|Over a week ago|
ImmunityBio expands cancer, infectious disease vaccine programs » 09:0711/1811/18/21
ImmunityBio announced the…
ImmunityBio announced the expansion of the company's cancer and infectious disease vaccine programs to include self-amplifying self-adjuvating RNA, recombinant protein vaccine candidates, and potent adjuvant formulations that enhance the quality, durability and breadth of immune responses to infectious diseases and cancer. When combined with the company's hAd5 T-cell-based vaccine candidate, the company believes this "mix-and-match" approach will enable a new generation of COVID-19 vaccines that could potentially confer long-term immune memory to overcome the threat of current and future variants of the SARS-CoV-2 virus. ImmunityBio has established partnerships to bring these technologies together to establish a vaccine consortium and develop multiple vaccine candidates, conduct comprehensive clinical testing, and to immediately further scale ImmunityBio's manufacturing capabilities for global capacity for each of these vaccine candidates. The creation of this novel "mix-and-match" platform, which is also rapidly amenable to incorporation of variant constructs as they emerge, is aimed at establishing widespread availability of cost-effective, broad-spectrum vaccines to meet the remaining global need for COVID-19 vaccines and boosts.
|Over a month ago|
Piper says ImmunityBio could have 'blockbuster opportunity' with Anktiva » 15:2810/1910/19/21
After ImmunityBio announced that Cohort B in patients with papillary only disease, the second indication of its QUILT 3.032 Phase 2/3 study of intravesical BCG plus Anktiva in patients with BCG-unresponsive high-grade non-muscle invasive bladder cancer, or NMIBC, also met its primary endpoints, Piper Sandler analyst Joseph Catanzaro said he thinks this agent "could represent a blockbuster opportunity." The analyst, who noted Cohort A in CIS patients also met its primary endpoint, estimates that an initial indication in CIS represents about a $300M peak U.S. sales opportunity with the potential to expand into papillary disease and potentially BCG-naive patients. He has an Overweight rating and $25 price target on ImmunityBio shares.
ImmunityBio reports QUILT 3.032 study met primary endpoint in second indication » 09:0610/1910/19/21
ImmunityBio announced that Papillary disease, the second indication of its QUILT 3.032 Phase 2/3 study of intravesical BCG plus Anktiva in patients with BCG-unresponsive high-grade NMIBC, also met its primary endpoints with disease-free survival of 57% of patients at 12 months. The company has previously reported that the primary endpoint of Cohort A, patients with CIS disease, has been met with a complete response of 72%. Current standard of care for high-grade papillary disease is intravesical BCG, with a 40% non-response rate. To date, 73 patients have enrolled in Cohort B with a median follow-up of 17.3 months. The primary endpoint was met with a disease-free rate at 12-months of 57% and at 18-months, 53% by Kaplan-Meier analysis. Durable responses were noted in both cohorts and the therapy resulted in significant avoidance of cystectomy. The safety profile of Anktiva in Cohort B was consistent with that seen in Cohort A, which was recently presented at the American Urological Association's 2021 Annual meeting, in which 0% SAEs, including 0% immune-related SAEs, were detected. In addition, 85% of the patients were able to avoid a cystectomy. A full analysis of efficacy and safety data for both Cohorts A and B has been submitted to the American Society of Clinical Oncology Genitourinary Cancer Symposium in February 2022.
ImmunityBio completes enrollment in Cohort C of immunotherapy trial » 09:0810/1310/13/21
ImmunityBio announced it…
ImmunityBio announced it has fully accrued the initial planned number of participants in Cohort C of its Phase 2 trial studying a combination immunotherapy in advanced metastatic pancreatic cancer. The majority of participants in the study to date remain on therapy and 90% of the evaluable patients have exceeded the approximately two-month historical survival rate. Of the 48 evaluable patients, 23 had extremely advanced disease upon enrollment and, of these patients, 20 out of 23 have exceeded historical survival rates. The company has submitted an amendment to increase enrollment in Cohort C.
NCI selects ImmunityBio's receptor agonist Anktiva -Keytruda combo for NSCLC » 08:5010/0410/04/21
ImmunityBio (IBRX) …
ImmunityBio (IBRX) announced the Lung Cancer Master Protocol public-private partnership-which includes the National Cancer Institute, the National Clinical Trials Network Cooperative Groups SWOG, ECOG-ACRIN, Alliance, and NRG, Friends of Cancer Research, and the Foundation for the National Institutes of Health -will study the company's IL-15 receptor superagonist complex, N-803, Anktiva, in the Lung-MAP trial. Anktiva will be given in combination with Merck's pembrolizumab, Keytruda (MRK), to participants with non-small cell lung cancer who have failed previous treatments. The combination therapy will be offered as a treatment to patients with tumors that do not have mutations targetable with a drug, which is the case for the majority of NSCLC patients. The Lung-MAP trial is open at more than 700 sites in the U.S. When fully enrolled, this trial group will include 478 patients. "While some patients with lung tumors have targetable genetics, the majority do not, and for them there are fewer treatment options," said John Wrangle, M.D., one of the researchers at the Medical University of South Carolina who developed the study. "The Lung-MAP study aims to change that by combining different therapies such as Anktiva and Keytruda in an effort to discover highly effective and targeted
ImmunityBio announces updated data from QUILT 3.032 study » 08:3409/1309/13/21
ImmunityBio 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, or CIS, bladder cancer. Of the 81 patients in the QUILT 3.032 study, 58 patients had a complete response at any time to intravesical BCG plus N-803 with median duration of CR of 19.9 months. The data also showed a 59% probability 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.
