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 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported updated clinical data from its ongoing Phase 2a trial evaluating atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

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The data are being presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (see Abstract #4013 and accompanying presentation) by Peter Vu, M.D., M.H.A., Associate Professor of Medicine and Medical Director, Cancer Quality, GI Medical Oncology, Experimental Therapeutics & Cellular and Regenerative Medicine at UC San Diego Moores Cancer Center. The presentation showcases data from an expanded cohort totaling 55 first-line pancreatic cancer patients.

"As pancreatic cancer clinicians, we are urgently seeking therapies capable of meaningfully extending survival while preserving patients’ quality of life," said Daniel Ahn, D.O., Mayo Clinic Arizona, an investigator on the Phase 2a trial of atebimetinib. "The median overall survival of 17.3 months observed in this study is incredibly encouraging relative to historical outcomes in first-line metastatic pancreatic cancer. Equally important, atebimetinib demonstrated a notably favorable tolerability profile, with limited severe treatment-related toxicities and encouraging indicators of preserved functional status, including weight stability – key characteristics for treatments balancing durable clinical benefit and patient experience. Data from this expanded cohort reinforce atebimetinib’s strong potential in first-line pancreatic cancer."

This open-label, single-arm Phase 2a trial evaluated atebimetinib at 320 mg once daily in combination with mGnP in participants with first-line metastatic pancreatic cancer, irrespective of mutational status. The Company reported the following as of the April 24, 2026 data cutoff date:

In the expanded 55-patient cohort, median overall survival was 17.3 months (95% CI: 11.2, not reached), compared to 8.5 months median overall survival in the pivotal Phase 3 MPACT study of standard of care gemcitabine/nab-paclitaxel (Von Hoff et al, NEJM, 2013). The median follow-up was 11.6 months.
Median progression-free survival was 8.3 months (95% CI: 5.9, 9.6), disease control rate (DCR) was 82%, and the confirmed overall response rate (ORR) was 36%.
In the original 34-patient cohort with longer follow-up (median 17.0 months), median overall survival was also observed to be 17.3 months (95% CI: 11.6, not reached) — supporting the consistency of the survival signal across cohorts with different durations of follow-up.
"The data presented at ASCO (Free ASCO Whitepaper) further strengthen our conviction that atebimetinib has the potential to redefine what it means to live with metastatic pancreatic cancer," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "The combination of compelling survival data and a highly favorable safety profile supports the evaluation of this regimen in our Phase 3 study for first-line pancreatic cancer patients, which is now recruiting. We believe the ability of our deep cyclic MEK inhibitors to improve overall survival, while maintaining tolerability, may represent an important advancement for patients and physicians alike."

Only two categories of Grade 3 or higher treatment-related adverse events occurred in at least 10% of participants, both related to chemotherapy. No Grade 4 adverse events related to atebimetinib and no Grade 5 treatment-related adverse events were reported. Only one participant discontinued atebimetinib while continuing mGnP. The safety profile observed in the trial compared favorably to historical experiences with intensive chemotherapy treatments and combination regimens under development in pancreatic cancer.

Additionally, 84% of participants with available data maintained or gained weight at three months, a potentially important indicator of preserved performance status and tolerability in this patient population where cachexia is common and correlated with poorer outcomes.

Immuneering is currently recruiting patients in MAPKeeper 301 (NCT07562152), a global randomized Phase 3 pivotal trial evaluating atebimetinib plus mGnP versus standard-of-care gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer. The trial’s primary endpoint is overall survival.

Upcoming Milestones

Mid 2026: First patient dosed in Phase 3 MAPKeeper 301 trial.
2H 2026: First patient dosed in Phase 2 trial of atebimetinib + anti-PD-1 (cemiplimab) in non-small cell lung cancer.
Q4 2026: Additional preclinical data supporting atebimetinib + anti-PD-1 in non-small cell lung cancer.
Mid 2027: Begin IND-enabling studies for next DCI drug program.
Late 2027: Preliminary Phase 2 data: atebimetinib + anti-PD-1 (cemiplimab) in non-small cell lung cancer.
Mid 2028: Phase 3 MAPKeeper 301 topline readout expected.
Conference Call

Immuneering will host a conference call and live webcast at 8:00 a.m. EDT / 7:00 a.m. CDT on June 1, 2026, to discuss the data. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 for U.S. callers and (646) 307-1963 for other locations and reference conference ID 7597768, or from the webcast link in the "investors" section of the company’s website at www.immuneering.com. A webcast replay will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

(Press release, Immuneering, JUN 1, 2026, View Source [SID1234666306])

On June 1, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported new radiochemistry data at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting taking place in Los Angeles, California.

