On June 3, 2025 Incyte (Nasdaq:INCY) reported that data from numerous programs in its hematology/oncology portfolio will be presented at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) congress, held June 12 – 15, 2025, in Milan (Press release, Incyte, JUN 3, 2025, View Source [SID1234653694]).

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"We’re looking forward to presenting new data from across our hematology/oncology portfolio at the 2025 EHA (Free EHA Whitepaper) Congress, including late-breaking data for our first in class, mutCALR-directed monoclonal antibody, INCA033989," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "We believe the data that will be presented at the late-breaking session demonstrate the impact of the novel mechanism of action of this monoclonal antibody against mutCALR-driven essential thrombocythemia (ET), and support its potential to be a disease modifying agent and thus transform the treatment of patients with myeloproliferative neoplasms (MPNs) like essential thrombocythemia (ET)."

Key Incyte abstracts accepted for presentation at EHA (Free EHA Whitepaper) include:

Late-Breaking Oral Presentation

INCA033989 (mutCALR)

INCA33989 is a Novel, First in Class, Mutant Calreticulin-Specific Monoclonal Antibody That Demonstrates Safety and Efficacy in Patients with Essential Thrombocythemia (ET)
(Session Title: Late-Breaking Oral Session. June 15, 3:15 – 4:45 a.m. EDT [9:15-10:45 a.m. CEST]. Abstract #LB4002.)

Oral Presentations

INCA035784 (mutCALR)

INCA035784, a Novel, Equipotent T Cell Redirecting Antibody for Patients with Myeloproliferative Neoplasms Carrying Different Types of Calreticulin Mutations
(Session Title: Novel and Experimental Approaches to Study and Treat MPN. June 15, 5:30 – 5:45 a.m. EDT [11:30 – 11:45 a.m. CEST]. Abstract #S212.)

Ruxolitinib

Clinical Outcomes in Patients with Myelofibrosis Treated with Ruxolitinib and Anemia Supporting Medications
(Session Title: Assessment of Risk and Survival in MPN. June 13, 11:45 a.m. – 12:00 p.m. EDT [5:45 – 6:00 p.m. CEST]. Abstract #S218.)

Tafasitamab

Tafasitamab (tafa) Plus Lenalidomide (len) and Rituximab (R) for Patients with Relapsed or Refractory Follicular Lymphoma (R/R FL): Results from the Phase 3 inMIND Study
(Session: Indolent and Mantle-Cell Non-Hodgkin Lymphoma – Clinical. June 14, 11:00 – 11:15 a.m. EDT [5:00 – 5:15 p.m. CEST]. Abstract #S230.)

Poster Presentations

Axatilimab

Trial in Progress: A Randomized, Open-Label, Phase 3 Study of Axatilimab Versus Best Available Therapy in Patients with Chronic Graft-Versus-Host Disease After ≥2 Prior Lines of Systemic Therapy
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1090.)

Dynamics of Overall and Organ-Specific Responses to Axatilimab in Chronic Graft-Versus-Host Disease: Analysis from the AGAVE-201 Study
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1035.)

Correlations of Clinician-Reported Responses with Other Response Measures in Patients with Chronic Graft-Versus-Host Disease: An Analysis From the AGAVE-201 Trial
(Session: Poster Session 1. June 13 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1041.)

The Effects of Prior Lines of Therapy on Clinical Outcomes for Patients with Chronic Graft-Versus-Host Disease Receiving Axatilimab: A Post Hoc Analysis of AGAVE-201
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS2029).

INCB057643 (BET)

Bromodomain and Extra-Terminal (BET) Protein Inhibitor, INCB057643, Improves Bone Marrow Function and Shifts Megakaryopoiesis to Erythropoiesis in Patients with Myeloproliferative Neoplasms (MPNs)
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF801.)

INCB057643, a Bromodomain and Extra-Terminal Protein Inhibitor, Has Novel Roles in Myeloid Cell Regulation and Immunosuppressive Tumour Environment Remodelling in Myelofibrosis
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1805.)

Safety and Efficacy of Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 in Patients (pts) with Relapsed or Refractory Myelofibrosis (MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1822.)

Ponatinib

Impact of Ponatinib Treatment on Pregnancy Outcomes
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1598.)

