Sorrento Announces First Patient Treated in Phase IB AL Amyloidosis Trial with STI-6129, an Anti-CD38 Antibody-Drug Conjugate

SAN DIEGO, March 18, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that the first patient has been treated in its Phase 1b Amyloid Light Chain (AL) Amyloidosis study of STI-6129, an ADC which uses STI-5171, a fully human monoclonal antibody (mAb) from Sorrento’s G-MAB™ library. This study is being conducted as a multicenter, open-label, dose-escalation clinical trial in patients with advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis with a primary objective to identify a Phase 2 dose for STI-6129 based on its safety, preliminary efficacy and pharmacokinetic profile.

STI-6129 is an ADC with covalently bound duostatin tubulin inhibitors (Duostatin 5) using a proprietary site-specific C-LOCK™ chemical linker designed to reduce the premature systemic release of duostatin and avoid the potential for toxicity, particular ocular toxicity, seen with other ADCs, especially first-generation products. STI-6129 has demonstrated an improved therapeutic index in animal models, as compared to traditional non-selective conjugates. STI-6129 has the potential for being a first-line treatment for amyloidosis as well as second line in those patients who have developed daratumumab resistance, an anti-CD38 mAb alone. STI-6129 binds to different epitopes than daratumumab and the addition of the targeted delivery of the duostatin can potentially manage those patients who have become refractory to such treatments.

“Enrollment into our amyloidosis study with STI-6129 is another important milestone for Sorrento, and although delayed due to COVID-19, we are pleased this study has started,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “Together with our CD38 CAR-T and DAR-T programs, STI-6129 has the potential to provide additional therapeutic options for patients in need and we are excited to see how it performs in treating patients with AL amyloidosis. We also are looking forward to further evaluating the safety and efficacy of STI-6129 in a soon to start refractory or relapsing multiple myeloma clinical trial.”

For the full press release, please visit: https://investors.sorrentotherapeutics.com/news-releases

SORRENTO-LEVENA Receives FDA ind clearance to initiate a phase i clinical TRIAL of its Cd38 antibody-drug conjugate (ADC) sti-6129 for patients with amyliodosis 

SAN DIEGO, May 26, 2020 /GlobeNewswire/ -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for STI-6129, a CD38-targeting antibody drug conjugate (ADC). STI-6129 utilizes several technology platforms that are under development by Sorrento Therapeutics, including a CD38 specific antibody identified from its fully human G-MAB™ antibody library, its proprietary drug payload Duostatin 5 and its site-specific C-LOCK conjugation technology.

“That the FDA cleared our STI-6129 IND application to proceed to human trials is another important milestone for Sorrento,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “Together with our CD38 CAR-T program, this has the potential to provide additional therapeutic options for patients in need. We are looking forward to further evaluating the safety and efficacy of STI-6129 in clinical trials.”

Sorrento intends to initiate a phase I multicenter, open-label, dose-escalation clinical trial in patients with advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis with a primary objective to identify a phase 2 dose for STI-6129 based on its safety, preliminary efficacy and pharmacokinetic profile. 

“This is Sorrento’s first ADC utilizing our site-specific C-LOCK conjugation technology that is advancing into clinical evaluation,” said Dr. Hui Li, head of Sorrento’s ADC business unit, Levena Biopharma. “STI-6129 demonstrated an improved therapeutic index in animal models, as compared to traditional non-selective conjugates, and we look forward to potentially expanding its utilization into additional ADC programs.”

For the full press release, please visit: https://investors.sorrentotherapeutics.com/news-releases

November 12-15, 2018, San Diego, USA

9th World ADC San Diego

Levena returns to World ADC Summit for 7 consecutive years with a full panels of ADC specialized experts. We will have Directors of Conjugation Service, Chemistry, Analytical, Cancer Research, and CMC available for discussion to answer all your questions. To make an appointment, please email us info@levenabiopharma.com. Join us at our booth for additional information.

June 27-28, 2018, Shanghai Pudong, China

Introducing world leading Antibody-Drug Conjugate (ADC) conference to Asia

Levena Biopharma expands its collaboration with Hanson Wade. After successful collaborations at the US and Europe ADC Summits, Levena Biopharma is now the Lead Sponsor of the 1st World ADC Asia Summit.

To schedule meetings, please contact:

info@levenabiopharma.com.

