On January 28, 2026 QureBio Ltd., a clinical-stage biotech company focusing on development of bispecific antibodies and other engineered Biopharmaceuticals for the treatment of cancer, inflammation, and other serious disorders, reported in 2026 ASCO (Free ASCO Whitepaper) abstract submission about the Phase Ib/II Clinical Data of its Q-1802 program.

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The report（Abstract #537934）is titled "PhaseⅠ/Ⅱ Trial of Anti-CLDN18.2/PD-L1 Recombinant Humanized Bispecific Antibody Q-1802 Plus XELOX in Treatment-Naive CLDN18.2-Positive Advanced GC/GEJ"

The authors, Dr. Gong et al, reported the followings : the study enrolled 62 Eligible pts: CLDN18.2-positive (≥40% tumor cells with 2+/3+ membranous staining), HER2-negative, treatment-naïve, histologically confirmed unresectable locally advanced/metastatic GC/GEJ. Pts received Q-1802 (10 mg/kg or 20 mg/kg Q2W) plus standard XELOX.

In this study, no DLT observed; MTD not reached. Most common Q-1802-related ≥3 Grade TEAE: thrombocytopenia (8.1%), followed by neutropenia (6.5%), anemia, WBC decrease, hypokalemia (4.8% each). Rate of Q-1802 permanent discontinuation due to TEAEs: 6.5%; no treatment-related death.

In all 60 efficacy-evaluable pts, ORR, DCR and mPFS were 70.0% (42/60), 98.3% (59/60), and 11.3 months respectively. In the 10 mg/kg cohort, ORR and mPFS were 73.0% (27/37) and 11.3 months in pts with CLDN18.2 high expression; ORR and mPFS were improved to be 81.8% and 12.2 months when CLDN18.2 high expression accompanied with PD-L1 CPS≥5 (N=11).

The authors, Dr. Gong et al, concluded that Q-1802 plus XELOX has manageable safety and promising antitumor activity as first-line therapy for CLDN18.2-positive/HER2-negative advanced GC/GEJ, supporting a phase III trial with Q-1802 10 mg/kg as recommended dose.

Q-1802 phase III trial has recently been approved by Chinese CDE.

About Q-1802

Q-1802, a humanized Claudin18.2/PD-L1 bispecific antibody, kills tumors by both innate immunity such as antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP) as well as adaptive immunity involving DC and T cells. It is a powerful agent with good safety profile, offering a novel therapeutic opportunity to patients with Claudin18.2 positive solid tumors. Q-1802 exhibits high affinity and selectivity.

(Press release, QureBio, JAN 28, 2026, View Source [SID1234662336])

On January 28, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), a publicly traded biotechnology and precision intracellular drug-delivery company, reported the strengthening of its long-standing collaboration with Canadian Nuclear Laboratories ("CNL") as part of its strategic effort to accelerate and expand its proprietary radiopharmaceutical program.

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Defence has been collaborating with CNL on the development of an Accum-enhanced radio-immunoconjugate program. This program is now approaching a key inflection point, with critical results being generated by both lab teams on this program that are intended to support candidate selection and enable preparation for first-in-human clinical studies.

Based on the exciting traction on the lead program, Defence and CNL are expanding their collaboration to initiate multiple other radioisotopes programs with Defence’s proprietary Accum, positioning the Company to rapidly expand its radiopharmaceutical portfolio as new data and strategic priorities emerge.

Radiopharmaceutical therapies require precise intracellular and nuclear localization to maximize efficacy, as radioactive payloads must reach the vicinity of the cell nucleus to induce lethal DNA damage. Defence’s proprietary Accum platform enables active intracellular and nuclear transport, unlocking the full therapeutic potential of targeted radiotherapies while increasing potency and reducing toxicity.

"This collaboration with CNL has become a cornerstone of our radiopharmaceutical strategy," said Sébastien Plouffe, CEO of Defence Therapeutics. "Radiopharmaceuticals now represent one of our top development priorities alongside our ADC program. By deepening our work with CNL and leveraging their world-class nuclear science expertise, we are building a strong, proprietary pipeline in this space and accelerating our path toward the clinic."

