ImmunityBio, Inc. - IBRX STOCK NEWS

ImmunityBio, Inc. (NASDAQ: IBRX) announced promising results from its late-stage bladder cancer trial (QUILT-3.032). Of the 83 patients with BCG-unresponsive non-muscle invasive carcinoma in situ (CIS), 71% achieved complete response, with a median response duration of 24.1 months, surpassing FDA-approved therapies like pembrolizumab (41%) and valrubicin (18%). The study showed over 90% cystectomy avoidance and a remarkable safety profile with no severe adverse events. This trial positions ImmunityBio's treatment as a potential new standard of care for bladder cancer patients.

ImmunityBio's Phase 1 study results for Anktiva (N-803), published in Nature Medicine, demonstrate the drug's ability to stimulate latent HIV replication in CD4+ cells and activate immune response. The study involved 16 participants, with no serious adverse events reported. Nearly 38 million people live with HIV globally, highlighting the need for alternative therapeutics as current treatments can be costly. Ongoing Phase 1 and 2 trials aim to validate Anktiva’s efficacy in eliminating HIV reservoirs in patients.

ImmunityBio, Inc. (NASDAQ: IBRX) reported promising interim results from its QUILT 88 trial, focusing on the Nant Cancer Vaccine for advanced pancreatic cancer. The median overall survival (OS) for patients who received the therapy exceeded historical data, reaching 6.3 months (N=30) after two prior therapies and 5.8 months (N=63) for those with even more advanced disease. Serious adverse events were infrequent, with no treatment-related deaths. The company plans to engage with the FDA to discuss the path forward for approval of combination therapies for pancreatic cancer.

ImmunityBio has entered into a definitive agreement to acquire a leasehold interest in a 409,000 square foot cGMP manufacturing facility in Dunkirk, New York, from Athenex (NASDAQ: ATNX). This facility will enable the production of one billion doses of RNA and adjuvant vaccines, significantly enhancing ImmunityBio's manufacturing capabilities. The investment aims to expedite the company's development and commercialization of immunotherapy and vaccine products, with production expected to commence in Q4 2022. The acquisition bolsters ImmunityBio's global manufacturing capacity.

ImmunityBio has been granted a U.S. patent for a novel NK cell therapy that combines genetically modified NK-92 cells with CD16 receptors to enhance monoclonal antibody efficacy against cancer. This patent, extending protection to 2036, addresses cancer relapse by boosting the patient’s natural immune response. The NK-92 cells offer higher cytotoxicity against tumors and are included in over 450 research studies. ImmunityBio’s comprehensive intellectual property portfolio includes more than 1,100 patents across various biotherapeutic domains, bolstering its market position.

Amyris and ImmunityBio have finalized their joint venture to commercialize a next-generation COVID-19 vaccine. This collaboration aims to leverage their combined strengths in vaccine technology and manufacturing capabilities. They plan to begin human trials and seek regulatory approval to deliver the vaccine by 2022, targeting underserved areas affected by vaccine accessibility challenges. The partnership aims to provide robust immunity against COVID-19 variants and adapt to future viruses. Further updates on trial outcomes will be provided as they become available.

CytRx Corporation (OTCQB:CYTR) has highlighted recent clinical developments from ImmunityBio, Inc. (NASDAQ:IBRX) concerning the cancer treatment aldoxorubicin. ImmunityBio's QUILT 88 study has shown promising results in patients with metastatic pancreatic cancer, with 90% exceeding historical survival rates. Furthermore, CytRx has the potential for up to $343 million in milestone payments and royalties from its collaboration with ImmunityBio. Aldoxorubicin is also being evaluated for triple-negative breast cancer, head and neck cancer, and glioblastoma.

ImmunityBio has announced the initiation of Phase 3 enrollment for the SISONKE Universal Boost COVID T-Cell vaccine trial in previously vaccinated participants in South Africa. The company has also expanded its GMP manufacturing capacity for various vaccine platforms across the U.S., South Africa, and Botswana. Significant clinical developments include a planned data cutoff for bladder cancer trials in January 2022 and a BLA filing expected in Q1 2022. ImmunityBio raised $470 million in financing in 2021 to support its clinical trials and expand operations. Key milestones include progressing 13 Phase 2/3 trials and securing pivotal patents.

ImmunityBio has expanded its vaccine programs to include self-amplifying self-adjuvating RNA (SASA-RNA) and recombinant protein candidates. This comprehensive platform aims to provide broad, durable protection against SARS-CoV-2 variants. Key developments include the Phase 2 SISONKE Boost trial in South Africa and partnerships with Amyris and Baylor College to accelerate production. The next-generation vaccines are designed to be cost-effective for global distribution, particularly in low- and middle-income countries, with enhanced stability and storage requirements.