On November 24, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the European Commission (EC) has granted approval to Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

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"This approval for Breyanzi in relapsed or refractory mantle cell lymphoma marks another important step as we continue to deliver on the promise of cell therapy for more eligible patients across Europe – the fourth approval for Breyanzi in Europe," said Emma Charles, senior vice president, Europe Region, Bristol Myers Squibb. "While frontline therapies have advanced over the years for this rare but aggressive form of non-Hodgkin lymphoma, the vast majority of patients relapse or become resistant and face reduced survival outlook, leaving a critical need for new treatment options. Breyanzi has the opportunity to address a treatment gap for this patient population based on its demonstrated clinical benefit."

The decision is based on results from the MCL cohort of TRANSCEND NHL 001, which enrolled adult patients with relapsed or refractory MCL who had received at least two prior lines of therapy including a BTK inhibitor. Among patients treated in the third-line plus setting, Breyanzi demonstrated a high overall response rate of 82.7% (95% CI: 72.7–90.2) and complete response (CR) rate of 71.6% (95% CI: 60.5–81.1), the study’s primary and key secondary endpoints, respectively. Responses were rapid and demonstrated sustained efficacy, with a median time to first response (CR or partial response (PR)) of 0.95 months (range: 0.7 to 3.0 months) and 50.8% (95% CI: 29.2–52.9) of patients still in response at 24 months.

Safety results were consistent with the well-established safety profile of Breyanzi observed across clinical trials and approved indications, with a predictable safety profile observed in MCL with early resolution. The majority of cytokine release syndrome (CRS) and neurologic toxicities developed during the first 14 days post infusion, reinforcing recent adjustments to short term monitoring requirements. For patients who received Breyanzi for MCL in the TRANSCEND NHL 001 trial, CRS occurred in 61% of patients, with only 1% of patients experiencing grade three or four CRS. The median time to onset was four days (range: 1 to 10 days). Any grade neurologic toxicities occurred in 31% of patients, including grade three or four in 9% of patients. The median time to onset of the first event was eight days (range: 1 to 25 days).

This expanded approval is applicable to all European Union (EU) member states as well as the European Economic Area (EEA) countries Iceland, Norway and Liechtenstein.* Breyanzi is also approved in the EU for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy, and for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of systemic therapy, and for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

*Centralized Marketing Authorization does not include approval in the United Kingdom (UK).

About TRANSCEND NHL 001

TRANSCEND NHL 001 (NCT02631044) is an open-label, multicenter, pivotal, Phase 1, single-arm, seamless-design study to determine the safety, pharmacokinetics and antitumor activity of Breyanzi in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B and mantle cell lymphoma. The primary outcome measures are treatment-related adverse events, dose-limiting toxicities and overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival.

About MCL

Mantle cell lymphoma (MCL) is an aggressive, rare form of non-Hodgkin lymphoma (NHL), representing roughly 3% of all NHL cases. MCL originates from cells in the "mantle zone" of the lymph node. MCL occurs more frequently in older adults with an average age at diagnosis in the mid-60s, and it is more often found in males than in females. In MCL, relapse after initial treatment is common, and for most, the disease eventually progresses or returns.

About Breyanzi

Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. The treatment process includes blood collection, CAR T-cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring.

Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) after two or more prior lines of systemic therapy, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy. Breyanzi is also approved in Japan, the European Union (EU), Switzerland, Israel, the United Kingdom, and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy, and in patients with relapsed or refractory FL after two or more lines of systemic therapy; and in the EU, Switzerland and the UK for the treatment of relapsed or refractory FL after two or more lines of systemic therapy.

Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in other types of lymphoma. For more information, visit clinicaltrials.gov.

The European Summary of Product Characteristics for Breyanzi will be available from the European Commission and EMA websites at www.ema.europa.eu.

Breyanzi U.S. FDA-Approved Indications

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
U.S. Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
Cytokine Release Syndrome

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache.

Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.

In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS.

