On June 1, 2026 Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a clinical stage biopharmaceutical company developing pre|CISION, a tumor-activated oncology delivery platform, reported updated Phase 1a/1b and pharmacokinetics (PK), safety, toxicity and preliminary efficacy data with faridoxorubicin (AVA6000, pre|CISION-enabled doxorubicin) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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Christina Coughlin, CEO of Avacta, commented:

"Today’s data further underscores our confidence in both our Gen One product faridoxorubicin (AVA6000) and our pre|CISION technology to significantly improve treatment options for cancer patients.

"We are particularly encouraged by signs of efficacy in patients with salivary gland cancers (SGC and the consistency of these data from Phase 1a and 1b support the potential for this agent to move to later stage trials. The excellent safety profile was further demonstrated by the absence of severe cardiac toxicity and lifting of the lifetime maximum, following careful analysis of drug concentration versus effect on the heart.

"We look forward to presenting further data updates from this trial later in June, at the BIO International Convention."

Faridoxorubicin demonstrates favorable safety and consistent efficacy in Phase 1a and the Phase 1b SGC expansion cohort: At the recommended dose for expansion (RDE) of 310 mg/m2, faridoxorubicin (AVA6000) demonstrated a safety profile consistent with that seen earlier during Phase 1a dose escalation, when comparing grade 3/4 adverse events. The rates of toxicities remain lower than those historically observed with conventional doxorubicin, despite the RDE representing a dose level that is nearly three times the maximum tolerated dose of conventional doxorubicin level (75 mg/m2).

Efficacy among patients in the SGC expansion cohort also remained consistent, with multiple confirmed responses (four partial responses and nine minor responses observed among 38 evaluable patients). The disease control rate remains consistent at 92% (35/38 with best response of stable disease or response). Nine patients are continuing treatment, and a further 11 patients remain in follow up for disease progression.

PK and exposure-response data lead to lifting of lifetime maximum exposure: Active doxorubicin is released following dosing with faridoxorubicin, as is cleaved from the inert drug by the FAP enzyme in the tumor microenvironment (TME). Only a small fraction of the active payload subsequently enters the circulation and reaches other organs, including the heart, with a delay and at lower concentrations. This contrasts with the profile seen with conventional doxorubicin dosed intravenously, which delivers high systemic concentrations from the outset. Here, released doxorubicin is rapidly distributed, and eliminated more slowly, consistent with the known PK of conventional doxorubicin.

Preliminary Population PK (PopPK) modeling demonstrates that the sharp systemic Cmax peaks, which are typical with conventional doxorubicin dosing, are eliminated with AVA6000. AVA6000 dosing results in higher clearance and larger central volume of distribution for released doxorubicin, compared with conventional doxorubicin. This shows that released doxorubicin enters plasma gradually following FAP-mediated cleavage in the TME.

There were no severe cardiac toxicity events reported and only minimal changes in left ventricular function (as measured by left ventricular ejection fraction, LVEF) observed in the 111 patients dosed to date, even with a subset of patients having reached the (protocol-defined) lifetime maximum exposure of 550 mg/m2. Only four patients (<4%) reported significant reductions in LVEF and no cardiomyopathy events of any grade were observed.

Due to limited evidence of cardiac toxicity, an exposure-response analysis was conducted to assess the relationship between exposure to released doxorubicin and changes in LVEF on a per-patient basis. This analysis found no 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. This supported removal of the lifetime maximum limit of dosing. The Company received Health Authority agreement with this conclusion and hence the limit was removed from the study protocol earlier this year.

The study continues to enroll patients and Avacta plans to present further data on the AVA6000 program at BIO International Convention, taking place June 22-25, 2026 in San Diego, CA, USA.

(Press release, Avacta Life Sciences, JUN 1, 2026, View Source [SID1234666356])

On June 1, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported new single-timepoint dosimetry data from its Phase 3 COMPETE trial in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The data were presented in a poster presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, held from May 30 – June 2, 2026, in Los Angeles, CA.

