IBRX stock rose 11.5% in after-hours trading on January 18, 2022, after the company reported trial incredibly awesome results on its pancreatic cancer study.
ImmunityBio Announces Results of Phase 2 Metastatic Pancreatic Cancer Trial at ASCO GI With Median Overall Survival of 6.3 Months in Patients With Third-Line Disease, More Than Doubling Historical Survival
On January 18, 2022, ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, announced interim results (N=63) in its metastatic pancreatic cancer trial (QUILT 88) showing that the overall survival rate for patients doubled compared to historical survival rate of three months after two prior lines of therapy (Manax ASCO GI 2019). The data of the Phase 2 trial studying a combination immunotherapy (Nant Cancer Vaccine) also show treatment-related serious adverse events were uncommon (8%) and no treatment-related deaths were reported. Based on these findings, ImmunityBio plans to meet with the FDA in 2022 to discuss the path for the approval of combination therapies for pancreatic cancer.
The results were presented today at the American Society of Clinical Oncology Gastrointestinal conference, which is being held virtually.
Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives in the U.S. every year. Surgery and subsequent adjuvant chemotherapy are the preferred treatment options for pancreatic cancer today, but the five-year survival rate for late-stage cases is just 3%. For the majority of patients who present with more advanced disease, treatment typically consists of chemotherapy alone or supportive care for metastatic patients, and chemotherapy with or without radiation for those with locally advanced disease, leaving patients seeking new options.
“There are thousands of patients in advanced stages of this disease and there are few, if any, treatment options for them,” said Patrick Soon-Shiong, M.D., Founder and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. “Based on this encouraging data from our QUILT 88 trial, we are hopeful that our Nant Cancer Vaccine can potentially address this unmet need. What’s more, we designed this therapeutic candidate to be administered in an outpatient setting making it more accessible to future patients than traditional immune checkpoint inhibitors.”
To date, 27% of third-line or greater patients (17/63) remain on study. The median overall survival in this highly advanced group of patients, who failed two to six prior lines of treatment, is 5.8 months (95% CI: 3.9, 6.9 months) exceeding the approximately three-month historical median overall survival. Of the 63 patients, 30 (48%) had progressed after two prior lines of therapy. Median overall survival in this group was 6.3 months (95% CI: 5.0, 9.8 months), more than doubling the historical overall survival. On the strength of this early data and significant unmet medical need, the company has expanded enrollment in the third-line or greater cohort.
QUILT 88 is an open-label study to evaluate the safety and efficacy of the Nant Cancer Vaccine, comprising ImmunityBio’s IL-15 receptor agonist Anktiva (N-803), its off-the-shelf targeted natural killer cells (PD-L1 t-haNK), and aldoxorubicin, an albumin-modulated agent, plus low-dose chemotherapy. This combination Nant Cancer Vaccine is randomized against standard-of-care high-dose chemotherapy for first- and second-line treatment; the third-line or greater cohort, with an original target of 50 patients, is a single arm with the primary endpoint of overall survival.
QUILT-88 Study Details
This Phase 2, randomized, three-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus low-dose chemotherapy in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The study is expected to enroll 328 subjects across all three cohorts giving effect to the expanded enrollment of Cohort C (63 of 80 participants are currently enrolled in Cohort C, third-line or greater). The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).
Currently, three trial sites have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota, which serves patients in the tri-state area (Iowa, Nebraska and South Dakota).
ImmunityBio is a leading late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company’s broad immunotherapy and cell therapy platforms—including Antibody cytokine fusion proteins, synthetic immunomodulators, vaccine technologies (hAd5 viral vector, mRNA, recombinant protein, and adjuvant), and genetically-modified, off-the-shelf natural killer cells (autologous and allogenic cytokine-enhanced memory NK cells)—activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”
ImmunityBio’s clinical pipeline consists of 21 clinical trials—13 of which are in Phase II or III development—across 12 indications in solid and liquid cancers (including bladder, pancreatic, and lung cancers) and infectious diseases (including SARS-CoV-2 and HIV). Anktiva™, ImmunityBio’s lead cytokine infusion protein, is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).
The company has established GMP manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R&D, clinical trial, and regulatory operations, and development teams. For more information, please visit: https://www.immunitybio.com
Athenex announces agreement with ImmunityBio on Dunkirk facility
On January 12, 2022, Athenex (ATNX) announced that it has entered into a definitive agreement for ImmunityBio (IBRX) to assume its leasehold interest in a manufacturing facility in Dunkirk, New York, and certain related assets for approximately $38M, subject to adjustment at closing. Proceeds from the sale will be used to service the Company’s debt obligations and for other general corporate purposes. The transaction is subject to customary closing conditions and is expected to close in the first quarter of 2022. Upon the closing, ImmunityBio will assume all capital expenditure and hiring obligations of Athenex pursuant to its agreements with New York State. Athenex will continue to operate its existing Athenex Pharmaceutical Division, APD, and Athenex Pharmaceutical Solutions, APS, divisions. Athenex has not assigned any of its rights to its corporate headquarters in Buffalo, New York and will retain all of its rights and obligations with respect to its corporate headquarters. ImmunityBio has entered into a preliminary agreement with Athenex to allow APS the ability to manufacture its 503B products at the Dunkirk facility and the parties plan to enter into a definitive preferred contract manufacturing agreement.
📺 Flashback: NantKwest’s Patrick Soon-Shiong on reverse merger with ImmunityBio
[embedyt] https://www.youtube.com/watch?v=rVMW4tByU3g[/embedyt]📉 IBRX Stock Technical Analysis
The long-term trend is still negative, but the short-term trend is neutral. The rising large players volume is bullish. It is advised to wait a little bit longer to see how this turns out. IBRX is currently trading near the lower end of its 52-week range, which is not a good sign. The S&P500 Index is trading in the upper part of its 52-week range, so IBRX is lagging the market.
There is support at 6.08 from a horizontal line in the daily time frame. There is also support at 5.66 from a horizontal line in the daily time frame.
There is a resistance zone ranging from 6.59 to 6.68. This zone is formed by a combination of multiple trend lines and important moving averages in multiple time frames. There is resistance at 6.85 from a trend line in the daily time frame. Finally, there is a resistance zone ranging from 7.02 to 7.08. This zone is formed by a combination of multiple trend lines and important moving averages in multiple time frames.
IBRX has a bad technical rating, but it does show a decent setup pattern. Prices have been consolidating lately and the volatility has been reduced. We notice that large players showed an interest for IBRX in the last couple of days, which is a good sign.
