On November 8, 2026 Johnson & Johnson (NYSE: JNJ) reported promising first-in-human Phase 1 results for the investigational combination of pasritamig and JNJ-9401, two bispecific antibodies designed to work together to drive the body’s immune response against advanced prostate cancer. At the recommended regimen, 73 percent (11 of 15 patients) achieved reductions of at least 50 percent in prostate-specific antigen (PSA), a marker used to monitor prostate cancer activity, including 47 percent (7 of 15 patients) who achieved reductions of at least 90 percent. Results were presented in a late-breaking oral session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting (Abstract #1175).1

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The combination represents the first dual-tumor-antigen-targeted bispecific antibody regimen clinically evaluated in prostate cancer, targeting kallikrein-related peptidase 2 (KLK2) and prostate-specific membrane antigen (PSMA) through complementary T-cell signals designed to activate and enhance the function of immune cells against cancer. In the study, deep and sustained PSA responses were observed, with all seven patients who achieved reductions of at least 90 percent remaining on treatment for more than six months without disease progression. No Grade 3 or higher treatment-related adverse events were reported in this early analysis.1

A first-of-its-kind approach: targeting two prostate cancer proteins with complementary T-cell signals

For patients with metastatic castration-resistant prostate cancer (mCRPC), treatment remains challenging as the disease progresses and available options become more limited.2 Median overall survival is approximately two to three years, highlighting the need for continued innovation.3,4 While immunotherapies have transformed the treatment of some cancers, their role in prostate cancer has historically been limited, and immune checkpoint inhibitors have shown minimal clinical benefit.5

Bispecific antibodies are designed to help the immune system recognize and attack cancer by activating T cells, a process that can be enhanced by generating two complementary signals.6,7 Pasritamig, a first-in-class, bispecific antibody targeting KLK2 has demonstrated single-agent antitumor activity,8 and is designed to provide the first signal by directing T cells toward prostate cancer cells. JNJ-9401, a novel bispecific antibody targeting PSMA, provides a second signal designed to strengthen and sustain T cell activity.

Expert and company perspectives on the potential of this dual-antigen targeted bispecific regimen

"Prostate cancer has long been difficult to treat with immunotherapy, which makes the activity we’re seeing particularly interesting," said Laura Graham, M.D.,* Assistant Professor of Medicine-Medical Oncology at the University of Colorado School of Medicine. "By combining two complementary approaches to T-cell activation, we are exploring a new way to engage the immune system against this disease. The depth of PSA reductions observed in this study, including responses sustained for six months or longer, provides encouraging early evidence for the pasritamig-JNJ-9401 combination that warrants further investigation in a larger Phase 3 study."

"This novel dual-antigen-targeted bispecific regimen combines pasritamig, a foundational component of our prostate cancer pipeline, with JNJ-9401, highlighting the potential of complementary mechanisms working together," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "With this combination now in Phase 3 development, we are building on the early promise of this approach as we work to bring new treatment options to patients with advanced disease."

Early results show promising deep and sustained PSA reductions

The ongoing, open-label, multicenter Phase 1 study is evaluating the safety and preliminary clinical activity of pasritamig in combination with JNJ-9401 in patients with metastatic castration-resistant prostate cancer (mCRPC), also known as metastatic androgen pathway modulation-resistant prostate cancer (mAPMR).1

These preliminary findings are based on a small number of patients at the recommended regimen, and further evaluation is needed to determine the clinical benefit and safety of the combination in a larger population.1

As of June 15, 2026, 144 patients had enrolled in the study. Patients treated at the recommended regimen were heavily pretreated, having received a median of four prior lines of systemic therapy (range, two to six). Among the 15 patients treated at this regimen, 73 percent achieved PSA reductions of at least 50 percent and 47 percent achieved reductions of at least 90 percent. Four patients achieved undetectable PSA levels. All seven patients who achieved PSA reductions of at least 90 percent remained on treatment for more than six months without disease progression.1

At the recommended regimen, no Grade 3 or higher treatment-related adverse events, dose-limiting toxicities, or treatment-related adverse events leading to discontinuation or death were reported. Cytokine release syndrome (CRS), an inflammatory reaction that can occur when T cells are activated, was observed in three patients (20 percent). All cases were mild (Grade 1), presenting as temporary fever, and none required treatment with tocilizumab. No cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported.1

