1stOncology™: Cancer Intelligence Service – Page 1153 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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])

Krystal Biotech Announces RMAT Designation Granted by FDA to KB707 for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

On February 9, 2026 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) reported that the United States Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to KB707, the Company’s redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment, for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC).

"The FDA’s decision to grant RMAT designation to KB707 reflects both the urgent unmet need for new NSCLC therapies as well as the promising early clinical evidence of efficacy we have observed with inhaled KB707 in patients with advanced NSCLC," said Suma Krishnan, President of Research and Development at Krystal Biotech. "This is the second RMAT designation granted to a Krystal program and, as such, we know first-hand the benefits that this designation can provide to accelerate development and shorten the path to a potential approval. We are excited to work closely with the FDA to maximize the potential impact of our KB707 program for patients with NSCLC."

The FDA’s RMAT designation is intended to support and expedite the development of regenerative medicine therapies, including gene therapies. An investigational regenerative medicine therapy is eligible for the RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and preliminary clinical evidence indicates potential to address unmet medical needs for that disease or condition. The designation provides all the benefits of the FDA’s Fast Track and Breakthrough Therapy designations, including potential for rolling review, intensive FDA guidance and interaction, and organizational commitment from senior managers at the FDA, as well as the ability to work more closely and frequently with the FDA to discuss innovative trial designs, surrogate or intermediate endpoints to support potential accelerated approval, and novel approaches to satisfy post-approval requirements.

Data to support the FDA’s RMAT designation included early clinical evidence from the Company’s ongoing KYANITE-1 study that demonstrated consistent and meaningful antitumor activity, including durable responses and clinically significant tumor reductions, in patients with heavily pre-treated advanced NSCLC receiving inhaled KB707. Enrollment in KYANITE-1 is ongoing, and further details will be presented at upcoming scientific conferences. Additional details about the study can be found at www.clinicaltrials.gov under NCT identifier NCT06228326.

(Press release, Krystal Biotech, FEB 9, 2026, View Source [SID1234662549])

Agenus to Present New Data at AACR-IO Exploring Systemic and Tumor Inflammation Biomarkers with BOT/BAL in Immunologically Cold Tumors

On February 9, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that new translational and clinical biomarker analyses from its botensilimab (BOT) immunotherapy program have been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)- Immuno-Oncology (AACR-IO) Conference, taking place in Los Angeles, CA on February 18–21, 2026.

The abstract, titled "Systemic and tumor-microenvironment inflammation shape outcomes in patients with immunologically cold, treatment-refractory tumors treated with Fc-enhanced anti–CTLA-4 botensilimab," evaluates how systemic inflammatory markers, tumor microenvironment (TME) immune activity, and peripheral immune cell states are associated with clinical outcomes in patients treated with BOT alone or in combination with balstilimab (BAL).

Botensilimab is an Fc-enhanced multifunctional anti-CTLA-4 antibody designed to help prime and activate the immune system, while BAL is an anti-PD-1 antibody designed to help sustain immune activity against cancer. Together, BOT+BAL targets complementary immune pathways and is being evaluated across multiple solid tumors, including immunologically "cold" or treatment-refractory cancers.

Presentation Details:

Poster Presentation Title: Systemic and tumor-microenvironment inflammation shape outcomes in patients with immunologically cold, treatment-refractory tumors treated with Fc-enhanced anti–CTLA-4 botensilimab
Presenting Author:

Chloe Delepine PhD, Biomarker Operations, Agenus

Session Date:

Thursday, February 19, 2026

Session Time:

12:15-3:15PM PT / 3:15-6:15 PM ET

Location:

JW Marriott, Platinum Ballroom

Poster Session:

Poster Session B

(Press release, Agenus, FEB 9, 2026, View Source [SID1234662548])