Adicet Bio Reports Third Quarter 2025 Financial Results and Provides Business Updates

On November 5, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the third quarter ended September 30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We were pleased to announce positive preliminary data last month from seven SLE and LN patients treated in our Phase 1 trial of ADI-001, underscoring its broad potential as a transformative, off-the-shelf, one-time therapy for autoimmune diseases. We are now preparing to discuss the trial design for a potentially pivotal study of ADI-001 with the FDA in the first quarter of 2026, with initiation targeted for the second quarter of 2026," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "As part of our broader clinical strategy, we are also exploring the potential to reduce or eliminate the need for conditioning with a separate Phase 1 trial of ADI-001 in treatment-refractory RA patients. We are actively enrolling patients in our Phase 1 trial across LN, SLE, SSc, IIM, SPS and AAV patients, with a clinical update for LN, SLE and SSc expected in the first half of 2026."

Mr. Schor continued: "In addition, we are continuing to advance ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to target prostate specific membrane antigen, and expect to submit a regulatory filing for the mCRPC program in the first quarter of 2026 and share initial clinical data in the second half of 2026, subject to regulatory clearance. ADI-212 is designed to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. Supported by our recent capital raise in October, which extended our cash runway into the second half of 2027, we are well-positioned to continue clinical execution across our pipeline of differentiated gamma delta 1 CAR T therapies."

Third Quarter 2025 and Recent Operational Highlights:

Autoimmune diseases

Announced positive preliminary data in LN and SLE patients from Phase 1 study of ADI-001 in autoimmune diseases. In October 2025, Adicet announced positive initial safety and efficacy data from seven patients (five LN and two SLE patients) dosed with ADI-001 in the ongoing Phase 1 trial, with follow-up ranging from two to nine months as of the August 31, 2025 data cut-off date. All patients demonstrated rapid and sustained reductions in the SLEDAI-2K score and PGA. All patients in the LN cohort achieved improved renal function, including three complete renal responses and Definition of Remission In Systemic lupus erythematosus (DORIS) remissions, and two partial responses. ADI-001 also demonstrated multiple hallmarks of immune reset with subsequent emergence of naïve and previously undetected B cell repertoire following single dose treatment. ADI-001 was generally well tolerated and demonstrated a favorable safety profile, with no Grade 2 or higher Cytokine Release Syndrome (CRS), and no cases of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) observed.
Based on these results, the Company plans to request a meeting with the FDA in the first quarter of 2026 to inform potential Phase 2 pivotal trial design, with the initiation of the study in LN or LN and SLE patients anticipated to commence in the second quarter of 2026.

Enrollment ongoing in ADI-001 Phase 1 program. Adicet is actively enrolling patients in its Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases which include: LN, SLE, SSc, IIM, SPS and AAV. Adicet expects to provide an LN and SLE clinical update as well as an SSc clinical update in the first half of 2026.
Actively enrolling patients with treatment-refractory RA in Phase 1 study of ADI-001 evaluating potential to reduce the need for conditioning. The Company is enrolling patients with treatment-refractory RA in a Phase 1 study of ADI-001 evaluating two lymphodepletion regimens: cyclophosphamide alone and cyclophosphamide with fludarabine. Adicet expects to provide a clinical update on the Phase 1 trial in the second half of 2026.
Solid tumor indications

Presented ADI-212 preclinical data at the 32nd annual Prostate Cancer Foundation Scientific Retreat. Adicet is continuing to advance preclinical development of ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to target PSMA. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 (mbIL-12) armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. In October, Adicet presented preclinical data at the 32nd Annual Prostate Cancer Foundation Scientific Retreat supporting these design elements and functional enhancements in multiple models of disease.
Regulatory filing on track for ADI-212 in mCRPC. Adicet plans to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the first quarter of 2026. The Company expects to share initial clinical data from the ADI-212 program in the second half of 2026, subject to regulatory clearance to proceed with a clinical trial.
Corporate updates

Raised $74.8 million in net proceeds in registered direct offering. In October 2025, Adicet successfully raised $74.8 million in net proceeds through an underwritten registered direct offering of equity securities, extending its cash runway into the second half of 2027.
Financial Results for Third Quarter 2025:

