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N-803/BCG Combo Shows Promising Responses, Tolerability in BCG-Unresponsive Bladder Cancer Bacille Calmette-Guérin (BCG) plus N-803 (ALT-803) yielded promising responses and an encouraging safety profile in patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), according to updated data from cohort A of the phase 2/3 QUILT-3.032 trial (NCT03022825) that were presented during the 2021 American Urological Association Annual Meeting. Results showed that the study met its primary end point, with a complete response (CR) rate of 72% (95% CI, 61%-81%), and a 58.6% (95% CI, 43.1%-71.2%) probability of maintaining a CR for at least 12 months. Additionally, at a median follow-up of 20.4 months, the median duration of CR was 19.9 months (95% CI, 7.8–not reached). “Eighty-five percent of our patients avoided a cystectomy,” according to lead study author Karim Chamie, MD, associate professor of urology at the University of California, Los Angeles. “This intravesical administration is quite favorable, and quite familiar amongst those who normally treat patients with BCG-unresponsive bladder cancer.” N-803 is an interleukin-15 superagonist that activates and proliferates endogenous natural killer and CD8-positive T cells without inducing T-regulatory simulation. QUILT-3.032 enrolled 81 patients with histologically confirmed BCG-unresponsive NMIBC, with persistent or recurrent CIS within 12 months of receiving adequate BGC treatment. Patients were treated with 50 mg of BCG plus 400 mg of intravesical N-803 weekly for 6 weeks, followed by re-induction for re-induction and maintenance for up to 3 years. The primary end point was biopsy confirmed CR at 3 and 6 months, with a lower bound 95% confidence interval of at least 20%. Secondary end points included duration of CR, cystectomy avoidance, and time to cystectomy. Furthermore, safety end points included incidence of serious adverse effects (AEs) and immune AEs. Notably, the analysis included patients who achieved a CR at 3 months, as well as those who achieved a CR after rescue and reinduction at 6 months. Those were enrolled were heavily pretreated patients with a median of 5.0 transurethral resections of a bladder tumor, and a median of 12.0 prior BCG instillations. Additionally, 42% of patients had received prior treatment with chemotherapy, and 17% were previously treated with checkpoint inhibitors, vicinium, interferon, etc. Additional data showed that among patients who achieved an initial complete response at 3 months, there was a 64% (95% CI, 47.3%-77.3%) probability of maintaining that response at 12 months, and a 61% (95% CI, 43.2%-74.5%) probability of maintaining it at 18 months. Notably, as of May 2021, the combination showed a 30% durable response at 18 months. Eighty-five percent of patients have not progressed to radical cystectomy through a data analysis as of this time point, as well. In terms of safety, the combination was well tolerated, with no incidence of treatment-related serious AEs, immune-related AEs, or treatment-related AEs (TRAEs) that were grade 4/5 in severity. Grade 3 TRAEs occurred in just 2 patients and included urinary tract infection and arthralgia. The most frequent grade 1/2 AEs were dysuria (22%), hematuria (16%), and pollakiuria (19%).

From Rich Adcock's Form 4 - "five percent (5%) of the RSUs (rounded down to the nearest whole share) will vest on the earlier of (A) December 31, 2022 and (B) the 60th day following approval by the Food and Drug Administration (FDA) of a biologics license application (BLA) or equivalent application for approval of Anktiva for use in the treatment of non-muscle invasive bladder cancer"

Sachs David C. converted options into 7,598 units of Common Stock, increasing direct ownership by 40% to 26,458 units

Adcock Richard converted options into 8,620 units of Common Stock and covered exercise/tax liability with 4,273 units of Common Stock, increasing direct ownership by 5% to 86,176 units

ImmunityBio’s IL-15 superagonist Anktiva (N-803) The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. N-803 is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding (not alpha) while avoiding T-reg stimulation. N-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo. N-803 is currently being evaluated for adult patients in two clinical NMIBC trials. QUILT 2.005 is investigating use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT 3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC.

