On May 21, 2026 Agendia, Inc., a leader in precision oncology for breast cancer, reported new data to be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2 in Chicago. The company will present two posters highlighting how MammaPrint (MP) + BluePrint (BP) provide biological insights into treatment response and help further refine therapeutic decision-making for patients with early-stage breast cancer (EBC).

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Poster #46 | June 1, 1:30 p.m. – 4:30 p.m. CDT | Presenter: Steven Isakoff

Association of the 70-gene assay and homologous recombination deficiency in patients with High Risk 2 breast cancers

This real-world analysis of 1,298 patients from the FLEX study evaluated whether MP + BP classifications are associated with homologous recombination deficiency (HRD) in hormone receptor positive, HER2-negative (HR+HER2-) EBC. A 228-gene HRD signature and a refined 26-gene panel were used to assess HRD-related biology indicative of impaired DNA repair.

Both signatures showed that MP High Risk 2 (H2) tumors demonstrated significantly higher HRD scores than High Risk 1 (H1) tumors (both p<0.001).
Among Luminal tumors, Luminal H2 tumors had significantly higher HRD scores than Luminal H1 tumors across both HRD signatures (both p<0.001).
Basal tumors demonstrated higher HRD scores than Luminal tumors within both H1 and H2 groups (all p≤0.002), with Basal H2 tumors showing the highest overall HRD levels.
"These findings provide a biological rationale for the anthracycline chemotherapy benefit observed in patients with MammaPrint High Risk 2 tumors," said Steven Isakoff, M.D., Ph.D., Medical Oncologist and Clinical Director, Breast Oncology Program, Mass General Brigham Cancer Institute. "Following the recent NCCN Guidelines update recognizing MammaPrint as the only genomic test to personalize the use of anthracycline-based regimens in HR+HER2- early-stage breast cancer, the data further validate the assay’s ability to stratify risk and guide treatment selection."

Poster #106 | June 1, 1:30 p.m. – 4:30 p.m. CDT | Presenter: David Page

Integration of molecular subtyping and immune profiling to predict pathologic complete response in HER2+ breast cancer treated with neoadjuvant dual HER2 therapy

This study evaluates whether combining BP molecular subtyping with the ImPrint immune signature could accurately predict outcomes (pathologic complete response [pCR]) in HER2-positive (HER2+) EBC treated with neoadjuvant dual HER2-targeted therapy. pCR rates were assessed in a cohort of 252 patients, following treatment with neoadjuvant chemotherapy in combination with trastuzumab and pertuzumab.

In the HR+HER2+ subgroup, 52% of tumors were further classified by BP as non-HER2 subtypes (Luminal A 6%, Luminal B 44%, Basal 2%), highlighting the genomic diversity within clinically HER2+ disease.
The highest pCR rates were observed in tumors classified as BP-HER2/ImPrint+, indicating that patients whose tumors were genomically HER2-type and immune-active derived the greatest benefit from neoadjuvant therapy.
In multivariate analysis, BP subtype and ImPrint status independently predicted pCR in HR+HER2+ disease, after controlling for nodal status and tumor size. The integration of molecular subtyping by BP and immune profiling by ImPrint maximized prediction of pCR, particularly in the HR+HER2+ subgroup.
"These findings demonstrate how integrating molecular subtyping with immune profiling may improve our ability to predict response to neoadjuvant therapy in HER2-positive early-stage breast cancer and may be hypothesis-generating for chemotherapy de-escalation studies," said William Audeh, M.D., Chief Medical Officer of Agendia. "Both the HRD and HER2+ studies highlight the utility of MammaPrint and BluePrint and emerging signatures for identifying clinically relevant breast cancer biology. Drawing on insights from the FLEX Study, which captures real-world treatment patterns as they evolve, we can address challenging clinical questions in a timely and relevant manner."

ImPrint was developed to be used in the clinic to predict the likelihood of patients responding to immunotherapies by looking at the biology of the patient’s tumor. Agendia currently holds a U.S. Food and Drug Administration Investigational Device Exempt status for the ImPrint signature, allowing for its use in the I-SPY2 trial and for other ongoing research with collaborators.

(Press release, Agendia, MAY 21, 2026, View Source [SID1234665968])

On May 21, 2026 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established laboratory services business and a therapeutic development business, reported that its full abstract has been released on the ASCO (Free ASCO Whitepaper) 2026 website. The abstract will be presented within the Head and Neck Cancer Track of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Rapid Oral Abstract Session on June 1, 2026, from 4:30pm to 6:00pm (CDT) in Hall D1 of McCormick Place, Chicago.

