Latest news with #AvactaTherapeutics
Yahoo
28-04-2025
- Business
- Yahoo
CISION® Candidate FAP-Dox (AVA6000) at the 2025 AACR Annual Meeting
Compelling Phase 1 safety and efficacy data for FAP-Dox (AVA6000) with preliminary evidence of efficacy in salivary gland cancers and no severe cardiac toxicity Progression free survival (PFS) data to date represents a near doubling of the benchmarking data in this patient population without reaching median PFS LONDON and PHILADELPHIA, April 28, 2025 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announced Phase 1 data from its lead program FAP-Dox (AVA6000), that were presented alongside preclinical pharmacokinetic results from its second pre|CISION® candidate AVA6103 (FAP-EXd) at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL. Both programs are designed to target fibroblast activation protein-alpha (FAPα), the protease that forms the basis of the pre|CISION® platform. FAP is consistently overexpressed across a broad range of solid tumors and enriched at the tumor-stroma interface, making it an ideal target for tumor-localized drug activation. Avacta's proprietary pre|CISION® chemistry leverages this tumor-specific biology to activate potent drugs selectively at the tumor site, enhancing efficacy while minimizing systemic toxicity. "Today's clinical results mark the achievement of a proof-of-concept milestone with our proprietary pre|CISION® platform demonstrating meaningful activity,' said Christina Coughlin, CEO of Avacta Therapeutics. 'With AVA6000 demonstrating strong early signs of efficacy in a specific patient population of salivary gland cancers and a differentiated safety profile, we are not only validating a tumor-targeted approach to cytotoxics delivery – we are establishing a foundation for this new class of precision oncology therapeutics. These data underscore the tremendous potential of our pipeline to deliver meaningful benefits for patients and drive sustained value creation for our key stakeholders.' AVA6000 (FAP-Dox) Clinical Highlights (Abstract #CT15, Apil 29, 2025) AVA6000 is a FAP-activated form of doxorubicin designed to reduce the systemic side effects of conventional chemotherapy. In the Phase 1a dose-escalation study, AVA6000 was well-tolerated across both every-three-week (Q3W) and every-two-week (Q2W) dosing regimens. No maximum tolerated dose (MTD) was reached despite dosing up to 385 mg/m² every three weeks. In patients with salivary gland cancers (SGC, n=11) treated at or above the dose level of 250 mg/m2, AVA6000 demonstrated multiple confirmed responses and a disease control rate of 91%. Median progression-free survival (PFS) has not yet been reached, with median follow-up exceeding 25 weeks (25.3 weeks, 5.9 months). These FAP-Dox PFS results compare favorably to recent benchmarking data in this patient population presented at ESMO 2024, with a reported PFS of 3.5 months (15 weeks) in a large cohort (n=54) in a similar setting of pretreated patients with SGC (Licitra et al. ESMO 2024). Despite dosing up to 4x the dose of conventional doxorubicin, the exposure of released doxorubicin in plasma and normal tissues is lower than that observed with conventional dose doxorubicin (75 mg/m2 Q3W) and the median tumor to plasma ratio is 100:1. In addition, no severe cardiac toxicity was observed, further supporting a markedly improved safety profile over conventional doxorubicin. The lack of toxicity is explained by the limited tissue distribution as well as limited first pass effect exposure of released doxorubicin. The full Phase 1a data across all patients (n=63), including a full assessment of the cardiac safety data with long-term follow-up are expected in the second half of 2025. Avacta continues to enroll patients in three Phase 1b expansion cohorts in salivary gland cancer, triple negative breast cancer and high-grade soft tissue sarcoma with data anticipated by the end of 2025. Abstract Number and Title: #CT15: Comparative pharmacokinetics and tumor activation of fibroblast activation protein (FAP)-enabled pre|CISION® peptide drug conjugates· Session Title: First-in-Human Phase I Clinical Trials 2· Session Date and Time: Tuesday, April 29, 2025, 9:00 a.m. - 12:00 p.m. CT For further information from Avacta, please contact: Avacta Group plcMichael Vinegrad, Group CommunicationsDirector Peel Hunt (Nomad and Broker)James Steel / Chris Golden Panmure Liberum (Joint Broker)Emma Earl / Will Goode / Mark Rogers ICR HealthcareMary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert avacta@ Investor ContactRenee Leck THRUST Strategic Communications renee@ Media ContactCarly ScadutoCarly Scaduto Consulting Carly@ About Avacta - Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION® platform. pre|CISION® is a proprietary warhead delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent warheads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates. About the pre|CISION® PlatformThe pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for in to access your portfolio
Yahoo
28-04-2025
- Business
- Yahoo
Avacta Therapeutics Presents Preclinical and Translational Data from pre
