On October 14, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive NMIBC with papillary-only tumors.

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The expanded FDA label reads as follows: Anktiva, in combination with Bacillus Calmette-Guérin (BCG), is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer.2

The broadened indication builds on the FDA’s April 2024 approval of ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS).3 with or without papillary tumors. CIS and papillary tumors are aggressive and associated with high risk of recurrence and progression in the BCG-unresponsive setting. This is the first FDA approval to include BCG-unresponsive NMIBC with papillary-only tumors.

"This approval marks an important expansion of ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC and advances our goal of harnessing the patient’s own immune system to achieve durable, tumor-free outcomes," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "An important first step as we develop immunotherapy 2.0."

The expanded approval is based on the FDA’s review of available scientific information, including the previously demonstrated efficacy of ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In Cohort A of the QUILT-3.032 trial, 62% of 77 patients achieved a complete response (95% CI: 51, 73); among responders, 58% maintained a response for at least 12 months and 40% for at least 24 months.4

The combination of ANKTIVA plus BCG has a tolerable safety profile, with the most common treatment-related adverse events (TRAEs) related to bladder instillation (e.g., dysuria, pollakiuria, and hematuria), and most of these TRAEs were grade 1 to 2. This is consistent with the side effects of BCG alone.4 The prescribing information includes a warning that delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.2

Expanding Treatment Options for BCG-Unresponsive NMIBC

Bladder cancer has among the most expensive cancers to treat over a patient’s lifetime, reflecting the substantial costs associated with ongoing surveillance, treatment, and disease management.5 NMIBC accounts for approximately 80% of all bladder cancer diagnoses in the U.S. and includes both CIS and papillary tumors.6 An estimated 85% to 90% of patients diagnosed with NMIBC present with papillary disease.7 Patients with high-grade papillary disease that becomes unresponsive to BCG face an increased risk of recurrence and progression and often have limited nonsurgical treatment options.

"Patients with high-grade papillary disease that no longer responds to BCG remain at meaningful risk for recurrence and progression and historically have had limited nonsurgical treatment options," said Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center. "The availability of an FDA-approved treatment for this population represents an important addition to the treatment landscape, providing appropriate patients with BCG-unresponsive disease another treatment option that may help preserve the bladder."

ANKTIVA’s expansion into BCG-unresponsive high-grade papillary-only NMIBC significantly increases its U.S. addressable patient population beyond the currently approved CIS with or without papillary indication.

"The expansion of ANKTIVA plus BCG into papillary-only disease broadens the eligible patient population and establishes it as the first FDA-approved therapy for both CIS and papillary-only disease in BCG-unresponsive NMIBC," added Richard Adcock, President and CEO of ImmunityBio. "Building on strong commercial growth since ANKTIVA’s initial approval, we remain focused on helping eligible patients access this therapy and are grateful to the patients, families, investigators, and clinical teams who made this progress possible."

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The interleukin-15 (IL-15) cytokine 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. ANKTIVA is a first-in-class IL-15 receptor 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 independent of 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 in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).

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 BCG-unresponsive NMIBC have evidence of high-grade disease 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.

USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. For more information, please see the Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, OCT 14, 2026, View Source [SID1234673436])

On October 14, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has received acceptance by the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) resubmission for tabelecleucel, with a proposed indication as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.

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The BLA has a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027.

"The acceptance of the tabelecleucel resubmission brings us one step closer to making this first-of-its-kind treatment available to patients in the U.S.," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We appreciate the Agency’s guidance and look forward to a collaborative review process. We will continue supporting PFP as it prepares for a potential U.S. launch."

Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disorders.

If tabelecleucel is approved, Atara would be eligible to receive a $31 million milestone payment under its commercialization agreement with Pierre Fabre Laboratories. Atara would also be eligible to receive significant double-digit tiered royalties on net sales and additional commercial sales milestones.

(Press release, Atara Biotherapeutics, OCT 14, 2026, View Source [SID1234673432])

On October 14, 2026 Alentis Therapeutics and PinotBio reported they have entered into a research collaboration and licensing agreement to discover and develop next-generation antibody-drug conjugates (ADCs) to expand the potential of claudin-1 as a therapeutic target in oncology.

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Claudin-1 is overexpressed in more than ten different tumor types, representing a significant opportunity for targeted cancer therapies. Alentis is the leader in developing claudin-1 targeted therapies, with two first-in-class ADC candidates in the clinic, while PinotBio has established itself as a leader in ADC innovation through its PINOT-ADC platform offering a toolbox of novel linkers and payloads. The collaboration aims to combine PinotBio’s technologies with Alentis’ antibody portfolio to develop the next generation of claudin-1 targeting ADCs, tailored to overcome resistance mechanisms and address unmet needs across a wide variety of cancers.

Under the agreement, Alentis will have an exclusive option to in-license novel linkers and/or payloads from PinotBio for use in its development candidates. The agreement includes an upfront payment to PinotBio plus development, regulatory and commercial milestones, as well as royalties on net sales for each ADC candidate that Alentis elects to develop.

"Claudin-1 continues to gain recognition as a highly promising target and, together with our partner PinotBio, we aim to further expand its therapeutic potential and maximize patient benefit across a range of high-unmet need cancers," said Dr. Mark Pruzanski, Chief Executive Officer of Alentis Therapeutics. "This expanded relationship builds on our successful research collaboration, during which we explored dozens of ADC constructs and saw firsthand the strength of PinotBio’s science and execution."

