Latest news with #Arovella
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
14-05-2025
- Business
- News.com.au
Biocurious: With its ‘molecular Lego' approach, Arovella is building hope for cancer patients one brick at a time
Arovella is one of only a handful of biotechs pursuing CAR-iNKT immunotherapies – and is the only ASX-listed exemplar The 'soldiers of the blood stream', CAR-iNKT cells offer potential advantages including easier off-the-shelf therapies The company plans to seek US FDA approval for its first-in-human trial of blood cancer patients Arovella Therapeutics (ASX:ALA) CEO Dr Michael Baker likens his company's cell therapy programs to building a Lego creation by adding new elements, one brick at a time. 'I refer to it as molecular Lego,' he says. 'We get the pieces of DNA we like and add them to the baseplate of cells.' Arovella is all about its core CAR-iNKT tech, which promises to deliver more effective off-the-shelf cancer immunotherapies. CAR-Ts are chimeric antigen receptor T-cells – and they have been around for a while. iNKTS are invariant natural killer T-cells, which could open a new frontier of cancer immunotherapy by overcoming some of the problems of CAR-Ts. Arovella is the only ASX-listed biotech delving into CAR-iNKT therapies – and one of only a handful globally. This quarter, the company expects to apply to the US Food & Drug Administration (FDA) to launch its first-in-human trial, enrolling non-Hodgkin's lymphoma and leukaemia patients. " Soldiers of the blood stream" iNKTs are elite beasts, accounting for a mere .01% to 1% of blood immune cells. In comparison, T-cells account for around 70% and natural killer (NK) cells another 15-20%. Dr Baker says because of their low propensity, iNKT cells were seen as having a less important role. The reality could be quite the opposite. Baker points to malignancies such as colorectal cancer, head and neck squamous cell carcinoma. 'If these patients have low iNKT cell counts, the prognosis is quite poor,' he says. 'That tells us this tiny population of cells is influencing the prognosis of these solid tumours. 'We see there's something unique and important about them.' More than extra 'i' and 't' Baker says iNKT cells are distinct from the more well-known natural killer, or NK, cells. It's more than a case of adding an extra 'I' and 'T'. Both T-cells and NK cells have limitations. 'T-cells can't be used off-the-shelf unless they are genetically engineered, which requires an extra step,' Baker says. 'NK cells can be given from one person to another, but the desired level of activity has not been seen to date.' NK cells are capable of quickly eliminating things in the body that are out of place, such as a tumour cells. 'But iNKT cells go a step further by influencing a longer-term immune response and activating other components of the immune system.' Given the different way in which iNKT cells recognise foreign objects, they are less likely than CAR-Ts to promote graft-versus-host disease when given from a healthy donor to patients. Pret a porter cells supersede bespoke approach To date, the FDA has approved seven CAR-T therapies – all for blood cancer – but no iNKT treatment. According to Biomed Central, more than 120 clinical trials globally are investigating CAR-NK therapies, for blood and solid cancer. ASX-listed CAR-T developers include Imugene (ASX:IMU), AdAlta (ASX:1AD), Prescient Therapeutics (ASX:PTX) and Chimeric Therapeutics (ASX:CHM). But CAR iNKTS research remains a rarefied field. Most of the treatments are based on using the patient's own cells - the autologous approach. This method is more bespoke but takes longer, is more expensive and uses potentially compromised cells. Arovella seeks to avoid the problems with the allogeneic method, by which cells are derived from healthy donors. The doses are deep frozen and shipped to clinical sites when needed. 'Once we get the manufacturing engine up for one program, future programs using different bits of Lego become a lot easier,' Baker says. Apart from 'pret a porter' cells, Arovella's other objective is to develop a therapy for solid cancers, which account for 90% of all cancers. Girding for first-in-human trial The phase 1 trial will enrol non-Hodgkin's lymphoma and leukaemia patients exhibiting the CD-19 biomarker, the target the company's CAR-iNKT cells recognise. While the planned trial is under the US 'investigational new drug' pathway, the company intends to carry out the initial dose escalation locally. The study then would expand to US sites. 'The dose escalation stage would enrol about 12 patients, expanding to 30-32 in the second leg,' Baker says. 