Once-monthly subcutaneous injections of CSL Ltd.’s CSL-312 (garadacimab) significantly reduced the rate of hereditary angioedema (HAE) attacks compared to placebo, meeting both primary and secondary endpoints in the pivotal phase III Vanguard trial. Based on the trial results, CSL will file global regulatory submissions later in 2023.
Medicinal cannabis company Zelira Therapeutics Ltd. secured $8.6 million in cornerstone funding from U.S.-based Cantheon Capital LLC that will progress Zelira’s Hope1 cannabinoid medicine to formal phase II/III clinical trials for behaviors associated with autism spectrum disorder.
Beginning July 1, Australia’s Therapeutic Goods Administration will allow medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for certain mental health conditions.
Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease.
In a blow to Aussie regenerative medicine company Regeneus Ltd., Japan’s Kyocera Corp. has pulled out of a licensing deal for Regeneus’ lead mesenchymal stem cell (MSC) therapy, Progenza, for osteoarthritis of the knee for the Japan market. Osteoarthritis of the knee is the first indication for Progenza, an allogeneic off-the-shelf adipose-derived MSC therapy.
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
Vaxxas Pty. Ltd. and the Coalition for Epidemic Preparedness Innovations (CEPI) signed a partnership agreement to develop Vaxxas’ vaccine-patch delivery technology in a project that could end the need for frozen storage of mRNA vaccines.
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
Immunotherapy company Cartherics Pty Ltd. is leading a consortium that received a AU$5.4 million (US$3.6 million) grant from the Medical Research Futures Fund to develop a new approach to enhance cancer therapy by engaging the patient’s own immune system to complement CAR cell therapy.
Investment in the fourth quarter of 2022 was dismal in Asia Pacific, as the global venture community focused on preserving capital. And the region faced other challenges throughout the year, as leaders in Australia and across Asia became acutely aware of the vulnerabilities in their supply chains. But the year also saw some big deals and collaborations involving companies across Asia Pacific, along with advances in regenerative and digital medicine.