On May 13, 2026 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported a business update.

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"Aptevo is entering a defining period as a company, supported by growing clinical momentum, a committed leadership team, and a pipeline with the potential to create significant long-term value," said Jeff Lamothe, President and Chief Executive Officer of Aptevo. "Mipletamig continues to generate compelling frontline AML data, combining strong remission activity with a differentiated safety profile with the potential as an important addition to standard-of-care therapy. At the same time, we are continuing to advance our next generation of multispecific immunotherapy programs, including our emerging trispecific candidates, which are designed to address complex solid tumors through differentiated mechanisms and targeted immune modulation. We believe our ADAPTIR and ADAPTIR-FLEX platforms position Aptevo to expand into multiple high-value areas of oncology innovation. With meaningful clinical and strategic milestones ahead, financial flexibility to support execution, and increasing validation of multispecific approaches throughout the industry, we believe we are building from an increasingly strong foundation for future growth and value creation."

RAINIER trial on track for completion and Phase 2 dose selection by year end.

Mipletamig continues to generate strong data in frontline acute myeloid leukemia (AML) in combination with venetoclax + azacitidine. Across 31 evaluable patients (includes data through RAINIER Cohort 5, plus 4 patients from the previously completed dose expansion trial), the data has demonstrated continued efficacy, including:

87% clinical benefit rate* that demonstrates broad anti-leukemia activity and blast reduction across response categories

81% CR or CRi (remission), compared to 66.4% in the Phase 3 VIALE-A trial**

65% achieved CR (complete remission), compared to 37% in the Phase 3 VIALE-A trial**

No cytokine release syndrome (CRS), a common and often dose-limiting toxicity associated with similar therapies, has been observed in frontline patients to date

The data also show that 52% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level, a result that is typically associated with stronger, more durable responses.

As the dataset continues to expand, efficacy and safety outcomes continue to deliver favorable results, further supporting mipletamig’s potential in the frontline setting.

*Clinical benefit rate: complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and partial remission (PR)

**Phase 3 VIALE-A trial evaluating venetoclax plus azacitidine in frontline intent-to-treat AML patients who were ineligible for intensive induction chemotherapy, the reported composite CR/CRi rate was 66.4%, and the CR rate was 37% (DiNardo et al., New England Journal of Medicine, 2020).

Completed Leadership Transitions; Company Poised for a Defining Year

Aptevo entered 2026 with purposeful momentum, highlighted by a planned executive leadership transition designed to support the company’s next phase of growth. Jeff Lamothe was appointed President and Chief Executive Officer, while Marvin White transitioned to Executive Chair. The move reflects continuity in strategy while positioning the organization for focused execution across clinical development, capital strategy, and long-term value creation.

Q1 2026 Cash Position

Aptevo had cash and cash equivalents totaling $14.5 million as of March 31, 2026. During the first quarter of 2026, the company raised $0.9 million, net, under the company’s Standby Equity Purchase Agreements (SEPAs) with Yorkville. For additional APVO financial information and complete access to the company’s filings, click here.

Enhanced Financial Flexibility Supports Upcoming Catalysts

During the quarter, Aptevo secured a $60 million SEPA, providing meaningful access to capital and extending financial flexibility as the company advances toward planned milestones. Management believes the facility better positions Aptevo to execute strategically, support ongoing development programs, and approach future opportunities from a position of greater strength.

(Press release, Aptevo Therapeutics, MAY 13, 2026, View Source [SID1234665645])

On May 13, 2026 Sapu Nano and Oncotelic (OTCQB: OTLC) reported that the first patient has been dosed in the Phase 1b clinical trial of Sapu003, the Company’s investigational intravenous Deciparticle formulation of everolimus.

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The trial: SP-03-B101- Sapu003 in Patients with Advanced mTOR-sensitive Solid Tumors, (NCT07369505), is a Phase 1b, open-label, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. The investigational product is administered intravenously over 30 minutes once weekly in 4-week cycles.

The study includes two cohort patients. Cohort A enrolls patients with HR-positive/HER2-negative breast cancer, receiving Sapu003 in combination with aromatase inhibitor and Cohort B enrolls patients with renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, or hepatocellular carcinoma, receiving Sapu003 as monotherapy. Dose escalation follows a Bayesian Optimal Interval design, with planned dose levels of 5 mg/m², 7.5 mg/m², and 10 mg/m², and an optional lower dose cohort of 3.5 mg/m² if required for safety.

"This first-patient-dosed milestone represents an important step in advancing Sapu003 from clinical readiness into active patient treatment," said Dr. Vuong Trieu, Chief Executive Officer. "Everolimus is a validated mTOR inhibitor with established activity across multiple cancers, but oral delivery has limitations including variable absorption and dose-limiting toxicity. Sapu003 was designed to re-engineer everolimus, as a weekly IV Deciparticle formulation, with the goal of improving exposure control and expanding the therapeutic potential of mTOR inhibition."

The Sapu003 program has also been featured at the 2025 San Antonio Breast Cancer Symposium, held December 9-12, 2025. The Sapu003 program is being developed in collaboration with Southern Oncology Clinical Research Unit, iNGENū CRO, and Shanghai Medicilon, supporting the clinical, translational, pharmacokinetic, and manufacturing development of Sapu003.