Soon-Shiong continued, “We are encouraged by these results showing the potential for a higher and longer-lasting rate of complete response than with the current standards of care in patients facing removal of the bladder as an alternative. This study provides insights into the power of harnessing the immune system, including NK cells and T cells, which are activated by N-803. What is more, the novel IL15 fusion protein N-803 being studied was designed to be administered safely in the urologist’s office, potentially enabling ease of administration and increasing access for patients.” The Urgent, Unmet Need to Treat NMIBC and Avoid Cystectomy For the last 30 years, BCG immunotherapy has been the standard for treating NMIBC. However, disease recurrence and progression rates remain unacceptably high. Standard-of-care recommendations for these patients include lifetime invasive surveillance and rapid treatment of recurrences, creating a substantial financial burden and drastic impact on quality of life. Of those patients who experience recurrence, approximately 30% will progress and succumb to their disease over a 15-year period, and another 50% will undergo radical cystectomy of the bladder— a surgery to remove the entire bladder that may require removal of other surrounding organs—in an attempt to control their disease4. Despite the advent of minimally invasive procedures and robotic techniques, the 90-day mortality and morbidity rates in patients who undergo cystectomy remain unacceptably high at 3-6% and 28-64%, respectively5 & 6. Based on this urgent need, FDA published guidance in February 2018 to address BCG unresponsive non-muscle invasive bladder cancer (NMIBC), stating that the goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy.

CULVER CITY, Calif.--(BUSINESS WIRE)--Sep. 13, 2021-- ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced updated data from an ongoing bladder cancer trial showing sustained complete response rates in patients with BCG-unresponsive non-muscle invasive carcinoma in situ (CIS) bladder cancer (Cohort A). Of the 81 patients in the QUILT 3.032 study, 58 patients (72%) had a complete response (CR) at any time (three or six months) to intravesical BCG plus N-803 (Anktiva) with median duration of CR of 19.9 months. The data also showed a 59% probability (95% confidence interval; 43.1%, 71.2%) that responding patients would maintain a complete response for more than 12 months, based on Kaplan-Meier analysis. For the patients who had a CR within the first three months, the CR rate was 77%, with a 61% probability of remaining disease free at 18 months with the median duration of complete response having not yet been reached in that group. 85% of patients in the cohort avoided a cystectomy with a median duration of follow-up of 20.4 months. Of note, the therapy was extremely well tolerated with 0% treatment-related SAEs, 0% immune-related AEs and 0% grade 4 or 5 treatment-related AEs. In contrast, the currently approved checkpoint therapy for this indication is associated with an incidence of 21% immune-related adverse events. “The data suggest that a high percentage of patients who respond within the first three months to treatment will maintain that complete response for 18 months and possibly beyond. But most importantly, 85% of the patients in the cohort avoided a cystectomy,” said Principal Investigator Karim Chamie, M.D., Associate Professor of Urology at UCLA. “The AUA-FDA workshop set a lofty, clinically meaningful benchmark: 30% of patients receiving treatment for their BCG-unresponsive bladder cancer remaining disease-free 18–24 months. Unfortunately, none of the FDA-approved (or under FDA evaluation) agents have come close to the goal; by 12 months, only 20% of patients are disease-free. But for the first time, we now have a product with N-803 + BCG that has hit the AUA-FDA 30% 18-month milestone. With its well-tolerated safety profile, I am confident that N-803 + BCG will make a meaningful impact on the lives of patients with BCG-unresponsive bladder cancer.” The data was announced on Friday, Sept. 10 during an oral presentation at the American Urological Association’s Annual Meeting titled “PD09-05: Phase 2/3 clinical results of IL-15aFc superagonist N-803 with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in-situ (CIS).” Bladder cancer has a high incidence worldwide; in 2020, an estimated 573,278 new cases were diagnosed and it was the cause of 212,536 deaths1. In the United States, bladder cancer is the fourth most commonly diagnosed solid malignancy in men and the twelfth for women. In the US, the American Cancer Society estimated 81,400 new cases and 17,980 deaths2. Approximately 75-85% of all newly diagnosed cases of bladder cancer are non-muscle invasive bladder cancer (NMIBC)3. “We are pleased with the sustained durable response and the significant avoidance of cystectomy in this patient population. In those patients who responded by three months after the initial treatment, it is encouraging to see that the median duration of that response, even after 18 months, has not yet been reached,” said Patrick Soon-Shiong, M.D., Founder and Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “In the resistant patients who were re-induced after failing to respond to N-803 and BCG in the first three months, but who responded following a “rescue reinduction” at six months, the median duration of response was shorter, but nonetheless, this immunotherapy candidate delayed cystectomy.”

