On October 19, 2025 Incyte (Nasdaq:INCY) reported the first clinical data evaluating its TGFβR2×PD-1 bispecific antibody (INCA33890) for patients with microsatellite stable (MSS) colorectal cancer; and its potent, selective and orally bioavailable KRAS G12D inhibitor (INCB161734) for patients with KRAS G12D mutations, specifically pancreatic ductal adenocarcinoma (PDAC). The data were featured in two oral sessions (Investigational immunotherapy; Abstract #1522MO and Developmental therapeutics; Abstract #916O, respectively) at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

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"The proof-of-concept data highlight the potential of INCA33890 and INCB161734 to address significant medical needs in patients with advanced solid tumors, including MSS colorectal cancer and PDAC," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "These results, including the favorable safety profiles as monotherapies, support continued clinical development. We look forward to exploring the development of these two novel targeted therapies in combination with current standard of care as frontline treatments."

INCA33890 (TGFβR2×PD-1)​

In an October 17, 2025, mini oral session at ESMO (Free ESMO Whitepaper), data were presented from the monotherapy arm (Part 1) of the INCA33890 Phase 1 trial, which included patients with advanced or metastatic solid tumors – including MSS colorectal cancer, ovarian cancer (OC), squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), gastric/gastroesophageal junction cancer (GC/GEJ) and PDAC – who experienced disease progression after receiving available therapies or were intolerant to, ineligible for or declined standard treatments, including immune checkpoint inhibitors. These patients received doses of INCA33890 ranging from 100 mg to 1,500 mg every two weeks (Q2W) to 900 mg intravenously (IV) every four weeks (Q4W) in continuous 28-day cycles. INCA33890 300 mg, 600 mg and 900 mg Q2W were selected as the recommended doses for expansion (RDE).

Initial data (cut-off July 25, 2025) showed promising clinical efficacy with INCA33890 treatment. This trial is ongoing, and the data will continue to mature. Of note:

INCA33890 demonstrated a manageable safety profile across all enrolled patients (n=260) – the occurrence and severity of immune related adverse reactions was similar to approved immune checkpoint inhibitors. The most common treatment-related adverse events (TRAEs) among individuals treated with INCA33890 across RDE (n=239) were fatigue (13.8%), pruritus (8.8%) and infusion-related reactions (8.4%).
Among patients with metastatic MSS colorectal cancer treated with INCA33890 at RDE (n=105), the vast majority (93.3%) had received more than two prior treatment regimens and 71.4% had active liver metastases at the time of treatment.
Within this cohort, 16 patients treated with INCA33890 responded (14 confirmed), with 15.2% achieving an objective response rate (ORR) and a median duration of therapy of 7.3 months.
The ORR among metastatic MSS colorectal cancer patients treated with INCA33890 was similar across RDE. Deep tumor responses were observed among patients with liver metastasis (n=9) – 12.0% achieved an ORR with a disease control rate (DCR) of 20.0%. Additionally, seven patients with no liver metastases treated with INCA33890 responded, achieving an ORR of 23.3% and DCR of 50.0%.
"Increased TGFβR2 expression is associated with poor prognosis in multiple solid tumor types, including colorectal cancer, which is third most common cancer and the second leading cause of cancer-related mortality worldwide," said Elena Garralda, M.D., Ph. D., Trial Investigator and Director of Early Drug Development at the Vall d’Hebron Institute of Oncology. "The efficacy data presented at ESMO (Free ESMO Whitepaper) in MSS colorectal cancer, coupled with tolerable safety profile, provide proof of concept for this differentiated approach of on-target inhibition of the TGF-β pathway. I look forward to seeing further development of this promising drug."

Evaluation of INCA33890 900 mg Q2W in combination with standard of care (SoC) treatments in patients with MSS colorectal cancer is ongoing. Dose escalation has been completed across combination therapy cohorts and no DLTs were identified. Incyte plans to initiate a registrational program for INCA33890 in MSS colorectal cancer in 2026.

