CAD-1883

The now-shuttered phase 2 study was evaluating the NR2B negative allosteric modulator alongside standard-of-care treatment to quickly reduce MDD symptoms. Novartis rolled the dice in 2020 with a $210 upfront acquisition of long-time neuroscience partner Cadent Therapeutics. But the bet seems to have come up empty, as the Swiss pharma discontinues a mid-phase major depressive disorder program.  The decision to shelve MIJ821 in patients with major depressive disorder (MDD) experiencing suicidal ideation with intent followed a “benefit-risk assessment of available data,” a spokesperson said in an emailed statement. “No new or changing safety signal was identified for study participants.” The now-shuttered phase 2 study was evaluating the NR2B negative allosteric modulator alongside standard-of-care treatment to quickly reduce MDD symptoms. According to ClinicalTrials.gov, the trial was set to wrap this past July. The spokesperson did not confirm if the study met its goal.  When Novartis acquired Cadent less than three years ago, the pharma took ownership of the company's crown jewel CAD-9303, an investigational schizophrenia med being studied in a phase 1 trial at the time, and movement disorder program CAD-1883.  However, neither one of the assets was ever publicly incorporated into Novartis' pipeline, the spokesperson confirmed to Fierce Biotech. Because plans were never announced for the two programs, the company didn't have an update to share on them, according to the Novartis spokesperson. That leaves one indication for MIJ821 in treatment-resistant depression, something Novartis has been testing since 2015—years before the acquisition—when it exclusively licensed the asset from Cadent. The intravenous injection is currently being tested in a phase 2 trial, according to Novartis’ pipeline, though the company declined to confirm the ongoing status of the study.  The Big Pharma will share an updated pipeline as part of its third-quarter earnings call on Oct. 24, the spokesperson said.  MIJ821 is Novartis’ only therapy in development for MDD. The rest of the company’s neuroscience portfolio focuses on migraines, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson’s disease, Alzheimer’s disease, progressive supranuclear palsy and spinal muscular atrophy.

PRESS RELEASE January 25, 2021 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced it received approximately USD $2.9 million (SEK 24.2 million) in an upfront payment resulting from the now completed acquisition of Cadent Therapeutics by a third party. Saniona holds an ownership stake of approximately 3% in Cadent Therapeutics resulting from Cadent’s previous acquisition of the Saniona spin-out Ataxion, which was created to leverage Saniona’s ion channel expertise for the treatment of movement disorders. Saniona previously announced the planned acquisition and its ownership stake in December 2020. “Saniona has developed a robust, proprietary drug discovery engine focused on ion channels, a rare scientifically validated drug class that remains significantly untapped,” said Jørgen Drejer, Chief Scientific Officer of Saniona. “It is gratifying to see our ion channel programs create value, and the funding that Saniona received from the Cadent transaction will be beneficial as we continue to advance our own, internal programs for the treatment of rare diseases.” Following the closing of the acquisition of Cadent Therapeutics by Novartis, Saniona received an upfront payment of approximately USD $2.9 million (SEK 24.2 million), after giving effect to preferred stock preferences and the satisfaction of transaction costs and other closing conditions. Saniona may receive additional contingent consideration upon the achievement of future milestones. In connection with Saniona’s license agreement with Cadent, Saniona is also entitled to receive royalties on any potential products developed and commercialized from the SK ion channel (small conductance, calcium-activated potassium ion channel) program that originated with Ataxion, including CAD-1883, a first-in-class selective positive allosteric modulator of SK ion channels that Cadent has advanced into Phase 2 clinical trials and which may have potential in movement disorders. Saniona has been a pioneer in the field of ion channels since its founding in 2011, and several members of the Saniona scientific team have been working in this field for more than 20 years. Since its inception, Saniona has out-licensed or spun-out multiple ion channel programs. Ataxion was established in 2013 by Saniona and Atlas Venture Inc. with the aim of developing Saniona's research on SK ion channels for movement disorders. In 2017, Ataxion was acquired by Luc Therapeutics, which later changed its name to Cadent Therapeutics. For more information, please contact Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email: trista.morrison@saniona.com The information was submitted for publication, through the agency of the contact person set out above, at 14:00 CET on January 25, 2021. About Saniona Saniona is a biopharmaceutical company focused on discovering, developing and delivering innovative treatments for rare disease patients around the world. The company’s lead product candidate, Tesomet, is in mid-stage clinical trials for the rare diseases Prader-Willi syndrome and hypothalamic obesity. Saniona also has a broad pipeline derived from its proprietary ion channel discovery platform, with lead candidate SAN711 entering Phase 1 studies for rare neuropathic disorders. Saniona intends to develop and commercialize its rare disease products internally. The company has out-licensed other programs, which may provide future supplemental revenue. Saniona is based in Copenhagen, Denmark and Boston, Mass., U.S. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at . Attachment