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Post by mnholdem on Sept 8, 2015 7:33:35 GMT -5
From a factsheet provided by MannKind Corporation in October 2010.
Product Pipeline:
AFREZZA® (insulin human [rDNA origin]) is an ultra rapid-acting mealtime insulin therapy in late stage clinical investigation for the treatment of adult patients with Type 1 and Type 2 diabetes mellitus for the control of hyperglycemia. It is a drug-device combination product,
consisting of AFREZZA Inhalation Powder pre-metered into single use unit-dose cartridges and the light, discreet and easy-to-use AFREZZA Inhaler. AFREZZA utilizes the company’s proprietary Technosphere® formulation technology.
MKC253
MKC253 is a Technosphere formulation of GLP-1 (glucagon-like peptide). In initial clinical studies, MKC253 showed a lack of the characteristic adverse events, like nausea and vomiting, that are frequently associated with long-acting GLP-1 analogs. Results from a
phase 1 trial support the hypothesis that inhalation of MKC253 may be able to simulate the incretin effect that is lost in patients with Type 2 diabetes.
MKC180
MKC180 is a novel Technosphere formulation of a natural hormone to control satiety for addressing obesity. The product is an inhaled oxyntomodulin intended for use at mealtime. In nonclinical studies, MKC180 demonstrated a dose dependent decrease in food
consumption up to six hours after pulmonary administration and was superior to both placebo and an IV infusion of oxyntomodulin.
MKC1106
MKC1106 is MannKind’s active immunotherapy platform, and there are three separate programs. MKC1106-PP, designed to target solid tumors, completed an open label phase 1 clinical trial and objective responses were observed in prostate cancer and renal cell carcinoma. MKC1106-MT, specific for melanoma treatment, also showed objective responses in a Phase 1 clinical trial. MKC1106-NS may be applicable to a range of solid
and blood cancers and is positioned for clinical evaluation.
MKC204
MKC204 is an IRE-1 alpha inhibitor with potential application in the treatment of multiple myeloma. IRE-1 alpha is a protein important in the regulation of the Unfolded Protein Response (UPR) cascade. Additional potential indications for UPR pathway inhibitors include autoimmune diseases, cardiovascular diseases and neurodegenerative disorders.
www.mannkindcorp.com/Collateral/Documents/English-US/MannKind%20Fact%20Sheet.pdf
With the exception of Afrezza, all pipeline drug development was halted following FDA issuance of a 2nd CRL related to the 2nd Generation Inhaler (DreamBoat).
MKC253 was picked up by Sanofi, who secured first rights to the GLP-1 in their Collaboration and Partnership Agreement with MannKind. Does anyone have any thoughts or information on the others? None of them sound like the two API recently mentioned as being the first to be developed now that Mannkind has turned the lights back on to their pipeline development. |
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Post by mssciguy on Sept 8, 2015 8:06:30 GMT -5
mnholdem From the current mannkind website. Showing only MKC253 (which wouldn't seem to be necessary with properly dosed Afrezza but with the RAAs... often enough to be of value). There are so many new peptide fragments out there. I am on the mailing lists of a couple of peptide labs and to read the new releases is just amazing, fragments of growth factors being very popular, also "sleep inducing" peptide, dermatological factors, peptides that have been shown to restore liver function, nootropic and stroke recovery peptides. All relatively new science, very potent with little or no side effects. I know that many of you know this, what I don't know is why Mannkind has only a few dozen employees. There is so much that could be done with Technosphere. Product Pipeline: OverviewAFREZZA® (pronounced uh-FREZZ-uh) is a first-in-class, ultra rapid-acting mealtime insulin therapy being developed to improve glycemic control in adults with Type 1 and Type 2 diabetes mellitus. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder single-use dose cartridges and the small, discreet and easy-to-use AFREZZA inhaler. Because of its unique pharmacokinetic profile, AFREZZA may be a promising new therapy for patients with Type 1 and Type 2 diabetes, as it has been shown in clinical studies to control post meal-time glucose levels, cause less weight gain and have lower risk of hypoglycemia than current standard insulin therapies.MKC253 is a Technosphere formulation of GLP-1 (glucagon-like peptide). In initial clinical studies, MKC253 showed a lack of the characteristic adverse events, like nausea and vomiting, that are frequently associated with long-acting GLP-1 analogs. Results from a phase 1 trial supported the hypothesis that inhalation of MKC253 may be able to simulate the incretin effect that is lost in patients with Type 2 diabetes.
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Post by peppy on Sept 8, 2015 12:49:48 GMT -5
MKC180
MKC180 is a novel Technosphere formulation of a natural hormone to control satiety for addressing obesity. The product is an inhaled oxyntomodulin intended for use at mealtime. In nonclinical studies, MKC180 demonstrated a dose dependent decrease in food
consumption up to six hours after pulmonary administration and was superior to both placebo and an IV infusion of oxyntomodulin.