INCB161734 (KRAS G12D)​

In an October 19, 2025, proffered paper session, data were presented from the monotherapy arm (Part 1) of the INCB161734 Phase 1 trial in patients with select advanced or metastatic solid tumors and documented KRAS G12D mutation – including PDAC, colorectal cancer, NSCLC, OC and other solid tumors – who received varying doses of INCB161734 ranging from 200 mg to 1,600 mg daily. The dose escalation portion of the study is complete – two doses, 600 mg daily and 1,200 mg daily, were selected for expansion.

Preliminary data (cut-off August 1, 2025) demonstrated evidence of clinical benefit in advanced or metastatic PDAC patients treated with INCB161734 (n=83). This trial is ongoing, and the data will continue to mature. Specifically:

INCB161734 demonstrated a manageable safety profile across all treated patients (n=136). No DLTs were reported in dose escalation, and the maximum tolerated dose (MTD) was not reached. No fatal adverse events (AEs) were considered related to treatment. The most common TRAEs across tumor types, nausea (58.1%), diarrhea (50.7%), vomiting (45.6%) and fatigue (17.4%), were mostly Grade 1.
PDAC patients receiving 600 mg (n=25) and 1,200 mg (n=29) INCB161734 daily demonstrated objective response rates (ORR; 20% and 34%) and high DCRs (64% and 86%). The study is ongoing for the majority of patients; data on durability of response is expected in the first half of 2026.
"PDAC is a highly aggressive cancer, and patients with G12D-mutated PDAC currently have an average five-year survival rate of less than ten percent," said Dr. Jayesh Desai, Tiral Investigator, Medical Oncologist and Associate Director of Clinical Research at the Peter MacCallum Cancer Centre. "It is encouraging to see promising antitumor activity and strong molecular response with INCB161734 monotherapy in this heavily pretreated patient population, and I believe these data speak to the potential of INCB161734 to be an impactful, selective targeted therapy for PDAC."

Evaluation of the data for INCB161734 in patients with PDAC is ongoing with results expected in 2026. Based on the findings, the company will conduct a comprehensive review of the data to inform next steps for the program, including discussions with regulatory authorities.

More information regarding the 2025 ESMO (Free ESMO Whitepaper) Congress and the data from Incyte’s oncology portfolio being featured at the meeting can be found on the ESMO (Free ESMO Whitepaper) website: View Source

Analyst Event and Webcast
The data from the ESMO (Free ESMO Whitepaper) oral presentations and additional results from INCA33890 in patients with MSS colorectal cancer and INCB161734 in patients with PDAC will also be discussed at an in-person analyst and investor event on Sunday, October 19, 2025, from 1:30 – 3:00 p.m. ET (7:30 – 9:00 p.m. CEST) at ESMO (Free ESMO Whitepaper).

The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 30 days.

More information regarding the 2025 ESMO (Free ESMO Whitepaper) Congress can be found at: View Source

About INCA33890
INCA33890 is an investigational, TGFβR2×PD-1 bispecific antibody, developed in collaboration with Merus using their Biclonics antibody platform, engineered to block TGF-β–mediated signaling in T cells co-expressing TGF-β and PD-1. TGFβ is known to promote cancer immune evasion and predicts poor response to PD-(L)1 targeted therapies. INCA33890 aims to spare tissues where TGF-β signaling is important for normal function, avoiding the known toxicity of a broad blocking of the TGF-β pathway. INCA33890 offers a promising targeted treatment strategy for patients with advanced or metastatic solid tumors, including microsatellite stable colorectal cancer.1,2,3,4

The open-label, multicenter Phase 1 study (NCT05836324) is evaluating the safety, tolerability, dose-limiting toxicities (DLTs), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of INCA33890 when administered as a monotherapy and in combination with other standard-of-care treatments (i.e., bevacizumab, bevacizumab and FOLFIRI, bevacizumab and FOLFOX, and cetuximab) in adults (≥18 years old) with advanced or metastatic solid tumors.

