On January 6, 2026 OncoNano Medicine, Inc. ("OncoNano") reported a research collaboration with Gilead Sciences, Inc. (Nasdaq: GILD) ("Gilead") to evaluate OncoNano’s ON-BOARD encapsulation technology with Gilead’s drug candidate.

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Under the terms of the agreement, OncoNano and Gilead will collaborate to evaluate the stability, selectivity and efficacy of Gilead’s drug candidate encapsulated by OncoNano’s ON-BOARD technology.

"Partnering with Gilead underscores the broad applicability of our ON-BOARD platform," said Kartik Krishnan, MD, PhD, CEO of OncoNano Medicine. "Our platform is designed to localize drug delivery into tumors with high spatial and temporal specificity. We believe it can complement Gilead’s oncology expertise to bring effective treatment options to patients."

Under the terms of the agreement, OncoNano will receive an upfront payment and is eligible to receive additional near-term preclinical milestones. OncoNano is also eligible to receive development, regulatory and commercial milestones, and royalties on net sales for the encapsulated asset. Gilead has the option to expand the collaboration by nominating an additional target for the ON-BOARD technology, in which case OncoNano would be eligible to receive up to an aggregate of $300 million, comprising the upfront payment and milestone payments, plus royalties.

(Press release, OncoNano Medicine, JAN 6, 2026, View Source [SID1234661788])

On January 6, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that China’s National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for AUGTYRO (repotrectinib) for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The approval is intended for patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options.

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"We are pleased with the NMPA’s approval of AUGTYRO for patients with NTRK-positive solid tumors. This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population," said Dr. Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "We believe this approval will help address the high unmet medical needs for patients across this treatment spectrum."

The NMPA’s decision is based on the results from the pivotal Phase 1/2 TRIDENT-1 study, which demonstrated robust and durable efficacy and a manageable safety profile of repotrectinib in patients with NTRK fusion-positive solid tumors. Zai Lab contributed to the global pivotal TRIDENT-1 study and dosed the first patient in Greater China in May 2021.

In May 2024, the NMPA approved AUGTYRO (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Zai Lab has an exclusive license agreement with Bristol Myers Squibb Co., following their acquisition of Turning Point Therapeutics, Inc., to develop and commercialize AUGTYRO in Greater China (mainland China, Hong Kong, Taiwan, and Macau, collectively).

About AUGTYRO

AUGTYRO (repotrectinib) is a next-generation tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers. Patients with solid tumors, including NSCLC, harboring ROS1 and NTRK gene fusions treated with approved targeted therapies often develop resistance mutations that limit binding of these drugs to their target. Ultimately, this leads to a shortened duration of response and tumor progression. Repotrectinib is the first next-generation ROS1 and NTRK TKI uniquely designed to improve durability of benefit, including in the brain, and to address acquired resistance.

In June 2024, AUGTYRO (repotrectinib) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

In May 2024, AUGTYRO was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. It was approved by the FDA for this indication in November 2023.

About NTRK-Positive Solid Tumors

NTRK-positive advanced solid tumors are life-threatening with poor prognoses and represent an area of significant unmet medical need in adult and pediatric patients. Existing targeted therapies have demonstrated clinical benefits but are limited by the duration of response due to the emergence of acquired resistance mutations.1 In China, the NMPA’s approval is the first to span both TRK TKI-naïve and TRK TKI-pretreated patients across solid tumors.

(Press release, Zai Laboratory, JAN 6, 2026, View Source [SID1234661787])

On January 6, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it will participate in and present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California, on Monday, January 12, 2026 at 9:45 AM PT. Robert W. Duggan, Chairman and Co-Chief Executive Officer, and Dr. Maky Zanganeh, President and Co-Chief Executive Officer, will present a corporate overview and a new update on the progress of our organization, including the development of our innovative investigational bispecific antibody, ivonescimab. Our leadership team will also participate in investor meetings during the conference.

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The presentation will be available live from our website: www.smmttx.com. An archived version of the presentation will be available on our website following the presentation.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, SITC (Free SITC Whitepaper), 2023) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with prior approved targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 3,000 patients have been treated with ivonescimab in clinical studies globally, and over 40,000 patients when considering those treated in a commercial setting in China as noted by Akeso.

Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second half of 2024, and top-line results were announced in May of 2025, with detailed results provided in September 2025.

HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression.

HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary tract cancer, colorectal cancer, breast cancer, pancreatic cancer, small cell lung cancer, and head and neck cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

(Press release, Summit Therapeutics, JAN 6, 2026, View Source [SID1234661786])

On January 6, 2026 BostonGene, the developer of the leading AI foundation model for tumor and immune biology, reported a strategic collaboration with AstraZeneca, a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, to advance oncology drug development using BostonGene’s multimodal AI platform.

