Bioshield Sparks Early Promise in Recurrent GBM, With 2 Near-CRs and 100% Disease Control - Dr Patrick Soon-Shiong

Patrick Soon-Shiong is back in the spotlight with early data from his Bioshield regimen in recurrent glioblastoma. The inventor of Abraxane and a transplant surgeon, Soon-Shiong says the approach could finally move the needle in one of oncology’s toughest indications.

In a series of posts on X, the ImmunityBio executive chairman called glioblastoma “medicine’s biggest challenge,” pointing to decades of limited progress with surgery, radiation and chemotherapy. Standard regimens, he noted, in 90% of cases deplete lymphocytes, crippling NK and T cells and leaving patients prone to relapse.

The new approach—described as a “chemo-free” combination of Bioshield (Cancer Vaccine), NK cell therapy plus an immune-stimulating device—aims to protect and rescue the immune system rather than destroy it.

So far, five patients with recurrent GBM have been treated. According to Soon-Shiong, two patients have achieved near-complete responses, while all five have shown 100% disease control. “When the immune system is protected, CR in tumors difficult to treat in recurrent GBM is possible,” he wrote.



Asked about the other three patients, Soon-Shiong said that one additional responder was seen early in the trial, and that the remaining two patients have just begun therapy and remain stable as they await follow-up MRIs.

The data are preliminary and based on five patients, but Soon-Shiong signaled that more readouts are on the way. ImmunityBio expects to present lung cancer data at the World Conference on Lung Cancer (WCLC25) next year.

The glioblastoma trial is open at CSSIFM.org.

Source: https://oncodaily.com/insight/soon-shiong-bioshield-glioblastoma-356671

ImmunityBio Company Review (2025)

ImmunityBio, Inc. (NASDAQ: IBRX) is a vertically integrated, clinical-stage biotechnology company headquartered in Culver City, California, specializing in targeted immunotherapies and cell therapies designed to enhance the human immune system against cancer and infectious diseases. Founded by Dr. Patrick Soon-Shiong, a surgeon and inventor known for developing ABRAXANE (sold to Celgene in 2010), the company emphasizes "Smart Therapies for Difficult Diseases®," focusing on activating natural killer (NK) cells, T cells, and immunological memory to achieve durable responses without severely weakening the immune system, unlike traditional chemotherapy or radiation. Their approach, dubbed "Immunotherapy 2.0" or "Cancer BioShield™," aims to treat the host rather than just the tumor, with platforms including cytokine fusion proteins, vaccine vectors, and engineered NK cells. As of mid-2025, ImmunityBio employs around 600 people and operates with a market cap of approximately $1.5-2 billion, though exact figures fluctuate with stock volatility.

Products and Pipeline

ImmunityBio's flagship product is **ANKTIVA (nogapendekin alfa inbakicept-pmln, or N-803)**, an IL-15 superagonist FDA-approved in 2024 for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in combination with BCG. It activates NK cells, CD8+ T cells, and memory T cells without boosting immunosuppressive cells, leading to prolonged responses—e.g., QUILT-3.032 trial data showed over 80% bladder preservation for 36 months in responders. In 2025, it received UK MHRA approval for the same indication and FDA Expanded Access for lymphopenia reversal in solid tumors, plus RMAT designation for pancreatic cancer combos.

The **NK-92® cell line** is a versatile, off-the-shelf NK cell platform used in therapies like CD19 CAR-NK for lymphomas (QUILT-106 trial showed complete responses in Waldenström Lymphoma patients) and as a bioanalytical tool for researchers. The pipeline includes investigational therapies for cancers (e.g., pancreatic, lung, glioblastoma, triple-negative breast) and viruses (HIV, HPV, Long COVID). Notable: A Phase 2 study for Long COVID launched in August 2025, leveraging ANKTIVA to address persistent symptoms affecting ~20% of COVID survivors. Collaborations include NCI for Lynch syndrome prevention (largest U.S. study) and Serum Institute for rBCG amid BCG shortages. 

Recent trial highlights: 100% disease control in 5 recurrent glioblastoma patients (2 near-complete responses) using ANKTIVA, NK therapy, and Optune Gio®—a breakthrough for this aggressive brain cancer. Early data from ASCO 2025 showed survival benefits in pancreatic cancer by reversing lymphopenia. BioShield™ platform targets "turbo cancers" linked to immune suppression from COVID/vaccines, per Dr. Soon-Shiong.

Financial Performance 

ImmunityBio has shown strong commercial momentum in 2025 post-ANKTIVA launch. Q2 revenue hit $26.4M (60% QoQ increase), with YTD sales at $43M and 246% unit growth since the January 2025 J-code (J9028) streamlined reimbursements. Q1 revenue doubled to $16.5M (129% YoY). However, the company reported a Q2 net loss, though it beat EPS estimates by 0.00% and revenue by 0.10%. Revenue growth of 2,423.90% highlights commercialization success, but profitability remains elusive due to high R&D burn (~$100-150M quarterly). Stock performance is volatile. Raised $80M in equity from institutional investors in 2025 to fund operations. Cash and equivalents: ~$136M pro forma as of Q1. Investors note short-selling pressure suppressing shares, potentially to force bankruptcy amid cash needs. Reddit discussions highlight frustration with low share prices despite promising data.

Employee and Culture Reviews

Employee sentiment is mixed to negative. On Glassdoor, only 23% recommend working there, with a 3.0/5 work-life balance rating; complaints include limited career growth and high-pressure environment. Indeed reviews echo this: "Poor work environment" and no advancement opportunities, though some praise hands-on experience in manufacturing. Culture scores low, with reports of delays in promotions and a demanding biotech pace.

Public and Market Sentiment

On X (formerly Twitter), sentiment leans positive toward scientific breakthroughs: Users hail ANKTIVA/BioShield for potential in glioblastoma, Long COVID, and "turbo cancers," urging FDA approvals and amendments to "Right to Try" for frontline use. Calls tag figures like @RobertKennedyJr and @DrMakaryFDA for faster action. Investor frustration focuses on stock manipulation by shorts and big pharma, with pleas for BioShield to combat viruses/cancers. Some compare it favorably to competitors like Northwest Biotherapeutics. Broader reviews praise innovation but note risks: High cash burn, manufacturing disruptions, and dependency on trial success. Analyst views: Promising upside but biotech volatility; one calls it a "high-growth tech stock" analog.

Strengths and Weaknesses

**Strengths**: - Innovative platforms with real-world impact (e.g., ANKTIVA approvals, glioblastoma data). - Revenue ramp-up and regulatory wins signal commercialization strength. - Broad applicability (cancer prevention, viruses) positions it as a leader in immunotherapy. - Strong leadership and collaborations (NCI, VA hospitals). **Weaknesses**: - Financial strain: Cash burn, dilution from financings, short-selling pressure. - Employee morale issues could impact retention/innovation. - Pipeline risks: Many therapies investigational; delays in BLA submissions (e.g., NMIBC papillary). - Competition from established players (e.g., Keytruda, CAR-T) in crowded immunotherapy space.

Overall Rating and Outlook

On a 1-10 scale, ImmunityBio rates a 7.5: Strong scientific foundation and 2025 momentum (revenue growth, approvals, trial data) make it a compelling biotech play, but financial hurdles and operational challenges temper enthusiasm. It's well-positioned for catalysts like WCLC 2025 lung data or BLA outcomes, potentially driving stock recovery. Investors should monitor cash flow and short interest; for patients/researchers, the pipeline offers hope in hard-to-treat areas. Cross-reference with SEC filings or clinicaltrials.gov for depth.