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What?!😳 They have actually released this in a global news service with the --- Session Date and Time: 17 October, 19:40 - 20:00 --- date and time?😱 The level of incompetence is staggering. Clearly Vinegrad alone wasn't responsible for all the cook-ups.

Significance

This Phase 1 data is highly significant for oncology drug development, particularly in anthracycline-refractory or FAP-enriched tumors:

• Mechanistic Validation: The 100:1 tumor targeting ratio and dose-responsive intratumoral delivery confirm the pre|CISION® platform's proof-of-concept, enabling safer escalation beyond conventional limits. This could revive doxorubicin's utility in indications like SGC and STS, where options are limited and historical response rates are low (<20% for doxorubicin monotherapy).

• Clinical Impact: Low toxicity allows cumulative dosing up to 550 mg/m² without cardiotoxicity caps, potentially improving durable responses (e.g., unreached PFS in SGC). Compared to the ANNOUNCE Phase 3 trial (doxorubicin 75 mg/m² Q3W in STS, median PFS ~6 months), these signals suggest superior tolerability and possible efficacy gains.

• Broader Implications: As a first-in-class FAP-targeted conjugate, it opens doors for combinations (e.g., with immunotherapy) and expansion to other FAP-high tumors (e.g., pancreatic, colorectal). Phase 1b expansions are ongoing, positioning AVA6000 for Phase 2 trials by 2026, which could accelerate regulatory paths if PFS/ORR benchmarks hold.

• Limitations and Context: Data is early-stage (small n per cohort, retrospective FAP testing), with efficacy exploratory (no formal powering). However, the safety margin and targeting metrics are robust enough to de-risk advancement, marking a potential paradigm shift in TME-targeted chemotherapy.

Overall, these results could transform targeted payload delivery, warranting attention from clinicians, investors, and researchers in precision oncology.

I asked Grok to review the poster PDF:

Overview of the Data

The document is a presentation from ESMO 2025 detailing results from a Phase 1 clinical trial of faridoxorubicin (AVA6000, or FAP-Dox), a novel peptide-drug conjugate designed to deliver doxorubicin specifically to the tumor microenvironment (TME) via fibroblast activation protein (FAP) cleavage. This targets FAP-overexpressing cancer-associated fibroblasts in solid tumors, aiming to minimize doxorubicin's off-target toxicities (e.g., cardiotoxicity and myelosuppression) while enhancing tumor exposure. The trial focused on FAP-positive solid tumors like salivary gland cancer (SGC), soft tissue sarcoma (STS), colorectal, and pancreatic cancers. Data cutoff was September 2025, with 63 patients enrolled.

Key Findings

• Safety Profile: Remarkably favorable, with no maximum tolerated dose reached even at ~4x conventional doxorubicin doses (up to 385 mg/m² Q3W). Only 3 dose-limiting toxicities (DLTs) across escalation arms, none cardiac-related at higher doses. Grade 3-4 adverse events (AEs) were low: neutropenia (19% vs. 49% historical for doxorubicin), leukopenia (10% vs. 24%), and no severe cardiac AEs. Left ventricular ejection fraction (LVEF) declines were minimal (2 patients met criteria, none at cumulative doses ≥500 mg/m²), supporting the hypothesis of reduced "first-pass" exposure to normal tissues.

• Pharmacokinetics and Targeting: Released doxorubicin exhibited a short half-life (0.71–1.01 hours vs. 34–77 hours for conventional), with a median tumor:plasma concentration ratio of 100:1 (p100 weeks). In STS (n=11), tumor shrinkage occurred, including confirmed responses in stromal-FAP-only cases. Waterfall plots across all patients (n=63) demonstrated shrinkage in multiple cohorts, indicating broad preliminary activity.

