First Site Activated in EU-Funded DE-ESCALATE Clinical Trial on Advance Metastatic Prostate Cancer

On June 10, 2025 The European Organisation for Research and Treatment of Cancer (EORTC) and Syreon Research Institute reported the official start of DE-ESCALATE, a pragmatic Phase III clinical trial focusing on metastatic prostate cancer (Press release, EORTC, JUN 10, 2025, View Source [SID1234653791]).

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DE-ESCALATE is one of three research projects coordinated by EORTC, alongside LEGATO and STREXIT-2, which are also funded by the Horizon Europe Programme.

About metastatic prostate cancer
Prostate cancer is the most frequently occurring cancer in men and the third leading cause of cancer death in men.¹ Despite dramatic improvements in early diagnosis and local treatment, one out of five prostate cancer patients will die from their disease.² While data about the rates of metastasis are limited, about 22% of prostate cancer cases metastasize.3 Advanced metastatic prostate cancer is a heterogeneous disease, for which androgen deprivation therapy combined with an androgen receptor pathway inhibitor (ARPI) is the mainstay of treatment.

Metastatic prostate cancer patients suffer from low quality of life and very burdensome symptoms, including treatment-related side effects.

About DE-ESCALATE
The study will evaluate whether intermittent intensified androgen deprivation treatment (iADT) in metastatic prostate cancer is not inferior to continuous treatment in terms of oncological benefit, while minimizing side effects and resource utilization and improving patient quality of life. It is also designed to detect early if iADT has a negative impact on overall survival compared to continuous therapy.

Up to 1,600 patients are expected to be enrolled in this study across Europe. The clinical trial will be opened in 80 sites in the following 8 countries within the EORTC network (Belgium, Croatia, Czechia, Denmark, Italy, Portugal, Romania, Slovenia) and 30 sites across national networks in Ireland, France, and Spain.4
The study is designed with a strong focus on patient centricity, employing a patient-developed health questionnaire to better assess quality of life improvements.

DE-ESCALATE is managed by a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists, and patient representatives.

To compare the effectiveness of the health interventions tested within the study, Syreon Research Institute will deliver a cost-effectiveness analysis and will also oversee the health policy aspects of the dissemination of the study findings.

The DE-ESCALATE study may lead to improved patient survival and quality of life while also improve health system sustainability.

Sanyou Biopharmaceuticals and Medicovestor, Inc. Forge Strategic Partnership to Develop First-in-Class Chemoimmunotherapy Antibody-Drug Conjugates

On June 10, 2025 Sanyou Biopharmaceuticals, a leading Shanghai-based high-tech biopharmaceutical company specializing in biologics R&D reported the signing of a strategic cooperation agreement with Medicovestor, Inc., a New York-based biotechnology company pioneering first-in-class chemoimmunotherapy antibody-drug conjugates (ADCs) (Press release, Medicovestor, JUN 10, 2025, View Source [SID1234653807]).

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The agreement, officially signed on June 6, brings together Medicovestor’s proprietary ADC platforms—ADoBind, a novel dimeric antibody architecture, and ADoTope, a bi-epitope targeting system—with Sanyou’s globally leading AI-STAL (Artificial Intelligence-enabled Super Trillion Antibody Library) technology and intelligent drug screening and preclinical research capabilities. The collaboration aims to accelerate the development of first-in-class chemoimmunotherapies for oncology and autoimmune diseases so that it is "chemoimmunotherapy" ADCs.

Medicovestor is a U.S.-based biotechnology company dedicated to developing next-generation chemoimmunotherapies antibody-drug conjugates (ADCs) for the treatment of cancer and autoimmune diseases. The company has two proprietary technology platforms that enable higher efficacy at lower doses and support combination therapies. Its lead program has entered the IND-enabling stage, with a pancreatic cancer therapy submitted for FDA Orphan Drug Designation. Medicovestor currently holds 11 granted patents and 3 pending applications, positioning the company with a distinct competitive edge in the ADC field.

Dr. Seah Lim, Founder of Medicovestor, has over 25 years of experience in the biopharmaceutical industry and is recognized as a leading global expert in translational medicine. In academia, Dr. Lim has served as a full professor at several prestigious universities in the United Kingdom and the United States, including Brown University and the University of Pittsburgh School of Medicine, where he held multiple leadership positions such as Division Chief. In industry, he has worked as a Product Development Consultant for companies including Bausch Health, Genzyme, and Burroughs Wellcome & Company. He also served as the Pediatric Lead in the Global Program at Sanofi and has held advisory roles such as Independent Director and Commercial & Scientific Advisor at Genie Therapeutics, Inc. Dr. Seah Lim brings not only deep scientific and industry expertise but also extensive clinical experience to the company.

"This partnership reflects our commitment to redefining ADCs by integrating our differentiated ADC platforms with Sanyou’s world-class expertise in antibody development to incorporate immunotherapy into ADCs," said Seah Lim, MD, PhD, Founder and CEO of Medicovestor. "Together, our complementary strengths create a powerful engine to unlock novel therapeutic possibilities for patients with limited treatment options."

