On February 2, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported the launch of ResQ215B, a Phase 2 clinical study evaluating a novel chemotherapy-free and lymphodepletion-free combination immunotherapy in patients with indolent B-cell non-Hodgkin lymphoma (iNHL), including Waldenström’s Macroglobulinemia.

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The outpatient study evaluates ImmunityBio’s novel, off-the-shelf CD19-targeted high-affinity natural killer (NK) cell therapy (CD19 t-haNK) in combination with nogapendekin-alfa inbakicept (NAI; ANKTIVA), an IL-15 superagonist, and the anti-CD20 monoclonal antibody rituximab. Notably, the regimen does not require any lymphodepleting chemotherapy, distinguishing it from conventional CAR-T cell therapies.

ResQ215B builds on promising results from the Phase 1 QUILT-106 study (NCT06334991), which evaluated CD19 CAR-NK cell therapy in combination with the anti-CD20 rituximab (without ANKTIVA). In that study, durable complete responses were observed in heavily pretreated patients with iNHL, including Waldenström’s Macroglobulinemia.

In an initial chemotherapy-free cohort of patients with Waldenström’s Macroglobulinemia treated with CD19 CAR-NK cells plus rituximab without any lymphodepletion, all four patients achieved clinical disease control. Two patients achieved rapid complete remissions (CR) that remain ongoing at 7 and 15 months of follow-up, respectively, without additional therapy beyond the planned treatment courses. The other two patients achieved stable disease, including one patient with declining IgM levels. These early findings demonstrated a 100% disease control in this small cohort using an outpatient, off-the-shelf CAR-NK cell therapy plus antibody combination without chemotherapy or inpatient hospitalization.

With the addition of ANKTIVA, ResQ215B is designed to evaluate whether further stimulation of innate and adaptive immune responses may enhance the depth and durability of anti-tumor activity. ANKTIVA is designed to promote the proliferation and activation of NK cells and CD8* T cells, potentially augmenting CAR-NK-mediated cytotoxicity and rituximab-driven ADCC.

Preclinical and clinical data suggests that IL-15 agonists may help restore immune function in the face of antibody resistance. In a previously published Phase 1 study (NCT02384954) Foltz et al. reported that combining an IL-15 superagonist with rituximab achieved a 78% complete response rate in patients with relapsed iNHL who had previously failed rituximab therapy.

"Our BioShield platform, which combines cell therapy, our IL-15 superagonist, and a monoclonal antibody in an outpatient, chemotherapy-free setting, represents our vision for Immunotherapy 2.0," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman, and Global Chief Medical and Scientific Officer of ImmunityBio. "Building on the durable complete remissions observed with our CD19 CAR-NK cell therapy plus rituximab in Waldenström’s Macroglobulinemia, we are now adding ANKTIVA to further arm the immune system. We believe this off-the-shelf immunotherapy platform can trigger powerful anti-tumor activity without the toxicities of traditional treatments, potentially transforming the treatment paradigm for patients with indolent B-cell malignancies."

"A therapy that does not require apheresis, individualized manufacturing, chemotherapy, or inpatient hospitalization would represent an important advance for patients with iNHL, who are regarded as having incurable lymphomas," said Lennie Sender, M.D., Chief Medical Officer for Cell Therapy and Liquid Tumors at ImmunityBio. "To date, all treated patients have received the therapy in an outpatient setting without significant immune-related toxicities, demonstrating the feasibility of delivering potent cellular therapy without hospital admission. With ResQ215B, we will evaluate whether adding ANKTIVA can further improve response rates and durability while maintaining this favorable safety profile. This could open the door to a more patient-friendly immunotherapy option for follicular lymphoma, Waldenström’s, and other indolent NHL subtypes that currently rely on more aggressive or continuous treatments. Indolent B-cell lymphomas, such as Waldenström’s Macroglobulinemia, remain an area of high unmet medical need."

About the ResQ215B Study

ResQ315B is a Phase 2, open-label study designed to evaluate whether the addition of ANKTIVA can enhance immune-mediated tumor control when combined with CD19 CAR-NK cells and rituximab. The study will enroll adults with CD19⁺/CD20⁺ indolent NHL, including Waldenström’s Macroglobulinemia, who are relapsed or are refractory after at least two prior lines of therapy. Treatment will be administered in 21-day outpatient cycles without preconditioning chemotherapy.