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The collaboration leverages BostonGene’s foundation model for tumor and immune biology to deliver predictive insights on patient-level safety and efficacy outcomes in early clinical trials. AstraZeneca will apply BostonGene’s omnimodal analytics to accelerate development timelines and reducing risk across its oncology portfolio.

"BostonGene’s platform combines deep biological insights with advanced AI and this collaboration will empower us to predict which patients will benefit from treatment helping us design safer, more effective therapies from the start," said Jorge Reis-Filho, MD, PhD, Chief of AI for Science Innovation, Enterprise AI Unit, AstraZeneca. "At AstraZeneca, we are focused on leveraging the vast and unparalleled potential of AI to accelerate clinical development and the delivery of innovative medicines to patients."

The initiative marks another key milestone in the application of foundation models to real-world clinical development. BostonGene’s approach integrates pre-trained foundation models combined with advanced multi-modal data analytics, including cell-free RNA (cfRNA) and tumor microenvironment profiling, to predict response dynamics and tolerability across diverse patient populations, enabling more adaptive, biomarker-informed development.

"We’re honored to partner with AstraZeneca, a global leader in oncology innovation," said Andrew Feinberg, President and CEO at BostonGene. "This collaboration demonstrates the power of foundational biology and multi-modal molecular insights to reshape how we develop, de-risk, and deliver therapies to patients. It is a major step toward transforming drug development through AI."

BostonGene is actively deploying its foundation model alongside global biopharma partners to accelerate clinical programs across the oncology spectrum. By integrating these AI-driven insights into R&D pipelines, BostonGene is optimizing regulatory pathways and securing evidence for label expansion. This partnership with AstraZeneca underscores the transformative power of AI-powered profiling to transform oncology development at scale.

(Press release, BostonGene, JAN 6, 2026, View Source [SID1234661785])

On January 6, 2026 DEM BioPharma, Inc. (DEM Bio), a biopharmaceutical company dedicated to discovering novel targets for solid tumors and developing innovative, first-in-class, cancer medicines, reported that preclinical data for DEM301, a first-in-class bifunctional antibody drug conjugate (ADC), will be presented at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), taking place January 8-10, 2026, in San Francisco, CA.

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DEM301 targets a novel plasma membrane-associated glycoprotein protein, DEM-TXX, that is overexpressed in colorectal cancer and several other gastrointestinal malignancies. DEM-TXX plays roles in cell adhesion and myeloid cell suppression, and its expression is negatively correlated with disease progression, underscoring its potential significance in tumor biology.

"This ASCO (Free ASCO Whitepaper) GI presentation represents an important milestone for DEM BioPharma as we introduce DEM301 and its underlying biology to the oncology community for the first time," said Nenad Grmusa, CEO of DEM Bio. "DEM-TXX emerged from our scientific founders’ functional genomics screen and validated by DEM BioPharma as a target that appears to contribute to immune suppression in GI cancers. DEM301 was purpose-built to translate that biology into a differentiated ADC designed with a dual mechanism of action to directly kill tumor cells while engaging immune-mediated mechanisms."

DEM301 is a first-in-class bifunctional antibody drug conjugate composed of an afucosylated monoclonal antibody directed against DEM-TXX and conjugated to a clinically validated linker-payload. The molecule is designed to selectively target tumor cells expressing DEM-TXX while leveraging both direct cytotoxic delivery and immune-mediated mechanisms of action.

The preclinical data to be presented at ASCO (Free ASCO Whitepaper) GI will highlight potent and durable single-agent anti-tumor efficacy in preclinical models of colorectal and other GI tumors and a favorable safety profile in a humanized DEM-TXX mouse model, supporting advancement toward clinical development. DEM Bio is currently advancing DEM301 through preclinical pharmacology and toxicology studies and has initiated CMC process development and manufacturing development in preparation for a planned Phase 1a/1b clinical trial expected to begin in the second half of 2026.

ASCO GI Poster Presentation Details

Title: DEM301, a novel anti-DEM-TXX antibody-drug conjugate with potent anti-tumor activity for the treatment of gastrointestinal tumors
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Abstract Number: 159; available on the ASCO (Free ASCO Whitepaper) GI website
Date & Time: January 10, 2026, 7:00 – 7:55 AM PST
Presenter: Sarah Carden, PhD, DEM BioPharma

(Press release, DEM BioPharma, JAN 6, 2026, View Source [SID1234661784])