The recommended regimen consists of JNJ-9401 200 mg administered subcutaneously every six weeks in combination with pasritamig 300 mg administered intravenously every six weeks, following two initial weekly pasritamig step-up doses. The findings suggest the combination has potential to be administered on this schedule in an outpatient setting.1

Advancing a new generation of immunotherapy combinations into Phase 3

The combination is being evaluated in the ongoing Phase 3 KLK2-comPAS (NCT07164443) study, which is investigating whether adding JNJ-9401 to pasritamig can improve outcomes for patients with mCRPC.9 The study represents an important next step in Johnson & Johnson’s broader development program for pasritamig, which is being evaluated both as a single agent and in combination with other therapies across advanced prostate cancer.

About the study

The Phase 1 study (NCT06095089) is an open-label, multicenter trial evaluating the safety and clinical activity of pasritamig in combination with JNJ-9401 in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received at least one prior systemic therapy. In Part 1, JNJ-9401 was dose escalated in combination with fixed-dose pasritamig, with primary objectives of evaluating safety and determining the recommended regimen. Dose expansion was initiated at the recommended regimen, including a frontline mCRPC cohort. The recommended regimen is JNJ-9401 200 mg administered subcutaneously every six weeks in combination with pasritamig 300 mg administered intravenously every six weeks, following two weekly pasritamig step-up doses. Treatment is administered in an outpatient setting.10

About pasritamig and JNJ-9401

Pasritamig and JNJ-9401 are investigational bispecific antibodies designed to work together to activate and enhance the immune response against prostate cancer. Pasritamig, a first-in-class KLK2xCD3 bispecific antibody, is designed to direct T cells to prostate cancer cells, while JNJ-9401, a PSMAxCD28 costimulatory bispecific antibody, is designed to provide an additional signal that enhances T-cell activation and function. By targeting two different prostate cancer proteins, KLK2 and PSMA, the combination is designed to deliver complementary signals to T cells.

Pasritamig is being studied as a monotherapy and in combination with other therapies across advanced prostate cancer. Pasritamig with or without JNJ-9401 is being evaluated in the Phase 3 KLK2-comPAS study in metastatic castration-resistant prostate cancer and pasritamig plus docetaxel is being evaluated in the Phase 3 KLK2-PASenger study in first-line mCRPC.

About metastatic castration-resistant prostate cancer (mCRPC)

Metastatic castration-resistant prostate cancer (mCRPC), also known as metastatic androgen pathway modulation-resistant prostate cancer (mAPMR), is an advanced form of prostate cancer that continues to progress despite treatments that target the androgen receptor pathway.2 As the disease progresses, it can spread to other parts of the body, including the bones and lymph nodes, and patients may receive additional treatments such as chemotherapy and radioligand therapy targeting prostate-specific membrane antigen (PSMA).11

Patients with metastatic prostate cancer that has become resistant to androgen pathway modulation face poor outcomes, with survival varying based on factors including the location and extent of disease, prior treatment history and response to therapy. Median overall survival ranges from approximately 13.5 to 31.6 months depending on the site of metastasis.

(Press release, Johnson & Johnson, NOV 8, 2026, View Source;johnson-reports-73-psa-response-rate-with-investigational-pasritamig-based-immunotherapy-combination-in-advanced-prostate-cancer-302932750.html [SID1234674440])

On November 6, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease and topically delivered therapeutics for skin cancer, today reported financial results and business highlights for the third quarter (Q3) ended September 30, 2026.

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Q3 2026 Highlights and Recent Events

● CyPath Lung test unit sales increased 100% through Q3 compared to the first nine months of 2025.
● CyPath Lung testing revenue for the first nine months of 2026 increased 79% to approximately $1.1 million, compared to the same period in 2025.
● In July 2026, the Company surpassed the total number of CyPath Lung test reports delivered to physicians during 2025.
● The number of ordering physicians increased by 89% in the third quarter of 2026 compared to the third quarter of 2025, continuing to expand clinical utilization of CyPath Lung. Physicians already ordering CyPath Lung tests increased their volume by 48% year over year.
● The Company expanded its government healthcare distribution network and commercial reach through an agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business and established distributor of medical-surgical and laboratory products and services to government agencies, including the Department of Veterans Affairs (VA).
● The ongoing longitudinal clinical trial designed to evaluate the clinical performance of CyPath Lung continued to advance. As of September 30, 2026, 11 clinical sites were active, including nine VA and military medical centers that had begun patient enrollment. The John P. Murtha Cancer Center Research Program at the Uniformed Services University of the Health Sciences is providing support and funding for the trial.

