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Arvinas Presents Preclinical Data Supporting Mechanistic Synergies and Enhanced Antitumor Activity with the Combination of ARV-393 and Glofitamab at the 2025 American Society of Hematology Annual Meeting and Exposition

On December 6, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported preclinical data for ARV-393, a PROTAC BCL6 degrader, in combination with glofitamab, a CD20×CD3 bispecific antibody, presented in a poster at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, held December 6–9, 2025, in Orlando, Florida. In a humanized high-grade B-cell lymphoma (HGBCL) cell line–derived xenograft (CDX) model, the combination of ARV-393 and glofitamab resulted in significantly enhanced tumor growth inhibition (TGI) and increased rates of tumor regression compared with either agent alone. These preclinical data suggest mechanistic synergies between BCL6 degradation with ARV-393 and T-cell engagement.

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"Despite advances in treatment options, many patients with diffuse large B-cell lymphoma continue to face limited options once standard therapies fail. By pursuing a chemotherapy-free combination approach, we aim to address this significant unmet need and potentially offer patients a more targeted, better-tolerated therapeutic alternative," said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer, Arvinas. "The initiation of our Phase 1 combination clinical trial, planned for 2026, represents an important step toward defining the potential of ARV-393 in the treatment of this aggressive form of lymphoma."

Key highlights from the poster presentation include:

In a humanized HGBCL CDX model ARV-393 (3 mg/kg) combined with glofitamab (0.15 mg/kg) achieved 81% TGI with concomitant dosing and 91% TGI with sequential dosing (ARV-393 followed by glofitamab), versus 38% for single-agent ARV-393 and 36% for glofitamab alone.
At a higher ARV-393 dose (6 mg/kg) combined with glofitamab (0.15 mg/kg), an increase in tumor regressions was observed with concomitant (10/10 mice) and sequential dosing (7/8 mice) vs single-agent ARV-393 (5/11 mice) or glofitamab (0/11 mice).
RNA sequencing and biomarker analyses revealed that ARV-393 upregulated CD20 expression and genes that promote interferon signaling and antigen presentation, while downregulating proliferation-associated gene sets. These collective effects likely contributed to the observed synergistic antitumor activity.

"We believe these results underscore the potential for ARV-393 and provide a strong mechanistic rationale for exploring ARV-393 in combination with glofitamab as a chemotherapy-free treatment strategy for patients with diffuse large B-cell lymphoma," said Angela Cacace, Ph.D., Chief Scientific Officer, Arvinas. "These preclinical results support our belief in the clinical potential and combinability of ARV-393 and the possibility to provide real benefit to patients in need."

ARV-393 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma and Arvinas plans to share clinical data from this trial at a medical congress in 2026. Additionally, Arvinas plans to add a glofitamab combination cohort in patients with DLBCL in the ongoing Phase 1 clinical trial of ARV-393 in 2026.

About ARV-393

ARV-393 is an investigational, orally bioavailable PROTAC designed to specifically target and degrade B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas. During B-cell development, tightly controlled BCL6 protein expression regulates >600 genes to facilitate rapid B-cell proliferation and tolerance of somatic hypermutation and gene recombination for antibody generation. Deregulated BCL6 expression is common in B-cell lymphoma and promotes cancer cell survival, proliferation, and genomic instability. PROTAC-mediated degradation has the potential to address the historically undruggable nature of BCL6.

(Press release, Arvinas, DEC 6, 2025, View Source [SID1234661193])

OTR Therapeutics Raises $100 Million in Series A Financing to Advance Early Innovation into Global Transformative Therapies

On December 5, 2025 OTR Therapeutics, a biotechnology company dedicated to transforming early-stage innovations into globally impactful therapies, reported the successful completion of a $100 million Series A financing closed in June 2025. The round was backed by True Light Capital, a wholly-owned subsidiary of Temasek, LAV, Pfizer Ventures, and Sirona Capital.

Founded in March 2025, OTR Therapeutics is establishing a novel, scalable, and capital-efficient model that synergizes internal R&D with strategic curation of high-potential external innovation. This integrated approach enables the company to focus on scientific rigor and operational agility, leveraging its deep regional insights and the development efficiency of the local ecosystem to accelerate innovative therapies to patients worldwide.

The proceeds of the financing will advance OTR’s pipeline of differentiated programs that target significant treatment gaps in immunology & inflammation, oncology, and other disease areas. The funds will also expand OTR’s R&D hub capability, which emphasizes both scientific excellence and strategic partnership agility to foster expedited development of high-impact therapies.

