On June 2, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported the differentiated mechanism of action of namodenoson in pancreatic cancer, including inhibition of the RAS signaling pathway, alongside encouraging clinical observations from its ongoing Phase 2a pancreatic cancer study.

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Recent presentations and publications emerging from the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting have reinforced the importance of targeting RAS-driven malignancies, particularly pancreatic ductal adenocarcinoma (PDAC), where KRAS mutations and downstream RAS activation are central drivers of tumor growth and therapeutic resistance. Can-Fite previously reported preclinical findings demonstrating that namodenoson exerts potent anti-tumor activity in pancreatic cancer through a multi-pathway mechanism involving deregulation of the RAS, Wnt/β-catenin, and NF-κB signaling pathways, leading to apoptosis and marked inhibition of tumor growth.

The Company also reported encouraging clinical observations from its Phase 2a study of namodenoson as a monotherapy in pancreatic cancer. Enrollment has been completed and several patients have demonstrated prolonged disease control, including one patient who has remained on therapy and follow-up for approximately 16 months.

"Growing clinical validation of RAS inhibition in pancreatic cancer supports the relevance of the pathway that namodenoson was shown to modulate in our preclinical work," said Pnina Fishman, Chairperson and CSO of Can-Fite BioPharma. "Importantly, namodenoson offers a differentiated approach through simultaneous targeting of RAS, Wnt/β-catenin and NF-κB signaling pathways together with a favorable safety profile observed across clinical programs. The durable observation in our pancreatic study further encourages continued development of namodenoson in this highly aggressive malignancy."

Pancreatic cancer remains among the most lethal malignancies, with limited treatment options and poor long-term survival. Approximately 90% of pancreatic cancers are associated with KRAS pathway activation, highlighting the importance of therapies capable of modulating this signaling network.

About Namodenoson

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

(Press release, Can-Fite BioPharma, JUN 2, 2026, View Source [SID1234666363])

On June 2, 2026 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) reported that SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), reported positive results from prespecified interim analyses of two Phase 3 studies evaluating izalontamab brengitecan (iza-bren), an investigational and potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). The studies demonstrated iza-bren achieved statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) in heavily pretreated, unresectable locally advanced or metastatic triple-negative breast cancer (TNBC; PANKU-Breast02/BL-B01D1-307) and recurrent or metastatic esophageal squamous cell carcinoma (ESCC; PANKU-Esophagus01/BL-B01D1-305). These data, presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, support iza-bren’s potential as a new standard of care in these challenging cancer types.

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Iza-bren has now shown clinical benefit in three Phase 3 trials, underscoring its broad therapeutic potential. PANKU-Breast02 is the first Phase 3 study of a bispecific ADC to report positive results for dual primary endpoints of both PFS and OS in TNBC, while PANKU-Esophagus01 marks the first Phase 3 trial of a bispecific ADC in esophageal cancer to report positive dual primary endpoints of both PFS and OS. Iza-bren previously demonstrated positive phase 3 results in recurrent or metastatic nasopharyngeal carcinoma (NPC), presented at ESMO (Free ESMO Whitepaper) 2025.

"As a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate, iza-bren has now shown significant clinical benefit in three Phase 3 trials in different cancer types, and the strength of these data presented at ASCO (Free ASCO Whitepaper) further reinforce the value iza-bren can deliver over current standards of care," said Dr. Yi Zhu, chief executive officer of Biokin. "We are proud to share these results as we continue to evaluate iza-bren to unlock the full potential of this dual mechanism of action to improve outcomes for patients in need."

"Iza-bren can address a critical gap for patients who develop resistance or experience disease progression after prior therapies and may also hold potential in earlier lines of therapy," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "We have a broad development program for iza-bren and believe it has the potential to be a cornerstone treatment in a number of different cancers and easily combined with other therapies."

Results from the Interim Analysis of PANKU-Breast02 (BL-B01D1-307)

The Phase 3 PANKU-Breast02 trial evaluated iza-bren in patients with unresectable locally advanced or metastatic TNBC whose disease progressed following 1-2 prior lines of systemic therapy for advanced disease, including prior taxane therapy. Patients were randomized 1:1 to receive iza-bren (n=207) or physician’s choice of chemotherapy (TPC; n=211), which included eribulin, capecitabine, gemcitabine, or vinorelbine. The study met both dual primary endpoints at a prespecified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in OS and BICR-assessed PFS with iza-bren compared to TPC.