(cont'd)

CONCLUSIONS

Faridoxorubicin (AVA6000) is safe and well-tolerated in both the Q3W and Q2W dosing regimens with, with preliminary evidence of efficacy in patients with soft tissue sarcomas (STS) and salivary gland cancers (SGC) and no severe cardiac toxicity. No MTD wasdetermined in the trial despite dosing up to 385 mg/m2 (~4x conventional dose doxorubicin)

• Faridoxorubicin treatment demonstrates low rates of severe toxicities that are associated with conventional doxorubicin

• Confirmed responses were observed in patients with stromal only expression of FAP with SGC and tumor cell expression of FAP in STS

• In the cohort of SGC patients, median PFS has not yet been reached. The median follow up is estimated at 51 weeks (using the Reverse K.a.p.l.a.n Meier method)

• The median tumor to plasma ratio of released doxorubicin is 100:1 and doxorubicin concentration in the tumor demonstrates a strong dose response. Effective cleavage and concentration in the tumor is evident at all levels of FAP expression including patients with tumors demonstrating minimal

conclusions

faridoxorubicin (ava6000) is safe and well-tolerated in both the q3w and q2w dosing regimens with, with preliminary evidence of efficacy in patients with soft tissue sarcomas (sts) and salivary gland cancers (sgc) and no severe cardiac toxicity. no mtd wasdetermined in the trial despite dosing up to 385 mg/m2 (~4x conventional dose doxorubicin)

• faridoxorubicin treatment demonstrates low rates of severe toxicities that are associated with conventional doxorubicin

• confirmed responses were observed in patients with stromal only expression of fap with sgc and tumor cell expression of fap in sts

• in the cohort of sgc patients, median pfs has not yet been reached. the median follow up is estimated at 51 weeks (using the reverse ****** meier method)

• the median tumor to plasma ratio of released doxorubicin is 100:1 and doxorubicin concentration in the tumor demonstrates a strong dose response. effective cleavage and concentration in the tumor is evident at all levels of fap expression including patients with tumors demonstrating minimal

Accompanying news item (RNS for Monday): Avacta Therapeutics presents compelling Phase 1a data for faridoxorubicin and the pre|CISION® platform at the European Society of Medical Oncology Annual Congress

https://avacta.com/avacta-therapeutics-presents-compelling-phase-1a-data-for-faridoxorubicin-and-the-precision-platform-at-the-european-society-of-medical-oncology-annual-congress/

Note that they included the old, wrong, day and time of the poster session.🙄

Avacta will present an Investor Meet conference to review the published data on Tuesday October 21, 2025. Details for the webinar will be posted on the Avacta home page.

Https://avacta.com/wp-content/uploads/2025/10/ESMO-2025_vfinal.pdf

I've only just completed the first module of my telaesthesia course, so sorry, can't help.

It isn't over till it's over. Dr Tap already into his third encore valiantly struggling to be heard amidst the screaming and shouting and deluge of assorted underwear.

Thompi, when Avacta put out the original RNS the ESMO Congress site was already saying the 19th and the evening of the 17th, the first day, was blank.

It was always the 19th. Avacta got it wrong.

😂

😳😂 Every BB has its BS'ing traders and naive investors. Lots of fun to be had watching.

Remember, do your own research and trust no one unless you personally know them and can judge their character. There are a lot of snakes and dogs out there.

Sunday will be truly massive. Folk have been hiking from Bideford and all points West just to be there. Special Security has been called up for crowd control and to impose strict backpack checks for hidden cameras and recording equiment. Dr Tap's AI-generated interactive 3D poster will be the sensation of the century! Believe me, I heard it first-hand from the Hurst Bot - and the number of deals that'll be signed over breakfast on Monday is just, literally, INCREDIBLE!😳

🤣🤣🤣HFH is a 🤡

In my inter years I worked on a farm for 5 years and could tell you exactly which cow had farted.

Isn't happening. Dr Tap has lost the poster. Don't panic! Don't panic!!

HL gets quotes from multiple MMs, so they say.

Looking forward to some good Avacta news as the parasite pub bore will then disappear as if by magic.

😂 That is funny.