On August 13, 2025 ImmunityBio (NASDAQ: IBRX), a leading immunotherapy company, reported early findings from its QUILT-106 Phase I trial, showing highly promising complete responses in the first two patients treated to date with late-stage Waldenstrom macroglobulinemia (WM)—a type of non-Hodgkins lymphoma (NHL)—using its CD19 CAR-NK (CD19 t-haNK) natural killer cell therapy (Press release, ImmunityBio, AUG 13, 2025, View Source [SID1234655197]).

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QUILT-106 (NCT06334991) is a first-in-human trial evaluating the safety and preliminary efficacy of CD19 CAR-NK cell therapy alone and in combination with rituximab in patients with relapsed or refractory (R/R) CD19⁺CD20⁺ B-cell NHL. The disease remains challenging to treat, and WM is considered incurable with existing treatment options, making novel immunotherapies an important avenue of exploration for potential effective treatments.

In the first two evaluable patients with WM who were heavily pretreated, an entirely chemotherapy-free, immunotherapy regimen induced encouraging responses. Both patients tolerated the regimen with no significant toxicities. Notably, all infusions (including CAR-NK cells and cytokines) were administered in an outpatient setting. One patient achieved a complete response (CR) with CD19 CAR NK monotherapy, while the second patient achieved CR with CD19 CAR-NK in combination with rituximab. Remission was maintained and is ongoing for six months to date.

The open-label study sponsored by ImmunityBio and led by Dr. Glenda Gray, former President and CEO of the South African Medical Research Council (SAMRC) and current Chair of the Global Antibiotic Research and Development Partnership (GARDP), has enrolled 13 patients with NHL at three sites in South Africa. Of the patients enrolled so far, three have WM. Eligible study participants express CD19 and CD20, with active disease after ≥2 chemotherapy-based lines of treatment. All patients receive a lead-in cycle of CD19 CAR-NK cell monotherapy, followed by a 1-week safety observation pause, then a second cycle combining CD19 CAR-NK with rituximab. Key endpoints include safety/tolerability and objective response rate (ORR) by standard criteria.

"The preliminary findings we have submitted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting provides the first evidence that novel immunotherapy combinations without chemotherapy lymphodepletion can provide deep and durable remissions in WM even after multiple prior treatments," said Dr. Jackie Thomson, Wits University Donald Gordan Medical Center, Johannesburg, South Africa and the lead author of the paper. "Recruitment in this rare subset of lymphoma is ongoing to confirm these findings and to establish this chemo-free strategy as a viable treatment option for relapsed WM."

ImmunityBio’s CD19 CAR-NK Therapy

CD19 CAR-NK is a targeted high-affinity natural killer cell therapy – an off-the-shelf, allogeneic NK cell line engineered to express a CD19-specific chimeric antigen receptor (CAR) and a high-affinity CD16 (FcγRIIIa 158V) receptor. This design enables dual anti-tumor mechanisms: direct CAR-mediated cytotoxicity and augmented antibody-dependent cellular cytotoxicity when paired with anti-CD20 monoclonal antibody rituximab. Combining CD19 CAR-NK cells with rituximab could thereby target CD19⁺/CD20⁺ lymphoma cells to enhance tumor cell killing.

On August 13, 2025 Flatiron Health reported eight abstracts leveraging its high-quality multimodal data have been accepted for poster presentation and e-Poster presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain (Press release, Flatiron Health, AUG 13, 2025, View Source [SID1234655219]).

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"AI is a transformative force enabling scale, speed, and novel insights that were previously impossible. By harnessing advanced AI across our global network of more than five million people with cancer, we’re setting a new standard for real-world data at scale," said Nathan Hubbard, Chief Business Officer, Flatiron Health. "Our research at this year’s World Conference on Lung Cancer exemplifies how high-quality, multimodal real-world data combined with responsible AI practices can illuminate treatment patterns, measure effectiveness, and reveal where innovation is most urgently needed."

A highlight of Flatiron’s presence at WCLC 2025 is the first published research leveraging the Flatiron Health–Caris Life Sciences Clinical-Molecular Database (CMDB), the largest and most robust multimodal dataset of its kind, to identify a novel gene signature that predicts risk of liver metastasis in patients with advanced non-small cell lung cancer (NSCLC). By integrating high-quality clinical data with comprehensive molecular profiling, the research addresses a critical unmet need—providing clinicians with a new tool to identify high-risk patients and potentially enable more personalized surveillance and treatment strategies.

