On April 16, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that it has activated the first U.S. clinical site in its Phase 2 THIO-101 expansion trial of its lead investigational therapy as a third-line (3L) treatment for non-small cell lung cancer (NSCLC).

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"We are thrilled to activate the expansion of our Phase 2 THIO-101 trial in the U.S., bringing our novel treatment to our country’s broad underserved NSCLC patient population. Every year, we estimate approximately 50,000 patients resistant to chemo and CPIs alone advance to third-line NSCLC in the U.S. The medical need is extensive," said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA.

The trial’s expansion into the U.S. marks a key milestone for MAIA, which is expected to open a significantly larger patient pool for evaluation of ateganosine, a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. In addition to the first location, Summit Medical Group in New Jersey, MAIA intends to open four additional sites in U.S. in 2026. The trial is ongoing in Europe and Asia with 44 active sites in 6 countries.

MAIA’s THIO-101 expansion study evaluates ateganosine in heavily pre-treated patients in 3L NSCLC who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy. Two treatment arms are being studied: ateganosine sequenced with cemiplimab (Libtayo) and ateganosine monotherapy. Third-line treatment evaluation in the U.S. is funded by a prestigious $2.3 million grant from the National Institutes of Health (NIH).

"The activation of Summit Medical Group as our first U.S. clinical site is a landmark moment for the THIO-101 study. This is expected to further advance ateganosine as a potential best-in-class therapy for third-line NSCLC," said Matthew Failor, MAIA’s Director of Clinical Operations. "Partnering with a premier institution like Summit should allow us to bring this highly innovative telomere-targeting approach to U.S. patients who have limited options."

"We are proud to be the first U.S. site to offer patients access to MAIA’s innovative THIO-101 expansion trial and contribute to advancing a promising new treatment strategy in lung cancer," added Charles J. Kim, M.D., Summit Health oncologist and principal investigator for the THIO-101 trial in New Jersey.

MAIA holds FDA Fast Track designation for its lead drug targeting advanced NSCLC. The Fast Track process is designed to facilitate development and expedite the review of drugs for serious conditions with no treatment options or limited low-efficacy therapies. If relevant criteria are met during the Fast Track process, a drug is eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).

In 2025, THIO-101 delivered exceptional efficacy data for MAIA’s lead investigational drug sequenced with a checkpoint inhibitor including disease control, response rates, and survival data well above standard of care benchmarks. MAIA recently reported overall survival (OS) beyond two years for eight patients treated with ateganosine sequenced with cemiplimab in Parts A and B of the trial. The eight patients include one with survival of 33 months and four with survival over 30 months. The measures of 3L OS beyond 24 months exceed all known benchmarks for advanced NSCLC treatment. The THIO-101 treatment regimen has shown an acceptable safety profile to date in a heavily pre-treated population.

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-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

(Press release, MAIA Biotechnology, APR 16, 2026, View Source [SID1234664456])

On April 16, 2026 StarkAge Therapeutics, a biotechnology company pioneering first-in-class senolytic antibody-drug conjugates (ADC) for age-related diseases with an initial focus on oncology, reported that it will present two posters at the AACR (Free AACR Whitepaper) Annual Meeting 2026. These data strengthen the company’s leadership in senescence-targeted oncology and support the development of STX-1, its first-in-class DPP4-targeting ADC, as a novel therapeutic strategy for patients with solid tumors who have limited treatment options.

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"These AACR (Free AACR Whitepaper) presentations underscore the growing recognition that therapy-induced senescence is a key driver of tumor progression and resistance," said Eric Angevin, MD, PhD, Chief Medical Officer. "By selectively eliminating DPP4-expressing cells in both tumor and stroma, particularly in the context of senescence, STX-1 has the potential to establish a new therapeutic approach for patients with limited treatment options. Our strategy is grounded in a strong translational foundation and aims to address a significant unmet need in solid tumors."

In the translational poster, StarkAge and Gustave Roussy Institute characterize the impact of treatment-induced senescence in metastatic colorectal cancer and highlight DPP4 (CD26) as a senescence-associated biomarker expressed in both stromal and tumor compartments. The study integrates immunohistochemistry, bulk and single-cell RNA sequencing analyses across large patient datasets and characterize senescence-related biology and its potential implications for disease progression and treatment resistance.