(Press release, Sapu Bioscience, MAY 13, 2026, View Source [SID1234665644])

On May 13, 2026 Astrazeneca reported high-level results from a planned interim analysis of the VOLGA Phase III trial showed perioperative treatment with Imfinzi (durvalumab) in combination with neoadjuvant enfortumab vedotin (EV) demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC) versus standard of care. Patients were ineligible for or had declined cisplatin-based chemotherapy. Patients in the comparator arm had a radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment.

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Perioperative Imfinzi plus Imjudo (tremelimumab) in combination with neoadjuvant EV demonstrated a statistically significant and clinically meaningful improvement in EFS and a favourable trend for OS; however, the OS data were not statistically significant at this planned interim analysis and will be formally reassessed at a subsequent analysis.

Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumour invades the muscle wall of the bladder, without distant metastases.1,2 As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities.3,4 The standard treatment for these patients has historically been radical cystectomy alone but, despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis.3-5

Thomas Powles, MD, Professor, Chair of Barts Cancer Centre (QMUL), London, UK, and International Coordinating Investigator for the trial, said: "Up to half of patients with muscle-invasive bladder cancer are not eligible for cisplatin and face high rates of disease recurrence, even after having their bladder removed, leaving a significant need for new effective and well-tolerated treatments. The VOLGA results show that perioperative durvalumab significantly extends event-free survival and overall survival when combined with neoadjuvant enfortumab vedotin, with a manageable safety profile, compared to surgery for patients in this curative-intent setting."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This interim analysis from the VOLGA trial highlights the benefit of perioperative Imfinzi with neoadjuvant enfortumab vedotin compared to surgery, a novel regimen that optimises treatment options for patients. Together with NIAGARA and POTOMAC, VOLGA is our third positive readout in bladder cancer, setting a strong foundation for Imfinzi as the immunotherapy backbone in this early-stage, curative-intent setting."​

The safety and tolerability of Imfinzi with or without Imjudo plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Imfinzi is approved in over 40 countries for patients with cisplatin-eligible MIBC, based on the NIAGARA Phase III trial. Additionally, Imfinzi added to Bacillus Calmette-Guérin therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial and is currently under review in the US, European Union (EU), Japan and several other countries. Imfinzi is also being investigated in locally advanced or metastatic disease in the NILE Phase III trial.  

Notes

Bladder cancer
Bladder cancer is the 9th most common cancer in the world, with more than 614,000 cases diagnosed each year.6 The most common type is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.7

In 2024, an estimated 117,500 patients were treated for MIBC with the standard of care, which included neoadjuvant cisplatin-based chemotherapy and radical cystectomy.5,8 In 2025, the NIAGARA Phase III trial established a new standard by adding perioperative Imfinzi to the regimen.9 However, up to half of patients are not eligible to receive cisplatin, and approximately 50% of MIBC patients who undergo bladder removal surgery experience disease recurrence.3,5 New treatment options that prevent both progression before surgery and recurrence after surgery are critically needed in this curative-intent setting.

VOLGA
VOLGA is a Phase III, randomised, open-label, multi-centre global trial evaluating perioperative Imfinzi with or without Imjudo in combination with neoadjuvant EV as treatment for patients with MIBC undergoing radical cystectomy who are not eligible for or have declined cisplatin compared to radical cystectomy with or without approved adjuvant therapy. In the trial, 695 patients were randomised 1:1:1 to Arm 1 (three cycles of Imfinzi and EV, plus two cycles of Imjudo prior to surgery, followed by nine cycles of Imfinzi plus one cycle of Imjudo as adjuvant therapy), Arm 2 (three cycles of Imfinzi and EV prior to surgery, followed by nine cycles of Imfinzi adjuvant monotherapy) and Arm 3, the comparator arm.

The trial was conducted in 182 centres across 25 countries in Europe, North America, South America and Asia. Its dual primary endpoints are EFS, defined as the time from randomisation to first recurrence post-radical cystectomy, first progression in patients who did not undergo radical cystectomy, failure to undergo radical cystectomy in patients with residual disease or death due to any cause, for both experimental arms versus the comparator arm. Secondary endpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to its indication in MIBC, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.

In addition to its indications in lung cancers, Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In resectable gastric and gastroesophageal junction cancers, perioperative Imfinzi added to standard-of-care chemotherapy is approved in the US and EU. Additionally, in April 2026, Imfinzi in combination with Imjudo, lenvatinib and transarterial chemoembolisation (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival versus TACE alone for patients with unresectable HCC eligible for embolisation in the EMERALD-3 Phase III trial.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours.

Imjudo
Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. In addition to its approved indications in liver and lung cancers, Imjudo is being tested in combination with Imfinzi across other tumour types including SCLC (ADRIATIC) and bladder cancer (NILE).

(Press release, AstraZeneca, MAY 13, 2026, View Source [SID1234665643])

On May 13, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the quarter ended March 31, 2026 and provided a corporate update on the advancement of its innovative DNase oncology platform.