ImmunityBio Announces Positive Durable Responses in BCG Unresponsive Bladder Cancer Patients with a Complete Response Rate of 72%, Median Duration of Complete Response of 19.9 Months, and 85% Remaining Cystectomy-free in Phase 2/3 Trial. 58 out of 81 (72%) patients achieved a complete response at any time (three or six months), which compares favorably to historical complete response rates of 41% and 18% for FDA-approved therapies pembrolizumab and valrubicin, respectively Median duration of complete response in all responders is 19.9 months and 85% of patients enrolled in the study have avoided a cystectomy as of May 2021 61% probability of initial responders (complete response at three months) remaining disease free at 18 months 0% treatment- or immune-related adverse events (AEs) or serious adverse events (SAEs) reported.

Stellenausschreibung: Manager, Quality Systems ImmunityBio, Inc.  Louisville, Colorado, Vereinigte Staaten von Amerika https://www.linkedin.com/jobs/view/2706807697

DekaBank Deutsche Girozentrale Takes $577,000 Position in ImmunityBio, Inc. (NASDAQ:IBRX) 9/8/21

Catalysts = 1. Bladder data update on Friday ( followed closely by BLA announcement-2H of 2021) 2. Hoag Hospital (USA) COVID-19 update in November (phase 1/2) 3. Hoag Hospital Pancreatic Cancer trial update in January ( Dr. Seery)

Johnson&Johnson May Follow ImmunityBio’s South African Covid Booster Shot Trial "While ImmunityBio’s trial is in its first phase, with about 50 participants, it is expected to reach its third and final stage in October, with about 10,000 people receiving doses, she said." https://www.bloomberg.com/news/articles/2021-09-08/j-j-may-follow-immunitybio-s-south-african-booster-shot-trial

“The timing is right for ImmunityBio to build out our commercial team and we could not have chosen stronger commercial leaders than Helen and Sigrid,” said Richard Adcock, President and CEO, ImmunityBio. “Their combined 35 years of commercial expertise in oncology therapeutics is well aligned with our growth strategy as we advance our Phase 3 trials for bladder and lung cancer and continue to make progress with our various Phase 2 trials. We are excited to have them on our team and value the energy they will inject into this key aspect of the business.” As Chief Commercial Officer, Luu will take on the vital responsibilities of the company’s global commercial strategy, including the design and execution of expansion into the oncology and urology markets, as well as establishing key external alliances to support the commercial success of ImmunityBio. With more than 16 years of experience in multichannel and specialty biotech operations, Luu thrives in rapidly changing, highly competitive environments and specializes in business development, corporate restructuring, sales optimization, and process improvement to drive corporate revenue. Luu began her biotech career at Gilead Sciences and was the top sales contributor for three consecutive years. Schreiner brings more than 25 years of biopharma experience to ImmunityBio. She will be responsible for developing the company’s global payer, reimbursement, and distribution strategies, as well as managing patient access and key accounts.

Prior to her role at Stemline Therapeutics, Schreiner held market access roles with Dendreon, Lash Group (AmerisourceBergen), Immunex, and CTI Biopharma. She also led strategic planning and process improvement projects at Deloitte Management Consulting for health plans and physician organizations. Luu joins ImmunityBio effective September 7, 2021, while Schreiner joins the company effective September 13, 2021. https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-builds-commercial-team-appointment-seasoned?field_nir_news_date_value[min]=

