On April 14, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that the first patient has been enrolled in the Phase 1b trial of CLR 121125 (CLR 125) for the potential treatment of triple negative breast cancer (TNBC).

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CLR 125 is Cellectar’s proprietary Auger-emitting radioconjugate incorporating iodine-125 to achieve intracellular delivery and direct DNA-level damage in tumor cells. The molecular structure of CLR 125 is identical to that of iopofosine I 131 (CLR 131) and the demonstrated clinical activity, safety, and tumor-targeting characteristics of iopofosine I 131 provide important validation of the platform and support translational relevance. However, these radioconjugates differ in their radiobiologic behavior at the tumor level, resulting in distinct mechanisms of action and therapeutic profiles. In preclinical studies, CLR 125 showed selective tumor uptake and statistically significant activity in vivo models of TNBC with no observed end-organ or hematologic toxicity at evaluated doses.

"Treating the first patient in this Phase 1b trial is a significant milestone for Cellectar and for those impacted by triple negative breast cancer, a condition still defined by a profound lack of targeted therapies," said James Caruso, president and chief executive officer of Cellectar. "CLR 125 embodies our commitment to optimize our proprietary PDC delivery platform to develop highly selective radioconjugates capable of delivering precise cytotoxic radiation while minimizing systemic toxicity. With additional study sites being activated in Q2, we are poised to rapidly advance this program and plan to provide dosimetry, safety, and efficacy updates throughout 2026."

The Phase 1b clinical trial is an open-label, dose-escalation study in patients with relapsed or refractory TNBC, designed to evaluate three dose levels and dosing regimens of CLR 125 (32.75 mCi administered over 4 cycles, 62.5 mCi over 3 cycles, and 95 mCi over 2 cycles), with approximately 15 patients enrolled per treatment arm. The study incorporates imaging-based assessments to characterize tumor uptake and biodistribution, supporting prediction of safety and therapeutic activity. Clinical endpoints include safety and tolerability, as well as preliminary efficacy measures, including tumor response per RECIST criteria and progression-free survival.

About Triple Negative Breast Cancer
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer characterized by the absence of estrogen receptors, progesterone receptors, and HER2 protein expression. This lack of common therapeutic targets makes TNBC particularly challenging to treat, with limited options beyond chemotherapy. TNBC tends to grow and spread more quickly than other breast cancer types and disproportionately affects younger women and those of African descent. In the U.S., approximately 12% of breast cancer diagnoses are TNBC. Studies suggest that approximately 25% of TNBC cases relapse after standard treatments like surgery, chemotherapy, and radiation. Due to its high recurrence rate and poor prognosis, there is a critical need for innovative, targeted therapies to improve outcomes for patients facing this difficult diagnosis.

(Press release, Cellectar Biosciences, APR 14, 2026, View Source [SID1234664351])

On April 14, 2026 Phrontline Biopharma reported the presentation of preclinical data for TJ106, a next-generation biparatopic HER2-targeting antibody-drug conjugate (ADC) with a dual-payload platform, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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The data demonstrate robust antitumor activity across HER2-expressing tumor models, including those with low or heterogeneous HER2 expression and models resistant to prior HER2-targeted therapies and antibody-drug conjugates, including Trastuzumab deruxtecan. These findings support the continued development of TJ106 as a potential treatment option for patients with HER2-expressing cancers who have progressed on existing therapies.

TJ106 is engineered with a biparatopic HER2 antibody designed to bind two distinct epitopes, promoting receptor clustering and enhancing internalization. This approach is intended to improve intracellular delivery of cytotoxic payloads and address limitations associated with heterogeneous HER2 expression and suboptimal uptake observed with earlier HER2-targeted therapies.

The molecule incorporates a dual-payload design combining a topoisomerase I inhibitor and a microtubule inhibitor. These payloads provide complementary and non-overlapping mechanisms of action, enabling sustained cytotoxic activity and the potential to overcome resistance associated with single-payload ADCs. In preclinical studies, TJ106 demonstrated consistent tumor growth inhibition across multiple models, including those previously exposed to HER2-directed therapies.

TJ106 also incorporates an optimized linker system designed to balance plasma stability with efficient intracellular payload release, supporting a favorable therapeutic window in preclinical evaluations.

"The data presented at AACR (Free AACR Whitepaper) highlight the potential of TJ106 to address key challenges in HER2-targeted therapy, including resistance and tumor heterogeneity," said Martin S. Olivo, M.D., M.Sc., Chief Medical Officer of Phrontline Biopharma. "By combining biparatopic targeting with a dual-payload approach, TJ106 is designed to enhance tumor delivery and provide durable antitumor activity while maintaining an acceptable safety profile."

