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Following FDA Compassionate Use Approval for Pancreatic Carcinoma with Can-Fite’s Namodenoson, Leading U.S. Medical Centers Seek Authorization for their Patients

On April 17, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that leading Medical Centers in the US are approaching the FDA, asking for compassionate use approval to treat patients with pancreatic carcinoma with the company oncological drug Namodenoson (Press release, Can-Fite BioPharma, APR 17, 2025, View Source [SID1234651970]).

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Namodenoson has recently received FDA approval for its first single-patient compassionate use treatment, marking a significant milestone in its clinical journey. This approval has sparked growing interest from oncologists at leading U.S. medical centers, who are now seeking to treat their pancreatic cancer patients with Namodenoson under compassionate use protocols.

Simultaneously, Can-Fite is actively enrolling patients in Israel for a Phase IIa study—an open-label trial designed for individuals with advanced pancreatic adenocarcinoma whose disease has progressed despite at least first-line therapy. The trial aims to assess the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this challenging patient population. The study is led by Dr. Salomon Stemmer, a renowned key opinion leader at the Institute of Oncology, Rabin Medical Center, Israel. Notably, Namodenoson has been granted Orphan Drug Designation by the U.S. FDA, further underscoring its potential as a promising therapeutic option.

"We are thrilled that more top-tier U.S. medical centers are recognizing the potential of Namodenoson and are eager to participate in our compassionate use program," said Motti Farbstein, CEO of Can-Fite. "Our goal is to provide this underserved patient population with a novel treatment that may extend survival and improve quality of life."

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

Clarity signs high-volume commercial-scale copper-64 Supply Agreement with Nusano

On April 17, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop and commercialise next-generation products that improve treatment outcomes for people with cancer, reported the signing of a commercial-scale Supply Agreement for copper-64 with Nusano (Press release, Clarity Pharmaceuticals, APR 17, 2025, View Source [SID1234651958]).

Nusano’s 190,000 square foot state-of-the-art facility in West Valley City, Utah is expected to begin production in 2025 with copper-64 isotope supply planned to commence in early 2026. The accelerator-based proprietary technologies employed by Nusano are particularly well suited for cost-effective mass production of copper-64. The Nusano facility is capable of producing more than 1,000 Ci (37,000 GBq) of copper-64 per day at capacity, which translates into more than 18,000 patient doses per day at 200 MBq per dose, with a 48-hour shelf-life, well in excess of commercial-scale demands across multiple large oncology indications in line with Clarity’s commercialisation strategy. Nusano is also developing in-house production of the target material for copper-64 manufacturing, nickel-64 (Ni-64), and plans to commence production of copper-67 (Cu-67 or 67Cu) and actinium-225 (Ac-225 or 225Ac) isotopes in 2025-2026. Both of these isotopes are used in Clarity’s pipeline of theranostic products in development.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The signing of this Supply Agreement with Nusano will complement Clarity’s existing network of US-based copper-64 suppliers, providing capacity to ensure abundant and seamless supply of the isotope. As Clarity is generating exceptional data in a number of late-stage clinical trials, we now also have a cost-effective, large-scale supply strategy locked in for the commercial roll-out of our Targeted Copper Theranostics (TCTs) in the largest healthcare market in the world, the US. This Agreement is an important part of a larger commercial manufacturing strategy, which we will continue implementing as we get closer to the filing of New Drug Applications (NDA) with the US Food and Drug Administration (FDA).

"The ability to make isotopes and products in the US for the treatment of the American people is an important advantage in the current geo-political and economic environment. By building a supply chain that is fully integrated, from high-volume isotope production, to centralised product manufacture, to delivering these ready-to-use diagnostics to imaging sites in every state of the US on time and on demand, we are aiming to build a model that is impervious to economic and political instability.

"In large oncology indications, such as prostate-specific membrane antigen (PSMA) positron emission tomography (PET) diagnostics (which Clarity is addressing with our key product, SAR-bisPSMA), ensuring stable, abundant and seamless supply of isotopes is crucial for a successful commercial launch.

