Special Report: AdAlta’s partnering initiatives have made further advancements as participants in the AD-214 Phase 1 extension study have received all doses successfully. The final results are expected to be available in February as scheduled.
AdAlta’s AD-214 partnering program gains momentum
The Phase 1 extension trial is being conducted to further investigate the safety and potential effectiveness of AD-214 in treating Idiopathic Pulmonary Fibrosis (IPF), a condition that leads to the thickening and scarring of lung tissue. The goal is to strengthen the understanding of the drug’s safety and determine its optimal dosage for the upcoming Phase 2 trial.
AdAlta’s (ASX:1AD) interim results to date It has been indicated that there were no toxic effects that restrict the dosage, no necessity to pause administering doses, and no need to give medication to handle side effects during the infusion.
Additionally, it seems that the 10mg/kg dosage has a lower occurrence of mild infusion-related reactions compared to what was observed at the 5mg/kg dosage in the initial Phase I study.
The bioavailability of AD-214 and its ability to block the CXCR4 receptor were consistent with previous studies involving single doses. This consistency was observed across all three doses and notably matched the predictions made by dose simulation models.
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Extension study on track
By the end of February 2024, the final results of the Phase 1 extension study will be delivered, as all participants have now received all doses successfully.
Having achieved this goal and received positive interim results so far, the company is currently working to gather a select group of partners for prompt discussions once the final results are obtained.
Continuing to engage in partnerships, 1AD participated in the Biotech Showcase and BIOPartnering@ JPM Week in San Francisco as part of JPMorgan Healthcare Week earlier this month. This annual event is highly important for collaborations and investment within the industry.
After that, I attended the Advanced Therapies Week in Miami, which is an important event for the cell and gene therapy industry, where developers, investors, and service providers come together.
In that specific time frame, 1AD conducted a total of 20 discussions regarding the licensing or asset financing of AD-214. These discussions included a request from a prominent pharmaceutical company ranked in the top 20, who sought a confidentiality agreement.
Partnering initiatives are aimed at:
- Obtaining funding for Phase 2 clinical trials of AD-214 can be achieved through either licensing to external parties or partnering with a third-party investment vehicle dedicated to financing this specific asset.
- Creating new partnerships for the joint development of i-CAR-T treatments using i-body technology.
- Ensuring availability of clinic-ready technology that complements the i-body® platform.
“Our investors and shareholders are very keen on our collaboration initiatives. Although we cannot predict their success or ultimate worth, we still believe that they have significant potential for growth for our shareholders if they are successful,” stated Tim Oldham, managing director of 1AD.
“I am extremely pleased with the progress we have made in January towards achieving our partnering goals for AD-214. Additionally, our i-CAR-T cell therapy strategy has been very well-received.”
