On February 18, 2026 ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that the European Commission has granted conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) 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 tumors.

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ANKTIVA in combination with BCG is the first authorized treatment in Europe for BCG-unresponsive NMIBC CIS. With this authorization, ANKTIVA is now approved in 33 countries spanning four regulatory jurisdictions, establishing a global commercial footprint in under two years from initial U.S. Food and Drug Administration (FDA) approval.

The conditional marketing authorization follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on December 11, 2025, which recommended authorization based on its determination that the benefit of making ANKTIVA available to patients—with a complete response rate of 71%, a median duration of complete response of 26.6 months, and individual responses ranging up to 54+ months and ongoing outweighs the risks associated with earlier access from a single-arm trial. The authorization covers all 27 EU member states Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden as well as Iceland, Liechtenstein, and Norway. ANKTIVA plus BCG is the first immunotherapy to receive marketing authorization in Europe for this NMIBC indication.

As part of the conditional authorization, ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy data to the EMA.

"The European Commission’s authorization of ANKTIVA in combination with BCG marks a defining moment for patients with BCG-unresponsive NMIBC CIS across Europe, who until now have had no authorized treatment and faced radical cystectomy as their only alternative," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "With ANKTIVA now authorized in 33 countries from the United States and United Kingdom to the European Union and Saudi Arabia, we have built the broadest global access platform for an immunotherapy in this indication. With more than 80% of treated patients preserving their bladder through three years of follow-up, ANKTIVA represents a meaningful advance designed to strengthen the immune response and extend the durability of BCG."

Global Regulatory Footprint

ANKTIVA in combination with BCG for BCG-unresponsive NMIBC CIS is now authorized across four regulatory jurisdictions encompassing 33 countries:

United States: FDA approval, April 2024 (NMIBC CIS with or without papillary tumors)
United Kingdom: MHRA approval, July 2025 (NMIBC CIS with or without papillary tumors)
Kingdom of Saudi Arabia: SFDA accelerated approval, January 2026 (NMIBC CIS with or without papillary tumors; metastatic non-small cell lung cancer)
European Union (30 countries): European Commission conditional marketing authorization, February 2026 (NMIBC CIS with or without papillary tumors). Covers all 27 EU member states plus Iceland, Liechtenstein, and Norway.
The Kingdom of Saudi Arabia remains the only jurisdiction where ANKTIVA has received authorization in two indications, including the first approval globally for ANKTIVA in metastatic non-small cell lung cancer and the first approval for subcutaneous administration.

Unmet Medical Need in Europe

Bladder cancer represents a significant public health burden in the European Union, ranking as the fifth most common cancer overall and the seventh most frequently diagnosed cancer among men.1,2 The European Association of Urology and the World Bladder Cancer Patient Coalition estimate that more than 200,000 new cases of bladder cancer will be diagnosed in 2025.3 Approximately 75% of these cases are NMIBC, the most common form of the disease, which is confined to the bladder lining and has not invaded the underlying muscle layer. For patients whose NMIBC does not respond to BCG therapy, there were no authorized treatment options in the European Union prior to this authorization. The primary alternative has been radical cystectomy, which carries significant morbidity, affects quality of life, and is not suitable for all patients.

Notably, unlike the United States, where only one BCG strain is approved, Europe recognizes and has approved approximately six major BCG strains, making standard-of-care BCG therapy broadly available across the region and supporting a reliable supply for the ANKTIVA plus BCG combination regimen.4

"Reaching 33 countries in under two years from our first regulatory approval is a testament to the strength of the clinical evidence and the urgency of the unmet need in BCG-unresponsive bladder cancer," said Richard Adcock, President and CEO of ImmunityBio. "We are now focused on working with EU member states to ensure timely pricing, reimbursement, and patient access across Europe. Six BCG strains are available in Europe for use in combination with ANKTIVA, and we are expeditiously developing our recombinant BCG candidate to address ongoing BCG shortages in the U.S. and help ensure that all eligible patients can benefit from this treatment."