In line with its strategy, OTR also announced the acquisition of a preclinical program with best-in-class potential for neurological diseases with high unmet needs. This acquisition is part of the company’s strategic and ongoing efforts to identify and advance promising early-stage assets into global clinical development, alongside its internal proprietary discovery programs to address a broader range of critical patient needs.

"The rapidly evolving global pharmaceutical R&D landscape demands greater novelty, speed and efficiency," said Dr. Zhui Chen, Founder and CEO of OTR Therapeutics. "At OTR, we aim to build a next-generation biotech model that delivers unprecedented R&D and capital efficiency. It enables us to stay agile while remaining rigorously focused on propelling novel, differentiated drug candidates through global clinical translation in a disciplined and efficient manner. We are grateful for the strong support from our investors and their confidence in our vision and capability to deliver transformative therapies for patients."

Co-founded by Zhui Chen, Ph.D., Shannon Chuai, Ph.D., and Yuan Shi, Ph.D., OTR Therapeutics is led by a team of seasoned drug hunters and entrepreneurs in the biotech and pharmaceutical industries with a proven track record of delivering breakthrough innovation, operational excellence, and financial success.

Yi Shi, Managing Director, LAV: "We believe the biopharma industry is shifting towards more capital-efficient and specialized R&D models. OTR Therapeutics is at the forefront of this evolution, demonstrating how a focused, integrated framework can expedite the journey of translating early-stage innovation into global clinical development."

Michael Baran, Partner, Pfizer Ventures: "Pfizer Ventures identifies and invests in emerging companies who are developing innovative medicines and technologies that have the potential to shape the future of our industry. To this end, we’re pleased to be able to support OTR Therapeutics as it scales its R&D capabilities and builds a portfolio of potentially transformative therapies."

(Press release, OTR Therapeutics, DEC 5, 2025, View Source [SID1234661191])

Natera Acquires Foresight Diagnostics

On December 5, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and Foresight Diagnostics, a leader in ultrasensitive molecular residual disease (MRD) detection, reported that Natera has completed a transaction to acquire Foresight.

Foresight is a cancer diagnostics company and CLIA-registered laboratory. The company’s circulating tumor DNA (ctDNA)-based MRD tests leverage its patented PhasED-Seq technology, targeting phased variants. With this technology, Foresight has reported performance with LOD95 of 0.3 parts per million and detection below 0.1 ppm1.

Foresight was founded by Stanford University physicians and scientists, Maximilian Diehn, M.D., Ph.D., Ash Alizadeh, M.D., Ph.D., and David Kurtz, M.D., Ph.D., together with Jake Chabon, Ph.D., Foresight’s chief scientific officer and chief executive officer. The company has authored more than 40 scientific publications and presentations and partnered with more than 30 biopharma and academic researchers.

Strategic Rationale

The transaction combines Natera’s leading commercial and operational infrastructure for the delivery of personalized MRD testing with Foresight’s unique phased variant technology and leadership in lymphoma. It builds on Natera’s broad intellectual property portfolio for tumor-informed and personalized MRD products including in phased variants, and promises to accelerate MRD adoption in lymphoma and other solid tumor types.

Signatera platform with phased variants: The integration of phased variants into the Signatera platform will further differentiate and strengthen test performance across solid tumors. This enhanced version is available immediately for research use for biopharma and academic partners and is expected to be launched for clinical use in 2026.
Leadership in lymphoma: The transaction builds on Foresight’s clinical research momentum in B-cell lymphomas, a large patient population with more than 75,000 new cases annually in the U.S.2 Earlier this year, Foresight data provided the foundation for the inclusion of ctDNA MRD into the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for diffuse large B-cell lymphoma. Additionally, Foresight’s CLARITY MRD assay for lymphoma is being used in three prospective MRD-driven clinical trials informing treatment decisions for patients. Foresight CLARITY joins Natera’s extensive MRD product portfolio and will continue to support clinical trials, translational research and future applications.
At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting beginning on December 6, Natera and Foresight will have a total of 15 abstracts featuring Signatera and PhasED-Seq, including seven oral presentations.

Transaction Terms

Natera has closed the acquisition of Foresight in an all-stock transaction consisting of a $275 million upfront with an additional $175 million in earnouts tied to the achievement of revenue- and reimbursement-based milestones.

"This acquisition reinforces Natera’s position at the forefront of precision oncology," said Steve Chapman, chief executive officer of Natera. "Foresight’s phased variant technology and leadership in lymphoma complement Natera’s strong capabilities in personalized MRD testing, improving the value we can deliver to patients, clinicians, biopharma partners and the broader healthcare system."