Ruxolitinib

JAK2 V617F VAF and Presence of Copy Neutral-LOH at Chromosome 9p (chr9p) Predicts Transformation to Myelofibrosis (MF) in Patients with Polycythemia Vera (PV) Enrolled in REVEAL
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF819.)

Clinical and Gene Expression Patterns Associated with Disease Progression in Patients with Low-Risk Myelofibrosis Enrolled in the Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1808.)

Tafasitamab

CD19 Expression is Retained in Patients with Relapsed/Refractory Follicular or Marginal Zone Lymphoma After Receiving Tafasitamab, Lenalidomide and Rituximab in the inMIND Study
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1006.)

Tafasitamab plus Lenalidomide and Rituximab in Relapsed or Refractory Follicular Lymphoma: A Post Hoc Analysis of Outcomes by POD24 Status from the inMIND Study
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1877.)

More information regarding the 2025 EHA (Free EHA Whitepaper) Congress can be found at: View Source

Conference Call and Webcast

Incyte will host an in-person analyst and investor event on Sunday, June 15, 2025 from 6:00 – 7:30 a.m. ET (12:00 – 1:30 p.m. CEST) to discuss key mutCALR data being presented at EHA (Free EHA Whitepaper).

The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 30 days.

About Mutations in Calreticulin (mutCALR)

Calreticulin (CALR) is a protein involved in the regulation of cellular calcium levels and normal protein production. Somatic, or non-inherited, DNA mutations in the CALR gene (mutCALR) can result in abnormal protein function and lead to the development of myeloproliferative neoplasms (MPNs),1 a closely related group of clonal blood cancers in which the bone marrow functions abnormally, overproducing blood cells.2,3 Among two types of MPNs, essential thrombocythemia (ET) and myelofibrosis (MF), mutCALR drives 25-35% of all cases.2,3

Incyte is at the forefront of developing novel therapies for patients with mutCALR ET or MF that target only malignant cells, sparing normal cells, including INCA033989, a first-in-class, mutCALR-specific therapy.

About Jakafi (ruxolitinib)

Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is a registered trademark of Incyte.

About Tafasitamab (Monjuvi)

Tafasitamab (Monjuvi) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.

In the United States, Monjuvi (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

About Niktimvo (axatilimab-csfr)

Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

Niktimvo is a trademark of Incyte.

All other trademarks are the property of their respective owners.

About Iclusig (ponatinib) tablets

Iclusig (ponatinib) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

On June 3, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the presentation of new results from the CALLA phase 3 study showing for the first time its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test detected cervical cancer progression, up to 16 months ahead of imaging (Press release, Personalis, JUN 3, 2025, View Source [SID1234653693]). The results demonstrate the potential of NeXT Personal to enable earlier detection in a cancer with high recurrence rates.

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The results were presented yesterday by Jyoti Mayadev, MD, from the University of California San Diego, at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting in Chicago in an oral presentation titled "Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses." The results from this study were also simultaneously published in the journal Annals of Oncology.

Samples were analyzed from patients with cervical cancer who had enrolled in the original CALLA clinical trial. In this new study analysis, NeXT Personal was used to look for small traces of ctDNA in blood samples from a cohort of 186 patients with locally advanced cervical cancer. Dr. Mayadev’s team found that overall ctDNA levels after chemoradiotherapy (CRT) treatment were strongly predictive of risk of cervical cancer progression.

"Despite standard chemoradiotherapy, up to half of patients with locally advanced cervical cancer relapse, underscoring the urgent need for better prognostic tools. In the CALLA phase 3 study, ultrasensitive, tumor-informed ctDNA analysis emerged as a powerful predictor of progression and survival—detecting relapse up to ~16 months before imaging. These findings highlight ctDNA’s potential to guide treatment decisions and personalize care in high-risk cervical cancer," said Dr. Mayadev.

Key findings presented:

Detection of ctDNA following CRT was independently prognostic of patient outcomes.
Risk of progression and death were at least 95% lower for patients where ctDNA was not detected ~3 months after completing CRT.
Detection of ctDNA after CRT was associated with high subsequent risk of disease progression, and was detected a median of ~5 months and up to ~16 months earlier than by imaging scans.
High ctDNA levels (≥ median) at baseline was associated with higher risk of progression and death.
"We are excited to see the results presented for NeXT Personal in this large phase 3 study in cervical cancer," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "Cervical cancer is the fourth most common cancer for women globally, resulting in hundreds of thousands of deaths each year. The new results show the strong potential for an ultrasensitive MRD test like NeXT Personal to inform treatment for cervical cancer patients."

