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Sorrento Therapeutics has received FDA clearance for its IND application to commence a Phase 1 clinical trial of STI-2099 (COVIDROPS), an intranasal antibody treatment for mild COVID-19. The trial aims to evaluate the safety and pharmacokinetics of STI-2099 in healthy volunteers and COVID-19 patients. This marks the first FDA approval for an intranasal neutralizing antibody against SARS-CoV-2. Following Phase 1, Sorrento plans to advance to Phase 2 trials, potentially utilizing STI-2099 alone or in combination with STI-2020 (COVI-AMG).
Sorrento Therapeutics announced FDA clearance for its anti-CD47 antibody, STI-6643, for a Phase 1B basket trial targeting relapsed or refractory malignancies. This trial will be conducted at Moffitt Cancer Center, showing no need for complex dosing regimens which have hindered previous anti-CD47 antibodies. Preclinical results indicate STI-6643 has lower toxicity and preserves anti-tumor immune cells, hinting at potential 'best-in-class' status. This marks Sorrento's second anti-CD47 candidate, joining IMC-002, now in human trials.
Sorrento Therapeutics (NASDAQ: SRNE) and its subsidiary Scilex Holdings have signed an exclusive licensing agreement with Aardvark Therapeutics to acquire ARD-301, a formulation for chronic pain treatment including fibromyalgia and post-COVID syndrome. Scilex plans to launch a Phase 2 trial for fibromyalgia, targeting over 10 million U.S. adults affected by the condition. ARD-301 offers a non-opioid solution, addressing the limitations of existing treatments and the opioid crisis. This collaboration aims to meet the high unmet medical needs in chronic pain management.
Lee's Pharma has received breakthrough therapy designation (BTD) from the China National Medical Products Administration (NMPA) for socazolimab, an anti-PD-L1 antibody, aimed at treating recurrent or metastatic cervical cancer. The company plans to file a new drug application (NDA) for fast-track conditional approval in Q2 2021. Dr. Benjamin Li Xiaoyi highlighted the significant unmet medical need for cervical cancer treatments in China. Sorrento Therapeutics, the licensor of socazolimab, intends to expand its partnership with Lee's Pharma for additional therapeutic antibodies.
Sorrento Therapeutics has formed ADNAB, Inc., a subsidiary to develop the ADNAB™ platform co-created with the Mayo Clinic, focusing on antibody-drug conjugates for treating cancers, including endometrial and ovarian. The ADNAB™ technology utilizes nanoparticle drugs conjugated with monoclonal antibodies and has nine candidates under development. Clinical studies are underway at Mayo, with filings for multiple INDs expected this year. The company aims to extend the platform beyond oncology into autoimmune diseases, highlighting its potential therapeutic impact.
Sorrento Therapeutics (SRNE) announced the successful treatment of COVID-19 patients using COVI-MSC, a stem cell therapy, in a Phase 1b study. All four ICU patients treated with COVI-MSC were discharged from the hospital after receiving three infusions. The most recent patient, who required mechanical ventilation, improved rapidly after treatment. The study focuses on the safety and preliminary efficacy of COVI-MSC for COVID-19-induced acute respiratory distress. No serious safety events were reported, affirming the treatment's promise in critical care settings.
Sorrento Therapeutics (Nasdaq: SRNE) announced preliminary results from its SARS-CoV-2 mutation surveillance program for neutralizing antibodies against COVID-19. Dr. Robert Allen presented data at PepTalk 2021, highlighting STI-2020's maintained efficacy against the B.1.1.7 variant and noting reduced potency against the B.1.351 variant. Additional neutralizing antibodies are under analysis for inclusion in the COVI-SHIELD-2021 cocktail. This data is critical as the CDC predicts these variants may dominate U.S. infections soon.
Sorrento Therapeutics (Nasdaq: SRNE) announced that Dr. Henry Ji, Chairman and CEO, will participate in a fireside chat during the B. Riley Securities Oncology Investor Conference. The event is scheduled for January 20, 2021, at 2:30 PM ET. A live webcast will be available for registered participants and can be accessed for over 90 days post-event. Sorrento is a clinical-stage biopharmaceutical company focusing on cancer treatments and developing antiviral therapies against coronaviruses.
Sorrento Therapeutics (Nasdaq: SRNE) announced that Dr. Henry Ji, Chairman and CEO, will participate in the H.C. WAINWRIGHT BIOCONNECT 2021 virtual conference from January 11-14, 2021. The corporate presentation will be available on-demand for 90 days starting January 11 at 6:00 AM EST. Sorrento is focused on developing innovative therapies for cancer, including its G-MAB™ library and CAR-T therapies. The company is also advancing antiviral therapies against coronaviruses and other treatments for pain management.
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