions? Is this a lapse in ethics or just laziness? It simply can't be deception because it is so easy to see. I would love an explanation. I think most of us would agree that shareholders expect a higher degree of professionalism. Now onto the specifics--

    I watched the presentation today by Joel Lewis and Dr. Boudes for the virtual conference at the BioConnect. The very first slide you see is the title, Corporate Overview September 2021. I said to myself, "Oh no, they are not going to be using the current estimated interim completion dates for the Navigate study!". But I was wrong. They used the same Corporate Overview PowerPoint presentation that is on the website but switched a couple of slides! (Note: my relative who also is a shareholder actually recorded this!). As they proceeded to go through the old presentation, when they got to slide #19 instead of it reading "phase 2b expected late 2023" it read "phase 2b expected Q1 2024". Dr. Boudes repeated that accurate date. And then on slide 24, again the switch was made from "Interim Analysis Data expected late 2023" to the current estimate of Q1 2024. Why not change the first slide to read Corporate Overview January 2022? That would have been a clean & easy fix. Obviously slides #19 and #24 are not part of the Corporate Overview September 2021 (proof of which has also been recorded). Does anyone else see, if nothing else, it's an ethical issue of implying those updated slides were from the September 2021 Overview? Perhaps even more important is on the press release announcing the BioConnect conference it states, "A replay will be accessible on Galectin's website for 90 days following the event". So does this mean, that after 3 months the record of those slides using the correct dates will disappear? If that happens, then the only way for an investor to know the current estimate dates is to go to the Business Update back in November.

    If you go on Galt's website right now and click on the Latest Corporate Presentation, you will see Corporate Overview September 2021 using the old estimated dates. Another question is then, will management be updating the Latest Corporate Presentation on their Home page reflecting a new date and new estimated completion dates? If not, why not?

    So who messed up? Investor Relations folks? Why did Joel Lewis not see this and correct it? Amazingly simple yet concerning. Just do the right thing! How about updating the estimated completion dates on Clinicaltrials.gov while you are at it? This site has already been updated several times changing other information but conveniently leaving the old estimated completion dates.

    On the positive side, in terms of the cancer program, Joel Lewis did talk about their decision making in focusing more on the Head & Neck cancer group vs. Melanoma. It made good sense and if things would out, it seems to maximize potential benefits for both patients and shareholders. Management did say that they were presently working on the design of any future cancer study and fine tuning their protocol. So imo that means it's going to be awhile before we hear anything about a possible partnership since they have not completed that phase of the process yet. As I previously have written, I believe Joel Lewis signaled that it was going to be a long process when discussing due diligence etc. last month. So it might be prudent to set your expectations accordingly.
  • L
    LGALS3
    Excited about the presentation this morning
    Bullish
  • L
    Lazar
    Dr. Pol F. Boudes, the Company CMO has Zero documented experimentally experience in the research field of Galectin Inhibitors, so his Opinion is worth, whatever one is willing to pay for.
  • S
    ScorpionLeather
    GALT publications in 2021 —

    Galectin-3 inhibition with belapectin combined with anti-OX40 therapy reprograms the tumor microenvironment to favor anti-tumor immunity
    Published online 2021 Mar 1.
    OncoImmunology

    Enhancing clinical and immunological effects of anti-PD-1 with belapectin, a galectin-3 inhibitor
    2021 April
    Journal for Immunotherapy for Cancer

    Title: Mechanism of galectin-3 binding by belapectin, a galectin-3 inhibitor developed for NASH cirrhosis
    Galectin-3, a glycan binding protein, plays a central role to foster liver inflammation and fibrosis in NASH cirrhosis. Belapectin is a galectin-3 inhibitor in development for NASH cirrhosis. We use heteronuclear Nuclear Magnetic Resonance (NMR) spectroscopy to evaluate the intimate, and unique, binding of belapectin to galectin-3.

    Publication Number: 2177
    Authors: Pol Boudes, M.D.; Eliezer Zomer, Ph.D.; Harold Shlevin, Ph.D.
    Session title: NAFLD and NASH: Therapeutics – Pharmacologic and Other
    November 12, 2021

    Title: Pharmacokinetic exposure and safety of belapectin, a candidate treatment for NASH-cirrhosis, in patients with hepatic insufficiency
    We share interim results of an open-label Phase I study assessing the pharmacokinetic and safety profiles of belapectin, a galectin-3 inhibitor, in patients with different degrees of hepatic insufficiency.

    Publication Number: 2177
    Authors: Pol Boudes, M.D., Barbara Lomeli, M.D.; Eliezer Zomer, Ph.D.; Stephen A. Harrison, M.D.; Juan Rondon, M.D., J.D.; Eric Lawitz, M.D.
    Session title: NAFLD and NASH: Therapeutics – Pharmacologic and Other
    November 12, 2021

    Title: Innovating in cirrhosis: NAVIGATE, a seamless, adaptive, phase 2b/3 of belapectin, a galectin-3 inhibitor, for the prevention of esophageal varices in NASH cirrhosis
    Drug development in NASH cirrhosis is a challenge. The safety profile of candidate drugs is difficult to establish, particularly for liver-related side effects, there is no overall measure of liver function available, and there is no sensitive method to measure cirrhosis improvement on histology. These challenges led to the proposal of an innovative study design for the NAVIGATE Study. The study evaluates the risk/benefit of belapectin to prevent esophageal varices in NASH cirrhosis.

