On March 16, 2026 Alessa Therapeutics ("Alessa"), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology for the treatment of early-stage prostate cancers, reported the presentation of positive preliminary data from its ongoing Phase 1 clinical trial of Enolen, the Company’s lead product candidate for the treatment of low to intermediate risk, localized prostate cancer. These results were shared as part of an oral presentation at the 2026 European Association of Urology Congress ("EAU2026"), taking place March 13-16, 2026, in London.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Enolen utilizes novel anti-androgen eluting implants containing the FDA-approved prostate cancer compound enzalutamide. It is currently being studied in a Phase 1 trial evaluating its safety, tolerability and preliminary efficacy for localized sustained delivery of enzalutamide into the prostate in men with localized prostate cancer undergoing prostatectomy. The study is being conducted at the National Cancer Institute (NCI), part of the National Institutes of Health.

Findings presented yesterday at EAU2026 by researchers at the NCI demonstrated that all 20 patients enrolled in the initial cohort were successfully implanted. These implantations achieved very high intraprostatic enzalutamide levels with minimal systemic drug exposure and resulted in no delay to surgery. Furthermore, pre-radical prostatectomy MRI’s conducted for 18/20 patients (2 pending) showed a reduction in tumor volume in 84% of the lesions over an average duration of 35 days. There were no reported effects on testosterone levels or negative effects on sexual function. Reported side effects were consistent with a biopsy-like procedure, and without impact on future surgery or imaging.

"The preliminary safety and efficacy data from this study are compelling and demonstrate the potential of Enolen to serve as a new treatment option for men with localized prostate cancer that avoids the negative side effects of current treatments," said Peter Pinto, M.D., Chief, Prostate Cancer Division at the National Cancer Institute and Principal Investigator on the study. "These initial findings, particularly MRI-documented tumor shrinkage and therapeutic enzalutamide levels in the prostate with minimal systemic exposure, strongly support further development of Enolen."

"Being the first study to demonstrate that enzalutamide can be safely and locally administered to the prostate via sustained drug eluting implants is a significant clinical milestone both for Alessa and for the broader treatment landscape for prostate cancer," said Pamela Munster, M.D., Chief Scientific Advisor and founder of Alessa. "We look forward to continuing our clinical advancement of Enolen, which includes further investigation of dose optimization and duration of drug exposure through two additional cohorts underway in this Phase 1 trial."

About Enolen

Enolen leverages Alessa’s proprietary local delivery technology which can deliver anti-androgens directly to diseased tissue in the prostate. This localized delivery can help eliminate the side effects of systemic anti-androgen and testosterone-lowering drugs, including fatigue, sexual dysfunction, muscle mass loss, cognitive issues, metabolic syndrome and cardiovascular events.

Preclinical and clinical studies to date demonstrate that Alessa’s implant technology can deliver durable and continuous release of effective anti-cancer agents, achieving high local drug concentrations while minimizing the negative side effects which can result from systemic exposure.

Alessa recently announced that it has received Fast Track designation by the U.S. FDA for Enolen, which is granted to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The designation is intended to facilitate development and expedite review of qualifying drugs.

(Press release, Alessa Therapeutics, MAR 16, 2026, View Source [SID1234663584])

On March 16, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported two peer-reviewed publications highlighting the clinical utility of Signatera, its personalized, tumor-informed circulating tumor DNA (ctDNA) assay, in anal squamous cell carcinoma (ASCC) and locally advanced rectal cancer (LARC).A recently published study evaluated 84 patients with ASCC to assess whether serial Signatera testing may offer a dynamic, treatment-responsive biomarker to further stratify recurrence risk and inform surveillance and treatment. Key findings include:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Signatera-status was strongly correlated with clinical outcomes. Patients who were Signatera-negative at baseline or cleared ctDNA during chemoradiotherapy (CRT) had favorable outcomes, including 100% one-year overall survival and progression-free survival, and 0% one-year local regional failure. Patients who remained ctDNA-positive after CRT had poorer outcomes (63% OS, 44% PFS, 39% locoregional failure at one year).
In 100% of recurrent cases, Signatera-positivity preceded clinical and/or radiographic recurrence highlighting ctDNA’s potential as an early indicator of relapse.
LARC: publication in Cancers

Another recent study evaluated 220 patients with LARC treated with neoadjuvant therapy (NAT) followed by non-operative management (NOM) (n=72) or surgery (n=148). The study examined how Signatera status after NAT may inform patient selection for organ-preserving NOM versus surgery and guide intensified surveillance strategies. Key findings include:

Signatera identified post-NAT patients at high risk of relapse requiring surgical intervention. Signatera-positive NOM patients were at 4.6x higher risk of regrowth requiring surgery (HR 4.62; p=0.003), even among those with a complete or near-complete clinical response.
Post-operative Signatera negativity was associated with excellent clinical outcomes. Signatera-negative patients (HR:15, p=0.001) experienced a relapse rate of 11.5% compared to 88.0% among Signatera-positive patients (p<0.0001).
"Together, these publications address key questions about monitoring treatment response and recurrence risk in anal and rectal cancers," said Alexey Aleshin, M.D., MBA, corporate chief medical officer and general manager of oncology at Natera. "By providing earlier insight into molecular residual disease, Signatera can support more individualized surveillance and treatment decisions."

