ImmunityBio, Inc. reports developments as a commercial-stage biotechnology company focused on immunotherapies designed to activate innate and adaptive immune responses for cancer and infectious disease. Its news centers on ANKTIVA® (nogapendekin alfa inbakicept-pmln), an IL-15 superagonist used with BCG for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary tumors.
Recurring updates cover ANKTIVA product revenue and unit demand, global regulatory authorizations and commercial availability, distribution partnerships, and scientific presentations involving bladder cancer, lung cancer, and broader IL-15 oncology programs. Company announcements also address BCG-naïve NMIBC clinical development, FDA promotional-compliance correspondence, and financing arrangements tied to revenue interests and convertible debt.
ImmunityBio (NASDAQ: IBRX) announced positive long-term results from its QUILT-3.032 study of ANKTIVA® plus BCG for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The study showed:
For CIS with/without papillary disease (N=100):
- 71% complete response rate with responses up to 53+ months
- 84.2% cystectomy avoidance rate at 36 months
- 99% disease-specific survival rate at 36 months
For papillary disease without CIS (N=80):
- 58.2% disease-free survival rate at 12 months
- 82% cystectomy avoidance rate at 36 months
- 96% disease-specific survival rate at 36 months
The treatment was well-tolerated with mostly grade 1-2 adverse events. ImmunityBio has submitted a supplemental BLA to FDA for ANKTIVA plus BCG in BCG-unresponsive NMIBC papillary disease indication.
ImmunityBio (NASDAQ: IBRX) will present new clinical findings for ANKTIVA® in non-muscle invasive bladder cancer at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29. The company will showcase updates from the QUILT-3.032 trial, demonstrating long-term efficacy data for ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS.
Key presentations include an oral session on complete responses to ANKTIVA plus BCG therapy, and keynote events by Dr. Patrick Soon-Shiong discussing innovation in urological cancers. The company has submitted a Supplemental Biologics License Application for BCG unresponsive NMIBC and applied for Expanded Access Authorization of ANKTIVA as a BioShield for patients receiving chemotherapy, radiation, and immunotherapy.
ImmunityBio (NASDAQ: IBRX) has made significant regulatory and commercial progress in Q1 2025. The company submitted a supplemental Biologics License Application (sBLA) for ANKTIVA® plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for papillary disease indication. Clinical data showed 88% and 82% probability of avoiding bladder removal at 2 and 3 years respectively.
The company also submitted an Expanded Access Protocol (EAP) for ANKTIVA to treat lymphopenia, following a Regenerative Medicine Advanced Therapy (RMAT) designation. Commercially, with a permanent J-code (J9028) awarded in January 2025, Q1 2025 saw strong growth with:
- Net product revenue of $16.5M, up 129% from Q4 2024's $7.2M
- ANKTIVA unit sales volume increased 150% over Q4 2024
- March sales volume grew 69% compared to February 2025
ImmunityBio (NASDAQ: IBRX) has secured a $75 million equity financing through a registered direct offering with a single institutional investor. The agreement includes the issuance of common stock and warrants for additional share purchases. If the warrants are fully exercised, they could generate up to approximately $90 million in additional gross proceeds.
The securities will be offered under the company's automatic shelf registration statement on Form S-3, with a final prospectus supplement to be filed with the SEC. The financing aims to provide working capital and support ongoing business operations.
ImmunityBio (NASDAQ: IBRX) has announced an Investor Day program scheduled for Tuesday, April 15, 2025, at 10:00 am PDT. The event will feature comprehensive updates on:
- Business operations and regulatory advances
- Clinical programs including bladder cancer, non-small cell lung cancer, and metastatic pancreatic cancer trials
- Natural killer (NK) cell therapy program and Lynch syndrome accrual
- Discussions on virally induced cancers and Long-COVID
The event will include fireside chats with distinguished key opinion leaders and a presentation by Dr. Patrick Soon-Shiong on the company's technology platforms. The in-person event will be held in El Segundo, California, with space availability, requiring advance RSVP. A live stream option will be available for remote attendance.
ImmunityBio (NASDAQ: IBRX) has announced an upcoming Investor Day scheduled for Tuesday, April 15, 2025, at 10:00 am PDT. The event will be hosted at their El Segundo, California facilities, offering both in-person attendance and live streaming options.
The program will feature comprehensive updates on business operations and R&D progress, including presentations from CEO Richard Adcock and Founder Dr. Patrick Soon-Shiong. Key highlights will include:
- Discussion of product candidate timelines and ongoing clinical trials
- Detailed overview of the company's technology platforms
- Presentation on ANKTIVA, their initial therapeutic
- Tour of manufacturing facilities demonstrating production capabilities
The company's focus remains on developing a Therapeutic BioShield across multiple tumor types, leveraging their innovative approach to immunology for long-term disease protection and prevention.
ImmunityBio (NASDAQ: IBRX) has initiated dosing of recombinant BCG (rBCG) in the U.S. through its FDA-authorized Expanded Access Program (EAP). U.S. Urology Partners is among the first providers to offer this alternative BCG treatment, with 60 sites preparing for launch.
The program addresses critical TICE® BCG shortages affecting bladder cancer treatment nationwide. A recent survey of 100 U.S. urologists revealed that 57% couldn't treat patients in the past year due to BCG access issues.
The rBCG, manufactured by the Serum Institute of India, has shown promising results in European clinical trials, demonstrating potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG formulations. The EAP is being managed by Anova Enterprises, Inc., providing an essential alternative source for this standard-of-care treatment in bladder cancer.