Hokkaido University Leverages BostonGene’s AI-powered Platform to Advance Precision Oncology

On May 11, 2026 BostonGene, developer of the leading AI foundation model for tumor and immune biology, reported the expanded strategic research collaboration with Hokkaido University. This multi-year initiative is designed to produce actionable, high-quality, clinically relevant data that support the development of precision therapies and ultimately improve outcomes for cancer patients in Japan.

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In collaboration with Hokkaido University, BostonGene will conduct next-generation sequencing and perform integrated analysis of DNA, RNA and immune system profiling using its proprietary AI-powered platform to analyze genomic and immune profiles from tumor samples across more than 20 cancer types. These analyses will help identify patient-specific disease drivers, profile underlying immune signatures, and guide optimal therapeutic decision-making.

"BostonGene’s AI-powered platform gives us the advanced analytics needed to turn clinical data into actionable insights," said Dr. Ichiro Kinoshita, Principal Investigator and Professor at the Division of Clinical Cancer Genomics/Department of Medical Oncology at Hokkaido University, and Dr. Yutaka Hatanaka, Associate Professor at the Center for Development of Advanced Diagnostics (C-DAD), Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital. "By contributing our scientific expertise and patient samples, we’re driving a more personalized, effective approach to oncology for Japanese patients.

"This partnership exemplifies how BostonGene’s AI-driven insights translate complex patient data into meaningful advances in drug development and clinical care, while reinforcing our commitment to advancing translational oncology in Japan, where there is significant and urgent clinical need," said Yukimasa Shiotsu, President and Representative Director of BostonGene Japan.

(Press release, BostonGene, MAY 11, 2026, View Source [SID1234665462])

ProBio and Curocell Achieve Key CAR-T Milestone with BLA Regulatory Approval and Commercial Readiness

On May 11, 2026 ProBio Inc. and Curocell reported to have achieved a significant milestone with the BLA regulatory approval and commercial readiness of Anbalcabtagene autoleucel (Anbal-cel; code: CRC01). This next-generation CD19-targeted CAR-T cell therapy is developed for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This approval not only highlights Korea’s growing innovation in advanced therapies but also marks a critical step towards bringing transformative treatment options to patients. To learn more about ProBio’s contributions to advanced therapeutic manufacturing, visit www.probiocdmo.com.

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Clinical data from Phase 1/2 studies has demonstrated compelling efficacy, with an overall response rate (ORR) of 82% and a complete response (CR) rate of 82% in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The therapy also exhibited a manageable safety profile, with the most commonly reported grade 3/4 adverse events including neutropenia, anemia, and thrombocytopenia.

A key differentiating feature of CRC01 lies in Curocell’s proprietary OVIS platform, which suppresses the expression of immune checkpoint receptors PD-1 and TIGIT in CAR-T cells. This innovative mechanism is designed to address immune suppression within the tumor microenvironment, potentially enhancing therapeutic efficacy compared to conventional CAR-T approaches.

As a strategic partner of Curocell, Probio has supported the journey from post-IND supplier change to BLA application and commercial production. We partnered closely with the client to manage complex change control activities and secure rapid regulatory approval for major process and site changes. With deep expertise in lentiviral vector manufacturing, we completed process characterization within four months, defined critical process parameters, implemented a robust control strategy, and achieved first‑pass success across all three validation batches. Our strong performance during the MFDS pre‑approval inspection, from audit readiness to real‑time responses, was recognized by both regulators and the client. We successfully obtained MFDS GMP certification, representing the first GMP approval for a lentiviral vector manufacturing facility in Korea and reinforcing our role as a pioneer in the local cell and gene therapy supply chain.

The program has now progressed into the commercial manufacturing phase. ProBio remains committed to delivering high-quality plasmid and viral products, supporting the broader adoption of CAR-T therapy, enabling patient access. "We are thrilled to witness this landmark achievement by Curocell," said Allen GUO, CEO from ProBio. "This approval not only represents a major step forward for patients in Korea but also reinforces the global potential of innovative CAR-T therapies. At ProBio, we remain committed to empowering our partners with integrated CDMO solutions to accelerate the development and commercialization of advanced therapies worldwide."

