Monte Rosa Therapeutics Announces Clinical Supply Agreement to Support Phase 2 Trial Evaluating MRT-2359 in Combination with Apalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer

On March 16, 2026 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported the company has entered into a supply agreement with Johnson & Johnson to evaluate MRT-2359 in combination with ERLEADA (apalutamide) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) with androgen receptor (AR) mutations in a planned Phase 2 study expected to initiate in the third quarter of 2026. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa. ERLEADA is an AR inhibitor developed by Janssen Research and Development, LLC, indicated for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) and patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

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Under the terms of the agreement, Monte Rosa will conduct and sponsor the trial and Johnson & Johnson will provide ERLEADA as part of a supply agreement.

"We are pleased to enter into this supply agreement with Johnson & Johnson to further explore the potential of MRT-2359 in combination with next-generation AR inhibitors such as apalutamide in patients with advanced prostate cancer," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "Based on the compelling clinical activity observed to date in heavily pretreated patients with AR mutations, we believe this combination approach holds significant promise. Data generated from these studies have the potential to further confirm MRT-2359’s clinical activity and may position the program for advancement into registrational studies, representing an important step forward for prostate cancer patients with limited therapeutic options for this respective patient population."

The planned Phase 2 study of up to 25 mCRPC patients is designed to efficiently assess the efficacy and safety of MRT-2359 plus ERLEADA in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets, including patients naïve to next-generation AR inhibitors, should the activity in the AR mutant patient population confirm. The study will evaluate PSA response, RECIST response, duration of response, progression-free survival (PFS), radiographic progression-free survival (rPFS), and safety.

Monte Rosa recently announced additional, positive data from the company’s ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC. The data were presented at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium on February 26, 2026.

About MRT-2359
MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) of GSPT1. MYC-driven cancers, including prostate cancer, depend on enhanced translation of oncoproteins to support rapid growth. MRT-2359 exploits this therapeutic vulnerability by disrupting translation through selective degradation of the translation termination factor GSPT1. MRT-2359 treatment reduced cellular abundance of many prostate cancer-relevant oncoproteins, including AR, MYC, and Cyclin D1-E2F, and demonstrated robust anti-tumor activity across multiple preclinical models of metastatic castration-resistant prostate cancer (mCRPC). MRT-2359 in combination with the AR inhibitor enzalutamide is being investigated in an ongoing Phase 1/2 study (clinicaltrials.gov identifier NCT05546268) in patients with mCRPC. In heavily pretreated mCRPC patients, MRT-2359 plus enzalutamide demonstrated encouraging early signals of clinical response.

(Press release, Monte Rosa Therapeutics, MAR 16, 2026, View Source [SID1234663586])

Medicus Pharma Announces SkinJect® Phase 2 Principal Investigator and Key Opinion Leader (KOL), Babar K. Rao MD, FAAD, to Provide Clinical Interpretation of Positive Data During Business Update Webcast on March 26

On March 16, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported that Babar K. Rao, MD, FAAD, an internationally recognized academic dermatologist and Principal Investigator of the SKNJCT-003 Phase 2 clinical study, will join the Company’s leadership team during a business update webcast on March 26, 2026 at 11:30 a.m. Eastern time.

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The SKNJCT-003 study represents a randomized, double-blind Phase 2 clinical trial designed to rigorously evaluate the therapeutic contribution of doxorubicin delivered through the SkinJect microneedle platform in patients with nodular basal cell carcinoma.

The update call will follow the filing of the Company’s Form 10-K for fiscal year 2025, expected after market close on March 25, 2026.

During the call, Dr. Rao will provide clinical interpretation and independent investigator perspective on the recently reported positive dataset from SKNJCT-003.

Basal cell carcinoma (BCC), a highly immunogenic tumor, is the most common cancer worldwide, and SkinJect is designed to provide a minimally invasive treatment option that could potentially reduce the need for surgical excision. The 73% clinical clearance observed in the 200-µg treatment cohort suggests that approximately three (3) out of four (4) treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention.