ImmunityBio Builds Commercial Team with the Appointment of Seasoned Marketing and Reimbursement Executives Helen Luu, former CEO of Cell BT, is named ImmunityBio’s first Chief Commercial Officer and brings a strong background in product commercialization in the urology market, business development, sales growth, and oncology market expansion. Sigrid Schreiner joins as Senior Vice President of Global Market Access, adding decades of market access experience to the leadership team, including the market launch of chemotherapy Abraxane®. CULVER CITY, Calif.--(BUSINESS WIRE)--Sep. 7, 2021-- ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced two key executive appointments that bring industry-leading market growth and access experience to the company. Helen Luu will serve as the company’s first Chief Commercial Officer, joining ImmunityBio from her position as CEO of CAR-T developer Cell BT. The company also named Sigrid Schreiner as Senior Vice President of Global Market Access. She joins the company from Stemline Therapeutics (now Menarini Group), a global commercial-stage oncology therapeutics company. “The timing is right for ImmunityBio to build out our commercial team and we could not have chosen stronger commercial leaders than Helen and Sigrid,” said Richard Adcock, President and CEO, ImmunityBio. “Their combined 35 years of commercial expertise in oncology therapeutics is well aligned with our growth strategy as we advance our Phase 3 trials for bladder and lung cancer and continue to make progress with our various Phase 2 trials. We are excited to have them on our team and value the energy they will inject into this key aspect of the business.” As Chief Commercial Officer, Luu will take on the vital responsibilities of the company’s global commercial strategy, including the design and execution of expansion into the oncology and urology markets, as well as establishing key external alliances to support the commercial success of ImmunityBio. With more than 16 years of experience in multichannel and specialty biotech operations, Luu thrives in rapidly changing, highly competitive environments and specializes in business development, corporate restructuring, sales optimization, and process improvement to drive corporate revenue. “I am thrilled to join ImmunityBio at this exciting time as the company approaches the potential global launch of the company’s oncology portfolio,” said Helen. “And I look forward to working with the ImmunityBio leadership team to ensure patients around the world will have access to the company’s innovative therapies.” Luu joined Cell BT as its first Chief Operating Officer where she was responsible for directing the company’s strategic positioning and operations, as well as expanding the scope of its pipeline. Prior to Cell BT, Luu was the head of business development at Dendreon, the leading innovator of immunotherapy for the treatment of prostate cancer. During her 10-year tenure at Dendreon, she held various commercial leadership roles and responsibilities, including the successful launch of the national urologic oncology hospital sales team to strategically accelerate revenue growth. Luu began her biotech career at Gilead Sciences and was the top sales contributor for three consecutive years. Schreiner brings more than 25 years of biopharma experience to ImmunityBio. She will be responsible for developing the company’s global payer, reimbursement, and distribution strategies, as well as managing patient access and key accounts.

ImmunityBio Announces Oral Presentation of Phase 2/3 Clinical Trial Results of Patients with BCG-Unresponsive Bladder Cancer Carcinoma at the Upcoming American Urological Association’s Annual Meeting CULVER CITY, Calif.--(BUSINESS WIRE)--Sep. 1, 2021-- ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced Karim Chamie, M.D., Associate Professor of Urology, UCLA Department of Urology, will be presenting the Phase 2/3 clinical results of IL-15 Superagonist N-803 with BCG in BCG-unresponsive bladder cancer at the American Urological Association’s Annual Meeting on Sept. 10th. Updated data will be presented as a follow-up to Dr. Chamie’s oral presentation at ASCO GU in February 2021 in which 72 subjects in Cohort A of the QUILT 3.032 trial were evaluated. Eighty-one subjects are now fully enrolled in Cohort A and evaluable with median follow-up of over 20 months. The full oral presentation, titled “PD09-05: Phase 2/3 clinical results of IL-15RαFc superagonist N-803 with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in-situ (CIS) patients,” will be available in the Events section of ImmunityBio’s Investor Relations website on Friday, Sept. 10 at 10:10 a.m. PDT. QUILT 3.032 is an open-label, three cohort multicenter Phase 2/3 study of intravesical BCG plus Anktiva™ (N-803) in patients with BCG-unresponsive high-grade NMIBC (NCT03022825) and was opened in 2017. The primary endpoint for Cohort A of this Phase 2/3 study is incidence of complete response (CR) of CIS at any time. The FDA had granted Fast Track Designation to the pivotal trial based on Phase I data. In December 2019, the FDA granted ImmunityBio Breakthrough Therapy Designation based on interim Phase 2 data indicating the primary endpoint of the trial was already met. https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-oral-presentation-phase-23-clinical-trial?field_nir_news_date_value[min]=