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Radiopharm Theranostics Advances to Cohort 3 in 177Lu-RAD202 Phase 1 Dose Escalating Clinical Trial

On April 8, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors1. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation.

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"We are encouraged by the rapid progress of the Phase 1 ‘HEAT’ trial of RAD202, as it underscores the favorable safety profile, allowing us to accelerate the dose escalation from Cohort 2 to Cohort 3." said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Considering the current progress and the strong execution, we remain on track to complete the Phase 1 dose escalation by the end of 2026."

The Phase 1 ‘HEAT’ study is currently being conducted at clinical centers across Australia. The announcement of the previous dose level in this study of 75mCi was released on 1 October 2025.

About 177Lu-RAD202:

RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution.

(Press release, Radiopharm Theranostics, APR 8, 2026, View Source [SID1234664258])

Incyclix Bio Raises Additional $5 Million in Series B Financing to Advance Clinical Trial of INX-315 in Patients with CDK4/6 Inhibitor Resistant ER+/HER2- Breast Cancer or CCNE1-Amplified Solid Tumors

On April 8, 2026 Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, reported that it has raised $5 million in additional funds for its Series B financing from new investor Hatteras Venture Partners. As part of the financing, Hatteras partner Kseniya Simpson, Ph.D., will join the Company’s board of directors and Hatteras general partner Christy Shaffer, Ph.D., will join as a board observer.

"We are encouraged by Hatteras’s strong enthusiasm for our CDK2 program and their support in advancing INX-315 toward meaningful clinical outcomes," said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. "Additionally, we’re pleased to welcome Kseniya and Christy to our board and look forward to working with them during this pivotal time of growth for Incyclix."

The additional funds will support of the clinical development of the Company’s lead compound INX-315, a novel, potent and selective CDK2 inhibitor, for the treatment of advanced and metastatic breast and ovarian cancer. Hatteras joins other top-tier investors who participated in the Series B round, including Boxer Capital, RA Capital Management, Eshelman Ventures, Eli Lilly and Company, Pharmacosmos and Cape Fear BioCapital.

"CDK2 inhibition represents an exciting opportunity to address unmet need that remains in breast and ovarian cancer treatment," said Kseniya Simpson, Ph.D. "We believe in Incyclix’s highly experienced team and their capabilities to bring a best-in-class treatment option to patients with advanced and resistant cancer."

The Phase 1/2 open-label, dose-escalation, combination and dose-expansion clinical trial of INX-315 is ongoing. More information on the INX-315-10 trial can be found at clinicaltrials.gov (NCT05735080).

(Press release, Incyclix Bio, APR 8, 2026, View Source [SID1234664257])

MAIA Biotechnology Expects Recent $33 Million Capital Raise to Fully Fund Ongoing Pivotal Phase 3 Trial of Novel Telomere-Targeting Anticancer Therapy

On April 8, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that net proceeds from its $33 million public offering of common stock in March 2026 are expected to fully fund the Company’s ongoing pivotal Phase 3 clinical trial of its lead investigational therapy, ateganosine, as a treatment for non-small cell lung cancer (NSCLC). Ateganosine is a dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug in third line (3L) NSCLC treatment.

"We are grateful for the support and confidence shown by the healthcare-dedicated investors and existing shareholders who participated in our recent offering. The $33 million raise is expected to complete the necessary funding for our pivotal Phase 3 trial through completion," said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA

"Statistical assessments point to a high probability of technical success in the third-line setting if Phase 3 data is consistent with our Phase 2 trial results," Dr. Vitoc continued. "Interim data from the Phase 3 trial, expected next year, may support a discussion with the FDA to present our case for early full commercial approval in third-line NSCLC."

MAIA’s pivotal Phase 3 trial, THIO-104, evaluates the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors alone and chemotherapy. The global multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients. Chemotherapy is the standard utilized treatment for third-line NSCLC patients.

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, APR 8, 2026, View Source [SID1234664256])

HUTCHMED Highlights Data to be Presented at AACR Annual Meeting 2026

On April 8, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place on April 17-22, 2026 in San Diego, California.

