Sorrento receives USFDA clearance to start a clinical trial of Anti-CD47 antibody

▴ Sorrento receives USFDA clearance to start a clinical trial of Anti-CD47 antibody
Sorrento receives USFDA clearance to start a clinical trial of Anti-CD47 Antibody, discovered from fully human G-MAB library, for treatment of multiple malignancies

Sorrento Therapeutics, Inc. announced that the USFDA has cleared Sorrento’s internally developed anti-CD47 monoclonal antibody, STI-6643, which was discovered from Sorrento's G-MAB™ library, for an initial clinical trial. The initial clinical trial will be a basket trial entitled “A Phase 1B, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Patients with Selected Relapsed or Refractory Malignancies.”

The cluster of differentiation 47 (also known as integrin-associated protein) (“CD47”) is a ubiquitously-expressed glycoprotein of the immunoglobulin superfamily that plays a critical role in self-recognition. Various solid and hematologic cancers exploit CD47 expression to evade immunological eradication, and its overexpression is clinically correlated with poor prognoses. One essential mechanism behind CD47-mediated immune evasion is that it can interact with signal regulatory protein-alpha (SIRPα) expressed on myeloid cells, causing phosphorylation of the SIRPα cytoplasmic immunoreceptor tyrosine-based inhibition motifs and recruitment of Src homology 2 domain-containing tyrosine phosphatases to ultimately result in delivering an anti-phagocytic “don’t eat me” signal. Given its essential role as a negative checkpoint for innate immunity and subsequent adaptive immunity, the CD47/SIRPα axis has been explored as a new target for cancer immunotherapy and its disruption has demonstrated great therapeutic promise.

In preclinical evaluations, STI-6643 displayed decreased red blood cell binding and hemolysis, while maintaining potent anti-tumour activity in solid tumour disease models. Clinical trials with anti-CD47 mAbs have historically experienced limitations due to significant anaemia, hemagglutination, and thrombocytopenia due to CD47 expression on normal red blood cells, ultimately requiring the employment of complicated clinical dosing regimens. These issues have not been seen to date with STI-6643 in preclinical studies conducted head-to-head against synthesized versions of other CD47 mAbs. Additionally, STI-6643 showed minimal T, B or NK cell depletion as opposed to other synthesized mAb clones, which could potentially result in improved efficacy by preserving infiltrating anti-tumour immune cells. STI-6643 has the potential to be a “best-in-class” product if these preclinical benefits are able to be reproduced in human trials. Sorrento is also conducting preclinical studies to compare the safety and efficacy of lymphatic delivery of STI-6643 to established parenteral routes of administration using Sorrento’s Sofusa™ technology. This study will be conducted at the Moffitt Cancer Center in Tampa, FL with Dr David A. Sallman as the coordinating lead investigator.

STI-6643 is the second anti-CD47 antibody that has been developed from the G-MAB library. The other anti-CD47 antibody (IMC-002) discovered from the G-MAB library was previously cleared by the USFDA, and is currently in Phase 1 human studies sponsored by ImmuneOncia Therapeutics, LLC, a joint venture company between Sorrento (35% ownership) and Yuhan Corporation.

Regarding the recent clearance for a clinical trial for STI-6643 by the FDA, Dr Henry Ji, Chairman and CEO of Sorrento, commented, “We have seen a great performance from STI-6643 in our IND-enabling studies. Our internal anti-CD47 program has now yielded two clinical candidates, a signal of our continued commitment to the development of innovative, safe and efficacious cancer treatments in addition to our commitment to fighting COVID-19.”

Tags : #SorrentoTherapeutics #LatestNewsonSorrentoTherapeutics3rdMar #LatestUSFDAClearance3rdMar #LatestPharmaNews3rdMar #LatestNewsonHematologicCancers #CancerImmunotherapy

About the Author

Team Medicircle

Related Stories

Loading Please wait...

Trending Now

80% of the diseases are psychosomatic which means they have roots in the mind and this is where homeopathy steps in - It resolves physical ailments by finding the cause in the mind – Dr. Sanket Dhuri, Consultant Homeopath April 14, 2021
A futuristic Vision of a Healthcare Entrepreneur: Shyatto Raha, CEO, and Founder of MyHealthcareApril 12, 2021
Saher Mehdi, Founder and Chief Scientist at wellOwise talks about aspects making healthcare more equitable and reachableApril 10, 2021
Wide variety of therapies to address autism in children explained by Dr. Shilpa Jasubhai, Clinical PsychologistApril 09, 2021
Allopathic and Homeopathic medicines should not be taken together says Dr. Sunil Mehra, Homeopath ConsultantApril 08, 2021
The charm of homeopathic medicine is that it can be taken with conventional medicines – Dr. Shruthi Shridhar, Consulting Homeopath April 08, 2021
Dissociative Identity Disorder and associated concepts explained by Dr. Vinod Kumar, Psychiatrist and Head of Mpower - The Centre (Bangalore) April 07, 2021
Dissociative Identity Disorder explained by Dr. Shilpa Jasubhai, Clinical PsychologistApril 05, 2021
Sehat Ki Baat, Karishma Ke Saath- Episode 6 Healthy Diet For Boosting Metabolism Which Can Help Thyroid Patients April 03, 2021
Significant Pointers on Kidney Health by Dr. Santosh Waigankar, Consultant Urooncologist and Robotic Surgeon at Kokilaben Dhirubhai Ambani HospitalApril 01, 2021
Dr. Vaishal Kenia, Ophthalmologist Talks About the Different Possibilities Available for the Treatment of Glaucoma Depending Upon Their Type and SeverityMarch 30, 2021
No Definitive Role of Diet in Treatment of Lymphedema but Intake of Calories, Salt and Long Chain Fatty Acids should be controlled says Dr. Ramani CVMarch 30, 2021
Dr. Kiran Chandra Patro, Senior Nephrologist Talks About Dialysis as the Temporary Process and Not a Permanent Cure for the Patients of Renal DysfunctionMarch 30, 2021
Two out of three new chronic kidney disease patients are found to have diabetes or hypertension informs Dr. Sreeharsha HarinathaMarch 30, 2021
Glaucoma Treatment: Medications or Surgery? A valuable piece of advice from Dr. Pranay Kapdia, Chairman and Medical Director of Kapadia Eye CareMarch 25, 2021
Dr. Shraddha Satav, Consultant Ophthalmologist Recommends that Everybody After 40, Should Go for the Complete Eye Checkup at Regular IntervalMarch 25, 2021
Childhood Obesity is not a Disease but a Condition which can be very well ManagedMarch 19, 2021
World Sleep Day - 19 th March 2021- Know More About Healthy Sleep As Per The Guidelines by The World Sleep Society March 19, 2021
Sipping Warm Water, the First Thing in the Morning is Good for DigestionMarch 18, 2021
Think Twice, Before Using Plastic Bags over Paper BagsMarch 18, 2021