• AdAlta AD-214 Phase 1 extension study participants receive final dose
  • Progress made on partnering activities with participation in key industry events
  • Third top 20 pharma company has requested confidentiality agreement


Special Report: AdAlta has continued to progress partnering initiatives as participants in its AD-214 Phase 1 extension study successfully received all doses – with final results on track for delivery in February.

The Phase 1 extension study for the use of AD-214 in the treatment of Idiopathic Pulmonary Fibrosis (IPF) – a common disease that causes thickening and scarring (fibrosis) of lung tissue – is aimed at reinforcing the safety profile and potential efficacy of the planned Phase 2 dose.

AdAlta’s (ASX:1AD) interim results to date have indicated there was no dose limiting toxicity, no need to interrupt doses and no requirement to administer medication to manage infusion reactions.

To top it off, the 10mg/kg dose appears to have lower frequencies of mild infusion-related reactions than observed at 5mg/kg in the original Phase I study.

Bioavailability of AD-214 and the blocking of its target receptor, CXCR4 was also in line with prior single dose studies, consistent across all three doses and, most significantly, in line with the predictions of dose simulation models.


Extension study on track

All participants in the Phase 1 extension study have now successfully received all doses, with final results on track for delivery by the end of February 2024.

With this objective completed and the favourable interim results received to date, the company is now working to assemble a shortlist of partners to advance discussions as rapidly as possible once final results are available.

Further progressing its partnering activities, 1AD attended the Biotech Showcase and BIOPartnering@ JPM Week in San Francisco as part of JPMorgan Healthcare Week earlier this month – one of the most significant industry events for partnering and investment each year.

This was followed by attending the Advanced Therapies Week in Miami, a key gathering of developers of, investors in and service providers to the cell and gene therapy industry.

During that period 1AD held 20 discussions relating to AD-214 licencing or asset financing, including a third top 20 pharma company requesting a confidentiality agreement.

Partnering initiatives are aimed at:

  • Securing financing for Phase 2 clinical studies of AD-214 by either out-licensing, or co-developing in a third party financed asset specific investment vehicle;
  • Establishing new co-development collaborations to develop i-body-enabled i-CAR-T therapies; and
  • Securing access to clinic ready technology that is complementary to the i-body® platform.

“Our investors and shareholders are extremely interested in our partnering initiatives. While we cannot forecast the success or ultimate value of these, we continue to believe that they represent considerable upside potential for shareholders if successful,” 1AD managing director Tim Oldham said.

“I am delighted with January’s progress towards our AD-214 partnering goals and the positive reception our i-CAR-T cell therapy strategy is receiving.”



This article was developed in collaboration with AdAlta, a Stockhead advertiser at the time of publishing.


This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.