Preclinical data for HMPL-A580, a first-in-class PI3K/PIKK-EGFR Antibody-Targeted Therapy Conjugate ("ATTC") will be presented. The payload of HMPL-A580 potently inhibited PI3K and PIKK family kinases, with IC50 ranging around 1 to 10 nM. Eurofins profiling across 418 kinases revealed the payload has excellent selectivity. By conjugating this potent payload with an anti-EGFR antibody via a cleavable linker, the ATTC compound HMPL-A580 demonstrated robust anti-tumor effect. Upon binding to EGFR-expression cancer cell line, HMPL-A580 underwent rapid internalization, lysosomal trafficking, payload release, and PAM and PIKK signaling inhibition to induce tumor cell apoptosis. In a 38-human solid tumor cell line panel, HMPL-A580 potently inhibited EGFR-expression tumor cell proliferation. The tumor cells harboring EGFR high expression, EGFR mut or PAM alterations were more sensitive to HMPL-A580. HMPL-A580 showed a strong bystander effect when EGFR-negative cells co-cultured with EGFR-expression cells. In human tumor xenograft models in mice, HMPL-A580, administered intravenously at 1~10 mg/kg once weekly for two weeks, demonstrated a dose / exposure-dependent anti-tumor activity in multiple EGFR-expression models, which is associated with much stronger target inhibition and suppression of downstream functions than antibody and payload alone treatment. The preliminary results demonstrated that HMPL-A580 was stable in human, monkey, rat and mouse plasma, and showed favorable PK property in cynomolgus monkeys.

Updated results from a multicenter, single-arm Phase Ib/II trial of surufatinib plus sintilimab and capecitabine in previously treated metastatic small bowel adenocarcinoma and appendiceal carcinoma, as well as results from a exploratory Phase II study of surufatinib combined with gemcitabine and nab-paclitaxel ("AG") for the treatment of locally advanced or metastatic pancreatic ductal adenocarcinoma patients following AG induction therapy will also be presented.

Details of the presentations are as follows:

Abstract title Presenter / Lead author Presentation details
SPONSORED STUDIES
Discovery of HMPL-A580, a first-in-class antibody-targeted therapy conjugate (ATTC) of a novel PI3K/PIKK inhibitor payload linked to an anti-EGFR antibody Yu Cai, HUTCHMED, Shanghai, China 4549
Poster Session (PO.ET01.03)
Tuesday, April 21, 2026

INVESTIGATOR-INITIATED STUDIES
Updated multicenter phase Ib/II analysis of surufatinib plus sintilimab and capecitabine in previously treated metastatic small bowel adenocarcinoma and appendiceal carcinoma Xiaoyu Xie, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China CT160
Poster Session (PO.CT01.05)
Monday, April 20, 2026
Sequential treatment with surufatinib combined with gemcitabine and nab-paclitaxel (AG) or AG alone as first-line therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC) after 6 weeks of AG induction therapy: A two-cohort, exploratory phase II study Jin Xu, Fudan University Shanghai Cancer Center, Shanghai, China CT146
Poster Session (PO.CT01.05)
Monday, April 20, 2026

About the ATTC Platform and HMPL-A580

HUTCHMED’s ATTC platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. Unlike traditional cytotoxin-based Antibody Drug Conjugates, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in efficacy and safety.

The first family of ATTCs are based on a novel payload that targets the PI3K/AKT/mTOR ("PAM") pathway, a critical intracellular network involved in cell growth, survival, and division. Alterations in the PAM pathway are frequently associated with poor prognosis and resistance to treatment across various cancers. However, existing PAM-targeted drugs face significant challenges, including on-target toxicities that restrict dosing, feedback loops that enable pathway reactivation, and insufficient tumor-specific delivery. Preclinical data from the first ATTC candidate based on this potent novel PI3K/PIKK inhibitor payload, HMPL-A251, was presented at AACR (Free AACR Whitepaper)-NCI-EORTC in October 2025.

HMPL-A580 is the second ATTC candidate based on this novel payload. It is a first-in-class ATTC comprising a highly selective and potent PI3K/PIKK small-molecule inhibitor payload linked to an anti-EGFR antibody via a cleavable linker. EGFR is highly expressed in multiple types of solid tumors and is well recognized as a driving force in tumorigenesis and disease progression. By conjugating this highly novel PI3K/PIKK payload to an anti-EGFR antibody, HMPL-A580 is designed to deliver targeted pathway inhibition directly into EGFR-expressing tumor cells, thereby potentially overcoming the systemic toxicity and narrow therapeutic index historically associated with PI3K/PIKK inhibitors. This approach aims to achieve deeper and more durable target inhibition while improving the overall tolerability profile.

