On December 4, 2025 Arima Genomics, Inc., a company leveraging whole-genome sequence and structure information to provide comprehensive cancer therapy selection insights, reported new data to be presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place in Orlando, FL from December 6–9, 2025.

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In the largest cohort to date comparing the Hi-C–based method for genome-wide analysis of fusions and rearrangements used in the Aventa Lymphoma test with conventional fluorescence in situ hybridization (FISH) in diffuse large B-cell lymphoma (DLBCL), investigators showed that the Hi-C assay identified additional clinically relevant rearrangements that routine FISH panels missed, and did so with higher sensitivity for key biomarkers associated with diagnosis and prognosis.

The retrospective study evaluated FFPE tumor samples from 159 patients with DLBCL uniformly treated with R-CHOP. All cases had previously undergone FISH testing for MYC, BCL2 and BCL6 rearrangements. Using the same Hi-C sequencing method that underlies the clinically available Aventa Lymphoma test, researchers compared genome-wide structural rearrangement calls to clinical FISH results and assessed the potential clinical impact of discordant findings.

Hi-C sequencing detected additional biomarker rearrangements in approximately one-quarter of DLBCL cases beyond what FISH reported. These included:

MYC, BCL2, and BCL6 rearrangements that were not detected by standard FISH probes
Classification biomarkers for other lymphoma entities (such as CCND1, CCND3, IRF4, ALK and MALT rearrangements)
Rearrangements involving genes that may enable additional treatment options, including PD-L1 and ATM
Across rearrangements the investigators classified as clinically relevant in this cohort, standard FISH detected only about two-thirds, whereas the Hi-C assay detected nearly all of them — meaning that more than one-third of clinically relevant rearrangements would have been missed by FISH alone.

The additional findings were not merely incremental: they supported refinement of lymphoma classification and treatment considerations. In selected cases, the Hi-C results:

Helped distinguish DLBCL from high-grade B-cell lymphoma with double-hit features
Prompted reconsideration of a different diagnosis that would suggest an alternative treatment approach
Identified patients with rearrangements (such as PD-L1, ALK, or ATM) that could make them candidates for targeted therapies or clinical trials
"In this multi-center cohort of 159 R-CHOP–treated DLBCL patients, we directly compared Arima’s innovative, genome-wide Hi-C sequencing assay with the FISH panels that pathologists routinely use today," said Ken H. Young, MD, PhD, Professor of Pathology and Director of the Hematopathology Division at Duke University School of Medicine. "Hi-C sequencing uncovered additional clinically important rearrangements that routine testing missed and helped clarify the diagnosis or provide additional therapeutic biomarkers in multiple cases. These results indicate that this comprehensive structural assay can significantly improve the workflow of pathology laboratories, without the complexity of anticipating correct targets or the need to run iterative FISH studies in a stepwise process, and represents a clinically meaningful advance in lymphoma diagnostics."

"This largest study to date using our technology in lymphoma confirms what we have seen both in research settings and clinically with Aventa Lymphoma: when you look genome-wide, you consistently uncover clinically important rearrangements that targeted panels miss," said Anthony Schmitt, PhD, Senior Vice President, Science, at Arima Genomics. "With Aventa Lymphoma, we aim to give pathologists and oncologists a practical tool for more confident classification, more refined risk assessment, and better alignment of patients with evolving treatment options and clinical trials."

The data will be presented in a poster session on December 7, 2025, from 6:00 PM – 8:00 PM EST:

Abstract Number: abs25-9162
Title: Hi-c FFPE sequencing analysis is highly concordant with FISH and detects additional variants informing diagnosis and treatment in diffuse large B-cell lymphoma
Session Name: 621. Lymphomas: Translational – Molecular and Genetic: Poster I

(Press release, Arima Genomics, DEC 4, 2025, View Source [SID1234661148])

On December 4, 2025 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), reported that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollment in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck, and ovarian/gynecological cancers.

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IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. The IND clearance marks an important milestone for this licensed program, supporting subsequent clinical development of IDE034, while highlighting Biocytogen’s technical capabilities in bispecific ADC discovery and development.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen, said: "The IND clearance for IDE034 is an important milestone in the development of this first-in-class TOP1 ADC licensed project, representing a significant advancement for IDEAYA in expanding its clinical pipeline with bispecific, precision-targeted strategies. It also validates our RenLite platform and proprietary linker-payload technologies that enable the discovery and optimization of bispecific ADCs. We look forward to seeing IDE034 demonstrate clinical potential across multiple B7H3/PTK7 co-expressing solid tumors, offering new therapeutic options for patients."

Preclinical studies have shown that IDE034 monotherapy induces deep and durable tumor regressions in multiple B7H3/PTK7-positive tumor models, demonstrating strong anti-tumor activity. In addition, IDEAYA plans to explore combination strategies with its PARG inhibitor IDE161 to enhance the durability of response and intends to present additional preclinical data supporting the combination rationale at a major medical conference in H1 2026. B7H3 and PTK7 are co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46%, and 27%, respectively, indicating the broad clinical potential of IDE034.

Looking ahead, Biocytogen will continue to provide high-quality source antibodies through RenBiologics to support the clinical translation of licensed projects and actively explore additional early-stage assets for external licensing opportunities.

(Press release, Ideaya Biosciences, DEC 4, 2025, View Source [SID1234661147])

On December 4, 2025 OTR Therapeutics, a biotechnology company dedicated to transforming early-stage innovations into globally impactful therapies, emerged from stealth and 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.