(Press release, Natera, MAR 16, 2026, View Source [SID1234663583])

On March 16, 2026 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported the addition of a platinum resistance AI signature to the growing portfolio of Caris AI Insights. This new signature is designed to predict early platinum resistance in patients with high-grade serous ovarian cancer (HGSOC) and provides clinicians with unprecedented molecular insight into how long a patient may benefit from first-line platinum-based chemotherapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Caris Life Sciences continues to advance precision oncology by integrating multimodal real-world datasets available with its proprietary CodeAI platform, enabling the creation of Caris AI Insights, an engine that utilizes Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS) and clinical data to generate deeper biological understanding and more actionable insights for clinicians and researchers.

By harnessing AI across its comprehensive real-world database, Caris is building next-generation multimodal models that accelerate biomarker discovery, enhance therapeutic decision-making and support the development of more personalized cancer treatments.

HGSOC is the most common and aggressive type of ovarian cancer and is often diagnosed at an advanced stage, creating urgency in treatment planning. Platinum resistance, defined as disease progression or recurrence within six months of finishing first-line platinum-based chemotherapy, is estimated to affect 20-30% of patients with advanced HGSOC. For clinicians, understanding a patient’s likelihood of chemotherapy resistance can guide the creation of a patient-specific treatment plan.

The ovarian platinum resistance signature is particularly relevant in light of the recent FDA approval of a combination therapy for patients with platinum-resistant disease. The FDA approved a new combination treatment that opens the door to another option for patients whose cancer has stopped responding to initial platinum-based chemotherapy. The approval underscores the importance of identifying resistance earlier in the treatment course so clinicians can make more informed decisions about subsequent therapy.

"The ability to anticipate which patients are likely to develop early platinum resistance has the potential to significantly improve how we approach ovarian cancer care," said David Spetzler, MS, PhD, MBA, Caris President. "Platinum-based chemotherapy works well for many patients, but when it doesn’t, patients need to be able to quickly move on to other therapeutic options."

By identifying complex molecular features associated with platinum resistance, this signature generates a risk score and a "platinum sensitive" or "platinum resistant" prediction that estimates the likelihood of early transition to the next line of treatment using features from the Caris industry-leading Whole Exome and Whole Transcriptome tissue platform. Also, clinicians receive supporting Kaplan-Meier curves to help contextualize the risk and assist with treatment planning. The Caris AI Insights for ovarian cancer is available now, by request, through the Caris Molecular Tumor Board Report when ordering Caris’ tissue-based test, MI Cancer Seek.

Caris received FDA approval in November 2024 for MI Cancer Seek, a tissue-based assay that is the first and only simultaneous WES and WTS-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.

(Press release, Caris Life Sciences, MAR 16, 2026, View Source [SID1234663582])

On March 16, 2026 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported two "trial in progress" presentations at the 2026 European Association of Urology congress (EAU) in London, UK. These trials investigate different stages of the diagnostic pathway, addressing data gaps to improve individual patient care and outcomes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The EAU annual meeting is one of the largest international meetings in the global urology calendar, showcasing the latest and most relevant clinical and scientific advancements in this area of patient care.

Photocure participated with its Hexvix product, designed for better detection and resection of bladder tumors. As in past sessions and as a service to non-attending urologists, Photocure will make 2026 EAU bladder cancer session highlights available to healthcare professionals after the event, by means of video interviews with the presenters of these sessions at the Photocure booth. This successful initiative is once again supported by two of the leading names in Bladder Cancer in Europe, Prof. M. Rouprêt, APHP, Sorbonne University Paris, France and Prof. P. Gontero, Division of Urology, University of Studies of Torino, Italy.

In addition to this educational activity, the EAU scientific program prominently featured Photocure’s Hexvix product and/or the blue light cystoscopy procedure in which it is used. In particular, two notable bladder cancer "trial in progress" presentations from Monday, March 16, 2026 were:

A0648: VI-RADS & PDD-TURBT to avoid Second-look and Resection (Re-TURBT) in Non-Muscle Invasive Bladder Cancers: The CUT-less Randomized Clinical Trial

F. Del Giudice, Rome (IT)

The CUT-less trial investigates whether second-look TURB can be safely omitted by combining preoperative staging accuracy of Magnetic Resonance Imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) with enhanced cystoscopy using blue-light-TURB

The primary endpoint of this randomized, single-center, non-inferiority trial is short-term bladder cancer recurrence. Patients eligible for second-look resection who are randomized to BL-TURB and demonstrate a very-low to low likelihood of muscle-invasive disease on MRI will omit the second-look resection, whereas patients randomized to WL-TURB will undergo the standard second-look resection. Over 3 years, 327 patients with intermediate- or high-risk NMIBCs* who are candidates for second-look TURBT will be enrolled. Results will also include building a health economic lifetime model, looking at cost-utility per quality-adjusted life year gained using 2-year clinical outcomes.

