On June 22, 2026 SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, reported that its parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), has received regulatory approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for iza-bren (BL-B01D1) for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. This approval marks the first regulatory approval for iza-bren and represents a significant milestone in the development of SystImmune’s proprietary bispecific antibody-drug conjugate platform.

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The approval is based on results from the pivotal Phase III BL-B01D1-303 study (NCT06118333). In this study, Iza-bren demonstrated a BICR-assessed confirmed ORR of 54.6% vs. 27.0% for chemotherapy (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 for iza-bren compared to 4.34 months for chemotherapy (hazard ratio of 0.44; 95% confidence interval 0.32-0.62). At the time of this analysis, the overall survival (OS) data were immature.

"This approval represents a significant milestone for patients with recurrent or metastatic nasopharyngeal carcinoma and for the development of iza-bren," said Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. "Patients who have progressed following platinum-based chemotherapy and immunotherapy face a poor prognosis with limited treatment options. The approval of iza-bren provides a new therapeutic option that has demonstrated clinically meaningful improvements in tumor response and progression-free survival compared to chemotherapy."

"Today marks a historic milestone for Biokin and SystImmune as we celebrate the first regulatory approval of iza-bren anywhere in the world," said Dr. Yi Zhu, Chairman and Chief Executive Officer of Biokin. "In fact, this is the first bispecific ADC approval of any kind globally. This approval validates our innovative EGFR×HER3 bispecific ADC design and the potential of our proprietary brengitecan-based ADC platform. Most importantly, it brings an important new treatment option to patients with recurrent or metastatic nasopharyngeal carcinoma who urgently need better therapies. We thank the patients, investigators, and healthcare professionals who made this achievement possible and look forward to advancing iza-bren for patients worldwide across multiple tumor types."

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 cancer that arises from the nasopharynx, the upper part of the throat located behind the nose. Although uncommon globally, NPC is endemic in southern China, Southeast Asia, and certain regions of North Africa. Epstein-Barr virus (EBV) infection is strongly associated with the development of NPC. Patients with recurrent or metastatic disease who have progressed after standard therapies continue to face poor outcomes, with 5-year overall survival rate generally less than 10%, representing a significant unmet medical need.

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, JUN 22, 2026, View Source [SID1234668869])

On June 22, 2026 Boehringer Ingelheim reported it is advancing biomarker-informed approaches and extending precision care across multiple cancers and stages of disease, reinforcing its ambition to bring unprecedented impact and improve long-term outcomes where unmet need remains high. The company has initiated two Phase III clinical trials within the DAREON program: DAREON-Lung-1 in small cell lung cancer (SCLC) and DAREON-NEC-1 in extrapulmonary neuroendocrine carcinoma (epNEC). In parallel, the Phase III Beamion LUNG-3 trial has been initiated in HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC).

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"People living with aggressive cancers often face a shortage of treatment choices," said Lykke Hinsch Gylvin, MD, Chief Medical Officer, Boehringer Ingelheim. "With the launch of these trials, we are advancing our precision oncology ambitions to move targeted therapies into earlier treatment lines and bring biomarker-informed science into late-stage development. By focusing on the biology of each tumor, we aim to give patients facing cancer more precise treatment options with the goal of improving outcomes where the need is greatest."

Biomarker-informed approaches: DLL3
The two DAREON Phase III trials mark a pivotal step for obrixtamig, Boehringer’s investigational DLL3/CD3 T-cell engager, and for the company’s broader biomarker strategy in aggressive neuroendocrine carcinomas (NECs) such as SCLC and epNEC. People with SCLC, the most aggressive type of lung cancer, often face short-lived therapeutic benefit and poor survival with existing approaches.5,7 EpNEC is a historically under-researched cancer for which survival outcomes have not improved in decades. For those living with these cancers, treatment options are limited and significant unmet needs persist.1,8

Delta-like canonical Notch ligand 3 is expressed on tumor cells in SCLC and epNEC while largely absent from non-cancerous cells. This makes it a potential predictive biomarker that could help to redefine treatment strategies for these aggressive cancers.9,10 DAREON-Lung-1 and DAREON-NEC-1 are designed to test whether the addition of obrixtamig, a DLL3 targeted T-cell engager, can improve outcomes in biomarker-informed patient populations versus the current standard of care.1,2 Together, the studies aim to position obrixtamig as part of a broader shift toward more personalized and potentially more transformative treatment approaches in these aggressive NECs.

