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.

On June 3, 2025 Johnson & Johnson reported first results from the Phase 3, randomized, double-blind, placebo-controlled AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations including BRCA (Press release, Johnson & Johnson, JUN 3, 2025, View Source;johnson-leads-with-first-parp-inhibitor-combo-to-improve-efficacy-in-patients-with-hrr-altered-mcspc-302471320.html [SID1234653689]). The results show a clinically meaningful and statistically significant improvement in both radiographic progression-free survival (rPFS) and time to symptomatic progression (TSP), with an early trend toward improved overall survival (OS)—highlighting the potential of the combination in this patient population to delay both cancer progression and the worsening of symptoms.1 This marks the first Phase 3 data to show clinical improvement with a PARP-based combination in mCSPC. The findings are being presented as a late-breaking oral presentation (Abstract #LBA5006) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data have also been selected for Best of ASCO (Free ASCO Whitepaper) and included in the ASCO (Free ASCO Whitepaper) Press Program.

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"Approximately 25 percent of patients with mCSPC have HRR alterations, with about half being BRCA. These patients typically experience faster disease progression and poorer outcomes," said Gerhardt Attard*, M.D., Ph.D., FRCP, John Black Charitable Foundation Chair of Medical Oncology, University College London Cancer Institute, Research Department of Oncology and presenting author. "The AMPLITUDE trial is the first to show that combining a PARP inhibitor with an androgen receptor pathway inhibitor both delays disease progression and postpones the onset of symptoms in HRR-altered mCSPC, supporting this combination as a new treatment option for these patients."

"Our aim with the AMPLITUDE study was to determine how long patients could live without their cancer worsening. What we found is that the combination of niraparib, abiraterone acetate, and prednisone is achieving just that, with the goal of offering patients precious quality time before the disease enters a more resistant phase," said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, at Johnson & Johnson Innovative Medicine. "This breakthrough highlights the need for early initiation of personalized treatment strategies for patients with mCSPC and HRR alterations, particularly BRCA, who typically face more aggressive disease."

The Phase 3 AMPLITUDE study of 696 patients with mCSPC and HRR alterations met its primary endpoint of rPFS. Patients with BRCA alterations (n=191) showed the greatest benefit of treatment with the combination of niraparib plus AAP, as the median rPFS was not reached compared to 26 months in patients treated with the placebo plus AAP, reducing the risk of radiographic progression or death by 48 percent (hazard ratio [HR] 0.52, 95 percent confidence interval [CI], 0.37-0.72, p<0.0001). In patients with any HRR alteration treated with the niraparib combination, median rPFS was also not reached in comparison to 29.5 months in patients treated with the placebo plus AAP, with a reduction in risk of progression or death by 37 percent (HR 0.63, 95 percent CI, 0.49-0.80, p=0.0001).1

These results also showed that treatment with the niraparib combination reduced the risk of symptomatic progression by 56 percent in patients with BRCA alterations (HR 0.44, 95 percent CI, 0.29-0.68, p=0.0001) and 50 percent in patients with HRR alterations (HR 0.50, 95 percent CI, 0.36-0.69, p<0.0001), meaning that patients experienced a longer delay to worsening symptoms and requiring radiation, surgical intervention, or needing a new anti-cancer therapy. The first interim analysis showed an early trend toward improved overall survival (OS) favoring the niraparib/AAP combination with a reduction in risk of death of 25 percent (HR 0.75, 95 percent CI, 0.51-1.11, p=0.15) in patients with BRCA alterations and 21 percent in HRR alterations (HR 0.79, 95 percent CI, 0.59-1.04, p=0.10); follow-up is ongoing for maturity of the data.1

Grade 3/4 adverse events (AE) were more frequent with the niraparib combination compared to the placebo group (75 percent vs. 59 percent), with anemia and hypertension being the most common; however, treatment discontinuations due to AEs remained low (14.7 percent vs 10.3 percent). To date, the safety profile of niraparib plus abiraterone acetate and prednisone has been consistent with prior experiences.1