● In July, the Company published a comprehensive clinical review and white paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, presenting a practical framework for incorporating CyPath Lung into pulmonology and oncology practices. Dr. Downie presented the framework to physicians in October at the annual meeting of the American College of Chest Physicians (CHEST 2026).
● The Company advanced CyPath Lung for potential use in surveillance of lung cancer survivors as a complement to imaging to monitor patients for cancer recurrence and new primary lung cancers.
● The Company presented positive research results at CHEST 2026 relating to its development of noninvasive tests to characterize lung inflammation and investigate biologic drug targets for asthma and COPD therapies. Further development and validation are underway to determine whether this approach can identify patients who may benefit from specific biologic therapies or support monitoring of lung inflammation over time.
● The Company announced a collaboration with Pictor, Inc., a targeted proteomic platform company, to support development and potential commercialization of bioAffinity Technologies’ next-generation diagnostic tests designed to provide a more complete picture of lung inflammation in patients with asthma and COPD.
● The Company continued research into potential topically delivered therapeutics for squamous and basal cell skin cancers. Preliminary research findings have demonstrated that self-delivering, stabilized small interfering RNAs (siRNAs) selectively kill squamous and basal carcinoma cells in vitro while sparing noncancerous cutaneous cells.
● In September, bioAffinity announced the grant of a Hong Kong patent covering CyPath Lung’s proprietary flow cytometry + AI platform for predicting the likelihood of lung cancer by characterizing cell populations in sputum. In October, the Company received a Notice of Allowance from the Japan Patent Office indicating its intention to grant a patent for the method of predicting the likelihood of lung cancer used by the CyPath Lung test.
● The Company raised an aggregate of $8.0 million in gross proceeds through a private placement offering in August 2026 and a registered direct offering and concurrent private placement in October 2026 for working capital and general corporate purposes, including support for the ongoing commercialization of CyPath Lung.

Management Commentary

"Our third-quarter results reflect CyPath Lung’s continued momentum in addressing the critical need for early lung cancer detection, driven by both new physicians ordering the test and increased use by existing customers. We believe this growth reflects increasing physician engagement and recognition of the role CyPath Lung can play in managing care for patients at risk for lung cancer. We are also advancing its potential use in surveillance following curative-intent treatment, where CyPath Lung could complement imaging in monitoring for recurrence and new cancers," said Maria Zannes, President of CEO of bioAffinity Technologies. "Peer-to-peer education and growing clinical experience with the test remain important drivers of adoption, while our longitudinal study is designed to generate robust, real-world data across multiple sites to further evaluate how CyPath Lung may support risk assessment and clinical decision-making. Together, these efforts advance our objective of establishing CyPath Lung as a standard of care for evaluating patients at risk for lung cancer.

"We continue to build the foundation for long-term growth. Beyond lung cancer, we are advancing our platform to take advantage of precision medicine opportunities in asthma and COPD, where sputum-based analysis may help characterize lung inflammation and help physicians better match individual patients to available treatments, including Tezspire, Dupixent and Nucala. The tests we are developing are designed to meet a critical need for precision diagnostics in the multi-billion-dollar asthma and COPD therapeutic markets.

"Our patent portfolio now includes 22 awarded U.S. and foreign patents and 36 pending applications. The recent Hong Kong patent and the Japanese patent allowance, once awarded, are important additions to our patent portfolio. Our distribution agreement with AvMEDICAL is intended to expand our reach into government healthcare markets, including the VA, where the substantial burden of lung cancer underscores the need for more effective ways to evaluate pulmonary nodules and improve patient outcomes.

Ms. Zannes concluded, "Our priorities remain disciplined execution, expanding commercial adoption and advancing our clinical and research programs. We are also pursuing topical therapeutic approaches for squamous and basal cell skin cancers based on promising findings involving the CD320 and LRP2 receptors. We believe our expertise in flow cytometry, automated data analysis and siRNA technology provides a foundation for developing differentiated products across these markets. Together, these programs demonstrate our commitment to translating scientific innovation into meaningful new opportunities for patients and the Company."

