On January 12, 2026 ConcertAI, a leading oncology real-world evidence data and AI SaaS technology company, and Foundation Medicine, a global, patient-focused precision medicine company, reported a collaboration to combine their data assets for life sciences research. The collaboration brings Foundation Medicine’s expansive de-identified multimodal dataset derived from its genomic testing portfolio together with ConcertAI’s high-quality clinical data, to support more efficient drug development and real-world evidence research. With the addition of Foundation Medicine’s data, ConcertAI now offers the largest and most comprehensive clinically-linked dataset with nearly half a million patients.

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The collaboration comes as oncology drug programs face rising trial complexity and tighter budgets, which puts more weight on high-quality data that can guide early decisions. Pairing Foundation Medicine and ConcertAI’s data captures the full journey of cancer patients from pre-diagnosis through treatment and outcomes, allowing life science researchers and biopharmaceutical developers to reduce guesswork in early research, tighten trial plans, and bring new therapies to patients faster, while ensuring the rigor of their research.

"Drug developers are increasingly pushed to accelerate their research pipelines but require more robust insights into both early genomic signals and patient outcomes to make this a reality," said Eron Kelly, CEO of ConcertAI. "By combining the largest and deepest set of clinical data with genomic insights, including whole slide imaging, we can help teams set a clearer plan and speed up their projects. Our collaboration with Foundation Medicine complements our full suite of partnerships aimed at advancing the development of vital therapies."

Foundation Medicine has U.S Food and Drug Administration-approved companion diagnostic indications for all four major classes of genomic alterations and for multiple genomic signatures. Detection of these major classes of alterations provide partners with a comprehensive view of their cohort’s genomic landscape, including difficult-to-detect alterations, such as MTAP loss, that are not detected well by all next-generation sequencing tests.1

In addition to genomic data, the combined dataset includes gene expression data, immunohistochemistry (IHC) results, and whole-slide images, alongside one of the most diverse clinical datasets from ConcertAI, whether measured by socioeconomic diversity, ethnic diversity, or rural vs. urban communities. By connecting these views, researchers can better study how cancers act in real life and how patients respond to treatments over time.

"By integrating our high-quality genomic data with ConcertAl’s electronic health data, we have created one of the most powerful new real-world data sets that enables insights to be turned into strategic decisions at critical milestones for our partners," said Dan Malarek, CEO of Foundation Medicine. "AI is the future and through our Al-driven analytical capabilities via FoundationInsights, our biopharmaceutical and research partners can access the right data when they need it and uncover answers faster. This accelerates development and helps patients benefit sooner from advances in precision medicine."

(Press release, Foundation Medicine, JAN 12, 2026, View Source [SID1234662000])

On January 12, 2026 Eureka Therapeutics, Inc., a clinical-stage biotechnology company advancing next-generation T-cell therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ECT204, a GPC3-targeting ARTEMIS CAR T-cell therapy, for the treatment of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer.

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The RMAT designation followed the FDA’s review of data from the completed Phase I cohort, together with additional clinical data, from Eureka’s ongoing Phase I/II ARYA-3 trial evaluating ECT204, an autologous ARTEMIS CAR T-cell therapy based on the AbTCR (Antibody-T Cell Receptor) architecture, in adult patients with GPC3-positive advanced HCC. RMAT designation, granted based on preliminary clinical evidence of potential to address unmet medical needs, provides the benefits of Breakthrough Therapy designation for regenerative medicines, including enhanced FDA interaction, alignment on development and manufacturing strategy, discussion of surrogate or intermediate clinical endpoints that may support accelerated approval, and eligibility for priority review of a future biologics license application (BLA).

"This represents an important inflection point for Eureka and for cell therapy in solid tumors," said Dr. Cheng Liu, Founder and Chief Executive Officer of Eureka Therapeutics. "ARTEMIS was designed to overcome the limitations of conventional CAR T-cell therapies in solid tumors, and early clinical observations with ECT204 in liver cancer reinforce our belief that the ARTEMIS architecture can meaningfully expand the therapeutic reach of cell therapy."

HCC is among the most biologically resistant solid tumors in oncology, characterized by an immunosuppressive tumor microenvironment that has posed significant challenges to the effectiveness of cell-based therapies. Unlike conventional CAR T cells that rely on a synthetically fused CD3-zeta (ζ) signaling domain linked to co-stimulatory molecules, which may contribute to constitutive activation and limited persistence in solid tumors, ARTEMIS CAR T cells were engineered using the AbTCR architecture and incorporate dual receptors that leverage human gamma delta (γ/δ) T cell receptor (TCR) signaling with co-stimulation delivered through separate receptors. This more natural TCR signaling design combines the precision of antibody-redirected tumor targeting with balanced and sustained T-cell activation, which may explain the improved tumor infiltration, persistence, and functional activity of the engineered T cells in hostile solid tumor environments.

