ProMIS Neurosciences commends Biogen for clarifying aducanumab regulatory filing

Ongoing rolling BLA submission to the FDA supports completion by Q3; ProMIS applauds advancement in profoundly challenging environment

TORONTO and CAMBRIDGE, Mass., April 22, 2020 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, applauds Biogen’s initiation of BLA (biologics license application) submission to the U.S. Food and Drug Administration (FDA) for aducanumab, its Alzheimer’s disease candidate targeting amyloid beta. If approved, aducanumab would be the first disease-modifying therapy for Alzheimer’s disease.

On April 22, 2020, Biogen announced it had commenced with a rolling BLA submission for aducanumab with completion expected by Q3. Biogen’s submission creates vast opportunity for second-generation therapies that demonstrate more precise targeting for amyloid beta toxicity. Significant published data show that the toxic oligomer of amyloid beta is the specific and correct target for Alzheimer’s disease drug development. Published data show PMN310, ProMIS’ antibody candidate for Alzheimer’s disease, is highly selective for only the toxic form of amyloid beta, signaling its anticipated role as a next-generation drug candidate with more precise targeting capabilities and a potentially improved safety and efficacy profile.

“We commend Biogen for persevering with its regulatory filing while pivoting as needed to advance this very important therapy in what is a profoundly challenging, unprecedented environment,” said Eugene Williams, executive chairman with ProMIS Neurosciences. “This significant step in aducanumab’s timeline to potential approval is further evidence of the palpable shift in Alzheimer’s drug development momentum, which is now focused on the promise of next-generation amyloid-beta targeting drugs. Our lead program, PMN310, offers sniper-like precision for the toxic form, and only the toxic form, of amyloid beta. We applaud Biogen for their steadfast support of aducanumab as a potential first-generation therapy and share their resolute focus on bringing these much-needed therapies to market as quickly as possible in the current environment.”

Biogen reported that the global pandemic caused by the new coronavirus sickened approximately 100 Biogen staffers and close contacts, which complicated aducanumab’s filing process. In Massachusetts, where Biogen is headquartered, the company became known as a COVID-19 “superspreader” following a February meeting in Boston that played a central role in spreading the virus throughout Massachusetts and beyond.

To learn more about the search for therapies for Alzheimer’s, Parkinson’s and other neurodegenerative diseases, listen to the podcast, Saving Minds, at iTunes or Spotify.

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery platform is based on the use of two complementary thermodynamic, computational discovery engines – ProMIS and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique precision approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn.

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Released April 22, 2020