In the preclinical poster, StarkAge will present data showing that STX-1 demonstrated strong affinity for DPP4, high internalization, target-dependent cytotoxicity and in vivo antitumor activity, with enhanced activity in senescent cell-enriched tumors. The abstract also reports that senescence induction through chemo- or radiotherapy increased DPP4 expression, while senescent cancer cells remained sensitive to STX-1 treatment. In vivo, enhanced activity was observed in senescence-enriched tumors, and STX-1 was reported to be well tolerated in toxicology studies in mice expressing human DPP4.

AACR 2026 Poster Details

Preclinical poster
Title: STX-1, a first-in-class ADC targeting DPP4 protein, acts as an anticancer and senolytic treatment
Session / Abstract #: PO.ET02.01 – Antibody-Drug Conjugates and Linker Engineering 1
Presenter: Benjamin Le Calvé, StarkAge Therapeutics
Date / Time: April 20, 2026, 9:00 AM – 12:00 PM
Location: Section 12

Translational poster
Title: Treatment-induced senescence in metastatic colorectal adenocarcinomas: implications for single-cell biology and therapeutic intervention
Session / Abstract #: PO.MCB04.02 – Senescence and Cell Stress
Presenter: Antoine Hollebecque, Drug Development Department (DITEP), Gustave Roussy, Villejuif, France
Date / Time: April 21, 2026, 2:00 PM – 5:00 PM
Location: Section 24

(Press release, StarkAge Therapeutics, APR 16, 2026, View Source [SID1234664455])

On April 16, 2026 Foundation Medicine, Inc., a global, patient-focused precision medicine company and an independent affiliate of Roche, reported it is set to expand its monitoring portfolio with SAGA Diagnostics’ tumor-informed molecular residual disease (MRD) platform as a result of Roche entering into a definitive merger agreement to acquire SAGA. Roche will pay a total of up to $595 million, inclusive of commercial and regulatory milestone payments. The transaction is subject to customary closing conditions including regulatory approvals, and is expected to close in Q3 2026, at the latest. Following the closing of the transaction, the platform will be fully integrated into Foundation Medicine.

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Pathlight’s MRD platform will strengthen Foundation Medicine’s portfolio of high-quality diagnostic tests and solutions that support treatment selection, and the monitoring of both treatment response and disease recurrence. Foundation Medicine also plans to leverage Roche’s AXELIOS sequencing platform1 and the Digital LightCycler PCR platform to develop a decentralized MRD solution which will enable patient access in healthcare settings worldwide.

Pathlight uses a proprietary combination of whole genome sequencing (WGS) and digital PCR to identify and track large-scale genomic changes known as structural variants (SVs). By optimizing for SVs, Pathlight enables ultra-sensitive MRD detection. Pathlight is covered by Medicare for cancer recurrence monitoring in early-stage breast cancer across all subtypes. It is currently available for patients within the United States,2 with plans for international launch.

"Pathlight strengthens our comprehensive portfolio of diagnostic solutions and reinforces our commitment to transforming cancer care throughout a patient’s experience," said Dan Malarek, CEO of Foundation Medicine. "MRD is one of the fastest-growing areas within diagnostics and this technology provides us with a clinically available ultra-sensitive offering. Pathlight has demonstrated strong clinical performance in breast and colorectal cancer, and we look forward to expanding its applicability across other tumor types and indications to improve the lives of even more patients."

"Our mission at SAGA is to intercept cancer early when patients are most treatable and curable," said Roopom Banerjee, Executive Chairman of SAGA. "Foundation Medicine’s commercial scale and innovation accelerates our ability to bring this unique MRD platform to more patients worldwide. We are proud of our team for advancing innovation in the MRD field and commercially launching Pathlight to improve patient outcomes."