New data from the CAPTURE study (Abstract #5094), also being presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting with simultaneous publication in the Annals of Oncology, reinforce that the presence of HRR, specifically BRCA alterations, among patients with mCSPC are associated with significantly worse prognosis. Despite the availability of life-prolonging ARPIs, patients with HRR-altered mCSPC experience approximately 30 percent faster disease progression and shorter survival, while patients with BRCA-altered mCSPC experience approximately 50 percent faster disease progression and shorter survival—highlighting the importance of genetic testing to inform treatment decisions and the urgent need for novel targeted therapies to improve outcomes and delay progression.2

Johnson & Johnson has nearly 20 years of leadership in prostate cancer, treating more than 750,000 patients worldwide. With the AMPLITUDE study, Johnson & Johnson becomes the first to show that a PARP inhibitor combination can benefit patients with mCSPC.3

About AMPLITUDE
AMPLITUDE (NCT04497844) is an ongoing, phase 3, randomized, double-blind, placebo-controlled, international study evaluating the efficacy and safety of niraparib and abiraterone acetate in a dual-action tablet (DAT) formulation with prednisone plus androgen deprivation therapy (ADT) compared to matching oral placebo/abiraterone acetate with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC). The primary endpoint is radiographic progression-free survival (rPFS).

About Metastatic Castration-Sensitive Prostate Cancer
Metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.4

About AKEEGA (niraparib and abiraterone acetate)
AKEEGA is a combination, in the form of a dual-action tablet (DAT), of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor. AKEEGA together with prednisone or prednisolone was approved in April 2023 by the European Medicines Agency, and in August 2023 by the U.S. FDA, for the treatment of patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). Patients are selected for therapy based on an FDA-approved test for genetic alterations. Additional marketing authorization applications are under review across a number of countries globally.

Additional ongoing studies include the Phase 3 AMPLITUDE study evaluating AKEEGA with prednisone or prednisolone in a biomarker-selected patient population with metastatic castration-sensitive prostate cancer (mCSPC).

In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GlaxoSmithKline [GSK] in 2019) for exclusive rights to niraparib in prostate cancer.

For more information visit View Source

AKEEGA IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

The safety population described in the WARNINGS and PRECAUTIONS reflect exposure to AKEEGA in combination with prednisone in BRCAm patients in Cohort 1 (N=113) of MAGNITUDE.

Myelodysplastic Syndrome/Acute Myeloid Leukemia
AKEEGA may cause myelodysplastic syndrome/acute myeloid leukemia (MDS/AML).

MDS/AML, including cases with fatal outcome, has been observed in patients treated with niraparib, a component of AKEEGA.

All patients treated with niraparib who developed secondary MDS/cancer-therapy-related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

For suspected MDS/AML or prolonged hematological toxicities, refer the patient to a hematologist for further evaluation. Discontinue AKEEGA if MDS/AML is confirmed.

Myelosuppression
AKEEGA may cause myelosuppression (anemia, thrombocytopenia, or neutropenia).

In MAGNITUDE Cohort 1, Grade 3-4 anemia, thrombocytopenia, and neutropenia were reported, respectively in 28%, 8%, and 7% of patients receiving AKEEGA. Overall, 27% of patients required a red blood cell transfusion, including 11% who required multiple transfusions. Discontinuation due to anemia occurred in 3% of patients.

Monitor complete blood counts weekly during the first month of AKEEGA treatment, every two weeks for the next two months, monthly for the remainder of the first year and then every other month, and as clinically indicated. Do not start AKEEGA until patients have adequately recovered from hematologic toxicity caused by previous therapy. If hematologic toxicities do not resolve within 28 days following interruption, discontinue AKEEGA and refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics.

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions
AKEEGA may cause hypokalemia and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. In post-marketing experience, QT prolongation and Torsades de Pointes have been observed in patients who develop hypokalemia while taking abiraterone acetate, a component of AKEEGA. Hypertension and hypertensive crisis have also been reported in patients treated with niraparib, a component of AKEEGA.

In MAGNITUDE Cohort 1, which used prednisone 10 mg daily in combination with AKEEGA, Grades 3-4 hypokalemia was detected in 2.7% of patients on the AKEEGA arm and Grades 3-4 hypertension were observed in 14% of patients on the AKEEGA arm.

The safety of AKEEGA in patients with New York Heart Association (NYHA) Class II to IV heart failure has not been established because these patients were excluded from MAGNITUDE.

