ASX Health Stocks: US FDA well pleased with Race Oncology; Mesoblast releases top line readouts of Phase 3

Race Oncology received positive feedback from the US FDA
HeraMed launches HeraCARE in Victoria
Mesoblast announced top line results from Phase 3 trial

US FDA pleased with Race Oncology submission

Race Oncology (ASX:RAC) has received positive feedback and guidance from the US FDA regarding lead drug Zantrene and its clinical plans.

Race had earlier submitted pre-IND (investigational new drug) documentations to the FDA in September, which included a summary of the preclinical and clinical data for Zantrene.

The package submitted also included an overview of the proposed clinical development plan, and specific questions on the requirements to open an IND application.

Opening an IND is a requirement before undertaking clinical trials in the United States, and is a key step in the process of obtaining a New Drug Application (NDA).

Race says the FDA has now provided positive feedback on the proposed clinical development plan for Zantrene, and acknowledged that Acute Myeloid Leukemia (AML) continues to have significant unmet clinical needs in the States.

Importantly, the FDA agreed that Race had adequately addressed outstanding clinical hold issues from an earlier IND application submitted in 2019.

Under current US regulations, if the FDA does not place a clinical hold within 30 days of an IND submission, the trial can proceed.

The FDA also confirmed today that the FDA505(b)(2) application pathway is a possible regulatory pathway for Zantrene, where data completed on Zantrene in the public domain can be used for the application.

While Race has no current plans to undertake any clinical trials in the US, receiving timely guidance from the FDA provides valuable commercial optionality.

“As Race becomes increasingly clinical in its operations, FDA guidance is invaluable to ensuring our readiness, and to having the necessary optionality, when we seek to pursue our USA based clinical plans,” said Race Oncology CEO, Phil Lynch.

Mesoblast’s Phase 3 top line readout

Cellular medicine specialist Mesoblast (ASX:MSB) today announced top-line long-term survival results for remestemcel-L from its pivotal Phase 3 trial in children with steroid-refractory acute graft-versus-host disease (SR-aGVHD).

The results showed durable survival through four years of follow-up.

Mesoblast says these new long-term survival data are a key component of the company’s resubmission to the FDA for remestemcel-L in the treatment of children with SR-aGVHD.

SR-aGVHD is a life-threatening condition with no approved treatments for children under 12 years.

The result showed that overall survival in the remestemcel-L cohort was 63% at one year, 51% at two years, and 49% at four years, with median survival of 2-3 years.

Mesoblast CEO Dr Silviu Itescu said: “These substantial and durable long-term survival outcomes seen in our Phase 3 trial with remestemcel-L are a cornerstone to our BLA resubmission.”

HeraMed launches in Victoria

HeraMed (ASX:HMD) has signed a new agreement for its hybrid connected maternity care platform HeraCARE.

Under the deal, leading obstetrician and gynaecologist, Associate Professor Vinay Rane, will lead the first private clinic commercial HeraCARE launch in Victoria.

This will involve deliveries of HeraCARE across private hospital networks, mainly at Frances Perry House, a leading private maternity hospital which is part of Ramsay Health Care.

250 mothers will take part in the initial stage of the commercial launch which will last approximately eight months.

These 250 licences (with a similar number of HeraBEAT smart foetal HR monitors) will generate a total of $169k for one year for HeraMed.

On successful completion of the first Phase, HeraMed and Dr Rane’s private practice ‘Melbourne Mothers’ aim to expand the platform into affiliates and collaborators.

This will provide an opportunity to enter long term agreements with an expected annual purchase of up to 1,500 licences of HeraCARE.

“This agreement represents the first with a private obstetrician and the second linked to a Ramsay Health Hospital,” said HereMed’s CEO, David Groberman.