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])

On June 1, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX, "Elicio" or the "Company"), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, reported the publication of a peer-reviewed manuscript in Science Advances, published by the American Association for the Advancement of Science, describing a series of novel AMP-DNA adjuvant candidates built from the lymph node-targeting Amphiphile ("AMP") platform technology.

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The manuscript, titled "Lymph node targeted DNA engages TBK1/IFN-I driven innate immunity to induce potent T cell responses and durable memory in mice and NHPs," highlights the ability of these preclinical novel AMP-DNA adjuvants to drive robust, durable immune responses through targeted delivery to lymph nodes and activation of innate immune pathways. This work further builds on the development of the TLR-9-specific AMP-CpG (ELI-004), providing an expanded portfolio of potent lymph node-targeted AMP immunomodulators.

"We are excited to see this work published in the prestigious peer-reviewed journal, Science Advances, as we believe it reinforces the breadth and versatility of our AMP platform beyond our initial clinical programs. These data highlight our ability to precisely direct immune activation to the lymph nodes and unlock powerful, durable T cell responses through novel mechanisms, such as TBK1 and type I interferon (IFN-I) signaling. We believe these new AMP-DNA immuno-activators represent a meaningful step toward expanding the AMP toolkit of next-generation immunotherapies across oncology and infectious disease," said Peter DeMuth, Ph.D., Chief Scientific Officer of Elicio.

The findings further expand the scientific foundation of Elicio’s AMP platform, which is designed to enhance immune responses by directing therapeutics to the lymph nodes—where immune responses are initiated and coordinated—while minimizing systemic toxicity.

Key Study Highlights

Superior Efficacy: Preclinically, AMP-DNA outperformed current clinical and commercial benchmark adjuvants in head-to-head comparisons, inducing substantially more robust cellular immunity

Potent T Cell Activation: AMP-DNA elicited high frequencies of antigen-specific, polyfunctional CD8+ and CD4+ T cell responses across tissues

Long-Term Immunity: Durable immune memory was observed for at least nine months, with rapid and robust recall responses upon antigen re-exposure

Validated in Primates: Findings were replicated in non-human primates, demonstrating strong cellular and humoral immune responses in a translationally relevant model

Lymph Node Precision: AMP-DNA targets lymph nodes to create a localized, highly immunostimulatory environment

Distinct Mechanistic Pathway: Immune activation is driven through TBK1/IFN-I signaling pathways, supporting a differentiated mechanism compared to AMP-CpG which activates TLR-9

Preclinical results demonstrated that AMP-DNA adjuvants significantly enhanced both cellular and humoral immune responses compared to unmodified DNA and clinically relevant adjuvant benchmarks. The technology enabled efficient lymph node delivery and induction of a pro-inflammatory cytokine environment critical for adaptive immunity. In non-human primates, AMP-DNA induced strong T cell responses and high titers of neutralizing antibodies, supporting its potential translational relevance for human applications.

(Press release, Elicio Therapeutics, JUN 1, 2026, View Source [SID1234666348])

On June 1, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported the oral presentation of Part 1 safety, dosimetry and pharmacokinetics data from the ProstACT Global Phase 3 Study of TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), in metastatic castration-resistant prostate cancer (mCRPC). The late-breaking data were presented today at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois by study Principal Investigator Pedro C. Barata, MD, Medical Oncologist, University Hospitals Seidman Cancer Center and Associate Professor of Medicine, Case Western Reserve University of School of Medicine, Cleveland, Ohio.

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Results demonstrated that TLX591-Tx, Telix’s lead prostate-specific membrane antigen (PSMA) targeted lutetium rADC therapy candidate, has an acceptable safety and tolerability profile when administered with standard of care (SoC) therapies in mCRPC, with no new safety signals observed.

ProstACT Global is an international, multi-center, randomized Phase 3 trial comparing TLX591-Tx, administered as two doses, 14 days apart with SoC (abiraterone, enzalutamide or docetaxel) versus SoC alone. The study is designed to reflect real-world clinical practice2 and enrolls PSMA-positive mCRPC patients previously treated with one androgen receptor pathway inhibitor (ARPI).

Patients were monitored for treatment-emergent adverse events and underwent serial SPECT/CT3 imaging after TLX591-Tx administration for dosimetry and blood sampling for pharmacokinetics. The primary endpoint was safety and tolerability of TLX591-Tx + SoC. Key secondary endpoints were pharmacokinetics and radiation dosimetry.

Results: Data from 36 patients (baseline median PSA4: 18.18 ng/mL) who received any study treatment were included: Cohort 1 (11 patients), TLX591-Tx + abiraterone; Cohort 2 (11 patients), TLX591-Tx + enzalutamide; Cohort 3 (14 patients), TLX591-Tx followed by docetaxel.

Safety and tolerability

Acceptable safety profile observed across all combination cohorts, tolerability of TLX591-Tx consistent with prior studies.
All 36 patients received both doses of TLX591-Tx per protocol.
No new safety signals identified.
Almost all treatment-emergent non-hematologic events were Grade 1–2, primarily fatigue (53%), nausea (28%) and dry mouth (25%).
Hematologic events were transient and manageable: Grade 3 thrombocytopenia (14%) and neutropenia (22%), and Grade 4 thrombocytopenia (31%) and neutropenia (25%) events were in line with the profile expected for this class of therapy and extent of disease.
Dosimetry and pharmacokinetics

Radiation exposure to key organs was well below established safety limits5.
Highest absorbed dose observed in liver (range, 1.62-5.08 mGy/MBq), with lower doses received by kidneys (0.336-0.961 mGy/MBq) and salivary glands (0.001-0.104 mGy/MBq).
Lesion dosimetry confirmed uptake across tumor sites and across all cohorts.
Pharmacokinetics demonstrated sustained activity at Day 15, corroborated by imaging which demonstrated prolonged tumor retention.
No evidence of drug-drug interactions impacting TLX591-Tx targeting, distribution or clearance.
Telix has initiated Part 2, a 2:1 randomized treatment expansion, in jurisdictions where regulatory approvals have been obtained. Engagement is underway with the United States (U.S.) Food and Drug Administration (FDA) to discuss Part 1 data and seek an Investigational New Drug (IND) amendment to progress Part 2 in the U.S.

Pedro C. Barata, MD, stated, "These results support the feasibility of administering TLX591-Tx alongside current standard-of-care therapies for mCRPC, including ARPIs. Imaging demonstrated sustained tumor retention through day 15, while dosimetry analyses showed radiation exposure below established safety thresholds and limited dose to key organs. Hematologic adverse events were generally consistent with those expected in this patient population and therapeutic class and were transient in most cases. Overall, the safety, dosimetry, and tumor-targeting findings, together with the high treatment compliance observed in this study, support further evaluation of this approach, in the randomized phase of the trial."

David N. Cade, MD, Group Chief Medical Officer, Telix added, "Despite meaningful advances in clinical practice, mCRPC remains a disease where patients urgently need additional first and second-line options. These Part 1 results, presented today at ASCO (Free ASCO Whitepaper), build on prior clinical findings and further support our view that TLX591-Tx in combination with contemporary standard of care has the potential to become a new treatment option for this aggressive disease."

The ASCO (Free ASCO Whitepaper) presentation abstract can be found here.

About ProstACT Global

ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET6 imaging agent (such as Illuccix, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one ARPI.

The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies7, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys8. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs9.

Additional information on the Phase 3 ProstACT Global study can be found at: View Source

(Press release, Telix Pharmaceuticals, JUN 1, 2026, View Source [SID1234666347])