Third Quarter 2026 Financial Results

Total revenue for the quarter ended September 30, 2026, was approximately $1.1 million, compared with approximately $1.4 million for the same period in 2025. The decrease is due primarily to a decrease in average reimbursement per CyPath Lung test and a slight decline in total cases completed at Precision Pathology Laboratory Services (PPLS) compared to the same period in 2025, in part due to internal business changes at three PPLS research clients. Multiple accounts previously serviced under these clients have since returned to PPLS. The Company is working to restore additional accounts and improve reimbursement levels.

Net loss for the quarter ended September 30, 2026, was approximately $5.3 million, compared with approximately $5.1 million for the third quarter of 2025. The increase in net loss is primarily due to the increase in loss from operations of approximately $3.5 million from approximately $2.3 million in the prior-year quarter, partially offset by a $1.2 million loss from the change in fair value of warrants, compared with a $2.7 million loss in the prior-year quarter.

Cash and cash equivalents were approximately $2.6 million as of September 30, 2026, compared with approximately $6.4 million at December 31, 2025. Subsequent to quarter-end, the Company completed a financing that generated approximately $4.0 million in gross proceeds.

Operating expenses for the third quarter of 2026 were approximately $4.6 million, compared with approximately $3.7 million in the third quarter of 2025.

● Direct costs and expenses were approximately $1.1 million, compared with $942,000 in the prior-year period. The increase primarily reflected additional personnel to process CyPath Lung commercial tests and tests associated with the longitudinal clinical study.
● Research and development expenses increased 18% year over year to approximately $389,000, primarily due to laboratory supplies and costs associated with relocating laboratory facilities in June 2026.

● Clinical development expenses increased 75% to approximately $251,000, compared with approximately $143,000 in the third quarter of 2025. The increase primarily reflected the initiation of clinical trial sites and patient enrollment in the longitudinal clinical study.
● Selling, general and administrative expenses increased 28% to approximately $2.8 million, compared with approximately $2.2 million in the prior-year period. The increase primarily reflected additional sales and marketing personnel and support services to expand commercialization of CyPath Lung.

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 analyzes the lung microenvironment by using advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. The test incorporates a novel 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. For more information, visit www.cypathlung.com.

(Press release, BioAffinity Technologies, NOV 6, 2026, View Source [SID1234674436])

On November 6, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease and topically delivered therapeutics for skin cancer, today reported financial results and business highlights for the third quarter (Q3) ended September 30, 2026.

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Q3 2026 Highlights and Recent Events

● CyPath Lung test unit sales increased 100% through Q3 compared to the first nine months of 2025.
● CyPath Lung testing revenue for the first nine months of 2026 increased 79% to approximately $1.1 million, compared to the same period in 2025.
● In July 2026, the Company surpassed the total number of CyPath Lung test reports delivered to physicians during 2025.
● The number of ordering physicians increased by 89% in the third quarter of 2026 compared to the third quarter of 2025, continuing to expand clinical utilization of CyPath Lung. Physicians already ordering CyPath Lung tests increased their volume by 48% year over year.
● The Company expanded its government healthcare distribution network and commercial reach through an agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business and established distributor of medical-surgical and laboratory products and services to government agencies, including the Department of Veterans Affairs (VA).
● The ongoing longitudinal clinical trial designed to evaluate the clinical performance of CyPath Lung continued to advance. As of September 30, 2026, 11 clinical sites were active, including nine VA and military medical centers that had begun patient enrollment. The John P. Murtha Cancer Center Research Program at the Uniformed Services University of the Health Sciences is providing support and funding for the trial.

● In July, the Company published a comprehensive clinical review and white paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, presenting a practical framework for incorporating CyPath Lung into pulmonology and oncology practices. Dr. Downie presented the framework to physicians in October at the annual meeting of the American College of Chest Physicians (CHEST 2026).
● The Company advanced CyPath Lung for potential use in surveillance of lung cancer survivors as a complement to imaging to monitor patients for cancer recurrence and new primary lung cancers.
● The Company presented positive research results at CHEST 2026 relating to its development of noninvasive tests to characterize lung inflammation and investigate biologic drug targets for asthma and COPD therapies. Further development and validation are underway to determine whether this approach can identify patients who may benefit from specific biologic therapies or support monitoring of lung inflammation over time.
● The Company announced a collaboration with Pictor, Inc., a targeted proteomic platform company, to support development and potential commercialization of bioAffinity Technologies’ next-generation diagnostic tests designed to provide a more complete picture of lung inflammation in patients with asthma and COPD.
● The Company continued research into potential topically delivered therapeutics for squamous and basal cell skin cancers. Preliminary research findings have demonstrated that self-delivering, stabilized small interfering RNAs (siRNAs) selectively kill squamous and basal carcinoma cells in vitro while sparing noncancerous cutaneous cells.
● In September, bioAffinity announced the grant of a Hong Kong patent covering CyPath Lung’s proprietary flow cytometry + AI platform for predicting the likelihood of lung cancer by characterizing cell populations in sputum. In October, the Company received a Notice of Allowance from the Japan Patent Office indicating its intention to grant a patent for the method of predicting the likelihood of lung cancer used by the CyPath Lung test.
● The Company raised an aggregate of $8.0 million in gross proceeds through a private placement offering in August 2026 and a registered direct offering and concurrent private placement in October 2026 for working capital and general corporate purposes, including support for the ongoing commercialization of CyPath Lung.

