Latest news with #Amplia
News.com.au
15-05-2025
- Business
- News.com.au
Health Check: Amplia shares surge on pancreatic cancer trial results; Immutep offers hope
Amplia says it has reached the requisite level of 'partial responders' in its mid-stage pancreatic cancer study Immutep reports 'remarkable' response rates in a German-based lung cancer trial Paradigm wins US ethics approval for knee osteoarthritis trial Given it's National Palliative Care Week, it's apt that two drug developers have posted hopeful trial updates pertaining to two of the most deadly cancers. Amplia (ASX:ATX) reports the latest results from its ongoing phase Ib/IIa pancreatic cancer trial are 'superior to chemotherapy alone'. The trial, dubbed Accent, is testing Amplia's narmafotinib (AMP-945), a focus kinase (FAK) inhibitor. The study combines AMP-945 with two widely used chemotherapies. Amplia confirmed a 'partial response' in 15 patients. That's "a level of response sufficient to demonstrate that the combination of narmafotinib and chemotherapy is superior to chemotherapy alone'. A partial response means a tumour has shrunk more than 30%, with the benefit sustained for two months or more. 'As pancreatic cancer is highly aggressive, it is extremely rare for patients to achieve a complete response,' the company says. Under the open-label trial design, all patients receive narmafotinib and the standard of care chemo, with the results compared to historic data. Since January 2024, Amplia has enrolled 55 advanced pancreatic cancer in the study, with 21 patients still involved. The company says 15 out of 50 patients would be enough to demonstrate efficacy 'with reasonable confidence'. FAK inhibitors are especially relevant for fibrotic tumours such as pancreatic and ovarian cancer. Amplia expects to release top-line data from the fully recruited trial in around October this year. The trial is being conducted at seven sites in Australia and five sites in South Korea (which, not coincidentally, has a high rate of pancreatic cancer). Immutep's efti spurs hefty share surge Immutep (ASX:IMM) shares bounced up to 11% this morning after the cancer immunotherapy developer reported 'remarkable' patient response rates in a German lung cancer trial testing its lead compound, efti. The trial, Insight 003, enrolled patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Proprietary to Immutep, efti (eftilagimod alfa) is a protein called Lymphocyte Activation Gene-3 (LAG-3), which stimulates the body's immune response to cancer. In a triple combo approach worthy of a Hungry Jack's menu, the subjects were delivered efti alongside the immune checkpoint inhibitor Keytruda and standard chemo. Admittedly, Immutep's dense announcements are too much for your scribe's frazzled synapses. Let's just say there's an interplay with PD-L1, a predictive biomarker expressed in cancers including lung and melanoma. PD-L1 is typically expressed on healthy cells and acts as the 'brake' preventing immune cells from attacking healthy tissues. High PD-L1 expression means the cancer cells can evade the immune system. While immune checkpoint inhibitors have revolutionised cancer treatment, as many as 80% of NSCLC patients do not respond to anti-PD-L1 monotherapy. The trial results showed a 60.8% response rate – the incidence of cancers shrinking or disappearing – compared with 48% for historical control data. Encouragingly, the triple combo worked best for patients with a PD-L1 score below 50% - a 59.6% response rate compared to 40.8% for the control data. 'These patients … have a high unmet need and represent over two-thirds of the NSCLC patient population,' the company says. The study is an adjunct to Immutep's main game: a pivotal phase III NSCLC combination trial, Tacti-004. 'Across two trials we have now efficacy data from 165 patients with NSCLC who have been treated with efti and Keytruda, either with or without chemotherapy,' Immutep chief Marc Voigt says. 