Research and Development (R&D) Expenses: R&D expenses were $22.9 million for the three months ended September 30, 2025, compared to $26.3 million during the same period in 2024. The decrease in R&D expenses was due to a $1.8 million decrease in payroll and personnel expenses, and a $1.0 million decrease in lab supplies and materials related to lower headcount, a $0.7 million decrease in expenses related to contract development and manufacturing organizations (CDMOs) and contracted R&D services due to lower utilization at external CDMOs, a $0.7 million decrease in expenses related to R&D consultants, partially offset by a $0.8 million of expenses related to contract research organizations; and a $0.1 million decrease in facility-related expenses.
General and Administrative (G&A) Expenses: G&A expenses were $5.1 million for the three months ended September 30, 2025, compared to $6.9 million during the same period in 2024. The decrease in G&A expenses was primarily due to a $1.6 million decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation expense, and a $0.1 million decrease in facility-related expenses.
Net Loss: Net loss for the three months ended September 30, 2025 was $26.9 million, or a net loss of $0.29 per basic and diluted share, including non-cash stock-based compensation expense of $2.5 million, as compared to a net loss of $30.5 million, or a net loss of $0.34 per basic and diluted share, including non-cash stock-based compensation expense of $6.8 million during the same period in 2024.
Cash Position: Cash, cash equivalents and short-term investments were $103.1 million as of September 30, 2025, compared to $176.3 million as of December 31, 2024. Subsequent to September 30, the Company received approximately $74.8 million of net proceeds from a registered direct offering. The Company expects that its cash and cash equivalents and short-term investments as of September 30, 2025, together with the proceeds raised after quarter end, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, NOV 5, 2025, View Source [SID1234659494])

Tempus Announces Six Abstracts Accepted for Presentation at the Society for Immunotherapy of Cancer Annual Meeting 2025

On November 5, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that six abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025. The meeting is taking place November 5 – 9 at the Gaylord National Convention Center in National Harbor, Maryland.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re excited to join the oncology community at this year’s meeting and highlight our latest research and progress in advancing the immuno-oncology field," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "Our latest findings demonstrate the potential of integrated, data-driven approaches to refine biomarkers, improve prediction of immunotherapy response, and inform the development of next-generation tools for patient stratification."

This year, Tempus will highlight its latest scientific and clinical research findings via six poster presentations.