Management Commentary

"Our third-quarter results reflect CyPath Lung’s continued momentum in addressing the critical need for early lung cancer detection, driven by both new physicians ordering the test and increased use by existing customers. We believe this growth reflects increasing physician engagement and recognition of the role CyPath Lung can play in managing care for patients at risk for lung cancer. We are also advancing its potential use in surveillance following curative-intent treatment, where CyPath Lung could complement imaging in monitoring for recurrence and new cancers," said Maria Zannes, President of CEO of bioAffinity Technologies. "Peer-to-peer education and growing clinical experience with the test remain important drivers of adoption, while our longitudinal study is designed to generate robust, real-world data across multiple sites to further evaluate how CyPath Lung may support risk assessment and clinical decision-making. Together, these efforts advance our objective of establishing CyPath Lung as a standard of care for evaluating patients at risk for lung cancer.

"We continue to build the foundation for long-term growth. Beyond lung cancer, we are advancing our platform to take advantage of precision medicine opportunities in asthma and COPD, where sputum-based analysis may help characterize lung inflammation and help physicians better match individual patients to available treatments, including Tezspire, Dupixent and Nucala. The tests we are developing are designed to meet a critical need for precision diagnostics in the multi-billion-dollar asthma and COPD therapeutic markets.

"Our patent portfolio now includes 22 awarded U.S. and foreign patents and 36 pending applications. The recent Hong Kong patent and the Japanese patent allowance, once awarded, are important additions to our patent portfolio. Our distribution agreement with AvMEDICAL is intended to expand our reach into government healthcare markets, including the VA, where the substantial burden of lung cancer underscores the need for more effective ways to evaluate pulmonary nodules and improve patient outcomes.

Ms. Zannes concluded, "Our priorities remain disciplined execution, expanding commercial adoption and advancing our clinical and research programs. We are also pursuing topical therapeutic approaches for squamous and basal cell skin cancers based on promising findings involving the CD320 and LRP2 receptors. We believe our expertise in flow cytometry, automated data analysis and siRNA technology provides a foundation for developing differentiated products across these markets. Together, these programs demonstrate our commitment to translating scientific innovation into meaningful new opportunities for patients and the Company."

Third Quarter 2026 Financial Results

Total revenue for the quarter ended September 30, 2026, was approximately $1.1 million, compared with approximately $1.4 million for the same period in 2025. The decrease is due primarily to a decrease in average reimbursement per CyPath Lung test and a slight decline in total cases completed at Precision Pathology Laboratory Services (PPLS) compared to the same period in 2025, in part due to internal business changes at three PPLS research clients. Multiple accounts previously serviced under these clients have since returned to PPLS. The Company is working to restore additional accounts and improve reimbursement levels.

Net loss for the quarter ended September 30, 2026, was approximately $5.3 million, compared with approximately $5.1 million for the third quarter of 2025. The increase in net loss is primarily due to the increase in loss from operations of approximately $3.5 million from approximately $2.3 million in the prior-year quarter, partially offset by a $1.2 million loss from the change in fair value of warrants, compared with a $2.7 million loss in the prior-year quarter.

Cash and cash equivalents were approximately $2.6 million as of September 30, 2026, compared with approximately $6.4 million at December 31, 2025. Subsequent to quarter-end, the Company completed a financing that generated approximately $4.0 million in gross proceeds.

Operating expenses for the third quarter of 2026 were approximately $4.6 million, compared with approximately $3.7 million in the third quarter of 2025.