Clinical Evidence Supporting Authorization

The conditional marketing authorization was based on results from the QUILT-3.032 study (NCT03022825), a single-arm, open-label, multicenter phase 2/3 clinical trial in 100 adults with BCG-unresponsive NMIBC CIS with or without papillary tumors who received ANKTIVA in combination with BCG administered intravesically.5, 6

Key Efficacy Findings:

Complete response (CR) rate: 71% (95% CI: 61%, 80%), with responses ranging up to 54+ months and ongoing
Median duration of complete response: 26.6 months (95% CI: 13.0, 49.9 months)
Complete response rate among responders at 12 months: 66%; at 24 months: 42%
Cystectomy-free survival among responders: 96% at 12 months, 90% at 24 months, and 84% at 36 months
Disease-specific survival for all patients: 99% at 24 months and 99% at 36 months
Key Safety Findings (Cohorts A and B combined, n=180):

Most treatment-related adverse events were grade 1 to 2
Grade 3 treatment-related adverse events occurred in 3% of patients; no grade 4 or 5 treatment-related adverse events were reported
Most common adverse reactions: dysuria, hematuria, pollakiuria, urinary tract infection, micturition urgency, fatigue, chills, musculoskeletal pain, and pyrexia
About ANKTIVA (nogapendekin alfa inbakicept)

ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist (ATC code: L03AC03) consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor alpha Fc fusion protein. In the European Union, ANKTIVA is available as a 400 µg concentrate for intravesical suspension. ANKTIVA binds with high affinity to IL-15 receptors on natural killer (NK) cells, CD4+ T cells, and CD8+ T cells, activating and expanding these immune effector populations. By activating NK cells, ANKTIVA addresses tumor immune escape mechanisms, while simultaneously restoring memory T cell activity to generate durable antitumor responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced antitumor activity compared to native IL-15 in vivo.

About Conditional Marketing Authorization

A conditional marketing authorization is an EU regulatory mechanism designed to facilitate early access to medicines that address an unmet medical need. This pathway allows the European Commission to grant marketing authorization when the benefit of a medicine’s immediate availability to patients outweighs the risk inherent in the fact that additional data are still required. The European Commission’s implementing decision for ANKTIVA (EU marketing authorization number: EU/1/25/2002/001; EMA product number: EMEA/H/C/006622/0000), referenced as C(2026)1197 and dated Brussels, February 16, 2026, was issued by the Director-General for Health and Food Safety under Regulation (EC) No. 726/2004 of the European Parliament and of the Council. As a condition of the authorization, ImmunityBio is required to submit long-term follow-up results from ongoing studies to confirm the efficacy and safety of ANKTIVA. The conditional marketing authorization is subject to annual renewal.

IMPORTANT SAFETY INFORMATION

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

WARNINGS AND PRECAUTIONS: The possibility of severe systemic BCG-infections with the necessity of anti-tuberculosis therapy should be considered before initiating the BCG-therapy.

Delaying cystectomy in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumours, treated with ANKTIVA therapy in combination with BCG could lead to development of muscle invasive or metastatic bladder cancer.

If patients with CIS that are medically eligible for cystectomy have not achieved a CR (absence of disease or low-grade Ta) to treatment after an induction course of ANKTIVA in combination with BCG at the 12-weeks assessment, cystectomy should be reconsidered as an alternative to re-induction. The risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.

DOSAGE AND ADMINISTRATION: For intravesical use only. ANKTIVA should NOT be administered by subcutaneous or intravenous or intramuscular use.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

ANKTIVA is administered intravesically as a mixture with BCG.

USE IN SPECIFIC POPULATIONS: Pregnancy: Treatment is not recommended during pregnancy and in women of childbearing potential not using effective contraception.

Please see the Summary of Product Characteristics for ANKTIVA available on the European Medicines Agency website at www.ema.europa.eu.