    Publication Number: 2304
    Authors: Pol Boudes, M.D.; Stephen A. Harrison, M.D.; Naga Chalasani, M.D.
    Session title: NAFLD and NASH: Experimental: Clinical
    November 12, 2021

    Title: Distribution of the AST/ALT (de Ritis) ratio in a cohort of patients with NASH cirrhosis and portal hypertension and correlation with portal pressure
    In patients with Non-Alcoholic Fatty Liver Disease (NAFLD), an increased AST/ALT ratio may indicate the progression to liver cirrhosis. This poster uses data from Galectin Therapeutics’ large Phase 2 clinical study in patients with well-documented liver cirrhosis due to NASH and hemodynamically measured portal hypertension. We explore whether the AST/ALT (de Ritis) ratio could be used as a simple, non-invasive way to estimate the degree of portal hypertension.

    Publication Number: 2307
    Authors: Pol Boudes, M.D.; Jörn M. Schattenberg, M.D.; Eric Lawitz, M.D.
    Session title: Portal Hypertension and Other Complications of Cirrhosis: Varices and Bleeding
    November 12, 2021

    Title: Features of portal hypertension predict health related quality of life over time in NASH cirrhosis
    Nonalcoholic steatohepatitis has a significant negative effect on health-related quality of life. In cirrhosis, age and features of clinically significant portal hypertension at baseline are determinants of lower quality of life.

    Publication Number: 1687
    Authors: Andrea Mladenovic, M.D.; Raj Vuppalanchi, M.D.; Pol Boudes, M.D.; Harold Shlevin, Ph.D.; Stephen A. Harrison, M.D.; Naga P. Chalasani, M.D.; Archita Parikh Desai, M.D.
    Session title: NAFLD and NASH: Epidemiology and Natural History, Prevention and Outcomes
    November 12, 2021

    Title: Development of machine learning histological scores that correlated with portal pressures and development of varices in NASH patients with cirrhosis
    In this study, portal pressure was accurately extrapolated from liver histology in patients with NASH cirrhosis by use of a machine learning algorithm. Clinically significant portal hypertension and the development of varices were also accurately predicted.

    Publication Number: 1591
    Authors: Mazen Noureddin, M.D., MHSc; Zachary Goodman, M.D., Ph.D.; Dean Tai, Ph.D.; Yayun Ren Sr., Pol Boudes, M.D.; Elaine Lay Khim Chng, Ph.D. Harold Shlevin, Ph.D.; Stephen A. Harrison, M.D.; Naga P. Chalasani, M.D.
    Session title: NAFLD and NASH: Diagnostics and Biomarkers
    November 12, 2021
    Bullish
  • A
    Anonymous
    Several very interesting scientific papers recently about Galectin3- one was a cirrhotic rat model where they found decreased cardiac contractility (cirrhotic cardiomyopathy) related to Galectin 3 in heart tissue of cirrhotic rats

    Also, several papers about LGALS3 genetic variants (SNPs) both in liver biopsies of patients undergoing Bariatric surgery as well as laryngeal cancer patients' histology

    Will not post these papers, sorry
  • L
    LGALS3
    RBC analysts:
    "single-asset companies in mid- to late-stage clinical development valued at around $1 billion to $5 billion will be the “sweet spot” for most M&A in 2022"
    Sounds like right in the GALT target valuation zone.
    Bullish
  • L
    LGALS3
    Dr. Carson stated, “Galectin Therapeutics and its drug candidate, belapectin, are at the forefront of research into galectin inhibition, which appears to be implicated in many diseases, including NASH cirrhosis, which is a large unmet medical need. More broadly, early results and potential for belapectin’s use in combination with immunotherapy in cancer suggests belapectin could address a multitude of indications where galectin-3 is involved." ///
    “Immunotherapy is a significant breakthrough in the treatment of many cancers, but tumor-induced immune suppression contributes to treatment resistance. Galectin-3 is an important driver of this tumor-induced immunosuppression, and this clinical study constitutes proof-of-concept that the addition of belapectin, a galectin-3 inhibitor, to a PD-1 inhibitor can benefit cancer patients,” said Dr. Brendan Curti, M.D., Earle A. Chiles Research Institute, a division of Providence, and the first author of the paper."
    Bullish
  • L
    LGALS3
    And then my next request…. was that 80% of my compensation be paid in stock. I felt like my goals and my success should be aligned with shareholders… As a business guy, I wish more CEOs would take that approach.
    -Joel Lewis interview
    Bullish
  • X
    X
    Interesting that I had my recent post deleted regarding Galt not updating their estimated Navigate Completion dates on Clinicaltrials.gov. (despite several updates of other other information).

    As noted, they have not incorporated the new estimate dates of end of 1st Q 2024 talked about in their November 15th Business Update press release (Read: "While we do need to extend the estimated completion of enrollment in the Phase 2b portion of the NAVIGATE trial by six months to around the end of the second quarter of 2022, we only need to extend the anticipated initial top-line results by three months, until the end of the first quarter of 2024.")

    We will see tomorrow if Lewis or Dr. Boudes uses their old estimated completion dates, the new estimate, or avoids the whole discussion when they do their presentation at the Wainwright's virtual BioConnect Conference tomorrow (Monday, Jan 10th).
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