The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily for at least 7 days following BREYANZI infusion at a REMS-certified healthcare facility for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI.

Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines.

Adverse Reactions

The most common adverse reaction(s) (incidence ≥30%) in:

LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.

(Press release, Bristol-Myers Squibb, NOV 24, 2025, View Source [SID1234660890])

On November 24, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV)(FSE: 7JO0) a biopharmaceutical company advancing cancer therapies through AI-enabled drug discovery, reported impressive results from its AI-enabled ATR program at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting which took place November 19-23 in Honolulu, Hawaii.

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The poster, titled "Discovery and development of a novel CNS-penetrating ATR inhibitor: Dual inhibition of ATR and mTOR in PTEN-deficient tumors," highlights the discovery and early characterization of novel ATR/mTOR dual inhibitors designed using the Enki generative AI platform. The compounds are engineered to modulate two well-established cancer-driving pathways that, despite their importance, have never before been combined in a single therapeutic agent. Notably, Rakovina’s lead molecules were designed specifically to cross the blood–brain barrier and reach tumor cells within the central nervous system, supporting their potential relevance in primary brain cancers and cancers with a high risk of brain metastasis.

Rakovina’s senior management team presented the findings showing that the AI-discovered ATR+mTOR inhibitors achieve meaningful CNS penetration, addressing a key limitation of current clinical ATR inhibitors, which have poor CNS distribution. In direct comparisons, multiple Rakovina compounds showed >50% ATR inhibition at 1 µM and exhibited equal or greater enzymatic potency than leading ATR inhibitors ceralasertib, tuvusertib, and elimusertib, while maintaining similar PIKK-family selectivity.

Importantly, these compounds were engineered with a mechanistic rationale to co-target ATR and mTOR, two pathways on which PTEN-deficient tumors (including those prone to brain metastasis) are highly dependent. By simultaneously blocking ATR-mediated DNA damage response and mTOR-driven survival signaling, these CNS-penetrant inhibitors have the potential to overcome key resistance mechanisms in PTEN-deficient cancers and deliver therapeutic effects not achievable with ATR-only agents.

PTEN deficiency in cancer

PTEN is one of the most frequently lost tumor-suppressor genes in human cancer and serves as a key brake on the PI3K/AKT/mTOR signaling pathway that governs cell growth, metabolism, and survival. Its loss promotes unchecked proliferation, genomic instability, therapy resistance, and aggressive tumor progression.

PTEN deficiency is particularly prevalent in cancers with a high propensity for CNS spread, including ovarian, lung, breast, and melanoma – where tumor cells rely heavily on mTOR-driven growth and survival. In these settings, mTOR becomes an adaptive escape pathway, especially under ATR inhibition, allowing PTEN-deficient tumors to accelerate growth and diminish the effectiveness of ATR-only therapeutic strategies.

Prevalence of PTEN deficiency and CNS metastases in major cancers
Cancer type Approximate frequency of PTEN loss Est. CNS Metastases Prevalence
Lung cancer ~ 35-55 % ~55% in NSCLC
Breast cancer ~ 30-40 % ~40%
Prostate cancer ~ 25-50 % ~8%
Colorectal cancer ~ 10-40 % ~6%
Ovarian cancer ~ 30-50 % ~5%
Endometrial carcinoma ~ 50 % 1-2%
Glioblastoma (brain) ~ 80-85 % n/a (primary brain tumor
Using the ENKI generative AI platform, the Company designed a virtual library of 138 predicted compounds, from which, 43 priority molecules were synthesized for evaluation in biochemical and cellular assays. Multiple compounds demonstrated >50% inhibition of recombinant ATR at 1 µM and exhibited potency comparable to or exceeding ATR inhibitors currently in development including ceralasertib, tuvusertib, and elimusertib.

Pharmacokinetic profiling in mice following a single 5 mg/kg intraperitoneal dose revealed favorable tolerability, metabolic stability in human liver microsomes, and measurable CNS exposure, supporting further evaluation in brain tumor models.