Precision oncology in earlier stages: HER2
In addition, the company is investigating zongertinib in earlier stages of disease with the initiation of Beamion LUNG-3. This global, randomized Phase III trial will study the efficacy and safety of zongertinib as adjuvant monotherapy compared with physician’s choice standard of care in patients with stage II-IIIB HER2 (ERBB2)-mutant NSCLC who have undergone complete surgical resection and have received either neoadjuvant or adjuvant therapy.3 The study is designed to evaluate whether zongertinib can improve disease-free survival compared to standard of care following surgery, addressing the significant risk of recurrence after curative-intent treatment.11 Beamion LUNG-3 reflects the company’s focus on advancing targeted therapies earlier in the treatment pathway, where effective targeted adjuvant treatment options are not available.12 This trial extends the investigation of zongertinib to early stage disease.3

Expanding the oncology portfolio
Boehringer Ingelheim continues to expand its portfolio of precision oncology approaches that combine targeted therapies for biomarker-defined populations with innovative strategies to both activate and direct the immune system. This includes next-generation immunotherapies such as T-cell engagers, alongside complementary modalities that aim to enhance anti-tumor responses and address tumor-intrinsic drivers of disease. By integrating these approaches, the company aims to expand treatment options for people facing cancers with high unmet medical need.

About obrixtamig
Obrixtamig is an investigational novel Immunoglobin G (IgG)-like bispecific T-cell engager designed to bind concomitantly to DLL3 on tumor cells and CD3 on T-cells, potentially resulting in destruction of tumor cells by the body’s own immune system. Obrixtamig is being evaluated in multiple, ongoing clinical trials, including a Phase I trial in combination with atezolizumab and chemotherapy in extensive-stage small-cell lung cancer (ES-SCLC) patients (DAREON-8), a Phase Ib study to investigate obrixtamig in combination with the current SoC (carboplatin + etoposide) as 1L treatment for patients with DLL3-positive NEC, including epNEC (DAREON-7), and a Phase II trial in patients with relapsed/refractory DLL3-high extrapulmonary neuroendocrine carcinomas (epNEC) (DAREON-5).12,13,14 The Phase III clinical development program includes DAREON-LUNG-1, which evaluates obrixtamig in combination with atezolizumab plus chemotherapy vs. atezolizumab plus chemotherapy for first-line use in patients with ES-SCLC.1 In addition, DAREON-NEC-1 is evaluating obrixtamig in combination with current SoC (carboplatin and etoposide) vs. SoC alone as first-line therapy in patients with DLL3-positive unresectable locally advanced or metastatic epNEC.2

In order to tackle hard-to-treat cancers, Boehringer is drawing on innovation enabled through collaboration. The company is developing obrixtamig through a long-term partnership with Oxford BioTherapeutics (OBT), using OBT’s OGAP platform to identify novel target opportunities for new immunotherapies harnessing its investigational T-cell engager, investigational cancer vaccine and exploratory oncolytic virus platforms.

About zongertinib
Zongertinib is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby minimizing associated toxicities.16,17 Zongertinib is approved in the U.S., China, Hong Kong and Japan as the first once-daily orally administered targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer. Zongertinib is not approved in other markets.

The treatment is being evaluated in ongoing trials across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574).18 Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

(Press release, Boehringer Ingelheim, JUN 22, 2026, View Source [SID1234668862])

On June 22, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported results from the final analysis of the dual primary endpoint of overall survival (OS) in the subset of patients without active liver metastases (non-liver metastases, NLM) in the phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with atezolizumab (Tecentriq) versus regorafenib in previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (mCRC). The results showed a non-statistically significant trend in OS favoring the combination in the NLM subpopulation (stratified hazard ratio: 0.83; 95% confidence interval: 0.66–1.05; P=0.1185), with median OS values of 15.9 months with zanzalintinib in combination with atezolizumab, and 12.7 months with regorafenib.

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The safety profile of zanzalintinib in combination with atezolizumab in the NLM subgroup was consistent with that previously reported in the intention-to-treat (ITT) population, and no new safety signals were identified.

Exelixis previously announced that STELLAR-303 met its other dual primary endpoint, demonstrating a statistically significant improvement in OS in the ITT population, which included all randomized patients regardless of the presence of active liver metastases. Detailed results demonstrating the statistically significant improvement in OS in the ITT population were presented at the 2025 European Society for Medical Oncology Congress and published in The Lancet.

In February 2026, Exelixis announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab, for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The FDA assigned a Prescription Drug User Fee Act target action date of December 3, 2026.

Detailed findings from the NLM subgroup analysis will be submitted for presentation at an upcoming medical conference.

