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Daiichi Sankyo and GENESIS Pharma Enter Exclusive Agreement for VANFLYTA® Commercialization in Central and Eastern Europe

On January 7, 2026 Daiichi Sankyo (TSE: 4568) and GENESIS Pharma reported to have entered into an exclusive license and supply agreement for the distribution and commercialization of VANFLYTA (quizartinib) in 13 markets across Central and Eastern Europe for the treatment of adult patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML).

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Under the terms of the agreement, Daiichi Sankyo will be responsible for the manufacturing and supply of VANFLYTA while GENESIS Pharma will lead medical affairs, market access and commercialization efforts in Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia. Financial terms of the agreement are not being disclosed.

VANFLYTA was approved in the EU in November 2023 for the treatment of adult patients with newly diagnosed FLT3-ITD positive AML in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation, based on the results from the QuANTUM-First trial.

"This agreement with GENESIS Pharma represents an important step in our ambition to expand access to our innovative targeted medicine across Central and Eastern Europe," said Markus Kosch, MD, Head, Oncology Business Division Europe and Canada, Daiichi Sankyo. "By combining our scientific expertise with the strong regional footprint of GENESIS Pharma, we aim to accelerate access to VANFLYTA for patients with newly-diagnosed FLT3-ITD positive AML and ultimately help improve outcomes in this high-risk population."

"This new strategic collaboration marks another significant milestone for our company, reinforcing our long-standing expertise and focus on advancing medicines for difficult-to-treat cancers," said Constantinos Evripides, Managing Director, GENESIS Pharma. "Daiichi Sankyo has entrusted us with a broad territory across Central and Eastern Europe and we look forward to working together to accelerate access to VANFLYTA across the region."

About FLT3-ITD Positive Acute Myeloid Leukemia

Almost 487,300 new cases of leukemia were reported globally in 2022, with more than 305,400 deaths.1 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.2,3 In Europe, approximately 18,000 people are diagnosed with AML each year and the five-year survival rate is reported at 17% for adult patients.4,5 A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common.6 Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.7,8 FLT3-ITD mutations occur in about 25-30% of all adult patients suffering from AML.7,8

About VANFLYTA

VANFLYTA is an oral, highly potent and selective type II FLT3 inhibitor approved in more than 30 countries/regions in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive based on the results from the QuANTUM-First trial. In the U.S., VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.

In Japan, VANFLYTA is also approved for the treatment of patients with relapsed/refractory AML that is FLT3-ITD mutation positive, as detected by an approved test, based on results from the QuANTUM-R trial.

(Press release, Daiichi Sankyo, JAN 7, 2026, https://www.businesswire.com/news/home/20260106502657/en/Daiichi-Sankyo-and-GENESIS-Pharma-Enter-Exclusive-Agreement-for-VANFLYTA-Commercialization-in-Central-and-Eastern-Europe [SID1234661779])

First Patients Enrolled in Groundbreaking Brain Cancer Study at Nationally Recognized Academic Medical Center

On January 6, 2026 Exvade Bioscience, a clinical-stage neuro-oncology company advancing a breakthrough platform for treating aggressive brain cancers, reported ongoing enrollment in a Phase 1 clinical trial (NCT04547777) at the Preston Robert Tisch Brain Tumor Center at Duke University. Early results indicate a favorable safety profile for Exvade’s Tumor Monorail, an FDA Breakthrough Device designed to provide physicians with safe, real-time access to brain tumors and their evolving microenvironment throughout treatment.

The trial marks the first-ever use of a bio-inspired implant designed to guide invasive brain-tumor cells away from critical brain regions toward a designated ‘safe zone’, outside of the brain, while also enabling repeated, minimally invasive sampling of live tumor tissue – once thought unattainable in glioblastoma (GBM), which is one of the most aggressive and treatment-resistant brain cancers. By enabling longitudinal access to tumor biology without repeat surgeries, Exvade aims to address a fundamental barrier to effective GBM treatment: the inability to dynamically assess tumor response to therapy over time.

The Phase 1 study is enrolling adults with recurrent glioblastoma (GBM) who have undergone prior standard therapy to evaluate a novel dual approach that combines two investigational immunotherapies (D2C7-IT and 2141-V11) with advanced tumor monitoring using Exvade’s Tumor Monorail. The surgically implanted catheter system is placed at the tumor site and remains in place throughout treatment, enabling continuous monitoring of tumor evolution and response to treatment. The trial includes two key components: one focused on evaluating the safety and feasibility of the Tumor Monorail for monitoring tumor during treatment in adult patients with recurrent glioblastoma, and the other – testing a combination therapy that delivers two experimental drugs, D2C7-IT in combination with an Fc engineered Anti-CD40 Monoclonal Antibody, directly into the tumor and surrounding tissue to target cancer cells more precisely.

D2C7-IT is an investigational immunotoxin designed to target and bind to both wild-type EGFR and EGFRvIII, two proteins frequently overexpressed in glioblastoma cells. This targeted therapy is intended to destroy tumor cells while minimizing damage to healthy brain tissue. D2C7-IT is administered in combination with 2141-V11, a fully-human anti-CD40 agonist antibody, which potentiate the immune response from the tumor breakdown initiated by D2C7-IT.

