Full-Time
Develops bispecific antibodies and ADCs
$90k - $130k/yr
Redmond, WA, USA
In Person
Full-time on-site work is mandatory in Redmond, with a planned move to Bothell in fall 2026.
PhD
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Systimmune is a biopharmaceutical company that develops antibody-based cancer therapies, including bispecific and trispecific antibodies and antibody-drug conjugates (ADCs). These products are designed to act on the solid tumor micro-environment to directly attack tumors and/or to activate the immune system to fight cancer. The company uses multiple immuno-oncology platforms and experienced scientists to create biologics that intervene in the tumor environment in systematic ways. Compared with competitors, Systimmune emphasizes integrating several antibody-based modalities (bispecifics, trispecifics, and ADCs) and a deep focus on the solid tumor micro-environment, aiming to translate biological insight into targeted, immune-engaging therapies. The goal is to produce biologics that effectively modulate the tumor environment and mobilize the body's own immune response to destroy cancer cells.
Company Size
11-50
Company Stage
N/A
Total Funding
N/A
Headquarters
Redmond, Washington
Founded
2014
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Health Insurance
Dental Insurance
Vision Insurance
Disability Insurance
401(k) Retirement Plan
401(k) Company Match
Paid Vacation
Paid Sick Leave
Paid Holidays
SystImmune announced that China's National Medical Products Administration has approved iza-bren for treating adult patients with recurrent or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. This is the second approved indication for iza-bren in China, following its recent approval for nasopharyngeal carcinoma. The approval was based on the PANKU-Esophagus01 study, which enrolled 497 patients across 80 centres in China. The trial met both primary endpoints, showing median overall survival of 9.8 months with iza-bren versus 7.2 months with chemotherapy, and median progression-free survival of 4.2 months versus 2.0 months. Iza-bren is a bispecific antibody-drug conjugate targeting EGFR and HER3. It is currently being evaluated in multiple global clinical studies across several solid tumour types.
SystImmune's parent company, Sichuan Biokin Pharmaceutical, has received China's NMPA approval for iza-bren (BL-B01D1) to treat recurrent or metastatic nasopharyngeal carcinoma in patients who progressed after platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. This marks the first regulatory approval globally for iza-bren and the first bispecific antibody-drug conjugate (ADC) approval of any kind worldwide. The approval follows results from the pivotal Phase III trial, where iza-bren demonstrated a confirmed objective response rate of 54.6% versus 27.0% for chemotherapy. Median progression-free survival was 8.38 months compared to 4.34 months for chemotherapy. Iza-bren is a first-in-class EGFR×HER3 bispecific ADC developed using SystImmune's proprietary platform.
ASCO: Bristol Myers' $800M bispecific ADC aces China breast cancer study, putting TROP2 drugs on notice. June 9, 2026 WOBN news, syndication comments off on ASCO: Bristol Myers' $800M bispecific ADC aces China breast cancer study, putting TROP2 drugs on notice. A first-in-class bispecific antibody-drug conjugate that Bristol Myers Squibb licensed from SystImmune, in a $800M deal has shown strong phase 3 breast cancer results from China. The findings suggest the therapy as a potential competitor in the TROP2 treatment landscape while underscoring growing interest in next-generation ADCs.
News and Publications > SystImmune Reports Phase 1 Data for BL-M14D1 Demonstrating Promising Activity in Small-Cell Lung Cancer at ASCO SystImmune Reports Phase 1 Data for BL-M14D1 Demonstrating Promising Activity in Small-Cell Lung Cancer at ASCO June 1st, 2026 Redmond, Washington June 1, 2026 Redmond, WA - Jun 1, 2026 - SystImmune, Inc., a clinical-stage biotechnology company, today announced the oral presentation of Phase 1 data for BL-M14D1 in patients with small-cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors (BL-M14D1-101, NCT06505824) at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting in Chicago. BL-M14D1 is a DLL3 targeting antibody drug conjugate being developed globally by SystImmune, a subsidiary of Biokin. This study evaluated the safety and efficacy of BL-M14D1 in Chinese patients with advanced SCLC, NEC, and other solid tumors. As of the November 30, 2025 data cut-off, BL-M14D1 demonstrated: - Promising antitumor activity in heavily pre-treated patients across multiple tumor types, including SCLC and other NECs - Manageable safety profile, with hematologic adverse events managed with standard supportive care A total of 127 patients with advanced solid tumors were treated, including 87 with SCLC and 40 with NEC. Most patients were heavily pre-treated. The most common adverse events were hematologic, including neutropenia, which were generally manageable and infrequently led to dose reductions or serious complications. The safety profile is consistent with other brengitecan based topo1 ADCs. One case of grade 3 interstitial lung disease was seen, and one treatment related death was reported. Among patients with SCLC treated at 4.0 mg/kg D1Q3W, the confirmed objective response rate was 62% (21 of 34 patients), with a median progression-free survival of 7.2 months. Based on these results, SystImmune plans to initiate a global registrational study in first-line extensive-stage SCLC. "These initial Phase 1 results for BL-M14D1 demonstrate compelling anti-tumor activity, including a 62% confirmed response rate and encouraging durability, in heavily pre-treated patients with small-cell lung cancer," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "Given the significant unmet need in this population, we believe these data support the potential for BL-M14D1 to become an important new treatment option, and we are rapidly advancing the program into global registrational studies in the first-line setting." About the BL-M14D1-101 Phase I clinical trial BL-M14D1-101 (NCT06505824) is a multi-center, Phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M14D1 in locally advanced or metastatic solid tumors. The study is being conducted in three parts (dose escalation, dose finding, and dose expansion) with patients being dosed on Day 1 of a continuous 21-day treatment cycle (D1Q3W). In the dose escalation and dose expansion phase, patients were treated with BL-M14D1 at 0.66, 2.0, 3.5, 4.0, 4.5, 5.0, and 6.0 mg/kg. In the dose expansion phase, SCLC and NEC patients were treated at 4.0 and 4.5mg/kg D1Q3W. The primary endpoint includes safety. Secondary endpoints include objective response rate (ORR) by RECIST 1.1 criteria, duration of response (DoR), disease control rate (DCR), and PK analysis. About BL-M14D1 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. 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. About SystImmune. SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential clinical benefits of iza-bren, the timing and outcomes of regulatory interactions, and the future development and commercialization of iza-bren. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. SystImmune undertakes no obligation to update any forward-looking statements contained herein, except as required by law. Media Contact SystImmune, Inc.
New clinical data for izalontamab brengitecan and novel ADC Pipeline to be presented at ASCO 2026. PR Newswire Today at 2:00pm PDT REDMOND, Wash., May 21, 2026 /PRNewswire/ - SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced 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) 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. "The data we are presenting at ASCO 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 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 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. About SystImmune SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the potential clinical benefits of iza-bren, the timing and outcomes of regulatory interactions, and the future development and commercialization of iza-bren. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. SystImmune undertakes no obligation to update any forward-looking statements contained herein, except as required by law. SOURCE SystImmune, Inc. This is a paid placement. For further inquiries, please contact PR Newswire directly.