On June 3, 2025 Bayer reported that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC) (Press release, Bayer, JUN 3, 2025, View Source [SID1234653692]). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction of 46% in the risk of radiographic progression or death (rPFS) for those treated with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT (hazard ratio [HR] 0.54; 95% CI 0.41-0.71; p<0.0001).1

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The randomized, double-blind, placebo-controlled Phase III ARANOTE trial was designed to assess the efficacy and safety of NUBEQA plus ADT in patients with mCSPC.1 A total of 669 patients were randomized 2:1 to receive either 600 mg of NUBEQA (N=446) or placebo (N=223) twice daily in addition to ADT.1

NUBEQA is indicated in the U.S. for the treatment of adult patients with mCSPC, both with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2

"Clinical data from the ARANOTE trial supporting this new regimen showed that NUBEQA plus ADT demonstrated powerful efficacy in men with mCSPC," said Fred Saad, M.D., Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM) and principal investigator of the ARANOTE trial. "Today’s approval further expands physicians’ options for using NUBEQA with and without docetaxel in this setting, providing a potential new choice for patients."

Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3 In 2020, an estimated 1.4 million men worldwide were diagnosed with prostate cancer, including nearly 300,000 in the U.S., and about 375,000 men died from the disease worldwide.4,5 Prostate cancer diagnoses are projected to increase to 2.9 million worldwide by 2040.6

"This approval, which is supported by strong clinical data, reaffirms NUBEQA as an important therapy for men with prostate cancer and underscores our commitment to delivering meaningful outcomes for patients and their families," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "We thank the scientists, doctors, patients and their families who made it possible to provide this new treatment option for metastatic castration-sensitive prostate cancer."

Results from the Phase III ARANOTE trial, presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and published in The Journal of Clinical Oncology.1 Results of the radiographic progression-free survival (rPFS) analysis were consistent across prespecified subgroups, including a 40% risk reduction (HR 0.60, 95% CI: 0.44-0.80) with NUBEQA plus ADT in patients with high-volume mCSPC and a 70% risk reduction (HR 0.30, 95% CI: 0.15-0.60) in patients with low-volume disease.1

The results were consistent with the established safety profile of NUBEQA. Rates of serious adverse events were similar between the treatment arms (24% for NUBEQA plus ADT compared to 24% for placebo plus ADT).1,2 Discontinuation due to treatment-emergent adverse events (TEAEs) was 6% for patients treated with NUBEQA plus ADT compared to 9% in patients receiving placebo plus ADT.1,2

About the ARANOTE Trial7

The randomized, double-blind, placebo-controlled Phase III ARANOTE trial study assessed the efficacy and safety of NUBEQA plus ADT in patients with mCSPC. A total of 669 patients were randomized to receive 600 mg of NUBEQA twice daily or matching placebo in addition to ADT.

The primary endpoint was rPFS, measured as time from randomization to date of first documented radiographic progressive disease or death due to any cause, whichever occurs first.

About NUBEQA (darolutamide)2

NUBEQA (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.

NUBEQA was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:

Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic castration-sensitive prostate cancer (mCSPC)
Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel
IMPORTANT SAFETY INFORMATION

Warnings & Precautions

Ischemic Heart Disease – Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo.

In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 0% receiving placebo with docetaxel.

Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – Seizure occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA.

In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA.

It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – The safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo. Fatal adverse reactions that occurred in ≥2 patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST (23%), decreased neutrophil count (20%), fatigue (16%), increased bilirubin (16%), pain in extremity (6%), and rash (4%). Clinically relevant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4%) and heart failure (2.1%).

In ARANOTE, serious adverse reactions occurred in 24% of patients receiving NUBEQA. Serious adverse reactions in ≥1% of patients who received NUBEQA included pneumonia (2%), urinary tract infection (1.8%), musculoskeletal pain (1.6%), hemorrhage (1.6%), arrhythmias (1.3%), and spinal cord compression (1.1%). Fatal adverse reactions occurred in 4.7% of patients receiving NUBEQA and those that occurred in ≥2 patients included sepsis (1.1%), craniocerebral injury (0.4%), and myocardial infarction (0.4%). The most common (≥10% with a ≥2% increase compared to placebo) adverse reaction is urinary tract infection (12%). The most common laboratory test abnormalities (≥15% with a ≥5% increase over placebo) are increased AST (32%), increased ALT (28%), increased bilirubin (17%), and decreased neutrophil count (16%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA included arrhythmia (8.8%), pneumonia (3.6%), and myocardial infarction (0.7%).

