Dimerix ACTION3 Phase 3 trial successfully passes first interim analysis endpoint
Mesoblast says US FDA supports accelerated approval pathway for rexlemestrocel-L
Imexhs raises $1.5 million in cap raise to sophisticated and institutional investors plus directors
Dimerix (ASX:DXB) has released highly anticipated interim analysis results from its ACTION3 Phase 3 trial of DMX-200 in patients diagnosed with focal segmental glomerulosclerosis (FSGS), demonstrating the achievement of its primary endpoint.
DXB says the Phase 3 trial has achieved success in its pre-specified interim analysis of the proteinuria (efficacy) endpoint, based on data from the initial 72 randomised patients.
The interim analysis indicates that DMX-200 is currently outperforming the placebo in reducing proteinuria, as measured statistically, within a significantly larger participant group compared to its earlier Phase 2 trial involving eight patients.
DXB says the interim analysis suggests the potential for a statistically significant and clinically meaningful reduction in proteinuria at the study’s conclusion.
Moreover, the trial’s Independent Data Monitoring Committee (IDMC) has affirmed no safety concerns related to DMX-200, further enhancing the drug’s safety profile.
The IDMC has formally recommended the continuation of the trial as originally planned.
“Passing this first interim analysis for DMX-200 is a key milestone for Dimerix and our FSGS program,” chief medical officer Dr David Fuller says.
“It demonstrates that DMX-200 is performing better than placebo in reducing proteinuria in a much larger cohort than our prior 8-patient Phase 2 study, and this validates our strategy and our prioritisation of this potentially valuable program in a disease where there are no FDA approved therapies.”
“We now look forward to rapidly expanding this study, which will include recruiting children down to 12 years old as well as adults.”
US FDA supports Mesoblast accelerated approval pathway
Mesoblast (ASX:MSB) has announced the US FDA supports an accelerated approval pathway for rexlemestrocel-L, the company’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD).
MSB says the FDA provided this feedback in formal minutes to the company following the Type B meeting held in February for rexlemestrocel-L (Revascor) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation.
“We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” says CEO Dr Silviu Itescu.
“We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”
MSB says more than 100,000 patients progress to end-stage HFrEF in the US annually. In these patients, more than 2,500 life prolonging LVADs are implanted with ~80% undergoing the procedure as destination or permanent therapy.
MSB says most patients receiving LVADs as destination therapy have an ischemic HFrEF etiology. Compared to patients with non-ischemic HFrEF, patients with ischemic HFrEF have a 76% lower likelihood of LV functional recovery following LVAD implantation, and increased mortality over the initial 1-2 years.
Imugene’s Phase 1 onCARlytics solid tumour trial set to advance
Clinical stage immuno-oncology company Imugene (ASX:IMU) has announced that its Phase 1 clinical trial of CD19 oncolytic virotherapy drug candidate onCARlytics (on-CAR-19, CF33-CD19 HOV4) has cleared its first cohort within the intratumoural monotherapy arm of the study.
IMU says the drug candidate is now ready to commence combination dosing solid tumour patients with CD19 targeting drug blinatumomab (marketed as Blincyto by Amgen).
Known as OASIS, the first-in-class clinical trial is targeting adult patients with advanced or metastatic solid tumours, and aims to evaluate the safety and efficacy of two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion, either alone, or in combination with blinatumomab.
OASIS is a dose escalation trial that will be conducted across multiple sites across the US, with 52 patients proposed to take part.
Blinatumomab currently is specifically approved only for liquid blood cancers. IME says OnCARlytics has the potential to target and eradicate solid tumours that otherwise cannot be treated with Blinatumomab therapy alone and will represent a paradigm shift in solid tumour treatment.
“Completion of this first monotherapy intratumoural cohort where ovarian, breast and melanoma patients were dosed paves the way for us to move into an important combination dosing with Blincyto, where we’ll be eager to see the greater potential of onCARlytics in targeting and eradicating solid tumours,” MD & CEO Leslie Chong says.
The DXB, MSB, & IMU share price today:
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