"The approval of Rimqarto is highly meaningful as it represents the commercialization of Korea’s first CAR-T therapy," said Kim Gun-soo, CEO of Curocell. "ProBio has played a key role throughout the entire process, from the clinical stage to process development, quality management, regulatory response, and preparation for commercial production, serving as an important partner in supporting the successful approval and laying the foundation for commercialization." He added, "Moving forward, Curocell plans to improve treatment access for patients in Korea based on a stable global supply chain and quality competitiveness, while continuing to expand into global markets and advance the development of next-generation CAR-T therapies."

(Press release, ProBio, MAY 11, 2026, View Source [SID1234665461])

Inhibrx Reports Interim Phase 2 Data for INBRX-106 in First-Line HNSCC; Initial Results Demonstrate Potential Costimulatory Benefit Over PD-1 Monotherapy

On May 11, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, reported positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).

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HNSCC was selected as a proof-of-concept indication, as PD-1 monotherapy is active in this tumor type but leaves significant room for improvement. The trial design was modeled after KEYNOTE-048, focusing on patients with high PD-L1 expression (CPS ≥ 20) in order to further sharpen the ability to detect a treatment effect above checkpoint inhibition alone. A clear signal of added benefit in this study design would support INBRX-106’s potential to enhance checkpoint inhibitor efficacy across checkpoint inhibitor-sensitive indications.

The Phase 2 portion of the HexAgon study enrolled 68 patients: 33 randomized to the combination arm and 35 to the control arm. Baseline prognostic factors are largely balanced between both arms and the study is being conducted at over 80 sites in the United States, Europe and Asia. Today, the Company presented preliminary data from 53 patients (25 in the INBRX-106 combination arm and 28 in the control arm) with a data cutoff of May 7, 2026, representing the evaluable population for confirmed response, defined as patients who had either experienced confirmed disease progression or death, or completed at least two on-study tumor assessments. The remaining 15 patients in the overall population across both arms had not yet reached the maturity threshold for response confirmation or were not evaluable at the time of this data cut and were therefore not included in this analysis. Active unconfirmed responses and ongoing tumor increases/reductions are present in both arms, and these patients are expected to contribute to the final efficacy dataset in a subsequent update.

In the evaluable population, 11 out of 25 patients (44.0%) in the INBRX-106 combination arm achieved a confirmed objective response, compared with 6 out of 28 patients (21.4%) in the control arm. This represents a 22.6% absolute increase in confirmed responses. Three complete responses were observed in the INBRX-106 combination arm, reflecting tumor clearance, while no complete responses were observed with pembrolizumab alone. Complete responses in first-line HNSCC remain uncommon and are generally associated with more durable outcomes.

These clinical findings were supported by pharmacodynamic data, which showed up to a 15-fold increase in peripheral CD8+ and CD4+ T-cell proliferation and up to a four-fold increase in activation in INBRX-106 combination-treated patients compared with up to 2.5-fold and 1.5-fold increases, respectively, in those receiving pembrolizumab alone. The observation of robust systemic T-cell expansion and activation in combination-treated patients, alongside the clinical activity observed in this arm, is consistent with the expected mechanism of action of INBRX-106 as a potent T-cell costimulator.

The combination of INBRX-106 and pembrolizumab was generally manageable, with a safety profile consistent with the addition of an active immunostimulatory agent to checkpoint blockade. The most common treatment-related adverse events were rash, diarrhea, fatigue, and infusion-related reactions, which were predominantly low-grade. No treatment-related deaths were reported in either arm.

"We are greatly encouraged by these early clinical results," said Mark Lappe, Chief Executive Officer of Inhibrx. "These data, coupled with the clear evidence of T-cell expansion and superior depth of response, give us confidence that INBRX-106 could be the first costimulatory agent to fundamentally shift the efficacy ceiling of immunotherapy, and open the door to combinations with new modalities that could be enhanced by OX40 agonism."

Next Steps

The progression-free survival data from the Phase 2 portion of the HexAgon study are expected to become available in the fourth quarter of 2026. The Company plans to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026.