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), neutrophil count decreased (2.8%), musculoskeletal pain (2.6%) and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. Fatal adverse reactions in ≥2 patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation (23%), rash (20%), decreased appetite (19%), hemorrhage (18%), increased weight (18%), and hypertension (14%). The most common laboratory test abnormalities (≥30%) are anemia (72%), hyperglycemia (57%), decreased lymphocyte count (52%), decreased neutrophil count (49%), increased AST (40%), increased ALT (37%), and hypocalcemia (31%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures (8%), ischemic heart disease (3.2%), seizures (0.6%), and drug-induced liver injury (0.3%).

Drug Interactions

Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and Cmax of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug.

NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Castration-Sensitive Prostate Cancer

Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3 In 2020, an estimated 1.4 million men worldwide were diagnosed with prostate cancer, including nearly 300,000 men in the U.S., and nearly 375,000 men died from the disease worldwide.4,5

At the time of diagnosis, most men have localized prostate cancer, in which their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this castration-sensitive, or hormone-sensitive, disease. Approximately 10% of men will already present with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), when first diagnosed.8,9,10 Men with mCSPC will start their treatment with hormone therapy, such as ADT, an androgen receptor inhibitor (ARi) plus ADT, or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mCSPC will eventually progress to castration-resistant prostate cancer (CRPC), which is associated with limited survival.

On June 3, 2025 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") reported a summary of current operating initiatives including the integration and disposition of assets acquired in February 2024 from the former IMV, Inc., the non-exclusive out-licensing of DPX to human and animal health companies, restarting clinical studies—notably DPX-surMAGE in advanced bladder cancer, expansion of the BioVaxys pipeline a through new formulations based on the DPX immune educating platforms, progress from our licensees, and most recently, the mitigation of risk through the significant reduction of a performance milestone provision in the Asset Purchase Agreement (APA) with Horizon Technology Finance Corp., and the engagement of D12 Capital Markets Inc. and its affiliate, Foundation Markets Inc., to act as agents in connection with a brokered private placement of minimum gross proceeds of $2,000,000 and maximum gross proceeds of up to $3,000,000 (Press release, BioVaxys Technology, JUN 3, 2025, View Source [SID1234653691]).

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Over the next year, the Company’s focus is on driving organic pipeline growth by:

Expanding its early-stage pipeline by pursuing multiple out licensing opportunities and research collaborations where the Company’s DPX platform can address specific needs (such as for a prophylactic food allergy vaccine and the collaboration with Sona Nanotech to develop novel cancer therapies), or antigen delivery limitations faced by LNPs (e.g. mRNA vaccines and neoantigen delivery);
Reducing internal risk & the considerable funding requirements of late-stage clinical studies by out-licensing maveropepimut-S (MVP-S) for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma and Ovarian Cancer, seeking a co-development partner for DPX-RSV, and pursuing non-dilutive funding for further advancement of the DPX-FLU (influenza) and DPX-anthrax vaccines.
Re-engagement of investigators at CHU de Québec-Université Laval and La Fondation du CHU de Québec, for a restart of the phase 1 study of DPX-surMAGE in advanced bladder cancer.
BioVaxys stands at the forefront of innovation with its mission to develop advanced treatments in oncology, infectious disease, antigen desensitization, allergy, autoimmune diseases, and other immune dysfunction based on its DPX antigen delivery and immune-educating technology platform. The DPX platform has been proven safe, well tolerated, and effective in multiple preclinical, phase 1, and phase 2b clinical studies. Through a differentiated mechanism of action, the DPX platform is a major innovation in vaccine development that is a solution for the limitations faced by vaccines using other antigen delivery methods. The DPX platform provides a new and singularly unique way to deliver active ingredients to the immune system using a novel mechanism of action that does not release active ingredients at the site of the injection, but rather forces an active uptake of immune cells and delivery into the lymphatic nodes. The programming of immune cells happens in vivo and offers a more efficient approach that mimics the natural function of the immune system. The Company’s late-stage clinical stage pipeline includes MVP-S in phase 2b clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and an innate immune activator and a universal CD4 T-cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific, anti-tumor immune response.

