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.

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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])

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).

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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])

On February 9, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported an update on patient outcomes observed in its ongoing Phase 1 ovarian cancer CAR-T clinical trial, following regulatory approval of a protocol amendment that enables substantial dose escalation.

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The ongoing Phase 1 trial is enrolling adult women with recurrent ovarian cancer, who have failed standard of care chemotherapy, and progressed after two or more prior therapies. To date, twelve patients have been treated in the trial at four dosage levels. Of these patients, seven have lived beyond their expected median survival of approximately three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment (17, 15 and 14 months, respectively) and three patients have survived 11, 8 and 8 months, respectively. Three patients that have reached 15, 14 and 8 months remain alive, and one additional patient who was treated more recently, is also currently alive.

While the study is designed to primarily demonstrate safety, Anixa believes this pattern of extended survival represents encouraging, albeit anecdotal, evidence of clinical activity in a patient population with limited therapeutic options. These survival observations have been accompanied by a clean safety profile. Importantly, no dose-limiting toxicities (DLTs) have been observed to date, prompting Anixa’s partner, Moffitt Cancer Center ("Moffitt"), to obtain Institutional Review Board (IRB) approval for a protocol amendment that permits significant dose escalation.

Under the amended protocol, dosing may increase from the original range of 1×10⁵ to 1×10⁷ CAR-positive cells per kilogram of body weight ("cells/kg") to as high as 1×10⁹ cells/kg, representing a two-order-of-magnitude increase. If no DLTs are observed at this level, additional escalation may be pursued at the discretion of the principal investigator.

Anixa and Moffitt believe the favorable safety profile observed to date is partially attributable to the direct intra-peritoneal delivery of CAR-T cells, which differs from conventional intravenous administration and may reduce systemic toxicity while enhancing localized tumor targeting.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "Although these patients were treated at doses we believe are below the optimal therapeutic range, we are encouraged by the number of individuals who have lived far longer than expected."

As part of the amended study design, the next patient cohort will receive 1×10⁷ cells/kg following treatment with cyclophosphamide and fludarabine, a preparatory regimen known as lymphodepletion. Lymphodepletion reduces competing immune cells, creating a more favorable environment for CAR-T expansion, persistence, and activity. While lymphodepletion is routinely used in CAR-T therapies for hematologic cancers, its role in solid tumors remains investigational. Anixa, Moffitt, and the U.S. Food and Drug Administration view this addition as an important opportunity to assess whether lymphodepletion can further enhance efficacy in a localized solid tumor setting, particularly when combined with intra-peritoneal CAR-T delivery.

Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt and principal investigator of the trial, added, "The absence of dose-limiting toxicities observed thus far has given us the flexibility to safely explore higher dose levels than originally planned. With regulatory approval now in place, the program is positioned to advance into higher-dose evaluation under the amended protocol. This amendment allows us to further evaluate both safety and potential therapeutic benefit as the study advances."

Dr. Kumar will further discuss the observations in the clinical trial, as well as provide updates on Anixa’s plans for 2026, in the upcoming Water Tower Research Fireside Chat Series taking place on Tuesday, February 10, 2026, at 11:00am ET. Interested parties can register for the event at: Fireside Chat Registration.

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer

Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, FEB 9, 2026, View Source [SID1234662542])

On February 9, 2026 Eli Lilly and Company (NYSE: LLY) and Orna Therapeutics, Inc., a biotechnology company dedicated to engineering immune cells in vivo, reported entry into a definitive agreement for Lilly to acquire Orna.

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Orna is advancing a new class of therapeutics utilizing engineered circular RNA paired with novel lipid nanoparticles to allow the patient’s own body to generate cell therapies that can treat underlying disease. Orna’s lead program is ORN-252, a clinical trial-ready, CD19 targeting in vivo Chimeric Antigen Receptor T-cell (CAR-T) therapy designed to treat B cell-driven autoimmune diseases. Experiments to date suggest that Orna’s circular RNA platform may deliver more durable expression of therapeutic proteins and therefore unlock treatments that are not feasible with current RNA or cell therapy platforms.