Based on these promising early results, the Company also aims to evaluate INBRX-106 across broader indications to potentially improve the efficacy of checkpoint inhibitors. This strategy includes initiating a study in the perioperative setting in non-small cell lung cancer (NSCLC) later this quarter. The Company believes OX40 agonism has the greatest potential to drive cure in earlier-stage disease settings, where patients typically retain a more active and responsive immune system. In addition, the Company is beginning to plan for expansion into the front-line metastatic NSCLC setting, with studies expected to begin in 2027. Outside of combination with checkpoint inhibitors, the Company plans to explore combinations with agents that could benefit from T-cell costimulation, such as vaccines, T-cell engagers, and CAR-Ts.

About INBRX-106

INBRX-106 is a hexavalent agonist targeting OX40 (CD134), a costimulatory receptor on T-cells. Utilizing Inhibrx’s proprietary single-domain antibody (sdAb) platform, INBRX-106 is designed to achieve the high-order receptor clustering necessary for robust T-cell activation and survival, a feat that has eluded traditional bivalent antibody approaches. To date, over 175 patients have been treated with INBRX-106.

(Press release, Inhibrx, MAY 11, 2026, View Source [SID1234665460])

Anixa Biosciences Reports Updated Positive Survival Observations from Ongoing Phase 1 Trial of Lira-cel Ovarian Cancer CAR-T Therapy

On May 11, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported updated positive survival observations from its ongoing Phase 1 clinical trial of liraltagene autoleucel, or lira-cel, the Company’s follicle-stimulating hormone receptor ("FSHR")-targeted CAR-T therapy being developed for the treatment of recurrent ovarian cancer.

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Updated data were presented on May 7, 2026, at the International Society for Cell & Gene Therapy ("ISCT") 2026 Annual Meeting by Cheryl Cox, MHA, Operations Director of the Cell Therapies and Gene Expression Engineering Facility at Moffitt Cancer Center. The presentation, titled "A Phase I clinical trial of an infusion of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor in patients with recurrent ovarian cancer," reviewed the trial design, objectives and current clinical status of Anixa’s ongoing Phase 1 trial of lira-cel.

Several trial participants have lived significantly beyond their median expected survival of three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment, at 18, 17 and 17 months, respectively, and four additional patients have survived 11, 11, 8 and 7 months, respectively. Three of the patients who reached 18, 17 and 11 months, respectively, remain alive, and one additional patient who was treated more recently is also currently alive.

Preliminary safety observations presented at ISCT include:

No dose-limiting toxicities ("DLTs") have been encountered in the first three dose cohorts.
All doses have been administered successfully by the intraperitoneal ("IP") route.
There have been no observations of Immune Effector Cell-Associated Neurotoxicity Syndrome ("ICANS") or significant Cytokine Release Syndrome ("CRS").
All significant adverse events observed to date have been unrelated to lira-cel administration.
Dr. Amit Kumar, Chairman and Chief Executive Officer of Anixa, stated, "The updated survival observations from this ongoing Phase 1 trial continue to be encouraging, particularly given the advanced disease status and limited treatment options for patients with recurrent ovarian cancer. While this remains an early-stage study, lira-cel has continued to demonstrate a favorable preliminary safety profile, with no dose-limiting toxicities, ICANS or CRS observed in the first three dose cohorts. We believe these findings support continued dose escalation and clinical evaluation."

Dr. Kumar continued, "We look forward to treating patients in the next dose cohort, which is expected to evaluate a dose approximately three times higher than the previous cohort and to include lymphodepletion with cyclophosphamide and fludarabine. This approach may create a more favorable environment for CAR-T cell expansion, persistence and activity."

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, is Anixa’s investigational autologous CAR-T therapy designed to target the follicle-stimulating hormone receptor ("FSHR"), which Anixa believes represents a unique CAR-T target in ovarian cancer. FSHR is selectively expressed on ovarian cells, tumor vasculature and certain cancer cells, but not in most healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

The trial is designed to evaluate the safety and tolerability of lira-cel, determine the maximum tolerated dose, and assess preliminary evidence of clinical activity.

(Press release, Anixa Biosciences, MAY 11, 2026, View Source [SID1234665459])

Partner Therapeutics Announces FDA Approval of BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner’s National Priority Voucher

On May 11, 2026 Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has approved BIZENGRI (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. This marks the first targeted therapy approved specifically for NRG1+ cholangiocarcinoma, a molecularly defined cancer with a profound unmet need. The approval was expedited by PTx’s receipt of a Commissioner’s National Priority Voucher (CNPV). BIZENGRI previously received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for NRG1+ cholangiocarcinoma, reflecting the unmet need in this patient population.

