On June 4, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported a patient enrollment update for its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC). To date, 29 patients have been dosed among 34 activated trial sites in 6 foreign countries.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA, commented, "Enrollment and dosing in our Phase 3 study is progressing at a strong pace. Based on this early momentum, we are targeting up to 100 patients by year-end and expect to have sufficient survival data to conduct an interim analysis in 2027."

Dr. Vitoc has previously stated that statistical assessments of MAIA’s lead therapeutic, ateganosine, suggest a high probability of technical success in the THIO-104 full approval trial if Phase 3 data is consistent with Phase 2 THIO-101 trial results. Median overall survival was 17.8 months in parts A and B of the Phase 2 trial. With chemotherapy, which is the standard utilized treatment for 3L NSCLC patients, expected survival in a heavily pre-treated population is 5.8 months.1

Ateganosine is a first-of-its-kind dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. As a potential breakthrough therapeutic, ateganosine holds substantial commercial opportunity in a projected $70 billion global NSCLC treatment market by 2030.2

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine as a 3L NSCLC treatment.

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 4, 2026, View Source [SID1234666454])

On June 4, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that the Company will present data from its ongoing Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, taking place in Stockholm, Sweden, June 11–14, 2026. The data will be featured in two poster presentations covering an updated ronde-cel safety analysis and translational insights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

EHA 2026 Poster Presentations

Low-Grade CRS and ICANS with Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell Product Candidate, in Patients with Large B-Cell Lymphoma: Updated Safety Analysis

Poster: PF962
Session: Large B-Cell Lymphomas – Clinical; Hall A
Time: Friday, June 12, 12:45 pm EDT / 6:45 pm CEST
Presenting Author: Sarah M. Larson, M.D., Associate Professor in the Division of Hematology-Oncology, David Geffen School of Medicine, UCLA
Durable Responses with Rondecabtagene Autoleucel (Dual-Targeting CD19/CD20 CAR
T-Cells) are Associated with Higher Proportion of Cytotoxic T Cells with Memory Potential in Infusion Products

Poster: PF1097
Session: Lymphoma Biology & Translational Research; Hall A
Time: Friday, June 12, 12:45 pm EDT / 6:45 pm CEST
Presenting Author: Akil Merchant, M.D., Associate Professor and Co-Director of the Lymphoma Program, Samuel Oschin Cancer Center, Cedars-Sinai Medical Center
Ronde-cel is currently being evaluated for the treatment of R/R LBCL across two pivotal clinical trials. In the 3L+ setting, the ongoing single-arm PiNACLE trial is expected to report updated data in the second half of 2026 and pivotal data by mid-2027, setting up a subsequent Biologics License Application (BLA) submission in 2027. In the 2L setting, the Phase 3 randomized PiNACLE-H2H trial is evaluating ronde-cel against investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel.

The posters will be available through the Science section of the Company’s website at www.lyell.com after the presentations.

(Press release, Lyell Immunopharma, JUN 4, 2026, View Source [SID1234666453])

On June 4, 2026 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported the clinical availability of the ArteraAI Prostate Test (mHSPC), the first digital pathology–based prognostic test designed to help inform treatment planning for patients with metastatic hormone‑sensitive prostate cancer (mHSPC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

mHSPC is a diverse disease state with widely variable outcomes, requiring complex treatment decisions that can significantly impact both survival and quality of life. While traditional clinical factors provide general prognostic insight, they do not offer individualized risk. The ArteraAI Prostate Test (mHSPC) addresses this gap by delivering a patient‑specific estimate of 5‑year prostate cancer–specific mortality (PCSM) in patients treated with androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI).

"Artera’s platform was built to bring greater clarity to cancer treatment decisions," said Andre Esteva, CEO of Artera. "With our expansion into metastatic hormone-sensitive prostate cancer, we are excited to leverage our validated MMAI approach for a more complex stage of disease, helping guide treatment decisions with greater confidence."

The ArteraAI Prostate Test (mHSPC) builds on Artera’s established biopsy‑based MMAI model used in localized prostate cancer and was further validated in patients with mHSPC receiving ADT plus ARPI as significantly prognostic for prostate cancer–specific mortality.

"As treatment options for metastatic hormone-sensitive prostate cancer have evolved, tools to accurately assess individual patient risk in the context of modern combination therapy have not fully evolved alongside them," said Calvin Chao, MD, PhD, Vice President of Medical Science at Artera. "This clinically validated test is poised to help clinicians better tailor treatment intensity and duration to the individual patient."

The ArteraAI Prostate Test (mHSPC) is available through Artera and its commercial partner, Tempus, supporting broad and convenient access within existing clinical workflows.

