ImmunityBio Announces ANKTIVA® Is Now Available in Saudi Arabia for Bladder and Lung Cancer Patients; Market Entry Achieved Within Two Months of MENA Partnership

On April 21, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that ANKTIVA (nogapendekin alfa inbakicept) is now commercially available in Saudi Arabia. Initial patients have been identified for treatment across both approved bladder and lung cancer indications in the Kingdom:

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In combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary disease; and
In combination with an immune checkpoint inhibitor for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC), as authorized by the Saudi Food and Drug Authority (SFDA)
ANKTIVA is being distributed through ImmunityBio’s partnerships with Biopharma and Cigalah Healthcare, leading healthcare distribution companies in the Middle East, with support from the company’s wholly owned subsidiary in Saudi Arabia.

"Thanks to our strategic partnership with Biopharma and Cigalah Healthcare, and despite a fluid situation in the region, we have been able to bring this innovative cancer treatment to patients ahead of the deadline we announced in February," said Richard Adcock, President and CEO of ImmunityBio. "We continue to work with the same level of diligence and commitment to expand access to ANKTIVA for eligible patients across the Middle East and North Africa."

The Middle East and North Africa (MENA) region faces one of the most rapidly growing burdens of cancer globally, including bladder and lung cancers, underscoring the need for additional treatment options. Lung cancer today is among the most common cancers in Saudi Arabia, while the incidence of bladder cancer is elevated in several countries across the region. 1 2

"We are pleased to support the introduction of this immunotherapy to physicians and their patients in Saudi Arabia," said Tamer Eissa, General Manager, Biopharma. "We look forward to expanding access across the region."

"This milestone represents an important step in expanding access to ANKTIVA for patients in Saudi Arabia," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "We are encouraged by the growing body of clinical data and experience supporting its use across multiple indications and remain committed to working with physicians to bring this immunotherapy to appropriate patients in need around the globe."

ANKTIVA received U.S. Food and Drug Administration approval in April 2024 in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS, with or without papillary tumors. It has subsequently received regulatory authorizations in multiple regions, including the United Kingdom (MHRA, July 2025), the European Union (European Commission, February 2026), Macau Special Administration Region of China (ISAF, March 2026), and Saudi Arabia (SFDA, January 2026); in addition, the SFDA approved ANKTIVA in combination with a checkpoint inhibitor for the treatment of metastatic non-small cell lung cancer.

Saudi Arabia Indication and Usage

BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ:

ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) of carcinoma in situ (CIS) with or without papillary disease.

Non-small cell lung cancer (NSCLC):

ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy).

This indication is approved under accelerated approval based on the increase of ALC associated with overall survival in single arm study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.

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.

(Press release, ImmunityBio, APR 21, 2026, View Source [SID1234664613])

Immuneering to Present New Survival Data from First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP in an Oral Presentation at the 2026 ASCO Annual Meeting

On April 21, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that updated data from the Phase 2a clinical trial evaluating atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients will be presented as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.

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The oral presentation will highlight data from an expanded cohort totaling 55 first-line patients, which includes the initial cohort of 34 patients that the company previously reported plus an additional 21 patients.

"We are excited to present new survival data from an expanded cohort of 55 first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP in an oral presentation at ASCO (Free ASCO Whitepaper)," said Ben Zeskind, Ph.D., CEO of Immuneering. "Atebimetinib was designed with three distinct mechanisms to promote survival: shrinking tumors durably, preserving body mass, and maximizing tolerability. We believe these mechanisms have the potential to both yield the best survival in the first-line setting, and to give patients the best chance of reaching and benefitting from second-line treatment. We look forward to sharing this updated dataset in first-line pancreatic cancer patients as we pursue our mission to help patients survive and thrive."

