Latest news with #CellTherapies
News.com.au
08-07-2025
- Business
- News.com.au
ASX biotechs join global race for cell therapy breakthroughs
ASX biotechs target global cell therapy market, projected to reach ~US$48bn by 2034 Arovella the only ASX-listed biotech delving into CAR iNKT therapies and one of few globally Chimeric aims to 'break new ground' in treatment of solid tumours with CAR-T and NK cell assets Cell therapies represent a promising frontier in modern medicine, offering potential to treat, and in some cases cure diseases previously considered untreatable. By using living cells, either from the patient (autologous) or a donor (allogeneic), cell therapies aim to repair, replace, or enhance biological functions within the body. Originally pioneered for blood cancers through technologies like chimeric antigen receptor (CAR) T-cell therapies, the field is rapidly expanding into solid tumours, autoimmune conditions, and neurological diseases. Australia has close ties to CAR T-cell therapy development. Melbourne-based Cell Therapies Pty Ltd, the country's largest Therapeutic Goods Administration (TGA) licensed cell and gene therapy manufacturer, was the commercial production partner for Novartis's Kymriah – the first CAR T-cell therapy approved by the US Food and Drug Administration (FDA) in 2017. While the science remains complex, advances in manufacturing, engineering, and clinical design are making next-generation cell therapies more accessible and scalable, positioning them as a key pillar of future healthcare. Several ASX biotechs are positioning themselves at the forefront of cell therapies to capture a share of the global market, which accounted for ~US$6.04 billion in 2024 and is anticipated to close in on US$48bn by 2034, growing at a CAGR of almost 23%. In particular focus here is the treatment of solid tumours, which account for 90% of all cancers but have so far proven difficult to treat with cell therapies. Arovella in rare biotech club targeting CAR-iNKT therapies Arovella Therapeutics (ASX:ALA) is the only ASX-listed biotech delving into CAR Invariant Natural Killer T-cells (iNKT) therapies, and one of only a few globally. CEO Dr Michael Baker told Stockhead iNKT cells were distinct from the more familiar natural killer, or NK cells, which along with T-cells had limitations. T-cells can't be used off-the-shelf unless they are genetically engineered. While NK cells can quickly eliminate abnormal cells such as tumour cells, iNKT cells go further. Not only do they kill like T and NK cells, but they also trigger a longer-lasting response by activating other key parts of the immune system. Because iNKT cells recognise foreign threats differently – unlike classic CAR-T cells – it has been shown in clinical trials that iNKT cells do not cause complications like graft-versus-host disease (GvHD) when administered from a healthy donor to a patient. The FDA has approved seven CAR-T therapies to date, all for blood cancers, but no iNKT treatments. While over 120 global trials are investigating CAR-NK therapies for blood and solid tumours, CAR iNKT research remains limited. Baker said most cell therapies use the patient's own cells (autologous), but this was costly, slow, and relies on compromised cells. Arovella is taking an allogeneic approach, using healthy donor cells to create off-the-shelf, frozen doses shipped to clinics as needed in a 'ready-to-use' model. Its lead therapeutic ALA-101 combines iNKT cells with a CAR that targets CD19, a protein commonly found on B-cell blood cancers like lymphoma and leukaemia. One of Arovella's next key milestones is to apply to the FDA for its first-in-human trial, enrolling non-Hodgkin's lymphoma and leukaemia patients. The company's other key goal is also tackling solid tumours. "The first approved blood cancer targeting CAR-T products have demonstrated just how important cell therapies will be for cancer treatment," Baker said. "We look forward to using our CAR-iNKT cell platform to expand upon that work and aim to create products capable of increasing access and reducing costs. "There is a lot of great science that will continue to advance the off-the-shelf cell therapy sector. "That is why we continue to scour the globe for new IP to build into our CAR-iNKT platform, to either strengthen our CAR-iNKT cells or to broaden the cancer types that we can target.' Imugene also aims to crack solid tumours Imugene (ASX:IMU) is developing cell-based immunotherapies, including allogeneic CAR T-cell therapies, oncolytic viruses and B-cell vaccines, to address both blood cancers and solid tumours. The company's lead cell therapy candidate azercabtagene zapreleucel (azer-cel) is an off-the-shelf CAR T-cell therapy targeting CD19, a protein commonly expressed on malignant B-cells. There are no allogeneic (off the shelf) CAR T therapies approved to date. Azer-cel is currently undergoing clinical trials