Latest news with #JamesMcDonnell
Mercury
12 hours ago
- Business
- Mercury
Prescient raises $9.8m to drive cancer therapies
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. Investors back Prescient with applications for $3m placement Brings total funds raised from the placement and recent SPP to $9.8m The company will use the funds to support its cancer treatment Special Report: Prescient Therapeutics has raised $3m in a placement to sophisticated and professional investors following a $6.9m SPP for a total $9.8m to advance its pioneering cancer treatment therapies. The clinical stage oncology company will use the funds to support the continued Phase 2 clinical development of its targeted therapy, PTX-100, which is progressing through clinical trials toward potential regulatory approval and access for patients. Two dosage levels of PTX-100 are being evaluated in an open-label design in up to 40 patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) across multiple sites in Australia, the US and Europe in its current Phase 2a study. CTCL is a rare cancer affecting white blood cells known as T cells, which normally help regulate the immune system. In CTCL, these cancerous T Cells migrate to the skin, where they grow, divide and attack uncontrollably. Treatment options remain limited for patients whose disease has relapsed or become resistant to therapy. On a mission to improve outcomes for cancer patients More than 74m shares are expected to be issued under the placement at 4c per share, the same price as the SPP. Prescient Therapeutics (ASX:PTX) CEO James McDonnell said this marks a significant step forward for the company and empowers the advancement of PTX-100 through Phase 2a development. 'I would like to thank all investors for their support of Prescient and its mission to improve outcomes for cancer patients,' he said. 'We eagerly look forward to the milestones ahead with the potential to turn the Phase 2b clinical study into a pivotal registrational study and setting the stage for PTX-100's potential market entry.' This article was developed in collaboration with Prescient Therapeutics, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as Prescient Therapeutics takes cap raise to $9.8m to fast-track cancer treatment
Mercury
4 days ago
- Business
- Mercury
Prescient advances cancer drug to unlock value
Prescient at critical stage of development with phase 2a trial underway for PTX-100 PTX-100 granted orphan drug and fast track designations by the US FDA, unlocking benefits Focus on advancing PTX-100 to potential registrational phase 2b trial to open commercial opportunities Special Report: Prescient Therapeutics has entered a critical stage where clinical data, regulatory support, and commercial potential begin to converge in a defining moment for a biotech company aiming to bring a new therapy to market. Prescient Therapeutics (ASX:PTX) is in phase 2a trial for its lead compound PTX-100 in patients with rare blood cancer relapsed/refractory Cutaneous T-Cell Lymphoma (r/r CTCL) with the potential for its phase 2b arm to be registrational. PTX-100 is a first-in-class compound with the ability to block an important cancer growth enzyme geranylgeranyl transferase-1 (GGT-1). It is believed to be the only GGT-1 inhibitor in the world in clinical development. The US Food and Drug Administration (FDA) has granted PTX-100 orphan drug designation (ODD) for all T-cell lymphomas and fast-track designation for treatment of adults with relapsed or refractory mycosis fungoides, the most common subtype of CTCL. Fast Track designation provides an expedited pathway to approval, with orphan drug designation offering market exclusivity for a period of seven years in the US. 'The aim is to improve the quality of life for people suffering from this terrible form of cancer and getting them the therapy they need as fast as possible,' CEO James McDonnell said. 'It's also an incentive for larger pharmaceuticals who are looking to add to their portfolio as the drug progresses through clinical development.' Potential regulatory trial for PTX-100 McDonnell is focused on getting PTX-100 through the phase 2a trial with the potential to make the second phase 2b arm a registration study. 'Fast Track designation opens a dialogue with the FDA for companies to provide ongoing trial updates, instead of a lengthy review at the end, to expedite therapies to patients who desperately need them,' he said. 'All we need to do is replicate the Phase 1b results, if the FDA agrees, they could potentially authorise Phase 2b as a registration study.' In the phase 1b trial PTX-100 delivered a 45% overall response rate and 64% clinical benefit in T-cell lymphoma, with just 4% serious side effects – well below the 30% benchmark. 'The first step now is to progress Phase 2a where we can define a dose which will also have some efficacy and safety data,' McDonnell said 'The registrational study means we are closer to approval and the momentum for PTX-100 really starts to accelerate and excitement grows on the commercial front.' Watch: James McDonnell discusses the first US site for the Phase 2a trial of PTX-100. Eyes on the commercialisation prize With over 27,000 new TCL cases every year, in eight major centres, PTX is targeting a market worth ~US$1.8 billion. Commercialisation of PTX-100 will become a key focus for Prescient if it advances to a registrational study, with all options on the table – including partnership, licensing, or taking the drug to market independently. 'We are confident in how PTX-100 could change the lives of thousands, we need the data now to back that confidence and provide the market a clear indication of the value the therapy can provide,' he said. 'PTX-100 is a first-in-class therapy with a unique mechanism of action which has shown very good results in the Phase 1b study. 'These results have exceeded our benchmarks and compare well to the available therapies on efficacy, duration and a safety perspective.' McDonnell said that Dimerix (ASX:DXB) was a great example of what a potential commercial pathway could look like for Prescient if Phase 2b became a registrational trial. Dimerix is advancing its lead candidate DMX-200 through the ACTION3 phase 3 trial for the rare kidney disease FSGS and has secured four regional licensing agreements to drive commercialisation. 