The study includes Part 1 evaluating INCA33890 as a monotherapy with Part 1A (dose escalation) and Part 1B (dose expansion). Inclusion criteria for Part 1 requires patients to have experienced disease progression after receiving available therapies or that they were intolerant to, ineligible for or declined standard treatment. Part 2 will evaluate INCA33890 administered in combination with other protocol-defined treatment(s) based on cohort assignment and also includes dose escalation (Part 2A) and dose expansion (Part 2B).

Primary endpoints include evaluating DLTs up to 28 days and safety/tolerability. Key secondary endpoints focus on preliminary efficacy (i.e., objective response rate [ORR], disease control rate [DCR], duration of response [DOR]) up to two years and PK parameters.

For more information about the study, please visit: View Source

About INCB161734
INCB161734 is an investigational novel, selective and orally bioavailable small molecule inhibitor targeting G12D-mutated KRAS. KRAS is one of the most frequently altered driver oncogenes in solid tumors. The G12D mutation, which represents approximately 40% of oncogenic KRAS mutations in patients with PDAC, is associated with aggressive tumor phenotypes and poor clinical outcomes.

The open-label, dose-escalation and dose-expansion Phase 1 study (NCT06179160) is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of INCB161734 when administered as monotherapy and in combination with other anticancer therapies in patients with advanced or metastatic solid tumors harboring the KRAS G12D mutation. The study includes Part 1 evaluating INCB161734 as a monotherapy, with Part 1A (dose escalation), Part 1B (cohort dose expansion), Part 1C (pharmacodynamics) and Part 1D (food-effect). Part 2 will evaluate INCA161734 administered in combination with other protocol-defined treatment(s) based on cohort assignment and also includes dose escalation (Part 2A) and dose expansion (Part 2B).

Primary endpoints include DLTs and TEAEs. Key secondary endpoints include objective ORR, DCR, DOR and PK parameters.

For more information about the study, please visit: View Source

(Press release, Incyte, OCT 19, 2025, View Source [SID1234656801])

On October 19, 2025 Taiho Pharmaceutical Co., Ltd. ("Taiho") and Arcus Biosciences, Inc. (NYSE:RCUS, "Arcus") reported that Taiho exercised its option to develop and, if approved, commercialize casdatifan (International Nonproprietary Name; development code: AB521), an investigational small molecule HIF (Hypoxia Inducible Factor)-2α inhibitor, in Japan and certain other territories in Asia (excluding mainland China). This option exercise is based on a 2017 option and license agreement between Taiho and Arcus. This is the fifth option exercise by Taiho to an Arcus program.

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In exchange for the exclusive license to casdatifan, Taiho will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercialization milestones, and, if any products from the program are approved, will pay royalties on net sales of such products.

Casdatifan is an investigational small molecule compound developed by Arcus. Arcus is currently conducting an ongoing global, registrational Phase 3 study, PEAK-1,* comparing the combination therapy of casdatifan and a VEGFR-targeted tyrosine kinase inhibitor (TKI) to monotherapy using a VEGFR-targeted TKI alone in patients with clear cell renal cell carcinoma (ccRCC). Japan is also expected to participate in the study starting in the first half of 2026.

*PEAK-1: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients with Advanced Clear Cell Renal Cell Carcinoma

Through this collaboration, Taiho and Arcus are committed to delivering casdatifan as a potentially innovative new medicine to patients and healthcare professionals as swiftly as possible.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2α, a master switch that turns on hundreds of genes in response to low oxygen levels; when oxygen levels return to normal, HIF-2α is turned off. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), this shut-off mechanism is deficient and HIF-2α remains activated even in the presence of oxygen, causing normal kidney cells to become cancerous. Casdatifan is designed to provide deeper and more durable inhibition of the HIF-2α pathway.