(Press release, Artera, JUN 4, 2026, View Source [SID1234666452])

On June 4, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, reported a strategic collaboration to evaluate circulating tumor DNA (ctDNA) dynamics and generate real-world molecular insights to support CytoDyn’s metastatic colorectal cancer (mCRC) development program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, Natera will assess CytoDyn clinical trial samples from the CLOVER Phase 2 study (ClinicalTrials.gov Identifier: NCT06699836) in patients with mCRC. SignateraTM, Natera’s personalized assay for the detection of molecular residual disease (MRD), will be used to evaluate ctDNA dynamics and molecular response patterns associated with leronlimab treatment.

Natera will also provide customized real-world data (RWD) analyses leveraging its proprietary oncology database, which is the largest multi-timepoint early- and late-stage oncology dataset with more than 2 million plasma timepoints and enriched clinical and imaging records. By integrating molecular response data from its MRD testing platform with curated electronic medical record (EMR) data, this multimodal dataset enables analyses of patient populations, treatment patterns, ctDNA response rates, and response dynamics across diverse clinical settings. Together, these capabilities are expected to generate insights into molecular response and disease progression that may help inform future clinical development of leronlimab, including clinical trial design, biomarker-driven patient selection strategies, and broader translational research efforts.

The collaboration builds on CytoDyn’s growing oncology program and follows completion of enrollment in the CLOVER study, which is evaluating leronlimab in combination with trifluridine/tipiracil (TAS-102) and bevacizumab in patients with previously treated mCRC. The collaboration is also expected to complement ongoing translational and biomarker analyses from the study aimed at further characterizing treatment response and informing future development strategies.

"Signatera has become an increasingly important tool in precision oncology and clinical development," said Jacob Lalezari, M.D., chief executive officer, CytoDyn. "Through this collaboration, we expect to gain valuable insights into ctDNA response kinetics and disease progression that may help guide future development strategies for leronlimab in colorectal cancer and potentially other solid tumor indications."

"We are pleased to partner with CytoDyn and provide their team with insights derived from one of the largest and most comprehensive real-world molecular oncology data platforms," said Matt Love, vice president, biopharma data & AI partnering, Natera. "Our platform enables biopharma partners to better understand disease biology, treatment response, and patient outcomes, helping inform key development decisions throughout the drug development lifecycle."

(Press release, CytoDyn, JUN 4, 2026, View Source [SID1234666451])

On June 4, 2026 Onchilles Pharma, a clinical-stage biotechnology company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, reported that the first patient has been dosed in its Phase 1/2 clinical trial evaluating N17350 in patients with advanced solid tumors. N17350, Onchilles’ lead tumor-directed therapeutic candidate, is designed to selectively kill cancer cells, while preserving immune cells, and to stimulate systemic anti-tumor immunity.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Dosing the first patient with N17350 marks a major step forward for Onchilles as we move from years of translational research into clinical evaluation," said Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles Pharma. "N17350 was developed to address a central challenge in cancer treatment: how to directly kill tumor cells while preserving and activating the immune system. This Phase 1/2 study gives us the opportunity to evaluate whether the broad, selective, immune-activating activity we have observed preclinically can translate into benefit for patients with advanced solid tumors."

N17350 is designed to leverage the ELANE pathway, a cancer-selective mechanism that induces immunogenic cancer cell death while sparing healthy tissue, including immune cells. In preclinical studies, N17350 demonstrated broad tumor-killing activity, immune cell preservation, and activation of anti-tumor immunity across multiple solid tumor models. The open-label, dose-finding and expansion study is designed to evaluate the safety, tolerability, recommended dose, anti-tumor activity, and biomarker effects of intratumorally administered N17350 in patients with advanced solid tumors.

"Patients with advanced solid tumors need new therapeutic approaches that can produce direct anti-tumor activity while potentiating, rather than compromising, anti-tumor immunity," said Matteo Carlino, M.D., PhD, investigator in the Phase 1/2 study, Westmead Hospital, Sydney, Australia. "N17350 is based on a novel biological rationale, and this first-in-human study is an important step in evaluating its safety, dose, activity, and immune effects in patients."

The Phase 1/2 study will initially evaluate N17350 in patients with advanced solid tumors accessible for intratumoral administration, with planned assessments of safety, dose escalation, anti-tumor activity, and translational biomarkers. Onchilles expects the study to support clinical evaluation of N17350 as both a monotherapy and, over time, as part of rational combination strategies with immunotherapy.

About Onchilles Therapeutic Programs Targeting the ELANE Pathway

At the core of this approach is the ELANE pathway, a unique cancer-selective killing mechanism that leverages altered histone H1 biology, a vulnerability shared by many cancer cell types. Our pipeline is led by N17350, our first-in-class, clinical-stage program, followed by NEU-002, the second program that extends this approach with systemic delivery. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 and NEU-002 are designed to rapidly eliminate tumors while mobilizing an adaptive immune response, offering the potential for sustained anti-tumor immunity. N17350 and NEU-002 offer a unique approach to treating cancer regardless of their genetic makeup, anatomical origin, or immune status, positioning them as potential gamechangers in cancer therapy.

(Press release, Onchilles Pharma, JUN 4, 2026, View Source [SID1234666450])