Is in 10-15 days inflammatory in vitro study Cardio or Fibrosis targting with steroid | NAVB Message Board Posts

Navidea Biopharmaceuticals, Inc.

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Msg  40534 of 40754  at  11/23/2023 3:04:56 PM  by


The following message was updated on 11/23/2023 7:41:43 PM.

 In response to msg 40526 by  moneyonomics
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Re: Is in 10-15 days inflammatory in vitro study Cardio or Fibrosis targting with steroid

a case for fibrosis in vitro first from MT website, CC and 10Q

 Mar 2023 CC

And as of May of 2021, to give you an idea of how large these efforts are globally, to do just what I told, there were 606 clinical trials that we're running or have been completed just to do what I just said related to cancers. It's a huge field. And you know what's cool about it is, really, we're at the forefront of that, not necessarily in the progression of our therapeutic constructs into humans, but in the technology and what our drugs have been show -- what we have been able to show they can do in the in vitro or preclinical phases.

So we're right there at the leading edge of this incredibly large opportunity field or space to help patients and to treat a large number of diseases from cancers to others. I can get into that in a moment. And that patent that Mike referenced was about -- was giving us our intellectual property around using our constructs to change the phenotype of the nature of macrophages, as I just described. And yes, there are going to be a whole series of patents that follow suit or applications around that...


...So I've mentioned in cancer, you want to drive the M2 or wound-healing pro-tumor type macrophages to M1 pro-inflammatory. In many other diseases, including almost all inflammatory and infectious diseases, you want to do the opposite. You want to take the inflamed pro-inflammatory macrophages that are doing a lot of stuff to try to attack whatever the infectious agent is, but the body has a hard time controlling those things precisely. So what you want to do is you want to drive those towards the more wound healing-type. And we have data suggesting that we can do that with our dexamethasone constructs.

So we can perturb the macrophages and drive them in one direction or the other. And with that, the world is kind of our oyster, and almost every disease is touched by the macrophage, or the macrophage plays a central or critical role. So that's my spiel. Hopefully, I addressed your question, Mike.

Nov 2022 Cc

This has important implications for our therapeutics as well. On the therapeutic asset front, we are advancing our candidates in the oncology and anti-inflammatory spaces in preclinical studies with the goal of filing investigational new drug applications or INDs to advance to human studies in 2024. These filings will be significant inflection points and opportunities for licensing and partnering deals, work on new drug delivery constructs and new targeted payloads has progressed. These new constructs carry new drug payloads that may be more effective than doxorubicin for beneficially altering the immune status of tumor macrophages for example. Results in mice have demonstrated that when administered alone or in combination with another cancer drug, these therapeutic constructs significantly reduced the rate of tumor growth by an average of 76%.


Some of our results covering new bisphosphonate payload constructs were recently presented at the Tumor Myeloid-Directed Therapies Summit meeting. More recently on November 10 in fact, the full spectrum of results for both our paclitaxel and novel bisphosphonate constructs were presented at the Annual Meeting of the Society for Immunotherapy of Cancer or SITC held in Boston, Mass. This work is about advancing to a lead candidate for macrophage phenotype altering drugs for oncology indications. I can tell you the work presented at SITC was well received and we had a steady stream of attention. In vitro studies examining the ability of our dexamethasone constructs for inflammatory indications have shown positive results as well demonstrating macrophage phenotype change, these constructs will soon be tested in preclinical models.

 Sept 2022
 So when that slide was crafted, it was really about taking an anti -- an immunotherapy for cancer to IND as well as an anti-inflammatory. And at the end of the day, optimistically, it might be more than one immunotherapy, give or take a year between the 2, and maybe an anti-inflammatory
Apr 2022
 Similarly, on the anti-inflammatory side, we're doing something very similar. Right now, the lead candidate is the dexamethasone-containing construct. So one of the things we had to do, and this actually overlaps with all of our constructs, is we had to optimize the linker that actually holds the targeted payload and then releases it. We've done some really good chemistry work to optimize those so that'll work most effectively. And we've demonstrated now in vitro that the dexamethasone-containing construct does what we think it should do. And now we're working with collaborators, and you'll hear about this before too long, I hope, moving those into -- or that construct into molecules -- I'm sorry, models of autoimmunity and inflammatory disease. So you'll hear about that.

 Nov 2023 10Q

Manocept Platform - Diagnostics and Therapeutics Background


Navidea’s Manocept platform is predicated on the ability to specifically target the mannose receptor (CD206) expressed primarily on activated macrophages. This flexible and versatile platform serves as a molecular backbone for purpose-built targeted imaging molecules that may significantly impact patient care by providing enhanced diagnostic accuracy, clinical decision-making, and target-specific treatment. This CD206-targeted drug platform is applicable to a range of diagnostic modalities, including SPECT, positron emission tomography (“PET”), gamma-scanning and intra-operative and/or optical-fluorescence detection, as well as delivery of therapeutic compounds that target macrophages and their role in a variety of immune- and inflammation-involved diseases. The United States Food and Drug Administration (“FDA”)-approved sentinel node/lymphatic mapping agent, Tc99m tilmanocept, is representative of the ability to successfully exploit this mechanism to develop powerful new products and to expand this technology into additional diagnostic and therapeutic applications.


Activated macrophages play important roles in many disease states and are an emerging target in many diseases where diagnostic uncertainty exists. Impairment of the macrophage-driven disease mechanisms is an area of increasing and proven focus in medicine. The number of people affected by all the inflammatory diseases combined is estimated at more than 40 million in the United States and up to 700 million worldwide, making macrophage-mediated diseases an area of remarkable clinical importance. There are many recognized disorders having macrophage involvement, including RA, atherosclerosis/vulnerable plaque/cardiovascular disease, nonalcoholic steatohepatitis (“NASH”), inflammatory bowel disease (“IBD”), systemic lupus erythematosus, cancer generally including Kaposi’s sarcoma (“KS”), leishmaniasis, and others that span general clinical areas in cancer immunology, autoimmunity, infectious diseases, cardiology, central nervous system diseases, and inflammation. For the near term, we have selected target diseases that may, if successfully developed, benefit from this technology.


The Company has developed processes for producing the first four therapeutic Manocept immuno-construct series, the Manocept doxorubicin (“MAN-DOX”) series, which is designed to specifically target and kill or modify activated CD206+ macrophages by delivering doxorubicin, a Manocept paclitaxel series (“MAN-PAC”), and a Manocept Bisphosphonate series (“MAN-BIS”). The MAN-PAC and MAD-BIS series are designed to modify CD206+ macrophages to make them more proinflammatory. The Company has also created a Manocept dexamethasone (“MAN-DEX”) series, which is designed to inhibit the inflammatory activity of activated CD206+ macrophages by delivering a potent anti-inflammatory agent, dexamethasone. We have expended significant efforts in recent years to improve chemical syntheses and to produce sufficient quantities of Manocept constructs representing all 4 series agents, along with the concomitant analytical standards, to provide material for current and planned preclinical animal studies and future clinical trials. Evaluation of representative examples of constructs from all four series have been successfully performed in human macrophage cell culture assays with MAN-DOX and MAN-PAC advancing to evaluations in various syngeneic mouse models of cancer.

 In Japan Manocept was number one compound tested in Nash. etc 7:45 minutes



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