'In multi-national settings, efti has generated consistent and remarkable improvements in response rates.' The investigator-led Insight-003 trial is being carried out at the Frankfurt Institute of Clinical Cancer Research and other German centres. Immutep is evaluating efti for other solid tumours including head and neck squamous cell carcinoma (HNSCC) and metastatic breast cancer. The US Food and Drug Administration (FDA) has bestowed fast track designation for efti, for first-line treatment of HNSCC and NSCLC. Paradigm gets the US go-ahead for pivotal knee trial Paradigm Biopharmaceuticals (ASX:PAR) has won US ethics approval to start its long-awaited phase III trial for knee osteoarthritis (OA), availing of a new streamlined procedure. The company plans to enrol 466 patients with moderate to severe OA in the pivotal trial, across 55 US sites. The first subject should enlist in the September quarter. Paradigm's treatment is an injected, repurposed drug candidate called pentosan polysulphate sodium, or iPPS. A central review board granted the ethics approval, which obviates the need for site-by-site clearance. The FDA approved the trial protocol in November last year. Australia's ethics gatekeeper also has granted approval, allowing Paradigm to initiate 10 clinical sites here. Patient recruitment is underway. The company cites a poultice of real-world evidence about iPPS's efficacy – notably former football with dodgy knees. But regulators want to see a randomised, double-blind, placebo-controlled effort, as per the Paradigm trial. Knee OA affects millions of people, yet there's no effective treatment. The company hopes an approved drug will reduce opioid use. With its anti-fibrotic action, iPPS may go further than just alleviating the symptoms and improve the fundamental condition of the joints. As at the end of March Paradigm had cash of $24.5 million – not enough to fully fund the trial. But in late January the company announced loyalty options, exercisable at 65 cents by February next year. Add-on 'piggyback' options are exercisable at $1 by February 2028. With Paradigm shares trading at just over 30 cents these options are not in the money, but if fully exercised would raise up to $112 million. Pause for thought Shares in HeraMED (ASX:HMD) and Chimeric Therapeutics (ASX:CHM) have entered trading halt today. The developer of foetal monitoring device, Heramed expects to issue a material update on its 'go-to-market strategy in the US due to changes in the business environment'. We'll know more on Monday. Cancer immunology player Chimeric has requested a 'temporary halt pending a further announcement'. Chimeric shares have been hammered by the healthcare upheaval in the US, where the company carries out third-party funded trials.
News.com.au
30-04-2025
- Business
- News.com.au
Health Check: Impedimed says ‘nuts' to tariffs as it squirrels away components
By stockpiling components, the US-focused Impedimed is taking no chances with tariffs Cashed-up Amplia forges ahead with promising pancreatic cancer trial Some biotechs are headed to the well, while others are rolling in the green stuff The maker of Sozo lymphoedema measurement devices, ImpediMed (ASX:IPD) says it will spend $1.2 million to stockpile foreign componentry in the US. CEO Parmjot Bains today said the items would be bought at 'pre-tariff prices to further reduce the risk of disruption.' Earlier this month Impedimed said it expected 'no material impact' from tariffs, given its Sozos are made in the US from 'substantial US componentry'. But the squirrelling of parts – mainly electronic components ultimately sourced from Asian countries including Taiwan and Malaysia – highlights the measures US exposed device and drug makers are taking to avoid any collateral damage. The Trump administration has plonked a 32% tariff on Taiwan – the world's computer chip capital – although the impost is on pause and open for negotiation with the Great Dealmaker. Impedimed, meanwhile, has pledged to rev up its US sales. This is despite posting record March quarter revenue of $3.4 million, 31% higher year on year. The company sold 36 Sozo units, 22 in the US. "While there's a lot to like in the result … we still need to see a significant acceleration in US sales," Bains said. And sales teams take note: she expects improved US turnover for the rest of the calendar year. After burning $3.5 million during the quarter, Impedimed had a lush $27.8 million cash balance. This includes a US$10 million drawdown on a US$15 million loan facility. Hitherto assessed with a tape measure, lymphoedema is the swelling of limbs because of cancer treatment. Amplia advances pancreatic cancer trial Amplia (ASX:ATX) today said it had $10.9 million in its kitty after expending $2.7 million during the quarter. This makes management even more confident of completing its encouraging local pancreatic cancer trial. Dubbed Accent, the 55-patient phase IIa trial tests Amplia's narmafotinib (AMP-945) alongside the standard-of-care chemotherapy (gemcitabine). In an update on Monday, the company said of the 29 advanced pancreatic cancer patients assessed to date, 11 had a partial response. This means they had a tumour shrinkage of 30% or more, sustained for at last two months. This response rate of 38% compares with the historical average of 23% for chemo alone. The results also show the patients remained on the trial for a median 208 days, compared with 117 days for the chemo-alone group. 