Monitor patients for hypertension, hypokalemia, and fluid retention at least weekly for the first two months, then once a month. Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia, or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. Control hypertension and correct hypokalemia before and during treatment with AKEEGA.

Discontinue AKEEGA in patients who develop hypertensive crisis or other severe cardiovascular adverse reactions.

Hepatotoxicity
AKEEGA may cause hepatotoxicity.

Hepatotoxicity in patients receiving abiraterone acetate, a component of AKEEGA, has been reported in clinical trials. In post-marketing experience, there have been abiraterone acetate-associated severe hepatic toxicity, including fulminant hepatitis, acute liver failure, and deaths.

In MAGNITUDE Cohort 1, Grade 3-4 ALT or AST increases (at least 5 x ULN) were reported in 1.8% of patients. The safety of AKEEGA in patients with moderate or severe hepatic impairment has not been established as these patients were excluded from MAGNITUDE.

Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with AKEEGA, every two weeks for the first three months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring and may require dosage modifications.

Permanently discontinue AKEEGA for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation, or in patients who develop ALT or AST ≥20 x ULN at any time after receiving AKEEGA.

Adrenocortical Insufficiency
AKEEGA may cause adrenal insufficiency.

Adrenocortical insufficiency has been reported in clinical trials in patients receiving abiraterone acetate, a component of AKEEGA, in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Monitor patients for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with abiraterone acetate. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased doses of corticosteroids may be indicated before, during, and after stressful situations.

Hypoglycemia
AKEEGA may cause hypoglycemia in patients being treated with other medications for diabetes.

Severe hypoglycemia has been reported when abiraterone acetate, a component of AKEEGA, was administered to patients receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide.

Monitor blood glucose in patients with diabetes during and after discontinuation of treatment with AKEEGA. Assess if antidiabetic drug dosage needs to be adjusted to minimize the risk of hypoglycemia.

Increased Fractures and Mortality in Combination with Radium 223 Dichloride
AKEEGA with prednisone is not recommended for use in combination with Ra-223 dichloride outside of clinical trials.

The clinical efficacy and safety of concurrent initiation of abiraterone acetate plus prednisone/prednisolone and radium Ra 223 dichloride was assessed in a randomized, placebo-controlled multicenter study (ERA-223 trial) in 806 patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer with bone metastases. The study was unblinded early based on an Independent Data Monitoring Committee recommendation.

At the primary analysis, increased incidences of fractures (29% vs 11%) and deaths (39% vs 36%) have been observed in patients who received abiraterone acetate plus prednisone/prednisolone in combination with radium Ra 223 dichloride compared to patients who received placebo in combination with abiraterone acetate plus prednisone.

It is recommended that subsequent treatment with Ra-223 not be initiated for at least five days after the last administration of AKEEGA, in combination with prednisone.

Posterior Reversible Encephalopathy Syndrome
AKEEGA may cause Posterior Reversible Encephalopathy Syndrome (PRES).

PRES has been observed in patients treated with niraparib as a single agent at higher than the recommended dose of niraparib included in AKEEGA.
Monitor all patients treated with AKEEGA for signs and symptoms of PRES. If PRES is suspected, promptly discontinue AKEEGA and administer appropriate treatment. The safety of reinitiating AKEEGA in patients previously experiencing PRES is not known.

Embryo-Fetal Toxicity
The safety and efficacy of AKEEGA have not been established in females. Based on animal reproductive studies and mechanism of action, AKEEGA can cause fetal harm and loss of pregnancy when administered to a pregnant female.

Niraparib has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow).

In animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (AUC) at the recommended dose.

Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of AKEEGA. Females who are or may become pregnant should handle AKEEGA with protection, e.g., gloves.

Based on animal studies, AKEEGA may impair fertility in males of reproductive potential.

ADVERSE REACTIONS
The safety of AKEEGA in patients with BRCAm mCRPC was evaluated in Cohort 1 of MAGNITUDE.

The most common adverse reactions (≥10%), including laboratory abnormalities, are decreased hemoglobin, decreased lymphocytes, decreased white blood cells, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, increased AST, increased ALT, edema, dyspnea, decreased appetite, vomiting, dizziness, COVID-19, headache, abdominal pain, hemorrhage, urinary tract infection, cough, insomnia, increased bilirubin, weight decreased, arrhythmia, fall, and pyrexia.