"Foresight’s mission has always been to improve the lives of cancer patients worldwide through innovative diagnostics," said Chabon. "As we join Natera, I’m deeply grateful to our employees, partners and investors who have helped bring us to this moment. Together, we can realize this mission on a far greater scale, accelerating the pace of discovery across both hematologic and solid tumors."

Gibson, Dunn & Crutcher LLP is serving as legal counsel to Natera. Wilson Sonsini Goodrich & Rosati is serving as legal counsel to Foresight, while Centerview Partners LLC is acting as its financial advisor.

(Press release, Natera, DEC 5, 2025, View Source [SID1234661181])

Guardant Health to Present 14 Abstracts Demonstrating the Power of Multiomic Liquid Biopsy Tests in Predicting Outcomes and Tailoring Treatment for Early and Metastatic Breast Cancer at the 2025 San Antonio Breast Cancer Symposium

On December 5, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present a total of 14 abstracts with its research collaborators from multiple studies demonstrating the value of its tissue-free liquid biopsy tests at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 9–12, 2025.

Oral presentations will highlight results generated with Guardant Reveal, the company’s tissue-free test for detecting minimal residual disease (MRD) and Guardant360 Liquid, the company’s comprehensive multiomic profiling test, both leveraging Guardant’s proprietary epigenomic technology powered by the Guardant Infinity Smart Platform. Collectively, these studies demonstrate how blood-based testing can uncover risk, guide treatment selection, and influence long-term patient management across the breast cancer continuum, from early-stage disease through metastatic settings.

Guardant’s MRD presentations reinforce the value of tissue-free circulating tumor DNA (ctDNA) testing for both neoadjuvant treatment response assessment and post-treatment surveillance in early-stage breast cancer. In a retrospective analysis of HER2-positive patients, ctDNA measured with Guardant Reveal demonstrated strong prognostic significance in the neoadjuvant setting, showing a correlation with pathological complete response and three-year invasive disease-free survival. In an independent study of triple-negative breast cancer patients, Guardant Reveal accurately predicted relapse risk and detected ctDNA more frequently and earlier than orthogonal methods.

Together, these findings demonstrate the validity of Guardant Reveal as a reliable approach for ctDNA detection and monitoring in both neoadjuvant and surveillance settings.

"Breast cancer care increasingly depends on understanding tumor biology at every stage of disease, and Guardant’s data continues to reaffirm the growing value of multiomic liquid biopsy as a powerful, non-invasive tool to equip providers with the data necessary to tailor therapy and treatment," said Dr. Craig Eagle, Chief Medical Officer at Guardant Health. "We look forward to sharing our findings demonstrating the power of blood in helping provide clinicians with deeper clarity and more confident decision-making for their patients."

Other data highlights to be presented include:

Data showcasing the clinical utility of Guardant Reveal in predicting outcomes in patients with early-stage HER2-positive breast cancer. In this analysis, early ctDNA clearance throughout treatment was linked to better outcomes, underscoring ctDNA as a sensitive marker of treatment response and highlighting the value of tissue-free testing for real-time response monitoring.
Data supporting the clinical value potential of non-invasive, methylation-based, continuous breast cancer subtype monitoring by Guardant360 Liquid to uncover tumor evolution and heterogeneity that may guide more precise treatment decisions. In this analysis, Guardant360 Liquid showed agreement to tissue-based monitoring and replicated previously reported accuracy.
Data showcasing Guardant360 Liquid methylation-based breast cancer subtyping feature as a noninvasive liquid tool to dynamically reassess ER, HER2 and triple negative status in patients who are resistant to ER therapy but don’t carry an ESR1 mutation. In this study, Guardant360 Liquid predicted real-world outcomes in previously AI-treated patients receiving subsequent lines of therapy.
Guardant-Led Research at SABCS 2025

Presentation

Title

Time / Location

Wednesday, December 10

PD2-09

Molecular Evolution in Early and Late-Stage Tumors

7:00 – 8:30am CST / 301 ABC

GS1-07

Circulating tumor DNA (ctDNA) in human epidermal growth factor receptor

9:30am – 12:00pm / Hall 1

PS1-12-05

Liquid biopsy–based molecular profiling using GUARDANT360 CDx at progression on CDK4/6i+ET: findings from the AGO-B CAPTOR study

