faridoxorubicin (AVA6000) / Avacta - LARVOL DELTA

Avacta Announces Two Key Clinical Updates to its Faridoxorubicin Program (GlobeNewswire) - "Agreed updates to the trial protocol include the removal of the maximum dosing limit and to allow flexibility in dosing levels. These two developments underscore the growing confidence from investigators and regulators in the tolerability profile of faridoxorubicin and should support a smooth transition to future efficacy studies....The Company’s second significant update relates to the determination of the dose for the study in efficacy trials. The final cohorts of patients with the selected indications in Phase 1b will be enrolled, enabling two dose levels to be compared in order to determine the optimal biologic dose in future trials."

Clinical protocol • Breast Cancer • Ovarian Cancer • Salivary Gland Cancer • Soft Tissue Sarcoma • Urothelial Cancer

A phase I trial of FAP-Dox (AVA6000), a Fibroblast Activation Protein (FAP)-released and tumor microenvironment (TME)-targeted doxorubicin peptide drug conjugate in patients with FAP-positive solid tumors (ESMO 2025) - P1 | "Multiple responses were observed in patients indicating activity of the PDC. The pre|CISION PDC concentrates payload in the TME while sparing normal tissues from exposure."

Biomarker • Clinical • P1 data • Tumor microenvironment • Oncology • Salivary Gland Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • FAP

A Phase I trial of AVA6000, a Fibroblast Activation Protein (FAP)-released and tumor microenvironment (TME)-targeted doxorubicin peptide drug conjugate in patients with FAP-positive solid tumors (AACR 2024) - "AVA6000 delivers high concentration of doxorubicin to the TME relative to plasma which results in antitumor activity in tumors with high FAP activity. A q2w dose escalation arm is ongoing."

Biomarker • Clinical • P1 data • Tumor microenvironment • Angiosarcoma • Biliary Tract Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • FAP

Outlook for 2026: Faridoxorubicin (AVA6000) program (GlobeNewswire) - "Multiple data updates in both patient groups, with salivary gland cancers and with triple negative breast cancer updates expected in H1 2026."

P1 data • Salivary Gland Cancer • Triple Negative Breast Cancer

Faridoxorubicin (AVA6000) Phase 1b cohort demonstrates clinically meaningful tumor shrinkage in patients with salivary gland cancers (GlobeNewswire) - "Among the total of 30 patients evaluable for efficacy treated at the dose of 250 mg/m2 and above in Phase 1a and 1b, 27 patients demonstrated partial or minor responses or stable disease, resulting in a disease control rate of 90% across the two arms in line with previously reported data. Clinically meaningful tumor shrinkage was observed with two patients with confirmed partial responses and seven patients with confirmed minor responses (across Phase 1a and 1b)."

P1 data • Salivary Gland Cancer

Avacta Therapeutics…expects to announce initial Faridoxorubicin Phase 1b data in the salivary gland cancer indication on December 17, 2025 (Avacta Press Release)

P1 data • Salivary Gland Cancer

Avacta Therapeutics Presents Compelling Phase 1a Data for Faridoxorubicin and the pre|CISION Platform at the European Society of Medical Oncology Annual Congress (GlobeNewswire) - "In patients with salivary gland cancers (SGC, n=11) treated at or above the dose level of 250 mg/m2, faridoxorubicin demonstrated multiple confirmed partial and minor responses with a disease control rate of 91%....In patients with soft tissue sarcomas (n=17 evaluable), multiple tumor responses are observed, even at lower doses including one responder at the 160 mg/m2 Q3W dose level....Avacta continues to enroll patients in the Phase 1b expansion cohorts with data in salivary gland cancer anticipated by the end of 2025."