Oral Presentation Details:
Title: Results from a phase 2a study of atebimetinib in combination with mGnP in advanced or metastatic pancreatic cancer
Session Type/Title: Rapid Oral Abstract Session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4013
Date and Time: June 1, 2026, 1:15 p.m. – 2:45 p.m. CDT
Presenter: Peter Vu, MD, MHA

(Press release, Immuneering, APR 21, 2026, View Source [SID1234664612])

Immatics Announces Four Upcoming Oral Presentations Across Its Clinical Cell Therapy and Bispecific Portfolio at 2026 ASCO Annual Meeting

On April 21, 2026 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, reported all submitted abstracts have been selected for oral presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held from May 29-June 2, 2026, in Chicago, Illinois, USA.

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The four oral presentations will include:

Phase 1b clinical data on anzu-cel, the Company’s lead PRAME cell therapy, in advanced cutaneous and uveal melanoma with a focus on characterizing response dynamics
Updated Phase 1a dose-escalation and Phase 1b dose-expansion data for the second-generation (GEN2) PRAME cell therapy candidate, IMA203CD8, in gynecologic cancers at clinically relevant dose levels, which could support its development toward a tumor-agnostic approach
Updated Phase 1 data on PRAME cell therapies in synovial sarcoma, further demonstrating the potential to address diverse tumor types beyond melanoma and gynecologic cancers
Updated results for the MAGEA4/8 bispecific, IMA401, across multiple cancers, highlighting its potential as part of a combination approach with the Company’s PRAME bispecific, IMA402, aimed at synergistic activity and expanded patient reach
Together, these data underscore the continued advancement of Immatics’ PRAME franchise and its focus on developing novel immunotherapies for patients with solid tumors.

Full abstracts will be available on the ASCO (Free ASCO Whitepaper) website on May 21, 2026, at 5:00 pm ET.

Details on Oral Presentations

PRAME Cell Therapies: Anzu-cel (IMA203) and IMA203CD8 (GEN2)
Title: Patient-level clinical response dynamics in advanced melanoma with anzutresgene autoleucel (anzu-cel), a PRAME-directed T-cell receptor (TCR) T-cell therapy
Presenting author: Davar Diwakar, MD
Session: Oral Abstract Session – Melanoma/Skin Cancers
Date / Time: June 1, 2026 / 8:00 – 11:00 am CDT
Abstract ID: 9508

Title: Phase 1a study results for IMA203CD8, a PRAME-directed T-cell receptor (TCR) T-cell therapy, in ovarian cancer
Presenting author: Antonia Busse, MD
Session: Rapid Oral Abstract Session – Gynecologic Cancer
Date / Time: May 30, 2026 / 8:00 – 9:30 am CDT
Abstract ID: 5509

Title: Phase 1 study results with PRAME-directed T-cell receptor (TCR) T-cell therapies in synovial sarcoma
Presenting author: Dejka M. Araujo, MD
Session: Rapid Oral Abstract Session – Sarcoma
Date / Time: May 31, 2026 / 4:30 – 6:00 pm CDT
Abstract ID: 11516

MAGEA4/8 Bispecific: IMA401
Title: First-in-human results with IMA401, a MAGEA4/8 targeted T-cell receptor-based bispecific T-cell engager (TCER), in recurrent or refractory solid tumors
Presenting author: Martin Wermke, MD
Session: Developmental Therapeutics – Immunotherapy
Date / Time: May 31, 2026 / 8:00 – 11:00 am CDT
Abstract ID: 2507

(Press release, Immatics, APR 21, 2026, View Source [SID1234664611])

Genprex Signs Sponsored Research Agreement to Study Biomarkers that May Predict Patient Response to Reqorsa® Gene Therapy

On April 21, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the Company has entered into a new Sponsored Research Agreement (SRA) with The University of Texas MD Anderson Cancer Center (UT MD Anderson) to study biomarkers that may predict patient response to Reqorsa Gene Therapy (quaratusugene ozeplasmid), the Company’s lead drug candidate that is in development for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

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Shortly after it was founded, Genprex entered its first SRA with UT MD Anderson in 2010, and the two parties have completed several subsequent SRAs. These efforts demonstrate Genprex’s commitment to innovative cancer treatments and improving outcomes for patients through the continued research and development of its oncology pipeline.

