|Over a week ago|
Sorrento Therapeutics gets FDA clearance to proceed with Phase 2 Sti-3031 study » 11:4204/2704/27/21
Sorrento Therapeutics and…
Sorrento Therapeutics and its development partners have advanced into clinical development a number of fully human monoclonal antibodies or the treatment of COVID-19 and various cancers. Two independent anti-PD-L1 mAbs are now in Phase 2 and Phase 3 clinical studies. A PD-L1 mAb was licensed to ImmuneOncia Therapeutics, a joint venture between Sorrento and Seoul-based Yuhan Corporation. IMC-001 has completed a Phase 1b study in patients with metastatic or locally-advanced solid tumors and is nearing completion of a Phase 2, open-label, "Neo-Chance" study in patients with resectable gastric cancer, esophageal cancer and liver cancer. ImmuneOncia has also started to enroll patients in a Phase 2 study in relapsed or refractory extranodal NK/T cell lymphoma, nasal type. Sorrento has filed an IND in the U.S. and received clearance from the FDA to proceed with a Phase 2a study for STI-3031 for advanced urothelial carcinoma. A second antibody, Socazolimab, is licensed to Lee's Pharmaceutical Holdings Limited in the Greater China territory, and has been cleared to begin a multicenter Phase 3 trial as a potential first-line treatment for patients with extensive-stage small-cell lung cancer. Professor Shun Lu is the Principal Investigator. Additionally, Phase 1b studies in several other indications have been completed for this product candidate, including: recurrent metastatic cervical cancer, advanced urothelial carcinoma, and high-grade osteosarcoma after adjuvant chemotherapy for maintenance. In addition, a Phase 1b/2 study has been initiated as a potential neoadjuvant treatment option for esophageal carcinoma. For cervical cancer, a pivotal study has been completed with a breakthrough therapy designation granted by the National Medical Products Administration in China. Sorrento intends to open an IND in the U.S. with the intent to have an end-of-phase 3 meeting or pre-NDA discussion with the FDA for various cancer indications.
Sorrento Therapeutics call volume above normal and directionally bullish » 13:4504/2604/26/21
Bullish option flow…
Bullish option flow detected in Sorrento Therapeutics with 29,657 calls trading, 4x expected, and implied vol increasing almost 3 points to 93.66%. 4/30 weekly 8.5 calls and 4/30 weekly 9 calls are the most active options, with total volume in those strikes near 6,700 contracts. The Put/Call Ratio is 0.13. Earnings are expected on May 10th.
Sorrento Therapeutics announces results of Phase 1b study of COVI-MSC treatment » 09:1604/2004/20/21
Sorrento Therapeutics announced the completion of enrollment in its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells infusions to treat COVID-19 induced acute respiratory failure or acute respiratory distress syndrome. This current study is a single arm, non-randomized Phase 1b study of the safety and preliminary efficacy of COVI-MSCs administered every other day for up to three infusions for a total of 1 x 106 cells/kg, with patients being followed for 28 days following the final infusion. A total of 10 patients were enrolled and all were discharged from the hospital to home within three days of their last infusion. At baseline, all patients required oxygen supplementation and had PaO2/FiO2 ratios ranging from 135 to 256. All patients had various medical co-morbidities in addition to obesity. The 10th patient had been under treatment for nearly 2 weeks without improvement and was discharged after the 2nd COVI-MSC infusion with oxygen saturations in the high 90s on room air. On follow up days later, the patient was still doing well. The study met its primary objective: to demonstrate the safety of intravenous infusion of allogeneic adipose MSC cells in patients with COVID-19-induced ARD or ARDS. Dr. Eyad Almasri, Associate Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine at UCSF Fresno, is the principal investigator of this study. Sorrento will be working with the FDA in the near future once the full dataset is available to plan a placebo-controlled pivotal study to support an emergency use authorization submission. The study is expected to be conducted across multiple sites in the United States and Brazil.
Sorrento Therapeutics files to sell 851,305 shares of common stock for holders 17:0804/0904/09/21
Sorrento subsidiary granted FDA approval for ZTlido label expansion » 15:0304/0904/09/21
Scilex Holding, an over…
Scilex Holding, an over 99% owned subsidiary of Sorrento Therapeutics, announced it has received a supplemental new drug application, or sNDA, approval from the FDA for ZTlido to make an efficacy labeling change with clinical data. "ZTlido is the only lidocaine topical system that has been studied under the water stress conditions, and now has FDA label reflecting its use while showering, swimming and bathing. It gives polymer-based ZTlido a competitive edge as other systems, especially water-based or hydrogel-based formulations, cannot be used when wet and must be removed prior to water exposure," the company stated.