'They were able to take orphan drug designated therapy DMX-200, which is currently in a phase 3 registration study, into significant licensing agreements worth approximately $1.4 billion,' he said. 'Dimerix have highlighted how these milestones, FDA designation and registrational study, can open commercialisation opportunities and drive value creation.' McDonnell said in biotech it often comes down to two questions with the first being: can you get a product to market? The second is: what kind of market is waiting at the end? Phase 2 trials usually provide clearer insights into a drug's potential, with data readouts serving as critical indicators that can drive value inflection points. Source: Prescient Therapeutics A series of upcoming catalyst Investors have plenty to watch out for in H2 CY25, with Prescient advancing its phase 2a study. 'We are excited for the release, once we reach 20 patients, of the initial data from the dose optimisation committee review, which will be a key event in determining the next steps for development of PTX-100,' McDonnell said. A share purchase plan aimed at raising $7 million to support Prescient's clinical program closed on July 25. 'There are several milestones we are looking to hit in the coming months and if we can potentially get that Phase 2b into a registration study we can start to shift our focus toward commercialisation opportunities,' McDonnell said. This article was developed in collaboration with Prescient Therapeutics, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as Prescient focuses on advancing lead cancer drug toward pivotal trial
News.com.au
08-07-2025
- Health
- News.com.au
WTF with PTX: Changing the game for T-Cell Lymphoma
What is Relapsed or Refractory T-Cell Lymphoma? Why is it so difficult to treat? What therapies currently exist? And what changes can the healthcare sector make in this area? Tylah Tully is joined in this episode by Prescient Therapeutics (ASX:PTX) CEO James McDonnell to answer these questions and more. This video was developed in collaboration with Prescient Therapeutics, a Stockhead advertiser at the time of publishing. This video does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as WTF with PTX: Changing the game for T-Cell Lymphoma
BBC News
30-06-2025
- Sport
- BBC News
Batchelor among six uncapped players to get call
Hull KR's James Batchelor and Leeds pair James McDonnell and Morgan Gannon are among six uncapped players called up for an England squad get-together to prepare for the autumn Ashes forward Batchelor has played a key role in his club's bid for a treble as they seek to add the League Leaders' Shield and, ultimately, Grand Final success to the Challenge Cup they won at Wembley in has switched his allegiance to England, having represented Ireland at the last World Cup in Robertson and George Delaney of St Helens as well as Owen Trout of Leigh Leopards are also called into an England squad for the first face three home Tests against Australia - at Wembley on 25 October, Everton's new Hill Dickinson Stadium on 1 November and AMT Headingley on 8 November. All three Tests will be televised live in the UK by the coach Shaun Wane's gathering is being described officially as an "off-feet squad session" with the emphasis on giving the players some time together during a busy and physically demanding domestic season without disrupting their club format means he has been able to call up three players who are currently recovering from long-term injuries - Warrington pair Matty Ashton and Danny Walker, and St Helens full-back Jack said: "It's been hard finding chances for the players to get together in such a busy Super League season, so it will be good for them to spend some time together thinking about the challenges ahead."England squad: Matty Ashton (Warrington Wolves), James Batchelor (Hull KR), Daryl Clark (St Helens), Ben Currie (Warrington Wolves), George Delaney (St Helens), Morgan Gannon (Leeds Rhinos), Ash Handley (Leeds Rhinos), Ethan Havard (Wigan Warriors), James Harrison (Warrington Wolves), Tom Holroyd (Leeds Rhinos), Tom Johnstone (Wakefield Trinity), Morgan Knowles (St Helens), Matty Lees (St Helens), Jez Litten (Hull KR), Mikey Lewis (Hull KR), Liam Marshall (Wigan Warriors), James McDonnell (Leeds Rhinos), Mike McMeeken (Wakefield Trinity), Elliot Minchella (Hull KR), Robbie Mulhern (Leigh Leopards), Harry Newman (Leeds Rhinos), Junior Nsemba (Wigan Warriors), Mikolaj Oledzki (Leeds Rhinos), Brad O'Neill (Wigan Warriors), Harry Robertson (St Helens), Harry Smith (Wigan Warriors), Luke Thompson (Wigan Warriors), Owen Trout (Leigh Leopards), Danny Walker (Warrington Wolves), Jake Wardle (Wigan Warriors), Jack Welsby (St Helens), George Williams (Warrington Wolves). A chance to foster team spirit - analysis While on-pitch sessions might be hard to come by for England head coach Shaun Wane because of an unrelenting domestic schedule, he at least has the ability to bring together his squad for some team building and make-up of the squad is interesting. There are those who have earned their place for consistency in England colours such as Harry Smith, Mike McMeeken, George Williams and Daryl Clark, and those who despite infancy as international players are essential picks, such as Junior there are those who have played their way into contention. Leigh's Owen Trout has showed his athleticism and versatility as a pack-man, playing second row and front row with ease, while the exciting Harry Robertson comes in having offered St Helens depth in a number of backline roles. Leeds' back-row pair of Morgan Gannon and James McDonnell have also shown consistency and combination at club has tapped into Hull KR's presence as a Super League force with James Batchelor following in brother Joe's footsteps to earn international recognition, alongside Elliot Minchella, Jez Litten and reigning Man of Steel Mikey Wane won't get to run the rule over this exciting mix of talent - which will later in the year be bolstered by the NRL-based players - on the paddock but he will get a chance to assess those have spoken glowingly of Wane's camps from a team-moulding perspective so if nothing else, it will continue to foster a sense of 'team' within players who spend a season bashing each other and then combine as one to face their greatest opponent yet in the Kangaroos.