"We are excited to collaborate with Medicovestor to realize the promise of their highly innovative chemoimmunotherapy ADC platforms," said David Lang, PhD, Founder and CEO of Sanyou Biopharmaceuticals. "By combining scientific excellence with execution capability, we aim to deliver transformative therapies that change patients’ lives."

The partnership includes joint research, technology transfer, and co-development of lead candidates. Both companies plan to announce development milestones and candidate selections in the coming quarters.

XENOTHERA confirms progress in the treatment of peripheral T-cell lymphoma (PTCL) through its LIS22 antibody

On June 10, 2025 Nantes-based biotech XENOTHERA reported the value of its LIS22 antibody in the treatment of peripheral T-cell lymphomas (PTCL). The PALT1 clinical trial (NCT06495723) has just passed a new milestone at the trial’s scientific committee meeting, confirming continued recruitment (Press release, Xenothera, JUN 10, 2025, View Source [SID1234654024]). Clinical and biological safety, as well as injection tolerance, are encouraging. Preliminary efficacy data, yet to be confirmed, are very encouraging.

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To date, 9 patients are participating in the trial. No DLT has been observed, so enrolment at the 6 mg/kg dose is continuing. PALT1 is a Phase I/II trial testing the safety and efficacy of LIS22 in patients with refractory relapsed PTCL. The trial is taking place in France and Italy, with Professor Gandhi Damaj at Caen University Hospital as principal investigator.

The results will be presented orally on Tuesday June 18 at 5:50 p.m. by Firas Bassissi, the biotech’s Scientific Director, at the World Congress on Lymphoma (18th International Conference on Malignant Lymphoma, Lugano, Switzerland, View Source), during the "Experimental Medicines" session under the title "LIS22: An Effective Multimodal Polyclonal Antibody targeting T-Cell Malignancies".

In addition, the PALT1 clinical trial is the subject of an abstract to be published in the proceedings of the same congress (abstract 847: "PALT trial: First in class glyco humanized polyclonal antibody directed against tumoral T cells, in patients with relapsed/refractory peripheral T cells lymphoma (PTCL)").

"To be able to present LIS22 orally and to benefit from an abstract published in the proceedings of the Lugano World Congress is an immense source of pride, and confirms the interest of our treatment, as well as the recognition by the medical and scientific community of the quality and potential of our therapeutic antibody. I am of course delighted to be able to continue this trial, thanks to these results, which are both a validation of our approach and, above all, a source of hope for PTCL patients who have reached a therapeutic impasse. I would like to congratulate the XENOTHERA teams, and above all to thank the patients and medical teams who are working alongside us to analyze the therapeutic potential of LIS22," says Odile Duvaux, President of the biotech company.

MacroGenics and Sagard Healthcare Partners Enter into ZYNYZ® Royalty Purchase Agreement

On June 10, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that it has entered into a royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ (retifanlimab-dlwr) (Press release, MacroGenics, JUN 10, 2025, View Source [SID1234653792]). ZYNYZ is a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017. MacroGenics retains its other economic interests related to ZYNYZ, including future potential development, regulatory and commercial milestones. MacroGenics will also continue to support a portion of global commercial manufacturing needs for ZYNYZ.

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Under the terms of the royalty purchase agreement, MacroGenics received a $70 million upfront payment for the sale of its royalty rights on global net sales of ZYNYZ. Following Sagard’s receipt of aggregate royalty payments totaling $140 million (or 2.0x), MacroGenics will resume collecting all future royalties on global net sales.

Additional information regarding the royalty purchase agreement is provided in a Current Report on Form 8-K filed by MacroGenics with the U.S. Securities and Exchange Commission.

As of March 31, 2025, MacroGenics had $154.1 million in cash, cash equivalents and marketable securities. This balance, combined with the $70 million upfront payment from Sagard, projected and anticipated future payments from partners, and anticipated savings from the Company’s ongoing cost-reduction initiatives, is expected to support its cash runway through the first half of 2027. MacroGenics’ expected funding needs reflect planned investments in ongoing clinical and preclinical programs.

About ZYNYZ

ZYNYZ (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

ZYNYZ is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

ZYNYZ is marketed by Incyte in the United States.

ZYNYZ is a registered trademark of Incyte.

MAIA Biotechnology to Present at BIO International Convention 2025

On June 10, 2025 MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported its participation in the upcoming BIO (Biotechnology Innovation Organization) International Convention 2025 taking place June 16-19, 2025, in Boston, Massachusetts (Press release, MAIA Biotechnology, JUN 10, 2025, View Source [SID1234653808]).

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MAIA Chairman and CEO Vlad Vitoc, MD, MBA will deliver a presentation featuring the latest findings from the Company’s THIO-101 Phase 2 clinical trial evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in advanced non-small cell lung cancer (NSCLC). Ateganosine is a small molecule telomere-targeting anticancer agent that acts by producing direct telomeric DNA damage and inducing cancer-specific immune responses. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment. MAIA recently announced the design for the expansion of the THIO-101 trial, which will further assess the efficacy of treatment in third-line NSCLC patients.

Presentation Details
Session date and time: June 18 at 11:30 AM EDT
Presenter: Vlad Vitoc, MD, MBA

Registered participants may request a meeting with MAIA management via the BIO Partnering platform on the BIO 2025 website.