Pathlight will expand Foundation Medicine’s monitoring portfolio, which includes FoundationOneMonitor3 and Foundation Medicine’s tissue-informed whole genome sequencing molecular residual disease test (Tissue-Informed WGS MRD) available for research use.4 FoundationOne Monitor is a circulating tumor DNA (ctDNA) monitoring test which uses a blood sample to support healthcare providers with clarity on their patient’s response to treatment and inform next steps in care. The Tissue-Informed WGS MRD test monitors hundreds to thousands of tumor-specific short variants, enabling accurate quantification of ctDNA in patients with cancer for a more complete picture after treatment. ​​​

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

SAGA Diagnostics is a registered trademark and Pathlight is a trademark of SAGA Diagnostics.

(Press release, Foundation Medicine, APR 16, 2026, View Source [SID1234664454])

On April 16, 2026 Researchers from City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, reported it will present new data at the AACR (Free AACR Whitepaper) Annual Meeting 2026, sharing insights into cancer risk, treatment resistance and emerging therapeutic strategies across solid and blood cancers.

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From April 17–22, expertise from City of Hope physicians and scientists will be spotlighted in 103 sessions, including in one major symposium, six minisymposia and three late-breaking poster abstracts.

As one of the world’s largest and most influential cancer research conferences, the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) brings together scientists, clinicians and patient advocates from across the globe.

City of Hope investigators will highlight leading-edge expertise and research across the spectrum, including the following:

In a major symposium presentation, Stephen J. Forman, M.D., will discuss first-line chimeric antigen receptor (CAR) T cell therapy for adults with acute lymphoblastic leukemia (SY17)
In an Advances in Diagnostics and Therapeutics session, Robert R. Jenq, M.D., will discuss the evidence on how studying the microbiome in CAR T cell patients can help explain why some patients do really well and others don’t do as well (ADT06)
Artificial intelligence reveals distinct microbiome patterns linked to early-onset colorectal cancer (3993)
A newly identified pathway explains why many colorectal tumors resist immunotherapy (6745)
Blocking a key metabolic protein slows leukemia progression in preclinical studies (4037)
New AI models improves prediction of immune targets for cancer vaccines and therapies (1298)
Together, the research underscores City of Hope’s efforts to translate leading‑edge science into more precise and effective approaches for patients who receive cancer care.

AI Reveals Microbiome Differences Linked to Early‑Onset Colorectal Cancer (3993)

City of Hope researchers will present new findings suggesting that among populations at increased risk, the gut microbiome differs between early‑ and late‑onset colorectal cancer. This line of investigation may explain why colorectal cancer has been rising in younger adults.

The study analyzed thousands of colorectal cancer tumor samples alongside microbiome data collected from patients with the disease. Researchers integrated these data with genomic profiles, clinical characteristics and social determinants of health, using AI tools to examine complex relationships across multiple data types.

The analysis showed that patients with early‑onset colorectal cancer had lower microbial diversity compared with those diagnosed later in life. Investigators also identified differences in microbial composition when stratifying patients by genetic ancestry, tumor mutation patterns, gene fusions, copy‑number alterations and social factors linked to health outcomes.

By applying AI‑guided integration, the researchers identified age‑specific microbial patterns that aligned with molecular and clinical features of disease — patterns that may have been difficult to detect using traditional analytic approaches alone. The findings highlighted the potential role of the gut microbiome in colorectal cancer development among younger patients.

"By bringing together microbiome data with genomic and clinical information, we were able to identify patterns that would have been difficult to detect using traditional approaches. This work demonstrates how AI can help us better understand complex factors that may contribute to earlier cancer development," said Sophia Manjarrez, B.S., doctoral student at City of Hope’s Irell & Manella Graduate School of Biological Sciences, the study’s presenting author.

"This study reflects the growing importance of examining cancer through multiple lenses — biological, clinical and social — rather than in isolation. Understanding how these factors intersect may ultimately help inform more tailored approaches to cancer prevention, risk assessment and early detection," said Enrique Velazquez‑Villarreal, M.D., Ph.D., study senior author and assistant professor in City of Hope’s Department of Integrative Translational Sciences.

New Molecular Pathway Identified in Colorectal Cancer Immune Resistance (6745)

City of Hope scientists will report the identification of a molecular pathway that helps explain why many colorectal cancers remain resistant to immunotherapy, particularly microsatellite-stable (MSS) tumors.

