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])

On June 1, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported an update on its newly implemented AI-based technological initiatives and improved pipeline discovery efficiencies, which are expected to lead to additional development candidates advancing into pre-IND development in 2027.

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"We have seen a marked acceleration in our discovery productivity following recent initiatives implementing AI-based technologies, which have been adapted to improve our drug engineering capabilities," said Michael Breen, Executive Chairman and Chief Executive Officer. "As we continue to demonstrate clinical execution acumen with GTB-3650 and GTB-5550 advancing through Phase 1 this year, we are now looking forward to our next-generation assets with potential for shorter development timeliness, increased probability of clinical success, and lower development costs in the coming years."

Implementation of AI-based technology for GT Biopharma’s Discovery Pipeline

AI-guided sequence and structural analyses are used to identify de novo candidate tumor-targeting engagers and multi-domain proteins with favorable binding, stability, and developability profiles, enabling early prioritization of molecules most likely to demonstrate translation success beyond discovery.
These tools further inform rational engineering by optimizing domain orientation, linker design, and spatial architecture to enhance binding, support productive immune synapse formation, and minimize structural liabilities that can impair potency, manufacturability, or consistency.
In downstream applications, AI-based structural modeling is applied to predict surface exposure, steric compatibility, and assay performance, guiding construct refinement prior to resource-intensive in vitro and in vivo studies.

(Press release, GT Biopharma, JUN 1, 2026, View Source [SID1234666350])

On June 1, 2026 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported it has completed enrollment of 108 patients in the Phase 3 trial evaluating belzupacap sarotalocan (bel-sar) as a frontline treatment for patients with early choroidal melanoma. Topline data for the 15-month primary endpoint are anticipated in the second half of 2027.

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"Completing enrollment in our Phase 3 CoMpass trial marks a significant milestone for Aura as we advance bel-sar toward a potential regulatory approval in early choroidal melanoma," said Dr. Jill Hopkins, Chief Medical Officer and President of R&D of Aura Biosciences. "We believe bel-sar has the potential to become the first approved frontline, vision-preserving therapy for this disease, addressing a critical unmet need for patients who today often face treatment options that can result in irreversible vision loss. We are deeply grateful to the patients, investigators, and clinical sites participating in the CoMpass trial and look forward to reporting topline data in the second half of 2027."

The ongoing CoMpass trial is the first registration-enabling study in patients with early choroidal melanoma. The global, randomized Phase 3 trial is evaluating bel-sar versus sham control in the frontline setting under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Aura previously received Orphan Drug Designation from both the FDA and the European Medicines Agency, as well as Fast Track designation from the FDA for the treatment of early choroidal melanoma.

(Press release, Aura Biosciences, JUN 1, 2026, https://www.globenewswire.com/news-release/2026/06/01/3304295/0/en/aura-biosciences-announces-enrollment-completion-in-phase-3-compass-trial-of-bel-sar-in-early-choroidal-melanoma.html [SID1234666349])