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Note new appointment

Kim Hart Paulsen

She/Her

Vice President Clinical Operations at Avacta Therapeutics

Riverton, New Jersey, United States

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"Over 25 years of cross-functional leadership in phases I-IV global clinical operations, specializing in oncology and hematology trials, ensuring compliance with regulatory standards and delivering projects on time and within budget. Possess a broad understanding of the bigger picture and how clinical operations and development works across all functions. Experience in programs from IND to NDA Submission, pinpointing resource requirements, and evaluating operational quality and risk spanning biotechnology companies, pharmaceutical companies, clinical research organizations, and the site level.

Areas of Expertise: Strategic cross-functional leadership, SOP development, Regulatory strategy development and compliance, Clinical trial design and management, Budget forecasting, Project planning, Risk assessment, Vendor selection and management, Advanced clinical data analysis, Hematology/ Oncology

Top skills

Clinical Trials • Cross-functional Team Leadership • Regulatory Strategy Development • Portfolio Optimization • Clinical Study Design

Vice President Clinical Operations

Avacta Therapeutics · Full-time

Jun 2026 - Present · 1 month

London, United Kingdom · Remote

https://www.linkedin.com/in/kim-hart-paulsen-9949386/

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Simply put courtesy https://x.com/Blueberrymgmnt/status/2062112678110224471/photo/1

"Marty McFly

@Blueberrymgmnt

·

11m

Dose dependent doxorubicin release is maintained as AVA6000 dose increases, yet plasma Cmax remains low and tightly controlled. This supports a tumor reservoir model where gradual spillover limits peak cardiac exposure and systemic adverse events. #AVCT

Thanks for sharing - next step announce commercial partner deal & fast track approval . As per plan .

92k reasons to be positive about my investment .

Gmcc

FYI Some positive coverage

Gmcc

https://cgxpwire.com/biopharma/avacta-reports-encouraging-ava6000-salivary-gland-cancer-data-at-asco-2026/

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📢 Avacta Therapeutics Reports Encouraging AVA6000 Salivary Gland Cancer Data at ASCO 2026

🔗 Read more: https://lnkd.in/gGZ4qnjd

Avacta Therapeutics reported encouraging #AVA6000 data in salivary gland #cancer at #ASCO 2026.

The findings support continued advancement of the company's precision #oncology platform.

About the Company:

• Clinical-stage #biotechnology company

• Precision #oncology #innovator

• Targeted #cancer therapy developer

About #AVA6000:

• Investigational #oncology therapy

• #Tumor-activated treatment platform

• Clinical-stage #cancer program

Key Highlights:

• Encouraging clinical data reported

• Advances rare #cancer research

• Strengthens precision #oncology pipeline

"Congratulations to Avacta Therapeutics." 🎉

Brian Hahn, Christina Coughlin, David Liebowitz, Yulii Bogatyrenko

🤝 “Rare cancer studies can provide important insights for broader oncology development.”

#Oncology #RareCancer #ASCO2026 #Biotech #Innovation

FDA The National Institutes of Health

Centers for Disease Control and Prevention

ISO - International Organization for Standardization

World Health Organization European Medicines Agency

American Society of Clinical Oncology (ASCO)

American Head and Neck Society

American Association for Cancer Research

ESMO - European Society for Medical Oncology

|| cGxP.wire || cGxP.Directory || cGxP.jobs || cGxP.Tech ||

Note updates - more patients & conditions

https://clinicaltrials.gov/study/NCT07454642?tab=history&a=3&b=4#version-content-panel

Gmcc

Courtesy of Ben : AVA6000 not perfect but great starting place . Fair explanation.

https://x.com/111BEN_111/status/2061363079414174022

"Ben

@111BEN_111

#avct First round of AVA6000 data is in

Cardiotox driven by low Cmax, heart almost completely protected. No clinically significant cardiac toxicities across all 111 patients, <4% with any LVEF change, zero cardiac failure events, on top of prior anthracycline exposure in some patients. Regression slope essentially zero up to equivalent of 550mg cumulative doxorubicin. Proves precision can be designed to remove the DLT for a given payload. For AVA6103 the target is neutropenia.

Neutropenia 30% grade 3/4 vs 50% conventional dox, but will creep up as 11 patients still being dosed. This still appears to be a slight issue and is what drove the dose reduction from 385 to 310mg. At 310 blood exposure is much lower than conventional dox vs 385 where serum AUC is comparable to dox, while cardiac exposure stays negligible (lower Cmax). Not off-target cleavage like ADCs (amazing) but slow leakage back from tumour into circulation ! AVA6103 sustained controlled release should also help address this.

PFS not given yet (expect at BIO), but just 2 events away from being found if they don’t recruit more. Baseline for this population around 6m+ from carboplatin/taxol data (Avacta cite 6.5m first line), especially as ACC splits type 1/2, SDC dosed and more first-line patients dosed here. 4 PRs, ORR 10% vs lenvatinib 12% in ACC. SGC is a tough indication with some emerging treatments but promising activity in a heterogeneous population.