Enrollment status • P1 data • Salivary Gland Cancer • Soft Tissue Sarcoma

Avacta to Present New FAP Dox (AVA6000) Data at the European Society for Medical Oncology (ESMO) Congress (GlobeNewswire) - "Avacta Therapeutics...announces that the Company will present an updated data analysis from the Phase 1a trial of FAP-Dox (AVA6000) at the 2025 European Society for Medical Oncology (ESMO) Congress....The poster presentation will be based on the most recent data analysis from the Phase 1a trial of FAP-Dox (AVA6000) in patients with Fibroblast Activation Protein (FAP)-positive solid tumors. Avacta completed the Phase 1a enrollment dose escalation portion of the clinical trial in late 2024, with patient enrollment ongoing in multiple dose expansion cohorts of a Phase 1b study."

P1 data • Trial status • Breast Cancer • Ovarian Cancer • Salivary Gland Cancer • Soft Tissue Sarcoma • Urothelial Cancer

Avacta Provides Q2 2025 Business Update Outlining Progress Against Strategic Objectives (Avacta Press Release) - "FAP-Dox (AVA6000), a pre|CISION-enabled form of doxorubicin chemotherapy, continues to progress in Phase 1b studies. During the second quarter, patient enrollment continued across the expansion cohorts, with early signs of efficacy observed, including a robust partial response in a patient with salivary gland cancer, with a nearly 50% reduction in tumor diameters. We remain on track to release the initial data in salivary gland cancer in late 2025 and in triple negative breast cancer in H1 2026...We are also discussing FAP-Dox with a range of parties who are keen to assess additional data which is due later this year and in H1 2026."

P1 data • Salivary Gland Cancer • Triple Negative Breast Cancer

New Response in the FAP-Dox (AVA6000) Phase 1b Trial (Avacta Press Release) - P1b | N=158 | NCT04969835 | Sponsor: Avacta Life Sciences Ltd | "Avacta Therapeutics...announces a new partial response observed in a patient with salivary gland cancer (SGC) in the dose expansion phase of the FAP-Dox (AVA6000) Phase 1b trial. This further signal of antitumor activity in this disease setting is encouraging as the expansion cohort continues to enroll in the indication of salivary gland cancer. This patient is a 69-year-old male with metastatic salivary gland cancer. His prior therapy includes surgery and radiation with no prior systemic therapy. His combined tumor diameter was reduced at the first scan by almost 50%, qualifying as a partial response."

P1 data • Salivary Gland Cancer

Preliminary Results for the Year Ended December 31, 2024 - "FAP-Dox (AVA6000) – first pre|CISION program: Completed Phase 1a enrollment dose escalation portion of clinical trial; Opening of the Phase 1b expansion cohorts in salivary gland cancers, triple negative breast cancer and high-grade soft tissue sarcoma; Anticipate releasing the initial data in salivary gland cancer in late 2025 and in triple negative breast cancer in H1 2026. Phase 2 trials in these indications planned for H1 2026. FAP-EXd (AVA6103): Clinical candidate selection enables move toward clinical testing, by advancing to Investigational New Drug (IND)-enabling studies and Good Manufacturing Practices (GMP) manufacturing process development to support initiation of the Phase 1 clinical trial in Q1 2026."

New P1 trial • New P2 trial • P1 data • Salivary Gland Cancer • Soft Tissue Sarcoma • Triple Negative Breast Cancer

Investigating fibroblast activation protein alpha (FAPα) as a therapeutic target for delivery of pre|CISION® cancer medicines: Expression, spatial localization and functional insights (AACR 2025) - "The potential of the pre|CISION® technology is highlighted by the promising clinical data from AVA6000, a pre|CISION® enabled Doxorubicin peptide drug conjugate...Avacta's preCISION® peptide-drug conjugates elicit bystander cell kill over a range of physiological FAP levels within these co-culture models. Combined, these analyses emphasize the significance of FAP as an important stromal target for focused delivery of targeted oncology therapeutics, and guide further development of the preCISION® pipeline."

Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CAFs • FAP

Comparative pharmacokinetics and tumor activation of fibroblast activation protein (FAP)-enabled pre|CISION® peptide drug conjugates (AACR 2025) - "Two payloads are described using this platform: AVA6000 (doxorubicin [dox]; pre-clinical and clinical) and AVA6103 (exatecan, pre-clinical). In the Phase 1 trial, AVA6000 exhibits promising tumor-targeting characteristics with encouraging clinical activity and reduced systemic toxicities validating the tumor-specific FAP cleavage mode of action. These AVA6000 data along with the preclinical PK data with AVA6103 have informed the predictive modeling to support the clinical development of AVA6103 by optimizing the delivery of the exatecan payload."

