On May 19, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated commercial-stage immunotherapy company, reported results from two indirect treatment comparison (ITC) analyses presented at the 2026 American Urological Association (AUA) Annual Meeting evaluating nogapendekin alfa inbakicept-pmln (NAI, ANKTIVA) plus Bacillus Calmette–Guérin (BCG) against two other U.S. Food and Drug Administration (FDA) approved therapies for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease.

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The AUA 2026 ITC presentations were:

Podium presentation – PD25-15 (Edwards et al.): NAI+BCG versus nadofaragene firadenovec-vncg in BCG-unresponsive NMIBC CIS with or without papillary disease
Interactive poster – IP50-12 (Jayram et al.): NAI+BCG versus TAR-200 in BCG-unresponsive NMIBC CIS with or without papillary disease
Comparative Effectiveness Versus Nadofaragene Firadenovec-vncg

In the absence of head-to-head randomized trials, ImmunityBio conducted a matching-adjusted indirect comparison (MAIC) using individual patient data from QUILT-3.032 (Cohort A, NAI+BCG, n=100) weighted against aggregate data from NCT02773849 (CIS Cohort, nadofaragene firadenovec-vncg, n=103). Baseline matching variables included age (≥65 years), sex, Eastern Cooperative Oncology Group (ECOG) performance status, race, and tumor stage. Effective sample sizes after weighting ranged from 71.7% to 84.2% across endpoints.

After matching, NAI+BCG demonstrated:

Anytime CR rate of 69.7% (weighted) versus 53.4% for nadofaragene firadenovec-vncg; OR 2.01 (95% CI: 1.08, 3.72); E-value 3.43
Median duration of complete response of 22.1 months versus 9.7 months, a difference of 12.45 months (95% CI: 8.17, 17.09); HR for end of response 0.57 (95% CI: 0.34, 0.95)
Cystectomy-free survival HR 0.40 (95% CI: 0.21, 0.75)
Overall survival HR 0.85 (95% CI: 0.22, 3.31), not statistically different between treatments
Kaplan-Meier curves for duration of response and cystectomy-free survival remained consistently above the nadofaragene firadenovec-vncg comparator throughout the follow-up period. Sensitivity analyses using simulated treatment comparison (STC) methodology produced consistent results.

"The magnitude and durability of complete response observed with NAI+BCG, combined with a meaningful reduction in the risk of cystectomy, are clinically relevant for patients with BCG-unresponsive NMIBC for whom bladder preservation is the priority," said Dr. Brooke B. Edwards, the Urology Group, Cincinnati, OH. "These comparative data, while subject to the inherent limitations of unanchored indirect comparisons, provide context that can support shared decision making with patients considering bladder-sparing therapy."

Comparative Effectiveness Versus TAR-200

A separate MAIC was conducted comparing individual patient data from QUILT-3.032 (Cohort A, NAI+BCG, n=100) with aggregate data from SunRISe-1 (Cohort 2, TAR-200, n=85). Matching variables included age, sex, ECOG performance status, race, prior BCG instillations, and tumor stage. Outcomes of interest were complete response rate at 12 months and treatment-related adverse events of any grade.

Key findings from the base-case adjusted MAIC:

At 12 months, NAI+BCG achieved a higher complete response rate than TAR-200 (49.2% versus 45.9%; OR 1.14; 95% CI: 0.61, 2.15); the difference did not reach statistical significance
Patients treated with NAI+BCG experienced substantially fewer treatment-related adverse events of any grade than patients treated with TAR-200 (61.7% versus 83.5%), a statistically significant 68% reduction in adverse event odds (OR 0.32; 95% CI: 0.15, 0.67); E-value 5.70
Sensitivity analyses using both MAIC and STC methodologies produced consistent safety findings, with E-values exceeding 5 across analyses, indicating that any unmeasured confounder capable of negating the safety finding would need to be approximately 5 times stronger than the measured baseline risk factors
"The comparative effectiveness data presented at AUA 2026 reinforce what we have observed across the ANKTIVA development program: that IL-15, working through the trifecta of NK cells, CD8+ T cells, and memory T cells, can produce complete responses that are not only more frequent but materially more durable than other approved therapies for BCG-unresponsive non-muscle invasive bladder cancer," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. "A duration of complete response more than twice as long as with nadofaragene speaks directly to the central question patients ask: ‘how long will my response last?’ These ITC analyses, while subject to the limitations of unanchored comparisons, add to the growing body of evidence that ANKTIVA plus BCG can serve as the immunological backbone of bladder cancer treatments. Beyond the data, the enthusiasm we heard directly from urologists at AUA about our continued advancement of recombinant BCG, and our parallel progress in developing an additional source of conventional BCG with the Tokyo strain, was a welcome confirmation that the field shares our urgency. It is exciting to be in a position to offer urologists and their patients additional sources of intravesical immunotherapy at a moment when the persistent U.S. TICE BCG shortage has made access the binding constraint on care in the urology setting."

