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ANKTIVA® with BCG Demonstrates 96% Survival from Bladder Cancer at Three Years with Median Survival Not Yet Reached in BCG-Unresponsive High-Grade Papillary-Only Non-Muscle Invasive Bladder Cancer

On December 16, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported treatment with ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) demonstrates efficacy at 12 and 36 months, including disease-free survival (DFS), disease-specific survival (DSS), long-term progression-free survival (PFS), and high cystectomy avoidance in patients with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer (NMIBC). Published in The Journal of Urology’s current January 2026 print edition, the findings also show tolerable safety that was consistent with BCG treatment alone, with 3% of grade 3 and no grade 4 or 5 treatment-related adverse events (TRAEs).1

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Specific key efficacy findings from cohort B (N=80) of the Phase 2/3 open-label, single-arm multi-center QUILT-3.032 study include:1

The DFS rate at 12 months (primary endpoint) was 58.2% (95% CI 46.6, 68.2); corresponding rates at 24 and 36 months were 52.1% (95% CI 40.3, 62.7) and 38.2% (95% CI 25.6, 50.6).
DSS rates were 98.7% (95% CI 91.4, 99.8) at 12 months and 96.0% (95% CI 88.2, 98.7) at 36 months; the median DSS has not been reached.
PFS rates were 94.9% (95% CI 86.9, 98.0) at 12 months and 83.1% (95% CI 69.5, 91.0) at 36 months.
Cystectomy avoidance rates at 12 and 36 months were 92.2% (95% CI 83.4, 96.4) and 81.8% (95% CI 68.1, 90.1).
The safety profile of ANKTIVA plus BCG, which was assessed for study cohorts A and B (N=180), was tolerable and consistent with BCG alone.1 Grade 1 or 2 TRAEs were seen in 61% of patients, with grade 3 events observed in 3% and no grade 4 or 5 events.1 The most frequently reported TRAEs (incidence ≥ 3%) for participants who received ANKTIVA plus BCG (cohorts A and B, N=180) were those expected for intravesical instillation of BCG and included dysuria, pollakiuria, and hematuria.1

"Patients with BCG-unresponsive papillary-only non-muscle invasive bladder cancer have few treatment options, with cystectomy being considered the definitive treatment," said lead author Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center. "Prolongation of progression-free survival, disease-specific free survival and avoidance of bladder removal are clinically meaningful goals of next-generation chemotherapy-free immunotherapy. Our findings provide evidence that ANKTIVA plus BCG would offer a novel and efficacious treatment option for these patients."

NMIBC comprises the subtypes of papillary (Ta, T1) and carcinoma in situ (CIS) disease, and while papillary disease is more common, the subtypes frequently occur together.2-4 Importantly, from a pathological standpoint, papillary tumors and carcinoma in situ (CIS) in non-muscle invasive bladder cancer are closely linked by both clonality and histology. Molecular sequencing studies show that papillary lesions and CIS frequently arise from the same clonal urothelial precursor, sharing common genetic alterations and evolutionary lineage, rather than representing separate diseases. Histologically, both originate from malignant transformation of the urothelium and reflect disordered growth of the same epithelial cell layer, differing primarily in architectural pattern rather than biological origin. Papillary tumors grow outward into the bladder lumen, while CIS spreads flat along the bladder lining, but both represent manifestations of the same clonal cancer process within the bladder epithelium.

Standard initial treatment for intermediate- or high-risk NMIBC of either subtype consists of transurethral resection of the bladder tumor, followed by intravesical instillation of BCG.3 While effective in many patients, approximately 40% will not respond to BCG, and for those who respond, about 50% will relapse and receive a diagnosis of BCG-unresponsive NMIBC.5 Currently, there are no approved therapies for the treatment of these patients.

"The 12- and 36-month rates for disease-free, progression-free, and disease-specific survival seen in this study are higher than those reported for other investigational therapies in this patient population," added Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "Together with the high rates of cystectomy avoidance, with the median to cystectomy not yet reached, and the 96% bladder cancer-specific survival at three years, also with median not yet reached, demonstrates the effectiveness of ANKTIVA in enhancing the immune response. These finding point to a potential paradigm change in the treatment of BCG-unresponsive high-grade papillary-only NMIBC."

