miRagen brings in Viridian Therapeutics

The acquisition includes clinical stage anti-IGF-1R monoclonal antibody VRDN-001, which is intended for treatment of thyroid eye disease

November17th,2020
Mel J. Yeates

BOULDER, Colo. and WALTHAM, Mass.—miRagen Therapeutics, Inc. has disclosed the completion of an acquisition of Viridian Therapeutics, Inc. Concurrent with the Viridian acquisition, miRagen has also entered into a definitive agreement for the sale of Series A non-voting convertible preferred stock in a private placement to a group of institutional accredited investors.

Investors were led by Fairmount Funds Management LLC, with participation from Venrock Healthcare Capital Partners, BVF Partners L.P., Cormorant Asset Management, Perceptive Advisors, Wellington Management, Ally Bridge Group, Logos Capital, Surveyor Capital (a Citadel company), Commodore Capital and Ridgeback Capital, as well as additional undisclosed investors.

“After a thorough evaluation of strategic alternatives, the board of directors of miRagen believes this acquisition represents the highest potential value creation opportunity for miRagen’s stockholders,” said Jeffrey S. Hatfield, chairman of the board of directors for miRagen. “My sincere thanks and appreciation [goes] to our board members and management team, both past and present, along with our investors for their support and commitment. We are excited by the potential for VRDN-001 to become a meaningful treatment option for patients living with TED.”

The private placement is expected to result in gross proceeds to miRagen of approximately $91 million. miRagen intends to primarily use the proceeds for the advancement of clinical studies of VRDN-001.

VRDN-001 is a clinical-stage insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody (mAb) in development for thyroid eye disease (TED). Thyroid eye disease is a debilitating condition that can cause proptosis, as well as double vision and possible blindness. miRagen intends to study VRDN-001 as a potential treatment for patients with TED.

More than 100 oncology patients have previously been treated with VRDN-001, in both U.S. and EU studies, under the name AVE-1642. This has enabled some understanding of VRDN-001’s pharmacokinetic and pharmacodynamic profile, as well as its safety and tolerability. Pending feedback from regulatory authorities, miRagen expects to initiate a Phase 2 clinical trial of VRDN-001 in TED sometime in 2021.

Worldwide rights to develop and commercialize VRDN-001 for all non-oncology indications that do not use radiopharmaceuticals — including the treatment of TED — were exclusively licensed by Viridian from ImmunoGen, Inc. Under the terms of the agreement, ImmunoGen received an upfront payment and is eligible for additional developmental milestones, as well as mid-single-digit royalty payments.

Viridian has also initiated a VRDN-002 program, which seeks to improve IGF-1R-targeted antibodies by incorporating half-life extension technology to reduce the dose required to achieve full efficacy in TED patients, and to enhance solubility to achieve the lowest possible injection volume. miRagen expects to file an Investigational New Drug application for VRDN-002 in 2021.

The current miRagen management team includes Lee Rauch, chief executive officer; Jason A. Leverone, chief financial officer; and Diana Escolar, M.D., FFAN, chief medical officer. Jonathan Violin, Ph.D., CEO of Viridian, will become president and chief operating officer of miRagen; and Vahe Bedian, Ph.D., chief scientific officer of Viridian, will become chief scientific officer at miRagen.

miRagen also announced earlier in October that the company had conducted an internal review of preliminary topline data from its Phase 2 SOLAR clinical trial of cobomarsen in patients with cutaneous T-cell lymphoma (CTCL), and decided to discontinue further internal development.

“We have completed this preliminary evaluation and will continue to analyze the final topline data and other secondary SOLAR data as we seek a partner for cobomarsen. Our research and development strategy remains focused on the advancement of our lead program MRG-229 for idiopathic pulmonary fibrosis (IPF),” noted Rauch in a press release.

Based on investigator assessments, the preliminary data in 37 patients suggest that cobomarsen lacks a compelling result for the study’s primary endpoint, which was objective skin response of at least four months duration (ORR4) relative to the vorinostat control arm. However, progression free survival (PFS) — which was a secondary endpoint for the study — indicated a treatment effect in favor of cobomarsen. The therapy was well tolerated, with no patient discontinuations due to cobomarsen-related adverse events.

The SOLAR study was designed to evaluate the safety and efficacy of cobomarsen given by intravenous infusion in an active control comparison trial for patients with the mycosis fungoides subtype of CTCL. miRagen announced in December 2019 that the company would halt enrollment in the SOLAR trial well short of the intended 126 CTCL patients, in order to reduce time and resource expenditure. The company pointed out that the downsized SOLAR study was not statistically powered for superiority or equivalence.

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