In this study, the Tumor Monorail is first inserted in proximity to the tumor recurrence, after which, D2C7-IT and 2141-V11 are administered directly into the intracerebral tumor using convection-enhanced delivery (CED)—a method that bypasses the blood-brain barrier to allow high concentrations of drug to reach tumor-infiltrated regions, after which, patients undergo repeated dosing of 2141-V11 subcutaneously in the upper neck area (cervical perilymphatic area). The initial intracerebral administration of D2C7-IT and 2141-V11 is intended to initiate a tumor breakdown and immune activation, while the repeated dosing of 2141-V11 in the cervical perilymphatic area aims to maintain a strong immune response. The Tumor Monorail is accessed by subcutaneous needle aspiration at each dosing of the 2141-V11 in the cervical perilymphatic area, allowing real time evaluation of the tumor status.

"By allowing real-time monitoring of the tumor over time, while on therapy, we will hopefully be able to more swiftly identify the degree of efficacy or the limitations of our therapies, while preventing the trauma and costs of repeated brain surgery," said Dr. Annick Desjardins, MD, FRCPC, neuro-oncologist, professor of neurosurgery and neurology at Duke University and the study’s principal investigator.

"Serial tumor sampling remains one of the most critical unmet needs – and what many consider the holy grail – in glioblastoma therapeutic development and clinical advancement" said Nassir Mokarram, co-inventor of Tumor Monorail and co-founder of Exvade Bioscience. "Many clinical trials today struggle to confirm whether therapies are effectively reaching the tumor, producing meaningful biological effects, or overcoming emerging resistance. We believe effective treatments for many glioblastoma patients may already exist – but progress has been constrained by the lack of timely, accurate, and actionable insight into the tumor and its microenvironment. Tumor Monorail has the potential to dramatically accelerate the pace at which new treatments are validated, optimized and personalized for patients."

Eligibility Criteria Include:

Adults aged 18 or older with histologically confirmed recurrent glioblastoma
Tumor recurrence after prior standard therapy (surgery, radiation, chemotherapy)
This study represents a paradigm-shifting step toward more personalized and precise treatment of brain tumors.

To learn more about the study and eligibility, visit the official clinical trial listing: View Source

About Glioblastoma
Glioblastoma is the most common and devastating primary malignant brain tumor in adults. With an incidence of approximately 3.2 per 100,000 population in the USA, approximately 12,300 people are diagnosed with a glioblastoma yearly. Standard of care for the treatment of glioblastoma is typically ‘maximal safe’ surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy with or without the Optune device. There is currently, no standard of care treatment at the time of tumor recurrence, which leads to a median survival from initial diagnosis of less than 21 months.

(Press release, Exvade Bioscience, JAN 6, 2026, View Source [SID1234661791])

Iksuda to Present Preliminary Analysis of Oesophageal Cancer Data From Phase 1 study of IKS014 at ASCO Gastrointestinal Cancer Symposium

On January 6, 2026 Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), reported the presentation of early analyses of activity in patients with oesophageal cancer during its Phase 1 study of IKS014, a human epidermal growth factor receptor 2 (HER2)-directed ADC, in patients with advanced HER2+ solid tumours, at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in San Francisco, US (8-10 January).

The Phase 1 study (NCT05872295) is a non-randomised, open-label, multicentre trial evaluating IKS014 in patients with locally advanced or metastatic solid tumours that express HER2. Data was presented from an unplanned sub-population of patients with oesophageal cancers from the dose escalation portion of the trial conducted in Australia, which was designed to establish the maximum-tolerated dose and/or recommended phase 2 dose for IKS014 as monotherapy and to provide initial safety, tolerability, efficacy, PK, PD, and immunogenicity data.

As of July 2025, 62 patients have been treated with IKS014 across five dose levels (40, 60, 90, 120 and 105 mg/m2), including 10 patients with HER2+ oesophageal cancers. Encouraging anti-tumour activity was seen across all dose levels in patients with a variety of tumour indications such as breast, ovarian, gallbladder, lung and oesophageal cancers, and in patients with HER2+ and HER2 low tumours.

Of the sub-set of 10 patients with HER2+ oesophageal cancer, who had received prior therapy (median 3, range 1-6), five achieved a response, including a complete response in one patient with non-measurable disease, whilst three other patients demonstrated stable disease for more than six months, resulting in a clinical benefit rate for IKS014 of 80%. These positive results warrant further exploration, and the dose expansion part of this Phase 1 study will now include an additional expansion cohort specifically for patients with HER2-expressing oesophageal adenocarcinoma who have previously received at least one prior line of standard treatment that may have included a HER2-directed therapy.

Dr. Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, commented: "The early signs of activity and clinical benefit rate in patients with pretreated advanced oesophageal cancer is extremely encouraging. This is a notoriously difficult cancer to treat, with relatively poor survival rates and high treatment toxicity. We look forward to continuing to explore the potential of IKS014 to improve clinical outcomes in this hard-to-treat cancer, as well as across several other HER2-expressing cancers."

Poster Presentation details:

Abstract Title:

Early analysis of activity in esophageal cancer during phase 1 dose escalation of IKS014, a HER2-targeting antibody drug conjugate (ADC), in participants with advanced HER2+ and HER2 low solid tumors

Session Title:

Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers

Date/Time:

8 January 2026, 11:30-13:30 PST

Location:

Level 1, West Hall

Abstract Number:

355

About IKS014

IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with a favourable Therapeutic Index compared with other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LigaChem Biosciences (View Source).

(Press release, Iksuda Therapeutics, JAN 6, 2026, View Source [SID1234661790])

OncoNano Medicine Announces Research Collaboration with Gilead to Apply ON-BOARD™ Delivery Technology to Gilead’s Drug Candidate

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.

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])

Zai Lab Announces National Medical Products Administration (NMPA) Approval of AUGTYRO™ (repotrectinib) for Patients with NTRK-Positive Solid Tumors

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.

"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])