Mount Sinai Licenses SARS-COV-2 Antibody to Sorrento Therapeutics Which Prepares for IND in Anticipation of Phase I Clinical Trial by Q3

Mount Sinai Licenses SARS-COV-2 Antibody to Sorrento Therapeutics Which Prepares for IND in Anticipation of Phase I Clinical Trial by Q3

Mount Sinai Health System (“Mount Sinai”) and Sorrento Therapeutics (Nasdaq: “SRNE,” “Sorrento”) have inked a deal to investigate an antibody cocktail called COVI-SHIELD™ that potentially can treat COVID-19 patients. This investigational product leverages the work conducted by Mount Sinai researchers who screened about 15,000 individuals who may have had and recovered from COVID-19 for the presence of anti-COVID-19 antibodies. The team leveraged the diagnostic test developed by Mount Sinai’s own Florian Krammer, PhD, and associated authorization for use in Mount Sinai under an FDA Emergency Use Authorization. This partnership grants Sorrento access to plasma containing antibodies against COVID-19 for the purpose of identification and production of monoclonal antibodies with potential for neutralizing activity against SARS-CoV-2.

The Background

Under the leadership of Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai, a team screened approximately 15,000 individuals who may have had and recovered form COVID-19 for the presence of antibodies.   Dr. Cordon-Cardo’s team leveraged the diagnostic test developed by Florian Krammer, which TrialSite News profiled.  Dr. Krammer’s test was approved or use under an FDA Emergency Use Authorization.  

Co-Development of COVI-SHIELD

Sorrento and Mount Sinai have joined forces to collaborate to develop antibody products that could serve as a “protective shield” against SARS-CoV-2 coronavirus infection, possibly blocking and neutralizing the activity of the virus in naïve-at-risk populations as well as those individuals recently infected. The development of COVID-SHEILD is based on the work Mount Sinai was able to accomplish thanks to the testing technology developed by Professor Kramer and the screening operation led by Dr. Cordon-Cardo. If approved, each dose of the product would deliver a cocktail of three antibodies which together would recognize the three unique regions of the SARS-CoV-2 Spike protein. No terms associated with this deal where shared with the public.

Implicating the partnership’s significant potential, Erik Lium, Executive Vice President and Chief Commercial Innovation Office of the Mount Sinai Health System, commented, “We look forward to advancing the development of an effective antibody cocktail with Sorrento.” 

Although the joint press release doesn’t mention exclusivity, Dr Lium noted, “We’re working with pharma and biotech partners, such as Sorrento to bring much needed therapies to the clinic,” which implies the health system could collaborate with others as well.  The health system provides a link for those interested in licensing the Mount Sinai serologic assay. 

COVID-SHIELD: Serious Potential

This investigational pursuit would lead to an antibody cocktail therapy establishing a high barrier to development of treatment resistance while offering a protective therapy for the population at large if the collaborative parties can successfully develop and secure approval. It is anticipated that COVID-SHIELD would be offered as a prophylactic for those returning to work and as a therapeutic to those who have bene exposed to SARS-CoV-2.  COVI-SHIELD prevention and treatment is designed to be administered as often as necessary, with each dose expected to offer antiviral protection for up to two months—of course, all conditioned-on approval by the regulatory authorities.

Such a product, if approved, represents serious potential for public health (and economic upside). Sorrento’s Chairman and CEO, Dr. Henry Ji, commented that with the opening up of the economy will more than likely come along local flareups of COVID-19 along with the unfortunate mutations associated with viruses possibly rendering future approved therapies ineffective. Hence the Chairman noted, “It is our intention to develop a triple antibody prophylactic and therapeutic agent that would shield healthcare workers and at-risk patients. This therapy is designed to be resistant to future virus mutations, and if approved, should be made available in support of testing, tracing, vaccination and other therapeutic approaches to allow for efficient management of viral infection by protecting those most at risk for up to two months at a time.”

Moving to Clinical Trials if IND Approved

Presently Sorrento is completing all Investigational New Drug Application (IND) filing requirements for the triple antibody combination therapy and expects to commence Phase I clinical trials of the drug candidate in the third quarter of 2020 (July 1-to Sept 31).

Other Comparable Initiatives

Some other companies are working on somewhat similar initiatives such as Regeneron Pharmaceuticals. The New York State-based biotech company plans clinical trials next month to test REGN-COV2, an investigational antibody treatment developed to prevent and treat infections associated with SARS-CoV-2. And Takeda, headquartered in Japan, is developing TAK-888, a plasma-derived therapy to be applied to high risk individuals who have contracted SARS-CoV-2 infection.

About Sorrento Therapeutics

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento’s multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir®”).  Sorrento is also developing potential coronavirus antiviral therapies, including COVIDTRAP™, ACE-MABTM COVI-MABTM, COVI-SHIELDTM and COVI-CELLTM. Sorrento’s commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients.  ZTlido® was approved by the FDA on February 28, 2018.

About Mount Sinai Health System

The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report’s “Honor Roll” of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.

Lead Research/Investigator Contacts

Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine at the Icahn School of Medicine at Mount Sinai

Florian Krammer, PhD, Professor, Microbiology, Icahn School of Medicine at Mount Sinai

Call to Action: Those interested in licensing of the Mount Sinai serologic assay can visit the following website.