"Sharing these data at SNO is an important milestone for our ATR/mTOR program," said Prof. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "To our knowledge, no company has previously generated a single small-molecule therapeutic designed to combine ATR and mTOR inhibition with CNS penetration. Seeing generative AI propose compounds with this level of precision gives us a fundamentally new way to address these difficult-to-treat cancers with a high risk of brain involvement."

"The reception to our data at SNO has been very encouraging," added Jeffrey Bacha, executive chairman of Rakovina Therapeutics. "This program showcases how combining Variational AI’s Enki platform with the translational capabilities at the Vancouver Prostate Centre allows us to rapidly pursue differentiated DDR-targeted therapeutics with potential clinical relevance in areas of significant unmet need."

(Press release, Rakovina Therapeutics, NOV 24, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-showcases-compelling-preclinical-data-on-ai-discovered-cns-penetrant-atr-mtor-inhibitors-at-the-2025-society-for-neuro-oncology-annual-meeting [SID1234660906])

On November 24, 2025 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported that three abstracts will be presented at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12.

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The studies collectively highlight the prognostic and predictive power of Artera’s MMAI model to help personalize treatment decisions, particularly in evaluating chemotherapy benefit in post-menopausal women. Leveraging data from four independent Phase III trials across Germany, Austria, and North America, these studies validate the performance of this unique AI model across more than 7,000 patients.

"These abstracts hold tremendous weight as they cover a diverse set of patients with HR+ early breast cancer, giving clinicians a lot of confidence in the validity of these results," said Prof. Nadia Harbeck, Director of the Breast Center at LMU University Hospital in Munich, Germany. "Traditional approaches can result in patients, especially those who are post-menopausal with node-negative tumors, receiving chemotherapy with limited benefit while still facing significant toxicities. It’s exciting to witness the emergence of new technologies that allow us to deliver the optimal breast cancer care."

Approximately 1 in 8 women (13%) in the U.S. will develop invasive breast cancer at some point in their lives, and many face complex treatment decisions. Chemotherapy carries well‑documented side effects, including neuropathy, risk of infection, and, for younger women especially, infertility and impaired fertility potential. These risks underscore the need for tools that help clinicians tailor treatment decisions, ensuring each patient receives care that is necessary, appropriate, and aligned with their unique clinical profile.

"Advancing precision medicine means ensuring every patient can benefit from individualized care," said Andre Esteva, CEO of Artera. "As we validate this technology across countries and cancer types, we’re showing that precision medicine can be more personalized and accessible while helping clinicians avoid unnecessary treatments without added time, cost, or complex processes."

Presentations at SABCS 2025

Poster Spotlight 11 (PD11-01) Development of a Multi-Modal Artificial Intelligence (MMAI) Model for Predicting Distant Metastasis in HR+ Early-Stage Invasive Breast Cancer (Abstract #1251)

Demonstrates the development of Artera’s MMAI model using data from over 12,000 patients enrolled in six Phase III clinical trials conducted in the United States, Germany, and Austria. The model effectively stratifies patients by 10-year risk of distant metastasis, identifying high-risk individuals who may benefit from closer monitoring, while 68% of patients were classified as low-risk and achieved an estimated 10-year DM-free survival of approximately 95%. These findings show the model’s potential to provide actionable prognostic information across diverse, international populations.

Poster Session 3 (PS3-04-08) Independent Validation of a Pathology-Based Multimodal Artificial Intelligence Biomarker for Predicting Risk of Distant Metastasis in Postmenopausal, Estrogen Receptor-Positive, Early-Stage Breast Cancer Patients: Analysis of the ABCSG Trial 8 (Abstract #1410)

Focuses on postmenopausal patients in the ABCSG 8 trial, a prospective study of individuals receiving endocrine therapy only. MMAI successfully classified patients into low, intermediate, and high-risk groups, with corresponding 10-year DM-free survival rates of roughly 95%, 89%, and 77%, respectively. Validation confirmed robust performance across clinical subgroups, including lymph node status, tumor grade, histology, and proliferation markers. The study further highlights the advantages of MMAI as a non-tissue-destructive, fast-turnaround test, providing an accessible alternative to more costly genomic assays.