Phrontline plans to advance TJ106 into IND-enabling studies with an anticipated Investigational New Drug (IND) submission in early 2027. A global Phase I clinical trial is expected to evaluate TJ106 in patients with HER2-expressing solid tumors, including breast and gastric cancers, with a focus on patients previously treated with HER2-targeted therapies, including ADCs. The clinical program is expected to incorporate dose optimization principles aligned with U.S. Food and Drug Administration Project Optimus, including evaluation of exposure–response relationships and multi-cycle tolerability.

About TJ106

TJ106 is an investigational biparatopic HER2-targeting antibody-drug conjugate (ADC) incorporating a dual-payload platform consisting of a topoisomerase I inhibitor and an eribulin-based microtubule inhibitor. The molecule is designed to enhance tumor targeting, internalization, and intracellular drug delivery to address resistance mechanisms in HER2-expressing cancers.

(Press release, Phrontline Biopharma, APR 14, 2026, View Source [SID1234664368])

On April 14, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the first patient has been dosed with TLX101-Tx (¹³¹I-iodofalan) in Telix’s pivotal IPAX BrIGHT trial1, marking the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, an aggressive form of brain cancer.

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The patient was dosed at Austin Health in Melbourne, Australia, under the supervision of Professor Hui Gan. IPAX BrIGHT is assessing the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone. The global, multicenter, open-label study will enroll patients with radiographically confirmed recurrent glioblastoma at first recurrence.

Telix’s commitment to advancing care for patients with glioblastoma is driven by the significant unmet need in this space. In the past 25 years, only two drugs have been approved by the United States Food and Drug Administration (FDA) for glioblastoma2, and no standard treatment currently exists for recurrent disease. Patients therefore face limited treatment options after initial therapy. TLX101-Tx offers a novel approach by targeting the L-type amino acid transporter 1 (LAT1), a transporter that enables the radiopharmaceutical to cross the blood-brain barrier and delivers therapy directly to the tumor.

IPAX BrIGHT expands upon promising data from earlier trials in the recurrent glioblastoma setting, including IPAX-13, which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis4. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx were consistent and confirmatory to IPAX-1, with a median OS of 12.4 months from initiation of treatment and 32.2 months from initial diagnosis5. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx.

Professor Gan, Director of Cancer Clinical Trials at Austin Health, said, "Based on the prior safety profile and early efficacy data for TLX101-Tx in the IPAX-1 and IPAX-Linz studies, I am pleased to continue to explore this therapeutic modality in the first radiopharmaceutical pivotal trial in recurrent glioblastoma, where there are currently few effective treatment options."

Dr. David N. Cade, Group Chief Medical Officer, Telix, added, "Through the IPAX BrIGHT trial, we aim to offer a new option for patients affected by glioblastoma. This registration-enabling study represents a major step forward in our mission to improve therapeutic options in neuro-oncology. With very limited innovation in treatment in recent decades, TLX101-Tx has the potential to become a first-in-class therapy that meaningfully improves patient outcomes."

The IPAX BrIGHT study has received regulatory approval in Australia, Austria, Belgium and the Netherlands with approval being sought in additional jurisdictions. Telix’s investigational PET6 imaging agent for glioma, TLX101-Px (floretyrosine F 18) will be used for patient selection in IPAX BrIGHT, as well as assessing metabolic tumor response according to PET RANO 1.07.

About TLX101-Tx

TLX101-Tx (131I-iodofalan) is a systemically administered radiopharmaceutical therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in glioblastoma. TLX101-Tx utilizes a small molecule approach due to the need to cross the blood brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain. In addition to the IPAX-1 and IPAX-Linz studies, TLX101-Tx is also under investigation in the IPAX-2 Phase 1 study in combination with post-surgical standard of care treatment in patients with newly diagnosed glioblastoma8. TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma. TLX101-Tx and TLX101-Px have not received a marketing authorization in any jurisdiction.

About glioblastoma

Glioblastoma (GBM), is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.9. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients10, with an expected survival duration of 12-15 months from diagnosis.

(Press release, Telix Pharmaceuticals, APR 14, 2026, View Source [SID1234664384])

On April 14, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC"), reported that it will be presenting two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22, 2026, in San Diego, California.