The big thing here is SGC activity observed where tumour cells don’t express FAP. Big deal for addressable population and 6103 read-across.

AVA6000’s true value is what it built, AVA6103, addressing both payload and cleavage efficiency. Read-across complete. AVA6000 is a kinder dox with quite a good chance of finding its place across the many chemo combo regimens where dox is currently used.

9:23 AM · Jun 1, 2026

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3,682

Views"

Gmcc

Nice find courtesy Stonks

https://www.clinicaltrialsarena.com/news/asco-2026-gastrointestinal-cancer-roundup/?cf-view

"ASCO26: Gastrointestinal cancers enter the limelight amid key readout surge

Readouts in hepatocellular carcinoma, as well as pancreatic, gastric and salivary gland cancer, are capturing attention at ASCO 2026.

Annabel Kartal Allen

June 1, 2026"

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"

Avacta’s salivary gland cancer drug shows early promise

While the buzz around GI cancer readouts continues to grow, Avacta Therapeutics has debuted data around the safety, toxicity and preliminary efficacy of its peptide-drug conjugate (PDC), AVA6000, in salivary gland cancer.

In this first-in-human study (NCT04969835), researchers found that a “small fraction” of the active payload, doxorubicin, enters the bloodstream and reaches other unintended organs at lower concentrations than when patients receive intravenous treatment with the chemotherapy agent.

This is, in part, linked to a reduction in the rate of treatment-linked toxicities when using AVA6000 over traditional doxorubicin, despite the recommended dose for expansion being nearly three times higher than the maximum tolerated dose of the chemotherapy when it’s administered via the traditional intravenous path.

There were also no severe cardiac toxicity events reported, though four of the 111 patients dosed to date have experienced significant reductions in left ventricular ejection fraction (LVEF). Exposure-response analysis found no meaningful relationships between the changes in LVEF and the release of doxorubicin exposure.

The drug also demonstrated early signs of efficacy in this trial, with four partial and nine minor responses observed amongst the 38 evaluable patients, while the disease control rate (DCR) sits at 92%.

AVA6000 acts by reaching the tumour microenvironment, which often has upregulated expression of fibroblast activation protein-a (FAP). This extracellular protein then cleaves the pre|CISION peptide attached to AVA6000, activating doxorubicin to enter cells at the tumour site. This precision approach, Avacta says, holds the potential to reduce the off-target toxicities linked to doxorubicin.

These results come as there are no specifically approved treatment options for salivary gland cancer. In the US, there are approximately 2,000 to 2,500 cases of salivary gland cancer reported each year."

Gmcc

Https://avacta.com/wp-content/uploads/2026/06/Ferrarotto-R-ASCO-2026_final.pdf

Look forward to seeing who will partner & terms of first deal - Obvious AVA6000 will provide much better SGC) patient treatment & unmet need .

Fantastic more evidence that the technology works + we have Next Gen AVA6103 pipeline already in clinic .

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"CONCLUSIONS

Faridoxorubicin (AVA6000) is safe and welltolerated in both the Q3W and Q2W dosing regimens, with preliminary evidence of efficacy in patients with salivary gland cancers (SGC) with multiple confirmed responses observed in Ph Ia and Ib and patients still with ongoing treatment

• Following faridoxorubicin (AVA6000) dosing, active doxorubicin is enzymatically released by FAP cleavage in the tumor microenvironment, and only a fraction of the active drug subsequently enters the systemic circulation, reaching other organs—including the heart—at delayed and lower concentrations.

"*******This is in direct contrast to conventional intravenous administration, which is known to deliver high concentrations of doxorubicin systemically from the outset*****"

"• Minimal LVEF changes and no severe cardiac toxicities were noted in the N=111 patients dosed to date with a subset of patients reaching the

protocol-defined lifetime maximum exposure of 550 mg/m2 and less than 4% of patients with clinically significant LVEF changes and no events of cardiomyopathy (of any grade) were observed

• The initial Population PK modeling demonstrates higher clearance and larger central volume of distribution for released doxorubicin with

faridoxorubicin vs. conventional doxorubicin, demonstrating released doxorubicin enters plasma gradually following FAP-mediated cleavage

in the TME, eliminating the sharp systemic peaks typical of conventional dosing

• Exposure-Response analysis found that there was not a meaningful relationship between the LVEF changes and released doxorubicin

exposure, suggesting that the cardiac toxicity observed with conventional dosing of doxorubicin is not observed with released doxorubicin from faridoxorubicin and supporting removal of the lifetime maximum limit of dosing "

Gmcc

Good Morning : Interesting AI snippets

https://business-news-today.com/avacta-therapeutics-aim-avct-names-richard-hughes-chairman-as-shaun-chilton-steps-back/

"This is a board being engineered for negotiation. Avacta Therapeutics has been explicit that it is engaging potential pharmaceutical partners for its pre|CISION oncology candidates, and partnering discussions with global drug majors are won or lost on the quality of the people in the room. A deputy chairman with a recognised biotech track record gives the company a senior figure who can speak the language of partner due diligence and validate the science to a counterparty’s satisfaction. The second-order implication is that management is signalling confidence that its lead assets are far enough along to attract that kind of conversation. Boards do not usually retool for deal-making unless they believe deals are realistically in view."

