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Sorrento Can't Nix $175M Arbitration Loss To LA Times Owner A California judge denied Sorrento Therapeutics' request Tuesday to vacate a $175 million arbitration award granted to billionaire Patrick Soon-Shiong's immunotherapy companies https://www.google.com/amp/s/www.law360.com/amp/articles/1573913

Kurze Zusammenfassung der aktuellen Lage: https://youtu.be/-aBb87tNGmY

Experts’ summary: This single-arm trial tested the IL-15 superagonist nogapen- dekin o-inbakicept (NAI, also known as N-803) plus bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC). A complete response (CR) at any time was observed in 71% (95% confidence interval [CI] 59.6-80.3%) of patients with BCG-unresponsive carcinoma in situ (CIS) + Ta/T1 and the med- ian duration of response was 26.6 mo. The disease-free survival (DFS) rate at 12 mo for patients with Ta/T1 tumors without CIS was 55.4% (95% CI 42.0-66.8%). CR was observed in only two of ten patients treated with NAI alone. The results show that the therapy was safe, with a low rate of adverse events [1]. Experts’ comments: This trial sets a new benchmark for 3-6-mo CR and 12-mo durability of response in patients with BCG-unresponsive

Dr. Pat Soon-Shiong @DrPatSoonShiong Experts in the field of #bladder cancer #nmibc, Words of #Wisdom @pcvblack @MariePierStLau1 https://mobile.twitter.com/drpatsoonshiong/status/1622037502797422595?s=12

IL-15 Superagonist NAI in BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer BACKGROUND Patients with Bacillus Calmette–Guérin (BCG)–unresponsive non–muscle-invasive bladder cancer (NMIBC) have limited treatment options. The immune cell–activating interleukin-15 (IL-15) superagonist Nogapendekin alfa inbakicept (NAI), also known as N-803, may act synergistically with BCG to elicit durable complete responses (CRs) in this patient population. METHODS In this open-label, multicenter study, patients with BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease were treated with intravesical NAI plus BCG (cohort A) or NAI alone (cohort C). Patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC also received NAI plus BCG (cohort B). The primary end point was the incidence of CR at the 3- or 6-month assessment visit for cohorts A and C, and the disease-free survival (DFS) rate at 12 months for cohort B. Durability, cystectomy avoidance, progression-free survival, disease-specific survival (DSS), and overall survival were secondary end points for cohort A. RESULTS In cohort A, CR was achieved in 58 (71%) of 82 patients (95% confidence interval [CI]=59.6 to 80.3; median follow-up, 23.9 months), with a median duration of 26.6 months (95% CI=9.9 months to [upper bound not reached]). At 24 months in patients with CR, the Kaplan–Meier estimated probability of avoiding cystectomy and of DSS was 89.2% and 100%, respectively. In cohort B (n=72), the Kaplan–Meier estimated DFS rate was 55.4% (95% CI=42.0% to 66.8%) at 12 months, with median DFS of 19.3 months (95% CI=7.4 months to [upper bound not reached]). Most treatment-emergent adverse events for patients receiving BCG plus NAI were grade 1 to 2 (86%); three grade 3 immune-related treatment-emergent adverse events occurred. CONCLUSIONS In patients with BCG-unresponsive bladder carcinoma in situ and papillary NMIBC treated with BCG and the novel agent NAI, CRs were achieved with a persistence of effect, cystectomy avoidance, and 100% bladder cancer–specific survival at 24 months. The study is ongoing, with an estimated target enrollment of 200 participants (Funded by ImmunityBio.)

ImmunityBio Announces Presentation at ASCO GI 2023 of Fully Enrolled Trial in Third-Line and Greater Pancreatic Cancer and Update on FDA Type B Meetings Regarding Paths to Registration https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-presentation-asco-gi-2023-fully-enrolled?field_nir_news_date_value[min]=

ImmunityBio, Inc. @ImmunityBio “…NAI plus BCG will be a game-changer in the community, probably more than it would be in academic medical settings." Read more about our QUILT 3.032 trial for N-803 + BCG in adults with #NMIBC in this interview with Karim Chamie, MD, via @UrologyTimes #BladderCancer

ImmunityBio will take part at the 41st Annual Healthcare Conference which will take place on January 9-12, 2023 in San Francisco, CA.