About clear cell renal cell carcinoma (ccRCC)

Kidney cancer is a disease with a rising worldwide incidence estimated at 400,000 new cases annually, and a worldwide mortality rate approaching 175,000 deaths per year. Current projections suggest incidence continuing to increase over the next decade, emphasizing the urgency of addressing this significant global health trend. ccRCC is the most common type of kidney cancer in adults, making up 75-80% of all cases.

(Press release, Taiho, OCT 19, 2025, View Source [SID1234656800])

On October 19, 2025 Carsgen therapeutcis reported primary plasma cell leukemia (pPCL) is a rare and highly aggressive plasma cell malignancy, often associated with complex genetic abnormalities. There is currently no standard treatment regimens, and conventional therapies for multiple myeloma are typically used. While targeted agents and autologous hematopoietic stem cell transplantation can slightly extend the overall survival of pPCL patients to 1.5–3 years, relapsed/refractory pPCL after multiple lines of therapy presents a significant clinical challenge due to the extremely limited treatment options and rapid disease progression, making it difficult to re-induce remission with existing therapies.

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CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen’s proprietary THANK-u Plus platform. It is currently being evaluated in investigator-initiated trials for plasma cell malignancy. As of the data cutoff date (Oct 17, 2025), two patients with relapsed/refractory pPCL had been enrolled. Details are as follows:

pPCL-01:

A 62-year-old male with IgG-λ type experienced poor disease control and rapid progression despite previous autologous hematopoietic stem cell transplantation and treatment with triple classes of drugs (proteasome inhibitor, immunomodulatory agent, and CD38 monoclonal antibody). By the screening period, his serum free light chain level had reached 10,374.86 mg/L. The patient underwent two CAR-T cell infusions approximately two months apart: he first received low-dose lymphodepletion and a relatively lower dose of CAR-T cells per protocol, then followed one cycle of bridge therapy. About one month after the failure of bridge therapy, he received a second CAR-T cell infusion. Following this infusion, he developed Grade 2 CRS, Grade 4 cytopenia, and a lung infection, but recovered after supportive treatment including tocilizumab, corticosteroids, autologous stem cell infusion, and anti-infective therapy. CAR-T cells expanded robustly, with a peak copy number (Cmax) of 161,971 copies/μg gDNA, and copy numbers remained at 10³ by Week 8. Efficacy assessments at both Week 4 and Week 8 post-infusion showed stringent complete response (sCR), and bone marrow minimal residual disease (MRD) was negative (< 10⁻⁶) at Week 4.

pPCL-02:

A 70-year-old male with κ light chain had previously been treated with triple classes of drugs (proteasome inhibitor, immunomodulatory agent, and CD38 monoclonal antibody). The patient developed Grade 1 CRS, Grade 4 neutropenia, and thrombocytopenia following lymphodepletion and CAR-T cell infusion. The CRS and cytopenias were resolved after treatment with tocilizumab and other supportive measures. CAR-T cells expanded robustly, with a Cmax of 151,654 copies/μg gDNA. The patient achieved sCR at the Week 4, Week 8, and Week 12 assessments post-infusion, with bone marrow MRD negative (< 10⁻⁶) at both Week 4 and Week 12.

Based on the current findings, CT0596 has exhibited robust and rapid efficacy in heavily pretreated patients with rapidly progressive relapsed/refractory pPCL. Both pPCL patients achieved sCR following CT0596 infusion, with peak CAR-T cell copy numbers exceeding 10⁵ copies/μg gDNA. Aside from expected CAR-T-associated toxicities such as CRS and hematologic adverse events, no significant organ toxicities were observed, indicating a manageable safety profile. These results lend strong support to the continued investigation of CT0596 across a broader spectrum of plasma cell neoplasms.