The researchers focused on the RNA-modifying enzyme NAT10 and its interaction with the oncogene MYC. They found that elevated NAT10 activity promoted immune evasion by enhancing autophagy-mediated loss of MHC class I molecules, which are essential for immune cells to recognize and target cancer.

High NAT10 expression was associated with immune-cold tumor environments with little to no immune cell activity and reduced predicted responses to immune checkpoint inhibitors. These effects were especially pronounced in MSS colorectal cancers, which account for the majority of cases and remain largely resistant to current immunotherapy approaches.

In preclinical models, disrupting the NAT10-MYC pathway restored immune signaling, increased immune cell infiltration and enhanced responses to immunotherapy, resulting in substantial tumor regression when combined with immune checkpoint blockade.

"These findings help explain why many colorectal tumors remain resistant to immunotherapy. By targeting this newly identified pathway, we may be able to improve immune recognition of tumors and expand the benefit of immunotherapy to more patients," said Junyong Weng, Ph.D., the study’s presenting author and a City of Hope visiting scholar.

"Our findings identify a previously unrecognized MYC-NAT10-autophagy axis as a mechanism of immune evasion and immunotherapy resistance in colorectal cancer. MYC is a key driver of this disease but remains difficult to target therapeutically, while autophagy is essential for normal cell survival. Our study suggests that targeting tumor-specific NAT10 upregulation may offer a more selective strategy to suppress aberrant autophagy, prevent MHC-I loss and improve antitumor immune recognition," said Ajay Goel, Ph.D., AGAF, senior author on the study and chair of City of Hope’s Department of Molecular Diagnostics and Experimental Therapeutics.

Targeting Cancer Metabolism Suppressed Acute Myeloid Leukemia in Preclinical Models (4037)

City of Hope researchers will present new data identifying a metabolic vulnerability in acute myeloid leukemia (AML), an aggressive blood cancer with limited treatment options and poor long‑term survival rates.

The study showed that leukemia cells depended on high levels of a protein called eIF4A1, which helped the cancer cells alter how they generate essential nutrients needed for survival. Blocking the protein eIF4A1 slowed the growth of leukemia cells, reduced their energy production and interfered with their ability to make new proteins.

Further analyses showed that eIF4A1 helped leukemia cells survive by supporting key enzymes involved in how the cells make and use nutrients. Disrupting this process weakened the cancer cells’ metabolism and slowed disease progression.

In several clinically relevant animal studies, blocking eIF4A1 reduced leukemia burden and helped models live longer. The effects were even stronger when the approach was combined with other drugs that target cancer cell metabolism, pointing to a potential new treatment strategy.

"We found that leukemia cells are heavily reliant on a specific protein to fuel their growth. By blocking eIF4A1, we were able to disrupt the cancer’s energy supply and slow the disease in preclinical studies, pointing to a promising new way to target AML," said Xiaoxu Zhang, the study’s presenting author and a City of Hope visiting graduate researcher at Beckman Research Institute of City of Hope.

"This study shows the power of looking at cancer as an interconnected system, not just a single target. By combining molecular biology, metabolism and computational analysis, our team was able to uncover a hidden weakness in leukemia — an approach that reflects City of Hope’s leadership in systems‑level cancer research," said Rui Su, Ph.D., senior author on the study and assistant professor at Beckman Research Institute of City of Hope.

AI Foundation Models Improved Prediction of Immune Targets for Cancer Therapy (1298)

Researchers will present a new AI approach designed to better predict how the immune system recognizes cancer cells — a key step in developing cancer vaccines and immune‑based therapies.

The approach used AI to better predict how immune cells recognize cancer cells by combining information about a protein’s shape with its genetic makeup, allowing the model to more accurately reflect how immune responses work.

Despite being trained on a relatively small dataset, the model achieved prediction accuracy comparable to leading tools currently used in the field. When combined with existing models, the approach further improved performance, highlighting the complementary value of structure‑ and sequence‑based methods.

The researchers say the AI model is especially useful in situations where data are scarce, such as rare patient immune types or newly identified cancer targets. The approach could help speed the development of personalized cancer vaccines and immune‑based treatments.