(Press release, ImmunityBio, FEB 18, 2026, View Source [SID1234662752])

On February 18, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that management will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference, taking place virtually from February 25-26, 2026. Management, including Ben Zeskind, Chief Executive Officer, and Brett Hall, Chief Scientific Officer, will discuss the company’s pipeline, platform, and business strategy.

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Format: Company Presentation and 1×1 Investor Meetings

Date/Time: Thursday, February 26, 2026, at 10:00 am ET

The presentation will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.

(Press release, Immuneering, FEB 18, 2026, View Source [SID1234662751])

On February 18, 2026 Iaso Therapeutics, Inc., a biotechnology company redefining infectious disease prevention with its novel synthetic vaccine platform, reported that it will present at the 2026 World Vaccine Congress in Washington, D.C., on Tuesday, March 31. President and CEO Robert Forgey, MS, MBA, will provide an overview of Iaso’s technology and commercial strategy during his live presentation at the Innovator Showcase.

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2026 World Vaccine Congress
Date: Tuesday, March 31
Time: 1:30 p.m. ET
Session: Innovator Showcase
Location: Walter E. Washington Convention Center, Washington, D.C.

The presentation will showcase how Iaso’s synthetic vaccine platform delivers the broad protection and scalable production needed to combat infectious diseases, including the escalating threat of antimicrobial resistance, to transform global health.

In addition to the presentation, Iaso will host meetings with industry stakeholders, including investors and strategic partners, at Booth 589 in the Emerging Business Zone.

(Press release, Iaso Therapeutics, FEB 18, 2026, View Source [SID1234662750])

On February 18, 2026 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the fourth quarter and full-year 2025 and provided guidance for 2026. For the quarter, revenue was $994.2 million, a decrease of 0.8% from $1,002.5 million in the fourth quarter of 2024.

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The impact of foreign currency translation increased reported revenue by 1.9%, and the divestiture of a small Safety Assessment site in 2024 reduced reported revenue by 0.1%. Excluding the effect of these items, revenue declined 2.6% on an organic basis, driven primarily by the Discovery and Safety Assessment (DSA) and Manufacturing Solutions (Manufacturing) segments.

In the fourth quarter of 2025, the GAAP operating margin was (28.5)%, compared to (16.7)% in the fourth quarter of 2024. The GAAP net loss available to common shareholders for the fourth quarter of 2025 was $(276.6) million, or $(5.62) per diluted share, compared to a net loss of $(215.7) million, or $(4.22) per diluted share for the same period in 2024. GAAP net income and earnings per share included non-cash intangible asset impairments of $211.0 million, or $3.22 per share, for the Biologics Solutions reporting unit (Manufacturing segment) and the Cell Solutions business (RMS segment) and a non-cash goodwill impairment totaling $165.0 million, or $3.35 per share, in the Biologics Solutions reporting unit in the fourth quarter of 2025, compared to a non-cash goodwill impairment of $215.0 million, or $4.20 per share, in the Biologics Solutions reporting unit in the fourth quarter of 2024. In the fourth quarter of 2025, the Company reported a gain of $0.10 per share on certain venture capital and other strategic investments, compared to a loss of $0.32 per share in the fourth quarter of 2024.

On a non-GAAP basis, the fourth-quarter operating margin decreased to 18.1% from 19.9% in the fourth quarter of 2024, primarily as a result of lower revenue, higher study-related direct costs in the DSA segment, and an unfavorable revenue mix in the RMS segment. Non-GAAP net income was $118.8 million for the fourth quarter of 2025, a decrease of 13.0% from $136.6 million for the same period in 2024. Fourth-quarter diluted earnings per share on a non-GAAP basis were $2.39, a decrease of 10.2% from $2.66 per share for the fourth quarter of 2024. The non-GAAP net income and earnings per share decreases were driven primarily by lower revenue and operating margin, as well as a higher tax rate.