About CT0596

CT0596 is an allogeneic BCMA-targeted CAR-T therapy developed using CARsgen’s proprietary THANK-u Plus platform. It is currently being evaluated in investigator-initiated trials for relapsed/refractory multiple myeloma (R/R MM) or plasma cell leukemia (PCL). CT0596 demonstrated preliminary favorable tolerability and encouraging efficacy signals. Further investigation is planned in additional plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells. The company anticipates submitting an Investigational New Drug (IND) application in the second half of 2025.

(Press release, Carsgen Therapeutics, OCT 19, 2025, View Source;preliminary-clinical-data-of-carsgens-allogeneic-bcma-car-t-product-ct0596-for-the-treatment-of-primary-plasma-cell-leukemia-302588331.html [SID1234656799])

On October 19, 2025 Multitude Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of ADC drugs, reported interim results from its ongoing Phase I/II open-label, multicenter dose escalation and expansion study evaluating AMT-253, a MUC18-directed antibody-drug-conjugate (ADC), in patients with melanoma and other advanced solid tumors. The data are being presented on October 19th at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting being held in Berlin, Germany.

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Phase I/II clinical trials are ongoing in both Australia and China. This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase II Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-253, in patients with advanced solid tumors. The Phase Ia portion will determine the recommended doses for expansion, and the Phase Ib/II portion will focus on further characterizing safety and efficacy in select tumor types.

As of September 8th, 2025, safety data are available for 170 patients who have received AMT-253 once every three weeks (Q3W) at doses ranging from 1.6 to 5.6 mg/kg. Primary tumor types are melanoma, endometrial cancer, cervical squamous cancer and uterine leiomyosarcoma. In heavily pretreated melanoma patients, with prior lines of therapy ranging from 1-7, promising efficacy was observed without MUC18 preselection. The overall response rate (ORR) was 28.6% in all melanomas (16/56, 15 confirmed, 1 unconfirmed still on-treatment) across all dose levels. In melanoma patients without prior chemotherapy, ORR was 35% (7/20, all confirmed), 50% (5/10; 4 confirmed, 1 unconfirmed still on-treatment), and 33.3% (1/3, confirmed) for the cutaneous, acral, and mucosal subtypes, respectively; preliminary mPFS was 8.6, 8.3, and 11.0 months. Among 18 cutaneous melanoma patients at the potential expansion doses, ORR was 38.9% (7/18, all confirmed), and preliminary mPFS was 8.6 months. Preliminary antitumor activity was also observed in endometrial cancer, cervical squamous carcinoma and uterine leiomyosarcoma patients. Responses were observed across MUC18 expression levels in all tumor patients evaluated. AMT-253 showed a safety profile consistent with other topoisomerase-1 (TOP1) inhibitor–based ADCs, with manageable hematologic toxicities as the most common treatment-related adverse events. No treatment-related cases of neuropathy or pneumonitis were observed as of the data cutoff.

"We are excited by the durable antitumor activity observed in the early clinical results of AMT-253, particularly in unselected, late-line metastatic melanoma patients, where the unmet medical need remains high," said Dr. Shu-Hui Liu, Co-founder and CSO of Multitude Therapeutics. "These initial data, together with our previously published preclinical findings*, highlight the potential of AMT-253 to offer meaningful outcome improvement to patients who have exhausted standard-of-care options. We look forward to further clinical confirmation of these results and to fully exploring the potential of this novel ADC for greater patient benefit."

*Shi et al., (2023) Cancer Research 83:3783-95

Poster Presentation Details:

Title: Ongoing Phase I trial results of AMT-253, a first-in-class MUC18-targeting antibody-drug conjugate in patients with melanoma and other advanced solid tumors
Session Title: Developmental therapeutics
Date and Time: October 19th – 09:00-17:00
Poster Number: 997P
Location: Hall 25, Level 2

About AMT-253

AMT-253, a MUC18 ADC, is composed of a proprietary antibody with high MUC18 binding affinity, a protease-cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is designed to complement the exatecan payload, enabling a stable and homogenous ADC. The payload is a weak substrate for BCRP/P-gp, which are drug efflux pumps that drive chemoresistance to many therapies. In preclinical data, this linker-payload has been shown to have an increased "bystander effect" compared to the equivalent of competitor ADCs**. AMT-253 has a drug-to-antibody ratio of eight. AMT-253 is being evaluated in a Phase I/II study in patients with melanoma and other advanced solid tumors. Additional information on the AUS PhI(NCT05906862) and China PhI/II (NCT06209580) trials can be found at clinicaltrials.gov.

