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Estrella Advances STARLIGHT-1 Trial into Phase II Following Positive DSMB Recommendation

On December 4, 2025 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported that an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I dose escalation portion of the STARLIGHT-1 trial. Based on the favorable safety profile observed, the DSMB recommended advancing the trial to Phase II, or the expansion phase, at the Recommended Phase II Dose (RP2D). The expansion phase will further evaluate the safety and preliminary efficacy of EB103, the Company’s CD19-redirected ARTEMIS T-cell therapy, in patients with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (NHL).

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In the Phase I dose escalation phase, no treatment-related serious adverse events (SAEs) were reported (n=9). Notably, the majority of patients treated are considered high-risk, including one with Central Nervous System (CNS) lymphoma. The high-dose cohort achieved a 100% complete response (CR) rate at Month 1 in all evaluable patients.

"The advancement of EB103 into the expansion phase of STARLIGHT-1 is a pivotal milestone for Estrella," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "The excellent safety profile and a 100% complete response rate observed in the high-dose cohort in Phase I demonstrated EB103’s potential to overcome the toxicity barriers that have historically restricted CD19 CAR-T use. We believe EB103 may significantly expand the commercial reach of cell therapy and deliver a best-in-class solution to a broader NHL population, including high-risk subgroups previously ineligible for commercial CAR-T."

The expansion phase is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the RP2D in subjects (≥ 18 years of age) who have R/R B-cell NHL. Data from this expansion cohort will be used to determine the pivotal trial strategy for EB103. Current active sites include UC Davis Comprehensive Cancer Center and Baylor Scott & White Research Institute. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Biopharma, DEC 4, 2025, View Source [SID1234661152])

Mission Bio’s Tapestri Single Cell Multi-Omics Platform for Exploratory Biomarker Analysis Supports Myeloproliferative Neoplasms (MPNs) Data Presentation at ASH 2025

On December 4, 2025 Mission Bio, Inc., a leader in single-cell multi-omic solutions for precision medicine, reported that its Tapestri Platform and custom assay development supported initial exploratory biomarker analysis data presented by Incyte at the ASH (Free ASH Whitepaper) 2025 conference in Orlando, Florida, in December. The data demonstrate Tapestri Platform’s ability to accelerate the understanding of Myeloproliferative Neoplasms (MPNs) disease biology at the single-cell level.

Myeloproliferative neoplasms (MPNs) are a type of blood cancer caused by genetic mutations in blood-forming stem cells. These mutations—found in the JAK2, TPO-R, or CALR genes—lead to uncontrolled growth of certain blood cells. INCA033989, an investigational monoclonal antibody, targets mutant calreticulin (CALR), a key driver in MPN pathogenesis.

The data presented at ASH (Free ASH Whitepaper) 2025 illustrate how the Tapestri’s single-cell data was leveraged to understand disease persistence and clonal expansion in MPNs. Subsequently, Tapestri’s single-cell DNA and protein profiling was applied to gain deeper insights into clonal evolution, disease progression, and treatment response in patients with MPNs.

The Tapestri Platform enables high-resolution detection of co-occurring mutations and cell surface protein expression, providing a more comprehensive picture of tumor heterogeneity and immune interactions in MPNs. By incorporating Mission Bio’s single-cell technology, Incyte was able to better characterize clonal diversity, track resistance mechanisms, and refine patient stratification strategies to help advance the development of precision therapies for MPNs.

"Our collaboration with Incyte highlights the role of single-cell multi-omics as an advanced clinical biomarker tool and the potential power of single-cell analysis in supporting targeted therapy development in the clinic," said Brian Kim, CEO at Mission Bio. "By unraveling the complexity of MPNs at the single-cell level, we can enhance complex biomarker analysis for targeted therapies in this space."

To learn more about Mission Bio, the Tapestri Platform, and Pharma Assay Development (PAD) services, please visit www.missionbio.com.

(Press release, Mission Bio, DEC 4, 2025, View Source [SID1234661151])

Orano Med Enters Next Phase of Collaboration with Roche

On December 4, 2025 Orano Med, a subsidiary of the Orano group specializing in nuclear medicine, reported that its long-standing collaboration with the multinational pharmaceutical company Roche (SIX: RO, ROG; OTCQX: RHHBY) is entering the next phase. Over the past years, the companies have conducted extensive preclinical research to develop a potential novel cancer treatment approach called "two-step pretargeted radioimmunotherapy" (or PRIT). This innovative technology, which pretargets the tumor with an antibody that is subsequently able to capture chelated lead-212 (212Pb) to target tumor cells, is now ready to advance into clinical development in humans. Orano Med will be responsible for the manufacturing of 212Pb, utilizing its industrial manufacturing platform in France and the US.