FAP-EXd (AVA6103) demonstrates tumor growth inhibition and durable complete responses in multiple therapy-resistant preclinical models LONDON and PHILADELPHIA, April 28, 2025 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announced preclinical results from its second pre|CISION® candidate FAP-EXd (AVA6103) and new analyses around the potential of the pre|CISION® platform at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL. The pre|CISION® programs are designed to target fibroblast activation protein-alpha (FAPα), the protease that forms the basis of the platform. FAP is consistently overexpressed across a broad range of solid tumors and enriched at the tumor-stroma interface, making it an ideal target for tumor-localized drug activation. Avacta's proprietary pre|CISION® chemistry leverages this tumor-specific biology to activate potent drugs selectively at the tumor site, enhancing efficacy while minimizing systemic toxicity. "The encouraging results we are showcasing at this year's AACR Annual Meeting highlight the versatility of our pre|CISION® platform,' said Michelle Morrow, CSO of Avacta Therapeutics. 'Our data presented today demonstrate that the platform can deliver potent payloads like exatecan with remarkable tumor selectivity and our novel sustained release mechanism. Together, these programs reinforce the broad potential of our pipeline to transform outcomes for patients and generate long-term value for shareholders.' AVA6103 (FAP-EXd) Preclinical Candidate Highlights (Abstract 3139, 28 April 2025) Avacta presented preclinical data from its second clinical candidate, AVA6103, a novel FAP-activated pre|CISION® PDC delivering the topoisomerase I inhibitor exatecan directly to the tumor-stroma interface. This mechanism minimizes systemic toxicity while ensuring precise delivery of the cytotoxic agent directly to the tumor with a sustained release mechanism that optimizes the pharmacokinetics of the released payload. Importantly, despite a very short half-life of 9 hours with conventional exatecan, FAP-EXd (AVA6103) is capable of delivering high tumor concentration vs. plasma with exposures of more than 60 hours projected with a single dose. Additionally, FAP-EXd's bystander effect enables exatecan to induce cytotoxicity in surrounding FAP-negative cancer cells, enhancing its therapeutic impact. The compound has demonstrated significant tumor growth inhibition and durable complete responses in multiple patient-derived xenograft models, including those that are resistant to topoisomerase I inhibition. These results reinforce the potential of FAP-EXd to deliver effective, targeted treatment with minimal off-target effects. The investigational new drug (IND) submission is anticipated in December 2025 and initiation of the first-in-human study in the first quarter of 2026. Abstract Number and Title: #3139: The novel PDC AVA6103 is a FAP-enabled pre|CISION® medicine which targets exatecan, a topoisomerase I inhibitor, to the tumor microenvironment following FAP cleavage· Session Category: Experimental and Molecular Therapeutics· Session Title: Therapeutic Approach to Attack the Tumor Microenvironment· Session Date and Time: Monday, April 28, 2025, 2:00 - 5:00 p.m. CT FAP Targeting Approach with pre|CISION® medicines (Abstract 2699, 28 April 2025) FAP is overexpressed across a wide range of solid tumors, with estimated frequency of over 90% of patients with evidence of FAP expression. This expression is spatially enriched at the tumor-stroma interface, demonstrating the effective nature of the pre|CISION® mechanism to deliver highly potent payloads directly to the tumor. Given the broad expression of FAP in human solid tumors and correlation of the protein and RNA levels of FAP, an AI-based approach to this target was employed with the Avacta strategic collaboration with Tempus. Avacta's work with Tempus has demonstrated several key aspects of the pre|CISION® platform, namely (1) FAP expression remains consistent across lines of therapy and in pre- and post-tumor samples, and (2) co-expression of genes associated with sensitivity to the payload and FAP identify the optimal patient populations for pre|CISION® medicines including FAP-EXd. These data reinforce the potential of Avacta's pre|CISION® platform to deliver potent therapies across multiple solid tumor indications with broad clinical utility. Abstract Number and Title: #2699: Investigating fibroblast activation protein alpha (FAPα) as a therapeutic target for delivery of pre|CISION® cancer medicines: Expression, spatial localization and functional insights· Session Category: Tumor Biology· Session Title: Targeting the Tumor Microenvironment: A Brave New World· Session Date and Time: Monday, April 28, 2025, 2:00 - 5:00 p.m. CT For further information from Avacta, please contact: Avacta Group plcMichael Vinegrad, Group CommunicationsDirector Peel Hunt (Nomad and Broker)James Steel / Chris Golden Panmure Liberum (Joint Broker)Emma Earl / Will Goode / Mark Rogers ICR HealthcareMary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert avacta@ Investor ContactRenee Leck THRUST Strategic Communications renee@ Media ContactCarly ScadutoCarly Scaduto Consulting Carly@ About Avacta - Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION® platform. pre|CISION® is a proprietary warhead delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent warheads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates. About the pre|CISION® PlatformThe pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for patients.