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The abstract is entitled "FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020". It presents interim data from the Company’s open-label, randomized Phase 2 study (NCT06332092). The study was designed to evaluate the efficacy of two different dosing regimens and to characterize the pharmacokinetics (PK) and safety and tolerability of FID-007 in combination with cetuximab in patients with disease progression after treatment with PD-1-based immune checkpoint inhibitor. As of the data cut-off date of December 20, 2025, FID-007 exhibited meaningful clinical activity and a favorable safety profile when combined with cetuximab in target patient population.

Key observations in the abstract include:

FID-007 combined with cetuximab demonstrated anticancer activity at both dose levels for the 1L–2L treatment of R/M HNSCC. Of the 42 patients evaluable for efficacy, the objective response rate (ORR) was 60% (58% in Arm A, 61% in Arm B), and the median progression-free survival (mPFS) was 7.2 mo [6.7 mo in Arm A (95% CI: 2.0-12.8), and 7.2 mo in Arm B (95% CI: 4.0-NR)]. The median duration of response (DoR) was 7.4 mo (7.4 mo in Arm A, NR in Arm B) with 56% (14/25) of responders continuing to respond at the time of data cut-off. The overall survival data (OS) are immature at present.
FID-007 exhibited a favorable safety and tolerability profile consisting mostly of grade 1-2 treatment-related adverse events (TRAEs). Grade 3-4 TRAEs occurring in ≥ 2 patients included neutropenia (3 in Arm A, 5 in Arm B), anemia (2 in Arm A, 4 in Arm B), leukopenia (3 in Arm B), acneiform dermatitis (2 in Arm A), maculo-papular rash and other rash (2 in Arm B). There was 1 Grade 5 TRAE (pneumonia in Arm B).
The full abstract is now available on the ASCO (Free ASCO Whitepaper) website, as well as on Fulgent’s investor relations website.

The final presentation slides with updated data will be available on Fulgent’s investor relations website at the start of the session on June 1, 2026.

Dr. Ray Yin, Co-Founder and President of Fulgent Pharma, said, "Based on available estimates, there are approximately 73,000 new head and neck Squamous Cell Carcinoma (HNSCC) cases in the U.S. and 930,000 worldwide each year, with 50% to 60% progressing to the recurrent or metastatic stage. We are encouraged by the clinical progress achieved so far and believe in the potential of FID-007 to serve as a meaningful treatment for R/M HNSCC patients, particularly given that the current standard of care offers a historical objective response rate (ORR) of just 5.8% to 19.1% and a progression-free survival (PFS) of only 2.3 to 3.7 months."

(Press release, Fulgent Genetics, MAY 21, 2026, View Source [SID1234665967])

On May 21, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported a landmark oncology data program for the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The meeting will take place May 29–June 2 in Chicago, IL.

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Together with its collaborators, Natera will demonstrate unmatched scale in evidence generation with 35 abstracts across molecular residual disease (MRD) testing and other innovations. Presentations will highlight Natera’s Treatment on MRD (TOMR) approach, showing more precise intervention upon molecular recurrence; the broad utility of Signatera as a pan-cancer foundational tool in MRD; the robust clinical performance of Natera’s ultrasensitive phased variant technology; and new real-world data on Signatera in hereditary risk assessment, treatment response monitoring, and longitudinal disease management.

"This is the most comprehensive oncology data program Natera has presented to date, reflecting the growing adoption of Signatera and the accelerating momentum behind precision MRD-guided care," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology. "Collectively, these studies reinforce Signatera’s broad clinical utility, highlight the continued advancement of our technology platform, and demonstrate the strength and depth of our evidence as we work to make cancer care more actionable and personalized."

Treatment on MRD (TOMR) in Colorectal Cancer (CRC)

Multiple analyses from the GALAXY study in CRC demonstrate the value of serial Signatera testing and the potential impact of MRD-guided decision making in the adjuvant setting.

In one analysis, patients who were initially Signatera-negative but later converted to Signatera-positive derived a substantial benefit from adjuvant chemotherapy (ACT) (HR 0.3), showing Signatera can identify a subset of patients with early molecular recurrence who could benefit from ACT. Patients with sustained negativity had excellent outcomes regardless of ACT, suggesting potential overtreatment.
A separate analysis showed that extending ACT beyond three months provided no added benefit for patients with sustained Signatera-negativity or Signatera clearance, whereas partial molecular responders (decrease in ctDNA) benefitted from continued ACT. Molecular progression (increase in ctDNA) on ACT indicated the need for more effective alternative treatment strategies.
Pan-Cancer MRD

Natera will present a large, first-of-its-kind, real-world meta-analysis of Signatera across 18 published studies, more than 3,000 patients, and 15 tumor types. The analysis demonstrated that Signatera-positivity was strongly associated with increased risk of recurrence or disease progression at all timepoints included in the analysis.

In a pooled analysis, Signatera-positivity in the adjuvant window was associated with significantly increased risk of recurrence or death (HR: 8.15).
In the surveillance setting, Signatera-positivity was associated with an even greater recurrence risk (HR: 18.30).
Phased Variant Technology

Natera’s phased variant technology continues to demonstrate powerful prognostic performance across both solid and hematologic cancers. This technology, which can detect circulating tumor DNA (ctDNA) levels below 1 part per 10 million, reinforces the potential of ultra-sensitive ctDNA detection to guide treatment response monitoring and long-term disease management.

One study in early-stage, non-small cell lung cancer (NSCLC), showed that 100% of patients who cleared ctDNA during or after adjuvant therapy did not recur. ctDNA detection also preceded recurrence in 94% of cases.
In a separate analysis in relapsed or refractory follicular lymphoma, patients treated with CAR T cell therapy who achieved MRD-negativity experienced substantially improved progression-free survival (PFS), including 36-month PFS rates of 81% compared to 56% in MRD-positive patients.
Platform Expansion: RWD and New Digital Tools

Natera and its collaborators will present real world data evaluating ctDNA dynamics and clinical outcomes in colorectal cancer, NSCLC, breast cancer, and additional tumor types. Natera will also unveil its Annotation platform at ASCO (Free ASCO Whitepaper), a new digital tool that integrates clinical, treatment, and genomic data to present multimodal, longitudinal patient journeys through a unified interface, bringing richer clinical context to Signatera results at the individual and cohort levels.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported a landmark oncology data program for the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The meeting will take place May 29–June 2 in Chicago, IL.

Together with its collaborators, Natera will demonstrate unmatched scale in evidence generation with 35 abstracts across molecular residual disease (MRD) testing and other innovations. Presentations will highlight Natera’s Treatment on MRD (TOMR) approach, showing more precise intervention upon molecular recurrence; the broad utility of Signatera as a pan-cancer foundational tool in MRD; the robust clinical performance of Natera’s ultrasensitive phased variant technology; and new real-world data on Signatera in hereditary risk assessment, treatment response monitoring, and longitudinal disease management.

"This is the most comprehensive oncology data program Natera has presented to date, reflecting the growing adoption of Signatera and the accelerating momentum behind precision MRD-guided care," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology. "Collectively, these studies reinforce Signatera’s broad clinical utility, highlight the continued advancement of our technology platform, and demonstrate the strength and depth of our evidence as we work to make cancer care more actionable and personalized."

Treatment on MRD (TOMR) in Colorectal Cancer (CRC)

Multiple analyses from the GALAXY study in CRC demonstrate the value of serial Signatera testing and the potential impact of MRD-guided decision making in the adjuvant setting.

In one analysis, patients who were initially Signatera-negative but later converted to Signatera-positive derived a substantial benefit from adjuvant chemotherapy (ACT) (HR 0.3), showing Signatera can identify a subset of patients with early molecular recurrence who could benefit from ACT. Patients with sustained negativity had excellent outcomes regardless of ACT, suggesting potential overtreatment.
A separate analysis showed that extending ACT beyond three months provided no added benefit for patients with sustained Signatera-negativity or Signatera clearance, whereas partial molecular responders (decrease in ctDNA) benefitted from continued ACT. Molecular progression (increase in ctDNA) on ACT indicated the need for more effective alternative treatment strategies.
Pan-Cancer MRD

Natera will present a large, first-of-its-kind, real-world meta-analysis of Signatera across 18 published studies, more than 3,000 patients, and 15 tumor types. The analysis demonstrated that Signatera-positivity was strongly associated with increased risk of recurrence or disease progression at all timepoints included in the analysis.

In a pooled analysis, Signatera-positivity in the adjuvant window was associated with significantly increased risk of recurrence or death (HR: 8.15).
In the surveillance setting, Signatera-positivity was associated with an even greater recurrence risk (HR: 18.30).
Phased Variant Technology

Natera’s phased variant technology continues to demonstrate powerful prognostic performance across both solid and hematologic cancers. This technology, which can detect circulating tumor DNA (ctDNA) levels below 1 part per 10 million, reinforces the potential of ultra-sensitive ctDNA detection to guide treatment response monitoring and long-term disease management.

One study in early-stage, non-small cell lung cancer (NSCLC), showed that 100% of patients who cleared ctDNA during or after adjuvant therapy did not recur. ctDNA detection also preceded recurrence in 94% of cases.
In a separate analysis in relapsed or refractory follicular lymphoma, patients treated with CAR T cell therapy who achieved MRD-negativity experienced substantially improved progression-free survival (PFS), including 36-month PFS rates of 81% compared to 56% in MRD-positive patients.
Platform Expansion: RWD and New Digital Tools

Natera and its collaborators will present real world data evaluating ctDNA dynamics and clinical outcomes in colorectal cancer, NSCLC, breast cancer, and additional tumor types. Natera will also unveil its Annotation platform at ASCO (Free ASCO Whitepaper), a new digital tool that integrates clinical, treatment, and genomic data to present multimodal, longitudinal patient journeys through a unified interface, bringing richer clinical context to Signatera results at the individual and cohort levels.

On May 21, 2026 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported the presentation of data on iza-bren (izalontamab brengitecan), BL-M14D1, T-Bren (BL-M07D1), and BL-M05D1, four distinct clinical programs from its antibody drug conjugate (ADC) pipeline, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting taking place May 29 – June 2 in Chicago. Iza-bren, a potentially first-in-class EGFRxHER3 bispecific ADC, is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China.

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"The data we are presenting at ASCO (Free ASCO Whitepaper) 2026 mark an important inflection point for SystImmune, with multiple late-stage readouts alongside continued expansion of our earlier pipeline," said Dr. Jie D’Elia, Ph.D., Chief Executive Officer of SystImmune. "From randomized Phase III trials of iza-bren to emerging proof-of-concept data across our next-generation ADC programs, we are demonstrating both the clinical potential and scalability of our platform. Together, these advances reinforce our ability to rapidly translate innovative science into differentiated therapies for patients with high unmet need worldwide."

Key data to be presented at ASCO (Free ASCO Whitepaper) include:

Highlighting the continued clinical advancement of iza-bren:

Late-breaking data from the first randomized, Phase III study evaluating iza-bren versus physician’s choice of chemotherapy in unresectable locally advanced or metastatic triple-negative breast cancer patients in China
Safety and efficacy data from a randomized, open label, multi-center, Phase III study evaluating iza-bren vs physician’s choice of chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma in China
Demonstrating breadth of ADC platform with updates from novel ADC programs:

Results from the first Phase I study in China of BL-M14D1, a novel DLL3 directed ADC, in patients with locally advanced or metastatic small-cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors
Safety and efficacy results from a Phase II study in China evaluating trastuzumab brengitecan (T-bren; BL-M07D1) in patients with recurrent or metastatic ovarian cancer
Results from a Phase II study in China of T-Bren monotherapy or in combination with pertuzumab in patients with treatment-naïve HER2-positive unresectable locally advanced or metastatic (LA/M) breast cancer
Results from the first Phase I study in China of BL-M05D1, a novel Claudin 18.2 directed ADC, in patients with locally advanced or metastatic Claudin18.2–expressing solid tumors
"We are particularly encouraged to present the Phase III data for iza-bren compared to standard chemotherapy in TNBC, which further supports its potential to deliver meaningful clinical benefit across multiple tumor types," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "In parallel, data from T-Bren, BL-M14D1, and BL-M05D1 highlight the breadth of our ADC portfolio, with early signals of activity and combination potential in several difficult-to-treat cancers. Collectively, these results strengthen our confidence in advancing both iza-bren and our broader pipeline into later-stage development."

Details of the presentations at ASCO (Free ASCO Whitepaper) are below:

Izalontamab brengitecan (iza-bren) versus physician’s choice of chemotherapy in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC): A randomized phase III study
Trial Reference: BL-B01D1-307 (NCT06382142), China
Session Title: Oral Abstract Session – Breast Cancer (Metastatic)
Abstract: LBA1003
Speaker: Jiong Wu (Shanghai, China)
Session Date & Time: Tuesday, June 2nd, 2026, 9:45 AM-12:45 PM CDT

Izalontamab brengitecan (iza-bren) versus chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC): A multicenter, randomized, open-label, phase III study
Trial Reference: BL-B01D1-305 (NCT06304974), China
Session Title: Oral Abstract Session – Gastrointestinal Cancer (Gastroesophageal, Pancreatic, and Hepatobiliary)
Abstract: 4008
Speaker: Zhihao Lu (Beijing, China)
Session Date & Time: Monday, June 1st, 2026, 9:45 AM-12:45 PM CDT

Phase I study of BL-M14D1, a novel DLL3-directed antibody-drug conjugate (ADC), inpatients with locally advanced or metastatic small-cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors
Trial Reference: BL-M14D1-101 (NCT06505824), China
Session Title: Oral Abstract Session – Developmental Therapeutics (Molecularly Targeted Agents and Tumor Biology)
Abstract: 3001
Speaker: Wei Li (Shanghai, China)
Session Date & Time: Monday, June 1st, 2026, 8:00 AM-11:00 AM CDT

T-Bren (BL-M07D1) in patients with recurrent or metastatic (R/M) ovarian cancer: Results from two phase II studies
Trial Reference: BL-M07D1-202/203 (NCT06031584/NCT06131450), China
Session Title: Oral Abstract Session – Developmental Therapeutics (Molecularly Targeted Agents and Tumor Biology)
Abstract: 3003
Speaker: Gongyi Zhang (Beijing, China)
Session Date & Time: Monday, June 1st, 2026, 8:00 AM-11:00 AM CDT

Phase II study of izalontamab (SI-B001) in combination with paclitaxel or docetaxel in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
Trial Reference: SI-B001-206 (NCT05054439), China
Session Title: Rapid Oral Abstract Session (Head and Neck Cancer)
Abstract: 6019
Speaker: Ye Guo (Shanghai, China)
Session Date & Time: Monday, June 1st, 2026, 4:30 PM-6:00 PM CDT

Phase I study of BL-M05D1, a novel Claudin18.2-directed antibody-drug conjugate (ADC), in patients with locally advanced or metastatic Claudin18.2–expressing solid tumors
Trial Reference: BL-M05D1-101 (NCT06349811), China
Session Title: Poster Session – Developmental Therapeutics (Molecularly Targeted Agents and Tumor Biology)
Abstract: 3030
Speaker: Siyuan Cheng (Beijing, China)
Onsite Poster Display Date: Saturday, May 30th, 2026, 1:30 PM-4:30 PM CDT

Phase II study of T-Bren (BL-M07D1) monotherapy or in combination with pertuzumab in patients with treatment-naïve HER2-positive unresectable locally advanced or metastatic (LA/M) breast cancer
Trial Reference: BL-M07D1-205 (NCT06445400), China
Session Title: Poster Session – Breast Cancer (Metastatic)
Abstract: 1049
Speaker: Yaping Yang (Guangzhou, China)
Onsite Poster Display Date: Monday, June 1st, 2026, 1:30 PM-4:30 PM CDT

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.

About SystImmune’s ADC Pipeline Programs (BL-M07D1, BL-M14D1, BL-M05D1)
SystImmune is advancing a portfolio of next-generation antibody-drug conjugates (ADCs) built on its proprietary brengitecan platform, which utilizes a potent topoisomerase I inhibitor payload designed for targeted delivery to tumor cells. The clinical progress of izalontamab brengitecan (iza-bren) provides initial validation of this platform’s potential to deliver meaningful anti-tumor activity across multiple cancer types.

T-Bren (BL-M07D1), BL-M14D1, and BL-M05D1 each incorporate the brengitecan payload and linker technology, paired with distinct targeting antibodies to address different tumor-associated antigens.

T-Bren (BL-M07D1) targets HER2, a well-established driver across multiple solid tumors, enabling targeted delivery of the brengitecan payload to HER2-expressing cancer cells.
BL-M14D1 targets DLL3, which is highly expressed in small-cell lung cancer and neuroendocrine tumors, facilitating selective delivery of the brengitecan payload to DLL3-positive tumor cells.
BL-M05D1 targets Claudin 18.2, a protein highly expressed in tumors such as pancreatic and gastric cancers, enabling targeted cytotoxic activity in Claudin 18.2–expressing tumors.
Across these programs, SystImmune’s brengitecan platform is designed to combine tumor-specific targeting with efficient payload delivery, with the goal of improving therapeutic index and expanding treatment options for patients with difficult-to-treat cancers.

(Press release, SystImmune, MAY 21, 2026, View Source [SID1234665965])

On May 21, 2026 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported updated positive clinical and pharmacodynamic data from its Phase 2 clinical trial of lucicebtide, a first-in-class antagonist of C/EBPβ, alone or in combination with chemoradiation standard-of-care (SOC) in patients with glioblastoma (GBM) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2, 2026, in Chicago and online.

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Despite being the most common and lethal malignant brain tumor, with more than 14,000 patients diagnosed each year in the United States, GBM remains an underserved disease, with limited progress in overall survival for patients over the last 20 years.1 C/EBPβ drives tumor growth and survival, and is a master regulator of the mesenchymal transformation in GBM, a state associated with chemotherapy resistance and aggressive disease, supporting it as a compelling therapeutic target for GBM. C/EBPβ is also recognized as regulating an immune-suppressive program in tumor-associated macrophages that contributes to tumor growth and progression. 2,3

Sapience’s ongoing Phase 2 Window-of-Opportunity study is evaluating lucicebtide alone or in combination with SOC in patients with GBM, with dosing administered before and after surgical resection. Nine patients are evaluable for analysis. As of April 27, 2026:

Patients with ndGBM treated with lucicebtide in combination with SOC achieved PFS and OS outcomes that exceed those reported in the published literature
Projected mPFS of 28.4 months meaningfully exceeds the 4.0 to 6.9-month historic benchmark range 4,5
mOS not yet reached; 6 of 9 patients remain alive beyond 22.3 months (per the cutoff date), exceeding the 14.6 to 17.0-month historic benchmark range 4,6
Lucicebtide activity is further demonstrated by on-target clinical pharmacodynamics
Target engagement confirmed via negative enrichment of C/EBPβ regulon in tumor and myeloid cells
Suppression of the mesenchymal GBM transformation observed by spatial transcriptomics analysis
Lucicebtide is well tolerated, with no DLTs or related SAEs observed
"The ASCO (Free ASCO Whitepaper) 2026 lucicebtide dataset continues to reinforce our conviction in the strength of this program," said Barry Kappel, Ph.D., Sapience’s Chief Executive Officer. "The maturing results show durable progression free and overall survival improvements, and clearly position lucicebtide as a promising, well‑tolerated therapy with the potential to elevate the standard of care in GBM. We are eager to advance this program to bring meaningful progress to patients and families affected by this devastating disease."

Details of the presentation are as follows:

Title: "Lucicebtide (ST101) Plus Chemoradiation in Newly Diagnosed GBM Patients: Efficacy, Pharmacodynamics, and Safety in Phase 2 Window-of-Opportunity Study"
Session Title: Poster Session – Central Nervous System Tumors
Poster Board: 444
Date and Time: Monday, June 1, 2026, 1:30 PM-4:30 PM CDT

More information can be found on the ASCO (Free ASCO Whitepaper) Annual Meeting 2026 website.

About Lucicebtide (formerly known as ST101)
Lucicebtide is a first-in-class peptide antagonist of CCAAT/enhancer-binding protein β (C/EBPβ), a transcription factor that drives tumor aggressiveness, immune evasion and therapy resistance in GBM. Lucicebtide has been studied in 125 patients and is observed to be safe, well-tolerated and clinically active both as a monotherapy in recurrent GBM (rGBM) and in combination with SOC chemoradiation in ndGBM. Lucicebtide was designed with a cell-penetration domain that enables it to cross the blood-brain barrier and enter the nucleus of cells, and a binding domain that specifically interacts with C/EBPβ, preventing it from dimerizing to an active state and driving it to be degraded by the cell’s own machinery.7 Lucicebtide has been granted Fast Track designation for rGBM from the U.S. Food and Drug Administration (U.S. FDA) and orphan designations for glioma from the U.S. FDA and the European Commission.

About the Lucicebtide Window-of-Opportunity Study
Lucicebtide has completed the main portion of a Phase 2 dose expansion study in rGBM (NCT04478279). An ongoing Window-of-Opportunity sub-study is evaluating lucicebtide in combination with radiation and temozolomide in patients with newly diagnosed GBM (ndGBM) and as a monotherapy in patients with rGBM, with patients receiving lucicebtide before and after surgical resection in both cohorts.

(Press release, Sapience Therapeutics, MAY 21, 2026, View Source [SID1234665964])