for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a hard-to-treat form of non-Hodgkin's lymphoma. In early-phase studies, azer-cel has demonstrated promising results, including high complete response rates and durable remissions in patients who have previously relapsed after autologous CAR T-cell therapies. "We are very pleased with the continued positive data coming from the azer-cel trial, which further reinforces its potential as a treatment for lymphoma patients who have failed on several previous therapies including auto CAR T," CEO and managing director Leslie Chong told Stockhead. Imugene's next-generation cell therapy platform OnCARlytics is designed to help overcome one of the biggest challenges in cancer treatment, making solid tumours visible to the immune system. The approach combines Imugene's proprietary CF33 oncolytic virus, which selectively infects and destroys cancer cells, with CD19-targeting CAR T-cells. The CF33 infects tumour cells and forces them to express CD19, a marker typically found on blood cancer cells but absent on solid tumours. By introducing CD19 into the tumour environment, the therapy effectively tags the cancer, allowing CD19-specific CAR T-cells to recognise and attack the tumour. Imugene's pipeline also includes multiple immunotherapy B-cell vaccine candidates, which involve inducing the body to produce polyclonal antibodies against specific tumour-associated antigens. The company's PD1-Vaxx is designed to generate antibodies that block the PD-1 receptor, potentially mimicking the effects of checkpoint inhibitors such as pembrolizumab (Keytruda). The company recently announced the first patient had been dosed in Australia as part of an investigator-sponsored Phase II Neo-POLEM clinical trial, which is evaluating PD1-Vaxx's potential to improve treatment outcomes for patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-high) colorectal cancer. This aggressive cancer subtype accounts for ~15% of all colorectal cancer cases. Chimeric advances cell therapy assets in solid tumours Chimeric Therapeutics (ASX:CHM) has three CAR T and NK cell assets in clinical trials. It has an ongoing phase 1/2 clinical trial for its novel CHM CDH17 CAR T-cell therapy targeting advanced colorectal cancer and Neuroendocrine tumours of the midgut. Their second program CHM CLTX CAR T is in a phase 1B clinical trial in recurrent/progressive glioblastoma, a form of brain cancer. CHM CORE-NK is a potentially best-in-class, clinically validated NK cell platform. Data from the complete phase 1A clinical trial, demonstrated safety and efficacy in blood cancers and solid tumours. Two additional Phase 1B clinical trials investigating CHM CORE-NK in combination regimens have been initiated in Acute Myeloid Leukemia (AML). "We're excited to be actively advancing in the clinic and pushing through dose levels as we break new ground in the solid tumour CAR T-cell therapy space," CEO Dr Rebecca McQualter told Stockhead. Prescient advancing cell therapy platforms While predominately focused on PTX-100, its first-in-class compound with the ability to block an important cancer growth enzyme geranylgeranyl transferase-1 (GGT-1), Prescient Therapeutics (ASX:PTX) is also advancing its proprietary OmniCAR and CellPryme platforms. OmniCar has potential to allow CAR T therapy cells to be more targeted, safer, more effective, cost-effective and of longer duration. CellPryme is a complementary application to OmniCar split into two components. CellPryme-M produces superior cells that are more potent and last longer, aiming to double tumour control. Meanwhile, CellPryme-A acts as an adjuvant therapy, increasing the expansion of CAR T-cells and enhancing their ability to penetrate the tumour. AdAlta adopts East to West cellular immunotherapy strategy AdAlta (ASX:1AD) and venture capital firm SYNthesis BioVentures Fund (SYNBV) launched AdCella in 2024 to adopt an East to West strategy and bring cutting-edge cellular immunotherapies from Asia, particularly China, into Western markets. SYNBV was co-founded by Professor Andrew Wilks, who alongside Amplia (ASX:ATX) CEO Dr Chris Burns received the 2024 Prime Minister's Prize for Innovation for co-inventing momelotinib, an FDA-approved treatment for myelofibrosis. The strategy leverages AdAlta managing director and CEO Dr Tim Oldham's deep expertise in cellular immunotherapies and extensive operational experience in Asia to identify and advance promising Asian cellular therapies that can be transitioned into regulated western markets. Oldham was previously CEO of Cell Therapies and said he'd been fortunate to witness firsthand the rapid evolution of China's biotech sector and remarkable progress in cellular immunotherapies for cancer treatment over the past 15 years. The East to West cellular immunotherapy strategy for cancer is now a core growth priority for AdAlta and a key driver of future pipeline growth and value creation.