"We have worked in close collaboration with Defence on their flagship program, delivering the technical results they require, and we are proud to contribute meaningfully to the advancement of their radiopharmaceutical pipeline," said Dr. Monica Regalbuto, Vice-President, Science & Technology at CNL. "We look forward to contributing our nuclear science expertise to help advance these programs toward the clinic."

This collaboration further strengthens Defence’s position in precision intracellular drug delivery and radiopharmaceutical development, supporting its strategy to transform advanced biologics into safer, more effective first-line cancer therapies.

(Press release, Defence Therapeutics, JAN 28, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-expands-collaboration-with-canadian-nuclear-laboratories-to-accelerate-its-proprietary-radiopharmaceutical-pipeline [SID1234662321])

On January 28, 2026 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported a study in Nature’s npj Breast Cancer journal titled, "Mechanisms of Resistance to Trastuzumab Deruxtecan in Breast Cancer Elucidated by Multiomic Molecular Profiling." Utilizing large-scale real-world clinico-genomic data and Caris’s comprehensive multiomic profiling, Caris scientists uncovered clinically relevant mechanisms of resistance to trastuzumab deruxtecan (T-DXd) in metastatic breast cancer. This study explains why patient responses vary and reveals how resistance can evolve over time.

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This study addresses a critical gap in understanding why responses to T–DXd, an antibody–drug conjugate approved by the FDA for HER2-positive and HER2-low metastatic breast cancer, vary widely since resistance to T–DXd is common. By combining large-scale, real-world clinical outcomes with Caris’s comprehensive molecular profiling, including whole exome sequencing (WES) and whole transcriptome sequencing (WTS), the study enables a population-level analysis of resistance pathways across DNA, RNA and protein expression.

"In this large real-world analysis, clinical outcomes allowed Caris to pinpoint molecular features linked to treatment-specific survival," said George W. Sledge, Jr., MD, Caris EVP and Chief Medical Officer. "Post–treatment molecular shifts further reveal biologically plausible routes to acquired resistance, underscoring that RNA–level and multiomic profiling can provide actionable insights beyond standard HER2 classification to better stratify patients and inform therapies."

The study analyzed 2,799 T–DXd–treated breast cancer patients and found that WTS identified ERBB2 (HER2) and ABCC1 as the strongest transcriptomic predictors of T–DXd–specific overall survival. Higher ERBB2 expression correlated with improved outcomes, while higher ABCC1 correlated with poorer outcomes, independent of HER2 category.

ABCC1 further stratified outcomes within HER2–defined subgroups, indicating predictive value beyond standard HER2 testing and post–treatment samples showed increased ABCC1 expression alongside enrichment of mutations in ERBB2, NFE2L2, KEAP1 and TOP1. Consistent with acquired resistance mechanisms. Preclinical models supported a functional, context–dependent role for ABCC1–mediated drug efflux in T–DXd resistance.

"This study demonstrates how population–scale, multiomic real–world data can drive high impact translational discoveries, reinforcing the value proposition for patients and equipping biopharma with actionable insights into resistance biology to guide next–generation drug development," said David Spetzler, MS, PhD, MBA, Caris President.

(Press release, Caris Life Sciences, JAN 28, 2026, View Source [SID1234662337])

On January 28, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug lirafugratinib as a second-line treatment option for cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement.

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CCA, also known as bile duct cancer, is rare, with about 8,000 people in the U.S. diagnosed each year, according to the American Cancer Society.

"This NDA reaffirms Elevar’s mission of bringing life-changing medicines to cancer patients worldwide, including for rare indications and for advanced stages where treatment options are limited," said Dong-Gun Kim, the company’s chief executive officer. "We are excited to work with the FDA as it reviews the submission while simultaneously preparing for a potential commercial launch. We could not be more appreciative of the patients who participated in lirafugratinib-focused clinical trials and everyone who brought us to this crucial point in its development."

