On April 20, 2026 Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an investigational immunotherapeutic for solid tumors and subsidiary of Beyond Air, Inc. (NASDAQ: XAIR), reported updated follow-up data from its Phase 1 UNO trial, which are being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, California.

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The Phase 1 trial (NCT05351502) was a clinical proof-of-concept trial that assessed the intratumoral administration of UNO in patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions. The trial enrolled ten heavily pretreated patients, including breast cancer (n=6), squamous cell carcinoma (n=2), and melanoma (n=2). Patients received a median of 4 prior systemic therapies and 11 total cancer-directed treatments. Six patients received 25,000 ppm UNO and four patients received 50,000 ppm UNO.

As of February 2, 2026, six of ten patients remain alive between 22 to 40 months following a single UNO injection. While the study was not designed to assess efficacy and lacks a control arm, these observations may suggest prolonged survival in this heavily pretreated population. Interpretation of these results is limited by the small sample size and early-stage design. Two patients with triple negative breast cancer continue to demonstrate no evidence of disease, based on available imaging, testing, and clinical examinations. Treatment demonstrated a generally favorable safety and tolerability profile, with most treatment related adverse events predominantly Grade 1 or Grade 2. One treatment-related serious adverse event (hypoxia) occurred during administration at 25,000 ppm; the event was not considered dose-limiting and resolved fully. Median overall survival had not yet been reached at last follow-up because more than 50% of patients remain alive at last follow up.

"We are pleased to present these updated and promising data from the UNO study at AACR (Free AACR Whitepaper)," said Robert Goodman, Chief Executive Officer of Beyond Air. "What stands out is not only the durability of survival, but the context in which it is occurring. These observations are notable in a salvage stage population with few therapeutic alternatives, where enrolled patients had exhausted standard treatment options and received a median of four prior systemic therapies. Observing prolonged survival following a single localized UNO injection reinforces our conviction that UNO has meaningful therapeutic potential and supports further development, including evaluation in combination with immune checkpoint inhibitors and in earlier lines of disease."

In addition, the company announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for a patent application titled, "System and Method for Delivery of Gas to a Tissue." Once issued, the patent will further strengthen the company’s intellectual property portfolio supporting its UNO platform.

About Nitric Oxide
Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.

About UNO Therapy for Solid Tumors
Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. Beyond Cancer, Ltd. believes that UNO has the potential to contribute to anti-tumor immune responses and may be explored for its role in preventing relapse or metastatic disease in future studies, including evaluation of dosing and treatment duration, and with limited toxicity or off-target effects.

(Press release, Beyond Cancer, APR 20, 2026, View Source [SID1234664558])

On April 20, 2026 Aditxt, Inc. (Nasdaq: ADTX) ("Aditxt" or the "Company"), a social innovation platform accelerating promising health innovations, reported that its precision oncology subsidiary, Ignite Proteomics, LLC ("Ignite" or "Ignite Proteomics"), has been featured in a peer-reviewed study published online ahead of print in npj Precision Oncology, a Nature journal. The study, led by investigators at Dana-Farber Cancer Institute, evaluated outcomes among patients with metastatic breast cancer treated with trastuzumab deruxtecan (T-DXd, marketed as Enhertu by AstraZeneca and Daiichi Sankyo) and assessed multiple quantitative HER2-related assays for their association with treatment outcomes.

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While conventional HER2 immunohistochemistry (IHC) showed some association with outcomes in the broader patient population, the study found that quantitative HER2-related assays provided more granular predictive information in several matched biomarker sub-cohorts. In those sub-cohorts, traditional IHC classification often showed limited predictive value compared with quantitative approaches. Ignite’s Reverse Phase Protein Array (RPPA) platform, the only commercially available multiplex assay in the study, was one of the quantitative methods that demonstrated meaningful predictive value for patient outcomes.

T-DXd is an approved treatment option for a broad population of patients with metastatic breast cancer, yet there is currently no reliable way to predict which patients will respond.

"According to several studies, approximately 40% of cancers do not respond to the FDA approved therapy at front line in a metastatic setting," said Jeff Busch, Chief Executive Officer of Ignite Proteomics. In oncology, published research and institutional analyses have shown that approved therapies often fail to benefit a substantial portion of the patients who receive them. A 2017 study published in the BMJ reported that 57% of cancer drug indications approved by the European Medicines Agency entered the market without evidence of improved survival or quality-of-life benefit. MIT researchers have noted that targeted tyrosine kinase inhibitors typically work for only 40% to 80% of patients expected to respond. Johns Hopkins has reported that only 15% to 20% of patients achieve durable results with immunotherapy.