Rapid Fire 3 (RF3-03) Evaluation of a digital pathology-based multimodal artificial intelligence model for prognosis and prediction of chemotherapy benefit in node-negative, hormone receptor-positive breast cancer patients: analysis of the NSABP B-20 trial. (Abstract #3685)

Evaluates MMAI’s ability to predict benefit from chemotherapy in node-negative HR+ patients in the NSABP B-20 trial. Among patients aged 50 and older, MMAI high-risk individuals experienced a 52% relative reduction in 10-year DM with chemotherapy, while MMAI low-risk patients derived no additional benefit. These findings demonstrate MMAI’s potential to guide personalized treatment decisions, helping clinicians avoid unnecessary chemotherapy for low-risk patients while identifying high-risk patients who are most likely to benefit.

Artera will be exhibiting at booth #1525 during SABCS, where attendees can learn more about the MMAI platform and the ArteraAI Breast Test.

(Press release, Artera, NOV 24, 2025, View Source [SID1234660922])

On November 24, 2025 Bristol Myers Squibb (NYSE: BMY) reported that, following the conclusion of the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, the company will hold a virtual investor event on Thursday, December 11, 2025, to highlight key Hematology programs.

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The company will host a webcast beginning at 9:00 a.m. ET, which is accessible here. Company representatives will provide investors and analysts an overview of the company’s Hematology development strategy and review recent data.

A replay of the webcast will be available at View Source approximately three hours after the event concludes. Materials related to the webcast will be available at View Source at the start of the presentation.

(Press release, Bristol-Myers Squibb, NOV 24, 2025, View Source [SID1234660891])

On November 24, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV)(FSE: 7JO0) a biopharmaceutical company advancing cancer therapies through AI-enabled drug discovery, reported that a second scientific abstract from its research and development programs was presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting, which took place November 19-23 in Honolulu, Hawaii.

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The poster titled "Discovery and development of novel CNS-penetrating PARP1-selective inhibitors," was developed in collaboration with investigators at the Vancouver Prostate Centre and the University of British Columbia, describes the Company’s work applying artificial-intelligence (AI) methods to the discovery and early characterization of novel, PARP1-selective small-molecule drug candidates with properties consistent with central nervous system (CNS) penetration.

The presentation outlines the use of Deep Docking and generative-AI computational approaches to virtually screen large chemical libraries and identify compounds predicted to demonstrate selective inhibition of PARP1, favourable drug-like properties, and characteristics supportive of CNS exposure.

According to the data reported, hundreds of prioritized compounds have been synthesized and evaluated in biochemical assays. A subset demonstrated PARP1-selective activity, as well as in vitro metabolic-stability and pharmacokinetic profiles that will inform additional optimization and testing. Examples of ADME and pharmacokinetic data from the first round of synthesized compounds, including comparisons with existing PARP inhibitors and next-generation benchmark compounds, were also presented.

Prof. Mads Daugaard, President of Rakovina Therapeutics, commented: "The data generated to date provide early insight into our AI-driven discovery platform and its ability to prioritize compounds with the features we are seeking, including PARP1 selectivity and properties supportive of CNS penetration. These results demonstrate timely progress of our PARP1-selective inhibitor program and validate our iterative AI approach."

This SNO 2025 presentation represents the second abstract from Rakovina Therapeutics at the conference and reflects the Company’s ongoing research efforts in the field of DNA-damage-response (DDR) therapeutics.

(Press release, Rakovina Therapeutics, NOV 24, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-inc-announces-presentation-of-second-abstract-at-the-2025-society-for-neuro-oncology-annual-meeting [SID1234660907])