Limitations

The QUILT-3.032 versus NCT02773849 and QUILT-3.032 versus SunRISe-1 analyses are unanchored, population-adjusted indirect treatment comparisons and should be interpreted with caution. Some baseline variables were not mutually reported across trials, including tumor grade, size, number of tumors, recurrence classification (relapse versus refractory), and timing of recurrence, limiting the ability to fully verify comparability across all clinically meaningful dimensions. Residual confounding was mitigated by including all reported prognostic variables and treatment effect modifiers in the adjustment process, and stability of results was assessed through sensitivity analyses and E-value tipping-point analyses.

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. 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

U.S. 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.

Investigational Use Notice: The Tokyo strain of BCG (manufactured by Japan BCG Laboratory) and recombinant BCG or rBCG (manufactured by Serum Institute of India under ongoing partnership with ImmunityBio) are investigational in the United States and have not been approved by the FDA. The safety and effectiveness of these investigational products have not been established. Availability of rBCG is limited to ImmunityBio’s FDA Expanded Access Program for eligible patients. To enroll in the Expanded Access Program for recombinant BCG, please visit View Source

(Press release, ImmunityBio, MAY 19, 2026, View Source [SID1234665858])

On May 19, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology and precision intracellular drug-delivery company, reported the expansion of internal capabilities to execute critical stages of its ACCUM‑enabled Antibody Drug Conjugates ("ADC") development pipeline. The Company has strengthened its purification, analytical characterization, conjugation development, and quality control ("QC") capabilities, while enhancing cellular testing and potency evaluation workflows within a more structured stage-gated framework to better support the advancement of its ADC partnership programs.

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"By strengthening our internal QC, analytical, and conjugation capabilities, Defence is positioning itself to become a leading authority in the development and controlled manufacture of ACCUM-enabled ADCs," said Mark Lambermon, PhD, Head of Quality & Operations at Defence Therapeutics. "Our focus is to establish robust, reproducible, and quality-driven processes that support the consistent generation of high-quality ACCUM-ADC candidates for our partnership programs."

To support the development of high-quality ACCUM-enabled ADC candidates, the Company has acquired an FPLC system to improve purification workflows and the consistency of conjugated materials, while also advancing the evaluation of multiple conjugation methods, including site specific strategies. These efforts are guided by a structured framework designed to identify the most suitable conjugation approach for each partner ADC based on format, chemistry compatibility, Drug-to-Antibody Ratio ("DAR") profile, and developability characteristics such as stability and aggregation.

In parallel, Defence Therapeutics is enhancing its analytical characterization and QC infrastructure through standardized analytical checkpoints, documentation practices, and reproducibility-focused processes designed to support reliable decision-making and partner-ready execution.

The Company has also expanded its cellular testing capabilities with the addition of an Incucyte live-cell imaging platform designed to generate kinetic potency and mechanism-relevant cellular data designed to better assess the internalization, intracellular delivery, and cellular potency of ACCUM-enabled ADC candidates. These capabilities are being integrated within a more structured stage-gated governance framework with clearly defined success criteria to support efficient lead candidate selection and downstream validation activities.

"As we continue to grow our ADC partnership activities, it is important that our internal capabilities evolve alongside the needs of our partners," said Amie Phinney, PhD, Defence Therapeutics’ Strategy & Business Advisor. "These expanded capabilities strengthen our ability to tailor ACCUM integration and support partner programs with greater confidence and precision."

"By bringing key development and analytical capabilities in-house, we are strengthening our ability to rapidly evaluate and advance ACCUM-enabled ADC candidates," said Sébastien Plouffe, Chief Executive Officer of Defence Therapeutics. "These expanded capabilities position us to accelerate our ADC partnership programs and support the development of more effective ADC therapies for patients."

(Press release, Defence Therapeutics, MAY 19, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-enhances-in-house-adc-development-platform-with-expanded-analytical-and-cellular-testing-capabilities [SID1234665857])

On May 19, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported it will host a webcast for investors to present updated results from its ongoing Phase 2 trial of silevertinib in frontline patients with EGFR mutated non-small cell lung cancer on Thursday, May 21, 2026, at 5:30 p.m. ET.

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Webcast information

The webcast can be accessed under "Events and Presentations" on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com. A replay of the webcast will be available following the completion of the event for a limited time.

(Press release, Black Diamond Therapeutics, MAY 19, 2026, View Source [SID1234665856])

On May 19, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported highly encouraging new preclinical data that further support the recently initiated Phase 1/2a clinical trial evaluating GLIX1 for the treatment of recurrent and progressive GBM and other high-grade gliomas.

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GBM remains one of the most aggressive and treatment-resistant cancers, urgently in need of breakthrough innovations and more effective treatment.

In a comprehensive pre-clinical program, orally administered GLIX1 demonstrated robust anti-tumor activity in orthotopic cell-derived xenograft (CDX) GBM models, as well as in a newly completed subcutaneous TMZ-resistant patient-derived xenograft (PDX) GBM model. In the three orthotopic CDX studies, significant tumor growth inhibition and survival benefit were observed following treatment with GLIX1 across all doses tested, with greater benefit at higher dose levels. In these models, mice treated with TMZ also showed significantly decreased tumor volume and survival benefit. Most notably, in the subcutaneous PDX model, GLIX1 demonstrated a robust anti-tumor effect while TMZ showed no effect.

