AdAlta AD-214 Phase I extension study results forecast for release at end of February
\nResults crucial as AdAlta looks to advance partnering discussions to take asset to Phase II trial
\n1AD\u2019s trademarked i-body platform advancing next generation of protein therapeutics\u00a0<\/p>\n
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Special Report: The countdown is on to the results of AdAlta\u2019s AD-214 Phase I extension study on track later this month with the clinical stage biotech gearing up for partnering opportunities to advance next phase studies.\u00a0<\/p>\n
The <\/span>AdAlta (ASX:1AD)<\/a> Phase I extension study for the use of AD-214 in treatment of Idiopathic Pulmonary Fibrosis (IPF)\u00a0\u2013 a common disease that causes thickening and scarring (fibrosis) of lung tissue \u2013 is aimed at reinforcing the safety profile and potential efficacy of the planned Phase II dose.<\/span><\/p>\n All participants in the Phase I extension study have successfully received all four doses.\u00a0<\/span><\/p>\n The interim findings to date reveal no dose-limiting toxicity, no need for dose interruptions and no necessity for administering medication to handle infusion reactions.\u00a0<\/span><\/p>\n The 10mg\/kg dose seems to also exhibit fewer mild infusion-related reactions compared to those observed with the 5 mg\/kg dose in the initial Phase I study.\u00a0<\/span><\/p>\n The bioavailability of 1AD\u2019s AD-214 and the blocking of its target receptor CXCR4 aligns with previous single-dose studies, maintains consistency across all three doses, and importantly, aligns with the predictions of dose simulation models.<\/span><\/p>\n 1AD managing director and CEO Tim Oldham said the Phase I extension study was the most rigorous test that could be given to the molecule.\u00a0<\/span><\/p>\n \u201cEverything we\u2019ve seen so far says we are going to get a result in line or better than what we\u2019ve seen previously,\u201d he says.\u00a0<\/span><\/p>\n \u00a0<\/p>\n Oldham says 1AD is actively cultivating partnering opportunities to support Phase II clinical studies of its lead therapeutic.\u00a0<\/span><\/p>\n Two strategies are being pursued in parallel; fully out-licensing AD-214 to larger biopharmaceutical companies, or co-developing AD-214 in a third-party financed, asset specific investment vehicle.<\/span><\/p>\n \u201cThe extension study results are important to this process because our pharma licencing partners and potential investors in the asset want to see the drug is safe at the doses that are going to be administered in Phase II and that there\u2019s no concerning immune responses,\u201d Oldham says. <\/span> \u00a0<\/p>\n \u201cThe AD-214 extension study results will do more than help unlock the partnering initiatives AdAlta has been working towards for so long. Those partnering initiatives are key to unlocking the future potential of the i-body platform,\u201d Oldham says.\u00a0<\/span><\/p>\n \u201cWe\u2019ve already seen the examples of the potential in our collaboration with Carina Biotech in the CAR-T space, which we think is a massive opportunity.\u201d<\/span><\/p>\n The company\u2019s collaboration with Carina Biotech, which is unlisted but backed by Andrew Forrest investment vehicles, is focused on the emerging oncology treatment area of <\/span>Chimeric antigen receptor T-Cell (CAR-T Cell) therapy.\u00a0<\/span><\/p>\n CAR-T cell therapy weaponises T-cells \u2013 a type of immune white blood cell \u2013 to recognise and destroy cancer cells.<\/span><\/p>\n \u201cEssentially, many companies have the capability to engineer the immune cells, but our i-bodies provide the smallest possible building block to enable them to target their CAR-T platform to different types of tumours,\u201d Oldham says.<\/span><\/p>\n \u201cWe have spoken to a number of CAR-T cell companies about the opportunity and Carina is the first of potentially several with whom we will collaborate.\u00a0<\/span><\/p>\n \u201cWe\u2019re also seeing the broad potential of the i-body as a drug discovery tool with the recent discovery of a novel anti-malaria i-body.\u201d<\/span><\/p>\n In collaboration with LaTrobe University, 1AD has <\/span>discovered a new i-body<\/span><\/a>, believed to be the first ever antibody-like molecule capable of protecting red blood cells and liver cells against invasion by multiple strains of the malaria parasite.<\/span><\/p>\n \u00a0<\/p>\n 1AD was established based on its trademarked i-body platform, aiming to explore and advance the next generation of protein therapeutics.\u00a0<\/span><\/p>\n Oldham says an i-body is a distinctive human protein combining the advantages of small molecules in terms of size and stability with the characteristics of antibodies, offering new treatment options for certain illnesses.\u00a0<\/span><\/p>\n 1AD\u2019s internal pipeline places a significant emphasis on G protein-coupled receptors (GPCRs), a crucial class of drug targets constituting approximately one-third of all approved drugs.