● Direct costs and expenses were approximately $1.1 million, compared with $942,000 in the prior-year period. The increase primarily reflected additional personnel to process CyPath Lung commercial tests and tests associated with the longitudinal clinical study.
● Research and development expenses increased 18% year over year to approximately $389,000, primarily due to laboratory supplies and costs associated with relocating laboratory facilities in June 2026.

● Clinical development expenses increased 75% to approximately $251,000, compared with approximately $143,000 in the third quarter of 2025. The increase primarily reflected the initiation of clinical trial sites and patient enrollment in the longitudinal clinical study.
● Selling, general and administrative expenses increased 28% to approximately $2.8 million, compared with approximately $2.2 million in the prior-year period. The increase primarily reflected additional sales and marketing personnel and support services to expand commercialization of CyPath Lung.

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 analyzes the lung microenvironment by using advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. The test incorporates a novel 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. For more information, visit www.cypathlung.com.

(Press release, BioAffinity Technologies, NOV 6, 2026, View Source [SID1234674436])

On November 6, 2026 MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies, reported preclinical findings from two studies presented at the 41st Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Phoenix, Arizona. The studies address two distinct mechanisms by which tumors resist treatment: immune-suppressive metastatic environments that limit checkpoint blockade, and senescent cells that persist after therapy. Together they show how one foundational iNKT biology, in unmodified and engineered form, can be directed against both through tumor-cell killing, immune modulation and engineered targeting.

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In one study, agenT-797 shifted suppressive immune populations toward an immune-stimulatory phenotype in a human organoid model of colorectal cancer liver metastases. Further, agenT-797, in combination with antigen-specific T cells and BOT+BAL, also increased tumor-cell killing.

In a second study, conducted in collaboration with Dr. Jesús Gil and his laboratory at the MRC London Institute of Medical Sciences, Imperial College London, both unmodified agenT-797 and MiNK-215, MiNK’s FAP-targeted, IL-15-armored CAR-iNKT candidate, killed senescent tumor cells. FAP-CAR engineering additionally enabled MiNK-215 to kill FAP-expressing fibroblasts, extending the platform’s reach into the tumor stroma. These concordant findings reinforce the scientific foundation of MiNK’s pipeline and add to the growing body of evidence supporting iNKT cell therapy across cancer indications.

"These findings demonstrate the breadth of our iNKT platform and its potential to address distinct mechanisms of immune dysfunction. In colorectal cancer, agenT-797 reprograms the tumor environment to support T-cell-mediated killing, providing a mechanistic rationale for our ongoing Phase 2 combination study. In parallel, our engineered iNKT platform expands our ability to target senescent and stromal cells implicated in persistent inflammation and tissue remodeling. This biology is also relevant to acute lung injury, where dysregulated inflammation can lead to lasting pulmonary damage and fibrosis. With agenT-797 advancing in a randomized Phase 2 study in acute respiratory failure, we are focused on translating these insights into clinical outcomes across serious diseases," said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics.

SITC 2026 Poster Presentations

Poster #270: "AgenT-797, An Allogeneic iNKT Cell Therapy, Enables Tumor-cell Killing In A Human Organoid Model of Immune Checkpoint Inhibitor-refractory Colorectal Cancer Liver Metastases."
Presenter: Shanmugarajan Krishnan, Ph.D.; Saturday, November 7, 2026; 10:00 a.m.–2:00 p.m. and 6:00–8:10 p.m. MST.

Poster #177: "Native and engineered allogenic invariant natural killer T (iNKT) cells eliminate senescent tumor cells and fibroblasts in oncogenic in vitro models."
Presenter: Jing Fang, Ph.D.; Friday, November 6, 2026; 12:15–1:45 p.m. and 6:40–8:10 p.m. MST.
Location: Phoenix Convention Center, North Building, Lower Level, Exhibition Halls 4–6, Phoenix, Arizona.

Reprogramming Immune Resistance in Colorectal Cancer Liver Metastases

Patients with microsatellite-stable (MSS) colorectal cancer and liver metastases represent a substantial unmet need with no approved immunotherapy option: the immune-suppressive metastatic environment limits the activity of existing therapies, and liver involvement is associated with resistance to checkpoint blockade.