"We have seen first-hand from the current generation of radio-diagnostics that efficient and timely product supply can make or break the adoption of the products and their expansion in the oncology practice. The current market leaders in PSMA PET imaging face several limitations associated with their short half-life (less than 2 hours vs. 12.7 hours for copper-64). These include short shelf-lives, restricted availability throughout the imaging site’s workday, and narrow imaging windows. At Clarity, our strategy is straightforward: we are determined to overcome these limitations and lay a strong foundation for the successful roll-out of TCTs globally.

"Our goal is to take radiopharmaceuticals to the next level by building a reliable and accessible supply that is consistent with the big pharma oncology model and deliver advantages to patients, their treating clinicians and imaging sites. Under this central manufacture model, the imaging sites will receive the copper-64 based diagnostics on demand, at any time and in volumes consistent with the rapidly growing demand of this blockbuster market. The clinicians have the added flexibility to administer the copper-based diagnostics and image patients over a significantly longer timeframe than what the current products allow. This translates into more flexibility for patient imaging and potentially higher lesion detection sensitivity that could lead to better identification of cancer lesions, helping to determine the best course of treatment for oncology patients.

"With our SAR-bisPSMA product generating a lot of exciting data and 3 US FDA Fast Track Designations granted for this product1,2,3 for accelerating its development, locking in commercial-scale supply of copper-64 means we are now closer than ever to changing the paradigm of prostate cancer diagnosis, ensuring no man is left waiting for a PSMA PET scan," said Dr Taylor.

Nusano’s Chief Executive Officer, Chris Lowe, commented, "Nusano is commercialising a breakthrough radioisotope production platform in 2025 capable of producing more than 25 radioisotopes for life science applications, including copper-64, copper-67 and actinium-225. We are excited to enter into a Supply Agreement with Clarity for copper-64 to enable their clinical and commercial efforts with a dependable supply of radioisotopes from our world-class production facility in Utah."

Additional Disclosure
The Supply Agreement is effective as of 16 April 2025 and is for an initial period of 3 years with automatic renewal for successive 2-year periods. Cancellation provisions are aligned with industry standard rates.

Ipsen delivers strong sales in the first quarter 2025 and confirms its full year guidance

On April 16, 2025 Ipsen, a global specialty-care biopharmaceutical company, reported sales for the first quarter of 2025 (Press release, Ipsen, APR 16, 2025, View Source [SID1234652994]).

BriaCell Phase 2 Survival Data Beats Leading Standard in HR+ Breast Cancer

On April 16, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients (Press release, BriaCell Therapeutics, APR 16, 2025, View Source [SID1234651969]).

In BriaCell’s Phase 2 clinical study in late-stage MBC, 25 of 37 patients treated with the ongoing pivotal Phase 3 Bria-IMT formulation were identified as having HR+ breast cancer. As shown in Table 1, the survival data of these 25 patients (17.3 months) exceeds those of the current ADC standard of care TRODELVY (14.4 months). The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2) receptors, was similar to TRODELVY but still markedly higher (70%) than those of chemotherapy.

"We are truly impressed with the survival benefit data of the regimen that exceeds or meets those of TRODELVY in HR+ and TNBC metastatic breast cancer patients, respectively. Bria-IMT appears to be very well-tolerated," stated Dr. William V. Williams, BriaCell’s President and CEO. "We look forward to further confirming this clinical data in our ongoing pivotal Phase 3 study with overall survival as its primary endpoint."

"HR+ and TNBC metastatic breast cancer represent a significant proportion of the patient population and are the most difficult patient groups to treat. They have limited therapeutic options and overall survival of only a few months," commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "Our clinical data supports our hypothesis that the Bria-IMT regimen + CPI has the potential to address the unmet medical needs of HR+ and TNBC MBC patients and provide an effective and well-tolerated therapeutic option."