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"Today’s FDA approval of BIZENGRI for NRG1 fusion-positive cholangiocarcinoma is a historic milestone for patients who have had no approved targeted therapy. We thank the patients, their families, and the investigators for their participation in the eNRGy trial. The results demonstrate meaningful tumor responses, durable benefit, and a favorable tolerability profile—and we are grateful that the FDA’s Commissioner’s National Priority Voucher pilot program greatly reduced the review time, helping bring this treatment to patients more quickly. We look forward to working with the oncology community to ensure appropriate patients can access BIZENGRI without delay."

— Pritesh J. Gandhi, Chief Development Officer, Partner Therapeutics

FDA APPROVAL FOR NRG1+ CHOLANGIOCARCINOMA

The FDA approved BIZENGRI based on safety and efficacy data from the eNRGy trial, a multicenter, open-label, multi-cohort Phase 2 clinical trial in adults with advanced solid tumors harboring NRG1 gene fusions. A total of 22 patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma were enrolled, with 19 evaluable for efficacy.

The major efficacy outcome measures were confirmed overall response rate (ORR), which is the percentage of patients in a clinical trial whose cancer shrinks or disappears after treatment, and duration of response (DOR). The ORR was 36.8% with a DOR range of 2.8 to 12.9 months.

The most common adverse reactions (≥20%), excluding laboratory findings, were fatigue, diarrhea, musculoskeletal pain, abdominal pain, nausea, cough, dyspnea, and decreased appetite.

"NRG1 fusion–positive cholangiocarcinoma represents a rare but clinically important subset of disease with limited therapeutic options and poor outcomes. In the eNRGy study, zenocutuzumab demonstrated a clinically meaningful overall response rate, and the drug was well tolerated with a favorable safety profile. Less than 1% of patients discontinued treatment due to a drug related adverse event, supporting its role as a targeted treatment option in this setting. These data further highlight the essential role of comprehensive molecular testing, particularly tissue-based RNA-based sequencing, to reliably detect gene fusions such as NRG1 and ensure patients are appropriately identified for targeted therapy."

— James Cleary, MD, PhD, Director of Clinical Research, Division of Gastrointestinal Oncology at Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School

BIZENGRI was first approved under accelerated approval in 2024 in advanced, unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma for patients harboring an NRG1 gene fusion on or after systemic therapy. Additionally, zenocutuzumab is included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for non-small cell lung cancer, pancreatic adenocarcinoma, and cholangiocarcinoma.

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

About NRG1+ Cholangiocarcinoma

Cholangiocarcinoma is a rare, aggressive malignancy of the bile ducts with an all-stage 5-year overall survival of less than 15%. NRG1 gene fusions occur in fewer than 1% of cholangiocarcinoma cases. NRG1 fusions typically occur in patients who are otherwise driver negative, leaving affected patients, many of whom are younger adults, without approved targeted therapy. Standard cytotoxic regimens carry substantial toxicity, and second-line options such as FOLFOX produce objective responses in only approximately 5% of patients.

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.*

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

*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication 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 PRECAUTIONS

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 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 transferase (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 transferase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

NRG1 Gene Fusion Positive Advanced, Unresectable or Metastatic Cholangiocarcinoma
Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive cholangiocarcinoma who received BIZENGRI (n=22).

In patients with NRG1 gene fusion positive cholangiocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased magnesium (59%), increased alanine aminotransferase (50%), fatigue (46%), decreased platelets (46%), decreased hemoglobin (41%), increased aspartate aminotransferase (41%), increased alkaline phosphatase (41%), decreased phosphate (41%), diarrhea (41%), abdominal pain (36%), musculoskeletal pain (36%), increased gamma-glutamyl transferase (36%), increased bilirubin (32%), decreased potassium (32%), decreased sodium (32%), nausea (27%), cough (27%), increased activated partial thromboplastin time (aPTT) (27%), dyspnea (23%), decreased appetite (23%), and decreased albumin (23%).

(Press release, Partner Therapeutics, MAY 11, 2026, View Source [SID1234665458])