Results from a phase 1b/2 study of MVP-S in combination with low-dose cyclophosphamide in patients with recurrent ovarian cancer showed that this combination was well-tolerated and generated an overall response rate of 21% and a disease control rate of 63%. Notably, the response was observed in both platinum-resistant and platinum-sensitive patients. MVP-S, plus the immunotherapy drug Keytruda (pembrolizumab), also showed promising results in the treatment of patients with relapsed/refractory DLBCL, according to findings from a phase 2b study. The study analyzed MVP-S plus Keytruda and cyclophosphamide—including eight patients with relapsed/refractory DLBCL—whose functioning has been minimally affected, if at all, by their disease. Three of the six patients in the study arm experienced confirmed complete responses, meaning that there was no trace of their cancer left after treatment (2/8 of the patients had progressive disease). Kenneth Kovan, BioVaxys President & Chief Operating Officer, stated "The clinical data from MVP-S is very compelling and we think the vaccine can become a valuable tool in cancer immunotherapy. The significant investment for internal development of a later-stage program is such that it makes more sense for remaining clinical studies with MVP-S to be pursued by a company with the appropriate resources. Without going into detail, we are in early discussions with prospective licensors to achieve this objective."

The Company also has data from phase 1 studies with DPX+surMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. Survivin and MAGE-A9 are well characterized tumor-associated antigens frequently overexpressed in bladder tumors. Kovan further stated "We are working with the Principal Investigators at Laval University that conducted the foundational research on the surMAGE antigen combination to continue the previous phase 1 bladder cancer study. Our goal together with the investigators is to see this study funded and started in the upcoming months." The current DPX-surMAGE data has been submitted for presentation later this year at a major cancer conference.

BioVaxys is seeking a partner for further clinical development of its DPX-RSV for Respiratory Syncytial Virus, which successfully completed a phase 1 human study for safety and efficacy. DPX-RSV demonstrated antigen-specific immune responses in 93% of subjects, with100% of responders in a 25μg single-dose cohort maintaining antigen-specific immunity one year post vaccination. Currently available RSV vaccines including GSK’s Arexvy, Moderna’s mResvia, and Pfizer’s Abrysvo target either the F or G proteins of the virus and provide protection by neutralizing the RSV virus. Clinical measures of efficacy focus on the amount of neutralizing antibodies in the bloodstream. DPX-RSV works differently, as it targets the SH viral ectodomain of the RSV virus and, instead of neutralizing the virus, it enables the immune system to recognize and destroy RSV-infected cells.

Completed BioVaxys preclinical proof of concept studies include DPX-rHA/DPX-FLU, an influenza vaccine candidate of recombinant hemagglutinin (whole protein ~300 amino acids) / whole heat killed virus package in DPX, and DPX-rPA, an and an anthrax vaccine consisting of DPX+ recombinant anthrax protective antigen. Animal challenge studies performed with lethal anthrax respiratory exposure levels with our DPX-based anthrax vaccine demonstrated 100% immunity following a single injection compared to current vaccines which require more than one dose. Kovan stated "We are looking for the right non-dilutive opportunities to further advance the clinical development of DPX-rHA/DPX-FLU with an even broader range of antigens. With DPX-rPA, we think it possible that with the excellent preclinical data, together with the clinical experience with DPX, might be sufficient to pursue registration "

Pipeline Expansion

Current research collaborations to expand the Company pipeline include a collaboration with AP Visionaries, Inc. of Ontario ("APVI") to jointly develop a proprietary DPX formulation to address the urgent need for a therapy to treat or alleviate the potentially life-threatening risk of certain food allergies, namely those triggered by exposure to peanut/tree nuts or eggs. Animal studies are slated to begin later this year when DPX-peanut antigen formulation is complete at The Schroeder Allergy and Immunology Research Institute of McMaster University in Ontario, an institute that consolidates clinicians, scientists, and data specialists in a one-stop shop to research the causes of life-threatening allergies and develop new treatments. Under the terms of the Collaboration, BioVaxys will provide funding for the preclinical study to evaluate in animal models the robustness of DPX antigen delivery and evaluate whether DPX transforms the underlying immunopathology of food allergy. APVI will oversee the preclinical program, with BioVaxys retaining all intellectual property rights to any resulting product. APVI will receive a royalty from BioVaxys on any gross sales from a resulting product, in addition to a milestone payment at first regulatory approval.