(Press release, Multitude Therapeutics, OCT 19, 2025, View Source [SID1234656798])

On October 19, 2025 SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, reported positive topline results from the BL-B01D1-301 trial. The trial has met one of the dual primary endpoints (BICR-assessed ORR) as iza-bren has demonstrated a statistically significant and clinically meaningful improvement in BICR-assessed ORR in recurrent or metastatic NPC patients who had progressed after at least two prior lines of chemotherapy, including platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. These results were presented today in a late-breaking oral presentation at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

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Iza-bren is a potentially first-in-class topoisomerase 1 inhibitor-based bispecific antibody-drug conjugate (ADC) which targets both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFRxHER3). It is being developed by Biokin in China and jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China.

Iza-bren has shown a BICR-assessed ORR of 54.6% vs. 27.0% (Odds Ratio 3.3; 95% confidence interval 1.9-5.8; p<0.0001). Median duration of response (DoR) was 8.5 months for iza-bren versus 4.8 months for physician’s choice of chemotherapy (Hazard ratio 0.43; 95% CI 0.22 to 0.83). Furthermore, median progression-free survival (PFS) was 8.38 months with iza-bren compared to 4.34 months for chemotherapy (hazard ratio of 0.44; 95% confidence interval 0.32-0.62). The ORR and PFS benefits were consistent across all subgroup analysis. At the time of this analysis, the overall survival (OS) data were immature.

Iza-bren was well-tolerated with a manageable safety profile. The most common adverse events were hematological toxicities, which were effectively managed with standard supportive care. Two patients in the iza-bren arm experienced Grade 2 interstitial lung disease (ILD), whereas two patients in the chemotherapy arm experienced Grade 3 ILD. The safety profile in the BL-B01D1-303 study was consistent with the known profiles of the therapy with no new safety signals identified.

"The positive topline results from the first registrational trial of iza-bren presented at ESMO (Free ESMO Whitepaper) demonstrated clear clinical benefits of iza-bren compared to traditional chemotherapy. These data add to the growing body of clinical evidence that continues to reinforce our confidence in iza-bren’s mechanism of action and therapeutic potential. We believe iza-bren can deliver clinically meaningful benefit by targeting key cancer biological pathways to improve outcomes for patients across a broad range of advanced malignancies," added Dr. Jonathan Cheng, Chief Medical Officer of SystImmune.

The New Drug Application (NDA) for iza-bren for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) has been submitted by Biokin to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) in China.

About BL-B01D1-303

BL-B01D1-303 is a phase III, randomized, open-label, multicenter study in China to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic nasopharyngeal carcinoma who have failed PD-1/PD-L1 monoclonal antibody and at least two lines chemotherapy (one line must contain platinum-based chemotherapy). For more detailed information, please visit clinical.trials.gov (NCT06118333).

About Nasopharyngeal Carcinoma (NPC)

Nasopharyngeal Carcinoma (NPC) is a type of head and neck cancer that originates in the nose. NPC is uncommon globally, but is endemic in southern China, southeast Asia and parts of Africa, and is rising among the immigrant population in US and Europe. NPC is strongly associated with EBV infection. There is a significant unmet need as 5-year overall survival rate is generally less than 10% in the later line metastatic setting.

About iza-bren

SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

(Press release, SystImmune, OCT 19, 2025, View Source [SID1234656797])