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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]=

"I am optimistic that the FDA will evaluate ImmunityBio's BLA favorably. If it has any reservations on this important therapy with its solid safety record, it should resolve them in favor of approval to give patients a chance to access this important life altering therapy. I have noticed an aura of mistrust on comment streams addressing FDA decisions. I have never given the suspicions much credence. Here we have a therapy where the little guy, ImmunityBio's anktiva, is set to challenge Merck's (MRK) KEYTRUDA (pembrolizumab) after having bested it in clinical trials. It will be interesting to see how it unfolds."

Seeking Alpha: ImmunityBio: PDUFA Pending https://seekingalpha.com/article/4546925-immunitybio-pdufa-pending

ImmunityBio to Participate in the Jefferies London Healthcare Conference https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-participate-jefferies-london-healthcare-conference?field_nir_news_date_value[min]=

On August 31, 2022, ImmunityBio, Inc. (the “company” or “we”) entered into a series of transactions including, in part, a new debt financing resulting in $125.0 million of gross proceeds, along with the amendment and restatement of the company’s nearest term debt maturity to extend the maturity from December 17, 2022 to December 31, 2023 and an adjustment to the interest rate to match the new debt issuance, and the amendment and restatement of the company’s fixed-rate debt maturing September 30, 2025 to add an equity conversion feature, in each case as further described below. New $125.0 million Variable-Rate Promissory Note On August 31, 2022, we executed a $125.0 million promissory note with Nant Capital, LLC (“Nant Capital”), an entity affiliated with Dr. Patrick Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer. This note bears interest at Term Secured Overnight Financing Rate (“Term SOFR”) plus 8.0% per annum. The accrued interest shall be payable quarterly on the last business day of March, June, September and December, commencing on September 30, 2022. The outstanding principal amount and any accrued and unpaid interest are due on December 31, 2023. We may prepay the outstanding principal amount, together with any accrued interest at any time, in whole or in part, without premium or penalty. We received net proceeds of $124.4 million from this financing, net of a $0.6 million origination fee paid to the lender, which we intend to use for commercialization efforts, clinical trials, working capital and general corporate purposes. Amendment and Restatement of Variable-Rate Promissory Note due December 17, 2022 As of June 30, 2022, we had a $300.0 million variable-rate promissory note with Nant Capital. This note bore interest at Term SOFR plus 5.4% per annum, which was paid quarterly. We may prepay the outstanding principal amount, together with any accrued interest at any time, in whole or in part, without premium or penalty. In the event of a default on the loan (as defined in the promissory note), including if we do not repay the loan at maturity, the company has the right, at its sole option, to convert the outstanding principal amount and accrued and unpaid interest due under this note into shares of the company’s common stock at price of $5.67 per share. On August 31, 2022, the terms of the variable-rate promissory note were amended and restated to extend the maturity date of the loan from December 17, 2022 to December 31, 2023, increase the spread on the loan from 5.4% to 8.0% per annum, and reset the quarterly interest payment date from the 17th to the last business day of March, June, September and December, commencing on September 30, 2022. No other material terms or conditions of this variable-rate promissory note were modified as part of this amendment and restatement.