On May 18, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated commercial-stage immunotherapy company, reported that five United States patents have been issued to ImmunityBio covering the combination of its IL-15 receptor agonist ANKTIVA (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for the treatment of cancer.

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The five patents (U.S. Patent Nos. 11,173,191; 11,679,144; 11,890,323; 12,268,731; and 12,318,432) with terms extending through at least 2035 include compositions of combinations of ANKTIVA and BCG. Together they protect the approved ANKTIVA plus BCG product, the specific intravesical dosing regimen, the two-vial commercial kit, and methods of treating non-muscle invasive bladder cancer (NMIBC) including BCG-naïve disease and bladder cancer.

The issued patent portfolio establishes composition-of-matter and method-of-use protection for ImmunityBio’s IL-15 receptor agonist and BCG combination platform through the next decade and beyond. This intellectual property position supports the Company’s commercial ANKTIVA plus BCG franchise in BCG-unresponsive NMIBC and bladder cancer, its pending supplemental BLA for BCG-unresponsive papillary-only disease, and the advancing QUILT-2.005 registrational trial evaluating ANKTIVA plus BCG versus BCG alone in BCG-naïve NMIBC carcinoma in situ.

The patent portfolio also intersects with ImmunityBio’s recently announced exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo strain of BCG (Tokyo-172), which is supported by the positive Phase III SWOG S1602 results demonstrating non-inferiority of Tokyo-172 BCG versus TICE BCG on high-grade recurrence-free survival (HR 0.82; 95.8% CI 0.63–1.08) in 984 randomized patients with BCG-naïve high-grade NMIBC. As ImmunityBio engages with the FDA to pursue U.S. approval of Tokyo-172 BCG, the issued patent estate protects the combination of any approved BCG strain with the Company’s IL-15 receptor agonist platform.

"Over the past decade, we have built an integrated immunotherapy platform grounded in the science of IL-15 and its capacity to activate NK cells, CD8+ T cells, and memory T cells without expanding suppressive regulatory T cells. These five issued patents protect that science at every layer that matters commercially: the compositions of matter, the method of treatment, the wild-type and mutant IL-15 plus BCG compositions, the intravesical dosing regimen, and the two-vial kit physicians administer. The IL-15 and BCG combination is the backbone of our bladder cancer franchise, and this patent estate protects it through at least 2035. In a similar vein, ImmunityBio has received issued patents covering the combination of ANKTIVA with checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio.

"This patent portfolio provides long-term protection for a cornerstone of ImmunityBio’s commercial franchise at a time when we are expanding the clinical utility of ANKTIVA plus BCG across multiple NMIBC settings, securing a second BCG supply source for the U.S. market, and generating 700% year-over-year revenue growth. The combination of durable patent protection, validated clinical data, and supply chain diversification positions ANKTIVA plus BCG as the standard of care in this disease for years to come," said Richard Adcock, President and Chief Executive Officer of ImmunityBio.

U.S. Patent No. 11,173,191 (issued November 16, 2021) covers the core method of treating cancer by administering BCG together with the IL-15N72D:IL-15RαSu/Fc complex (ALT-803/ANKTIVA), with dependent claims specific to bladder cancer, NMIBC, BCG-naïve NMIBC, and intravesical administration. This is the foundational method-of-treatment claim that reads directly on the FDA-approved use of ANKTIVA plus BCG.
U.S. Patent No. 11,679,144 (issued June 20, 2023) covers the pharmaceutical composition combining BCG with a wild-type IL-15:IL-15RαSu complex, including the two-vial kit format (one vial BCG, one vial IL-15:IL-15RαSu, plus directions for use in treating cancer including bladder cancer). This broadens composition and product-form protection beyond the IL-15N72D mutant to wild-type IL-15 combinations.
U.S. Patent No. 11,890,323 (issued February 6, 2024) covers the method of treating NMIBC, including BCG-naïve NMIBC, by intravesical instillation of BCG plus a wild-type IL-15:IL-15RαSu complex. This patent pairs with 11,173,191 to cover both the IL-15 mutant and wild-type forms of the combination, closing a potential design-around route.
U.S. Patent No. 12,268,731 (issued April 8, 2025) covers the defined-dose composition itself: a single intravesical dose, matching the ANKTIVA plus BCG dosing regimen used in the FDA-approved label and in the QUILT-3.032 and QUILT-2.005 trials. Claims also cover the corresponding two-vial bladder cancer treatment kit.
U.S. Patent No. 12,318,432 (issued June 3, 2025) covers the commercial two-vial kit itself: a first vial of BCG and a second vial of ANKTIVA (dimeric IL-15RαSu/Fc plus two IL-15N72D molecules) with instructions for treating neoplasia. This patent protects the as-supplied product configuration that physicians receive and administer.
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 18, 2026, View Source [SID1234665824])