About CD19 t-haNK

ImmunityBio’s CD19 t-haNK is an off-the-shelf, allogeneic NK-92-based cell therapy genetically engineered to express a CD19-specific chimeric antigen receptor (CAR) and a high-affinity CD16 (FcγRIIIa 158V) receptor. This dual-engineered design enables two complementary mechanisms of action: direct CAR-mediated cytotoxicity against CD19-expressing malignant B cells, and augmented antibody-dependent cellular cytotoxicity (ADCC) when paired with an anti-CD20 antibody such as rituximab. By targeting both CD19 and CD20, the combination is designed to reduce immune escape and improve overall response rates.

(Press release, ImmunityBio, FEB 2, 2026, View Source [SID1234662394])

On February 2, 2026 Onchilles Pharma, a private biotech company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, reported the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for N17350 to initiate first-in-human clinical studies in patients with advanced solid tumors. N17350, the company’s first-in-class tumor-directed therapeutic candidate, leverages the ELANE pathway, an innate immune mechanism that selectively kills a wide range of cancer cells while preserving and activating the immune system.

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"IND clearance for N17350 marks an important milestone for Onchilles and reflects years of rigorous work establishing the ELANE pathway as a clinically actionable mechanism to improve the treatment of cancer," said Lev Becker, Ph.D., Co-Founder and Chief Scientific Officer of Onchilles Pharma. "From the beginning, this work was driven by fundamental observations in patients. What emerged was a mechanism that broadly kills cancer cells while preserving and activating immune cells, thereby transforming cancer cell death into long-lasting anti-tumor immunity. We now have the opportunity to evaluate in the clinic a differentiated, cancer-selective mechanism that overcomes limitations of current treatment paradigms."

N17350 demonstrated consistent efficacy in preclinical models spanning dozens of cancer cell lines, patient-derived samples, and multiple in vivo models, including chemotherapy-resistant and immunologically "cold" tumors, where it induced immunogenic cancer cell death and drove CD8+ T cell–mediated immune activation. These findings support its evaluation in a broad first-in-human clinical study.

"The preclinical data supporting N17350 suggest a mechanism that kills tumors and simultaneously primes the immune system," said Alain P. Algazi, M.D., Onchilles N17350 Clinical Advisory Board Chair and Director, Program Leader, UCSF Head and Neck Medical Oncology. "If this dual activity translates clinically, it could represent a meaningful advance for patients with tumors that are difficult to treat with existing cytotoxic or immunotherapy approaches."

The first-in-human study will evaluate the safety, tolerability, and preliminary clinical activity of N17350 as a monotherapy in patients with advanced solid tumors, including melanoma, head and neck neoplasms, squamous cell carcinoma of skin, non-small-cell lung carcinoma, triple-negative breast neoplasms (ClinicalTrials.gov Identifier: NCT07339176). The trial is also designed to assess pharmacodynamic biomarkers associated with ELANE pathway engagement and immune activation, providing early clinical insight into the mechanism. Onchilles plans to initiate first-in-human dosing at multiple sites in the U.S. and Australia.

"N17350 is fundamentally different from traditional cytotoxic chemotherapies or immunotherapies," said Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles Pharma. "By leveraging the ELANE pathway, we are advancing a cancer-selective therapeutic approach designed to eliminate tumors as well as preserve and train the immune system to respond at the same time. As we move into clinical testing, we believe this approach has the potential to address unmet needs across many different tumor types."

About Onchilles Therapeutic Programs Targeting the ELANE Pathway

At the core of this approach is the ELANE pathway, a unique cancer-selective killing mechanism that leverages a vulnerability shared by many cancer cell types: elevated histone H1 levels. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 and NEU-002 are designed to rapidly eliminate tumors while mobilizing an adaptive immune response, offering the potential for sustained anti-tumor immunity. N17350 and NEU-002 offer a unique approach to treating cancer regardless of their genetic makeup, anatomical origin, or immune status, positioning them as potential game-changers in cancer therapy.

(Press release, Onchilles Pharma, FEB 2, 2026, View Source [SID1234662410])

On February 2, 2026 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company granted an aggregate of 1,799 restricted stock units (RSUs) to four newly-hired employees. These RSU awards were granted as of January 31, 2026 (the "Grant Date") pursuant to the Company’s 2022 Inducement Stock Incentive Plan, as amended, as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each RSU award will vest over three years, with 33 1/3% of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the Grant Date. The vesting of each RSU award is subject to the employee’s continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates.