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Details of the poster presentations are as follows:

Abstract title:
Leronlimab induces PD-L1 expression and is associated with long term survival with an ICI in PD-L1 low metastatic TNBC
Presenter: Richard Pestell, M.D., Ph.D., FRCP AO, Lead Consultant in Preclinical and Clinical Oncology at CytoDyn
Date and Time: April 19, 2026, from 2:00 p.m. – 5:00 p.m. PST.
Poster ID: 1033
Location:
Section 41, Board 1


Abstract title:
Preliminary results of a phase 2 study of leronlimab in combination with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer
Presenter: Pashtoon M. Kasi, M.D., M.S., Medical Director at City of Hope
Date and Time: April 21, 2026, from 2:00 p.m. – 5:00 p.m. PST.
Poster ID: 6466
Location:
Section 41, Board 14

"We are encouraged by the continued progress being made as we advance leronlimab and explore its potential applications across solid tumors," said Jacob Lalezari, M.D., CEO of CytoDyn. "The research being presented at AACR (Free AACR Whitepaper) reflects the growing body of scientific work examining CCR5 biology and its role in the tumor microenvironment. Together, these studies help deepen our understanding of how leronlimab may enhance immune responses and inform our broader strategy to develop new treatment approaches for patients with difficult-to-treat cancers."

A copy of the presentations will be made available on CytoDyn’s website under the Publications & Posters section after it is presented at the symposium.

(Press release, CytoDyn, APR 14, 2026, View Source [SID1234664352])

On April 14, 2026 GlycoNex, Inc. (4168, hereinafter referred to as GNX), clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the initiation of a first-in-human (FIH) Phase 1 clinical trial of GNX1021, the company’s lead antibody-drug conjugate (ADC) candidate, in patients with advanced gastrointestinal cancers.

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This milestone marks GlycoNex’s transition into clinical-stage development for its proprietary glycan-targeting ADC platform and represents a significant step toward addressing high unmet need in gastric and other gastrointestinal malignancies.

The multi-center, multinational Phase 1 study in patients with advanced gastrointestinal cancers is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of GNX1021 and to establish a recommended dose range for subsequent clinical development. The first phase of the trial will be conducted in Japan and Taiwan. Patient enrollment in Japan is expected to begin in June 2026. GlycoNex plans to submit an Investigational New Drug (IND) application in Taiwan in June 2026, with enrollment anticipated to begin in the third quarter of 2026.

"PMDA approval to initiate our first-in-human study is a defining milestone for GlycoNex and a critical validation of our glycan-targeting platform," said Dr. Mei-Chun Yang, Chief Executive Officer of GlycoNex. "GNX1021 represents a differentiated approach to ADC development, designed to address tumor heterogeneity by targeting glycan structures broadly expressed across multiple cancer-associated proteins. We believe this unique mechanism, combined with the selective expression of the bLeB/Y antigen in gastrointestinal tumors, positions GNX1021 to potentially deliver meaningful clinical benefit, particularly in gastric cancer where new treatment options are urgently needed."

GNX1021 is an innovative ADC designed to target branched glycan antigens that are abnormally overexpressed on tumor cell surfaces. Unlike conventional targeted therapies that recognize a single protein epitope, GNX1021 exploits aberrant glycan structures across multiple tumor-associated membrane proteins, enabling multi-target engagement and potentially overcoming a key limitation of existing precision oncology agents.

GNX1021 targets the bLeB/Y antigen, which is highly expressed in epithelial tumors—including gastric, pancreatic, and colorectal cancers—while showing minimal expression in healthy human tissues. This unique targeting mechanism enables GNX1021 to identify cancer cells with high specificity, significantly improving the therapeutic index and patient safety.

In preclinical safety assessments, GNX1021 demonstrated a controlled and predictable safety profile in toxicology studies involving rats and cynomolgus monkeys. Results indicated a stable metabolic process with no significant drug accumulation or unanticipated damage to major organs. These findings not only validate the biosafety of GNX1021 but also provide robust scientific evidence to support its transition into human clinical trials.

Dr. Yang concluded: "We are encouraged by continued global interest in novel ADCs with differentiated targets. As GNX1021 advances through clinical development, we believe it has the potential to generate significant strategic partnering interest while, more importantly, advancing a new therapeutic approach for patients with difficult-to-treat cancers. Reflecting on recent global ADC licensing trends, drugs with unique targets that have reached Phase 1 clinical trials often command total deal values ranging from several hundred million to over a billion USD."

(Press release, GlycoNex, APR 14, 2026, View Source [SID1234664369])