Yahoo
31-03-2025
- Business
- Yahoo
Avacta Provides Business Update for the First Quarter of 2025 Outlining Progress Against Strategic Objectives
AVA6000 Phase 1b expansion cohorts enrolling with data targeted for later in 2025 AVA6103 IND-enabling studies underway with a Phase 1 trial anticipated to begin in the first quarter of 2026 Multiple presentations at the AACR Annual Meeting highlight the promise of the pre|CISION® platform Transformation into a pure-play therapeutics company prioritizes proprietary pre|CISION® platform and extends cash runway into Q1 2026 LONDON and PHILADELPHIA, March 31, 2025 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT, 'the Company'), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today provides a business update on progress for the first three months of 2025 and a review of upcoming milestones. Christina Coughlin, M.D., Ph.D., Chief Executive Officer of Avacta, said: 'We made a strong start to 2025, continuing to make excellent progress against all of our strategic objectives. We are very encouraged by the Phase 1 data from FAP-Dox (AVA60000) so far, which continue to show an excellent tolerability profile and increasingly durable responses in salivary gland cancers. We are now enrolling in multiple dose expansion cohorts, including triple negative breast cancer with preliminary data targeted for later in 2025. 'Our pre|CISION®-enabled exatecan program (FAP-EXd, AVA6103) also continues to progress toward a Phase 1 trial initiation early next year, underscoring our deep commitment to pioneering a novel, differentiated class of medicines to revolutionize drug delivery mechanisms. We are enthusiastic about the promise of a potent topoisomerase I inhibitor delivered in this mechanism.' pre|CISION® Medicine Pipeline FAP-Dox (AVA6000), a pre|CISION-enabled form of doxorubicin chemotherapy, advances to Phase 1b dose expansion. During the first quarter, Avacta completed the Phase 1a dose escalation portion of the trial, demonstrating promising early efficacy and a favorable safety profile. As of the most recent data cut-off, AVA6000 continues to show improved tolerability compared to conventional dose doxorubicin, with no observed events of severe cardiac toxicity. Encouraging progression-free survival (PFS) data has also been observed in patients with salivary gland cancers. The Company has begun enrolling patients in the Phase 1b expansion cohorts, including salivary gland cancer, triple negative breast cancer and high-grade soft tissue sarcoma and plans to report updates from these trials later in 2025. For more details see announcement from 07 March 2025 here. AVA6103, a pre|CISION®-enabled PDC comprised of the pre|CISION peptide linked to the potent topo I inhibitor exatecan, continues preclinical development. AVA6103 is currently in investigational new drug (IND)-enabling studies with a Phase 1 trial anticipated to begin in the first quarter of 2026. Upcoming Data Presentations at AACR. Avacta is presenting three posters at the American Association for Cancer Research (AACR) Annual Meeting from April 25-30, 2025 in Chicago, IL. The presentations will feature data from the Company's proprietary pre|CISION® platform and pipeline of next generation peptide drug conjugates (PDCs), including clinical data on AVA6000 and preclinical pharmacology highlights for AVA6103. For more details see announcement from 26 March 2025 here. Novel data from our strategic collaboration with Tempus AI continues to be reported, including at the AACR Annual Meeting in Chicago. Executive Leadership Team Addition Strengthened management team. In January Avacta strengthened the management team with the appointment of Brian Hahn as Chief Financial Officer ('CFO'). Brian is a seasoned CFO with over 25 years' biopharma financial and operational experience. He spent 15 years as CFO and Senior Vice President of GlycoMimetics, Inc., where he led the company's 2014 initial public offering ('IPO') on Nasdaq. Notice of 2024 Preliminary Results Avacta expects to report its Preliminary Results for the 12 months ended 31 December 2024 during May 2025. For further information from Avacta, please contact: Avacta Group plcMichael Vinegrad, Group CommunicationsDirector Peel Hunt (Nomad and Joint Broker)James Steel / Chris Golden Panmure Liberum (Joint Broker)Emma Earl / Will Goode / Mark Rogers ICR HealthcareMary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert avacta@ Investor ContactRenee LeckTHRUST Strategic Communications renee@ Media ContactCarly ScadutoCarly Scaduto Consulting Carly@ About Avacta - Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION® platform. pre|CISION® is a proprietary payload delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent payloads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates. About the pre|CISION® PlatformThe pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for in to access your portfolio
