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Full Year and Q4 2025 results

On February 10, 2026 AstraZeneca reported full year and Q4 2025 results.

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(Press release, AstraZeneca, FEB 10, 2026, View Source [SID1234662554])

Estrella Immunopharma Presents Promising Updated Data on EB103 in Oral Presentation at the 2026 Tandem Meetings of ASTCT® & CIBMTR®

On February 9, 2026 Estrella Immunopharma, Inc. (Nasdaq: ESLA, ESLAW) ("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 positive STARLIGHT-1 Phase I results at the 2026 ASTCT & CIBMTR Tandem Meetings (American Society for Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research).

The oral presentation highlighted clinical data from the Company’s ongoing STARLIGHT-1 study evaluating EB103, a CD19-redirected ARTEMIS T-cell therapy, in patients with aggressive B-cell Non-Hodgkin Lymphoma (NHL). In the dose escalation portion of the STARLIGHT-1 trial, EB103 demonstrated a 100% Complete Response (CR) rate in the high-dose cohort at Month 1. Notably, all patients who achieved a CR have remained in CR through the data cutoff. The median Duration of Complete Response (DOCR) has not yet been reached, with response durations currently ranging from 3 to 18 months. Clinical highlights also include a complete responder with Primary Central Nervous System Lymphoma (PCNSL), a highly aggressive NHL subtype with an extremely poor prognosis of about 30% 5-year survival rate.

Most patients enrolled in this study are considered high-risk and were ineligible for existing commercial CD19 products. To date, the STARLIGHT-1 study (n=9) has reported no treatment-related serious adverse events (SAEs), reinforcing EB103’s potential as a safer, more accessible "best-in-class" therapy for broader patient populations.

"Being selected for an oral presentation at this year’s Tandem Meetings is a testament to the clinical potential of EB103," said Naseem Esteghamat, MD MS, Principal Investigator of the STARLIGHT-1 study at University of California, Davis. "What we’re seeing with EB103 is truly remarkable and very exciting for our patients. This is a heavily pre-treated population with many high-risk features, yet they had impressive response to EB103 with very manageable toxicity. The clinical findings give us tremendous confidence as we continue to advance this potentially transformative therapy."

"These data represent an important milestone for Estrella and underscore the potential of EB103 to address the significant unmet medical need in B-cell NHL," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "The unique design of ARTEMIS T cells aims to address the safety barriers and durability limitations of conventional CD19 CAR-T therapies, potentially opening the door for broader patient populations and long-lasting disease control."

A copy of the abstract presented at the 2026 Tandem Meetings is available at View Source

(Press release, Estrella Biopharma, FEB 9, 2026, View Source [SID1234662553])

NextPoint Therapeutics Announces Clinical Entry of NPX372, a First-in-Class B7-H7–Targeted T Cell Engager to Treat Solid Tumors

On February 9, 2026 NextPoint Therapeutics, a clinical-stage biotechnology company developing a new world of precision therapeutics through its leading scientific work on the novel B7-H7 axis, reported the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate clinical development of NPX372, a first-in-class T cell engager (TCE) for the treatment of patients with solid tumors.

B7-H7 is highly specific to tumor epithelial cells and largely absent from normal tissue, setting it apart as a much cleaner and more selective target for a T cell engager. NPX372 is an IgG-like bispecific T cell engager designed to drive target expression–proximal cytotoxicity while minimizing non-specific T cell activation. In preclinical studies, NPX372 demonstrated complete tumor regression in solid tumor models, while displaying great tolerability in relevant preclinical safety assessment and no evidence of cytokine release syndrome.

"T-cell engagers represent a novel approach to delivering sustained anti-tumor immune responses to cancer patients," said Leena Gandhi, MD, PhD, Chief Medical Officer of NextPoint Therapeutics. "This IND clearance enables us to accelerate the delivery of targeted immune therapy to broad patient populations in need, including patients with lung adenocarcinoma, renal cell carcinoma and pancreatic adenocarcinoma. Our clinical program deploys an efficient dose escalation algorithm and utilizes a novel biomarker assay to select patients with the highest chance of benefit from a B7-H7 targeting TCE."

"The NPX372 IND clearance represents the strategic initiation of our clinical use of B7-H7 as a highly specific tumor-targeting antigen for potent direct tumor killing therapeutics," said Ivan Cheung, Chief Executive Officer of NextPoint Therapeutics. "The ideal expression profile of B7-H7 and the meticulous construct design of NPX372, along with a clinical trial design that enables fast and impactful data readouts, position NPX372 as a frontrunner in the emerging T cell engager field for solid tumors."