============================================================================================== Looking at GLP-1 today, trying to understand it... I came across OXYNTOMODULIN in the body.
Intestinal enteroendocrine cells are not clustered together but spread as single cells throughout the intestinal tract.[8]
Hormones secreted include somatostatin, motilin, cholecystokinin, neurotensin, vasoactive intestinal peptide, and enteroglucagon.[9]
K cells secrete gastric inhibitory peptide, an incretin, which also promotes triglyceride storage.[10]
L cells secrete glucagon-like peptide-1, an incretin, PYY peptide YY, oxyntomodulin and glucagon-like peptide-2. L cells are primarily found in the ileum and large intestine (colon), but some are also found in the duodenum and jejunum.[11]
Added: Oxyntomodulin is a naturally occurring 37-amino acid peptide hormone found in the colon, produced by the oxyntic (fundic) cells of the oxyntic (fundic) mucosa. It has been found to suppress appetite. A recent study has found that it can be used as a weight loss treatment.[1][2][3][4]
The mechanism of action of oxyntomodulin is not well understood. It is known to bind both the GLP-1 receptor and the glucagon receptor, but it is not known whether the effects of the hormone are mediated through these receptors or through an unidentified receptor studies listed en.wikipedia.org/wiki/Oxyntomodulin
Interesting
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Post by mnholdem on Sept 8, 2015 13:05:15 GMT -5
Incidentally, for those who are not aware, In the License and Collaboration Agreement with MannKind Corporation, Sanofi only secured the rights to any GLP-1 drug that could be used for the treatment of diabetes. Sanofi did not get any rights whatsoever to other future GLP-1 drugs delivered by Technosphere. As peppy and others have pointed out, GLP-1 drugs treat much more than diabetes.
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Post by mssciguy on Sept 8, 2015 13:09:37 GMT -5
peppy Short peptides are where it's at in terms of efficacy and safety. The big problem that big pharma has is that you can't patent them (natural products). Technosphere is very underappreciated thanks to Pfizer's blunders with ......... If Mannkind were hq'd in Silicon Valley, what do you think it would be valued at? 5x, 10x, 20x as much... need PR, give it spin, give it pep!
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Post by peppy on Sept 8, 2015 15:00:55 GMT -5
Crazy and disgusting talk: Do the animals we kill in the stock yards have oxyntomodulin in their intestinal endocrine cells?
Or 
How many fat people are there that would breathe through a dreamboat before their meal to lose weight?
Oh the humanity.
"Keep your stomach, try a dream boat."
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Post by mssciguy on Sept 8, 2015 15:21:07 GMT -5
Crazy and disgusting talk: Do the animals we kill in the stock yards have oxyntomodulin in their intestinal endocrine cells?
Or
How many fat people are there that would breathe through a dreamboat before their meal to lose weight?
Oh the humanity.
"Keep your stomach, try a dream boat."
Yes our industrial agriculture system produces a lot of cheap food to feed the fast food industry, which makes sure there is sufficient fat and salt to make the drive thru window a kind of "crack" equivalent (seriously, no joke, salt is almost as addictive, google it). Great idea about appetite suppressant peptides by Dreamboat. Also, once the body is "reset" cravings may vanish. It does sound too good to be true... a Dreamboat. I could use one with sleep-inducing peptide from time to time, especially as long as the hedge funds use this stock like pinata. |
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Post by lakers on Nov 15, 2015 3:33:05 GMT -5
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Post by purge on Nov 15, 2015 7:56:34 GMT -5
Are you all aware how dangerous the agriculture industrial complex is to our existence in the USA today? Did you know nearly 70% of all antibiotics used in USA today are not used under the regulatory umbrella of the FDA? They are used under the USDA.
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Post by u1682002 on Nov 15, 2015 11:01:24 GMT -5
I am more interested in the old license agreement signed with Tolero back in 2012. "Under the terms of the agreement, Tolero will pay MannKind upfront and milestone payments linked to the development, approval and commercialization of products, for total potential upfront and milestone payments of approximately $130 million.MannKind will also receive tiered royalties on sales of products and a percentage of sublicensing revenue. In addition, MannKind has an option to re-acquire the rights to the program at pre-specified terms until 60 days after the conclusion of the first Phase 1 study." www.bloomberg.com/article/yyyy-mm-dd/a1L8QwYRFsZs.htmlI sent email to Matt asking for the status about this deal and got no reply yet. |
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Post by mnholdem on Nov 15, 2015 15:33:30 GMT -5
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