Celcuity’s Gedatolisib Combination Regimens Doubled the Likelihood of Survival without Disease Progression or Death Compared to Alpelisib plus Fulvestrant in the PIK3CA Mutant Cohort of the Pivotal Phase 3 VIKTORIA-1 Trial in Patients with HR+/HER2- Advanced Breast Cancer

On June 2, 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 detailed efficacy and safety results from the PIK3CA mutant ("MT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), PIK3CA mutated, locally advanced or metastatic breast cancer ("ABC"), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. VIKTORIA-1 is the first Phase 3 clinical trial to compare the efficacy of two PI3K/AKT/mTOR ("PAM") inhibitors in this patient population.

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The study results will be presented in a late-breaking abstract ("LBA") oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting today, Tuesday, June 2, 2026, 12:09 p.m. CDT.

The PAM pathway is a key oncogenic driver of HR+/HER2- breast cancer that requires inhibition of multiple molecular components to comprehensively blockade excessive PAM signaling in tumors with or without a PAM variant. Gedatolisib is the first multitarget PAM inhibitor to demonstrate superior efficacy relative to a single-target inhibitor of this pathway. In the PIK3CA MT cohort of the Phase 3 VIKTORIA-1 trial, the gedatolisib-triplet demonstrated a statistically significant and clinically meaningful improvement in median PFS among patients, increasing the likelihood of survival without disease progression or death by two times compared to alpelisib plus fulvestrant (based on a hazard ratio [HR] of 0.50; 95% CI: 0.37-0.68; p<0.0001). The median PFS, as assessed by blinded independent central review ("BICR"), was nearly two-times longer, 11.1 months versus 5.6 months, compared to alpelisib plus fulvestrant. The ORR of the gedatolisib-triplet was 48.9% compared to 26.0% with alpelisib plus fulvestrant and the median DOR for the gedatolisib triplet was 15.7 months compared to 7.5 months for alpelisib plus fulvestrant.

For the gedatolisib-doublet, the median PFS was more than two-times longer, 11.3 months versus 5.6 months, compared to alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33-0.79; descriptive p=0.0013). The ORR of the gedatolisib-doublet was 35.7% and the median DOR was 24.2 months.

The topline gedatolisib-triplet efficacy data from the VIKTORIA-1 PIK3CA MT cohort established several new milestones in the history of drug development for HR+/HER2- ABC:

● First Phase 3 trial to demonstrate superiority of one PAM inhibitor versus another.

● The median PFS of 11.1 months for the gedatolisib-triplet is the highest reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving a regimen including endocrine therapy as second-line treatment.

● The objective response rate of 48.9% for the gedatolisib-triplet is the highest reported by any Phase 3 clinical trial for a regimen including endocrine therapy in second-line HR+/HER2- ABC.

"Therapies that target only PI3Kα or AKT typically offer modest benefit for patients with PIK3CA mutant HR+/HER2- advanced breast cancer whose disease has progressed while on or after treatment with a CDK4/6 inhibitor," said Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women’s Health and Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial. "By comprehensively blocking the PI3K/AKT/mTOR, or PAM, pathway, gedatolisib combined with fulvestrant, with or without palbociclib, showed it can offer these patients two times the likelihood of survival without disease progression or death relative to a single-target inhibitor of the PAM pathway. With these results, the gedatolisib regimens, if approved, represent a new potential standard of care for patients with HR+, HER2-negative, PIK3CA mutant advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor."

The gedatolisib-triplet and -doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common Grade 3+ TRAEs for the gedatolisib-triplet, the gedatolisib-doublet, and alpelisib plus fulvestrant groups included neutropenia (58.8%, 0%, and 0.7% of patients, respectively); stomatitis (16.3%, 5.8%, and 5.3% of patients, respectively); rash (6.5%, 5.8%, and 15.1% of patients, respectively); and hyperglycemia (2.6%, 0%, and 14.5% of patients, respectively). TRAEs led to the discontinuation of study treatment in 2.6% of patients in the gedatolisib-triplet group, 3.8% in the gedatolisib-doublet group, and 7.1% in the alpelisib plus fulvestrant group. 1One Grade 5 TRAE in the gedatolisib-triplet group, which was related to palbociclib, was reported, no Grade 5 TRAE’s were reported in the gedatolisib-doublet group, and two Grade 5 TRAE’s were reported in the alpelisib plus fulvestrant group.

"Both gedatolisib regimens were well-tolerated with few VIKTORIA-1 patients discontinuing treatment due to an adverse event," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "These safety results compare very favorably to those from the patient group treated with alpelisib and fulvestrant, which we believe reflects the benefit of gedatolisib’s multi-target mechanism of action, pharmacokinetic profile, and intravenous administration."

Overall survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, showed promising trends for both the gedatolisib-triplet and -doublet.

Celcuity intends to submit these data to the U.S. Food and Drug Administration ("FDA") as a supplemental New Drug Application ("sNDA") and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission.

"It is rare in oncology for a targeted therapy to offer both improved efficacy and better safety results relative to another drug in its class," said Brian Sullivan, CEO and co-founder of Celcuity. "This second positive Phase 3 data readout further underscores the broad potential of multi-target PAM inhibition and increases our excitement about our two Phase 3 trials in the first-line setting for HR+/HER2- advanced breast cancer. We are on track to launch gedatolisib commercially, in anticipation of its potential FDA approval in the third quarter of 2026, and we look forward to the possibility of bringing this important therapy to physicians treating patients with advanced breast cancer."

The FDA has granted Priority Review of Celcuity’s New Drug Application ("NDA") for gedatolisib in patients with HR+/HER2-/PIK3CA wild-type ("WT") ABC and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and the PAM pathway , are primary oncogenic drivers of HR+/HER2- ABC.3 Therapies inhibiting these pathways are approved and used in various combinations for ABC. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

About the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The trial enrolled 701 subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Detailed results from the PIK3CA WT cohort of VIKTORIA-1 have been previously reported. For the PIK3CA MT cohort, 350 subjects who met eligibility criteria and had confirmed PIK3CA mutations were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib-triplet, alpelisib and fulvestrant, or the gedatolisib-doublet.

About Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.

(Press release, Celcuity, JUN 2, 2026, View Source [SID1234666364])

Can-Fite Reports Positive Clinical Observation in Phase 2a Pancreatic Cancer Study and Highlights Namodenoson’s RAS Signaling Inhibition Mechanism

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])

Izalontamab Brengitecan (Iza-Bren) Demonstrates Statistically Significant and Clinically Meaningful Improvements in Overall Survival and Progression-Free Survival in Patients with Triple-Negative Breast Cancer and Esophageal Squamous Cell Carcinoma

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])

Multidisciplinary Physician Panel to Share Real-World Benefits of bioAffinity Technologies’ Noninvasive CyPath Lung Cancer Test in Upcoming Society for Advanced Bronchoscopy Webinar

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])

Laverock Therapeutics awarded in excess of £2.2M through two innovation grants to support AI-powered platform development and to expand therapeutic programmes outside of oncology

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])