GenVec Will Not be Affected by Novartis AG' Dissolution of CAR-T Unit

Published: Sep 01, 2016

GenVec Will Not be Affected by Novartis AG's Dissolution of CAR-T Unit September 1, 2016
By Alex Keown, Breaking News Staff

GAITHERSBURG, Md. – Novartis is shutting down its Cell and Gene Therapy Unit, which should not impact the deal it has with Maryland-based GenVec, Inc. , a clinical-stage gene delivery company, to develop that company’s lead hearing loss and balance disorder candidate, CGF166.

In a federal filing with the U.S. Securities and Exchange Commission on Wednesday, GenVec said Novartis told the company that it remains engaged with the experimental drug and the internal changes at Novartis “are not expected or intended to reduce its support for the program.” As a result, shares of GenVec have jumped more than 11 percent this morning, trading at 58 cents per share.

Earlier this week, it was announced that Novartis intended to shut down its gene therapy unit and merge those programs into other company divisions—a move that was in line with the Swiss-based company’s integrated development model, which includes three focused, customer-facing divisions.

CGF166 uses the company’s GV11 gene delivery system to regenerate sensory cells in an effort to restore hearing loss. CGF166 also features a cell-specific promoter that limits the expression of the atonal gene to the supporting cells of the inner ear, according to GenVec’s company website.

In July, GenVec announced that its Phase I/II trial for CGF166 was being removed from clinical hold by the U.S. Food and Drug Administration after it had been placed on hold in January. The trial was paused following a review of data by the trial's Data Safety Monitoring Board in accordance with criteria in the trial protocol. At the time, Douglas J. Swirsky, president and chief executive officer of GenVec, said it was important the trial proceed with care “to gain a broad understanding of a product's therapeutic profile."

In late April, the board recommended the trial resume and in July it was cleared by the FDA. Top-line data is expected sometime next year.

Early animal models showed CGF166 was effective in restoring the sensory cells and hearing.

GenVec is not the only company to use a gene therapy approach to treating hearing loss. Startup Decibel Therapeutics, headquartered in Massachusetts, is focusing on therapies that use gene-silencing technology RNA interference. Other companies in the field include Otonomy Inc. , Auris Medical , Autifony Therapeutics, and Audion Therapeutics. On Aug. 1, Otonomy announced the successful completion of a one-year, multiple-dose clinical safety trial of OTO-104 in patients with Ménière’s disease. In July, the U.S. Food and Drug Administration granted Fast Track Designation to Auris’ Keyzilen for acute peripheral tinnitus.

GenVec and Novartis struck their partnership in 2010. The deal has the potential to earn GenVec up to $213 million. In addition to the $5 million upfront payment from Novartis, GenVec received $8 million in a milestone payment after the first patient was dosed with the drug in 2014, the company said. It anticipates the next milestone payment will occur following the dosing of the first patient in a Phase IIB study of the experimental drug, the company said on its website.

In addition to hearing loss, GenVec is also developing a vaccine candidate for Respiratory Syncytial Virus (RSV). Currently, there is no preventive vaccine available. According to the company, in preclinical testing, GenVec's RSV vaccine candidate, GV2311, produced broad, durable RSV virus neutralization in animal models.

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