(Press release, NextPoint Therapeutics, FEB 9, 2026, View Source [SID1234662552])

Iambic Announces Collaboration with Takeda to Advance AI-Driven Design of Small Molecules

On February 9, 2026 Iambic, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, reported a multi-year technology and discovery collaboration agreement with Takeda that will use Iambic’s industry leading AI drug discovery models to advance a select set of high-priority small molecule programs, initially in Takeda’s Oncology and Gastrointestinal and Inflammation therapeutic areas. Through the agreement, Takeda will also gain access to NeuralPLexer, Iambic’s industry leading model for predicting protein-ligand complexes.

"Our collaboration with Takeda is a powerful opportunity to apply our AI-driven discovery and development platform, and we are excited to partner with their team to quickly advance new and better drug candidates," said Tom Miller, PhD, Co-Founder and CEO of Iambic. "This collaboration further validates our industry-leading technology and highlights both the breadth of our discovery capabilities and the scale at which we can operate."

"We are excited to be able access Iambic’s proprietary computational platform while we work with their team to develop small molecule therapeutics with the potential to address critical unmet patient needs," said Chris Arendt, Ph.D., Chief Scientific Officer and Head of Research at Takeda. "At Takeda, our focus is on accelerating the development of impactful new medicines by leveraging cutting-edge science, including the latest advances in artificial intelligence. Iambic’s small molecule platform aligns with this ambition and offers the potential to de-risk candidate selection, improve probability of success, and more quickly advance select programs from early project start to IND."

Under the terms of the agreement, Iambic will receive upfront, research cost, and technology access payments and is eligible to receive success-based payments that could exceed $1.7 billion. The company is also eligible to receive royalties on net sales of any products generated from this collaboration.

The collaboration will utilize Iambic’s AI models as well as the company’s fully integrated, high-throughput, and automated wet lab capabilities. These core capabilities support a rapid Design-Make-Test-Analyze cycle that can accelerate program advancement.

(Press release, Iambic Therapeutics, FEB 9, 2026, View Source [SID1234662551])

Nuvation Bio Announces Pivotal Global Phase 3 SIGMA Trial (G203) for Safusidenib in IDH1-Mutant Glioma

On February 9, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported finalization of a protocol amendment to the ongoing global SIGMA study (also known as G203; NCT05303519) of safusidenib that expands it to a Phase 3 trial. SIGMA is evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with high-risk or high-grade IDH1-mutant astrocytoma following standard-of-care. Safusidenib is a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1.

The new protocol broadens patient eligibility in the registrational portion of the trial and includes those with grades 2 and 3 IDH1-mutant astrocytoma with high-risk features and grade 4 IDH1-mutant astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. The primary endpoint is progression-free survival as assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0. To support regulatory submissions for patients with astrocytoma, the protocol amendment significantly increases trial enrollment from 100 to 300 patients in the U.S., Australia and China.

The trial will now also enroll a non-pivotal single-arm cohort to examine the efficacy and safety of safusidenib in chemotherapy- and radiotherapy-naïve patients with grade 3 IDH1-mutant oligodendroglioma. The primary endpoint for this arm is objective response rate. This cohort is expected to enroll approximately 40 patients.

"These SIGMA protocol updates reflect alignment with U.S. regulators to support the potential approval of safusidenib as swiftly as possible for a patient population that is in dire need of options," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Following discussions with regulatory agencies, advocacy groups and physicians, we substantially expanded the study to include most patients with an IDH1-mutant glioma who currently have no approved targeted therapies available. We are encouraged by the promising results seen in the Phase 2 study, which included both astrocytoma and oligodendroglioma, and are eager to explore the potential of safusidenib across multiple settings through this registrational trial. We expect initial data for the separate oligodendroglioma cohort in 2027."

"Patients with IDH1-mutant gliomas face a lack of available therapies with proven ability to extend long-term survival while maintaining quality of life," said David Arons, President and Chief Executive Officer of the National Brain Tumor Society. "This is particularly true for patients with higher-risk or high-grade IDH1-mutant astrocytoma and oligodendroglioma, where available treatment options — including clinical trials specific to their tumor type — are historically few and far between. Including such patients in pivotal trials, we hope, could bring meaningful benefit for this area of high-unmet medical need."

About IDH1-Mutant Glioma

Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,400 people are diagnosed with IDH1-mutant gliomas each year. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high grade tumors.

About Safusidenib

Safusidenib is a novel, oral, potent, brain-penetrant, targeted inhibitor of mutant IDH1. In Phase 1 and 2 clinical studies, safusidenib was well-tolerated and demonstrated anti-tumor activity and high blood-brain barrier penetration.

(Press release, Nuvation Bio, FEB 9, 2026, View Source [SID1234662550])