Ignite’s RPPA platform measures multiple protein biomarkers, including pathway activation and payload-relevant markers, from a single tumor sample. In the Dana-Farber study, Ignite’s platform was the only commercially available multiplex assay evaluated and demonstrated predictive value in matched biomarker cohorts where conventional HER2 IHC showed limitations. Notably, the study found that TOPO1 expression, the target of T-DXd’s cytotoxic payload, was detectable by Ignite’s platform in certain HER2-negative patients, highlighting the potential value of measuring tumor biology beyond HER2 expression alone. Ignite’s assay is CLIA-certified, CAP-accredited, listed on the Medicare Clinical Laboratory Fee Schedule under AMA CPT code PLA 0249U, and orderable today on standard biopsy tissue.

"Cancer therapy has made extraordinary progress, but oncology still has a treatment-selection problem," added Busch. "Too many patients receive therapies without enough information about whether those therapies are likely to work for their tumor biology. That is not an indictment of the drugs. These are powerful therapies. The issue is that cancer is complex, and single-marker testing often does not capture the functional biology that drives response or resistance. Ignite’s RPPA platform was built to address that gap by measuring multiple proteins, pathway activation, and payload-relevant biology from the same tumor sample. In this study, one of the world’s leading breast cancer research teams evaluated our platform alongside standard testing, and our platform demonstrated predictive value where conventional testing had limitations. That is the opportunity: better data, better treatment selection, and fewer patients receiving therapies that were never likely to help them."

"This publication represents an important milestone for our subsidiary Ignite and reflects the strength of Aditxt’s model of advancing and scaling impactful health innovations," said Amro Albanna, Co-Founder and Chief Executive Officer of Aditxt. "Peer-reviewed clinical evidence from one of the world’s leading cancer research institutions is key to accelerating the commercialization of this platform and expanding access to it for millions of patients making treatment decisions without clear guidance on what will work. Our goal is to help ensure that more patients receive the right therapy at the right time, with the potential to improve outcomes and make a meaningful difference in people’s lives."

The full study is available open access at: View Source

(Press release, Dana-Farber Cancer Institute, APR 20, 2026, View Source [SID1234664575])

On April 20, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that positive Phase II results from the COMPASSION-26 study evaluating cadonilimab, its first-in-class PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma (PDAC), were presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

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As of the October 20, 2025 data cutoff, with a median follow-up of more than two years, the cadonilimab plus chemotherapy combination continued to deliver robust and durable survival benefits. Results were particularly strong in patients with locally advanced disease, where the median PFS reached 11.1 months and the median OS exceeded 23 months. Landmark survival rates in this group included a 12-month OS rate of 91.7% and a 24-month OS rate of 44.1%.

The cadonilimab regimen also provided strong tumor control across the overall study population. Of the patients evaluable for efficacy (95% had at least one post-baseline tumor assessment), the objective response rate (ORR) was 33.9% and the disease control rate (DCR) reached 96.4%. Response rates were similar between patients with locally advanced and metastatic disease, indicating consistent benefit across both subgroups.

No new safety signals were identified, and the overall safety profile of the cadonilimab combination remained favorable and manageable.

Cadonilimab is the world’s first approved bispecific antibody for cancer immunotherapy, having received marketing approval in 2022. In extensive real-world clinical practice and multiple Phase III studies, it has demonstrated clinically meaningful benefit across all patient populations regardless of PD-L1 expression status, addressing a significant unmet medical need and earning broad recognition from physicians and patients.

As a cornerstone therapy in the era of tumor immunotherapy 2.0, cadonilimab not only offers the significant advantage of clinical benefit across broad patient populations, but has also demonstrated important breakthrough potential in difficult-to-treat settings, including immunotherapy-refractory disease and immunologically "cold" tumors. Akeso is fully leveraging its global leadership in bispecific antibody development for oncology to continue addressing major unmet clinical needs and advancing transformative treatment options for patients with challenging cancers.

(Press release, Akeso Biopharma, APR 20, 2026, View Source [SID1234664559])

On April 20, 2026 Takara Bio USA, Inc., a wholly owned subsidiary of Takara Bio Inc. ("Takara Bio"), reported data from a benchmark study comparing key performance metrics of its Trekker FX technology against conventional spatial methods. This study was conducted using formalin-fixed paraffin-embedded (FFPE) tissue samples from human lung squamous cell carcinoma. This study is the first in a planned series of independent studies to validate the advantages of Trekker FX technology over other existing spatial transcriptomics products. Takara Bio USA will present a poster on the findings at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference, taking place this week in San Diego.

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"This benchmark study demonstrates that Trekker FX enables higher resolution, easier scalability, and deeper unbiased spatial characterization and insights than other methods," said Andrew Farmer, PhD, CSO of Takara Bio USA. "By combining true single-cell spatial mapping with broad molecular detection, the Trekker approach represents an entirely new class of spatial technology that complements existing single-cell sequencing workflows and expands what researchers can reveal in a cell’s native tissue environment."