James C. Foster, Chair, President and Chief Executive Officer, said, "We were pleased with our 2025 financial results, including substantial improvement in DSA net bookings in the fourth quarter that demonstrates the stabilization of the biopharmaceutical demand environment. We are making significant progress on several strategic initiatives that will enable the Company to better capitalize on future growth opportunities, and we remain intently focused on scientific innovation that will reinforce our position as the leader in preclinical drug development."
"As we look ahead, we are cautiously optimistic that positive demand trends will continue in 2026. We remain committed to driving our strategy forward, including through selective and strategic acquisitions that align with our core competencies; taking decisive actions to drive efficiency and process improvements that will deliver continued benefits; and by strengthening and refining our organization to enhance our speed and responsiveness. This approach ensures Charles River remains the partner of choice for our clients as the biopharmaceutical demand environment continues to improve," Mr. Foster concluded.

Fourth-Quarter Segment Results

Research Models and Services (RMS)
Revenue for the RMS segment was $206.3 million in the fourth quarter of 2025, an increase of 1.0% from $204.3 million in the fourth quarter of 2024. The impact of foreign currency translation increased revenue by 1.9%. Organic revenue decreased by 0.9%, due primarily to lower revenue for large research models and for small research models in North America. The decline was partially offset by higher revenue for research model services, including in the Insourcing Solutions business, and small research models in China and Europe.
In the fourth quarter of 2025, the RMS segment’s GAAP operating margin decreased to (33.6)% from 6.7% in the fourth quarter of 2024 primarily due to the intangible asset impairment related to the Cell Solutions business. On a non-GAAP basis, the operating margin decreased to 21.9% from 22.8%. The non-GAAP operating margin decrease was primarily driven by the unfavorable revenue mix related to large research models and lower revenue for small research models in North America.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $591.6 million in the fourth quarter of 2025, a decrease of 2.0% from $603.3 million in the fourth quarter of 2024. The impact of foreign currency translation increased DSA revenue by 1.5% and the divestiture of a small DSA site reduced reported revenue by 0.2%. Organic revenue decreased by 3.3%, driven primarily by lower sales volume for discovery services, and also for regulated safety assessment services.
In the fourth quarter of 2025, the DSA segment’s GAAP operating margin increased to 14.3% from 10.4% in the fourth quarter of 2024. The increase was primarily driven by a favorable comparison to the prior year’s large model (NHP) inventory write down. On a non-GAAP basis, the operating margin decreased to 20.1% from 24.7% in the fourth quarter of 2024. The non-GAAP operating margin decrease was primarily driven by lower revenue, as well as higher study-related direct costs related to large-model sourcing and staffing.
Manufacturing Solutions (Manufacturing)
Revenue for the Manufacturing segment was $196.4 million in the fourth quarter of 2025, an increase of 0.7% from $194.9 million in the fourth quarter of 2024. The impact of foreign currency translation increased Manufacturing revenue by 2.8%. Organic revenue decreased 2.1%, driven by lower revenue in the CDMO business, partially offset by higher revenue in the Microbial Solutions and Biologics Testing businesses.
The Manufacturing segment’s GAAP operating margin was (115.9)%, compared to (93.6)% in the fourth quarter of 2024. The decrease was primarily the result of larger impairments in the fourth quarter of 2025 related to the Biologics Solutions reporting unit, which includes both the CDMO and Biologics Testing businesses. On a non-GAAP basis, the operating margin increased to 32.1% from 28.7% in the fourth quarter of 2024, driven primarily by the benefit of cost savings resulting from the Company’s restructuring initiatives.
Full-Year Results
For 2025, revenue decreased by 0.9% to $4.02 billion from $4.05 billion in 2024. Revenue declined by 1.6% on an organic basis.
The GAAP operating margin decreased to 0.6% from 5.6% in 2024, and on a non-GAAP basis, the operating margin decreased to 19.8% from 19.9%.
On a GAAP basis, the net loss available to common shareholders was $(144.3) million in 2025, a decrease from net income available to common shareholders of $10.3 million in 2024. The diluted loss per share on a GAAP basis in 2025 was $(2.91), a decrease from diluted earnings per share of $0.20 in 2024.
On a non-GAAP basis, net income was $512.3 million in 2025, a decrease of 3.9% from $532.9 million in 2024. Diluted earnings per share on a non-GAAP basis in 2025 were $10.28, a decrease of 0.4% from $10.32 in 2024.
Research Models and Services (RMS)
For 2025, RMS revenue was $846.1 million, an increase of 2.0% from $829.4 million in 2024. Revenue increased by 1.2% on an organic basis.