A novel multi-omic algorithm to predict real-world outcomes among patients with rare, advanced, solid cancers treated with off-label immune checkpoint inhibitors
Date/Time: Friday, November 7, 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 157
Summary: This study investigates the utility of the Immune Profile Score (IPS) as a molecular signature to predict the effectiveness of immune checkpoint inhibitor (ICI) therapy in rare, advanced solid cancers. Given the clinical unmet need for rare, heterogeneous cancers, the study evaluated 90 eligible patients from Tempus’ de-identified real-world database who had a rare, advanced solid cancer diagnosis and received off-label ICI treatment, excluding those with high TMB or MSI. Patients were further categorized as IPS-high or IPS-low. The findings demonstrated that IPS-high patients experienced significantly longer overall survival compared to those categorized as IPS-low. Importantly, IPS maintained its prognostic significance across all patient subgroups and clinically relevant confounders. These results support IPS as a pan-cancer biomarker capable of accurately stratifying ICI treatment outcomes and potentially supporting the label expansion of ICIs to various rare cancer types.
MAIT cell abundance within tumors are associated with key clinical characteristics across solid tumors
Date/Time: Friday, November 7, 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 133
Summary: An analysis of 190,189 patients, utilizing T-cell receptor (TCR) sequencing data from Tempus’ de-identified real-world database, investigated the prevalence and distribution of mucosal-associated invariant T (MAIT) cells across numerous solid tumor types. The study determined MAIT cell abundance using TCRα chains, with comparisons adjusting for overall T cell infiltration or total TCR’s detected where relevant. MAIT cell abundance was highest in tumors of mucosal origin, such as colorectal and gastroesophageal cancers, and higher MAIT cell levels were statistically significantly in younger patients, males, and non-smokers. Furthermore, the prevalence of MAIT cells showed associations with important clinical and molecular factors, including reduced MAIT cell abundance in PD-L1 high (TPS ≥50%; pan-cancer), microsatellite instability (MSI)-high (pan-cancer and colorectal cancer), and microbial factors such as lower bacterial load (pan-cancer). These findings suggest that MAIT cell prevalence may have important clinical implications and may serve as a promising biomarker and immunotherapy target.
TargetR: Automated multi-omics report framework for target characterization and validation of immunotherapy and targeted therapy candidates across cancers
Date/Time: Friday, November 7; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 1115
Summary: A detailed computational framework, TargetR, was developed by integrating public and real-world multi-omics datasets to accelerate the discovery and validation of immunotherapy targets. This approach unified pharmacologic, genomic, transcriptomic, and proteomic data, utilizing advanced analytics to assess target potential based on criteria such as normal tissue expression, mutational load, and copy number variation (CNV) correlation with expression. Validation of findings can then be performed using Tempus’ de-identified real-world database, which provides clinical features and outcome data. The framework generated an automated, user-friendly report with actionable insights, enabling the identification and prioritization of targets for treatments like bispecific T-cell engagers and CAR-T therapies, thereby supporting the development of next-generation immunotherapies.
A multi-omic immune profile score (IPS) stratifies real-world outcomes of microsatellite stable (MSS) advanced colorectal cancer patients treated with immune checkpoint inhibitors
Date/Time: Saturday, November 8; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 134
Summary: This exploratory study investigated the potential of Tempus’ Immune Profile Score (IPS), a DNA- and RNA-based molecular signature, to act as a predictive biomarker for immune checkpoint inhibitor (ICI) benefit in patients with microsatellite stable (MSS) advanced colorectal cancer (CRC). Tempus’ de-identified real-world database was utilized to identify 46 eligible MSS CRC patients who received an ICI alone or ICI-containing regimen in the third line (3L) or beyond. Using pre-ICI tissue, patients were stratified into IPS-High versus IPS-Low groups. The results demonstrated a clinically meaningful improvement in real-world overall survival (rwOS) for the IPS-High group compared to the IPS-Low group. Furthermore, a comparison of IPS risk stratification on ICI therapy versus prior non-ICI regimen provided additional insight about IPS’s utility as an ICI-specific biomarker. This hypothesis-generating data address an unmet need for patients whom an ICI therapy and predictive biomarker are urgently needed.
Ultrahigh tumor mutational burden (TMB) is associated with improved survival outcomes in patients (Pts) treated with immune checkpoint inhibitors (ICIs)
Date/Time: Saturday, November 8, 2025; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 136
Summary: This research evaluates the prognostic value of defining an "ultrahigh" tumor mutational burden (TMB) threshold (≥40 mutations/MB) compared to the standard 10 mt/MB cutoff for patients receiving immune checkpoint inhibitor (ICI) therapy. Using Tempus Lens, the research team defined a cohort of 17,449 patients with five different cancer types (melanoma, lung, GI, non-melanoma skin, and uterine) from Tempus’ de-identified multimodal database. The analysis sought to compare real-world objective response rates (rwORR) and overall survival (rwOS) across low, high, and ultrahigh TMB groups. The findings indicate that patients in the ultrahigh TMB group experience significantly improved clinical outcomes, including enhanced rwORR and better rwOS. This ultrahigh TMB status is also linked to a distinct tumor microenvironment, specifically showing a higher degree of regulatory T cell and myeloid cell infiltration, suggesting that ultrahigh TMB may serve as a novel marker for predicting ICI responsiveness.
Impact of androgen receptor mutations on immune infiltration in castration resistant prostate cancer
Date/Time: Saturday, November 8; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 140
Summary: A detailed analysis using Tempus’ de-identified real-world database examined the relationship between androgen receptor (AR) alterations and the immune microenvironment in 1,556 patients with castration-resistant prostate cancer (CRPC). The study specifically investigated AR mutations, amplifications, and ARv7 splicing detected via DNA (Tempus xT) and RNA (Tempus xR) sequencing. Over half of the CRPC patients exhibited these AR alterations, which were associated with significantly decreased immune infiltration and reduced expression of key immunotherapy targets like PD−1, PD−L1, and CTLA−4. Regression analysis confirmed this link to decreased immune infiltration was independent of tumor mutational burden (TMB) and tumor purity. These findings suggest that AR mutations contribute to a reduced immune response, potentially serving as a mechanism of resistance to treatment, and underscore the necessity of using AR status to stratify CRPC patients for immunotherapy.

(Press release, Tempus, NOV 5, 2025, View Source [SID1234659493])

Vir Biotechnology Provides Corporate Update and Reports Third Quarter 2025 Financial Results

On November 5, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and announced financial results for the third quarter ended September 30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our third quarter demonstrated exceptional execution across our clinical portfolio," said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. "We completed ECLIPSE 1 enrollment approximately two months ahead of schedule and continue to see strong momentum across ECLIPSE 2 and 3, positioning us well for our hepatitis delta regulatory submissions. We are excited to provide guidance for a comprehensive VIR-5500 data update in the first quarter of 2026, and we recently expanded into first-line prostate cancer with our ARPI combination study. These achievements reflect our team’s commitment to delivering transformative therapies to patients with significant unmet medical needs."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