Serious adverse reactions reported in >2% of patients included COVID-19 (7%), anemia (4.4%), pneumonia (3.5%), and hemorrhage (3.5%). Fatal adverse reactions occurred in 9% of patients who received AKEEGA, including COVID-19 (5%), cardiopulmonary arrest (1%), dyspnea (1%), pneumonia (1%), and septic shock (1%).

DRUG INTERACTIONS
Effect of Other Drugs on AKEEGA

Avoid coadministration with strong CYP3A4 inducers.

Abiraterone is a substrate of CYP3A4. Strong CYP3A4 inducers may decrease abiraterone concentrations, which may reduce the effectiveness of abiraterone.

Effects of AKEEGA on Other Drugs

Avoid coadministration unless otherwise recommended in the Prescribing Information for CYP2D6 substrates for which minimal changes in concentration may lead to serious toxicities. If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate drug.

Abiraterone is a CYP2D6 moderate inhibitor. AKEEGA increases the concentration of CYP2D6 substrates, which may increase the risk of adverse reactions related to these substrates.

Monitor patients for signs of toxicity related to a CYP2C8 substrate for which a minimal change in plasma concentration may lead to serious or life-threatening adverse reactions.

Abiraterone is a CYP2C8 inhibitor. AKEEGA increases the concentration of CYP2C8 substrates, which may increase the risk of adverse reactions related to these substrates.

Please see the full Prescribing Information for AKEEGA.

On June 3, 2025 PAVmed Inc. (Nasdaq: PAVM) ("PAVmed" or the "Company") a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, and its majority-owned digital health subsidiary Veris Health Inc. ("Veris"), reported that Veris has entered into a strategic partnership agreement with The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), a National Cancer Institute (NCI)-Designated Comprehensive Cancer Center (Press release, The Ohio State University Comprehensive Cancer Center, JUN 3, 2025, View Source;james-cancer-hospital-and-solove-research-institute-302471800.html [SID1234653688]). This agreement follows the successful completion of a pilot program which enrolled patients across several OSUCCC – James cancer care service lines on the Veris Cancer Care Platform.

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Pursuant to the agreement Veris and OSUCCC – James entered into a long-term, multi-project strategic partnership to utilize, and further the development and commercialization of the Veris Cancer Care Platform and its implantable physiologic monitor.

The agreement includes expansion of commercial utilization of the platform across cancer care service lines; full electronic health record (EHR) integration; initiation of a large clinical registry of patients enrolled on the platform to be launched in the coming weeks; and launch of a large clinical trial of patients receiving the implantable physiologic monitor, to be launched upon FDA clearance, expected next year. It also calls for close collaboration on the development of clinical cancer care pathways, platform software enhancements, and best practices for clinical use of the implantable physiological monitor.

"We are thrilled to advance our strategic partnership with OSUCCC – James, one of the largest and most prestigious academic cancer centers in the nation, following the successful completion of a pilot program demonstrating the strong clinical utility of our platform," said Brian deGuzman, M.D., Chief Operating Officer of Veris Health. "This commercial transition represents a major milestone for Veris. We look forward to working closely with the OSUCCC – James team to enhance the care of thousands of cancer patients there every year."

"At the OSUCCC – James, delivering personalized, world-class cancer care remains our top priority," said David Cohn, M.D., M.B.A., Chief Operating Officer and Chair of Gynecologic Oncology at The James Cancer Hospital and Solove Research Institute. "After a successful pilot program, we are excited to be entering into a long-term strategic partnership with Veris Health to expand access to the Veris Cancer Care Platform and enhance the care of our patients."

The Veris Cancer Care Platform is a comprehensive digital cancer care platform with remote physiological data collection, symptom reporting, telehealth capability, and electronic health record integration. The platform seeks to offer enhanced personalized cancer care through the early detection of complications, reduced unplanned hospitalizations, the provision of longitudinal trends of physiological and clinical data, data-driven risk management tools, and increased patient and provider satisfaction.