"We are delighted to expand our collaboration with Alentis, as this agreement represents an important milestone for PinotBio and further validates the strength of our PINOT-ADC platform," said Dr. Doo Young Jung, Chief Executive Officer of PinotBio. "Our platform provides the flexibility to pair novel linkers and payloads to create ADCs with enhanced efficacy and specificity, while addressing limitations associated with first-generation ADC approaches, including poor responses, treatment resistance, and toxicities."

(Press release, Alentis Therapeutics, OCT 14, 2026, View Source [SID1234673429])

On October 14, 2026 Likang Life Sciences reported it will serve as a sponsor and exhibitor at the Abu Dhabi Future Health Summit 2026, to be held October 20–22 at the ADNEC Centre in Abu Dhabi, the United Arab Emirates. Shannon Cheung, Co-Founder and Vice Chairman of Likang, will join a panel discussion titled "The Future of Cancer" on October 21 to explore advances in precision oncology and the translation of innovative cancer treatments into clinical practice.

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Convened by the Department of Health – Abu Dhabi (DoH), the summit brings together policymakers, researchers, clinicians, investors, and industry leaders from around the world. Under the theme "To Sense Is to Predict," the event focuses on artificial intelligence, genomics, advanced diagnostics, and the future of personalized healthcare. Organizers expect participants from approximately 100 countries and more than 175 exhibiting organizations.

As part of the summit’s Abu Dhabi Blueprints series, "The Future of Cancer" panel will examine advances in cancer care and the roles of research, investment, policy, and international collaboration in bringing innovative therapies to patients.

Likang Life Sciences is developing personalized cancer immunotherapies through its proprietary AI-powered neoantigen discovery platform, which identifies and prioritizes patient-specific tumor neoantigens. The platform supports a pipeline spanning personalized therapeutic cancer vaccines and neoantigen-specific T-cell therapies.

Its lead investigational candidate, LK101, is a personalized neoantigen mRNA-DC therapeutic cancer vaccine. LK101 received clinical trial authorization from China’s National Medical Products Administration (NMPA) in 2023 and U.S. FDA Investigational New Drug (IND) clearance in 2025.

At the summit, Likang Life Sciences will highlight its technology platform, clinical development programs, and experience in advancing personalized immunotherapies from research into clinical development. The company also looks forward to engaging with international healthcare institutions, researchers, and industry partners, particularly within Abu Dhabi’s growing precision medicine ecosystem, to explore opportunities for scientific and clinical collaboration.

Through its participation, Likang Life Sciences aims to strengthen international scientific and clinical collaboration, accelerate the development of personalized cancer immunotherapies, and contribute to the advancement of precision oncology worldwide.

(Press release, Likang Life Sciences, OCT 14, 2026, View Source [SID1234673362])

On October 14, 2026 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported that the first patient has been dosed in a Phase 1 clinical trial evaluating ORM-1153, the Company’s investigational CD123-GSPT1 DAC, in patients with relapsed or refractory acute myeloid leukemia (AML) and other CD123-expressing hematologic malignancies.

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ORM-1153 combines Orum’s internally developed CD123-targeting antibody with a proprietary GSPT1 degrader payload. The antibody was engineered for efficient internalization into target cells and reduced Fc-gamma receptor interactions, with a linker designed for plasma stability. Preclinical studies demonstrated activity across primary AML patient samples and models with TP53 mutations, providing a rationale for evaluating ORM-1153 in patients with difficult-to-treat disease.

"We have built a substantial preclinical data package for ORM-1153, and our task now is to establish how those findings translate clinically," said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. "The preparation of our team and the support of our clinical site partners enabled us to move efficiently from IND clearance through site activation to dosing. The study will allow us to assess whether the improvements in payload delivery observed preclinically translate into a favorable balance of activity and tolerability in patients."

"Patients with relapsed or refractory AML, particularly those with high-risk molecular features, continue to have poor outcomes and need additional treatment options," said Andrew Sochacki, M.D,. Associate Director of Hematology at START Midwest. "Targeted delivery of a GSPT1 degrader offers a different approach to treating these cancers. This Phase 1 study will provide important initial information about ORM-1153’s safety, pharmacology, and potential activity in patients."

The first-in-human Phase 1 study is an open-label, dose-escalation trial designed to identify the optimal biological dose and evaluate the safety and tolerability of ORM-1153. The study will also characterize its pharmacokinetic and pharmacodynamic profile and assess preliminary antileukemic activity. Approximately 42 patients are expected to be enrolled at multiple clinical sites initially in the United States, potentially followed by sites in other regions. Additional information is available on ClinicalTrials.gov under identifier NCT07809906.

About ORM-1153

ORM-1153 is a CD123-GSPT1 degrader-antibody conjugate developed using Orum’s proprietary GSPT1 degrader platform. The molecule combines a proprietary GSPT1-degrading payload with an internally developed anti-CD123 antibody engineered for high internalization efficiency through a cleavable β-glucuronide linker. Following internalization and payload release, ORM-1153 is designed to induce cancer cell death through targeted degradation of GSPT1. In preclinical studies presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, ORM-1153 demonstrated activity across primary AML patient samples and TP53-relevant models, along with antileukemic activity at low doses in vivo. Its safety and efficacy in patients have not been established.

(Press release, Orum Therapeutics, OCT 14, 2026, View Source [SID1234673356])