Look like broad market is having another hiccup again… perhaps a smaller one than the February big sneeze.I like to see price bounces off the 15 & 5 MA support to show that the bulls are still in charge. We will see next week.
$IBIO continued to hold its ground at $0.26. News came out last Wednesday, “iBio Selects Lead Candidate for its Fibrosis Therapeutics Program” pretty much set the stage for the coming IND filing for its IBIO-CFB03 for the treatment of systemic scleroderma, idiopathic pulmonary fibrosis, and other fibrotic diseases. While this may seem like old news, the significance of the news came from the fact that their cGMP manufacturing of Fc fusion proteins for therapeutic pharmaceutical applications is pronounced successful from last week news.
Excerpt from Wednesday news highlighted the importance of the Fc Fusion capability:
Dr. Feghali-Bostwick had demonstrated that a 48-amino acid peptide derived from endostatin named E4 can inhibit and reverse dermal fibrosis in an ex vivo human skin model as well as in both dermal and lung fibrosis mouse models in vivo. However, the E4 peptide had physical properties that made it undesirable for use as a drug without further modification. Therefore, iBio developed a portfolio (designated IBIO-CFB03) of distinct but related drug candidates that share a common mechanism of action with the E4 peptide, from which the E4 fusion protein has now been selected as the lead candidate for further development. The Fc fusion candidate, now being scaled up at iBio’s CDMO facility in Bryan, Texas, has improved pharmaceutical and pharmacologic properties when compared with other variants.
The way I understand it, E4 peptide, as a whole, is undesirable for use as a drug but Fc fusion allowed iBio to modify the E4 so its beneficial mechanism can be used in the IBIO-CFB03 drug.
In a nutshell, iBio’s success in cGMP manufacturing of Fc fusion proteins moved them closer to the filing of IND for its IBIO-CFB03 drug.
Progresses so far were also explained in the news:
Current tests are designed to determine minimal effective dosing by both oral and injection routes based upon prior data and to compare efficacy with FDA-approved fibrosis drugs. Data including body weight, lung weight, quantitative lung histopathology, and broncho –alveolar lavage collection and typing of inflammatory cells from lungs, will be used to support an application for human safety testing. Exploratory biomarker studies are also being conducted on harvested biofluids.
Upon completion of these studies, iBio will schedule manufacturing of cGMP compliant material at its Texas CDMO facility to support an IND filing and a human Phase 1 clinical trial. iBio plans to focus clinical research first on systemic sclerosis, for which iBio has U.S. Orphan Drug Designation, followed later by additional fibrotic disease indications as data indicate. These may include pulmonary fibrosis, liver fibrosis, corneal fibrosis, and Chagas disease-induced cardiac fibrosis.
“Upon completion of these studies” is a loaded statement since we are all wondering how far along has the studies been going on. How close are they in getting ready to schedule manufacturing of cGMP compliant material to support an IND filing and a human Phase 1 clinical trial?
Asides from the filing of IND, buy and hold is essential to capture other big surprises which could come in other forms such as possible FDA approval of AEMD’s hemopurifier commercial pathway, or a contract with BP for supplying Fc fusion proteins.
$AEMD is supposed to meet with FDA next week. So, there is drum rolls going on and I’m excited to find out what kind of commercial pathway its hemopurifier will be guided by FDA.
$DFFN is still stuck in the mud until enough buyers think it is ready to move. My main focus is the coming trial with UCLA in testing the stroke victims using their TSC drug treatment in a live ambulance runs. Everything else is just noise.
$LRAD is holding it ground while I’m waiting for news regarding its mass notification system sales.
$TRXC dropped a bit further due to volatility from short-term trading absent of news. I continue to hold and you can read my thought by clicking -> here.
Due to minor corrections, my port gave back a little for the week.
LRAD TRXC IBIO AEMD DFFN & cash (up 9.9% YTD)
My 2 cents
From my camera: