On September 24, 2025 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported the presentation of data on iza-bren (izalontamab brengitecan) and BL-M07D1, two distinct clinical programs from its antibody drug conjugate (ADC) pipeline, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21 in Berlin, Germany (Press release, SystImmune, SEP 24, 2025, View Source [SID1234656207]). 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 breadth of data we are presenting at ESMO (Free ESMO Whitepaper) this year reflects not only the strength of our ADC platform but also the speed and depth with which we are advancing our clinical pipeline across tumor types," said Dr. Jie D’Elia, Ph.D., Chief Executive Officer of SystImmune. "From our late-stage pivotal trials to our earlier proof-of-concept studies, these achievements demonstrate SystImmune’s ability to translate our differentiated ADC platform into potential medicines that have the power to change treatment paradigms for cancer patients worldwide."

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

Highlighting the continued clinical advancement of iza-bren:

Late-breaking data from the first randomized, open-label, multicenter, Phase III study evaluating iza-bren versus physician’s choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma in China
Results from the first Phase 1 study of iza-bren in a global patient population (BL-B01D1-LUNG-101) with metastatic or unresectable non-small cell lung cancer (NSCLC) and other solid tumors
Safety and efficacy results of iza-bren as a monotherapy in patients with advanced stages of ovarian cancer in China
Safety and efficacy results of iza-bren in combination with serplulimab, an anti-PD-1 monoclonal antibody, in patients with extensive-stage small cell lung cancer in China
Demonstrating strength of ADC platform with a second novel ADC program BL-M07D1

Safety and efficacy data of BL-M07D1 in patients with metastatic breast cancer and HER2-positive advance gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) will be presented.
"We are excited to present the first randomized data of iza-bren compared to systemic chemotherapy in advanced nasopharyngeal carcinoma demonstrating the clinical benefit of iza-bren for these patients. In addition, the breadth of data being presented at ESMO (Free ESMO Whitepaper) underscores the potential versatility of iza-bren across multiple tumor types," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are strongly encouraged by the single-agent activity seen in ovarian cancer and EGFR-mutated NSCLC, as well as the potential for rational combinations observed in small cell lung cancer. These results reinforce our commitment to advancing iza-bren as a therapy that could meaningfully expand treatment options for patients with difficult-to-treat cancers."

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

Iza-Bren (BL-B01D1), an EGFR×HER3 Bispecific Antibody-drug Conjugate, versus Physician’s Choice of Chemotherapy in Heavily Pretreated Recurrent/Metastatic Nasopharyngeal Carcinoma: A Randomized, Open-Label, Multicenter, Phase III, Pivotal study
Trial Reference: BL-B01D1-303 (NCT06118333), China
Session Title: Proffered paper session: Development therapeutics
Presentation Number: LBA35
Speaker: Huaqiang Zhou (Guangzhou, China)
Session Date & Time: Sunday, October 19th, 2025, 2:45 PM-4:15 PM CEST

Phase 1 Global Study of Iza-Bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
Trial Reference: BL-B01D1-LUNG-101 (NCT05983432), Global
Session Title: Mini oral session: Developmental therapeutics
Presentation Number: 921MO
Speaker: Helena A. Yu (New York, USA)
Session Date & Time: Friday, October 17th, 2025, 4:00 PM-5:30 PM CEST

Phase II Study of iza-bren (BL-B01D1) in Combination with Serplulimab in Patients with Small Cell Lung Cancer (SCLC)
Trial Reference: BL-B01D1-204-01 (NCT06437509), China
Session Title: Developmental therapeutics
Presentation Number: 934P
Speaker: Fei Zhou (Shanghai, China)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

Phase Ib/II Study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Recurrent Metastatic Ovarian Cancer (OC)
Trial Reference: BL-B01D1-202 (NCT05803018, NCT05990803), China
Session Title: Developmental therapeutics
Presentation Number: 933P
Speaker: Wu Yong (Shanghai, China)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

A phase 1/2a, open-label, dose-finding study of the safety, pharmacokinetics, and preliminary efficacy of iza-bren (BL-B01D1) combinations in patients with advanced solid tumors
Trial Reference: CA244-0001 (NCT06618287), Global
Session Title: NSCLC, metastatic
Presentation Number: 2080eTIP
Speaker: Marie Florescu (Montreal, Canada)

BL-M07D1, a novel HER2 antibody-drug conjugate, in subjects with locally advanced or metastatic breast cancer and other solid tumors: Results from a phase 1 study
Trial Reference: BL-M07D1-101 (NCT05461768), China
Session Title: Developmental therapeutics
Presentation Number: 935P
Speaker: Hong Zong (Zhengzhou, China, Henan)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

Primary efficacy and safety of BL-M07D1 in patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ)
Trial Reference: BL-M07D1-101, 102, 202 (NCT05461768, NCT05631964, NCT06031584), China
Session Title: Developmental therapeutics
Presentation Number: 937P
Speaker: Shuqin Ni (Jinan, China)
Onsite Poster Display Date: Sunday, October 19th, 2025, 12:00 PM-12:45 PM CEST

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 BL-M07D1
SystImmune is developing BL-M07D1, an ADC comprising a monoclonal antibody component binding HER2 and a linker-payload component composed of a topoisomerase I inhibitor payload and a stable enzyme-cleavable linker. HER2 is highly expressed in multiple solid tumors. BL-M07D1 works by triggering antibody-dependent cellular cytotoxicity (ADCC) when it binds to HER2 on cancer cells. In addition, the binding to HER2 causes its internalization followed by the release of the payload, which then kills the tumor cell.