The ECLIPSE 1 Phase 3 trial has completed enrollment approximately two months ahead of the Company’s internal projections. Primary completion is expected in the fourth quarter of 2026, with topline data expected in the first quarter of 2027. ECLIPSE 1 evaluates the combination of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or in other regions where its use is limited.
The ECLIPSE 2 Phase 3 trial continues enrolling well, and topline data are expected in the first quarter of 2027. ECLIPSE 2 evaluates the switch to the combination of tobevibart and elebsiran in participants who have not achieved undetectable hepatitis delta virus RNA with bulevirtide treatment.
The ECLIPSE 3 Phase 2b trial is progressing ahead of schedule with strong enrollment momentum, and topline data are expected in the first quarter of 2027. ECLIPSE 3 evaluates the combination of tobevibart and elebsiran compared to bulevirtide monotherapy in bulevirtide treatment-naïve participants.
Following positive data presented at American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2024, the Company will present Week 48 endpoint results from its SOLSTICE Phase 2 clinical study, in patients with CHD at AASLD The Liver Meeting 2025. The oral presentation will take place on Sunday, November 9.
Solid Tumors

VIR-5500, a PRO-XTEN dual-masked T-cell engager (TCE) targeting prostate-specific membrane antigen (PSMA), continues to advance through Phase 1 dose escalation as a monotherapy in heavily pre-treated patients with metastatic castration-resistant prostate cancer (mCRPC) and has demonstrated promising early anti-tumor activity and a favorable safety profile.
First patient dosed in Phase 1 clinical study of VIR-5500 in combination with ARPIs in first-line mCRPC.
The Company plans to share a comprehensive VIR-5500 data update in late-line patients in the first quarter of 2026.
VIR-5818, a PRO-XTEN dual-masked TCE targeting HER2, continues in a Phase 1 dose escalation study in combination with pembrolizumab.
VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development and is being evaluated in multiple tumor types, including metastatic colorectal cancer (CRC).
VIR-5525, a PRO-XTEN dual-masked TCE targeting EGFR, continues enrollment in the Phase 1 trial as expected.
VIR-5525 leverages learnings from VIR-5500 and VIR-5818 and is being evaluated in a variety of EGFR-expressing solid tumors in areas of high unmet need, such as non-small cell lung cancer, CRC, head and neck squamous cell carcinoma, and cutaneous squamous cell carcinoma.
Preclinical Pipeline Candidates

Harnessing the Company’s deep immune system expertise combined with its discovery and engineering platform and proprietary dAIsY (data AI structure and antibody) AI engine, the Company continues to advance multiple undisclosed PRO-XTEN masked TCEs directed toward validated targets with potential application across a number of solid tumors.
Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2025, the Company had $810.7 million in cash, cash equivalents and investments, representing a decrease of approximately $81.4 million during the third quarter of 2025.

Revenues: Total revenues for the third quarter of 2025 were $0.2 million compared to $2.4 million for the same period in 2024.

Cost of Revenue: The change in cost of revenue for the third quarter of 2025 compared to the same period in 2024 was nominal.

Research and Development Expenses (R&D): R&D expenses for the third quarter of 2025 were $151.5 million, which included $5.5 million of non-cash stock-based compensation expense, and $75.0 million of milestone payments paid from restricted cash, compared to $195.2 million for the same period in 2024, which included $8.9 million of non-cash stock-based compensation expense and $102.8 million of license expenses. The decrease was primarily driven by lower license expenses and cost savings from previously announced restructuring initiatives, partially offset by higher clinical expenses from our ECLIPSE registrational program for CHD and progression of our oncology programs.

The $75.0 million milestone payment to former shareholders of Amunix Pharmaceuticals, Inc. was triggered by VIR-5525 achieving first-in-human dosing and was paid from restricted cash held in escrow since the execution of the license agreement with Sanofi S.A. (Sanofi), therefore having no impact on our reported cash position or runway. The prior year license expenses were primarily due to the recognition of the $102.8 million Sanofi upfront payment as in-process research and development expense in the third quarter of 2024.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the third quarter of 2025 were $22.2 million, which included $5.8 million of non-cash stock-based compensation expense, compared to $25.7 million for the same period in 2024, which included $7.8 million of non-cash stock-based compensation expense. The decrease was largely due to efficiencies and cost savings from previously announced restructuring initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges, Net: The Company incurred no restructuring, long-lived assets impairment and related charges, net for the third quarter of 2025 compared to $12.7 million for the same period in 2024. The decrease was due to the fact that our restructuring initiatives implemented in prior years were substantially completed by the end of 2024.

