Sorrento Takes Another Leap Forward with Recent FDA Clearance, Says Top Analyst

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="And the W’s just keep on coming for Sorrento Therapeutics (SRNE). Reflecting a major step forward in the advancement of its candidate, STI-6129, a CD38-targeting antibody-drug conjugate (ADC), the company received the all-clear from the FDA to submit an Investigational New Drug (IND) application.” data-reactid=”12″>And the W’s just keep on coming for Sorrento Therapeutics (SRNE). Reflecting a major step forward in the advancement of its candidate, STI-6129, a CD38-targeting antibody-drug conjugate (ADC), the company received the all-clear from the FDA to submit an Investigational New Drug (IND) application.

Part of the excitement surrounding this announcement is related to the design of the asset itself. STI-6129 was created using SRNE’s unique technology that includes a CD38-specific antibody identified from its fully human G-MAB antibody library, its patented drug payload Duostatin 5 and its site-specific CLOCK conjugation technology.

On top of this, the company wants to kick off a Phase 1 multi-center, open-label, dose-escalation clinical trial in patients with advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis, with the primary goal being the identification of a Phase 2 dose for STI-6129.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Commenting on the development for H.C. Wainwright, five-star analyst Raghuram Selvaraju thinks the asset “could constitute a next-generation approach to treatment of AL amyloidosis.”” data-reactid=”15″>Commenting on the development for H.C. Wainwright, five-star analyst Raghuram Selvaraju thinks the asset “could constitute a next-generation approach to treatment of AL amyloidosis.”

“The prospects for a CD38-targeted approach in this indication appear buttressed by data from a prospective Phase 2 trial of daratumumab, a well-known fully human monoclonal anti-CD38 antibody agent that is already commercially available for the treatment of multiple myeloma (MM) under the trade name DARZALEX… Renal response occurred in 10 of 15 patients (67%) with renal involvement and cardiac response occurred in seven out of 14 patients (50%) with cardiac involvement. In our view, these data bode well for the deployment of an anti-CD38 agent in AL amyloidosis,” Selvaraju added.

As approximately 20,000 people are affected by AL amyloidosis in the U.S. alone, the indication represents a niche opportunity for SRNE. With the clinical benefit produced using daratumumab to treat AL amyloidosis serving as a partial proof-of-concept for STI-6129, it’s no wonder the news is promising, in Selvaraju’s opinion.

Even though Selvaraju tells clients that the candidate has not been built into his models, he believes the announcement demonstrates “the steadily growing depth and breadth of Sorrento’s pipeline.”

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Based on all of the above, Selvaraju stayed with the bulls. Along with a Buy rating, he kept a $24 price target on the stock. This indicates upside potential of a whopping 369%. (To watch Selvaraju’s track record, click here)&nbsp;&nbsp;” data-reactid=”19″>Based on all of the above, Selvaraju stayed with the bulls. Along with a Buy rating, he kept a $24 price target on the stock. This indicates upside potential of a whopping 369%. (To watch Selvaraju’s track record, click here)  

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="What does the rest of the Street think about SRNE’s long-term growth prospects? It has been relatively quiet when it comes to analyst activity, with the stock receiving only one other Buy rating in the last three months. This makes the consensus rating a Moderate Buy. In addition, the $24 average price target matches Selvaraju’s. (See Sorrento stock analysis on TipRanks)” data-reactid=”20″>What does the rest of the Street think about SRNE’s long-term growth prospects? It has been relatively quiet when it comes to analyst activity, with the stock receiving only one other Buy rating in the last three months. This makes the consensus rating a Moderate Buy. In addition, the $24 average price target matches Selvaraju’s. (See Sorrento stock analysis on TipRanks)

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