FDA Says No To Epilepsy Drug, IMV Advances COVID-19 Vaccine, ISEE Delays Study

Today’s Daily Dose brings you news about the FDA rejecting Eton Pharma’s Lennox-Gastaut syndrome drug, the progress in IMV’s COVID-19 vaccine program, delay in IVERIC bio’s dry age-related macular degeneration trial, and Vaxart’s deal with Emergent BioSolutions for the development of an oral vaccine candidate for COVID-19.

Read on…

As expected, the FDA has refused to approve Eton Pharmaceuticals Inc.’s (ETON) ET-105, an innovative formulation of Lamotrigine, proposed as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older.

Eton Pharmaceuticals acquired the U.S. marketing rights to ET-105 from Aucta Pharmaceuticals in June 2019.

In its complete response letter, the FDA has raised the Dosing and Administration related topics and minor questions and clarifications related to the Product Quality section of the review.

Eton continues to believe that all issues in the letter can be resolved and addressed in a resubmission during the second or third quarter of this year.

ETON closed Wednesday’s trading at $2.84, down 11.11%.

IMV Inc. (IMV), a clinical-stage biopharmaceutical company, is advancing its vaccine candidate DPX-COVID-19 in collaboration with lead investigators for the phase 1 clinical study.

According to the Company, the goal of this development program is to establish the clinical safety and immunogenicity of a vaccine candidate based on its DPX delivery technology and incorporating peptides targeting novel *epitopes from the coronavirus strain. (*An epitope refers to the specific target against which an individual antibody binds. Source: Pacific Immunology).

In other news, the Company announced that it has entered into an equity distribution agreement, dated March 18, 2020, with Piper Sandler & Co. Pursuant to this agreement, such a number of common shares as would have an aggregate offering price of up to US$30 million would be sold, from time to time, through “at-the-market” offerings on the Nasdaq Capital Market.

IMV closed Wednesday’s trading at $2.30, up 13.30%. In after-hours, the stock was down 6.09% to $2.16.

IVERIC bio Inc. (ISEE) has decided to delay the initiation of enrollment of patients in the second pivotal clinical trial for Zimura for the treatment of geographic atrophy secondary to dry age-related macular degeneration, in light of the COVID-19 pandemic. The trial, dubbed ISEE2008 trial, was supposed to have begun this month.

On October 28, 2019, the Company reported positive results from a pivotal phase 2b trial of Zimura demonstrating a reduction in the rate of geographic atrophy growth in patients with dry age-related macular degeneration.

Kourous A. Rezaei, Chief Medical Officer of IVERIC said, “We want to thank clinical investigators and their teams for their enthusiasm and support in completing the activities necessary to begin enrolling patients at a number of clinical sites, including identification of potential patients for this trial. We will continue our efforts to prepare additional clinical sites, so that we can begin enrolling patients expeditiously, once the COVID-19 threat dissipates.”

ISEE closed Wednesday’s trading at $2.83, down 24.53%.

Johnson & Johnson’s (JNJ) subsidiary Janssen Pharmaceutical has submitted a New Drug Application to the FDA for Ponesimod for the treatment of adult patients with relapsing multiple sclerosis.

The NDA is based on the head-to-head phase III study, dubbed OPTIMUM, which showed superior efficacy of Ponesimod 20 mg on the primary endpoint of reduced annualized relapse rate (ARR), as well as most secondary endpoints, compared to Sanofi’s approved drug Aubagio 14 mg in adults with relapsing multiple sclerosis.

In other news, Paul Stoffels, the chief scientific officer of J&J, when talking to CNBC on Tuesday, revealed the Company expects to start a human clinical trial of its COVID-19 vaccine in early November.

JNJ closed Wednesday’s trading at $134.96, down 1.19%.

QIAGEN (QGEN), which is all set to be acquired by Thermo Fisher Scientific Inc. (TMO) has obtained CE marking for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic for the detection of SARS-CoV-2. The Company is also working with the FDA to gain emergency use authorization for the test in the U.S.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections.

The Company began shipping QIAstat-Dx test kits to various markets in February 2020 for clinical evaluation and has dramatically ramped up production of the respiratory panels.

The acquisition of QIAGEN by Thermo Fisher Scientific is expected to be completed in the first half of 2021.

QGEN closed Wednesday’s trading at $38.36, up 0.29%.

Vaxart Inc. (VXRT) has entered into an agreement with Emergent BioSolutions Inc. (EBS) for the development and manufacturing of oral vaccine candidate for COVID-19.

Vaxart’s oral recombinant vaccine candidate is based on its proprietary VAAST platform.

Under the terms of the agreement, development services will begin immediately, and upon Vaxart’s election, Emergent is expected to produce bulk cGMP vaccine allowing Vaxart to initiate a Phase 1 clinical study early in the second half of 2020.

Emergent will provide development services out of its Gaithersburg, MD location and manufacture drug substance at its Bayview facility in Baltimore, MD, designated a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the U.S. Department of health and Human Services.

VXRT closed Wednesday’s trading at $2.34, up 21.24%. In after-hours, the stock gained another 5.13% to $2.46.

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