The CUT-less trial aims to generate evidence supporting a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway across the European Union and potentially worldwide.

ClinicalTrial.gov identifier (ID): NCT05962541 Read more: View Source

A0649: Trial in progress: Evaluation of urinary minimal residual disease and outcomes in high-risk non-muscle invasive bladder cancer surveilled with blue light compared to white light cystoscopy

A.K. Smith, Bethesda (US)

Urinary comprehensive genomic profiling offers a non-invasive method to assess the presence or extent of bladder cancer. The urinary biomarker UroAmp (Convergent Genomics) detects minimal residual disease (MRD). By enhancing tumor margin visualization, Blue Light Cystoscopy (BLC) may improve TURBT (transurethral resection of bladder tumors) completeness. This randomized controlled trial (RCT) enrolls high-risk NMIBC patients receiving either standard of care white light or Blue Light Cystoscopy. UroAmp will be used to evaluate completeness of resection for each modality.

The study will enroll 200 subjects undergoing TURBT for suspected high risk NMIBC randomized 1:1 to WLC or BLC-enhanced cohorts. Urinary MRD analyses will be conducted at all major decision points during treatment. The primary endpoint is the post-TURBT difference in MRD scores between the BLC and WLC arms. Secondary clinical outcomes include recurrence-free survival at 12 and 24 months.

Clinical Trial Registry number is NCT06525571. Read more: View Source

"Photocure’s support for these trials underscores our commitment to the transformation toward more personalized, data-driven care in uro-oncology, enabling better clinical outcomes and supporting the shift toward precision medicine. Minimally invasive procedures are on the rise and these trials address data gaps in the care pathway and in the impact of complete TURBTs using BLC to reduce tumor burden on clinical outcomes for high-risk patients. At Photocure, we strongly believe that the clinical utility of different precision diagnostic techniques can be optimized by using them in combination and in sequence throughout the patient pathway to inform physician decision-making and provide value for patients and healthcare. The same is true for their use in clinical trials," said Anders Neijber, Chief Medical Officer of Photocure.

During the EAU Congress on March 13, 2026, Photocure, in collaboration with medac, hosted a well-attended scientific event titled "Optimising Care in Bladder Cancer." The session was moderated by Mr. John McGrath (Consultant Urological Surgeon North Bristol Trust). The program brought together leading clinicians to discuss current challenges and advances in bladder cancer management, with a focus on improving patient pathways, in particular outcomes for women. This collaboration between Photocure and medac reflects a shared commitment to advancing evidence-based practice and supporting healthcare professionals in delivering high-quality, patient-centered bladder cancer care.

(Press release, PhotoCure, MAR 16, 2026, View Source [SID1234663581])

On March 16, 2026 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), reported it will host an investor webinar on Wednesday, March 18th at 3:30pm ET to discuss follow-up data from its first-in-human study of its Targeted Hyperthermia Therapy ("THT") (the "Study") that resulted the generation of immune responses in 8/10 treated and biopsied tumors, with complete responses seen in 6/10. Interested parties can register for this webinar via the following link: View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Joining on the webinar will be the study’s principal investigator, Dr. Carlos Rojas, executive director of the Centro de Investigacion Clinica, Bradford Hill, along with Sona’s CEO, David Regan, and CMO, Dr. Carman Giacomantonio. Data to be presented will include patient follow-up assessments, including evidence that THT treatments generated a clinical response in secondary, untreated tumors, known as an abscopal effect, in a Study patient. This study of ten, late-stage melanoma patients who had failed on standard-of-care immunotherapy protocols, was undertaken to assess the safety, tolerability and efficacy of THT in humans.

David Regan, Sona’s CEO, commented, "We are excited to be able to share our perspectives on some follow-up data from our first-in-human study from the Principal Investigator. While the Study was intended to assess THT’s safety, tolerability and ability to prime tumors for further treatment, THT given as a monotherapy treatment demonstrated in an astounding 80% clinical response rate ("CRR"), with 60% of treated, biopsied tumors cleared in only two weeks. In particular, evidence of an abscopal effect will be discussed with an opportunity for participants to question the study’s Principal Investigator."

A recording of the webinar will be made available following the webinar in the Investor Information section of the Company’s website.

(Press release, Sona Nanotech, MAR 16, 2026, View Source [SID1234663576])