Additional highlights include:

a poster highlighting ongoing gaps in biomarker testing after assessing over 13,000 patients with NSCLC in the US and UK
a poster providing new insights into how NSCLC is managed in the UK, including details on the most commonly used treatments, patterns in biomarker testing, and overall survival outcomes
Schedule a meeting with Flatiron Health at WCLC 2025 and follow Flatiron Health on X and LinkedIn for more updates from #WCLC25.

Abstracts and Poster Presentations
A Novel Predictive Gene Signature for Liver Metastasis (LM) in NSCLC Using a Comprehensive Linked Clinical-Molecular Database
Partner: Caris Life Sciences
Poster
Session: P2.06 – Pathology and Biomarkers
Presentation Number: P2.06.45
Location: Exhibit Hall
Session Start/End: Monday, September 8, 10:30AM – 12PM

Real-world Biomarker Testing and Treatment Initiation in Patients with Resected Early-stage NSCLC (eNSCLC) in the US and UK
Poster
Session: P1.07 – Early-Stage Non-small Cell Lung Cancer
Presentation Number: P1.07.05
Location: Exhibit Hall
Session Start/End: September 7, 10:30AM – 12PM

Real-World Outcomes of Prophylactic Cranial Irradiation in Extensive-Stage Small Cell Lung Cancer Treated with First-Line Immunotherapy and Platinum-Etoposide
Poster
Session: P3.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: P3.13.10
Location: Exhibit Hall
Session Start/End: September 9, 10 – 11:30AM

Real-World Survival Outcomes in Non–Small Cell Lung Cancer: Insights from UK EHR-Derived Data
E-Poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.34

Disease Burden and rwPFS as a Surrogate Endpoint for rwOS in NTRK+ NSCLC and Other Advanced/Metastatic Solid Tumors
Partners: Bristol-Myers Squibb, University of Colorado Cancer Center
E-poster
Session: EP.12 – Metastatic Non-small Cell Lung Cancer – Targeted Therapy
Presentation Number: EP.12.23

Real-World Treatment Patterns in ES-SCLC Highlight Continued Unmet Medical Need in the Era of New Therapies: ESSENCE Study
Partners: Montefiore Medical Center, GSK, Rush University
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.25

Evolving Treatment Patterns in Early-Stage Non-Small Cell Lung Cancer in the United States
Partners: Lilly
E-poster
Session: EP.17 – Global Health, Health Services, and Health Economics
Presentation Number: EP.17.33

Real-World Treatment Patterns and Clinical Outcomes in Patients With Metastatic Neuroendocrine Neoplasms of the Lung (NEN-L)
Partners: Merck & Co
E-poster
Session: EP.13 – Small Cell Lung Cancer and Neuroendocrine Tumors
Presentation Number: EP.13.44

On August 13, 2025 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Kezar Life Sciences, AUG 13, 2025, View Source [SID1234655198]).

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"We are on track with our clinical development and regulatory submission plan for zetomipzomib in autoimmune hepatitis," said Chris Kirk, PhD, CEO and co-founder of Kezar. "We are committed to working closely with the FDA to align on our next trial design, which we have proposed as a registration-enabling study. The Type C meeting will be an important milestone as we continue to believe that zetomipzomib has the potential to positively transform the lives of patients living with autoimmune hepatitis."

Zetomipzomib: Selective Immunoproteasome Inhibitor
•In March, Kezar reported topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib in patients with autoimmune hepatitis (AIH). In relapsed or refractory AIH patients who entered screening on steroid-based therapy, 36% (5 of 14) of zetomipzomib-treated patients achieved a complete biochemical response (CR) and clinically significant steroid taper to 5 mg/day or less by 6 months, compared to 0 of 7 placebo patients. The median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks (including the ongoing open-label extension at the time of the data cutoff), and no disease flares were reported in any zetomipzomib-treated patient achieving CR during study. A favorable safety profile was observed during the 6-month blinded treatment period.

•In July, Kezar announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with AIH.
•Kezar submitted a Type C meeting request to the FDA to meet during the fourth quarter of 2025 to discuss the AIH development plan for zetomipzomib.

•Kezar submitted a complete response to the FDA Division of Rheumatology and Transplant Medicine with a request to remove the clinical hold on zetomipzomib in lupus nephritis.
Medical Conferences
•An abstract featuring PORTOLA Phase 2a data has been selected for an oral presentation at The Liver Meeting 2025, taking place November 7-11, in Washington, DC.
•An abstract featuring PORTOLA biomarker data has been selected for poster presentation at The Liver Meeting 2025.
Business Updates
•In June, Zung To was promoted to Chief Development Officer. Mr. To joined Kezar in 2023 as Senior Vice President & Head of Clinical Development and brings 35 years of industry experience, with more than 20 years in senior leadership roles in early-and late-stage clinical development. He has been instrumental in leading Kezar’s development strategy and has played a pivotal role in progressing the Company’s clinical trials with speed and precision.