Gmcc

Thanks my mistake

Gmcc

Seems RH might have plenty of time to concentrate on Avacta . Only one entry on companies House apparently based in Spain .

https://find-and-update.company-information.service.gov.uk/officers/X31rBX4kaxxui0qObD24Rn7e79g/appointments

Gmcc

"Richard Hughes

@hughesy0707

In my personal view 2026 will be a defining point for #AVCT and ultimately for long term cancer patients.

Thanks to all shareholders and stakeholders for their support.

1:47 PM · May 29, 2026

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Richard Hughes

@hughesy0707

·

6m

Delighted to be appointed as chairman of #AVCT

My core priority is to ensure the value of preCISION is exploited to its fullest, for the benefit of all shareholders.

I am more than confident we have the team and the intellectual property to enable this.

Very little volume

https://www.barchart.com/stocks/quotes/AVCTF/price-history/historical

Solution install more Leakbot devices, speed up rollout - increase recurring revenues , charge insurance companies more per device - ONDO just need scale - " USP free plumbing network" stick with the plan , negotiate better insurance deals on roll /take-up numbers . Guess easier said than done .

Gmcc

Courtesy stonks _ Francis Wilson spreading the word.

https://www.linkedin.com/posts/uk-biotech-day_ukbiotechday-lifesciences-biotech-activity-7465764417528549377-Ox_v/

@JStonker

More #AVCT publicity - "Tackling undruggable targets - Innovation approaches and success stories"

https://ukbiotechday.org/agenda.html

https://linkedin.com/posts/ukbiotechday-lifesciences-biotech-share-7439954380566663168-0CTJ

#AVCT"

Gmcc

Insurers & homeowners love the free plumbing service great pity ONDO got their sums mixed up .

https://www.linkedin.com/company/leakbot/posts/?feedView=all

"Jim Strickland reposted this

View company: LeakBot

LeakBot

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Homeowners love it. The data confirms it. ❤️

LeakBot holds a 4.7 on Trustpilot, 4.7 on the App Store, and an NPS of 83 - based on over 3,750 survey responses at a 54% response rate.

After in-home plumbing visits, homeowners rate the service 4.9 out of 5.

That's not just a product metric. That's trust. And in a category where most people only hear from their insurer when something goes wrong, that trust matters more than ever.

#CustomerExperience #NPS #HomeInsurance #LeakBot #Insurtech"

Gmcc

Yes thanks for sharing :

"3. Conjugates and the Fibroblast Activation Protein Convergence

Peptide drug conjugates pair a targeting peptide with a cytotoxic or radioactive payload, and the most clinically advanced non-radioligand example is Avacta's faridoxorubicin (AVA6000). It uses a peptide that is cleaved by fibroblast activation protein in the tumor microenvironment to release doxorubicin locally, an approach designed to spare the heart from the cumulative cardiotoxicity that limits conventional doxorubicin. After durable responses in salivary gland cancer, the program had its lifetime maximum dose limit removed on cardiac-safety grounds in February, and the company raised additional capital in March to push expansion cohorts (Avacta Q1 2026 update).

The forward-looking theme here is convergence on fibroblast activation protein as a shared target across modalities. The same stromal protein that Avacta's peptide conjugate exploits for payload release is also a peptide radioligand target, with several lutetium-177, yttrium-90, and actinium-225 ligands in early clinical testing (Frontiers in Nuclear Medicine review, late 2025). One target, attacked by two peptide modalities, is exactly the kind of convergence that signals a maturing field."

Gmcc

bv : thought rns info implied " agreement on dose selection for subsequent trials." .

rns 19th may 2026 -unaudited preliminary full year 2025 results

"· gen one (ava6000):

o reported highly encouraging efficacy and safety data from patients with salivary gland cancer.

o program continued to enroll patients in the phase 1b trial to assess the efficacy of ava6000 (faridoxorubicin, pre|cision®-enabled doxorubicin) in more ****genous, defined patient populations.

o positive health authority interactions resulted in the lifting of lifetime maximum dose due to highly favorable cardiac safety and agreement on dose selection for subsequent trials."

gmcc

Good Morning

Every chance AVA6000 will soon move to phase two . Continue with a partner to treat SGC patients - granted full FDA rare orphan exclusivity . That deal will provide Avacta funding to concentrate on Next Gen AVA 6103 pipeline . SGC deal will also trigger other AVA600 drug candidate deals e.g, TNBC

Future looks very bright indeed for shareholders & cancer patients . Recent abstract data all ok in fact better than ok as highlights progression free survival with less side effects ..

Gmcc

Thanks

"Conclusions:

Faridox is active in SGC and well tolerated, delivering high concentration of free dox to the TME relative to plasma. Responses were observed and prolonged disease stabilization in patients with SGC indicating activity of the PDC."