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As previously reported at ENETS 2025, the Phase 3 COMPETE trial met its primary endpoint, with 177Lu-edotreotide (ITM-11) demonstrating clinically and statistically significant improvement in progression-free survival compared to everolimus (23.9 vs. 14.1 months; p=0.022). Results from a prospective dosimetry sub-study of COMPETE were presented at EANM 2025. Data, which included one of the largest prospective dosimetry datasets ever generated in a Phase 3 radiopharmaceutical trial, demonstrated that 177Lu-edotreotide (ITM-11) delivered targeted radiation to tumors while maintaining healthy organ exposure well below established safety thresholds. Building on this dataset, investigators applied PBMS NLMEM modeling to evaluate whether accurate individualized dose estimates for kidneys and tumors could be achieved from a single imaging session.

"Individualized dosimetry has long been recognized as clinically valuable in radiopharmaceutical therapy, but widespread implementation has been limited by the complexity and burden of repeated imaging procedures," said Dr. Deni Hardiansyah, co-author and associate professor at the University of Indonesia. "These findings demonstrate that a population-based modeling approach may enable accurate dosimetry estimates using substantially fewer imaging timepoints, supporting more practical integration into routine clinical practice."

The analysis utilized dosimetry data from patients treated with 177Lu-edotreotide in the Phase 3 COMPETE trial, including planar and SPECT/CT imaging data collected from 207 kidney datasets and 154 tumor datasets. Investigators evaluated the accuracy of PBMS NLMEM-derived single-timepoint dosimetry estimates compared with established Madsen and Hänscheid approaches.

Key findings included:

The PBMS NLMEM approach accurately estimated absorbed doses for both kidneys and tumors using a single imaging timepoint, achieving mean absolute percentage error (MAPE) values of 3–20% for kidney dosimetry across evaluated timepoints
PBMS NLMEM outperformed comparator single-timepoint dosimetry methods with respect to MAPE and R20 for kidney absorbed dose estimation across all evaluated timepoints
Findings suggest individualized dosimetry may be achievable with just one scan approximately six hours after treatment, offering an alternative for centers with limited imaging capacity and potentially expanding the routine use of personalized dosimetry
"These data build on the extensive dosimetry dataset generated through the COMPETE trial and reflect ITM’s continued commitment to advancing precision radiopharmaceutical therapy," said Dr. Celine Wilke, chief medical officer of ITM. "The possibility of accurate, same-day dosimetry from a single scan may help reduce patient burden and workflow complexity, as well as reduce inter-center disparities, making personalized dosimetry practical for a far broader range of clinical settings."

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

(Press release, ITM Isotopen Technologien Munchen, JUN 1, 2026, View Source [SID1234666355])

On June 1, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on developing novel therapies for difficult-to-treat cancers, reported that two presentations were given at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The presentations featured post-hoc efficacy and biomarker analyses from the randomized Phase 2 study (NCT03678883), along with clinical data from a Phase 2 study conducted at Mass General Brigham Cancer Institute of elraglusib in combination with FOLFIRINOX (FFX) and the TGF-β inhibitor losartan in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

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"The consistency of the survival benefit, the depth and durability of responses, and the favorable safety profile observed across studies with both gemcitabine/Abraxane and FOLFIRINOX continue to underscore the broad clinical promise of elraglusib in combination with established chemotherapy regimens," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "We believe these data further strengthen the positioning of elraglusib as a potentially differentiated backbone therapy and expand future development opportunities in key patient populations across multiple combination settings. The potential to combine with RAS/RAF/MEK inhibitors in patients where those therapies would be appropriate, along with significant survival benefit in patients without those molecular mutations, speaks to the broad therapeutic potential of elraglusib. Looking ahead, the planned addition of our oral formulation should enable broader combination strategies, greater dosing flexibility, and expanded clinical and commercial potential."