Financial Results
•Cash, cash equivalents and marketable securities totaled $100.8 million as of June 30, 2025, compared to $132.2 million as of December 31, 2024. The decrease was primarily attributable to cash used in operations.
•Research and development (R&D) expenses for the second quarter of 2025 decreased by $6.7 million to $9.6 million, compared to $16.3 million in the second quarter of 2024. This decrease was primarily due to the decreased clinical activities resulting from the completion and closeout of clinical trials, a decrease in personnel costs including non-cash stock-based compensation and a decrease in facility related expenses.
•General and administrative (G&A) expenses for the second quarter of 2025 decreased by $0.6 million to $5.0 million compared to $5.6 million in the second quarter of 2024. The decrease was primarily due to a decrease in non-cash stock-based compensation and personnel-related expenses.
•Restructuring and impairment charges for the second quarter of 2025 decreased by $1.5 million, compared to the second quarter of 2024. The decrease was primarily attributed to the impairment charge in 2024 related to the right-of-use asset for the vacated floor in the company’s leased office facility.
•Net loss for the second quarter of 2025 was $13.7 million, or $1.87 per basic and diluted common share, compared to a net loss of $21.5 million, or $2.96 per basic and diluted common share, for the second quarter of 2024.
•Total shares of common stock outstanding were 7.3 million shares as of June 30, 2025.

On August 13, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the creation of its Oncology Scientific Advisory Board (SAB) (Press release, Zai Laboratory, AUG 13, 2025, View Source [SID1234655220]). The newly formed Oncology SAB is comprised of distinguished oncology leaders and will support the advancement of the Company’s robust oncology products and pipeline, including multiple internally developed investigational therapies.

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"We are honored to bring together this esteemed group of oncology leaders who will support our continued development and advancement of innovative treatment options for patients globally," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "The formation of this Board is an important step for Zai; we know our clinical programs will benefit tremendously from the guidance and perspective of this highly regarded and experienced group of individuals."

Zai Lab’s Oncology SAB comprises the following:

Lieping Chen, M.D., Ph.D., is a United Technologies Corporation chair in cancer research, professor of immunobiology, dermatology and medicine at the Yale University School of Medicine.

Richard S. Finn, M.D., is director of the Signal Transduction Program in the Jonsson Comprehensive Cancer Center at University of California, Los Angeles (UCLA).

Thomas F. Gajewski, M.D., Ph.D., directs the Melanoma Oncology Clinic and leads the Immunology and Cancer Program at the University of Chicago Comprehensive Cancer Center.

Melissa L. Johnson, M.D., directs lung cancer research at the Sarah Cannon Research Institute.

Matthew Krebs, M.D., Ph.D., is a clinical senior lecturer in experimental cancer medicine at the University of Manchester and leads early phase clinical trials at The Christie NHS Foundation Trust, Manchester, U.K.

Patricia LoRusso, M.D., D.O., is director of the Early Phase Clinical Trials Program and Associate Center Director of Experimental Therapeutics at Yale Cancer Center.

Michael T. Lotze, M.D., FACS, is professor of surgery, immunology and bioengineering, and director of the DAMP Laboratories at the University of Pittsburgh Medical Center Hillman Cancer Center.

Timothy Yap, M.B.B.S., Ph.D., FRCP, is a medical oncologist, physician-scientist and professor at the University of Texas MD Anderson Cancer Center.

On August 13, 2025, the Strategic Collaboration and License Agreement between Adaptive Biotechnologies Corporation ("Adaptive") and Genentech, Inc. ("Genentech"), dated as of December 19, 2018 (the "Agreement"), was terminated, with termination effective February 9, 2026 (Filing, 8-K, Adaptive Biotechnologies, AUG 13, 2025, View Source [SID1234655339]). Adaptive and Genentech entered into the Agreement in 2018 to collaborate on research and development of certain cancer cell therapy products.

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The parties will wind down activities under the Agreement. Upon termination, Adaptive will be released from exclusivity obligations with respect to cell therapies in oncology.

As a result of the termination, Adaptive expects to recognize $33.7 million during the second half of 2025 in non-cash revenue from the remaining amortization of the cash consideration received under the Agreement.

Adaptive’s ongoing Immune Medicine programs and financial goals continue to focus on: (i) developing and deploying digital TCR-antigen prediction models that enable novel immunology applications and partnering opportunities; (ii) developing a pre-clinical data package for the lead T-cell depletion program in autoimmunity; and (iii) achieving the fiscal year 2025 Immune Medicine cash burn target of $25–$30 million.