Vaxxas Pty. Ltd. raised AU$34 million (US$23 million) to advance its needle-free COVID-19 vaccine program, which began in early November, and readouts from the study are expected in late February or early March, Vaxxas CEO David Hoey told BioWorld. The COVID-19 vaccine patch is based on the company’s high-density microarray patch technology that delivers Hexapro, a second-generation version of the spike protein used in all major U.S.-approved COVID-19 vaccines.
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.
Immutep Ltd.’s lead immunotherapy candidate eftilagimod (IMP-321, efti) met the primary endpoint in its phase II trial evaluating the combination of efti and Merck & Co. Inc.’s Keytruda (pembrolizumab) as first-line treatment of non-small-cell lung cancer (NSCLC), reporting final data that show an overall response rate of 40.4%.
Que Oncology Inc.’s Q-122 significantly reduced the frequency and severity of moderate and severe vasomotor symptoms, or hot flashes, in women taking endocrine therapy for breast cancer, and phase II results showed associated improvement in quality of life, compared with placebo.
“We look at Japan with some envy with what they’ve been able to achieve and their approach to regenerative medicine, which has been supported significantly by their federal government,” said Silvio Tiziano, CEO of the Center for the Commercialization of Regenerative Medicine Australia, during the recent Ausbiotech conference in Perth.
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
The potential for psychedelics to deliver long-lasting benefits for people with anxiety, depression, post-traumatic stress disorder and addiction is being put to the test in Australia, where new research and discovery centers are adding to a global enterprise of nearly 100 clinical trials underway in the space.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
A new analysis of Actinogen Medical Ltd.’s phase II Xanadu trial showed that in biomarker-positive patients with mild Alzheimer’s disease there was a clear clinical effect with lead compound Xanamem not seen in the earlier trial.
A review of Australia’s National Medicines Policy was begun in August 2021 but was paused until after the federal election in May to allow stakeholders more time to provide feedback.
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