Soon-Shiong Pumps Another $107 Million into ImmunityBio https://labusinessjournal.com/biosciences/soon-shiong-pumps-another-107-million-into-immunitybio/

ImmunityBio: Upcoming PDUFA, Solid Data, Confusing Finances https://seekingalpha.com/article/4568334-immunitybio-upcoming-pdufa-solid-data-confusing-finances

ImmunityBio Announces $157 Million Financing From Nant and Institutional Investor https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-157-million-financing-nant-and?field_nir_news_date_value[min]=

As previously disclosed, in 2019, NantCell, Inc., a wholly-owned subsidiary of ImmunityBio, Inc. (the “Company”), along with Immunotherapy NANTibody, LLC (“NANTibody” and collectively, “Claimants”), a joint venture between the Company and Sorrento Therapeutics, Inc. (“Sorrento”), filed an arbitration proceeding against Sorrento and its Chairman, president and Chief Executive Officer, Dr. Henry Ji, for claims of fraud, breach of contract, breach of the covenant of good faith and fair dealing, tortious interference with contract and unjust enrichment, and seeking damages and declaratory relief relating to allegations of Sorrento’s fraud and breach of obligations to provide antibody-based cancer therapies pursuant to two exclusive license agreements. On December 2, 2022, the arbitrator executed a final award in the aggregate amount of $173.5 million for Sorrento’s breaches of both license agreements, of which $156.8 million is payable to the Company and the remainder is payable to NANTibody, the Company’s subsidiary. In addition, the arbitrator determined that the Claimants are entitled to declaratory relief that both license agreements remain in full force and effect, with respect to ImmunityBio’s PD-L1 NK cell. The arbitrator further declared that Sorrento and Claimants have no further rights or obligations under either license agreement with respect to other targets. Sorrento has no further obligation to contribute materials or know how with respect to the PD-LI antibody, and Claimants are not required to return any materials or know how received from Sorrento.

ImmunityBio to Participate in 34th Annual Piper Sandler Healthcare Conference https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-participate-34th-annual-piper-sandler-healthcare?field_nir_news_date_value[min]=

The Company is providing updates regarding the registrational development strategy and status for certain of the Company’s product candidates. For example, the Company has completed enrollment of the papillary cohort (cohort B) of its QUILT 3.032 clinical trial studying N-803 plus BCG in adults with BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”), and the Company has a related Type B meeting scheduled with the United States Food and Drug Administration (“FDA”) in December 2022. In addition, the Company has completed enrollment in the third-line or greater cohort (cohort C) of its QUILT 88 clinical trial studying low-dose chemotherapy in combination with PD-L1 t-haNK, N-803 and aldoxorubicin in subjects with metastatic pancreatic cancer, and the Company has submitted a related briefing book to the FDA and has a related Type B meeting scheduled with the FDA in December 2022. Further, as previously disclosed, in May 2022, the Company announced the submission of a Biologics License Application (“BLA”) to the FDA for N-803 in combination with BCG for the treatment of patients with BCG-unresponsive NMIBC with CIS with or without Ta or T1 disease. In July 2022, the Company announced the FDA had accepted the Company’s BLA for review and set a target Prescription Drug User Fee Act (“PDUFA”) action date of May 23, 2023. It is unclear when the FDA will approve the Company’s BLA, if at all. In anticipation of the PDUFA date and as part of the Company’s overall strategy, the Company is exploring to partner with a large biopharmaceutical company for commercialization of N-803 plus BCG for administration intravesically. While the Company is pursuing discussions with multiple prospective global pharmaceutical partners with a view towards completing a transaction by the first quarter of 2023, there can be no assurance that the Company will complete a transaction on acceptable terms in accordance with this timeline or at all.

https://ir.immunitybio.com/node/9571/html

NEJM Evidence Publishes Results for ImmunityBio’s QUILT 3.032 Registrational Trial of IL-15 Superagonist N-803 Plus BCG in Patients with Bladder Cancer https://ir.immunitybio.com/news-releases/news-release-details/nejm-evidence-publishes-results-immunitybios-quilt-3032-0?field_nir_news_date_value[min]=