On May 18, 2026 Eli Lilly and Company (NYSE: LLY) reported it will participate in Bernstein’s 42nd Annual Strategic Decisions Conference on May 28, 2026. Daniel M. Skovronsky, M.D., Ph.D., chief scientific and product officer, and president of Lilly Research Laboratories, will take part in a fireside chat at 1:30 p.m., Eastern time.

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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, MAY 18, 2026, View Source [SID1234665823])

On May 18, 2026 Cytovation ASA, a clinical-stage biotechnology company developing therapies targeting β-catenin-driven cancers, reported a clinical supply agreement for tislelizumab (TEVIMBRA) with BeOne Medicines as part of the initiation of a clinical trial to evaluate getacatetide (CY-101) in combination with tislelizumab in patients with metastatic colorectal cancer (CRC).

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The Phase 2 study will investigate the potential of getacatetide to overcome β-catenin-driven immune exclusion, activate cytotoxic T cells and enhance response to checkpoint inhibition in patients with advanced CRC, with a particular focus on those with liver metastases. CRC is the third most common cancer worldwide, with almost two million new cases diagnosed every year. The liver is the most common site of CRC metastasis, and progression of hepatic metastases is a major contributor to mortality. CRC with liver metastases is largely refractory to checkpoint inhibition in the microsatellite-stable (MSS) setting, and β-catenin–driven immune exclusion is a key mechanism of resistance.

Getacatetide is designed to degrade β-catenin while enhancing antigen exposure within the tumor microenvironment. When administered directly into liver lesions, getacatetide has previously demonstrated the potential to overcome the immunosuppressive liver microenvironment and to initiate a cytotoxic T cell anti-tumor response, providing a mechanistic basis for combination with PD-1 blockade.

The trial builds on emerging clinical and translational data supporting systemic immune activation following administration of getacatetide, with abscopal activity across metastatic sites and organs.

"Checkpoint inhibitors have transformed the treatment landscape in many cancers. Unfortunately, the vast majority of colorectal cancer patients with liver metastases remain without an effective immunotherapy option. The liver is a critical immunological bottleneck – a site where anti-tumor immunity is actively suppressed, blunting the benefit of checkpoint blockade," said Lars Prestegarden, Co-founder and CEO of Cytovation. "This supply agreement allows us to directly assess getacatetide’s ability to address this challenge, harness the full potential of PD-1 inhibition and potentially deliver a powerful dual therapeutic combination in this large and underserved patient population."

About getacatetide (CY-101)

Getacatetide is a first-in-class bifunctional peptide designed to degrade β-catenin while enhancing antigen exposure and inducing immunogenic cell death within the tumor microenvironment. Getacatetide activates cytotoxic T cells against tumors that are resistant to checkpoint inhibition and has demonstrated clinical activity in patients with advanced solid tumors and visceral metastases.

(Press release, Cytovation, MAY 18, 2026, View Source;utm_medium=rss&utm_campaign=cytovation-to-advance-development-of-cy-101-for-cancers-driven-by-dysfunction-of-wnt-%25ce%25b2-catenin-signalling-under-international-nonproprietary-name-of-getacatetide-2 [SID1234665822])

On May 18, 2026 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI/ML, reported financial results for the first quarter of 2026 and provided a corporate update.