In a human organoid model incorporating colorectal cancer, liver-associated and immune cells, agenT-797 shifted suppressive immune populations toward a more immune-stimulatory phenotype, depleting CD206+ M2-like macrophages and increasing CD86+/HLA-DR+ antigen-presenting cells. When combined with antigen-specific T cells and botensilimab (BOT), an Fc-enhanced anti-CTLA-4 antibody, plus balstilimab (BAL), an anti-PD-1 antibody, the triple combination increased CD8 T-cell density, raised granzyme B, IFN-γ, TNF-α, CXCL-9, CCL3 and IL-8, reduced EpCAM+ tumor-cell content and increased tumor-cell apoptosis. Critically, the model was refractory to BOT+BAL alone, which produced no statistically significant tumor-cell killing. Adding agenT-797 unlocked killing, and the full effect required all three components.

These findings provide a mechanistic rationale for the ongoing Phase 2 study of agenT-797 with BOT+BAL in previously treated microsatellite stable (MSS) colorectal cancer with liver metastases (CRC LM) (NCT07550088; funded by Scripps Institute, PI Darren Sigal).

Eliminating Senescent Cells with Unmodified and Engineered iNKT Therapies

Senescent cells can accumulate after cancer treatment or other cellular stress. Although they stop dividing, they can release signals that contribute to inflammation, tissue remodeling and immune escape. Dr. Jesús Gil and his team evaluated whether unmodified and engineered iNKT cell therapies could recognize and eliminate these cells and identified the cellular factors and resistance mechanisms that determine whether iNKT killing succeeds.

MiNK-215 is an allogeneic CAR-iNKT cell engineered to target fibroblast activation protein (FAP), which is expressed on cancer-associated and senescent fibroblasts — they support cells that surround tumors — and armored with IL-15 to support persistence and immune activation.

In this model, three findings emerged. First, both unmodified agenT-797 and MiNK-215 killed therapy-induced senescent breast cancer cells, which carried high levels of the NKG2D stress ligands MICA/B and ULBP2/5/6 and low checkpoint-ligand expression. Second, FAP-CAR engineering enabled MiNK-215 to kill non-senescent, FAP-high lung fibroblasts that unmodified agenT-797 did not; a targeting capability conferred by the CAR. Third, senescent lung fibroblasts resisted both therapies and carried elevated PD-L1, PD-L2 and CD155 — making checkpoint-ligand upregulation a defined, addressable obstacle that the next generation of engineered iNKT therapies can be built to overcome.

Loading the lipid antigen α-galactosylceramide (α-GalCer) restored unmodified agenT-797 killing of the less-sensitive senescent fibroblasts, indicating that this resistance can be overcome through antigen presentation and informing engineering and combination strategies. Because cellular senescence and fibroblast activation contribute to persistent tissue remodeling in cancer and fibrotic diseases, these findings provide a rationale for further investigation of engineered iNKT therapies in fibroinflammatory conditions.

"The different responses across these models show that senescence does not create a single uniform immune target. Observing the signals associated with sensitivity and resistance will help us define where iNKT-based approaches are most useful," said Jesús Gil, Professor of Cell Proliferation, MRC London Institute of Medical Sciences, Imperial College London, and corresponding author of the study.

Extending iNKT Biology from Acute Inflammation to Tissue Remodeling and Fibrosis

MiNK is advancing agenT-797 in C-1300-02, a randomized, placebo-controlled Phase 2 trial in acute hypoxemic respiratory failure, including ARDS (NCT07615010), evaluating acute clinical outcomes. Severe acute lung injury involves dysregulated immune responses, epithelial and endothelial damage, and persistent inflammation that, in some patients, progresses to abnormal tissue repair and pulmonary fibrosis.

The SITC (Free SITC Whitepaper) findings highlight complementary mechanisms relevant to this continuum: agenT-797’s ability to reprogram suppressive immune environments, and the capacity of unmodified and engineered iNKT cells to recognize selected senescent and FAP-expressing cells involved in tissue remodeling. These observations extend the potential of MiNK’s pulmonary strategy, from intervening during acute inflammatory injury to exploring engineered iNKT approaches for persistent fibroinflammatory disease.

(Press release, MiNK Therapeutics, NOV 6, 2026, View Source [SID1234674428])

On November 6, 2026 Azalea Therapeutics, Inc., a biotechnology company redefining precision genomic medicines in vivo, reported new preclinical data demonstrating durable anti-tumor activity and the versatility of its proprietary in vivo TRAC-CAR T cell platform. The findings, to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting (SITC 2026), taking place November 4 – 8, 2026, in Phoenix, Arizona, highlight the platform’s ability to generate functional CAR T cells through precise genomic integration, achieve durable tumor control across hematologic and solid tumor models and enable advanced engineering strategies designed to address key limitations of conventional CAR T cell therapies.