The NDA is supported by positive clinical data from the phase 1/2 ReFocus trial (NCT04526106), in which lirafugratinib demonstrated clinically meaningful anti-tumor activity, measured by objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS), as well as manageable and tolerable safety in patients with advanced/metastatic CCA and other solid tumors with fibroblast growth factor receptor 2 (FGFR2) alterations.

The abstract "Efficacy and safety of lirafugratinib in FGFRi-naïve cholangiocarcinoma (CCA) patients harboring FGFR2 fusions/rearrangements (FGFR2 f/r)" was presented earlier this month at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers Symposium.

Independent review committee-assessed ORR was 46.5%, and median DOR was 11.8 months (mos) (95% CI, 7.5-13.0), where 76.2% of responses lasted >6 mos. Median PFS was 11.3 mos (95% CI, 9.2, 14.8), with 12-month rate of 49.2%. Median OS was 22.8 mos (95% CI, 18.1-27.2), with 12-month rate of 74.6%. The disease control rate was 96.5%. Most common Grade ≥3 treatment-related adverse events (TRAEs) were palmar-plantar erythrodysesthesia (32.8%) and stomatitis (12.1%). TRAEs led to dose reduction, dose interruption, and treatment discontinuation were observed in 75.9%, 82.8%, and 4.3%, respectively.

Elevar is also developing lirafugratinib for patients with other FGFR2-altered other solid tumors. The company acquired worldwide rights to develop and commercialize lirafugratinib in December 2024. Earlier that year, Relay Therapeutics met with the FDA to discuss data from the ReFocus trial and potential regulatory pathways. The FDA recommended the company first file an NDA for FGFR2-driven CCA, followed by a supplemental NDA for FGFR2-altered other solid tumors.

For more information about lirafugratinib, visit ElevarTX.com.

About Lirafugratinib Lirafugratinib (RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in vitro and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 f/r, who have not treated with prior FGFR inhibitors.

(Press release, Elevar Therapeutics, JAN 28, 2026, View Source [SID1234662322])

On January 28, 2026 WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), and Sinorda Biomedicine reported a strategic collaboration for the development and manufacturing of SND006, a novel bispecific antibody, for the potential treatment of inflammatory bowel disease (IBD) and other autoimmune diseases.

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Under the agreement, Sinorda Biomedicine will leverage WuXi Biologics’ extensive experience and manufacturing capabilities in biologics development and manufacturing to advance SND006’s preclinical pharmacology studies and clinical supply, accelerating the Investigational New Drug (IND) application process. SND006 is an innovative bispecific antibody independently developed by Sinorda Biomedicine, for which the company holds worldwide rights. Sinorda Biomedicine has completed in vitro functional validation studies of SND006 and plans to submit IND applications to both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) in 2026. In the future, the two companies will further expand their collaboration around Sinorda Biomedicine’s potential pipeline, including multiple integrated projects spanning from molecule discovery to clinical manufacturing.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "Over the past decade, we have accumulated experience across hundreds of projects in bispecific and multispecific antibodies, which have become one of our fastest‑growing areas. We are pleased to accelerate the development and manufacturing of Sinorda Biomedicine’s innovative bispecific antibody SND006 through our integrated technology platforms and comprehensive capabilities. Looking ahead, we will continue accelerating and transforming biologics discovery, development and manufacturing to empower global partners and make innovative biologics more accessible and affordable for patients worldwide."

Dr. Pingsheng Hu, Chairman and General Manager of Sinorda Biomedicine, commented, "SND006 is a potentially best-in-class innovative bispecific antibody discovered and developed by Sinorda Biomedicine, with the potential to deliver breakthroughs in the treatment of gastrointestinal and multiple autoimmune diseases. WuXi Biologics is a global leader in CRDMO services, offering truly end‑to‑end solutions underpinned by accumulated know-how, comprehensive technology platforms, and a strong track record—particularly in the development and manufacturing of bispecific antibodies. We believe this collaboration will accelerate the IND filings of our innovative biologics in China and worldwide, address unmet medical needs in autoimmune diseases, and ultimately bring safe and effective therapies to patients."

(Press release, WuXi Biologics, JAN 28, 2026, View Source [SID1234662338])