Healthcare Roundup – Regeneron teams with Roche to triple supply of its COVID-19 drug, Sorrento files IND for COVI-GUARD

医疗保健精选——再生元与罗氏提高COVID-19药物供应量,Sorrento Therapeutics提交COVI-GUARD新药申请
Published on: August 20, 2020
Author: Amy Liu

Regeneron teams with Roche to triple supply of its COVID-19 drug

Regeneron (NASDAQ:REGN) has teamed up with Roche (OTCQX:RHHBY) to increase the supply of its COVID-19 drug via a new production/distribution deal.

The two will collaborate on developing and manufacturing REGN-COV2 – Regeneron’s investigational two-antibody “cocktail” now in late-stage clinical trials – with Regeneron handling U.S. distribution and Roche taking care of distribution outside the U.S.

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That should increase overall capacity of REGN-COV2 by 3.5 times, they say, if regulators approve.

Initial study results are expected by the end of September, which could precede an emergency authorization by year-end.

The two will dedicate a certain manufacturing capacity to REGN-COV2 each year, and have already begun the technology transfer.

Sorrento files IND for COVI-GUARD; shares slip 9%

Sorrento Therapeutics (SRNE -9.3%) is filing an Investigational New Drug (IND) application for COVI-GUARD (STI-1499) for hospitalized COVID-19 patients today.

COVI-GUARD neutralizing and high potency antibody is engineered to eliminate interactions with host Fc receptors, thereby potentially decreasing risk of antibody dependent enhancement of SARS-CoV-2 infection.

Animal data generated in Syrian Golden Hamsters infected with SARS-CoV-2 justify the IND filing and continued clinical development.

STI-1499 antibody evaluated in preclinical studies has also shown to be 100% effective even against the highly contagious D614G mutant strain at a low dose.

Sorrento shares sold off in the after hours Tuesday following the disclosure that the CFO was “terminated in its entirety, effectively immediately” Monday, according to Tuesday’s filing.

Quant Ratings are Neutral while Wall Street sell-sides are Bullish.

SRNE has shown exponential growth of over 440% over the past year.

Merck’s Keytruda extends survival in first-line esophageal cancer

Merck (NYSE:MRK) announces positive results from a Phase 3 clinical trial, KEYNOTE-590, evaluating Keytruda (pembrolizumab), combined with chemo, for the treatment of locally advanced or metastatic esophageal cancer in a first-line setting.

An interim analysis by the independent Data Monitoring Committee showed that the study met the primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemo plus placebo.

A key secondary endpoint, objective response rate (ORR), was also met.

No new safety signals were reported.

The company plans to share the data with global regulatory authorities and submit the results for presentation at ESMO in late September.

Keytruda is currently approved in the U.S. and China for second-line squamous cell carcinoma of the esophagus whose tumors express PD-L1.

Shares up 1% premarket on light volume.

J&J to acquire Momenta Pharmaceuticals for $6.5B

Johnson & Johnson (NYSE:JNJ) has agreed to acquire Momenta Pharmaceuticals (NASDAQ:MNTA) for $52.50 per share in cash for a total of $6.5B.

The transaction should close in H2.

Momenta develops therapies for rare immune-mediated disorders leveraging its Fc Multimerization Platform. Lead candidate is nipocalimab, in Phase 3 development for warm autoimmune hemolytic anemia and Phase 2 for hemolytic disease of fetus and newborn and myasthenia gravis.

MNTA is up 70% premarket.

CytoDyn requests “Fast Track Approval” in U.K. for COVID-19 trial

CytoDyn (OTCQB:CYDY) has provided its top-line report from its recently completed Phase 2 clinical trial for patients with mild-to-moderate COVID-19 symptoms to regulatory authorities in U.K.

The Company has requested for the regulatory pathway for Fast Track approval noting the efficacy and safety results from the Phase 2 trial.

“We are eager to see the capabilities of leronlimab in our Phase 3 clinical trial for the severe-to-critical patient population. Our enrollment is now at 182 and we are very optimistic we will reach 195 by the end of August,” stated Nader Pourhassan, Ph.D., President and CEO.

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