Latest news with #FAP-EXd
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
