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.
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