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Recent Highlights

Generated robust translational data supporting the DNase I platform across multiple oncology settings

Completed process improvement and analytical development activities supporting future clinical manufacturing readiness

Established translational and biomarker insights intended to help inform and de-risk future clinical trial design

Collaboration partner received approval from Israeli Ministry of Health to conduct investigator-initiated exploratory study of DNase I in combination with anti-CD19 CAR T cells in large B-cell lymphoma

"We entered 2026 with a clear focus on advancing the translational, manufacturing and clinical foundation of our DNase I platform while maintaining financial discipline," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "During the quarter, we achieved important progress across investigator-initiated studies, translational research and manufacturing readiness activities. We believe the growing body of translational evidence supporting NET-targeting approaches, combined with the expanding understanding of NETs as drivers of tumor progression, immune suppression and therapy resistance, continues to strengthen the potential opportunity for DNase I as a differentiated adjunctive immuno-oncology therapy across multiple cancer settings."

Xenetic’s proprietary DNase technology is being developed as a potential adjunctive therapeutic approach designed to improve the effectiveness of existing cancer treatments, including immunotherapies, through the targeting of NETs, which are increasingly recognized as key drivers of immune suppression and therapeutic resistance within the tumor microenvironment.

Summary of Financial Results for First Quarter 2026

Royalty revenue for the three months ended March 31, 2026 increased approximately 36% to approximately $0.8 million, compared to approximately $0.6 million for the comparable prior year period, primarily driven by increased royalty payments recognized under the Company’s sublicense agreement with Takeda Pharmaceuticals Co. Ltd.

Research and development expenses for the three months ended March 31, 2026 decreased approximately 25% to approximately $0.7 million from approximately $0.9 million for the comparable prior year period, primarily due to lower preclinical and exploratory study costs, partially offset by increased manufacturing development efforts supporting the Company’s DNase I program.

General and administrative expenses for the three months ended March 31, 2026 decreased by approximately 1.4%, to approximately $0.6 million from approximately $0.7 million in the comparable quarter in 2025. The decrease was primarily due to a decrease in personnel costs and share-based expenses related to our interim Chief Executive Officer substantially offset by an increase in legal expenses related to our strategic review process during the first quarter of 2026 compared to the same period in 2025.

Net loss for the quarter ended March 31, 2026 decreased approximately 49% to approximately $0.5 million, compared to approximately $0.9 million for the same period in 2025.

The Company ended the first quarter of 2026 with approximately $7.3 million in cash and cash equivalents, compared to approximately $7.9 million as of December 31, 2025.

(Press release, Xenetic Biosciences, MAY 13, 2026, View Source [SID1234665642])

On May 13, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported a 36-month duration of response (DOR) of 64.5% (95% CI, 54.6% – 72.8%) by Kaplan-Meier estimate in patients who achieved a complete response (CR) at three months (79.6%) in the pivotal Phase 3 ENVISION trial of ZUSDURI (mitomycin) for intravesical solution. At a median follow-up of 35.5 months, the median DOR had not been reached. These data demonstrate that a substantial proportion of complete responders remained disease-free at three years, and durable outcomes were achieved without the need for maintenance therapy.

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"This update from the pivotal ENVISION trial shows that many patients who achieve a complete response with ZUSDURI remain disease-free through three years," said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. "Among patients who achieved a complete response, the event rate over time has remained stable. Importantly, ZUSDURI’s durability was achieved without maintenance therapy, supporting a treatment approach that can provide lasting disease control while reducing ongoing treatment burden for patients."

As a non-surgical, in-office treatment, ZUSDURI offers patients an opportunity to achieve meaningful disease- and treatment-free living without the burden of repeated TURBT procedures under general anesthesia. The current standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates following surgery, patients often undergo multiple TURBTs over their lifetime, leading to a cycle of repeat procedures that can impact quality of life and increase cumulative risk, particularly in older patients with comorbidities. An estimated 59,000 patients with LG-IR-NMIBC recur annually.

"The ENVISION 36-month DOR data reinforce ZUSDURI’s potential to shift the treatment paradigm for recurrent LG-IR-NMIBC," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "By delivering durable responses without maintenance therapy, ZUSDURI provides an opportunity to move beyond the cycle of repeated surgical interventions and toward a more durable, lower-burden treatment approach over time."

The most common (≥ 10%) adverse reactions (ARs), including laboratory abnormalities, that occurred in patients were dysuria, increased potassium, increased creatinine, decreased hemoglobin, increased eosinophils, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. ARs were mainly mild to moderate. Serious ARs occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%).

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the United States every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

About ENVISION
The Phase 3 ENVISION trial is a single-arm, multinational, multicenter pivotal study evaluating the efficacy and safety of ZUSDURI (mitomycin) for intravesical solution as a chemoablative therapy in adult patients with recurrent LG-IR-NMIBC. The Phase 3 ENVISION trial completed target enrollment with 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of ZUSDURI. The primary endpoint evaluated the CR rate three months after the first instillation, and the key secondary endpoint evaluates durability over time in patients who achieved a CR at the three-month assessment. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550).

(Press release, UroGen Pharma, MAY 13, 2026, View Source [SID1234665641])