Title: Post-hoc efficacy and biomarker analysis of elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone in metastatic pancreatic ductal adenocarcinoma

First Author: Devalingam Mahalingam, MD, PhD, Gastrointestinal Oncologist and Professor of Medicine at Northwestern University Feinberg School of Medicine

A comprehensive post-hoc efficacy and biomarker analysis of the randomized Phase 2 1801 Part 3B study showed that elraglusib plus gemcitabine/nab-paclitaxel (GnP), compared with GnP alone, provided meaningful clinical benefit across multiple patient subgroups in previously untreated mPDAC.

Key Findings from the Analysis

Striking survival advantages of elraglusib/GnP vs GnP alone were observed in patients with wild-type (WT) tumor genomics:
Patients with KRAS WT treated with elraglusib/GnP achieved a mOS of 16.9 vs 10.1 months (p<0.001), a nearly 7-month improvement.
This survival advantage was consistent across key tumor suppressor gene subgroups analyzed:
TP53 WT: 13.4 vs 7.6 months, (p=0.002)
CDKN2A WT: 10.4 vs 7.6 months, (p=0.002)
SMAD4 WT: 10.1 vs 7.1 months, (p=0.003)
Positive OS trends were observed in both the intent-to-treat (ITT) and modified intent-to-treat (mITT) populations treated with elraglusib plus GnP versus GnP alone.
In a landmark analysis of patients completing at least one treatment cycle, mOS was approximately 12.5 months in the elraglusib/GnP arm compared with 8.5 months in the GnP control arm, with a near doubling of the one-year survival rate versus GnP alone.
Exploratory subgroup analyses demonstrated improved OS in patients treated with elraglusib/GnP vs GnP who had:
ECOG performance status of 0 (12.2 vs 8.0 months; p=0.007)
Baseline albumin ≥3 g/dL (10.8 vs 7.6 months; p=0.02)
Baseline CA19-9 <8000 U/mL (12.2 vs 7.8 months; p=0.01)
Lower tumor grade (Grade 1+2, 14.3 vs 7.8 months, p=0.005)
Lower tumor mutational burden, lower circulating tumor DNA (ctDNA) fraction, and lower tumor grade were correlated with improved survival outcomes only in elraglusib/GnP-treated patients, providing a foundation for prospective patient selection in future studies.
Title: A Phase II Study of FOLFIRINOX (FFX) Combined with the Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor Elraglusib (ELRA) and the Transforming Growth
Factor-β (TGF-β) Inhibitor Losartan (LOS) in Patients with Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

First Author: Priyadarshini Pathak, Mass General Brigham Cancer Institute, Boston, USA

The Phase 2 study evaluated elraglusib in combination with FFX and losartan (LOS) across four treatment arms in a first-line population of patients with mPDAC.

Key Findings

Arms incorporating elraglusib demonstrated meaningful improvement: elraglusib/FFX and elraglusib/FFX+LOS each achieved mOS of 9.8 months and mPFS of 6.0 and 6.5 months, respectively, vs 7.7 months and PFS of 5.1 with FFX alone.
A subset of patients in elraglusib combination arms demonstrated deep and durable responses, with ongoing biomarker analyses evaluating features associated with long-term benefit.
The combination was generally well tolerated. Grade 3 or higher treatment-related adverse events occurred in 34.7% of patients, with the most common being diarrhea, fatigue, hypokalemia, and decreased platelet count, a profile consistent with the known toxicities of FOLFIRINOX, further supporting the tolerability of elraglusib.

(Press release, Actuate Therapeutics, JUN 1, 2026, View Source [SID1234666353])

On June 1, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported positive clinical data from three clinical data poster presentations at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2, 2026 at McCormick Place, Chicago, Illinois. The presentations will include two poster presentations featuring data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (ClinicalTrials.gov identifier: NCT06072612) and one poster highlighting further analyses of Phase 2 data.

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"Late-stage metastatic breast cancer (MBC) is often associated with a poor prognosis and very short survival rates," stated Saranya Chumsri, MD, principal investigator in the Phase 3 study of Bria-IMT+CPI, and Professor of Oncology at Mayo Clinic Florida. "We are pleased to report Phase 2 study median overall survival rates as high as 16.6 months and a high rate of long-term survival in our late-stage MBC patients including in patients resistant to multiple prior therapies."