Yahoo
26-03-2025
- Business
- Yahoo
Avacta Therapeutics Announces Presentations at 2025 AACR Annual Meeting
LONDON and PHILADELPHIA, March 26, 2025 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announced that the Company will have three presentations at the American Association for Cancer Research (AACR) Annual Meeting from April 25-30, 2025 in Chicago, IL. The poster presentations will feature data from the Company's proprietary pre|CISION® platform and pipeline of next generation peptide drug conjugates (PDCs), including AVA6000, a PDC consisting of doxorubicin conjugated with a peptide moiety that is specifically cleaved by FAP in the tumor microenvironment via a pharmacokinetics and clinical presentation, and preclinical pharmacology highlights for AVA6103, a PDC comprised of the pre|CISION® peptide linked to exatecan. The third presentation will describe detailed analysis of the target fibroblast activation protein-alpha (FAPα), the protease that forms the basis of the pre|CISION® platform. Details for Avacta's poster presentations are below and can be found on the AACR website: Abstract Number and Title: #3139: The novel PDC AVA6103 is a FAP-enabled pre|CISION® medicine which targets exatecan, a topoisomerase I inhibitor, to the tumor microenvironment following FAP cleavage Session Category: Experimental and Molecular Therapeutics Session Title: Therapeutic Approach to Attack the Tumor Microenvironment Session Date and Time: Monday, April 28, 2025, 2:00 - 5:00 p.m. CT Abstract Number and Title: #2699: Investigating fibroblast activation protein alpha (FAPα) as a therapeutic target for delivery of pre|CISION® cancer medicines: Expression, spatial localization and functional insights Session Category: Tumor Biology Session Title: Targeting the Tumor Microenvironment: A Brave New World Session Date and Time: Monday, April 28, 2025, 2:00 - 5:00 p.m. CT Abstract Number and Title: #CT15: Comparative pharmacokinetics and tumor activation of fibroblast activation protein (FAP)-enabled pre|CISION® peptide drug conjugates Session Title: First-in-Human Phase I Clinical Trials 2 Session Date and Time: Tuesday, April 29, 2025, 9:00 a.m. - 12:00 p.m. CT For further information from Avacta, please contact: Avacta Group plcMichael Vinegrad, Group CommunicationsDirector Peel Hunt (Nomad and Broker)James Steel / Chris Golden Panmure Liberum (Joint Broker)Emma Earl / Will Goode / Mark Rogers ICR HealthcareMary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert avacta@ Investor ContactRenee Leck THRUST Strategic Communications renee@ Media ContactCarly ScadutoCarly Scaduto Consulting Carly@ About Avacta - Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION® platform. pre|CISION® is a proprietary warhead delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent warheads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates. About the pre|CISION® PlatformThe pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for in to access your portfolio
Yahoo
10-03-2025
- Business
- Yahoo
Avacta Therapeutics to Present at the 2025 Leerink Global Healthcare Conference
LONDON and PHILADELPHIA , March 10, 2025 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announced that the Company will present at the Leerink Global Healthcare Conference on Wednesday, March 12, 2025, at 10:00 a.m. ET in Miami. A live webcast of the presentation will be available in the investors section of the Company's website at The webcast will be archived for at least 30 days following the presentation. For further information from Avacta, please contact: Avacta Group plcMichael Vinegrad, Group CommunicationsDirector Peel Hunt (Nomad and Broker)James Steel / Chris Golden / Patrick Birkholm Panmure Liberum (Joint Broker)Emma Earl / Will Goode / Mark Rogers ICR HealthcareMary-Jane Elliott / Jessica Hodgson / Max Bennett avacta@ Investor ContactRenee Leck THRUST Strategic Communications renee@ Media ContactCarly ScadutoCarly Scaduto Consulting Carly@ About Avacta - Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION® platform. pre|CISION® is a proprietary warhead delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent warheads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates. About the pre|CISION® PlatformThe pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for in to access your portfolio