"The compelling results from these studies, including the recently completed TMZ-resistant PDX model, are very exciting as they suggest that GLIX1 may bring hope to a broad range of patients with GBM," said Philip Serlin, Chief Executive Officer of BioLineRx. "In addition, the pre-clinical dose-response characterization adds important information for dose optimization in the Phase 2 part of the ongoing clinical study. We believe GLIX1 has the potential to offer a novel therapeutic approach in this cancer indication, as well as in multiple other cancer indications where DNA damage repair is critical for cancer survival."

BioLineRx and Hemispherian plan to present the data from these studies at one or more future medical conferences.

About Glioblastoma
Glioblastoma is the most common primary brain tumor and remains one of the most aggressive and treatment-resistant cancers, urgently in need of breakthrough innovations and more effective treatment. The standard of care for newly diagnosed GBM established since 2005 consists of surgery, followed by radiotherapy and treatment with temozolomide (TMZ), with no established standard of care for recurrent GBM. However, patients with unmethylated MGMT[1] promoter status (who represent more than half of all GBM patients) have demonstrated a limited response to TMZ.

About GLIX1
GLIX1 is a first-in-class, orally administered, brain penetrating, small molecule activator of the Ten-Eleven Translocation 2 (TET2) pathway that is commonly inhibited in cancer. Activating the novel TET2 pathway by GLIX1 overwhelms the DNA repair capacity of cancer cells, resulting in apoptotic cancer cell death.

About the Phase 1/2a Trial with GLIX1
The Phase 1/2a trial is an open-label, multicenter trial. Part 1 of the trial is a dose escalation study where patients receive GLIX1 daily as monotherapy. This part is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Updates to the Phase 1/2a trial are anticipated during H2 2026, with full results on the dose escalation part expected in 2027.

The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers, with GLIX1 as monotherapy or in combination with standard of care (including in combination with PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan.

For more information on the Phase 1/2a trial, please visit NCT07464925.

[1] MGMT stands for O6-methylguanine-DNA methyltransferase, a DNA repair enzyme.

(Press release, BioLineRx, MAY 19, 2026, View Source [SID1234665855])

On May 19, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the IPAX-2 study1 of TLX101-Tx (¹³¹I-iodofalan) in patients with newly diagnosed glioblastoma has completed patient enrolment. No dose-limiting toxicities (DLTs) have been observed to date, including with two doses of 5GBq (total administered activity of 10GBq), the maximum administered dose in the study.

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IPAX-2 is an international, multicenter, open-label Phase 1 dose finding study to evaluate the safety and tolerability of TLX101-Tx in combination with post-surgical standard-of-care treatment (external beam radiation therapy and temozolomide) in primary glioblastoma. Twelve patients were enrolled into three dose escalating cohorts across four sites in Australia, Austria and the Netherlands to assess the safety and tolerability, and to assess the maximum tolerated dose (MTD) for further development. Patients remain on standard-of-care treatment until study completion, after which the MTD primary endpoint will be confirmed.

Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, "We are pleased to have completed enrolment in IPAX-2, an important milestone in the development of TLX101-Tx as a potential treatment for first-line glioblastoma. The tolerability amongst patients, and the absence of dose-limiting toxicities observed on this study strongly support the continued development of this targeted radiopharmaceutical candidate. We thank the principal investigators, their clinical teams, and the patients who have participated in this important research."

TLX101-Tx is currently also under evaluation in the pivotal IPAX BrIGHT2 trial to assess the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone in patients with recurrent glioblastoma (last line). IPAX BrIGHT is actively enrolling and dosing patients in Australia and the Netherlands and is also approved in Austria and Belgium with enrollment to begin soon. This marks the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma.

Telix’s PET imaging candidate TLX101-Px (floretyrosine F 18) has been used across the IPAX series of trials to identify participants with overexpressed LAT1 as suitable candidates for TLX101-Tx therapy, and to provide baseline and follow-up information on tumor response and progression.

About TLX101-Tx

TLX101-Tx (¹³¹I-iodofalan) is a systemically administered radiopharmaceutical therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in glioblastoma. TLX101-Tx utilizes a small molecule approach due to the need to cross the blood brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain. In addition to IPAX-2, TLX101-Tx was also the subject of the IPAX-1 study3 in recurrent glioblastoma, which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis4. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx in the recurrent setting were consistent and confirmatory to IPAX-1, with a median OS of 11.9 months from the relapse prior to trial enrollment and 32.2 months from initial diagnosis5. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx.

TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma. TLX101-Tx and TLX101-Px have not received a marketing authorization in any jurisdiction and are for investigational use only.

About glioblastoma

Glioblastoma (GBM), is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.6. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients7, with an expected survival duration of 12-15 months from diagnosis

(Press release, Telix Pharmaceuticals, MAY 19, 2026, View Source [SID1234665846])