"BriaCell’s Phase 3 data are highly encouraging because they address one of the key challenges in treating late-stage breast cancer patients: delivering clinical benefit while limiting toxicity that can lead to voluntary treatment discontinuation," stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women’s Cancer Program.

"We are increasingly optimistic with the early quality of life and biomarker data from our ongoing pivotal Phase 3 Bria-ABC trial demonstrating sustained clinical activity in patients with advanced MBC who did not respond to multiple prior treatments," noted William V. Williams, MD, BriaCell’s President & CEO.

The details of the presentations are listed below.

Abstract Title: Survival with Bria-IMT + CPI in advanced metastatic breast cancer at 12 and 24 months.
Session Type/Title: Poster Session – Breast Cancer—Metastatic
Poster Board: 222
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Clinical Data: 32 Phase 2 Bria-IMT patients were randomized to receive immune checkpoint inhibitor (CPI) in the first cycle or delayed to the second cycle. Two Bria-IMT formulations were also evaluated. Patients had median age of 61 (range 41-80) and had received median 6 prior therapies (range 2-13). Treatment was well tolerated with injection site reactions, mostly mild in severity, the most frequent side. The clinical benefit rate was 62% overall in long-term survivors. Of patients treated with the Phase 3 formulation, 10 of 21 (48%) survived over a year.

Median overall survival ("OS") was 13.3 months for patients who initiated checkpoint inhibitor ("CPI") therapy in Cycle 1 (as is being done in the Phase 3 Bria-ABC study) versus 7.4 months for those who initiated CPI therapy in Cycle 2 with estimated 12-month and 24-month OS rates being 50% and 25% for initiating CPI in the first cycle. Among patients who developed an immune response, as measured by delayed-type hypersensitivity ("DTH"), median OS was 11.9 months in DTH-positive patients versus 4.7 months in DTH-negative patients, with 48% versus 0% 12-month survival, respectively. Estimated 12-month and 24-month OS rates were 41% and 24%, respectively, for the entire Phase 2 population. For patients treated with the Phase 3 regimen, the median OS was 16.6 months with >55% OS at 1 year and >27% at 2 years (see Figure 1 below. Note that the CPI at C1 and IP w/o IFNγ is the Phase 3 Bria-IMT regimen). There were no treatment-related discontinuations and no unexpected safety signals.

Conclusions: In heavily pretreated MBC patients, Bria-IMT demonstrated an excellent safety profile and the emergence of a long-term survivor cohort. Durable survival rates were observed beyond 12 and 24 months. Differential survival favored the Phase 3 formulation, DTH positivity, lower baseline circulating tumor cell (CTC) levels, and early CPI sequencing. These findings support prospective validation of DTH and CTC as predictive biomarkers for effectiveness of the Bria-IMT regimen and the continued use of the Phase 3 formulation in the ongoing Phase 3 study Bria-ABC. The clinical findings further confirmed the preferred formulation for the ongoing pivotal Phase 3 study.

Abstract Title: Quality of life and treatment tolerability of Bria-IMT + CPI in metastatic breast cancer.
Session Type/Title: Poster Session – Breast Cancer—Metastatic
Poster Board: 221
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Summary: Heavily pretreated MBC patients in the pivotal Bria-ABC study demonstrated stable global health and key functional domains. Measurements included quality of life (QOL) and time without symptoms or toxicity (TWiST). Blinded data indicated that QOL was preserved in a heavily pretreated population with prior antibody-drug conjugate (ADC), check point inhibitor (CPI), and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor exposure. Clinical data demonstrates meaningful benefits without significant toxicity. Ongoing follow up will further characterize durability of patient-reported outcomes and clinical correlation. Data further supports decentralized care and potential home self-administration of the Bria-IMT+CPI regimen.