PK/PD data • Oncology • Salivary Gland Cancer • Solid Tumor

AVA6000 (FAP-Dox) Clinical Highlights (Abstract #CT15, Apil 29, 2025) (GlobeNewswire) - P1a | N=158 | NCT04969835 | Sponsor: Avacta Life Sciences Ltd | "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%....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."

P1 data • Salivary Gland Cancer • Soft Tissue Sarcoma • Triple Negative Breast Cancer

Avacta Therapeutics Announces Presentations at 2025 AACR Annual Meeting (GlobeNewswire) - "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."

Preclinical • Oncology

AVA6000 Generates Early Efficacy, Is Safe in Advanced Salivary Gland Cancers (OncLive) - "'We are very excited to move the development of AVA6000 to the next level to generate data that demonstrates clinically meaningful efficacy and durability of response in patients with previously treated salivary gland cancers,' Alan Ho, MD...stated in a news release. 'It is important to note the high degree of unmet need in this disease where few agents have shown efficacy. I am happy to participate in the trials of AVA6000 in this disease setting in the future.'"

Media quote

Avacta Announces Promising Early Efficacy and Safety Data for AVA6000 in the Phase 1a Dose Escalation and Ongoing Enrollment in the Phase 1b Expansion Cohorts (Firstwordpharma Press Release) - "Alan Ho, MD...commented: 'We are very excited to move the development of AVA6000 to the next level to generate data that demonstrates clinically meaningful efficacy and durability of response in patients with previously treated salivary gland cancers. It is important to note the high degree of unmet need in this disease where few agents have shown efficacy. I am happy to participate in the trials of AVA6000 in this disease setting going forward.'"

Media quote

Avacta Announces Promising Early Efficacy and Safety Data for AVA6000 in the Phase 1a Dose Escalation and Ongoing Enrollment in the Phase 1b Expansion Cohorts (GlobeNewswire) - P1 | N=158 | NCT04969835 | Sponsor: Avacta Life Sciences Ltd | "Avacta Therapeutics...is pleased to announce that the lead program of the Company, AVA6000...has completed the Phase 1a dose escalation with encouraging PFS data in patients with salivary gland cancers. The Company has initiated enrollment in the Phase 1b expansion cohorts with multiple patients treated....Among these 11 patients, one patient experienced a confirmed partial response as best response (greater than -30% reduction in tumor diameters by RECIST criteria), four patients had minor responses (-10 to -29% reduction by RECIST criteria), and only one patient had disease progression for a disease control rate of 91%....The Company anticipates providing a further update from the Phase 1a dose escalation data in 2Q 2025 and Phase 1b dose expansion cohort data at the end of 2025. The full Phase 1a data will be presented in 2H 2025, including a full assessment of the cardiac safety data with long-term follow up."

P1 data • Trial status • Salivary Gland Cancer • Soft Tissue Sarcoma • Triple Negative Breast Cancer

Avacta Announces Positive New Data from the AVA6000 Phase 1 trial Demonstrating Clinically Meaningful Tumor Shrinkage in Patients with Salivary Gland Cancers (GlobeNewswire) - P1a | N=158 | NCT04969835 | Spnonsor: Avacta Life Sciences Ltd | "The data demonstrates robust and meaningful tumor shrinkage in patients with salivary gland cancers, a disease with no standard therapy defined in the metastatic setting...Among 10 patients treated at the dose of 250 mg/m2 and above, five patients demonstrate tumor shrinkage (one partial and four minor responses); Six of these 10 patients are continuing treatment and an additional two patients, who have reached maximum cycles, are still in follow up for progression free survival; The safety profile of AVA6000 continues to demonstrate a robust reduction in severe hematologic and cardiac toxicities that are associated with conventional dose doxorubicin."