Other Income: Other income for the third quarter of 2025 was $10.5 million compared to $17.8 million for the same period in 2024. The decrease was primarily driven by lower interest income.

Provision for Income Taxes: The provision for income taxes for the third quarter of 2025 was nominal.

Net Loss: Net loss for the third quarter of 2025 was $163.1 million, or $1.17 per share, basic and diluted, compared to a net loss of $213.7 million, or $1.56 per share, basic and diluted for the same period in 2024.

2025 Financial Guidance

Based on current operating plans, the Company expects its cash, cash equivalents and investments to fund operations into mid-2027.

Conference Call

Vir Biotechnology will host a conference call to discuss the third quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on View Source and will be archived for 30 days.

(Press release, Vir Biotechnology, NOV 5, 2025, View Source [SID1234659492])

Lunai Bioworks achieves complete regression of both primary and metastatic pancreatic tumors in preclinical humanized models, marking a breakthrough in allogeneic cancer immunotherapy

On November 5, 2025 Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, reported a major scientific breakthrough: its next-generation immune cell therapy led to complete regression of both primary and metastatic pancreatic tumors in humanized mouse models.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study was published in a new Brief Report in Vaccines on November 2, 2025. The peer-reviewed Brief Report details the development of a second-generation, clinical-grade DC construct that achieved complete regression of both primary and metastatic pancreatic tumors in preclinical humanized models. Pancreatic cancer is one of the deadliest cancers, often diagnosed late and resistant to conventional treatments. Lunai’s therapy uses engineered dendritic cells — specialized immune cells created from stem cells — that are genetically enhanced to activate the body’s immune system against cancer. This publication details a second-generation, clinical-compliant version of this platform, with the provided evidence critical in advancing ongoing partnering conversations for the therapy.

This new publication builds on Lunai’s earlier study (Vaccines 2025 Jul 12;13(7):749; doi:10.3390/vaccines13070749), which first demonstrated potent anti-tumor activity of CD34+ hematopoietic stem cell (HSC)-derived DCs engineered to overexpress CD40L, CD93, and CXCL13 in humanized mouse models of pancreatic cancer. While the initial study utilized a research-grade lentiviral vector, the latest report describes an optimized, clinically compliant construct that preserves equivalent efficacy while improving design and manufacturing attributes to support future clinical translation.

The second-generation construct features a strong mammalian promoter and enhanced genetic elements to drive expression of key immune-modulating molecules. In preclinical humanized models, Lunai’s next-generation DC therapy triggered robust activation of cytotoxic T cells and NK cells and led to complete regression of both primary and metastatic pancreatic tumors. These findings mirrored the outcomes achieved with the original research-grade product. While the allogeneic DC product has been evaluated in pancreatic cancer models, its therapeutic potential extends to a broad range of solid tumors.

"These findings demonstrate that our vector optimization strategy maintains therapeutic potency while bringing our allogeneic DC platform to the threshold of IND-enabling studies," said David Weinstein, CEO of Lunai Bioworks. "This represents an important inflection point as we move from research innovation to clinical translation—positioning Lunai at the forefront of next-generation cell-based immunotherapies."

The full article, titled "Modified Hematopoietic Stem Cell-Derived Dendritic Cell Therapy Retained Tumor-Inhibitory Function and Led to Regression of Primary and Metastatic Pancreatic Tumors in Humanized Mouse Models," is available in Vaccines (View Source).

(Press release, Lunai Bioworks, NOV 5, 2025, View Source [SID1234659491])

Anixa Biosciences Announces Execution of Data Transfer Agreement with Cleveland Clinic

On November 5, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has executed a data transfer agreement ("DTA") with Cleveland Clinic, as a key step in the process of transferring the breast cancer vaccine clinical trial data and sponsorship to Anixa for future clinical development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With enrollment completed and encouraging immune response data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND. The IND, currently sponsored by Cleveland Clinic, is in the process of being transferred to Anixa. The DTA will allow for the transfer of all relevant data and information, collected and generated from the Phase 1 clinical trial, to Anixa.

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against α-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein.

"Execution of the DTA represents a significant step in the transfer of IND sponsorship to Anixa. We look forward to completing the remaining steps with Cleveland Clinic, and eventually advancing to a Phase 2 trial under our sponsorship," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We are pleased with the progress and preliminary findings from our Phase 1 clinical trial, and are excited about the presentation of the final Phase 1 data, by Cleveland Clinic, at the San Antonio Breast Cancer Symposium on December 11."

(Press release, Anixa Biosciences, NOV 5, 2025, View Source [SID1234659490])