Nicolas Maes, Chief Executive Officer of the Orano group, commented: "We are very pleased about the progress made in collaboration with Roche for the development of a potential new treatment approach for cancer patients. After the licensing agreement signed with Sanofi last year for our most advanced clinical program, AlphaMedix, the achievement with this potential new drug candidate marks an important milestone that we accomplished jointly with another major player in the pharmaceutical industry. It illustrates our capacity to execute our long-term strategy, aimed at developing a solid pipeline of 212Pb-targeted alpha therapies to treat multiple oncology indications. In addition, thanks to the Orano Group’s expertise in the nuclear industry and its access to thorium-232, a scarce raw material required for producing 212Pb, Orano Med is also responsible for the entire production and distribution chain for these isotopes."

Julien Torgue, Chief Scientific Officer of Orano Med, commented: "The application of two-step pretargeted radioimmunotherapy represents a potentially game-changing advancement in radioligand therapies and cancer treatment more broadly. Instead of delivering radiation and targeting vector together, the novel technique separates the process into two precise steps: first, allowing time for antibodies to accumulate on the tumor, and then capturing the alpha particle emitting radioactive isotope lead-212, which allows for the precise targeting of cancer cells while sparing healthy tissue. In preclinical studies, we could already demonstrate both strong efficacy and, importantly, a reduction in off-target uptake in healthy tissues. If these results translate to the clinic, this could bring us a major step closer to a more effective and for patients also safer form of radioligand therapy. We are looking forward to further continue the development of this innovative approach with Roche."

Under the terms of the agreement, Orano Med and Roche have committed to develop this new therapeutic solution targeting a specific antigen known as carcinoembryonic (CEA), a cell surface glycoprotein overexpressed in several cancers. This antigen serves as a marker for various types of cancer, such as colorectal, pancreatic, and gastric cancers, as well as certain lung cancers. These are cancers for which the current therapeutic options are often limited or insufficient to meet patients’ needs. CEA shows restricted expression in normal tissues, making it a very suitable target for antibody-based therapies and radioimmunotherapy.

The Roche sponsored phase 1 clinical trial is expected to start in the first half of 2026, initiating the development of a broader platform dedicated to alpha radioimmunotherapies, underscoring Orano Med’s global leading position in the field of targeted alpha therapies.

About 212Pb two-step PRIT
Compared with conventional radioligand therapies (RLT), where the isotope and targeting moiety are co-delivered, pretargeted radioimmunotherapy (PRIT) uses a sequential approach. A tumor-targeting bispecific antibody (bsAb) is first administered, followed by a radioligand carrying the radioactive payload. The delay gives the bsAb the necessary time to accumulate on the tumor cells while unbound radioligand is rapidly cleared. It thus enables highly specific antibody targeting while remaining compatible with the relatively short half-life of 212Pb (10.6 hours). By introducing the cytotoxic radioligand only after the bsAb has largely cleared from circulation, radiation is concentrated in the tumor. This sequential approach is designed to minimize systemic radiation exposure, achieve high tumor-to-nontumor ratios, and thus improve safety and tolerability compared to other RLTs.

One of the main challenges of the PRIT approach has been to ensure fast excretion of the radioactive payload while maintaining high affinity for the slower-clearing pretargeting molecule. An intermediate step to clear or neutralize circulating pretargeting antibodies has often been employed to prevent off-tumor capture of the radioligand, but this adds complexity and safety risks, posing challenges to the clinical implementation of PRIT.

The new approach developed by Roche and Orano Med represents a novel two-step PRIT regimen for CEA-positive tumors that eliminates the need for an intermediate clearance step. This strategy combines a complementary bispecific antibody pair with the chelated ²¹²Pb, demonstrating both high efficacy and improved tolerability in preclinical studies compared with three-step PRIT.

Preclinical studies have confirmed proof of mechanism and therapeutic efficacy of the two-step PRIT, showing a favorable biodistribution with substantial uptake in CEA-positive tumors and rapid clearance of unbound 212Pb-DOTAM, with limited accumulation in kidneys and other organs. This confirms the excellent 212Pb tumor specificity and its high potential to significantly delay tumor growth.

(Press release, Orano Med, DEC 4, 2025, View Source [SID1234661150])

Arima Genomics Reports New Data at ASH 2025 Supporting More Complete Rearrangement Profiling in DLBCL With Hi-C Technology Used in Aventa Lymphoma

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.

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])

IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance

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.

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])