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Azalea’s proprietary dual-vector platform combines T cell-targeted enveloped delivery vehicles (EDVs) delivering transient CRISPR-Cas9 complexes with T cell-tropic adeno-associated viruses (AAVs) carrying a promoterless CAR gene. This approach enables precise insertion of the CAR gene at the TRAC locus, placing CAR expression under control of the endogenous T cell promoter. The platform is designed to generate potent, durable and physiologically regulated CAR T cells directly inside the body, without the need for individualized ex vivo manufacturing.

"These data reinforce both the potency and versatility of our precision in vivo CAR T platform," said Jenny Hamilton, Ph.D., co-founder, president and chief executive officer of Azalea Therapeutics. "Beyond generating functional CAR T cells directly in the body, we are demonstrating the ability to engineer increasingly sophisticated CAR designs that address important challenges in cell therapy, including antigen escape, solid tumor activity and long-term disease control. Combined with our previously reported non-human primate findings, these results strengthen our confidence in the platform’s potential to deliver a new generation of more accessible and durable cell therapies."

Key Findings from the SITC (Free SITC Whitepaper) Presentation

The presentation highlights new preclinical data demonstrating:

Durable leukemia tumor clearance, including following rechallenge
A single intravenous administration of EDV and AAV generated TRAC-CAR T cells in humanized mouse models, resulting in dose-dependent CAR T cell generation and complete clearance of CD19-positive NALM6 leukemia at active dose levels. In select treatment groups, tumor control was maintained following a secondary tumor challenge approximately 60 days after initial treatment, without additional dosing, supporting the potential for durable anti-tumor activity.
Dual-antigen targeting to address tumor escape
The modular platform enabled in vivo generation of dual CD19/CD20-targeted TRAC-CAR T cells, demonstrating activity against antigen-heterogeneous leukemia cells and supporting the potential to limit antigen escape, an important mechanism of resistance to CAR T cell therapy.
Enhanced solid tumor activity through CAR armoring
In a humanized mouse model of mesothelin-expressing solid tumors, in vivo-engineered TRAC-CAR T cells demonstrated strong anti-tumor activity, with co-delivery of performance-enhancing peptides (PEPs) further improving tumor control. These findings support the platform’s ability to incorporate additional functional elements to enhance CAR T cell activity in challenging tumor settings.
Precise genomic integration
Genome-wide integration-site analysis in human splenocytes from humanized mice showed that 99% of sequencing reads passing filtering mapped to the intended TRAC locus, supporting the genomic locus-specific integration capabilities of the platform.
Robust pharmacodynamic activity in non-human primates
Consistent with previously reported results, a single intravenous administration generated TRAC-CAR T cells in immunocompetent non-human primates, with CAR T cells reaching up to 41% of peripheral T cells and deep B cell depletion observed across peripheral blood, lymph nodes and bone marrow without prior lymphodepletion.
"One of the key advantages of our approach is the ability to combine cell-selective delivery with precise, programmable genomic integration," said Connor Tsuchida, Ph.D., scientific co-founder and vice president of research and development at Azalea Therapeutics. "The durable tumor control following rechallenge, along with our ability to engineer dual-targeting and armored CAR T cells, demonstrates the flexibility of this platform to address diverse therapeutic challenges even beyond hematologic malignancies. Importantly, the activity observed across mouse and non-human primate models provides further support for advancing this technology toward clinical translation."

Azalea will present these data at the SITC (Free SITC Whitepaper) 2026 Annual Meeting.

Abstract Number: 950
Title: In vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration results in potent tumor clearance in mice and B cell depletion in non-human primates
Presenting Author: Connor Tsuchida, Ph.D., Azalea Therapeutics
Presentation Date: Saturday, November 7, 2026
Poster Presentation Times: 12:15 – 1:45 pm and 6:45 – 8:10 pm MST
Location: Phoenix Convention Center

The ePoster will be available on the SITC (Free SITC Whitepaper) virtual meeting platform beginning Friday, November 6, 2026, at 9:00 am ET.

(Press release, Azalea Therapeutics, NOV 6, 2026, View Source [SID1234674427])