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The poster presented a systematic evaluation of chelator-to-antibody ratio (CAR) optimization for Actinium-225 (225Ac)-labeled antibody radioconjugates, a critical but often underappreciated design parameter that directly influences radiolabeling efficiency, antigen binding, internalization, and biodistribution. The findings reinforce a proprietary radiochemistry capability that underpins the Company’s broader pipeline. Practically, CAR governs how many radioactive payloads each tumor-seeking antibody carries. Too few a payload causes a radioconjugate drug to under deliver, too many and the antibody loses its aim and leaks dose into healthy tissue. Therefore, identifying the optimal ratio is what separates a technically active therapy from one that can be dosed effectively and safely.

Sandesh Seth, Actinium’s Chairman and CEO, said, "Our CAR optimization data underscore the depth of our radiochemistry expertise and our focus on maximizing therapeutic index, which we believe is a key differentiator of our platform. Getting the chelator-to-antibody ratio right is fundamental to preserving the biological integrity of an antibody while enabling robust 225Ac labeling and favorable pharmacokinetics. These findings have direct implications for the design of next-generation radioconjugates, and reinforce a radiochemistry advantage that supports successful clinical translation across our pipeline."

Highlights from the SNMMI 2026 Poster Presentation
Poster Titled: Optimizing Chelator-to-Antibody Ratio Improves Tumor Targeting and Pharmacokinetics of 225Ac-Labeled Antibodies

Optimizing the chelator-to-antibody ratio (CAR) is a critical but often underappreciated design parameter in antibody-based radiopharmaceuticals. Actinium’s scientists conducted a systematic evaluation of CAR for 225Ac-labeled antibody radioconjugates, with findings directly applicable to the development of Actinium’s radiopharma pipeline:

Antibody-DOTA conjugates spanning CAR 0.7–9 were prepared. CAR ≥1.7 enabled robust 225Ac labeling, while CAR 0.7 was insufficient. This establishes the minimum loading needed to carry an effective radioactive dose

Antigen binding stayed high at low CAR (91–98% at CAR 0.7–3.2) but fell at high CAR (79–85% at CAR 7–9), and low-CAR conjugates internalized more, keeping more of the antibody functional. Median Fluorescence Intensity (MFI) is a proxy for binding or antigen affinity retention. Findings suggest overloading the antibody degrades its ability to find and enter cancer cells

In vivo, both conjugates showed comparable tumor uptake and sustained retention through 192 h, but the low-CAR (2.5) conjugate significantly reduced liver and spleen uptake, providing a basis for a wider therapeutic index

Both conjugates remained stable over 7 days (radiochemical purity above 97%), showing that CAR can be optimized for performance without compromising manufacturability or clinical supply. Safety and targeting gains can come with no manufacturing trade-off
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A wider therapeutic index could allow more dose to reach the tumor at a given level of safety, a proprietary radiochemistry framework Actinium is applying to de-risk its broader pipeline resulting in lower technical risk across the portfolio

(Press release, Actinium Pharmaceuticals, JUN 1, 2026, View Source [SID1234666322])

On June 1, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for a patent covering key aspects of Anixa’s ovarian cancer vaccine technology.

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The allowed patent, exclusively licensed from Cleveland Clinic, includes methods of administering an immunogenic composition comprising a nucleic acid encoding the anti-Müllerian hormone receptor 2 (AMHR2) polypeptide to elicit an AMHR2-specific immune response to prevent or treat ovarian cancer.

Anixa’s ovarian cancer vaccine, being developed in a collaboration between Cleveland Clinic and the National Cancer Institute (NCI), represents a novel approach to preventing and treating ovarian cancer, particularly among high-risk populations such as those carrying BRCA mutations or with a family history of the disease.

The Canadian Notice of Allowance expands the international scope of Anixa’s intellectual property portfolio around its ovarian cancer vaccine technology and complements the Company’s existing patent protection in the United States. In July 2025, Anixa announced the issuance of U.S. Patent Number 12,357,593 covering key aspects of its ovarian cancer vaccine technology, including broad claims related to methods of eliciting an immune response targeting AMHR2.

"This Canadian Notice of Allowance further strengthens the international patent protection around our ovarian cancer vaccine program and supports the novelty of our AMHR2-targeted immunoprevention approach," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "Together with our U.S. patent protection for ovarian cancer vaccine technology and our separate intellectual property portfolio for breast cancer vaccine technology, this allowance supports our strategy of building a broad cancer vaccine platform based on retired-protein targets. Our breast cancer vaccine recently completed a Phase 1 clinical trial, funded by a grant from the U.S. Department of Defense and conducted in collaboration with Cleveland Clinic, in which all primary endpoints were met."

Anixa’s ovarian cancer vaccine is based on immunizing against AMHR2, a protein expressed in normal ovaries prior to menopause and also aberrantly expressed in certain types of ovarian cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, is designed to train the immune system to recognize and target cells associated with ovarian cancer while seeking to avoid harm to normal tissue.

By expanding its patent protection in Canada, Anixa is continuing to build a broader international intellectual property position around its cancer vaccine technologies. The Company believes this intellectual property foundation is important as it evaluates future clinical, regulatory and strategic development opportunities for its vaccine programs.

(Press release, Anixa Biosciences, JUN 1, 2026, View Source [SID1234666338])

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])