Cancer patients enrolled on the platform receive a VerisBox of Veris-branded connected health care devices which transmit physiologic data to the cloud-based clinician portal via embedded cellular connections. A complementary patient portal enables patients to report symptoms, as well as general health and quality of life parameters, to their cancer care team through the Veris patient smartphone app. The app also allows patients to invite caretakers and family members to follow along on their cancer care journey. Veris is also developing an implantable physiological monitor, designed to be implanted alongside a vascular access port, which will interface with the Veris Cancer Care Platform. The implantable monitor will further enhance the clinical and commercial value of the platform by providing remote physiologic data independent of patient compliance.

Cancer centers and oncology practices interested in learning more about Veris and the Veris Platform, please visit www.verishealth.com to contact a company representative.

On June 3, 2025 AVEO Oncology, an LG Chem company ("AVEO"), a biopharmaceutical company committed to providing differentiated solutions to improve cancer patients lives, reported three posters during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 annual meeting in Chicago, IL, including one exploratory sub-analysis for tivozanib and two trials in progress (Press release, AVEO, JUN 3, 2025, View Source [SID1234653687]).

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Michael Bailey, president and Chief Executive Officer, stated, "We were really excited to present these three posters at this year’s ASCO (Free ASCO Whitepaper) annual meeting, which we believe further showcase the use of tivozanib after frontline ICI-based combination therapy, but also AVEO’s pipeline which is focused on developing therapies that improve the lives of patients with cancer."

Poster title: "Efficacy of second line (2L) treatment with tivozanib (Tivo) as monotherapy or with nivolumab (Nivo) in patients (pts) with metastatic renal cell carcinoma (mRCC) previously treated with an immune checkpoint inhibitor (ICI) combination of ipilimumab (Ipi)/Nivo or vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR-TKI)/ICI in the Phase 3 TiNivo-2 study." – (Abstract: 4540; Poster: 340)

AVEO presented data from an exploratory sub-analysis of the TiNivo-2 study, evaluating the efficacy of tivozanib as a 2nd line treatment option in patients who failed 1st line vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) and immune checkpoint inhibitor combination therapy. The subgroup analysis indicates that tivozanib monotherapy at 1.34mg daily showed activity, including substantial tumor size reduction, in patients who previously received a contemporary 1st line metastatic renal cell carcinoma (mRCC) treatment regimen. Additionally, the sub-analysis showed no benefit in the addition of nivolumab to tivozanib in this context, akin to the results of the parent TiNivo-2 trial.

Poster Title: "FIERCE-HN: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of ficlatuzumab (HGF/cMET Mab) in combination with cetuximab in participants with recurrent or metastatic (R/M) HPV negative head and neck squamous cell carcinoma (HNSCC)."– (Abstract: TPS6115; Poster: 520a)

AVEO presented a trial in progress poster for the Phase 3 FIERCE-HN trial, which is evaluating the combination of ficlatuzumab and cetuximab in patients with recurrent or metastatic (R/M) HPV-negative head and neck squamous cell carcinoma (HNSCC). The purpose of this study is to evaluate the efficacy and safety of ficlatuzumab (10 or 20 mg/kg) in combination with cetuximab (500 mg/kg) against placebo plus cetuximab in participants with HPV-negative R/M HNSCC. The study is evaluating whether ficlatuzumab combined with cetuximab is superior to cetuximab alone in terms of overall survival.

FIERCE-HN opened for enrollment in December 2023 and currently expects to complete enrollment by May 2026. For more information, visit www.FIERCEHN.com.

Poster Title: "A phase 1b dose escalation study of AV-380 (anti-GDF15 monoclonal antibody) in combination with standard-of-care therapy in cancer patients with cachexia."– (Abstract: TPS12142; Poster: 159a)

AVEO presented a second trial in progress poster for their AV-380 phase 1b dose escalation study. During the meeting, the company also announced the official molecule name for AV-380: rilogrotug (pronounced rye-low-grow-tug). Rilogrotug is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia. This open label ascending dose study is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of rilogrotug in cancer patients with cachexia.

FOTIVDA (tivozanib)

INDICATIONS
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Hypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs.

Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome.

Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation.

Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS
Common adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.

Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS
Avoid coadministration with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS
Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

The recommended dosage for patients with end-stage renal disease has not been established.

Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA (tivozanib).

About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.