|Over a quarter ago|
CytRx highlights preliminary results of Cohort C of pancreatic cancer trial » 08:5707/2907/29/21
CytRx (CYTR) highlighted…
CytRx (CYTR) highlighted that ImmunityBio (IBRX) has been granted a patent by the U.S. Patent and Trademark Office for its proprietary NANT Cancer Vaccine . ImmunityBio's investigational treatment for cancer is designed to bolster a patient's own immune response to cancerous cells, augment that response with additional natural killer and T-cell therapies to overcome the cancer's resistance, and induce long-term T-cell memory to induce remission across multiple tumor types. As previously disclosed, CytRx out-licensed global development, manufacturing and commercialization rights for Aldoxorubicin to ImmunityBio in 2017. The Company has an agreement with ImmunityBio that can yield up to $343M in potential milestone payments and single and double-digit royalties on sales of Aldoxorubicin. To study the safety and early efficacy signals across multiple tumor types, ImmunityBio has launched a series of Quantitative Lifelong Trials QUILT. To date, the vaccine has been studied in more than 100 patients across multiple tumor types, including pancreatic, breast, colorectal, and head and neck cancers. Among these studies is QUILT 88, a Phase 2 trial that includes Aldoxorubicin and is studying the vaccine in metastatic pancreatic cancer patients. Enrollment of Cohort C, which includes Aldoxorubicin and patients who have previously failed two lines of standard-of-care therapy, is expected to be completed in the third quarter of 2021 and an early readout of survival data is expected in the first quarter of 2022.
ImmunityBio's NANT Cancer vaccine awarded U.S. patent » 09:0607/2707/27/21
ImmunityBio announces that it has been granted a patent by the U.S. Patent and Trademark Office for its proprietary NANT Cancer Vaccine. This novel investigational treatment for cancer is designed to bolster a patient's own immune response to cancerous cells, augment that response with additional natural killer and T-cell therapies to overcome the cancer's resistance, and induce long-term T-cell memory to induce remission across multiple tumor types...To study the safety and early efficacy signals across multiple tumor types, the company has launched a series of Quantitative Lifelong Trials . To date, the NANT Cancer Vaccine has been studied in more than 100 patients across multiple tumor types, including pancreatic, breast, colorectal, and head and neck cancers. Among these studies is QUILT 88, a Phase 2 trial studying the NCV in metastatic pancreatic cancer patients. Enrollment of Cohort C, patients who have previously failed two lines of standard-of-care therapy, is expected to be completed in the third quarter of 2021 and an early readout of survival data is expected in the first quarter of 2022. "We are excited to be developing this orchestrated approach to activate as many elements of the immune system that we can and overcome cancer's ability to evade the immune system...This closely aligns with the FDA's recent 'Project Optimist' guidelines for exploring lower doses of therapeutic agents."
ImmunityBio gets OK from South Africa for dual-antigen T-cell for Covid booster » 09:0707/1407/14/21
ImmunityBio announced authorization from the South Africa Health Products Regulatory Authority, SAHPRA to proceed with the South Africa Sisonke T-Cell Universal Boost trial. The Phase 1/2/3 study, which will begin in Q3 2021, is designed to evaluate hAd5 Spike + Nucleocapsid as a boost for South African healthcare workers previously vaccinated with an S-only vaccine. "With the virus continuing to spread, moving forward with this boost trial is crucial," said Leonard Sender, M.D., Chief Operating Officer of ImmunityBio. "We are encouraged by the preliminary safety findings in our ongoing Phase 1 studies in both the U.S. and South Africa. In addition, our U.S. data show that just a single prime subcutaneous vaccination with our COVID-19 vaccine candidate induces a 10-fold increase in T cell response-equivalent to T cell responses from patients previously infected with SARS-CoV-2. We have also shown that the T-cell responses are maintained against variants, which is critical to providing protection against this ever-changing virus." In the trial, the effect of combining vaccination by two routes of administration-subcutaneous and sublingual -will be assessed. This combination has the potential to deliver protection from the virus with a single jab followed by droplets placed under the tongue. Methods that do not require injection such as SL, intranasal, and oral capsule offer potential advantages depending on the participant's needs or situation. Sublingual administration results in the most rapid absorption, while nasal spray or oral capsule delivery have the potential to provide mucosal immunity, which could reduce both the chance of infection and potential spread of the virus via the respiratory tract. The three non-jab formulations also can be administered without a trained healthcare worker and are easier to transport and store. The SL and nasal routes of administration are also currently being tested in a separate Phase 1 trial in South Africa.
Ambrx Biopharma appoints Sonja Nelson as CFO » 08:2106/3006/30/21
Ambrx (AMAM) announced…
Ambrx (AMAM) announced the appointment of Sonja Nelson to CFO. Nelson is an experienced financial executive, who joins Ambrx with 10 years of executive experience within the biotechnology industry. Most recently, she served as CFO at NantKwest, now ImmunityBio (IBRX).