Parabilis Medicines to Present Updated Clinical Data for Zolucatetide in Patients with Desmoid Tumors at ESMO Congress 2026

Parabilis Medicines (Nasdaq: PBLS) will present updated zolucatetide data in patients with desmoid tumors at ESMO Congress on October 24, 2026.

Rhea-AI Summary

Parabilis Medicines (Nasdaq: PBLS) will present updated zolucatetide data in patients with desmoid tumors at ESMO Congress on October 24, 2026. The presentation covers the ongoing Phase 1/2 trial, using a June 22, 2026, data cutoff, and includes both dose escalation and dose optimization results. The desmoid tumor-specific dose optimization cohort is designed to inform dose and schedule selection for a planned registrational Phase 3 trial.

Mrinal Gounder of Memorial Sloan Kettering Cancer Center will present during the sarcoma session, scheduled for 14:45–16:15 CEST in Madrid. Parabilis will host an investor webcast that day at 18:00 CEST / 12:00 p.m. EDT, with a replay available afterward. Zolucatetide has FDA Fast Track and Orphan Drug designations for treating desmoid tumors.

Key Figures

Data cutoff: June 22, 2026

Data cutoff

June 22, 2026

Updated Phase 1/2 desmoid tumor trial data

Key Terms

phase 1/2 trial, dose escalation, dose optimization, fast track designation, +1 more

5 terms

phase 1/2 trial medical

"ongoing Phase 1/2 trial"

A phase 1/2 trial combines the earliest human safety testing with an initial look at whether a treatment works, typically starting by checking tolerability and side effects and then expanding to measure early signs of benefit and the best dose. For investors, results from these trials are an early indicator of a drug’s clinical promise and regulatory path: positive data can materially increase a company’s value and reduce development risk, while negative data can sharply lower expectations.

dose escalation medical

"both the dose escalation and dose optimization portions"

Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.

dose optimization medical

"both the dose escalation and dose optimization portions"

Dose optimization is the process of finding the amount and schedule of a drug that gives the best balance between benefit and side effects for patients, often determined through clinical testing and data analysis. For investors, it matters because the optimal dose affects a medicine’s safety profile, approval chances, label, and market acceptance—like setting a thermostat to be comfortable without wasting energy, the right dosing can maximize value and reduce risk.

fast track designation regulatory

"received both Fast Track Designation and Orphan Drug Designation"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

orphan drug designation regulatory

"received both Fast Track Designation and Orphan Drug Designation"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

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Oral presentation will include updated data from the ongoing Phase 1/2 trial, with dose optimization arm designed to inform dose and regimen selection for Phase 3 registrational trial in desmoid tumors

Company to host webcast on Saturday, October 24, 2026, at 6 p.m. CEST / 12 p.m. EDT

CAMBRIDGE, Mass., Oct. 19, 2026 (GLOBE NEWSWIRE) -- Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today announced that updated clinical data for zolucatetide in patients with desmoid tumors will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27, 2026, in Madrid, Spain.

The oral presentation will report data from a June 22, 2026, data cutoff, including data from both the dose escalation and dose optimization portions of the ongoing Phase 1/2 trial. Dose optimization in the desmoid tumor-specific cohort is designed to inform selection of the dose and schedule to be carried forward into the planned registrational Phase 3 trial of zolucatetide in patients with desmoid tumors.

Zolucatetide has received both Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors.

Presentation Details

Title: A phase 1/2 trial of zolucatetide, a first-in-class direct β-catenin:TCF inhibitor: updated safety and efficacy in patients with desmoid tumors

Abstract Number: 3715O
Presenter: Mrinal Gounder, M.D., Memorial Sloan Kettering Cancer Center
Session: Proffered Paper Session: Sarcoma
Date & Time: Saturday, October 24, 2026, 14:45–16:15 CEST (8:45–10:15 a.m. EDT)
Location: Malaga Auditorium - Hall 3, IFEMA Madrid, Madrid, Spain

Investor Webcast
Parabilis will host an investor webcast on Saturday, October 24, 2026, at 18:00 CEST (12:00 p.m. EDT) to discuss the updated zolucatetide data that will be presented at ESMO Congress 2026. The webcast will be available on the Investors section of the Parabilis website at https://investors.parabilismed.com. A replay will be available following the event.

About Desmoid Tumors
Desmoid tumors are locally invasive soft-tissue tumors that arise in connective tissues and can be aggressive and recurrent, often causing chronic pain, limited mobility, disfigurement and organ dysfunction. An estimated 30,000 people in the U.S. alone are living with desmoid tumors, including approximately 11,000 who are actively managed, with significant unmet need globally as well. Desmoid tumors typically present in young adults, with many patients requiring prolonged or intermittent treatment. Wnt/β-catenin pathway-activating mutations are the causal driver of desmoid tumors, yet no approved therapies directly target this underlying biology of the disease.

About Zolucatetide
Zolucatetide is an investigational first-in-class and first-and-only direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, a genetically validated driver of numerous cancers and other serious diseases that has long been considered undruggable. Developed using Parabilis’ Helicon™ peptide platform, zolucatetide is designed to prevent the activation of disease-driving genes by directly targeting β-catenin:TCF, a key downstream node in the Wnt/β-catenin pathway. This approach has the potential to address aberrant Wnt/β-catenin signaling regardless of the upstream APC or β-catenin mutations driving pathway activation, potentially overcoming a key limitation of approaches targeting earlier steps in the pathway.

Zolucatetide is currently being evaluated in an ongoing Phase 1/2 clinical trial (NCT05919264) across a range of indications, including desmoid tumors, familial adenomatous polyposis (FAP), adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC) and additional Wnt-driven tumor types.

About Parabilis Medicines 
 Parabilis Medicines (Nasdaq: PBLS) is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The Company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The Company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP), adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC) and a range of other rare and common solid tumor indications. Beyond zolucatetide, Parabilis is pursuing a follow-on β-catenin degrader program and advancing additional Helicon-based programs focused on other challenging targets, including ERG and allosteric AR^ON in prostate cancer, where we believe our medicines could have life-altering impact. For more information, visit www.parabilismed.com or follow us on LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, and the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “designed to,” “expect,” “may,” “plan,” “planned,” “potential,” “potentially,” and similar expressions. These statements include, but are not limited to, statements regarding the use of data from the dose optimization portion of our Phase 1/2 trial to inform the selection of dose and schedule for our planned Phase 3 registrational trial of zolucatetide in desmoid tumors; the planned Phase 3 trial; and the potential of zolucatetide, including its design and potential advantages over other approaches.

These statements are based on management’s current expectations and beliefs and are subject to risks and uncertainties that could cause actual results to differ materially, including: that data from early-stage trials, including from a specific data cutoff and a limited number of patients, may change with additional patients and follow-up and may not be predictive of later results; that dose and schedule selection may not support, or may require changes to, our planned Phase 3 design; that we may not initiate or complete clinical trials as planned, and the FDA or comparable foreign authorities may disagree with our trial design or require additional studies; that zolucatetide may not demonstrate the safety, tolerability or efficacy we expect, and clinical development may be delayed or fail; and other risks described under “Risk Factors” in our most recent Quarterly Report on Form 10-Q and our other filings with the U.S. Securities and Exchange Commission. These risks also apply to forward-looking statements made during the investor webcast. Forward-looking statements speak only as of the date of this release, and, except as required by law, we undertake no obligation to update them.

Media Contact
Jessica Freifeld
media@parabilismed.com

Investor Contact
Tom Kotarakos
investors@parabilismed.com