With a median follow-up of 11 months, median OS was 15.9 months with iza-bren vs. 12.5 months with TPC (HR: 0.60; 95% CI: 0.42-0.85; p=0.0019)
Median PFS by Blinded Independent Central Review (BICR) was 8.5 months with iza-bren vs. 3.1 months with TPC (HR: 0.29; 95% CI: 0.22-0.38; p<0.0001)
The confirmed objective response rate (ORR) assessed by BICR was 51.7% with iza-bren compared to 20.5% with TPC (odds ratio, 4.3; 95% CI: 2.8-6.7)
"While there have been significant advancements in breast cancer treatment, advanced triple-negative breast cancer has remained a challenge, with patients facing poor outcomes," said Dr. Jiong Wu, Fudan University Shanghai Cancer Center. "These results highlight the potential for iza-bren to be a new standard of care as the first bispecific ADC to show improved progression-free and overall survival in a Phase 3 study in this patient population."

Iza-bren showed a manageable safety profile in this heavily pre-treated patient population, with no new safety signals observed. Grade >3 treatment-emergent adverse events (TEAEs) were predominantly hematologic toxicities and consistent with the known safety profile of iza-bren. Any grade interstitial lung disease (ILD) was reported in 3 (1.4%; 1 case of grade 1 and 2 cases of grade 2) patients treated with iza-bren and 0 patients treated with TPC. Treatment discontinuation due to TEAEs occurred in 4 (1.9%) patients treated with iza-bren and 1 (0.5%) patients treated with TPC.

Results from the Interim Analysis of PANKU-Esophagus01 (BL-B01D1-305)

The Phase 3 PANKU-Esophagus01 trial evaluated iza-bren in patients with recurrent or metastatic esophageal squamous cell carcinoma who had progressed after first-line treatment with a PD-1/PD-L1 inhibitor plus platinum-based chemotherapy (n=249) compared to chemotherapy of physician’s choice (n=248). Results from the interim analysis show iza-bren demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of OS and BICR-assessed PFS.

Median OS was 9.8 months with iza-bren vs. 7.2 months with chemotherapy (HR: 0.64; 95% CI: 0.49-0.83; p=0.0004).
Median PFS by BICR was 4.2 months with iza-bren vs. 2.0 months with chemotherapy (HR:0.50; 95% CI: 0.40-0.63; p<0.0001).
Iza-bren also demonstrated an improvement in responses with an ORR by BICR of 35.3% compared to 13.1% with chemotherapy.
"Metastatic esophageal squamous cell carcinoma is an aggressive disease with a five-year survival rate of less than 5%, and there remains a critical unmet need for treatment options after first-line immunotherapy and chemotherapy," said Dr. Lin Shen, Peking University Cancer Hospital and Institute. "As the first Phase 3 clinical trial of a novel EGFRxHER3 bispecific antibody-drug conjugate to report positive data in this patient population, these results show the potential for iza-bren to set a new benchmark in significantly extending survival for patients with recurrent or metastatic esophageal squamous cell carcinoma."

Iza-bren also showed a manageable safety profile in this patient population. Grade >3 treatment-related adverse events (TRAEs), which were predominantly hematologic toxicities, occurred in 85.1% of patients treated with iza-bren and 60.2% of patients who received chemotherapy. TRAEs that led to treatment discontinuation occurred in 2% of patients treated with iza-bren and 3.3% treated with chemotherapy. Treatment-related deaths occurred in 1.2% of patients treated with iza-bren and 1.6% of patients treated with chemotherapy. The rates of all grades and grade >3 ILD were low in the iza-bren arm (1.6%/0.8%) and the chemotherapy arm (0.4%/0.4%).

A New Drug Application for iza-bren for the treatment of recurrent or metastatic esophageal squamous cell carcinoma has been accepted by the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) and included in the priority review process.

The PANKU-Breast02 and PANKU-Esophagus01 studies are sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), in Mainland China. Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement.

About iza-bren

Iza-bren (BL-B01D1) is 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, Bristol-Myers Squibb, JUN 2, 2026, View Source [SID1234666362])

On June 2, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, reported the Society for Advanced Bronchoscopy (SAB) will host a webinar on CyPath Lung’s expanding role in pulmonary, oncology and surgical practices for the detection and management of early-stage lung cancer.

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The live webinar, "Navigating Lower Cancer-Risk Nodules in High-Risk Patients with Noninvasive CyPath Lung Testing," will take place Tuesday, June 16, at 7 p.m. ET. Clinicians, pulmonologists, oncologists, thoracic surgeons, healthcare professionals and the public are invited to register here (https://bit.ly/3PaFPSR) for the complimentary education event.

"We are seeing a significant increase in patients with indeterminate lung nodules as a result of expanded lung cancer screening and imaging for other conditions. When we consider not only prior smoking history but also an aging population, environmental and occupational exposures, and a better understanding of genetic predispositions, we recognize the real clinical challenges of managing this condition, of distinguishing between malignant and benign nodules," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies.