\u00a0<\/span><\/p>\n There are only two approved antibody drugs in the GPCR class. Given the difficulty antibodies face in addressing GPCR-mediated diseases, the i-bodies developed by 1AD could be uniquely effective.\u00a0<\/span><\/p>\n Currently, 1AD\u2019s GPCR-targeted pipeline is concentrated on diseases related to fibrosis, inflammation, and cancer.<\/span><\/p>\n AD-214 is the first drug 1AD developed using the i-body platform, starting back in 2015. The biotech has invested around $45 million in developing 1AD to the end of Phase 1.<\/span><\/p>\n \u00a0<\/p>\n Oldham says 1AD does not focus on funding larger scale advanced clinical trials, but rather on earlier-stage assets.\u00a0<\/span><\/p>\n \u201cIt\u2019s very common in biotech for companies to operate at a specific stage of the development pipeline,\u201d he says.\u00a0<\/span><\/p>\n \u201cBecause of our technology, we\u2019re good at drug discovery, capable of taking drugs through Phase I to demonstrate they\u2019re safe, but at that point hand them over to those with deeper pockets and better clinical expertise to do the clinical proof of concept.\u00a0<\/span><\/p>\n \u201cWhat our shareholders want to see is multiple shots at goals that we\u2019re hitting on a regular basis, and we can\u2019t do that with a four-year Phase II program.\u201d\u00a0<\/span><\/p>\n He says larger biotechs further along the drug pipeline have a greater risk appetite for advanced stage trials of de-risked assets, realising the potential valuation uplift.\u00a0<\/span><\/p>\n \u201cThey\u2019re willing to take that defined risk over a longer period of time through Phase II and III, but often they do not want exposure to the public markets,\u201d Oldham says.\u00a0<\/span><\/p>\n Oldham says 1AD\u2019s current key focus is on realising a return on the investment the company has made in developing AD-214, which is the first product it\u2019s taken as far possible based on its strategy.\u00a0<\/span><\/p>\n \u201cOur strategy and business model now says it\u2019s time for others to take over AD-214 beyond ourselves,\u201d he says.\u00a0<\/span><\/p>\n \u201cRealising that goal unlocks all the other strategic opportunities for this company.\u201d\u00a0<\/span><\/p>\n Oldham says the Phase II program for AD-214 with all the bells and whistles that we would like to put on it would cost about $40-60 million over the next four years.<\/span><\/p>\n \u201cWe either out licence it to bigger pharmaceutical companies who have the resources to take it all the way or we put it into a different entity or vehicle that attracts different types of investors with a different risk appetite to take it to the next stage,\u201d he says.\u00a0<\/span><\/p>\n \u201cThat\u2019s very common in the sector because big pharma can\u2019t hope to generate all the leads they need in-house so rely on this plethora of biotech companies like AdAlta and academic institutions to fuel the front end of their pipeline.<\/span><\/p>\n \u201cThey are machines who can run the larger Phase II and Phase III clinical programs more effectively than any of us can.\u201d\u00a0<\/span><\/p>\n 1AD in January attended the JPMorgan Healthcare week in San Francisco, where it took part in potential partnering discussions.\u00a0<\/span><\/p>\n \u00a0<\/p>\n Oldham says during Q2 FY24 the company strengthened its balance sheet, maintaining its cash reserves to ensure it has the financial resources necessary to progress partnering discussions while retiring debt related to advances against its R&D tax incentive rebate.\u00a0<\/span><\/p>\n 1AD has a loan facility under the Victorian Government R&D Tax Cash Flow Incentive scheme, with a $2 million drawn down at the end of Q2 FY24 after repaying $2 million during the quarter from its RDTI rebate for FY23.\u00a0<\/span><\/p>\n A further repayment of $600k was made in January 2024. The company finished Q2 FY24 with an improved cash balance of <\/span>$3.68 million after an oversubscribed placement offer raised $1.65 million.\u00a0<\/span><\/p>\n \u201cWe are grateful for the additional funds contributed by shareholders during the quarter that will allow us to further those partnering discussions once final results from this study are received,\u201d Oldham says.\u00a0<\/span><\/p>\n \u00a0<\/p>\n\n \ufeff<\/span>\u00a0<\/span><\/p>\n This article was developed in collaboration with AdAlta, a Stockhead advertiser at the time of publishing.\u00a0<\/span><\/em><\/p>\n \u00a0<\/p>\n This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/span><\/em><\/p>\n <\/span><\/p>\n The post Countdown on to AdAlta trial results as biotech advances partner discussions<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"Partners to advance AD-214 to Phase II studies<\/h2>\n
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\n<\/span>\u201cWe are on track, interim results look good, but obviously we won\u2019t know the exact results until the end of this month.\u201d\u00a0<\/span><\/p>\nBroad utility of the i-body platform<\/h2>\n
The i-body platform<\/h2>\n
Focus on early-stage assets enables diversification and risk reduction<\/h2>\n
Strong Q2 FY24 results\u00a0<\/h2>\n