The advantages of ARTEMIS CAR T cells over conventional CAR T cells have been validated by independent research conducted in collaboration with the National Cancer Institute, including NCI-led, peer-reviewed studies published in Cell Reports Medicine. In preclinical solid tumor models, ARTEMIS CAR T cells demonstrated significantly greater tumor infiltration and anti-tumor activity than conventional CAR T cells using the same antigen-binding domain, including in low antigen density settings that typically limit conventional CAR T efficacy.

ECT204 previously received FDA Orphan Drug Designation (ODD) in January 2022, reflecting the significant unmet need in advanced HCC. With RMAT designation in place, Eureka will work closely with the FDA to advance ECT204 through the ongoing ARYA-3 trial while continuing to build on the broader applicability of the ARTEMIS platform across different cancer indications.

About ECT204

ECT204 is an autologous T-cell therapy engineered with Eureka’s proprietary ARTEMIS CAR platform. Unlike conventional CAR T cells, ARTEMIS T cells are designed to mimic the natural biological regulation of T-cell activation, potentially improving safety, tumor infiltration, and persistence in solid tumors. ECT204 targets GPC3 (Glypican-3), an oncofetal antigen found on more than 70% of HCC cells but rarely on healthy tissues. The GPC3 protein is also expressed in other solid tumors, including ovarian and lung cancer. ECT204 is currently being investigated in Eureka’s ongoing ARYA-3 study, an open-label, dose escalation, multi-center Phase I/II clinical trial in adult patients with GPC3-positive HCC.

(Press release, Eureka Therapeutics, JAN 12, 2026, View Source [SID1234661999])

On January 12, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR) reported key program updates, including new positive data from the ongoing SOLSTICE Phase 2 trial in chronic hepatitis delta (CHD). Participants receiving the combination therapy of tobevibart, an investigational neutralizing monoclonal antibody (mAb), and elebsiran, an investigational small interfering RNA (siRNA), showed increased and sustained viral suppression of HDV RNA versus treatment with the antibody alone in participants who have reached Week 96 of treatment.

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The Company also announced that safety and efficacy data from the Phase 1 trial of VIR-5500, its PSMA-targeted PRO-XTEN dual-masked T-cell engager (TCE) being evaluated in prostate cancer, will be shared in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February.

"We are poised for a year of significant clinical progress where we will report initial topline data from our Phase 3 program in CHD, present substantive Phase 1 safety and efficacy data from our PSMA-targeted VIR-5500 TCE program and continue to advance our broader portfolio of PRO-XTEN masked TCEs through dose escalation," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. "The latest data from our SOLSTICE Phase 2 trial evaluating tobevibart and elebsiran combination therapy in CHD are very promising, showing that monthly treatment with this combination therapy has the potential to achieve an undetectable viral load in a large number of patients, which could redefine the standard of care in CHD."

Vir Biotechnology will present at the 44ᵗʰ Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 3:45 p.m. PT. The webcast and presentation will be accessible from the Company’s website under Events & Presentations.

Recent Updates and 2026 Clinical Milestones

Tobevibart and elebsiran combination therapy for CHD

Data from the Phase 2 SOLSTICE trial to be presented at the 44ᵗʰ Annual J.P. Morgan Healthcare Conference demonstrate that undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) was achieved and maintained by 77% (24/31) of participants receiving the combination of tobevibart and elebsiran at Week 72, and this rate increased to 88% (21/24) in the subset of participants evaluated through Week 96. By contrast, HDV RNA TND was achieved by 53% (17/32) of participants receiving tobevibart antibody monotherapy at Week 72 and 46% (11/24) in the subset of participants evaluated through Week 96. There were no grade 3 or higher treatment-related adverse events in the combination arm, and treatment emergent adverse events were generally mild to moderate and transient. Complete results at Week 96 will be presented at a future medical meeting. Previous positive Phase 2 SOLSTICE data at Week 48 were published in the New England Journal of Medicine.2

The registrational ECLIPSE program in CHD is ongoing, with ECLIPSE 1 and ECLIPSE 3 fully enrolled. Topline data from the ECLIPSE 1 trial is expected in the fourth quarter of 2026. Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.

Last month, Vir Biotechnology granted Norgine Pharma UK Limited, an affiliate of Norgine, an exclusive license for the commercial rights to the combination of tobevibart and elebsiran for the treatment of CHD in Europe, Australia and New Zealand. Vir Biotechnology has retained all commercialization rights for tobevibart and elebsiran in the United States and other markets outside of the Greater China Territory.3

PRO-XTEN dual-masked TCE immunotherapy portfolio

PSMA-targeted PRO-XTEN dual-masked TCE VIR-5500 is currently being evaluated as monotherapy and in combination with androgen receptor pathway inhibitors (ARPIs) for the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC). Vir Biotechnology will share updated Phase 1 data at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February. The Company previously shared preliminary data from the ongoing trial in January 2025 and will provide an update that includes safety and efficacy data of VIR-5500 monotherapy in the later-line mCRPC patients, including RECIST and PSA responses, durability and dose-response relationship.

