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 One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, reported financial support via a Paris-Saclay Cancer Cluster (PSCC) BOOST grant to develop the first single-cell assay for antibody-drug conjugates (ADC) therapies in oncology.

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The rapid growth of ADCs is driving demand for more sophisticated biomarker strategies. By capturing tumor complexity at cellular resolution, single-cell profiling has the potential to enhance patient selection and support the development of next-generation ADCs. Ultimately, it will help match the right patients to the right therapies, maximizing therapeutic benefit.

The PSCC BOOST-funded project seeks to bring a new level of precision to ADC development. It will be conducted in collaboration with Adcytherix, a clinical-stage biotech company developing differentiated ADCs for cancers with high unmet medical need.

The collaboration will combine Adcytherix’s expertise in ADC development with One Biosciences’ AI-powered single-cell profiling technology to analyze tumor samples and explore cellular and molecular signatures associated with treatment response. The long-term objective is to support more precise patient selection and lay the foundation for future companion diagnostic development.

"This grant is an important milestone for One Biosciences and for the broader adoption of single-cell technologies in oncology drug development," said Hedi Ben Brahim, CEO of One Biosciences. "This project enables us to deploy our single-cell platform in the context of an innovative ADC development program with the aim of better understanding treatment response and thereby supporting the development of more precise therapeutic strategies."

Supported by a PSCC BOOST grant, this project aims to position France at the forefront of precision oncology innovation while accelerating the emergence of clinical-grade single-cell companion diagnostics for cancer drug development.

One Biosciences is already accelerated by PSCC and works with many partners within the cluster. This project will further reinforce the company’s ties with the oncology community.

(Press release, One Biosciences, JUN 22, 2026, View Source [SID1234668898])

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 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics and targeted therapeutics, reported it will present preclinical findings for a novel therapeutic approach that uses small interfering RNAs (siRNAs) that kill squamous and basal skin cancer cells in vitro while leaving non-cancerous skin cells unharmed.

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The newly released findings support the Company’s efforts to develop topical treatments for squamous cell and basal cell carcinoma, two of the most common forms of skin cancer. An estimated 5.4 million cases of these skin cancers are diagnosed every year in the U.S., according to the American Cancer Society. Although surgery is the standard treatment, many patients require additional intervention because of incomplete resection, in which all of the cancerous tissue is not removed, or the risk of recurrence. To date, there is no commercial topical siRNA therapy specifically indicated for basal cell or squamous cell carcinoma.

David J. Elzi, PhD, bioAffinity Technologies Vice President of Product Development, will present the Company’s research at the 2026 RNA Therapeutics (RNATx) Symposium. RNATx brings together researchers, biotech/pharma, clinicians and industry focused on RNA therapeutics, oligonucleotides, mRNA, siRNA, gene editing and translational medicine.

"Basal cell and cutaneous squamous cell carcinomas are among the most common cancers we treat," said surgical oncologist Rosa Cuenca, MD, who is not affiliated with bioAffinity Technologies. "Unfortunately, surgical removal is not always the end of the story. A topical therapeutic that selectively targets malignant cells while preserving healthy skin could potentially expand our treatment options, particularly for patients with recurrent lesions or cosmetically sensitive tumors."

The research builds on earlier findings showing that siRNA silencing of two specific cell surface receptors, CD320 and LRP2, impaired cell viability across multiple cancer cell lines in vitro – including lung, breast, prostate, brain, and skin cancer – while sparing healthy primary cells. That discovery is the subject of U.S. Patent No. 12,305,171, "Compositions and Methods for Treating Cancer," issued in 2025.

"Our in vitro findings indicate that silencing specific cell surface receptors was selectively cytotoxic to or impaired the proliferation of squamous skin cancer cells while leaving normal skin cells unaffected," Dr. Elzi said. "The selectivity observed in these preclinical studies suggests the potential for further development of noninvasive, targeted topical approaches for common cutaneous cancers, subject to further research and regulatory review."

"Our preclinical results represent an encouraging step toward developing less-invasive treatments for some of the most common cancers affecting patients today," said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. "This research reinforces our innovative approach to cancer treatments and expands our mission to improve cancer outcomes by developing technologies designed to detect and treat cancer earlier and more precisely."

In the in vitro study, researchers synthesized siRNAs targeting specific cell receptors and transfected them into squamous and basal skin cancer cell lines and non-cancerous skin cells. Non-cancerous skin cells were unaffected by silencing the receptors, while squamous and basal skin cancer cell proliferation was significantly impaired. Microscopic analysis corroborated these findings, demonstrating cancer cell cytotoxicity following treatment without observable harm to healthy cells. These results were obtained in controlled laboratory conditions and may not be predictive of results in human clinical trials. The Company’s preclinical findings have not been tested in humans, and no Investigational New Drug (IND) application has been filed with the U.S. Food and Drug Administration (FDA).

About the Research

The poster, "siRNAs targeting CD320 and LRP2 are selectively cytotoxic to squamous skin cancer cells while leaving normal skin cells unharmed," will be presented at RNATx 2026 June 24-26 hosted by the RNA Therapeutics Institute at UMass Chan Medical School in Worcester, MA.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, JUN 22, 2026, View Source [SID1234668899])

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])