In this benchmark study, Trekker FX delivered improved whole-transcriptome detection through its unique donation-based spatial tagging approach, which maintains single-cell NGS sensitivity. This results in Trekker FX being able to identify key subpopulations relevant in tumor biology (i.e., Tregs, plasmacytoid dendritic cells, lymphatic endothelial cells, and others). Trekker FX also identified 3X more statistically significant ligand-receptor interactions to better uncover how cells communicate within the tumor microenvironment.

The benchmark study was conducted by Takara Bio Genome Analysis Center in Japan, leveraging its world-class service capabilities and expertise across various spatial products and solutions. As a global leader in biotech research and development, Takara Bio offers a wide range of services that help scientists around the world push their research to new frontiers with a comprehensive array of technologies. Takara Bio USA, a subsidiary of Takara Bio Inc., published this study as the first in a new benchmarking series. This technology is now being further explored by top independent researchers, reflecting strong external validation beyond Takara Bio.

AACR poster presentation details

Title: Cross-platform comparison of spatial transcriptomics technologies in an FFPE lung squamous cell carcinoma sample
Abstract: View Source!/21436/presentation/10770
Session date and time: April 21, 2026, from 9:00 am–12:00 pm PST
Presenter: Bryan Bell, PhD
Location: Section 31
Poster board number: 17
Presentation number: 4960

(Press release, Takara Bio, APR 20, 2026, View Source [SID1234664576])

On April 20, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapy, each in combination with Padcev (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of August 17, 2026.

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If approved, these indications would expand the use of KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, as the first perioperative treatments for patients with MIBC regardless of cisplatin eligibility and build on the previously approved indications of the combination for the treatment of patients with MIBC who are ineligible for cisplatin-based chemotherapy.

"Results from KEYNOTE-B15 challenge long-held expectations for patients with muscle-invasive bladder cancer," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "Even with curative-intent surgery and chemotherapy, patients still experience disease progression or limited survival. These data add to the growing body of evidence demonstrating that KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, have the potential to reshape how we approach treatment for these patients and improve outcomes for people facing this aggressive disease."

The sBLAs are based on data from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas, which were presented at the recent American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium. The companies plan to share these results with regulatory authorities worldwide for potential regulatory filings.

KEYTRUDA plus Padcev is currently approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan and several other countries around the world. KEYTRUDA plus Padcev is also approved in the U.S. for the treatment of adult patients with MIBC who are ineligible for cisplatin-based chemotherapy. KEYTRUDA as a monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).

KEYTRUDA plus Padcev has now demonstrated an overall survival (OS) benefit across three Phase 3 trials in bladder cancer. In addition to KEYNOTE-B15, these trials include previously announced positive results from KEYNOTE-905 for the treatment of patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy and positive results from KEYNOTE-A39 for the treatment of adult patients with la/mUC. Three additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic disease. Two of these studies are in MIBC including KEYNOTE-866 (NCT03924856) and KEYNOTE-992 (NCT04241185). KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in KEYNOTE-676 (NCT03711032).

KEYNOTE-B15 is one of six Phase 3 studies of a KEYTRUDA-based regimen in an earlier stage of cancer to demonstrate an OS benefit. It was also the 15th positive pivotal trial for a KEYTRUDA-based regimen in earlier-stage cancers.

About KEYNOTE-B15/EV-304

KEYNOTE-B15, also known as EV-304, is an open-label, randomized Phase 3 trial (ClinicalTrials.gov, NCT04700124) evaluating perioperative KEYTRUDA in combination with Padcev and surgery (radical cystectomy and pelvic lymph node dissection) versus neoadjuvant chemotherapy (gemcitabine plus cisplatin) and surgery in patients with MIBC who are cisplatin-eligible. The trial enrolled 808 patients who were randomized to receive either:

Four cycles (each cycle length is 21 days) of neoadjuvant KEYTRUDA intravenous (IV) infusion plus enfortumab vedotin IV infusion, followed by surgery, followed by 13 cycles of adjuvant KEYTRUDA IV infusion plus five cycles of enfortumab vedotin IV infusion, or;
Four cycles (each cycle is 21 days) of standard of care neoadjuvant chemotherapy followed by surgery.
The primary endpoint is event-free survival (EFS), defined as the time from randomization to the first occurrence of the following events: radiographic disease progression precluding radical cystectomy and pelvic lymph node dissection, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review or death due to any cause. The key secondary endpoints are OS and pathologic complete response rate.

About bladder cancer

In 2022, bladder cancer changed the lives of more than 600,000 people around the world. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC has been neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, nearly half of patients who undergo this standard treatment experience recurrence.

(Press release, Merck & Co, APR 20, 2026, View Source [SID1234664543])