ANKTIVA is currently approved by the U.S. Food and Drug Administration, United Kingdom and Conditional Marketing Authorization by the European Union with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

"The evidence that CIS and papillary disease are clonally linked, combined with the QUILT-3.032 findings showing long-term cystectomy avoidance, sustained avoidance of progression to muscle-invasive disease, and 96% bladder cancer-specific survival at three years, supports the consideration that ANKTIVA plus BCG addresses the unmet need for patients with papillary disease alone who face the prospect of total radical cystectomy following failure of BCG therapy," said Dr. Soon-Shiong.

QUILT-3.032 (NCT03022825) is a registrational, open-label, single-arm multicenter phase 2/3 trial of ANKTIVA plus BCG in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Cohort B (N=80) enrolled participants with histologically confirmed BCG-unresponsive high-grade Ta/T1 papillary NMIBC. During induction, participants in cohort B received ANKTIVA plus BCG intravesically through a urinary catheter to the bladder weekly for 6 consecutive weeks. The primary endpoint was DFS at 12 months. Secondary efficacy endpoints included PFS, DSS and cystectomy avoidance. Efficacy was assessed at 12, 24 and 36 months. Treatment-related adverse events (TRAEs) were evaluated for study cohorts A and B (N=180) and monitored throughout the study.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, DEC 16, 2025, View Source [SID1234661457])

Lilly to participate in J.P. Morgan Healthcare Conference

On December 16, 2025 Eli Lilly and Company (NYSE: LLY) reported it will participate in the 44th Annual J.P. Morgan Healthcare Conference, Jan. 12-15, 2025. David A. Ricks, Lilly chair and CEO, will take part in a fireside chat on Tuesday Jan. 13 at 5:15 p.m., Eastern time.

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

(Press release, Eli Lilly, DEC 16, 2025, View Source [SID1234661456])

CytoAgents Appoints Dr. Johannes Wolff as Chief Medical Officer and Michael Howell as Chief Scientific Officer

On December 16, 2025 CytoAgents, Inc. a clinical-stage biotechnology company developing CTO1681, a novel, steroid-sparing inhibitor of prostaglandin-mediated inflammation, reported the appointment of Dr. Johannes Wolff, MD, PhD, as Chief Medical Officer (CMO) and Michael D. Howell, PhD, as Chief Scientific Officer (CSO).

Dr. Johannes Wolff, MD, PhD, Chief Medical Officer

Dr. Wolff brings over three decades of distinguished leadership in academic medicine and the pharmaceutical industry, with deep expertise in clinical trial strategy, drug development, and medical affairs. Originally trained as a pediatric hematologist-oncologist, Dr. Wolff has held senior roles in both academic and industry settings, including Vice President of Clinical Development at Replimune, Senior Medical Director at AbbVie and Novartis, and department chair positions at leading institutions such as Cleveland Clinic and Tufts Medical Center. He has led successful Investigational New Drug applications, pivotal trials, and regulatory approvals across a broad spectrum of hematologic and solid tumor indications. Dr. Wolff is also a scholar, with more than 200 peer-reviewed publications, multiple books, and extensive experience mentoring the next-generation of clinical researchers.

Michael D. Howell, PhD, Chief Scientific Officer

Howell joins CytoAgents with more than 25 years of experience in research and drug development, spanning immunology, dermatology, oncology, and translational science. He has served as Chief Scientific Officer at Zura Bio and DermTech, and held senior scientific leadership roles at Incyte, AstraZeneca/MedImmune, and the Immune Tolerance Network. Howell is recognized as a scientific innovator and inventor on multiple patents, including monoclonal antibodies and biomarker strategies, and has played a pivotal role in securing significant funding and advancing precision medicine initiatives. His expertise in translational biomarker development and strategic leadership in both early and late-stage clinical programs will be instrumental as CytoAgents advances its pipeline.

"Johannes and Michael’s combined expertise in clinical development, translational science, and strategic leadership will be invaluable as we accelerate our mission to deliver transformative therapies for immune-mediated diseases," said Teresa Whalen, CEO of CytoAgents. "To truly expand CAR T access for patients, we must find better ways to manage toxicities, and broaden awareness within the medical community."

(Press release, CytoAgents, DEC 16, 2025, View Source [SID1234661455])

Cellectar Biosciences Announces Strategic Supply Agreement with Ionetix for Actinium-225 and Astatine-211 to Advance Targeted Alpha Therapies

On December 16, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported a multi-year supply agreement with Ionetix Corporation, a leading cyclotron technology innovator and full-service radioisotope manufacturer, for two critical alpha-emitting radioisotopes: Actinium-225 (Ac-225) and Astatine-211 (At-211).