News.com.au
13-05-2025
- Business
- News.com.au
Peter Mac's Cell Therapies powers ASX cancer plays
Peter MacCallum Cancer Centre is Australia's only public hospital dedicated to cancer care, research and education It is home to Australia's only biomedical facility capable of manufacturing CAR T-cells and other cell therapies at commercial scale – operated by Cell Therapies Several ASX companies have partnered with Cell Therapies as they work to develop their promising cancer therapeutics Melbourne's Peter MacCallum Cancer Centre – aka Peter Mac – is Australia's only public hospital dedicated to cancer care, research and education. Peter Mac has Australia's most extensive cancer research site in Australia, with more than 700 laboratory and clinical researchers, nurses, and support staff. Since its humble beginnings in 1949, the centre has been at the forefront of innovation in cancer diagnostics and treatment. It is a global leader in nuclear medicine and an early adopter of positron emission tomography (PET) imaging for cancer diagnosis. This year, the centre plans to evaluate GE HealthCare's next-generation total-body PET/CT scanner, designed to improve cancer detection, staging, and treatment planning. In partnership with the University of Melbourne, Peter Mac recently established the Collaborative Centre for Genomic Cancer Medicine. The Wilson Centre for Blood Cancer Genomics and Victorian Centre for Functional Genomics are also located at Peter Mac. The cancer centre actively partners in clinical trials with pharmaceutical companies of all sizes – from global giants to smaller players – giving patients access to cutting-edge treatments. And crucially Australia's largest TGA licensed cell and gene therapy contract development and manufacturing organisation (CDMO), Cell Therapies Pty Ltd, is co-located within Peter Mac. Cell Therapies' sovereign advanced manufacturing facility and highly-skilled workforce support clinical trial and commercial supply of innovative cell-based therapies such as Chimeric Antigen Receptor (CAR) T-cell therapies, for the treatment of cancer and other diseases. It was the commercial manufacturing partner for Novartis' Kymriah – the first CAR T-cell therapy approved by the US FDA back in 2017. "Our state-of-the-art clean rooms and production and testing facilities in Melbourne rank among the best in the world and paired with a highly specialised workforce, play a crucial role in enabling our Australian partners to advance the development of cutting-edge cell and gene therapies," Cell Therapies CEO Dr Bev Menner told Stockhead. Cell Therapies is integral to the success of several Australian companies focusing on CAR T-cell therapies and other cell-based therapies, which are showing promise in the treatment of cancers and other life-threatening conditions. AdAlta advances Cell Therapies with help from pioneer AdAlta (ASX:1AD) and venture capital firm SYNthesis BioVentures Fund (SYNBV) launched AdCella in 2024, with an East to West strategy to bring cellular immunotherapies from Asia, particularly China, into Western markets. AdAlta managing director Dr Tim Oldham was also CEO of Cell Therapies from 2013 to 2017 and said Peter Mac's capabilities were critical to the success of AdCella's East to West strategy. "Peter Mac's long history and capability in the delivery of CAR T-cell therapy is pivotal to our ability to attract innovation from Asia and further develop those technologies in Australia," Oldham told Stockhead. "Without those capabilities Peter Mac has developed we wouldn't be able to execute our East to West cell therapy strategy." Oldham said many globally leading cancer hospitals realised that to be at the forefront of new technologies such as CAR T-cell therapies they needed to be able to manufacture them onsite. "In Peter Mac's case they make their world-class cell therapies manufacturing capabilities available to not just their own researchers but other companies on a contract basis," he said. Cell Therapies manufactures Arovella's lead asset for clinical trial Arovella Therapeutics (ASX:ALA) also uses Cell Therapies as its CDMO to manufacture its lead therapeutic candidate ALA-101 as it prepares for a phase I clinical trial program. Arovella's proprietary allogeneic (one to many) platform uses healthy donor-derived invariant Natural Killer T (iNKT) cells, engineered with chimeric antigen receptors (CARs) to target specific cancer antigens. ALA-101 combines iNKT cells with a CAR that targets CD19, a protein commonly found on B-cell blood cancers like lymphoma and leukaemia. Arovella has licensed the manufacturing process, which is patent protected, from Imperial College London. "Arovella's worked with Cell Therapies for quite some time and over that journey we've developed an excellent working relationship and are highly impressed with the breadth and manufacturing work they can undertake," CEO Dr Michael Baker told Stockhead. Arovella is currently completing manufacturing of clinical batches of ALA-101 with Cell Therapies in preparation for first-in-human studies and aims to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA). This will enable the company to start is phase I trial for ALA-101 in CD19-positive blood cancer patients in CY25. Arovella also plans to present proof-of-concept data for its CLDN18.2-CAR-iNKT cell gastric cancer program in coming months. "Arovella is excited to take ALA-101 into clinical trials and the partnership between Arovella and Cell Therapies has been critical to make that happen," Baker said. "As we embark on our strategy to expand our pipeline with new programs targeting solid tumours, we look forward to strengthening our partnership with Cell Therapies." Chimeric looks to manufacture and bring trials to Peter Mac Clinical stage cell therapy company Chimeric Therapeutics (ASX:CHM) is also partnering with Cell Therapies to explore the potential to manufacture its CAR-T assets in Australia. Chimeric CEO Dr Rebecca McQualter told Stockhead that while the company is listed on the ASX, its operations have been US-based. "That is great for active trials running in the US but because we're an ASX company and focused on local shareholders we're focused on bringing our technology home," she said. Chimeric has three CAR T & NK cell assets all in clinical trials, two of which it would like to bring to Australia, funding permitted. It has an ongoing phase 1/2 clinical trial for its novel CHM CDH17 CAR T-cell therapy targeting advanced colorectal cancer. "Unfortunately, the rate at which people are being diagnosed with bowel cancer from 20 to 30 years old is significantly increasing so we'd like to bring a site to Australia so we're working to be able to do that with Cell Therapies," McQualter said. Their second program CLTX CAR T is in a phase 1B clinical trial in recurrent/progressive glioblastoma, a form of brain cancer. "Peter Mac has an amazing brain tumour CAR T program so because we have a site running in Austin, Texas they also want to open a site and that means manufacturing with Cell Therapies," McQualter said. "We can do everything end-to-end at Peter Mac and don't have to go anywhere else but we're still in the phase of funding our amazing ideas."
