ImmunityBio Updates Phase 2 Clinical Results from QUILT 3.078
ImmunityBio announced updated Phase 2 clinical results from QUILT 3.078, evaluating a chemotherapy-free combination immunotherapy regimen in patients with second-line recurrent or progressive glioblastoma, as well as patients treated under single-patient INDs across first- to third-line disease. Primary endpoint of QUILT-3.078 is overall survival; median overall survival has not yet been reached, with 19 of 23 enrolled patients alive as of January 22. Fourteen patients have evaluable data, with the longest survival from time of disease recurrence reaching 12 months to date and ongoing. Baseline mean absolute lymphocyte count among these 14 patients was 0.9 x 103/uL, confirming severe lymphopenia at enrollment. ALC increased within one treatment cycle, with mean ALC rising to greater than or equal to 1.4 x 103/uL. Immune competence was maintained, with statistically significant increases from baseline observed at all assessments through 20 weeks with Anktiva + CAR-NK ANKTIVA + CAR-NK demonstrated a manageable safety profile following a total of 219 doses administered to date, with three treatment-related serious adverse events reported among 41 GBM patients enrolled across QUILT-3.078 and single-patient INDs. Randomized controlled trials in both first line and second line glioblastoma are in development.
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- Mid-Stage Study Launch: Immunitybio announced the initiation of a mid-stage clinical study targeting indolent B-cell non-Hodgkin lymphoma (iNHL), evaluating the combination of CD19 CAR-NK cell therapy with Anktiva and Rituximab without the need for traditional lymphodepleting chemotherapy, thereby offering a safer treatment option for patients.
- Recruitment of Refractory Patients: The study will enroll patients with Waldenström's Macroglobulinemia who have relapsed or are refractory after at least two prior lines of therapy, aiming to enhance the depth and durability of anti-tumor activity through further stimulation of innate and adaptive immune responses, showcasing the company's innovative potential in treating difficult-to-treat tumors.
- FDA Application Progress: Immunitybio recently met with the U.S. FDA to discuss its application for Anktiva in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer, which was rejected in 2025; however, the company plans to submit additional information within 30 days to support a resubmission, demonstrating its ongoing commitment to the market.
- Positive Market Reaction: On Stocktwits, retail sentiment around IBRX shares remains in the 'bullish' territory with high message volume, and IBRX stock has gained approximately 90% over the past 12 months, reflecting investor confidence in the company's future developments.
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- Current Market Landscape: As of February 2, the most shorted stocks include those with market caps above $2 billion and free floats exceeding 5 million shares, ranked by short interest, highlighting the market's focus on these stocks and their associated risks.
- Study Launch: ImmunityBio has announced the initiation of the ResQ215B study, evaluating a novel chemotherapy-free and lymphodepletion-free CAR-NK cell therapy aimed at treating indolent B-cell non-Hodgkin lymphoma (iNHL), including Waldenström’s Macroglobulinemia, marking a significant advancement in immunotherapy.
- Positive Clinical Results: In the Phase 1 study, all four patients with Waldenström’s Macroglobulinemia achieved clinical disease control when treated with CD19 CAR-NK cells combined with rituximab, with two patients maintaining complete remission at 7 and 15 months follow-up, indicating the therapy's potential.
- Significant Therapy Advantages: The design of the ResQ215B study eliminates the need for lymphodepleting chemotherapy, offering a safer treatment option that could transform the current treatment paradigm for indolent B-cell malignancies, particularly for patients deemed incurable.
- Enhanced Immune Response: By incorporating ANKTIVA, the study aims to further stimulate NK and CD8 T-cell activity, enhancing anti-tumor efficacy and potentially overcoming tumor resistance to rituximab, thereby improving the depth and durability of treatment responses.
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- Executive Appointments: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Clinical Data Breakthrough: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, tripling the historical response rate of 6-11%, demonstrating significant efficacy in this difficult-to-treat population.
- FDA Alignment Success: Oncolytics has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this challenging therapeutic area, further solidifying its market position.
- Strategic Expansion: The company has also expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, aiming to accelerate clinical development across multiple indications and enhance overall R&D capabilities.
- Leadership Enhancement: Oncolytics Biotech has appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy, significantly surpassing the historical 6-11% response rate, indicating its potential in difficult-to-treat patient populations.
- FDA Designation Approval: Oncolytics secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the initiation of the only immunotherapy registration trial planned for this challenging area, further solidifying its market position.
- Advisory Board Expansion: The company has expanded its Scientific Advisory Board by adding globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, laying the groundwork for accelerated clinical development across multiple indications.