Under the agreement, Ionetix will provide Cellectar with a reliable, clinical and commercial-scale supply of cGMP-grade Ac-225 and At-211 to support its drug development programs through clinical trials and into potential commercial launches of targeted alpha therapy (TAT) candidates.

"As we prepare for the future expansion of Cellectar’s radiotherapeutic pipeline beyond our beta and Auger emitter clinical programs and work to advance CLR-225 into clinical trials as a potential treatment for challenging solid tumor cancers such as pancreatic cancer, establishing a dependable and fully scalable supply of high-quality alpha-emitting isotopes is essential for the development of our targeted PRC pipeline," said Jarrod Longcor, chief operating officer of Cellectar Biosciences. "This collaboration with Ionetix ensures sufficient supply of these isotopes moving forward."

Cellectar’s proprietary phospholipid ether platform technology has demonstrated robust delivery of a wide variety of isotopes directly to tumor cells for a broad range of cancers. This unique capability allows Cellectar to identify the optimal isotope for the targeted tumor type. When paired with the platform, Ac-225 and At-211 are ideal alpha-emitting radioisotopes designed to deposit highly localized, high-energy radiation, that can destroy tumors while sparing surrounding healthy tissue.

"We are excited to collaborate with Cellectar to support their mission to deliver life-extending therapies for cancer patients," said David Eve, vice president of medical affairs at Ionetix. "We are currently installing a second cyclotron at our Michigan facility, which will now house two cyclotrons on-site—one dedicated to commercial-scale Ac-225 production and the other dedicated for At-211 production. Our cyclotron-based platform is designed to meet the growing demand for Ac-225 and the rapidly emerging need for At-211—both essential to advancing Cellectar’s next-generation TATs."

(Press release, Cellectar Biosciences, DEC 16, 2025, View Source [SID1234661454])

Can-Fite Provides Update on Clinical and Financial Status

On December 16, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs targeting oncological and inflammatory diseases, reported an update on its clinical development activities and financial status.

Namodenoson drug candidate: Can-Fite is currently enrolling patients in a pivotal Phase III clinical study evaluating Namodenoson for the treatment of advanced hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 liver function. This patient population represents a significant unmet medical need, as no approved therapies are currently available. An interim analysis from the Phase III study is expected to be in approximately Q4 2026. Subject to positive interim results, the Company may be eligible to seek conditional regulatory approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In parallel, Can-Fite is enrolling patients in a Phase IIb clinical study of Namodenoson for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This study follows positive results from a completed Phase IIa trial, which demonstrated anti-inflammatory, anti-steatotic, and anti-fibrotic effects, with data published in peer-reviewed literature.

In addition, Namodenoson is being evaluated in a Phase IIa clinical study in patients with pancreatic cancer who have failed first-line treatment. Patient enrollment in this study is nearing completion, and the Company expects to report data during the second quarter of 2026.

Piclidenoson drug candidate: Can-Fite is currently enrolling patients in a pivotal Phase III clinical study for the treatment of psoriasis. In this study, patients receive Piclidenoson orally, administered twice daily. The primary efficacy endpoints of the trial are PASI 75 (Psoriasis Area and Severity Index) and Physician’s Global Assessment (PGA), consistent with regulatory guidance for late-stage psoriasis studies. Based on the Company’s current assumptions, interim analysis data is expected to be released in the second quarter of 2026. The Company also completed the development of a Phase II study protocol for the rare genetic disease Lowe Syndrome and plans to submit it to regulatory authorities in Italy and EMA during Q1 2026.

Cash and cash equivalents: As of June 30, 2025, Can-Fite had cash and cash equivalents and short term deposits of $6.45 million. On July 28, 2025, Can-Fite completed a public offering for aggregate gross proceeds of $5 million. In November 2025 Can-Fite Raised $2.2M through its ATM facility.

"Our advancing clinical programs reflect Can-Fite’s focused strategy of addressing significant unmet medical needs with orally administered, well-characterized drug candidates," said Motti Farbstein, Chief Executive Officer of Can-Fite BioPharma. "With pivotal Phase III studies ongoing in liver cancer and psoriasis, alongside progressing mid-stage programs in MASH and pancreatic cancer, we believe we are well positioned to generate meaningful clinical data over the coming quarters while maintaining disciplined execution."

(Press release, Can-Fite BioPharma, DEC 16, 2025, View Source [SID1234661453])