Table 1: Comparable Analysis of median overall survival (estimated using the Kaplan-Meier method) for the BriaCell Phase 2 study of BriaCell’s Bria-IMT plus CPI versus other drugs in MBC patient subsets

* Patients treated with the Phase 3 formulation
** Number of prior chemotherapy-containing regimens
1. View Source

Abbreviations:
HR+: hormone receptor-positive
TNBC: Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth factor receptor 2 (HER2))

The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6) who received the Bria-IMT regimen plus checkpoint inhibitor. Of these 54 patients, 37 were treated with the formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612 ). No Bria-IMT related discontinuations have been reported to date.

Bayer to Unveil Latest NUBEQA® (darolutamide) Data and Prostate Cancer Research at American Urological Association (AUA) 2025 Annual Meeting

On April 16, 2025 Bayer reported that it will present new data for NUBEQA (darolutamide) in prostate cancer at the upcoming American Urological Association (AUA) Annual Meeting taking place in Las Vegas from April 26-29, 2025 (Press release, Bayer, APR 16, 2025, View Source [SID1234651965]). These data support the potential of NUBEQA as a treatment option across the prostate cancer disease spectrum and in diverse patient populations.

NUBEQA is indicated in the U.S. for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1

The company will present post-hoc analyses of ultra-low prostate-specific antigen (PSA) responses (<0.02 ng/mL) and the correlation of ultra-low PSA responses with clinical outcomes from the Phase III ARANOTE trial evaluating NUBEQA and androgen deprivation therapy (ADT) in mHSPC.

An additional ARANOTE analysis on the efficacy and safety of NUBEQA plus ADT in Black men with mHSPC will be presented.

Additionally, data from the Phase III ARASENS Rollover trial evaluating the long-term safety and tolerability benefit of extended treatment with NUBEQA will be presented.

Other key data to be presented include the North American subgroup analysis from the third interim analysis of the Darolutamide Observational (DAROL) trial evaluating the safety and efficacy of NUBEQA in a real-world setting in patients with nmCRPC, and an update on the in progress Phase III ARASTEP trial, evaluating NUBEQA plus ADT in patients with high-risk biochemical recurrence.

A separate presentation will highlight results from a U.S.-based quantitative survey on the challenges and unmet needs of caregivers of men with prostate cancer.

Details on selected abstracts from Bayer at the AUA 2025 Annual Meeting follow:

NUBEQA (darolutamide):

Ultra-low PSA Response (<0.02 ng/mL) with Darolutamide Plus ADT in ARANOTE Correlates with Greatly Improved Clinical Outcomes
Interactive Poster Session: IP26-07; April 29, 9:30-11:30 a.m. PDT
Efficacy and Safety of Darolutamide Plus Androgen-Deprivation Therapy (ADT) in Black Patients with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) from the Phase 3 ARANOTE Trial
Moderated Poster: MP16-01; April 27, 1:00-3:00 p.m. PDT
Long-Term Safety and Tolerability of Extended Treatment with Darolutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Insights from ARASENS Rollover Study
Interactive Poster: IP26-06; April 29, 9:30-11:30 a.m. PDT
Prespecified Third Interim Analysis of the Darolutamide Observational (DAROL) Study in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): North American (NAm) Subgroup Analysis
Interactive Poster: IP26-25; April 29, 9:30-11:30 a.m. PDT
Darolutamide Plus Androgen-Deprivation Therapy (ADT) in Patients with High-Risk Biochemical Recurrence (BCR) of Prostate Cancer: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ARASTEP)
Clinical Trials in Progress Presentation: April 28, 2:44- 2:52 p.m. PDT
Prostate Cancer:

Challenges and Unmet Needs of Caregivers for Patients with Prostate Cancer: A US-based Quantitative Survey
Abstract IP04-31; April 26, 9:30-11:30 a.m. PDT
About NUBEQA (darolutamide)1

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 is 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 hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
IMPORTANT SAFETY INFORMATION

Warnings & Precautions

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 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 – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic 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 – 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 vs. 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 vs. 3.2% of patients receiving placebo. Fatal adverse reactions in 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 adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

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 Hormone-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.2 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide.3,4

At the time of diagnosis, most men have localized prostate cancer, meaning 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 hormone-sensitive disease. Approximately 10% of men will already present with mHSPC when first diagnosed.5,6,7 Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.