'The patients will have a variety of blood cancers caused by B cells, the common element being they express the CD-19 on their surface.' Arovella also has a solid tumour program, for indications including gastric cancer. Building the asset, brick by brick Brick by brick, the company has acquired auxiliary programs to make the tech relevant to wider cancers. Last Monday, Arovella announced an exclusive option with the Baylor College of Medicine to licence two novel CAR receptors. These receptors target solid tumours, including neuroblastoma (highly prevalent in children) and hepatocellular carcinoma (liver cancer). The option also includes manufacturing technology and iNKT cell genetic modifications that 'may enhance Arovella's CAR-iNKT cell platform'. Both CARs have been studied in human clinical trials, reducing the need for extensive preclinical testing. Arovella has six months to decide whether to exercise the option, at an undisclosed price. In late 2023, Arovella signed an exclusive deal with Sparx Group, to develop a world-first iNKT cell therapy targeting a Claudin 18.2. Claudin 18.2 is expressed in gastric cancers, gastroesophageal junction and pancreatic cancers. The deal involves an equity-based upfront licensing fee and 'industry standard' cash and equity milestones. The company is on the lookout for other bolt-on programs to expand its indications or increase the potency of the treatment. 'For the Lego to work, the marker needs to be on the surface of the cancer cells and it also need to be absent from healthy cells," Baker says. The US vibe: alert but not alarmed Baker is keeping a clear head about the sweeping changes affecting the US healthcare sector, which this week was manifested in Donald Trump's intention to reduce US drug prices by as much as 80%. 'We can see there will possibly be more big changes to the FDA and the National Institutes of Health," he says. Last week, Vinay Prasad was appointed as the head of FDA's Center for Biologics Evaluation and Research. Given Prasad has a history of criticising the FDA, his appointment could result in stricter approval processes. 'It's best to work with the information we have and remain level-headed and don't assume anything,' he says. 'We don't know stance on cell and gene therapies, but it may be quite promising. Until we have concrete information, we just continue to put our best foot forward.' Don't Lego of the dream With cash of $23 million after a recent $15 million raising, Arovella is funded to fully enrol the phase I study and progress to interim reporting stage. It's also enough to complete studies to enable an FDA appication to launch a Claudin 18.2 trial. Meanwhile, Arovella shares have lost half their value since the start of the year. Across the sector, many investors have been spooked by the failure of eye disease house Opthea's two phase III trials. Another reason was that during Arovella's recent placement, a cornerstone Australian-based private investor failed to settle. 'It's not going to go unnoticed with a public company when a cornerstone investor doesn't settle,' Baker says. 'Despite the deteriorating market sentiment, we went back to the market to complete the capital raise. 'We are now incredibly well funded with great programs coming and we look forward to getting more milestones ticked off and restoring shareholder value.' With the building blocks in place, can Baker look forward to adding 'Lego Master' to his achievements, which include a doctorate in biochemistry? 'We will find out in 12 months' time when we have the data coming through from phase I,' he says.
News.com.au
05-05-2025
- Health
- News.com.au
WTF with ALA: What are iNKT cell therapies?
What are iNKT cell therapies, how do they work, and why are they promising for cancer treatment? Arovella Therapeutics (ASX:ALA) managing director and CEO Dr Michael Baker joins host Tylah Tully to to explore these questions and more. The company's focused on developing its innovative invariant natural killer T (iNKT) cell therapy platform, with its lead program, ALA-101, targeting blood cancers. While Arovella didn't invent iNKT cells – they occur naturally in the human body – the company is harnessing their unique properties to fight cancer. Baker explains how iNKT cells could transform the patient experience over the next five to ten years and potentially treat both deadly blood cancers and solid tumours. While Arovella Therapeutics is a Stockhead advertiser, it did not sponsor this content. The interviews and discussions in this video are opinions only and not financial or investment advice.