About STELLAR-303
STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high mCRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes, including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. The zanzalintinib development program includes a series of ongoing and planned pivotal trials to explore its therapeutic potential in CRC, clear cell and non-clear cell renal cell carcinoma, and neuroendocrine tumors, as well as earlier-stage trials in meningioma, lung cancer and castration-resistant prostate cancer.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC
CRC is the third most common cancer and a leading cause of cancer-related deaths in the U.S.1 Approximately 159,000 new cases will be diagnosed in the U.S. in 2026, with around 55,000 expected deaths from the disease.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is around just 15%.1,2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.

(Press release, Exelixis, JUN 22, 2026, View Source [SID1234668861])

On June 22, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported data from Cohort C of the ongoing ALLOHA Phase 1 study, evaluating TSC-101 generated with the commercial-ready manufacturing process, in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (allo-HCT).

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"These data provide important support for our commercial-ready manufacturing process and reinforce our confidence in the consistency and quality of the product candidate being delivered to patients," said Gavin MacBeath, Ph.D., Chief Executive Officer. "We are very encouraged by the 11 of 14 patients who showed complete donor chimerism approximately three weeks after their first infusion as well as the complete chimerism seen in all 5 patients who were assessed after their second infusion of TSC-101. Furthermore, even in a higher-risk patient population when compared to patients in Cohort A and our control arm, 93% of patients responded to TSC-101 with decreasing recipient chimerism. Taken together, these findings support our planned transition into the pivotal Phase 3 study of TSC-101 this month. We look forward to advancing further development of TSC-101 with the goal of preventing relapse following allo-HCT and improving outcomes for these patients."

"The initial results from Cohort C continue to exhibit strong clinical efficacy while maintaining a positive safety profile in patients receiving TSC-101 after their standard of care allo-HCT," said Chrystal U. Louis, M.D., Chief Medical Officer. "This cohort enrolled ahead of schedule and highlights the strong investigator engagement and growing interest in the TSC-101 clinical development program. As relapse remains a leading cause of death following allo-HCT, we are encouraged by the potential of TSC-101 to address residual disease and thereby improve long-term outcomes for patients with heme disorders."

Key Data Highlights

•
19 patients were enrolled in Cohort C:

•
~90% manufacturing success rate (17/19) with commercial-ready process

•
14/19 patients went to transplant and received their first infusion of TSC-101

•
10/14 patients have received their planned second infusion, and 1/14 patients received a third infusion

•
3/19 patients did not proceed to transplant due to clinical reasons

•
Chimerism data as observed by high sensitivity NGS assay (Alloheme) with assay cut-off of 0.2%:

•
11 of 14 patients achieved complete donor chimerism within ~3 weeks of receiving their first infusion of TSC-101 and 2 of the remaining 3 patients are approaching complete donor chimerism

•
One patient with TP53 mutated AML remained in complete donor chimerism 6 months post-HCT

•
TSC-101 infusions were generally well-tolerated, safety was consistent with Cohort A, and observed adverse events were consistent with post-HCT adverse events.

Virtual Key Opinion Leader (KOL) Event

The Company will host a virtual KOL event featuring Ran Reshef, M.D., M.Sc., today, June 22, 2026, at 8:30 a.m. ET to discuss initial data from Cohort C of the ALLOHA Phase 1 study using its commercial-ready manufacturing process, as well as plans and expectations for initiating a pivotal Phase 3 study for TSC-101. The Company will also discuss follow-on product candidates and the market opportunity for the heme program. A replay of the webcast will be available following the call.

(Press release, TScan Therapeutics, JUN 22, 2026, View Source [SID1234668858])

On June 22, 2026 PharmaMar (MSE: PHM) reported the enrollment of the first patient in its Phase 1/2 clinical trial evaluating PM54 in combination with pembrolizumab for the treatment of patients with advanced-stage solid tumors. The study, for which the IND application was cleared by the FDA in December 2025, is designed to assess the safety, tolerability, and preliminary efficacy of this combination therapy in patients with previously treated advanced malignancies.

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The primary objectives of the study include the evaluation of the safety and tolerability of PM54 in combination with pembrolizumab and to establish the recommended dose, as well as the assessment of the antitumor activity, in terms of clinical benefit rate (CBR) and objective response rate (ORR) based on investigator evaluation. The study includes patients with tumors characterized by significant unmet medical needs, including advanced-stage melanoma, endometrial cancer, extrapulmonary neuroendocrine tumors and mesothelioma.

For more information on the study, please visit clinicaltrials.gov

PM54 in combination with pembrolizumab is intended to enhance antitumor immune responses and provide a potential new treatment option for patients with advanced-stage solid tumors.

(Press release, PharmaMar, JUN 22, 2026, View Source [SID1234668856])