Sorrento's Scilex gets approval from FDA for Ztlido » 09:5504/0904/09/21
Sorrento Therapeutics' majority owned subsidiary Scilex was informed in a letter from the FDA of an NDA approval for Ztildo for relief of pain associated with post-herpetic neuralgia, according to a post to the agency's website. Reference Link
Sorrento Therapeutics enters merger agreement to acquire ACEA Therapeutics » 09:0304/0504/05/21
Sorrento Therapeutics announced the signing of a merger agreement pursuant to which Sorrento will acquire ACEA Therapeutics. The acquisition will include late clinical stage drug Abivertinib, clinical stage candidate AC0058, preclinical stage candidate AC0939, and ACEA's extensive proprietary library of small molecules, which potentially have applications for numerous human disease indications, including non-small cell lung cancer, B cell lymphomas, systemic lupus, rheumatoid arthritis, multiple sclerosis and viral infections. These compounds are being actively studied in clinical trials and/or preclinical models to advance the most promising candidates rapidly to clinical stage development. Abivertinib, a novel small molecule tyrosine kinase inhibitor that selectively targets both a mutant form of the epidermal growth factor receptor and Bruton's tyrosine kinase, was originally identified from ACEA's compound library. Abivertinib has the potential to improve outcomes in resistant prostate cancer, systemic lupus erythematosus, and various B cell lymphomas in addition to NSCLC, an indication for which a registrational/Phase 3 trial has been completed. It is currently being studied as a Phase 2 treatment for COVID-19-induced respiratory compromise in the US and Brazil. A second clinical candidate, AC0058, is a next generation BTK inhibitor, currently in a Phase 1b trial for Lupus patients in the US, which can potentially be expanded to other autoimmune diseases such as multiple sclerosis. The acquisition will also include ACEA's state of the art cGMP facility located in Quzhou, China, on a 23-acre campus with five buildings. This facility has successfully manufactured multiple batches of the active pharmaceutical ingredient and final product in capsules for Abivertinib and AC0058 for clinical studies. The ACEA facility currently has capacity to manufacture up to 5,000 kg/year of APIs and 50,000,000 capsules of final drug product. The ACEA next generation BTKi and other TKI small molecule drug candidates are highly synergistic with Sorrento's broad biological product pipelines in therapeutic antibodies, antibody drug conjugates, autologous chimeric antigen receptor-T and allogeneic dimeric antigen receptor-T cell therapies, oncolytic viruses and IL-2 immune modulators. The synergy will potentially enable Sorrento to develop many life-saving, combinational drugs for difficult-to-treat human illness in oncology, autoimmune and infectious diseases. As previously announced on October 16, 2020, Sorrento and ACEA entered into a letter of intent setting forth the terms and conditions by which Sorrento would acquire ACEA. In consideration for the acquisition, at the closing of the merger, ACEA's equity holders will receive up to an aggregate of $38 million in shares of Sorrento common stock, subject to certain adjustments, based on a price per share calculated in accordance with the merger agreement. In addition to the foregoing consideration, and subject to the achievement of certain clinical and sales milestones, Sorrento will also pay the ACEA equity holders up to $450,000,000 in additional payments, subject to the receipt of certain regulatory approvals and achievement of certain net sales targets with respect to the assets acquired in the merger and with respect to specified royalty-bearing products, five to ten percent of the annual net sales thereof, in each case in accordance with the terms of an earn-out agreement. The amount referenced in clause of the preceding sentence includes the amounts that would have otherwise been due to ACEA under that certain License Agreement, dated July 13, 2020, which agreement will terminate in its entirety at the effective time of the merger. The merger is expected to close in the second quarter of 2021, subject to customary closing conditions and regulatory approval.
|Over a month ago|
Sorrento data make case for expedited EUA filing path, says B. Riley Securities » 10:0103/2603/26/21
After Sorrento Therapeutics announced "significantly positive results" in hospitalized COVID-19 induced acute respiratory distress syndrome patients from its Phase Ib study to evaluate the safety and efficacy of COVI-MSCs, B. Riley Securities analyst Mayank Mamtani said he is "encouraged" by the 100% discharge rate maintained at a relatively larger patient sample size. The analyst, who thinks the early data on COVI-MSC "makes the case for an expedited path" to a potential Emergency Use Authorization filing, reiterates a Buy rating and $26 price target on Sorrento shares.
Sorrento announces updated 'positive' results of Phase 1b study of COVI-MSC » 16:0103/2503/25/21
Sorrento Therapeutics announced updated "positive" results from its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells, or "COVI-MSC," for patients suffering from COVID-19-induced acute respiratory distress or acute respiratory distress syndrome. This ongoing study is a single arm, non-randomized Phase 1b study of the safety and preliminary efficacy of COVI-MSCs administered every other day for three infusions for a total of 1 x 106 cells/kg. The primary objective of this study is to evaluate the safety of intravenous infusion of allogeneic adipose MSC cells in patients with COVID-19-induced ARD or ARDS. Intensive care unit patients with COVID-19-induced respiratory failure, diffuse pulmonary infiltrates and evidence of poor oxygenation: ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ranging from an average of 135 to 225 were enrolled. All nine patients responded rapidly with markedly reduced need for high inspired oxygen concentration and were able to be transferred out of the ICU and discharged from the hospital within several days of their 3rd COVI-MSC infusion. No infusion related safety events have been reported. Currently, Sorrento is working with the FDA to plan a placebo-controlled Phase 2 study to be conducted across multiple sites in the United States, Brazil and Mexico, and to determine the sample size and data necessary to support an emergency use authorization, or EUA. Dr. Henry Ji, President and CEO of Sorrento Therapeutics, stated, "It brings us great pleasure to see our treatments help to save lives, which is our primary goal at Sorrento. We look forward to advancing this important product into Phase 2 development."
Benzinga to hold a virtual conference » 04:5503/2503/25/21
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Benzinga Biotech Small…
Benzinga Biotech Small Cap Virtual Conference will be held on March 24-25. Webcast Link