Dr. Rao is widely recognized as a leading academic dermatologist, dermatopathologist, and clinical investigator in skin oncology.

He currently serves as:

Professor of Dermatology and Pathology, Rutgers Robert Wood Johnson Medical School
Clinical Associate Professor of Dermatology, Weill Cornell Medical College
Adjunct Professor of Dermatology, California Health Sciences University
Dr. Rao is a board-certified dermatologist and Fellow of the American Academy of Dermatology (FAAD) with decades of experience in dermatologic oncology, dermatopathology, and clinical research.

He completed his dermatology residency and chief residency at Cornell University Medical Center, followed by advanced training at internationally recognized institutions including, New York University Medical Center, Boston University School of Medicine, University of Texas Southwestern Medical Center and St. John’s Institute of Dermatology, University of London.

Dr. Rao has authored more than 200 peer-reviewed scientific publications and multiple academic book chapters and has served as principal investigator in multiple dermatology clinical trials evaluating novel treatments for skin cancer and other dermatologic diseases.

Dr. Rao serves as Principal Investigator of the SKNJCT-003 clinical trial, titled:

"A randomized, double-blind, three-arm Phase 2 study evaluating two dose levels of microneedle-mediated delivery of doxorubicin compared with a device-only control in patients with nodular basal cell carcinoma."

The randomized design of SKNJCT-003, including a device-only control arm, provides a rigorous framework for evaluating the incremental therapeutic contribution of doxorubicin delivered through the SkinJect microneedle system.

The study results demonstrate clear separation in clinical response between the D-MNA treatment arm (73%) and P-MNA treatment arm (38%) in the 200-µg cohort at Day 57, supporting the continued development of SkinJect as a potential non-surgical treatment option for patients with basal cell carcinoma.

The biological activity observed in the device-only arm likely reflects tumor disruption and localized immune activation resulting from microneedle insertion, a phenomenon previously described in intratumoral and microneedle-mediated device studies evaluating solid tumors.

The 200-µg treatment cohort demonstrated the strongest efficacy signal, achieving 73% clinical clearance and 40% histological clearance at Day 57.

Importantly, the magnitude of response observed in the active treatment cohort relative to the device-only control arm provides clinically meaningful evidence of drug-mediated therapeutic effect within a biologically active microneedle delivery platform.

The Company believes the dataset represents decision-grade evidence supporting continued development of the SkinJect program and advancement toward regulatory discussions and potential strategic partnerships.

Corporate Update Call Details

Event: Medicus Pharma Business Update Conference Call
Date: Thursday, March 26, 2026
Time: 11:30 a.m. Eastern Time
Pre-registration: View Source
Dial-in (U.S./Canada) 833-890-6070
Dial-in (international) 412-504-9736
Webcast: View Source

Participants will include:

Dr. Raza Bokhari — CEO & Executive Chairman, Medicus Pharma
Carolyn Bonner—President & CFO. Medicus Pharma
Dr. Babar K. Rao — Principal Investigator, SKNJCT-003
Members of the Medicus executive leadership team
Topics will include:

Financial performance of the company and overview of the business outlook
Clinical interpretation of the SkinJect Phase 2 topline dataset
Investigator perspective on study endpoints and tumor response mechanisms
Development and partnership outlook for the SkinJect program
Development and partnership outlook for the Teverelix Program
Participants are encouraged to pre-register for the conference call using this link to receive a dial-in number and PIN to bypass the live operator. Participants may pre-register at any time, including up to and after the call start time. Those unable to pre-register can participate by dialing 833-890-6070 (U.S./Canada) or 412-504-9736 (international). A webcast of the call can be accessed.

(Press release, Skinject, MAR 16, 2026, View Source [SID1234663585])

Alessa Therapeutics Announces Positive Preliminary Safety and Efficacy Data from Enolen Phase 1 Trial

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.

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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])

Two Publications Highlight Clinical Utility of Signatera™ in Anal and Rectal Cancers

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:

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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])

Caris Life Sciences Introduces Powerful New Caris AI Insights to Identify Early Platinum Resistance in Ovarian Cancer

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.

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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])