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"Q1 2026 reflects continued execution across all of our programs in line with our strategic priorities," said Eran Ophir, Ph.D., President and CEO of Compugen. "With enrollment progressing across all COM701 MAIA-ovarian trial sites, we remain on track for having the median progression-free survival at the interim analysis by Q1 2027, a key potential inflection point for COM701 as a maintenance therapy in a patient population with significant unmet medical need and no current standard of care."

Dr. Ophir continued, "Our partner AstraZeneca continues to broadly advance rilvegostomig. Data presented by AstraZeneca at AACR (Free AACR Whitepaper) 2026 reinforces our confidence in its differentiated bispecific design and potential as an immuno-oncology backbone across multiple tumor types, as AstraZeneca progresses rilvegostomig across 11 Phase 3 trials. In addition, we continue to advance the Gilead-partnered GS-0321 Phase 1 trial."

Dr. Ophir concluded, "Our solid financial position with cash runway expected into 2029, based on our current plans, enables us to advance our differentiated immuno-oncology pipeline and leverage our AI/ML powered computational discovery platform Unigen, to discover novel ways to activate the immune system against cancer. I remain encouraged by the progress of our fully owned programs, strengthened by validating partnerships with AstraZeneca and Gilead, which together offer approximately $1 billion in potential milestones plus royalties."

First Quarter 2026 Financial Highlights

Cash: As of March 31, 2026, Compugen had approximately $134.9 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities.

Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2029. This does not include any additional cash inflows. The Company has no debt.

Revenue: Compugen reported approximately $2.2 million in revenues for the first quarter ended March 31, 2026, compared to approximately $2.3 million in revenues for the comparable period in 2025. The revenues reported in the first quarters of 2026 and 2025 reflect recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead.

R&D expenses for the first quarter of 2026 were approximately $6.9 million compared with approximately $5.8 million for the comparable period in 2025. The increase is mainly due to an increase in clinical expenses related to MAIA-ovarian trial as well as drug supply costs supporting our trials.

G&A expenses for the first quarter of 2026 were approximately $2.3 million compared to approximately $2.4 million for the comparable period in 2025.

Net loss for the first quarter of 2026 was approximately $7.7 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $7.2 million, or $0.08 per basic and diluted share, in the comparable period in 2025.

Full financial tables are included below.

Conference Call and Webcast Information

The Company will hold a conference call today, May 18, 2026, at 8:30 AM ET to review its first quarter 2026 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

(Press release, Compugen, MAY 18, 2026, View Source [SID1234665821])

On May 18, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of its anti-cancer agent/ALK inhibitor Alecensa (generic name: alectinib) for advanced or recurrent ALK fusion gene-positive solid tumors, including pediatric patients. This is the world’s first tumor-agnostic approval for an ALK inhibitor.

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"We are delighted that Alecensa, discovered by Chugai, has been approved as the world’s first tumor-agnostic therapy for patients with ALK fusion-positive solid tumors.
This approval expands access to Alecensa beyond its established use in non-small cell lung cancer and anaplastic large cell lymphoma, bringing a new treatment option to patients across a wide range of cancer types. We will continue striving to further contribute to personalized healthcare, delivering the most appropriate treatment to each patient, regardless of cancer type or age," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results of the TACKLE study, an investigator initiated Japanese Phase II clinical study evaluating the efficacy and safety of Alecensa in pediatric and adult patients with rare cancers harboring ALK gene abnormalities (fusion / rearrangement genes, activating mutations, and gene copy number amplification) in advanced or recurrent settings. In this study, the response rate as assessed by the central review committee, which was the primary endpoint, was 43.8% (7/16 patients, 95% CI: 19.8%-70.1%) in the full analysis set (FAS) of the main cohort. In the ALK fusion gene-positive subpopulation within this cohort, the response rate was 70.0% (7/10 patients, 95% CI: 34.8%–93.3%). In addition, in the ALK fusion gene-positive subpopulation of the overall FAS pooled across all cohorts, the response rate was 76.5% (13/17 patients, 95% CI: 50.1%-93.2%), and the efficacy data in patients with ALK fusion gene-positive tumors from this study were considered the key basis for regulatory approval. The incidence of adverse events was 73.1% (19/26 patients), with the main adverse reactions being lymphocyte count decreased, and neutrophil count decreased at 23.1% each (6/26 patients), anemia at 19.2% (5/26 patients), and blood creatinine increased at 15.4% (4/26 patients). The safety profile observed in this study was similar to the previously established safety profile of Alecensa, with no new safety signals identified.