12:30pm – 2:00pm / Exhibit Hall

PS1-11-09

Real-world prevalence of estrogen receptor (ER) 1 mutations (ESR1m) among patients with ER+/ human epidermal growth factor receptor 2 (HER2)− metastatic breast cancer (MBC) after first-line (1L) treatment with endocrine therapy (ET) and/or cyclin dependent kinase 4/6 inhibitors (CDK4/6i)

12:30pm – 2:00pm / Exhibit Hall

RF3-05

Tissue-free circulating tumor DNA detection in patients with early triple negative breast cancer from the c-TRAK-TN trial

12:30pm – 2:00pm / Exhibit Hall

PS2-07-02

Tissue-free epigenomic circulating tumor DNA (ctDNA) analysis pre- and post-surgery in early breast cancer: clinical features and prognostic utility

4:30pm – 5:30pm / Stars at Night

PS2-07-18

Prognostic effects of methylation-based HR and HER2 assessments by liquid biopsy in ESR1 mutation negative advanced breast cancer

4:30pm – 5:30pm / Stars at Night

PS2-07-16

Clinicogenomic characterization and ctDNA detection of ESR1 fusion positive metastatic breast cancer

5:00pm – 6:30pm / Exhibit Hall

PS2-09-21

Real-world clinical outcomes and genomic insights for patients with PIK3CA-mutant metastatic breast cancer following progression on CDK4/6 inhibitor therapy

5:00pm – 6:30pm / Exhibit Hall

PS2-08-17

Prevalence and clinical significance of exon 6 ESR1 gene fusions in advanced breast cancer after disease progression on aromatase inhibitors

5:00pm – 6:30pm / Exhibit Hall

PS2-10-19

Circulating tumor DNA (ctDNA) as a strong prognostic biomarker of minimal residual disease (MRD) using a tissue-free, epigenomic assay in early-stage breast cancer.

5:00pm – 6:30pm / Exhibit Hall

Thursday, December 11

PD9-03

Comprehensive genomic profiling and clinically targetable mutations of metastatic invasive lobular and no special type breast cancer

7:00am – 8:30am / Hemisfair Ballroom

PS4-01-11

Exploration of racial differences in variants of uncertain significance (VUS), ESR1 and PIK3CA mutation frequency, matched therapy use, and outcomes in metastatic breast cancer (mBC)

7:00am – 8:30am / Hemisfair Ballroom

PS4-02-10

Agreement of cell-free DNA methylation-based molecular breast subtyping and tissue subtyping in hormone receptor positive metastatic breast cancer: a clinical cohort analysis

5:00pm – 6:30pm / Exhibit Hall

The full abstracts for Guardant Health and a list of all abstracts being presented at SABCS 2025 can be found on the SABCS website.

For information and updates from the conference, visit booth #942 and follow Guardant Health on LinkedIn, X (Twitter) and Facebook.

(Press release, Guardant Health, DEC 5, 2025, View Source [SID1234661180])

IceCure Receives Notice of Patent Allowance in China for a Novel Cryogen Flow Control to Optimize Patient Cryoablation Outcomes

On December 5, 2025 IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, reported it received a Notice of Allowance for a patent from the China National Intellectual Property Administration for its invention titled "Cryogen Flow Control" which relates to its next-generation XSense cryoablation system and probes.

A patent for this invention has been granted in Japan and is currently pending approval in the European Union, the U.S., and other major markets.

"We believe IceCure’s commitment to technology innovation and our drive to make a significant impact on patient outcomes has resulted in our intellectual property portfolio in cryoablation reaching 55 patents granted and allowed across the globe," said Eyal Shamir, IceCure’s Chief Executive Officer. "Our cryoablation systems and probes already have regulatory approval in China for indications including breast cancer, and we continue to innovate next-generation liquid nitrogen-based systems including XSense to further improve patient outcomes."

The notice of allowance for the patent addresses precise temperature control, which is crucial for efficacy and tissue safety in cryoablation procedures. Cryogenic flow control achieves this by utilizing sensor data to regulate the flow of cryogens, ensuring the desired temperature is reached and maintained at the distal tip of catheters and probes. This optimized cryogenic delivery enhances treatment effectiveness in cryoablation procedures. Advanced cryogen flow control systems may also offer functionalities, such as navigation and mapping support within the patient’s anatomy, and be incorporated into a wide range of cryosurgical tools.

The ProSense Cryoablation System is the first and only medical device to receive U.S. Food and Drug Administration ("FDA") marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and older, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company’s website. XSense is the Company’s next-generation cryoablation system.

(Press release, IceCure Medical, DEC 5, 2025, View Source [SID1234661179])