Sponsored

Imugene Ticks Off a Key Milestone in PD1-Vaxx Phase 1 Trial, Shares Up

Summary

  • Imugene Limited (ASX:IMU) has obtained approval from CRC to proceed to the third-highest dose cohort in PD1-Vaxx Phase 1 clinical trial.
  • No serious adverse reactions and no dose-limiting toxicities were observed at mid-dose (50µg) level of PD1-Vaxx.
  • The Mayo Clinic in Arizona has received IRB approval for PD1-Vaxx Phase 1 clinical trial in the USA.

In a significant update, biotech player Imugene Limited (ASX:IMU) has announced that PD1-Vaxx will proceed to the third-highest dose (100µg) cohort in its Phase 1 clinical trial. The Cohort Review Committee (CRC) has confirmed the dose escalation of PD1-Vaxx to the final highest dose.

Furthermore, the prestigious Mayo Clinic in Phoenix Arizona, has also obtained the Institutional Review Board’s (IRB) approval to kick-start and join PD1-Vaxx Phase 1 clinical trial in the USA.

Following the key updates, Imugene shares rallied by about 11.5 per cent to AUD 0.145 mid-day (as at 2:08 PM AEST).

PD1-Vaxx is Imugene’s B-cell activating immunotherapy that has been designed to treat tumors like lung cancer. The Company is progressing with the Phase 1, multi-centre, first-in-human, dose escalation trial of PD1-Vaxx, which is recruiting patients suffering from non-small cell lung cancer (NSCLC).

Also Read: Imugene Limited (ASX:IMU) Proceeds to Next Dose Escalation in PD1-Vaxx’s Phase 1 Trial

CRC’s Approval for 3rd PD1-Vaxx Phase 1 Cohort

The Cohort Review Committee reviewed all safety and tolerability data for the 2nd mid-dose (50µg) patients administered with Imugene’s PD1-Vaxx as monotherapy. The committee unanimously agreed PD1-Vaxx to be safe. The CRC observed no serious adverse reactions & no dose-limiting toxicities.

The committee advised the Company to proceed with the opening of the third and final PD1-Vaxx Phase 1 cohort at the highest dose level of 100µg at the completion of the review meeting.

The primary objective of the Phase 1 study of PD1-Vaxx is to determine safety as well as an mOBD or an optimal biological dose as a monotherapy. Immune response, tolerability and efficacy will also be evaluated. The CRC will determine mOBD, which requires successive dosing of PD1-Vaxx within cohorts of at least three patients each.

Encouraging Assays

Imugene received promising results after six weeks (Day 43) of treatment with PD1-Vaxx, as stated below:

  • One patient’s tumor was non-measurable, demonstrating a complete response (CR).
  • Three patients showed stabilization of disease (SD).
  • One patient’s tumor was progressing (PD).

At Day 85, the status of two patients from Cohort 1 (1 x CR, 1 x SD) was unchanged.

The Company informed that these results are encouraging in patients who have progressed after prior treatment with checkpoint inhibitors, comprising Opdivo®, Keytruda® or Tecentriq®.

The clinical results suggest that the Company’s PD1-Vaxx is exhibiting early signs of an immune response in patients with non-small cell lung cancer. Antibodies to the target biomarker PD1 are also evident in validated assays. The Company expects further results and scans over the coming weeks.

The continuing Phase 1 data signify a clinical proof-of-concept signal for Imugene’s PD1-Vaxx monotherapy with early signals of efficacy. Besides, the data suggest that B-cell activating immunotherapies can prompt clinically active antibody responses against a significant immune regulation receptor target.

Must Read: Imugene Limited (ASX:IMU) Doses First Patient in Cohort 2 under PD1-Vaxx Phase 1 Trial

Comment


Disclaimer

Ad

GET A FREE STOCK REPORT


Top Penny Picks under 20 Cents to Fit Your Pocket! Get Exclusive Report on Penny Stocks For FREE Now.


   
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. OK