FoundationOne CDx Cancer Genomic Profile is used as a companion diagnostic to identify people that could potentially benefit from Alecensa for ALK fusion-positive solid tumors. The MHLW granted the approval for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic of Alecensa on March 9, 2026.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines for patients and healthcare professionals.

Approval Information *Relevant sections only, with modifications underlined

Indications:
◯ ALK fusion-positive advanced or recurrent solid tumors
◯ Adjuvant treatment in ALK fusion-positive non-small cell lung cancer
◯ ALK fusion-positive recurrent or refractory anaplastic large cell lymphoma

Dosage and Administration:

The usual adult dosage is 300 mg alectinib administered orally twice a day.
The usual pediatric dosage of alectinib is based on body weight as shown below and administered orally once or twice daily.

Body Weight Daily dose Dose per administration
(morning/evening)
≥6 kg and <15 kg 150mg 150mg/0mg
≥15 kg and <25 kg 300mg 150mg/150mg
≥25 kg and <35 kg 450mg 300mg/150mg
≥35 kg 600mg 300mg/300mg
[Reference Information]

Chugai Files for Additional Tumor-Agnostic Indication of Alecensa for ALK Fusion / Rearrangement Gene-Positive Solid Tumors Including Pediatric Patients (News release issued on June 26, 2025)
View Source

Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Alecensa for ALK Fusion Gene-Positive Solid Tumors (News release issued on May 18, 2026)
View Source

About the TACKLE study

The TACKLE study (NCCH1712/MK003, jRCT2091220364) is an investigator initiated, multicenter, open-label, single-arm, Japanese Phase II clinical study evaluating the efficacy and safety of Alecensa in pediatric and adult patients with unresectable rare cancers harboring ALK gene abnormalities (fusion / rearrangement genes, activating mutations, gene copy number amplification). In this study, safety and efficacy were evaluated in 26 patients, utilizing genomic information, including data registered with the Center for Cancer Genomics and Advanced Therapeutics (C-CAT). The primary endpoint was response rate, and secondary endpoints included progression-free survival, overall survival, and safety. The TACKLE study is being conducted as a substudy of the MASTER KEY project,1 which promotes the development of treatments for rare cancers through industry-academia collaboration led by the National Cancer Center Hospital, and is being carried out at four sites in Japan: National Cancer Center Hospital, Kyoto University Hospital, Kyushu University Hospital, and Hokkaido University Hospital.

About ALK fusion / rearrangement gene-positive solid tumors

ALK fusion / rearrangement genes are abnormal genes created when the ALK (anaplastic lymphoma kinase) gene fuses with other genes (such as EML4, NPM) as a result of chromosomal translocation.2,3 ALK fusion / rearrangement proteins produced from these fusion / rearrangement genes are thought to promote cancer cell proliferation. ALK fusion / rearrangement genes have been identified in patients with inflammatory myofibroblastic tumors, lung cancer, breast cancer, colorectal cancer, and other cancers.2,4,5

About Alecensa

Alecensa is an oral medicine discovered by Chugai, which is highly selective for ALK and active in the central nervous system. ALK fusion / rearrangement gene-positive lung cancer is found in approximately 3-5% of NSCLC cases.4 Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK fusion / rearrangement gene-positive metastatic NSCLC, including in the United States, Europe, Japan, China, and Taiwan. For adjuvant therapy of ALK fusion / rearrangement gene-positive NSCLC, Alecensa received approval in the United States in April 2024, followed by Europe in June 2024, and Japan in August 2024. In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion / rearrangement gene-positive anaplastic large cell lymphoma.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, MAY 18, 2026, View Source [SID1234665820])