"One of the biggest challenges in immunotherapy is determining which peptides are actually presented by MHC molecules and can be recognized by T cells. By combining AlphaFold 3 structural predictions with a geometry-aware learning framework, our approach captures the physical interactions underlying peptide–MHC binding, allowing us to identify promising epitopes with higher accuracy even in low-data settings," said Kamel Lahouel, Ph.D., assistant professor in TGen’s Early Detection and Prevention Division and the study’s presenting author.

"This work shows how combining biological insight obtained from sophisticated AI methods with experimental data can change how we approach immunotherapy and vaccine development. Rather than relying on massive experiments alone, which would take decades to perform and would never be complete, these new methods can provide meaningful predictions in a more efficient and scalable way," said Cristian Tomasetti, Ph.D., senior author on the study, professor and director of City of Hope’s Center for Cancer Prevention, Early Detection and Monitoring, and professor in the Early Detection and Prevention Division at TGen.

Select Late-Breaking Poster Sessions from City of Hope:

LB238: Spatial transcriptomics identifies distinct molecular and immune pathways in endometrial cancer in African American women
LB389: Changes in cancer screening rates by housing status, race, and ethnicity following a multi-component implementation strategy at an urban Federally Qualified Health Center, 2023-2025
Awards

Three City of Hope scientists received the Early-Career Scholar in Cancer Research Award: Greisha Ortiz-Hernandez, Ph.D., Sophia Manjarrez, B.S., and Francisco (Paco) Carranza, Ph.D.
Enrique Velazquez Villareal, M.D., Ph.D., is a recipient of the 2026 AACR (Free AACR Whitepaper) Faculty Scholar in Cancer Research Award.

(Press release, City of Hope, APR 16, 2026, View Source [SID1234664453])

On April 16, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported that the first patient has been dosed in a Phase 1 clinical trial of JANX014 in patients with metastatic castration-resistant prostate cancer (mCRPC). JANX014 is a double-masked, prostate-specific membrane antigen (PSMA) directed T cell engager (TCE) designed to leverage Janux’s tumor-activated technology platform to selectively activate T cells in the tumor microenvironment.

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Janux is building a portfolio of tumor-activated PSMA therapies designed to address multiple treatment settings and mechanisms of immune engagement. Early clinical data from JANX007 have demonstrated what Janux believes is potentially a best-in-class clinical profile in mCRPC, including a favorable safety profile with no Grade 3 cytokine release syndrome observed at clinically relevant dose levels using the current CRS mitigation strategy. These data continue to guide Janux’s development strategy in prostate cancer. JANX014 represents an exploratory extension of the strategy, emerging from platform work initiated in early 2024 evaluating multiple PSMA-directed approaches. JANX014 will also explore potential future use cases where enhanced safety margins and ease of administration may be particularly important.

"We are pleased to have initiated clinical evaluation of JANX014," said David Campbell, Ph.D., President and Chief Executive Officer of Janux Therapeutics. "JANX007 remains our lead prostate program, and we believe it has established a strong clinical foundation for PSMA-directed TRACTr therapy. Insights from programs such as JANX007 and JANX008 have informed our continued platform development. We are building a prostate cancer portfolio designed to address patients across multiple stages of disease, including both single and combination approaches. Advancing programs such as JANX014 reflects our strategy of expanding on that foundation while maintaining disciplined execution on our lead program."

William Go, M.D., Ph.D., Chief Medical Officer of Janux Therapeutics, added, "Janux’s tumor-activated technology allows us to evaluate multiple molecular designs against the same validated target. As we advance JANX007, we are also developing complementary approaches within our platforms, including JANX013, our CD28 co-stimulatory PSMA-TRACIr program, along with exploratory approaches like JANX014. This innovative work is intended to help us understand how different mechanisms and masking strategies may translate into clinical benefit across patient populations in prostate cancer."

The Phase 1 study is a first-in-human, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX014 in adults with mCRPC.

Additional information about the study will be available at clinicaltrials.gov.

(Press release, Janux Therapeutics, APR 16, 2026, View Source [SID1234664452])