HUTCHMED has demonstrated how its partnerships leverage the expertise of multinational pharmaceutical companies to accelerate bringing novel medicines to address large unmet needs around the world, and plans to apply this strategy to its ATTC technology this year.

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA. HUTCHMED currently retains all rights to surufatinib worldwide.

(Press release, Hutchison China MediTech, APR 8, 2026, View Source [SID1234664255])

Hemispherian Initiates Phase 1/2a Clinical Trial of GLIX1 in Glioblastoma

On April 8, 2026 Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported the initiation of a first-in-human Phase 1/2a clinical trial of GLIX1 in patients with recurrent and progressive glioblastoma (GBM) and other high-grade gliomas (NCT07464925). The study is being conducted in collaboration with BioLineRx Ltd. (NASDAQ/TASE: BLRX).

GLIX1 is an orally available, first-in-class small molecule designed to activate TET2 and drive tumor-selective DNA damage. By restoring TET2 activity, GLIX1 induces DNA damage selectively in cancer cells, representing a differentiated approach to targeting the DNA damage response with potential applicability across a broad range of tumors.

Glioblastoma was selected as the initial indication due to its highly suppressed TET2 activity and significant unmet medical need. Despite existing therapies, GBM remains one of the most aggressive and treatment-resistant cancers.

In extensive preclinical studies, including orthotopic in vivo GBM models, GLIX1 demonstrated:

Potent anti-tumor activity
Robust blood-brain barrier penetration
Favorable safety profile in toxicology studies
The trial will be conducted across three leading academic centers. The first site to initiate patient enrollment is NYU Langone Health, led by Dr. Alexandra Miller. Additional sites include Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, and Moffitt Cancer Center, led by Dr. Patrick Grogan.

"The initiation of this Phase 1/2a study marks a defining milestone for Hemispherian and represents the culmination of years of dedicated research and development work by our team and our collaboration partner, BioLineRx. GLIX1 has a compelling preclinical profile and a truly differentiated mechanism of action, and we look forward to bringing this innovative therapy to patients who urgently need new treatment options. We are proud to be advancing this program alongside world-leading glioblastoma investigators and anticipate initial data readout in the first half of 2027," said Zeno Albisser, Chief Executive Officer of Hemispherian AS.

"GLIX1 is built on a fundamentally new understanding of how to exploit DNA repair vulnerabilities in cancer. The strength and consistency of the preclinical data give us confidence as we now transition this mechanism into the clinic," remarks Adam Robertson, Chief Scientific Officer at Hemispherian.

Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center at the Perlmutter Cancer Center, NYU Langone Health, stated:

"I am pleased to be the first investigator able to enroll patients into this critical study, which brings new hope to patients who are in desperate need of innovative and novel treatment options."

Dr. Roger Stupp, Medical Director of the Malnati Brain Tumor Institute at Northwestern University in Chicago and lead investigator of the study, added:

"GLIX1 is a promising innovative molecule with impressive pre-clinical data, and I could not be more excited to participate in this study. The protocol will rigorously assess the safety of an agent with an entirely novel mechanism of action, with the potential to ultimately integrate well and synergize with the current treatments. We urgently need breakthrough innovations for our patients suffering from glioblastoma, one of the most aggressive and difficult malignancies to treat."

Clinical Trial Design (NCT07464925)

The Phase 1 portion of the study will enroll up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish the maximum tolerated dose (MTD) and/or a recommended dose based on safety, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary efficacy. Data from Phase 1 are anticipated in the first half of 2027.

The Phase 2a expansion is expected to include multiple patient cohorts, including newly diagnosed and recurrent GBM, as well as additional tumor types. Combination approaches, including with PARP inhibitors, will also be evaluated. These cohorts are designed to generate early efficacy signals, inform dose optimization, and support subsequent clinical development.

(Press release, Hemispherian, APR 8, 2026, View Source [SID1234664254])