P1 data • Salivary Gland Cancer

ALS-6000-101: A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours (clinicaltrials.gov) - P1 | N=158 | Recruiting | Sponsor: Avacta Life Sciences Ltd | N=80 ➔ 158 | Trial completion date: Jun 2023 ➔ Aug 2026 | Trial primary completion date: May 2023 ➔ Mar 2026

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Breast Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Salivary Gland Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

A phase I trial of AVA6000, a fibroblast activation protein (FAP)-released, tumor microenvironment (TME)-targeted doxorubicin peptide drug conjugate in patients with FAP-positive solid tumors (ESMO 2024) - P1 | "AVA6000 delivers high concentration of free dox to the TME relative to plasma, resulting in antitumor activity in FAPhigh tumor types with reduced systemic dox exposure, resulting in lower toxicity versus conventional dox."

Biomarker • Clinical • P1 data • Tumor microenvironment • Oncology • Salivary Gland Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • FAP

Avacta Reports Updated Phase 1 Clinical Data of AVA6000 at the European Society for Medical Oncology (ESMO) Congress Demonstrating Multiple Ongoing, Durable Responses in Solid Tumors (GlobeNewswire) - P1 | N=80 | NCT04969835 | Sponsor: Avacta Life Sciences Ltd | "Patients had a median of two prior systemic cancer therapies (range 0-7) with 65% including cytotoxic exposure. Reduction in the sum of longest diameters (SLD) is used to measure response per RECIST 1.1 with partial responses of >30% reduction and minor responses of between >10% and <30% reduction. Among patients with FAPhigh cancers (n=23), three partial responses and four minor responses were observed...Among patients with FAPmid cancers (n=26), two minor responses were observed...Treatment with AVA6000 continues to be well-tolerated with the addition of the Q2W dosing regimen (Arm 2) with a favorable safety profile and reduction in severe and mild-to-moderate treatment-emergent toxicities as compared with conventional dose doxorubicin. A maximum tolerated dose has not been identified in either arm of the trial...No new dose limiting toxicities were observed and neither arm has determined an MTD."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Avacta to present updated clinical data on AVA6000 at the European Society for Medical Oncology (ESMO) Congress (GlobeNewswire) - "Avacta Group plc...announces that the company will present updated data from the Phase 1a trial of AVA6000 at the 2024 European Society for Medical Oncology (ESMO) Congress....The poster presentation will be based on an updated data cut from the Phase 1a trial of AVA6000 in patients with Fibroblast Activation Protein (FAP)-positive solid tumours. AVA6000 is a peptide drug conjugate consisting of doxorubicin conjugated with a peptide moiety that is specifically cleaved by FAP in the tumour microenvironment."

P1 data • Solid Tumor

Avacta reports further progress in chemotherapy trial (Sharecast) - "Avacta Group announced the successful completion of the first cohort and the start of dosing for three patients in the second cohort of the second arm in its phase one trial of AVA6000, a peptide drug conjugate form of doxorubicin chemotherapy, on Thursday....The first cohort in the second arm was completed without any adverse safety signals, and the second cohort had started dosing, with three patients already treated....Avacta said it remained on track to achieve its goals for the second half of 2024, including the start of the dose expansion phase 1b efficacy study and the presentation of further data from the AVA6000 trial."

New P1 trial • Trial status • Biliary Tract Cancer • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastroesophageal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Soft Tissue Sarcoma • Solid Tumor

Avacta Group - AVA6000 Abstract Release by AACR and Full Presentation Update (GlobeNewswire) - "Avacta Group plc...announces that the abstract of the poster to be presented at the American Association of Cancer Research ('AACR') Annual Meeting in San Diego, California on Tuesday 9 April has now been released by AACR. The poster presentation will be based on data from the Phase 1a trial of AVA6000, a peptide drug conjugate consisting of doxorubicin conjugated with a peptide moiety that is specifically cleaved by fibroblast activation protein (FAP) in the tumor microenvironment."

P1 data • Solid Tumor