New option listings for March 10th include Burgundy Technology Acquition Corporation (Class A Stock) (BTAQ), Better World Acquisition Corporation (BWAC), CONX Corporation (Class A Stock) (CONX), Decarbonization Plus Acquisition Corporation (Class A Stock) (DCRB), dMY Technology Group Inc III (Class A Stock) (DMYI), FG New America Acquisition Corp (Class A Stock) (FGNA), FirstMark Horizon Acquisition Corp (Class A Stock) (FMAC), Gores Holdings VI Inc (Class A Stock) (GHVI), Greenrose Axquisition Corporation (GNRS), Health Assurance Acquisition Corporation (Class A Stock) (HAAC), Horizon Acquisition Corporation II (Class A Stock) (HZON), ION Acquisition Corp 1 Ltd (Class A Stock) (IACA), ImmunityBio Inc (IBRX), IG Acquisition Corporation (Class A Stock) (IGAC), Landcadia Holdings III Inc (Class A Stock) (LCY), Ribbit LEAP Ltd (Class A Stock) (LEAP), Lefteris Acquisition Corporation (Class A Stock) (LFTR), Lux Health Tech Acquisition Corporation (Class A Stock) (LUXA), Merida Merger Corporation I (MCMJ), Oncorus Inc (ONCR), Pine Island Acquisition Corp (Class A Stock) (PIPP), Revolution Acceleration Acquisition Corporation (Class A Stock) (RAAC), RMG Acquisition Corporation II (Class A Stock) (RMGB), Sports Entertainment Acquisition Corp (Class A Stock) (SEAH), Supernova Partners Acquisition Company Inc (Class A Stock) (SPNV), Sypris Solutions (SYPR), Main Thematic Innovation (TMAT), TS Innovation Acquisition Corporation (Class A Stock) (TSIA), TWC Tech Holdings II Corporation (TWCT), Foley Trasimene Acquisition Corp (Class A Stock) (WPF), DPCM Capital Inc (Class A Stock) (XPOA), and Yalla Group Limited (Class A ADS) (YALA). Option delistings effective March 10th include NantKwest Inc (NK).
NantKwest announced that its stockholders approved by the required vote each of the proposals related to the pending merger of NantKwest and ImmunityBio, Inc. presented at the special meeting of stockholders held earlier in the day, including approval of the merger by a majority of unaffiliated stockholders of NantKwest. The merger is expected to close on March 9, 2021, subject to the satisfaction of customary closing conditions. Following the closing of the transaction, the combined company will assume the ImmunityBio name and its shares of common stock are expected to trade on NASDAQ under the symbol "IBRX" commencing on March 10, 2021.
ImmunityBio and NantKwest announced the first cohorts of their South Africa and U.S. COVID-19 vaccine trials have received their initial doses of the company's T-cell-based COVID-19 vaccine candidate, hAd5. This candidate is unique in targeting both the spike and nucleocapsid proteins of the SARS-CoV-2 virus. These trials will determine which route combination provides the strongest immune response and long-term immunity, as well as the vaccine candidate's effectiveness against the growing number of mutated variants of the virus. In the three trials, the hAd5 vaccine candidate is being administered in a subcutaneous, oral, or sublingual formulation. The Phase I trial in Cape Town, South Africa is using subcutaneous administration and nine participants have been dosed to date. It is expected to be followed by sublingual delivery and room temperature-stable oral capsule trials. The two U.S. Phase Ib trials are studying a combination of subcutaneous/sublingual and subcutaneous/oral formulations; six participants have been dosed in each trial to date. In total, 140 participants will be enrolled in the South African and U.S. trials.
ImmunityBio and NantKwest announced they have received FDA authorization to expand Phase I testing of a bivalent hAd5 T-cell COVID-19 vaccine. The FDA authorized the expansion of a currently active multi-cohort trial of the subcutaneous version of the vaccine in order to study the addition of sublingual boosts. The FDA also authorized a second Phase I study that will examine the addition of an oral boost to the subcutaneous prime administration. As a result, the companies will enroll another 105 participants in the U.S. trials of their vaccine candidate, which is unique in targeting both the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus. The expectations of inducing protective immune responses in healthy volunteers - with this novel combination of an oral boost with a subcutaneous prime - are based on the positive findings reported in the NIH/BARDA-sponsored Non-Human Primate (NHP) study. This recent data showed that when administered with an oral boost, the bivalent vaccine resulted in potent stimulation of S- and N-specific T cells with potent antibody release from memory B cells following viral challenge. Additionally, activation of the full immune system by S and N proteins resulted in complete viral clearance of SARS-CoV-2 in lung and nasal passages following the challenge. On the basis of these findings, ImmunityBio has expanded the current Phase 1 study of subcutaneous prime with oral or sublingual boost to explore the potential of this second-generation vaccine to reduce disease and transmission of the virus.
CytRx (CYTR) highlighted that NantKwest (NK) and ImmunityBio have announced that their ongoing Phase 2 clinical trials of a novel combination immunotherapy - which include CytRx's licensed drug aldoxorubicin - for locally advanced or metastatic pancreatic cancer have produced early indications of increased survival rates for patients with no other approved treatment options. Interim results of the three-cohort trials, known as QUILT 88, show median survival rates more than doubled that of the historic rate in patients with advanced metastatic pancreatic cancer.
NantKwest and ImmunityBio announced early interim results of its PD-L1 t-haNK protocols showing median survival rates more than doubled that of the historic rate in patients with advanced metastatic pancreatic cancer for which no other FDA-approved treatment exists. These trials, which were based on the original Cancer Moonshot hypothesis and exploratory QUILT trials initiated in 2017, appear to validate the theory that by orchestrating natural killer and T-cell therapy, survival rates could be improved without high-dose chemotherapy.
CytRx (CYTR) congratulated ImmunityBio and NantKwest on their proposed merger and announced plans to create a leading immunotherapy and cell therapy company. 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. In their announcement, ImmunityBio and NantKwest highlighted that the combined entity will have a broad clinical-stage pipeline - including 13 assets in clinical trials and 11 in Phase 2 to 3 programs - as well as a robust early-stage pipeline to address other difficult to treat cancers. The companies also noted that the combination of NantKwest's Natural Killer cell platform and ImmunityBio's immunotherapy platforms - including albumin-based tumor microenvironment immune modulators- have already resulted in complete responses in aggressive and late-stage metastatic cancers. To date, complete responses have been noted in patients with second-line or greater metastatic pancreatic cancer, triple-negative breast cancer, head and neck cancer, and Merkel Cell Carcinoma. Notably, ImmunityBio and NantKwest recently announced the addition of a third cohort to an ongoing Phase 2 study of a novel combination immunotherapy - which includes aldoxorubicin - for locally advanced or metastatic pancreatic cancer (QUILT-88). As previously outlined in CytRx's October 7, 2020 announcement regarding the successful treatment delivered to former Nevada Senator Harry Reid for his stage IV pancreatic cancer, the randomized, open-label study is evaluating the safety and efficacy of a combination immunotherapy that includes aldoxorubicin, ImmunityBio's IL-15 superagonist Anktiva NantKwest's PD-L1 t-haNK and standard of care. The study results will be compared to standard of care chemotherapy for first- and second-line treatment. However, the third-line cohort is a single arm with no comparator and each cohort will be evaluated independently to provide a more precise comparative.