On a GAAP basis, the RMS segment operating margin decreased to 5.3% in 2025 from 13.8% in 2024. On a non-GAAP basis, the operating margin increased to 24.8% in 2025 from 23.7% in 2024.
Discovery and Safety Assessment (DSA)
For 2025, DSA revenue was $2.40 billion, a decrease of 2.0% from $2.45 billion in 2024. Revenue declined by 2.6% on an organic basis.
On a GAAP basis, the DSA segment operating margin decreased to 17.7% in 2025 from 18.1% in 2024. On a non-GAAP basis, the operating margin decreased to 24.2% in 2025 from 25.7% in 2024.
Manufacturing Solutions (Manufacturing)
For 2025, Manufacturing revenue was $766.4 million, a decrease of 0.4% from $769.3 million in 2024. Revenue declined by 1.6% on an organic basis.
On a GAAP basis, the Manufacturing segment operating margin decreased to (24.0)% in 2025 from (9.3)% in 2024. On a non-GAAP basis, the operating margin increased to 28.8% in 2025 from 27.4% in 2024.
2026 Guidance
The Company is providing financial guidance for 2026, which does not include the impact of planned divestitures that represent approximately 7% of annual revenue for 2025 and estimated 2026. On an organic basis, this outlook assumes that the robust DSA booking trends in the fourth quarter of 2025, combined with an expectation that favorable booking activity will continue in 2026, will result in a return to organic revenue growth in the second half of 2026 on both a consolidated basis and for the DSA segment. In addition, the Company also expects revenue will increase organically in the Manufacturing segment, as a result of the anniversary of the loss of a large, commercial CDMO client in 2025 and a continuation of solid demand trends in the Microbial Solutions business. The revenue increase is expected to be partially offset by lower revenue in the RMS segment due to lower large model revenue, as well as lower revenue in its Insourcing Solutions business, principally related to its CRADLTM operations.
Non-GAAP earnings per share are expected to increase by approximately 4% to 9% in 2026, as a result of the benefit from incremental cost savings related to restructuring and efficiency initiatives, as well as the earnings accretion from the completed acquisition of the assets of K.F. (Cambodia) Ltd. A lower tax rate will also contribute to non-GAAP earnings per share growth in 2026.
The Company’s 2026 guidance for revenue and earnings per share is as follows:

2026 GUIDANCE (1)
Revenue growth/(decrease), reported
At Least Flat to +1.5%
Impact of divestitures/(acquisitions), net
0.0% – (0.5)%
(Favorable)/unfavorable impact of foreign exchange
(1.0)% – (1.5)%
Revenue growth/(decrease), organic (2)
(1.0)% to At Least Flat
GAAP EPS estimate
$6.30 – $6.80
Acquisition-related amortization and other acquisition- and integration-related costs (3)
$3.50 – $3.60
Costs associated with restructuring actions (4)
$0.80 – $0.85
Non-GAAP EPS estimate
$10.70 – $11.20

Footnotes to Guidance Table:
(1) Revenue and earnings per share of the planned divested businesses remain embedded in the Company’s guidance for the full-year 2026.
(2) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and divestitures (as well as the planned acquisition of PathoQuest SAS), as well as foreign currency translation.
(3) These adjustments primarily include amortization related to intangible assets, as well as the purchase accounting step-up on inventory and certain long-term biological assets. In addition, these adjustments include some costs related to the evaluation and integration of acquisitions and divestitures.
(4) These adjustments primarily include site consolidation (including site transition costs), severance, impairment, and other costs related to the Company’s restructuring actions.