(Press release, Karyopharm, FEB 2, 2026, View Source [SID1234662395])

On February 2, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company and research collaborators at Mayo Clinic and the Alliance for Clinical Trials in Oncology reported publication of the largest study to date evaluating circulating tumor DNA (ctDNA) for MRD detection in patients with resected stage III colon cancer after surgery and before adjuvant chemotherapy. Results of the study, published in the Journal of Clinical Oncology, show that detecting ctDNA with the Guardant Reveal blood test better predicts recurrence and overall survival than standard staging.

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Researchers found that about 20 percent of patients in the phase III trial, which was presented at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, involving more than 2,000 patients still had detectable ctDNA in their blood after surgery. Guardant Reveal identified patients at a four-to-six-fold higher rate of disease recurrence or reduced survival. Even patients with smaller tumors or fewer affected lymph nodes found as part of traditional staging had an over 6-fold higher rate of events if ctDNA was detected. The findings support the integration of tissue-free ctDNA testing into routine postoperative management to better identify patients at high risk of recurrence who may benefit from intensified surveillance or alternative adjuvant strategies.

Measuring the amount of cancer DNA in the blood, a marker known as tumor fraction, further distinguished those at the highest risk of early recurrence and worse survival. This additional layer of information may help clinicians prioritize patients who need the most intensive surveillance or consideration of alternative therapies.

"The data suggest that not only the presence of ctDNA, but the amount of ctDNA, as identified by Guardant Reveal may help refine risk beyond standard TNM staging, and could be used to guide adjuvant treatment and surveillance decisions," said Frank Sinicrope, MD, professor of oncology and medicine at Mayo Clinic and principal investigator for the study. "ctDNA testing after surgery improves the accuracy of estimating a patient’s risk of cancer recurrence, enabling more tailored recommendations for adjuvant chemotherapy and follow-up monitoring. It also identifies high risk patients who are likely to recur despite standard treatment, and who may benefit from alternative therapeutic approaches."

"This large study adds to growing evidence that ctDNA testing with Guardant Reveal after surgery helps answer the question patients care about most: Am I really cancer-free?" said Dr. Craig Eagle, Guardant Health Chief Medical Officer. "Personalizing care after surgery is essential as clinicians and patients decide what comes next. Guardant Reveal fits easily into routine practice and provides timely, actionable insight—helping identify patients at high risk while sparing others unnecessary treatment and anxiety."

Today’s announcement is the latest data reinforcing the clinical utility of Guardant Reveal in molecular residual disease and beyond. Guardant recently expanded Reveal to support late-stage therapy response monitoring, enabling ctDNA-based assessment of treatment effectiveness across solid tumors. This adds to evidence from early-stage breast cancer publications that Reveal’s tissue-free approach can identify patients at elevated risk of recurrence and support more personalized care.

(Press release, Guardant Health, FEB 2, 2026, View Source [SID1234662411])

On February 2, 2026 MAA Laboratories, Inc. reported that it has completed early regulatory engagement with the Therapeutic Goods Administration (TGA) of Australia for its Dasatinib Nanoparticle Tablets, developed using the Company’s proprietary NanoCont platform technology.

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The engagement provides procedural clarity on the applicable regulatory pathway for the program in Australia. The product is being developed under a Category 1, Type F regulatory framework, consistent with global regulatory precedents for differentiated, suprabioavailable formulations of approved drug substances.

MAA’s Dasatinib Nanoparticle Tablets are designed to achieve equivalent systemic exposure at lower doses through enhanced bioavailability, enabling a development strategy centered on bioavailability and bioequivalence (BA/BE) studies. Under this pathway, regulatory evaluation is conducted at the time of submission.

Importantly, this approach is aligned with scientific advice previously received in Europe and Canada, as well as IND clearance by the U.S. Food and Drug Administration, where a BA/BE-based development strategy without additional clinical efficacy, safety, or toxicology studies was considered appropriate for this differentiated formulation.

"We view Australia as an important market for innovative, patient-focused therapies," said Dr. Anjani Jha, Founder and CEO of MAA Laboratories. "Our engagement with the TGA provides clarity on the appropriate regulatory framework and is consistent with the global development strategy we are executing across the U.S., Europe, and Canada."

MAA Laboratories’ NanoCont platform enables the development of differentiated, branded products that retain the regulatory efficiencies of established molecules while offering the potential benefits of improved bioavailability, optimized dosing, and enhanced tolerability. The Company continues to advance its dasatinib program and broader oncology pipeline toward global registration and commercialization.

(Press release, MAA Laboratories, FEB 2, 2026, View Source [SID1234662396])