On April 14, 2026 Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, reported the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for BIZENGRI (zenocutuzumab-zbco), seeking approval for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion. Cholangiocarcinoma is a rare, aggressive malignancy of the bile ducts with few effective treatment options. There are no approved therapies specifically targeting cholangiocarcinoma harboring NRG1 gene fusions.

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"This submission marks an important step in advancing BIZENGRI for patients with NRG1 fusion positive cholangiocarcinoma, a population with limited treatment options, and historically poor outcomes. Cholangiocarcinoma remains a challenging and aggressive disease, and we believe these data support the potential of BIZENGRI to address a critical unmet need for patients whose tumors are driven by NRG1 gene fusions. Tissue‑based RNA testing is essential to identify rare oncogenic fusions such as NRG1 and ensure patients with these actionable alterations are not overlooked," said Pritesh J. Gandhi, Chief Development Officer, Partner Therapeutics.

The sBLA is supported by data from the eNRGy study evaluating zenocutuzumab-zbco in patients with NRG1 fusion-positive cancers, including cholangiocarcinoma. In the cholangiocarcinoma cohort, BIZENGRI demonstrated an overall response rate (ORR) of 36.8% (95% CI: 16.3, 61.6%) and a median duration of response (DOR) of 12.9 months, as assessed by blinded independent central review (BICR). Treatment was generally well tolerated, and no patients discontinued therapy due to adverse events.

Based on these data, National Comprehensive Cancer Network (NCCN) added zenocutuzumab‑zbco to the Oncology Clinical Practice Guidelines for biliary tract cancers as a Category 2A subsequent‑line therapy and as a Category 2B recommendation for front‑line treatment of NRG1 fusion–positive cholangiocarcinoma.

"Cholangiocarcinoma remains a devastating disease, particularly in the advanced setting. The identification of NRG1 gene fusions has highlighted an actionable biomarker, and the eNRGy study data suggest that targeted inhibition with zenocutuzumab may represent a meaningful treatment approach for these patients" said Dr. James Cleary, Dana-Farber Cancer Institute.

BIZENGRI received U.S. Food and Drug Administration accelerated approval for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma harboring NRG1 gene fusions with disease progression on or after prior systemic therapy.

For more information on the eNRGy trial and zenocutuzumab-zbco, please visit www.partnertx.com.

National Comprehensive Cancer Network

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

About NRG1 Gene Fusions

NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activate downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably the combination of tissue-based DNA and RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1.

About BIZENGRI (zenocutuzumab-zbco)

INDICATIONS
BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECUATIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions
BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis
BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis.
In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated.
Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction
BIZENGRI can cause left ventricular dysfunction.
Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.
In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.
Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity
Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS
NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC
Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).
In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transpeptidase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).
NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma
Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure.
In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transpeptidase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

(Press release, Partner Therapeutics, APR 14, 2026, View Source [SID1234664367])

On April 14, 2026 4D Path, a company dedicated to personalizing cancer care through a novel, physics-informed approach to predicting tumor response to therapy, reported a collaboration with Daiichi Sankyo (TSE: 4568) to develop next-generation predictive biomarkers in an antibody drug conjugate (ADC) clinical development program.

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ADCs are among the most promising therapeutic classes in oncology, yet there remains a significant unmet need for scalable biomarkers that predict which patients are most likely to benefit from increasingly complex regimens and combination therapies. This collaboration brings together 4D Path’s ability to compute biologically grounded, physics-informed treatment predictive biomarkers from routine pathology specimens with the ADC innovation leadership of Daiichi Sankyo.

Under the collaboration, 4D Path will apply its proprietary Q-Plasia OncoReader (QPOR) platform to standard Hematoxylin and Eosin (H&E)-stained tumor biopsy slides to compute interpretable, quantitative biomarkers associated with cell-cycle deregulation and tumor microenvironment dynamics. These biomarkers will be evaluated for their ability to identify patients most likely to benefit from the select ADC, helping enable more precise, non-invasive, and cost-effective patient selection, potentially improving response rates and accelerating clinical trials.

This approach is designed to be compatible with both retrospective analyses of archived clinical specimens and prospective evaluation in ongoing and future studies.

"While the introduction of ADCs has improved outcomes for patients, more advanced biomarkers that are predictive of response to these agents is needed. 4D Path’s novel approach to utilizing biological and physical characteristics from routine H&E-stained biopsy slides to predict benefit from ADCs has the potential to improve outcomes, helping patients get the right therapy at the optimal time in their disease course," said Lee Schwartzberg, medical oncologist and Scientific Advisory Board member, 4D Path.

The collaboration is expected to also generate functional mechanistic insights into tumor-specific patterns of response and resistance—helping illuminate how biological context may interact with ADC designs. By transforming routine pathology images into actionable, physics-informed collective tumor state variables, the agreement aims to enrich translational understanding while supporting more personalized and effective treatment strategies.

"The deep precision medicine focus of this collaboration in digital pathology brings in 4D Path’s QPOR platform-derived pan-cancer insights identifying patients likely to respond to treatment, by one-shot computation of cell cycle and tumor microenvironment dynamics from routine tissue images. Additionally, this will potentially shed light on tumor specific biological understanding of response and resistance, enriching knowledge of the relative impact of targets, linkers, and payloads on outcomes and accelerating precision ADC treatments," said Satabhisa Mukhopadhyay, Ph.D., co-founder and chief scientific officer at 4D Path.

This collaboration underscores the industry-wide shift toward AI-driven, image-based biomarkers that can be deployed at scale using standard-of-care specimens—supporting faster, more confident treatment decisions and improving the probability of success in clinical development.

(Press release, Daiichi Sankyo, APR 14, 2026, https://www.businesswire.com/news/home/20260408304934/en/4D-Path-Announces-Collaboration-with-Daiichi-Sankyo-to-Advance-AI-Driven-Predictive-Biomarkers-for-an-Antibody-Drug-Conjugate-Program [SID1234664383])

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])