Study patients were heavily pretreated, consistent with BriaCell’s prior Phase 2 population, with a median of 6 prior systemic therapies (range: 2–14), including prior ADCs in 84%, CPIs in 27%, and CDK4/6 inhibitors in 61%. Blinded Phase 3 data suggest sustained quality of life despite advanced disease and poor prognostic characteristics. TWiST analysis demonstrated meaningful time alive without disease symptoms or significant treatment-related toxicity, supporting a favorable benefit-risk profile.

Abstract Title: Monitoring blood-based biomarkers as early predictors of progression-free survival in a randomized Bria-ABC Phase 3 trial for advanced metastatic breast cancer: An ongoing analysis.
Session Type/Title: Poster Session – Developmental Therapeutics—Immunotherapy
Poster Board: 442
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
Summary: In an ongoing analysis of heavily treated MBC patients, we observed that in the entire blinded population, 65% of patients had stability/drop in Cancer-Associated Macrophage-Like cells (CAMLs) and this significantly correlated with better progression free survival (PFS).

Results:

≥1 circulating tumor cells (CTC)s were found in 25% at baseline (BL) and 20% at the first on-treatment assessment(T1)
≥1 Cancer-associated macrophage-like cells (CAMLs) were found in 93% at BL & 93% at T1
≥1 CTC significantly correlated with progression free survival (PFS) at BL, but not at T1
A decrease or stable CAML counts between BL and T1 (seen in 60% of patients) significantly correlated with better progression-free survival
In this ongoing blinded analysis of heavily pretreated metastatic breast cancer patients, stable or decreased CAML counts from baseline to Cycle 3 were observed in 60% of evaluable patients and significantly correlated with improved PFS. Baseline CTC positivity was associated with more rapid progression. These findings support further evaluation of CAML dynamics as a potential early blood-based biomarker of clinical outcomes in the Phase 3 Bria-ABC study.

Following the presentation, copies of the posters will be available at View Source

(Press release, BriaCell Therapeutics, JUN 1, 2026, View Source [SID1234666352])

On June 1, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported a poster presentation on May 31, 2026, featuring the methodology and study design for its pivotal Phase 3 clinical trial (THIO-104) at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2026), being held May 29 – June 2, 2026, in MAIA’s home city of Chicago, Illinois. THIO-104 evaluates the efficacy of MAIA’s telomere targeting agent, ateganosine, administered in sequence with a checkpoint inhibitor (CPI) in third-line non-small cell lung cancer (NSCLC) patients resistant to CPIs and chemotherapy. MAIA reported the first patient dosed in THIO-104 in December 2025, and screening and enrollment is underway in Europe and Asia.

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"We’re pleased to be back at ASCO (Free ASCO Whitepaper), where many of the world’s leading oncology experts gather to discuss the latest advances shaping the future of cancer treatment," said MAIA CEO Vlad Vitoc, M.D. "The level of engagement and enthusiasm surrounding our clinical programs is very encouraging, particularly as investigators continue enrolling patients in both our pivotal Phase 3 THIO-104 trial and Phase 2 THIO-101 trial expansion."

MAIA’s ASCO (Free ASCO Whitepaper) 2060 poster, titled "A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress," was presented by Tomasz Jankowski, M.D., Phase 2 THIO-101 lead investigator for Poland, enrollment advisor for the pivotal Phase 3 THIO-104 clinical trial and co-author of several MAIA scientific presentations. The poster is attached to this press release and is also available on the Publications page of MAIA’s website maiabiotech.com.

"Investigators are increasingly focused on therapies that can potentially overcome resistance mechanisms and improve outcomes for patients with advanced NSCLC," said Dr. Jankowski.

"Ateganosine has generated meaningful interest within the oncology community and may offer a promising new therapeutic option for patients who currently face very limited treatment choices."

The ASCO (Free ASCO Whitepaper) Annual Meeting is the world’s largest cancer research meeting, with nearly 45,000 attendees and 166 countries represented in 2025.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-104 Phase 3 Clinical Trial

THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.

(Press release, MAIA Biotechnology, JUN 1, 2026, View Source [SID1234666351])