In preclinical studies, research collaborators have identified TROP2 and PTEN as two potential biomarkers that may increase the likelihood of patient response to REQORSA. TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that functions as a cell surface receptor. TROP2 overexpression in adult tissues is a hallmark of many solid tumors, making it a major target for modern cancer therapies. PTEN (phosphatase and tensin homolog) is a tumor suppressor gene that serves as a multi-functional cancer biomarker for risk assessment, diagnosis and treatment planning in a number of cancers.

"We are very excited to expand our research of TROP2 and PTEN to better understand how these biomarkers might predict and improve outcomes in patients treated with REQORSA," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe this research agreement demonstrates Genprex’s commitment to developing tailored treatment options for lung cancer patients who have unmet medical need, and we believe this research sets Genprex at the forefront of precision oncology treatment."

Research with TROP2 and PTEN may provide insights that could refine Genprex’s patient selection strategies for its Acclaim-1 and Acclaim-3 clinical trials and optimize clinical outcomes.

Acclaim-1 is a Phase 1/2 clinical trial that uses a combination of REQORSA and AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC that has activating epidermal growth factor receptor (EGFR) mutations and progression on treatment with Tagrisso or Tagrisso-containing regimens. Genprex is currently enrolling and treating patients in the Phase 2a expansion portion of the Acclaim-1 clinical trial following the successful completion of the Phase 1 dose escalation portion of the study. The Phase 1 portion showed REQORSA was generally well tolerated with no dose limiting toxicities (DLTs) despite doubling the starting dose. Importantly, the results showed early signs of efficacy with some patients experiencing prolonged progression free survival and one patient having a partial response. There were three patients out of the twelve originally enrolled in the Phase 1 dose escalation portion of the study who had prolonged progression-free survival (PFS). One patient attained a partial remission after the second course of REQORSA and Tagrisso and has maintained this response through 60 courses of treatment (approximately 42 months), and this patient continues to receive REQORSA and Tagrisso treatment to date.

Acclaim-3 is a Phase 1/2 clinical trial that uses a combination of REQORSA and Genentech, Inc.’s Tecentriq (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients are treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. Genprex is currently enrolling and treating patients in the Phase 2 expansion portion of the Acclaim-3 clinical trial following the successful completion of the Phase 1 dose escalation portion of the study, which showed no DLTs. One patient in the Phase 1 portion of the study achieved an unconfirmed partial remission after 24 cycles of therapy and continues to receive study treatment in the trial after more than 18 months.

"We have seen in our Acclaim clinical trials that there are some patients whose cancer progresses after a short number of cycles of treatment, but we have also seen that some patients benefit from REQORSA for a very long time, in one case for more than three years," said Mark Berger, Chief Medical Officer at Genprex. "It is important to understand why some patients are responding very well to REQORSA, and we believe that the identification of biomarkers will allow us to predict which future patients may have these similar, positive responses. This meaningful research will not only benefit patients, but we believe it will allow for better prediction of those likely to benefit in the future."

(Press release, Genprex, APR 21, 2026, View Source [SID1234664610])

Clinical trial update

On April 21, 2026, Erasca, Inc. (the "Company") reported to have narrowed the time period for the anticipated Phase 1 monotherapy data readout for the Company’s pan-RAS molecular glue ERAS-0015 from the AURORAS-1 and JYP0015M101 clinical trials to no later than mid-May of 2026, from the prior guidance of the first half of 2026. The Company is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors, and the Company’s licensor, Guangzhou Joyo Pharmatech Co., Ltd. (Joyo), is evaluating ERAS-0015 in the JYP0015M101 trial in China in patients with advanced solid tumors harboring specific RAS mutations.

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(Press release, Erasca, APR 21, 2026, View Source [SID1234664609])