On May 7, 2025, the Company and Sona Nanotech Inc. ("Sona") jointly announced that they entered into a research agreement to collaborate on the development of new cancer therapeutics based on the Company’s DPX Immune Educating Platform in combination with Sona’s Targeted Hyperthermia Therapy, a photothermal cancer therapy that uses highly targeted infrared light and intra-tumoral gold nanorods to treat solid tumors. The collaboration will evaluate the immune stimulatory properties of DPX (without an antigen cargo) administered together with THT, as a characteristic of DPX is that it helps prime the innate immune system which in turn can activate and strengthen the adaptive immune response. The collaboration will also evaluate the combination use of THT together with a DPX formulation as a carrier for novel neoantigens expressed on the surface of tumor cells following immunotherapy, such as with THT. Neoantigens are unique proteins that are not present in healthy tissues that arise from changes in cancer cells and play a crucial role in stimulating anti-tumor immune response. Immunotherapy such as THT can trigger these tumor cell changes and the expression of neoantigens, so packaging a tumor neoantigen in DPX for presentation to the immune system is anticipated to accelerate THT’s efficacy. The research studies based on the BioVaxys and Sona technologies will be conducted at Dalhousie University, Halifax, Nova Scotia, under the direction of Sona’s CMO, Carman Giacomantonio, MD MSc FRCSC, Division of General and Gastrointestinal Surgery, Department of Pathology, Dalhousie University, and Barry Kennedy, PhD, of the Giacomantonio Immuno-Oncology Research Group at Dalhousie University.

Other collaborations and licensing discussions are being finalized for expanding DPX formulations in the treatment of Zika virus.

Licensing

The Company has revenue generating licenses with Zoetis Inc. and SpayVac-for-Wildlife, Inc. for vaccines in the animal health field based on the Company’s lipid encapsulation technology, with both licensors making excellent progress towards commercialization.

SpayVac anticipates regulatory approval for a pZP immunocontraceptive vaccine for feral horses in the US, with supplemental regulatory submissions planned for the EU and Australia. Ongoing research with other antigens is targeting commercial aquaculture, companion animals, and other applications. On April 22, 2025, the Company announced the expansion of the Fields of Use in the current License Agreement with SpayVac to include commercial aquaculture, plus the farm-raised fish market, which will further increase BioVaxys’ royalty revenue.

Zoetis is preparing for regulatory submission for a pZP immunocontraception vaccine based on the Company’s lipid encapsulation technology for cattle in Australia and Brazil.

Recent News

In a significant step to minimize risk, BioVaxys and Horizon Technology Finance Corporation ("Horizon") executed last month a follow-on Amendment ("Amendment") to the Asset Purchase Agreement dated February 11th, 2024 ("APA") for BioVaxys to acquire the entire portfolio of assets and intellectual property based on the DPX immune educating platform technology developed by Canadian biotechnology company, IMV Inc. The May 2025 Amendment lowers a performance milestone provision in the original APA for BioVaxys to demonstrate an aggregate capital raise of USD $10M, so that the new net performance milestone required to be raised in any form (including, but not limited to equity, grants, licensing fees, or loans) is now significantly lowered to USD $2,028,636. If BioVaxys is successful in meeting this milestone by September 30, 2025, the milestone requirement shall end and be of no further force or effect.

To help support its objectives, on May 22, 2025, the Company announced a proposed consolidation of the common shares of the Company on the basis of ten (10) pre-consolidation Common Shares for one (1) post-consolidation Common Share. As at May 22, 2025, the Company has 293,425,203 Common Shares issued and outstanding. James Passin, CEO of BioVaxys, stated "The share consolidation is a necessary step to attract the institutional capital necessary for business development as well as to tighten up the float to increase the likelihood of sustained share appreciation on future catalysts."

Immediately following the Consolidation and excluding the Common Shares to be issued in connection with this Offering, will have approximately 29,342,520 Common Shares issued and outstanding, prior to rounding of fractional Common Shares.

On June 3, 2025 AbbVie (NYSE: ABBV) reported that it will participate in the Goldman Sachs 46th Annual Global Healthcare Conference on Tuesday, June 10, 2025 (Press release, AbbVie, JUN 3, 2025, View Source [SID1234653690]). Management will participate in a fireside chat at 10:20 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.