"Advanced navigational bronchoscopy serves as an accurate tool to diagnose lung cancer without major surgery, particularly in nodules greater than a centimeter. For smaller nodules, CyPath Lung complements bronchoscopy by helping to risk stratify and identify patients who should move forward with more invasive follow-up," Dr. Downie said.

Moderated by pulmonologist Robert Sussman, MD, former Medical Director of the Atlantic Health System Pulmonary Clinical Research Center, the webinar will feature:

● Vijay K. Gunuganti, MD – Medical oncologist and hematologist at Texas Oncology
● Reginald Carl Baptiste, MD – Thoracic and cardiovascular surgeon at Christus St. Michael Health System
● Sai Karan Vamsi Guda, DO – Director of Interventional Pulmonary at Texas Pulmonary and Critical Care Consultants, P.A.

The panel will discuss how CyPath Lung, a noninvasive test that uses automated flow cytometry and artificial intelligence to analyze the lung microenvironment, is being incorporated into their practice to help:

● aid in the detection of lung cancer at its earliest and most treatable stages
● support surgical and treatment decision-making
● lower overall healthcare costs by reducing unnecessary invasive procedures
● support surveillance of cancer patients after they complete treatment.

"We are honored to collaborate with the Society for Advanced Bronchoscopy to provide clinicians with an opportunity to discuss innovative tools like CyPath Lung that support earlier intervention leading to better patient outcomes," said Maria Zannes, President and CEO of bioAffinity Technologies.

About the Society for Advanced Bronchoscopy

The Society for Advanced Bronchoscopy (SAB) is a national organization dedicated to advancing the field of bronchoscopy through innovation, collaboration and education. Founded to improve patient outcomes, SAB fosters excellence in interpretive skills, technical knowledge, research, and training for advanced bronchoscopic techniques. The society unites a multidisciplinary community – including physicians, advanced practice providers, respiratory therapists, and technologists – to push the boundaries of minimally invasive lung diagnostics and interventions, ultimately transforming the standard of care and enhancing the diagnosis and treatment of respiratory diseases worldwide.

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 2, 2026, View Source [SID1234666361])

On June 1, 2026 Laverock Therapeutics (‘Laverock’), a biotechnology company developing disease-responsive advanced therapies through its unique, programmable gene control technology, reported it has been awarded two new grants totalling in excess of £2.2M to support the next generation of its gene-control platform development, and expansion into additional non-oncology therapeutics areas.

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The new grants provide further validation for Laverock’s differentiated technology and therapeutics pipeline. This expands on previous awards where the Company raised £1.8M in non-dilutive funding from UK Research and Innovation as part of Investor Partnership, Biomedical Catalyst and SMART business awards.

To date, Laverock’s gene-control platform has been demonstrated across a wide range of therapeutic applications and cell types, including developing programmed T-cells and macrophages for solid tumour indications, as well as hypoimmunogenic pancreatic islet cells for Type-1 diabetes.

The first grant-funded project will focus on scaling the Company’s platform within a T-cell product context, utilising solid tumour-based patient datasets, and foundational data around both intracellular signalling and antigen expression. Leveraging single cell and AI-powered approaches Laverock will be able to rapidly identify the preferred combination of product features to unlock efficacy and safety in solid tumour cancer indications, tailored to tumour type, and using patient derived models for rapid prototyping and evaluation.

The second grant will enable the expansion of Laverock’s macrophage-based programmes into non-oncology indications, building upon the platform’s ability to program myeloid cell phenotypes and precisely control the expression of therapeutically relevant payloads. This work will be part of a consortium effort pulling in leading experts in the disease indication of interest and across the product development workflow to enable rapid translation to the clinic.

David Venables, Laverock Therapeutics CEO, said: "Success in these two highly competitive grant competitions provides further validation of our approach and will enable us to expand our efforts across platform and product development. As we push towards the clinic for our lead programme this additional funding will help unlock the true breadth of what our technology can achieve. We can’t wait to get started!"

(Press release, Laverock Therapeutics, JUN 1, 2026, View Source [SID1234668715])

On June 1, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, reported it will host a conference call and live webcast to review results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial on Tuesday, June 2, 2026 at 8:00 a.m. EDT / 7:00 a.m. CDT.

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Webcast and Conference Call Information

The Celcuity management team will host a live webcast and conference call on Tuesday, June 2, 2026, at 8:00 a.m. EDT / 7:00 a.m. CDT to discuss the results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. A replay of the webcast will be available on the Celcuity website.

(Press release, Celcuity, JUN 1, 2026, https://www.globenewswire.com/news-release/2026/06/01/3304375/0/en/celcuity-to-hold-conference-call-to-discuss-results-for-the-pik3ca-mutant-cohort-of-the-phase-3-viktoria-1-clinical-trial-of-gedatolisib-regimens-in-hr-her-advanced-breast-cancer-o.html [SID1234666358])