Webcast
Charles River has scheduled a live webcast on Wednesday, February 18th, at 8:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.
Non-GAAP Reconciliations
The Company reports non-GAAP results in this press release, which exclude often-one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release.

On February 18, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, reported additional preliminary data from the ongoing Phase 1 ACESOT-1051 trial evaluating its investigational WEE1 kinase inhibitor APR-1051.

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The Company reported a second unconfirmed partial response at first on-treatment scan in a patient with advanced endometrial cancer being treated at the 220 mg dose level (Cohort 8).

At the first on-treatment imaging assessment of single dose daily APR-1051, the responding patient achieved a 50% reduction from baseline in target lesion measurements, consistent with partial response per RECIST v1.1 criteria. In addition, there was a notable decline in the tumor biomarker CA-125, with levels dropping from 362 U/mL at baseline to 47 U/mL (-87%), further supporting the anti-tumor activity of APR-1051. The patient’s tumor harbors a PPP2R1A mutation. To date, the patient had only Grade 1 treatment-emergent adverse effects and continues treatment.

The observed unconfirmed partial responses for both patients with PPP2R1A mutations require confirmation at subsequent imaging assessments to be designated as confirmed responses under standard criteria.

A further update from the trial is expected in the second quarter of 2026.

"We are encouraged to see a second patient in the ongoing ACESOT trial achieve an unconfirmed partial response," said Eugene Kennedy, MD, Chief Medical Advisor at Aprea. "We believe the magnitude of tumor reduction and the substantial drop in CA-125 in this patient provides further evidence of APR-1051’s biologic activity and potential therapeutic impact. Importantly, this patient was refractory to her most recent two prior therapies. The response in a tumor with a PPP2R1A alteration underscores the potential of genomically guided patient selection in our DDR program."

Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea, commented, "We believe the emergence of a second unconfirmed partial response strengthens the clinical trend we are observing as dose escalation progresses. These results reinforce our confidence in the therapeutic potential of WEE1 inhibition in genetically defined difficult-to-treat cancers. In addition, the good safety profile of APR-1051 to date supports our development strategy of a differentiated WEE1 inhibition through a potentially improved therapeutic index (TI), as low TI has been a major hurdle in the development of WEE1 inhibitors. We remain focused on advancing APR-1051 and look forward to providing further updates from this trial."

ACESOT-1051 Trial Key Findings to Date

The ongoing Phase 1 trial is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of APR-1051 in patients with advanced solid tumors. A total of 22 patients have been treated to date, at doses ranging from 10 mg to 220 mg.

Partial Responses: Two patients have achieved partial responses (unconfirmed) at their first scan, both with endometrial cancer, and with tumors harboring PPP2R1A mutations. These responses were observed at the 150 mg and 220 mg dose levels of APR-1051. Both patients remain on therapy.
Stable Disease: A total of five patients in the trial have had stable disease:
70 mg cohort: HPV-positive head and neck squamous cell carcinoma (HNSCC)
100 mg cohort: FBXW7-mutated colon cancer; KRAS & p53-mutated colon cancer; CCNE1 & TP53 mutated uterine cancer
150 mg cohort: FBXW7-mutated colon cancer
Favorable tolerability: APR-1051 has been generally well tolerated

Taken together, these data support the potential activity of APR-1051 in genomically defined cancers across multiple solid tumor types.

Enrollment in the 220 mg dose cohort continues, and the Company plans to further expand enrollment of PPP2R1A endometrial and HPV-positive HNSCC patients within the study.

About the ACESOT-1051 Trial

ACESOT-1051 is a first-in-human, open-label Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in patients with advanced solid tumors harboring cancer-associated genetic alterations. The dose-escalation portion of the study is expected to enroll up to 50 patients. APR-1051 is administered orally once daily in continuous 28-day cycles. To date, enrollment has evaluated doses up to 150 mg, with the 220 mg cohort currently enrolling. For more information, visit ClinicalTrials.gov (NCT06260514).

(Press release, Aprea, FEB 18, 2026, View Source [SID1234662747])