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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 4, 2025, View Source [SID1234661146])

On December 4, 2025 AvenCell Therapeutics, Inc., a leading clinical-stage cell therapy company focused on advancing both switchable and allogeneic CAR-T cell therapies, reported that the FDA and the European Medicines Agency (EMA) have cleared the company’s IND and approved the Clinical Trial Application (CTA), respectively, for QUADvance (AVC-203-01), a Phase II/II trial of AVC-203 for the treatment of relapsed/refractory B-cell malignancies.

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AVC-203 is a CRISPR-engineered allogeneic CAR-T candidate designed to target and eliminate cells expressing receptors CD19 and/or CD20, which are known to be expressed in nearly all B-cell malignancies.

"We are excited to build on the early success and promising activity and safety of our ongoing clinical program of allogeneic CAR-T in AML (NCT05949125) by now advancing into B Cell Lymphoma with what we believe to be the most scientifically compelling allogeneic technology in the industry," said Andrew Schiermeier, AvenCell’s President & CEO. "To date, attempts at solving the key scalability and cost issues of autologous CAR-T therapy by engineering cells from unrelated donors have fallen short. Nevertheless, the obvious benefits of such an approach, including consistency and potency of an actual drug product – something in vivo approaches cannot provide – remain as compelling as ever. AvenCell remains focused on ensuring that any patient who can benefit from CAR-T therapy can receive it, through the massive scaling of supply and dramatic reductions in cost of goods, with a product that is as good or better than best-in-class autologous CAR-Ts."

About AVC-203

AVC-203 is a CRISPR-engineered allogeneic CAR-T therapy incorporating four key innovations:

Dual antigen targeting: AVC-203 CAR-T cells contain a receptor that simultaneously targets CD19 and CD20.

Immune evasion: CRISPR/Cas9 engineering enables donor cells to avoid both Graft-versus-Host Disease (GvHD) and rejection by the patient’s immune system.

Improved T-cell fitness and off-the-shelf availability: Allogeneic manufacturing from healthy donors leverages better T-cell fitness and eliminates patient-specific production, enabling immediate treatment

Switchable targeting: A RevCAR receptor dimerized to the CD19/CD20 CAR enables flexible targeting of additional tumor antigens through bi- or tri-specific bridging proteins, allowing future target expansion beyond CD19/CD20.
Trial Designs and Objectives

The phase I/II study will be conducted at multiple sites in the US and Europe and will evaluate the safety, tolerability, efficacy, and pharmacokinetics of AVC-203 in adults with relapsed or refractory B-cell malignancies. The phase Ia dose escalation study is expected to be followed by a phase Ib dose expansion study and a Phase II pivotal trial.

B-cell malignancies

B-cell malignancies — including non-Hodgkin lymphomas, multiple myeloma, and B-cell acute lymphoblastic leukemia (B-ALL) — account for the majority of blood cancers. Approximately 120,000 and 150,000 new cases are diagnosed annually in the United States and Europe, respectively.

(Press release, AvenCell Therapeutics, DEC 4, 2025, View Source;302632517.html [SID1234661145])

On December 4, 2025 PreciseDx, the leading innovator behind PreciseBreast, a novel AI digital pathology test, reported the upcoming presentation of three abstracts that further validate the test’s ability to assess risk of recurrence in early-stage breast cancer. Ongoing studies aim to demonstrate PreciseBreast’s ability to predict treatment benefit.

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Three abstracts will be presented during the annual San Antonio Breast Cancer Symposium (SABCS) taking place December 9-12, 2025, in San Antonio, TX. These presentations underscore the growing momentum and clinical success of PreciseBreast which utilizes our proprietary AI platform to combine AI-enabled image feature data with key clinical factors to deliver a PreciseBreastⓇ Score that accurately stratifies patients by recurrence risk.

SABCS-accepted abstracts presented by PreciseDx

PS113-13: Clinical validation of an Artificial Intelligence digital pathology-based prognostic test to predict risk of recurrence using biopsy specimens from patients with invasive breast cancer

Author/Presented by: Michael J. Donovan, PhD, MD
Poster Presentation: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM
PS4-12-28: A novel approach for phenotyping triple negative breast cancer using an Artificial Intelligence digital pathology-based prognostic test to assess recurrence risk and response to therapy

Author/Presented by: Nicholas Stanzione MD, David Geffen School of Medicine, UCLA
Poster Presentation: Thursday, December 11, 2025, 5:00 PM – 6:30 PM
SABCS-accepted abstract presented by Lankenau Medical Center/Main Line Health

PS3-06-02: Prospective Evaluation of "PreciseBreast" AI Tool in Early-Stage Invasive Breast Cancer Risk Stratification

Author/Presented by: Lankenau Medical Center, Main Line Health, Talar Telvizian, MD
Poster Presentation: Thursday, December 11, 2025, 12:30 PM – 2:00 PM
"These results build on our prior publications validating PreciseBreast’s clinical and analytical accuracy in early-stage invasive breast cancer by demonstrating the ability to use the patient’s biopsy specimen to risk stratify as well as advancing our understanding of patients with triple negative breast cancer," shared Eric Converse, CEO of PreciseDx. "We’re particularly excited about the independent, real-world experience at Lankenau Medical Center using PreciseBreast in patients with HR+, HER2- early breast cancer and continuing our collaboration with NSABP to further evaluate PreciseBreast’s ability to predict chemotherapy benefit in this population."

(Press release, PreciseDx, DEC 4, 2025, View Source [SID1234661144])