Levena Biopharma’s Partner BioAtla Announces FDA clearance of Its Investigational New Drug Application for CAB-AXL-ADC Therapeutic

SAN DIEGO, Jan. 24, 2018 – Levena Biopharma’s partner, BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has cleared BioAtla's Investigational New Drug application (IND) for BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), in patients with solid tumors. Under this IND, the company intends to initiate a first-in-human, open label, multicenter, dose escalation and dose expansion study of CAB-AXL-ADC in patients with locally advanced or metastatic solid tumors. CAB-AXL-ADC will be BioAtla's first CAB investigational product to enter clinical trials in the United States.

Levena Biopharma has collaborated with BioAtla in its ADC product development area over the past few years and provided process development and GMP production of linker-toxin to support the IND filing of BA3011 program. Since the inception of Levena’s GMP facility in Suzhou, China, the company has supported IND filing of novel ADC therapies in US, China and Korea.

About BioAtla, LLC
BioAtla is a global biotechnology company with operations in San Diego, California, and Beijing, China. BioAtla develops novel monoclonal antibody and other protein therapeutic product candidates designed to have more selective targeting, greater efficacy, and more cost-efficient and predictable manufacturing than traditional antibodies.

About Levena Biopharma, Co., Ltd.

Levena Biopharma Co., Ltd., established in 2013, is a biotechnology company dedicated to enable novel antibody-drug conjugate (ADC) therapeutic development. The company offers partners site-specific conjugation technology (K-LOCK and C-LOCK) and novel proprietary linker toxin. Levena Biopharma currently operates in its research and manufacturing facilities in Suzhou, Nanjing and San Diego with capabilities from ADC discovery research, process/analytical development to GMP production of linker-toxin and ADC conjugate.

March 26-28, 2018 | Berlin, Germany

Levena Biopharma is exhibiting at the 8th World ADC Berlin Conference.

To schedule a personal meeting please contact info@levenabiopharma.com.

Levena Biopharma Supplies GMP Linker-Toxin for Alteogen’s Her-2 ADC Program

November 30, 2017

Suzhou and Daejeon, November 30, 2017-- Levena Biopharma Co. Ltd., today announced a supply agreement with Alteogen, a public traded biotechnology company based in South Korea, to support the development of its leading antibody drug conjugate (ADC) product ALT-P7.

In August 2017, Alteogen announced its plan to start phase I clinical trial of ALT-P7, an ADC product utilizing Alteogen’s proprietary NextMabTM ADC technology, in patients with HER-2 positive breast cancer. Under this agreement, Levena Biopharma will provide GMP grade of linker-toxin for Alteogen’s clinical program. Levena Biopharma completed its GMP facility in 2017 and this is its first GMP supply agreement with a Korean partner. Earlier in 2017, Levena has supported partners in China and US for their linker-toxin GMP production.

About Alteogen Inc

Alteogen Inc. is a biopharmaceutical company devoted to develop the next generation long-acting biobetters which have properties of the increased in-vivo half life. ALTEOGEN is also developing monoclonal antibody biobetter with ALTEOGEN’s proprietary ADC (Antibody Drug Conjugate) technology and monoclonal antibody biosimilars with blockbuster market potential.

Based on excellent and experienced R&D professionals and our own original biotechnologies, ALTEOGEN is focusing on developing and marketing biobetters and biosimilars by partnership with global pharmaceutical companies.

About Levena Biopharma, Co., Ltd.

Levena Biopharma Co., Ltd., established in 2013, is a biotechnology company dedicated to enable novel antibody-drug conjugate (ADC) therapeutic development. The company offers partners site-specific conjugation technology (K-LOCK and C-LOCK) and novel proprietary linker toxin. Levena Biopharma currently operates in its research and manufacturing facilities in Suzhou, Nanjing and San Diego with capabilities from ADC discovery research, process/analytical development to GMP production of linker-toxin and ADC conjugate.

September 20 – 22, 2017 | San Diego, CA

Levena Biopharma is the proud senior partner at the 8th World ADC Conference.

To schedule a personal meeting please contact info@levenabiopharma.com.

Openning of cGMP Facility in Suzhou, China

SAN DIEGO, May 2, 2017 /PRNewswire/ -- LevenaBiopharma (Levena), is a subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE; "Sorrento"). Levana has three sites locations in San Diego, Suzhou, and Nanjing China. It announced today a recently completed construction project in Suzhou has finished the first phase of the new cGMP production facility with the release of a cGMP API. The second phase of this construction project will add an additional 24.5 K sq ft is to be completed in Q4 2017. This new state of art facility will provide the much needed expertise and resources for our domestic and international partners. Management expect to realize significant revenues utilizing the capacities and capabilities as a CRO/CMO in the development and commercial productions of Antibody Drug Conjugates by 2020.