"Early autologous CAR-T studies have shown the promise of cell therapy for patients with autoimmune diseases, but the complexity, cost, and logistics of ex vivo approaches make it challenging to deliver these breakthroughs to the broader population of patients who need them," said Francisco Ramírez-Valle M.D., Ph.D., Senior Vice President, Head of Immunology Research and Early Clinical Development. "We look forward to working with Orna colleagues to potentially unlock an entirely new class of genetic medicines and cell therapies for patients who today have limited or no treatment options."

"At Orna, we believe our circular RNA technology paired with our best-in-class LNP delivery platform have the potential to unlock in vivo CAR-T therapies for patients across a wide range of B cell-driven autoimmune diseases. We are excited to join forces with Lilly, an industry leader in the development of patient-centric therapeutics to realize the full potential of these technologies," said Joe Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics."

Under the terms of the agreement, Lilly will acquire Orna, and Orna shareholders could receive up to $2.4 billion in cash, inclusive of an upfront payment and subsequent payments upon achievement of certain clinical development milestones.

Lilly will determine the accounting treatment of this transaction in accordance with Generally Accepted Accounting Principles (GAAP) upon closing. This transaction will thereafter be reflected in Lilly’s financial results and financial guidance.

Paul, Weiss, Rifkind, Wharton & Garrison LLP is acting as legal counsel to Lilly. Lazard is acting as financial advisor to Orna. Goodwin Procter LLP is acting as legal counsel to Orna.

(Press release, Eli Lilly, FEB 9, 2026, View Source [SID1234662543])

On February 9, 2026 IN8bio (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ ) T cell therapies and T cell engagers for cancer and autoimmune diseases, reported the promotion of Kate Rochlin, Ph.D., to President and Chief Operating Officer, effective immediately.

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Dr. Rochlin has served as IN8bio’s Chief Operating Officer since December 2021, following her tenure as Vice President and Associate Vice President of Operations and Innovation beginning in August 2020. In her expanded role, she will continue to oversee company operations as IN8bio advances its clinical and preclinical pipeline and prepares for its next phase of growth.

"Kate has been instrumental in translating IN8bio’s strategy into disciplined execution," said William Ho, Chief Executive Officer and Co-Founder of IN8bio. "Through her leadership and ability to align teams across operations, manufacturing, clinical, and research, she has played a central role in advancing our clinical programs, and T cell engager platform and delivering critical milestones on schedule. I am confident that her promotion to President will further strengthen the organization."

Dr. Rochlin brings more than 17 years of experience across biotechnology company development, including scientific research, intellectual property, business development, clinical manufacturing and operations spanning corporate strategy, partnering, and team buildout. Prior to joining IN8bio, she was Chief Business Officer at Curadigm, a biotech developing precision-targeted drug delivery technologies, where she helped lead the company’s spin-out from Nanobiotix.

Since joining IN8bio, Dr. Rochlin has played a key role in advancing the company’s programs, including INB-619, a potential first-in-class, pan-γδ T cell engager for deep B cell depletion in autoimmune disease. IN8bio recently presented preclinical data showing that INB-619 achieved complete B cell depletion comparable to approved T cell engagers, with minimal adverse cytokine release and robust expansion of γδ T cells. These results validate the differentiation of IN8bio’s T cell engager platform and support continued regulatory engagement and advancement toward the clinic. Dr. Rochlin has also been instrumental in developing and expanding IN8bio’s clinical manufacturing program, leading analytical, quality, regulatory and GMP manufacturing teams across multiple Phase 1 and 2 clinical programs in glioblastoma and hematological cancers.

"I’m honored to take on this expanded role and broader leadership responsibilities at such an important time for IN8bio," said Dr. Rochlin. "With encouraging clinical data emerging from our γδ T cell therapy programs and novel gamma-delta T cell engager technology, we are well positioned to build on this momentum. I look forward to continuing to work closely with our team to execute on our corporate priorities and position IN8bio for long-term success."

Dr. Rochlin earned a Ph.D. in Molecular Biology and Genetics from Weill Cornell Medical College, conducted research at Sloan Kettering Institute, and earned a BA in Biology from the University of Pennsylvania.

(Press release, In8bio, FEB 9, 2026, View Source [SID1234662545])