'That's probably the most important data, because we expect that will translate into progression-free survival (PFS) data and ultimately overall survival (OS).' says Amplia CEO Dr Chris Burns. Burns, by the way, co-invented the US-approved myelofibrosis drug Ojjaara. PFS is the length of time a patient lives with a disease without the disease getting worse. OS is the length of time from diagnosis or treatment until death, regardless of the cause of death. 'That's what you care about as a patient: how long am I able to take these drugs to stop the disease progressing," Burns says. The company expects a read-out on PFS data in the September quarter. Pancreatic cancer is one of the deadliest of all cancers, with an average nine months' life expectancy with the current chemotherapy. 'Commercially, while it is challenging you don't have to do a lot for it to be meaningful,' Burns says. Time to rattle the can … With today marking the cut-off for March quarter reports, lodgements are flooding in like Wivenhoe Dam after one of these one-in-100-year floods that happen every couple of years. While there's plenty of cheer, some biotechs clearly need cash if they are to remain viable. A developer of natural pesticides and insecticides, Bio-Gene Technology (ASX:BGT) had cash burn of $644,000 and no revenue, reducing its cash to $683,000. 'A capital raising is imminent and the company believes these activities will be successful in raising cash,' the company says. Bio-Gene also has US$3 million in grants across two US military programs, including a push to banish bed bugs (an itchy problem in those shared dorms). Opyl (ASX:OPL) late yesterday reported receipts of $2000 and burn of $262,000, taking its cash to a mere $64,000. The company also has $380,000 of drawn loans and $25,000 of loan headroom. Today, Opyl shares entered trading halt as the company was 'considering, planning and executing a capital raising'. Opyl is interesting, having developed an algorithmic tool to predict the outcome of clinical trials (and to run them optimally). The developer of blood and glucose tests and quality control assays for winemakers, Universal Biosensors (ASX:UBI) upped receipts by 28%, to $1.6 million. But the company's burn of $3.7 million reduced cash to $4.9 million. Universal is having capital raising discussions with 'various interested stakeholders' and the 'likelihood of success is high'. Device innovator Hydrix (ASX:HYD) has a lot of groundbreaking projects. But with its cash whittled down to $289,000, short-term survival is the key and management is taking action including chasing tardy debtors. … while others are rolling in cash Mesoblast (ASX:MSB) burnt through US$12.7 million but has a handy US$182 million in the bank as it commercialises its now US-approved treatment for paediatric graft-versus-host disease. Genetic Signatures (ASX:GSS) is also strongly positioned, with $37.4 million of cash, having burnt a modest $300,000 in the quarter. Genetic also posted $2.9 million of sales, up 71%. As with Mesoblast, the company is in the early stages of US commercialisation, for its recently approved gastrointestinal bug test Easyscreen. Percheron Therapeutics (ASX:PER) burnt $4.47 million during the quarter and ended up with $12.9 million of cash. The dosh is the residue of a capital raising to support Percheron's now-abandoned Duchenne muscular dystrophy program. Having survived a second board spill last week, management is scouring for an alternative asset to deploy the residual spendoolies. Orthocell (ASX:OCC) earlier reported a generous cash balance of $31.7 million. That's more than enough to support Orthocell's product commercialisation including the rollout of its Remplir nerve repair device in the US. But the stock spiked up to 13% this morning for a different reason: Canada – a.k.a. the 51 st state – has also approved Remplir.