Vir Biotechnology is also currently enrolling patients in its Phase 1 dose escalation trials for VIR-5818 in HER2-expressing solid tumors and VIR-5525 in EGFR-expressing solid tumors. Phase 1 dose escalation response data for VIR-5818 are expected in the second half of 2026.

Additionally, the Company is currently progressing a number of PRO-XTEN masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors, including lung, colorectal and bladder. All candidates have been discovered and optimized by leveraging Vir Biotechnology’s antibody and TCE discovery and engineering platform, which includes dAIsY (data AI structure and antibodY), a proprietary artificial intelligence engine, and the universal PRO-XTEN masking technology.

2025 ending cash position (unaudited) and runway projection

Cash, cash equivalents and investments were approximately $781 million as of December 31, 2025.1 As a result of the anticipated net cash benefits from the Norgine licensing agreement, and through continued financial discipline, the Company expects cash, cash equivalents and investments to fund operations into the fourth quarter of 2027.

About the ECLIPSE Registrational Program

ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a Phase 2b head-to-head trial evaluating combination tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets.

About Tobevibart and Elebsiran

Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

About Chronic Hepatitis Delta (CHD)

CHD is the most severe form of chronic viral hepatitis4 and was recently classified as carcinogenic by the International Agency for Research on Cancer.5 People living with the disease rapidly progress to cirrhosis, liver failure6 and liver-related death.4 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally.

About VIR-5500, VIR-5818, VIR-5525

VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO-XTEN masking technology and target PSMA, HER2 and EGFR, respectively.

TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The universal PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.

(Press release, Vir Biotechnology, JAN 12, 2026, View Source [SID1234661998])

On January 12, 2026 Kivu Bioscience, a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) for difficult-to-treat cancers, reported that the first patient has been dosed in its Phase 1 clinical trial of KIVU-107, a next-generation PTK7-targeting ADC for patients with advanced solid tumors.

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"Dosing the first patient with KIVU-107 marks an important milestone for Kivu and for patients with advanced solid tumors who urgently need better treatment options," said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. "Advancing KIVU-107 from preclinical development to first-in-human dosing in under 12 months underscores the efficiency of our platform and our commitment to developing a new generation of ADCs designed to expand the therapeutic window and deliver meaningful benefit to patients."

The first-in-human Phase 1 study (NCT07229313) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KIVU-107 in patients with advanced solid malignancies. KIVU-107 is built using GlycoConnect and HydraSpace site-specific conjugation technologies, enabling precise and stable drug-to-antibody ratios and optimized pharmacokinetics to improve the therapeutic window. KIVU-107 is designed to deliver potent, targeted cytotoxic activity in PTK7-expressing tumors while improving safety and tolerability compared to earlier-generation ADCs. The study has received regulatory approval in the United States and Australia.

(Press release, Kivu Bioscience, JAN 12, 2026, View Source [SID1234661997])

On January 12, 2026 Tempus, a leader in artificial intelligence and precision medicine, and NYU Langone Health, one of the nation’s premier academic medical centers, reported a multi-year strategic collaboration aimed at transforming cancer care through advanced molecular profiling and data-driven insights. The collaboration will support NYU Langone Health’s Center for Molecular Oncology at the Laura and Isaac Perlmutter Cancer Center, a comprehensive, pan-cancer initiative to more deeply understand disease biology over time.

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The research seeks to enhance genomic diagnostics to improve patient outcomes, inform future clinical practice, and accelerate the development and validation of novel assays and algorithmic diagnostics. As part of this work, the two organizations are launching a prospective observational study titled, "Serial Molecular Profiling and Monitoring of Human Cancer," in which patients enrolled in the study will be sequenced throughout their treatment journey in an effort to collect the longitudinal data critical to this research. The collaboration, which evolved independently from Tempus’ relationship as a trusted provider of NGS testing services, also includes a series of subsequent studies focused on assay validation, biomarker discovery, biological modeling, real-world data analysis, and the development of AI-powered predictive algorithms.

"Through the integration of advanced genomic technologies and data science, we are deepening our understanding of cancer’s complexity and pioneering transformative approaches for patient monitoring and treatment," said Ezra Cohen, MD, Chief Medical Officer, Oncology at Tempus. "Our research is focused on generating actionable insights through better understanding of cancer response, resistance, and trajectory that will not only refine and enhance current assays, but also drive the creation of innovative diagnostic tools and algorithms that can empower clinicians to deliver truly individualized care to their patients."

"This strategic collaboration will further our ability to analyze cutting-edge serial molecular profiling technology in the routine care of patients at the Perlmutter Cancer Center at NYU Langone Health," said Shridar Ganesan, MD, PhD, Director of the Center for Molecular Oncology at Perlmutter Cancer Center. "This approach will enable us to better understand the biology of individual cancers, inform our ability to implement and develop targeted therapies, and assess response and emerging resistance."

(Press release, Tempus, JAN 12, 2026, View Source [SID1234661996])