Remyelination

SATT[1] Conectus and Find Therapeutics Sign Licensing Agreement to Develop a Promising New Therapy for Multiple Sclerosis and other demyelinating diseases

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Tuesday, June 7, 2022
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Promising preclinical data show that this innovative therapy, by overcoming the molecular barriers of myelin regeneration, could restore myelin function.

Key Points: 
  • Promising preclinical data show that this innovative therapy, by overcoming the molecular barriers of myelin regeneration, could restore myelin function.
  • According to the Multiple Sclerosis Society of Canada, Canada has one of the highest MS rates in the world with 1 in every 400 people affected.
  • Initial preclinical pharmacology studies, funded by SATT Conectus, have demonstrated very encouraging results, delivering increased myelin and better function after treatment.
  • Find Therapeutics, is dedicated to the development of next generation trans-membrane allosteric modulators to treat rare and inflammatory diseases.

Clene Salutes Collaboration of ALS Community and Major League Baseball on Lou Gehrig Day

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Thursday, June 2, 2022
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In recognition of Lou Gehrig Day, Clene will broadcast a message of support on the Nasdaq MarketSite tower in New Yorks Times Square.

Key Points: 
  • In recognition of Lou Gehrig Day, Clene will broadcast a message of support on the Nasdaq MarketSite tower in New Yorks Times Square.
  • Established in 2021, Lou Gehrig Day has become an important occasion for public awareness as part of the large-scale movement to find a cure for ALS.
  • We salute the collaboration of the ALS community and Major League Baseball in remembering Lou Gehrig for his inspiration to what is a continued fight against this devastating disease, said Rob Etherington, President and CEO of Clene.
  • For more information about Major League Baseballs Lou Gehrig Day activities, visit www.lg4day.com .

New Data from Clene’s RESCUE-ALS Study to be Presented at 2022 ENCALS Meeting

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Wednesday, June 1, 2022
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The results from the RESCUE- ALS study provide evidence of safety and suggest efficacy of CNM-Au8 in patients with early ALS.

Key Points: 
  • The results from the RESCUE- ALS study provide evidence of safety and suggest efficacy of CNM-Au8 in patients with early ALS.
  • Furthermore, during the OLE, subjects originally randomized to CNM-Au8 continued to maintain stable ALSSQOL-SF scores through 84 weeks or more of treatment.
  • These emerging data highlight the significantly reduced risk of mortality following early and sustained treatment with CNM-Au8., said Rob Etherington, President and CEO of Clene.
  • We look forward to the next major data readout from the HEALEY ALS platform trial that is expected in the third quarter.

Mapi Pharma to Present Late Breaking Poster Presentation on GA Depot for Treating Primary Progressive Forms of Multiple Sclerosis at CMSC 2022 Annual Meeting

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Tuesday, May 31, 2022
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GA Depot is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone/Glatopa).

Key Points: 
  • GA Depot is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone/Glatopa).
  • GA Depot consists of extended-release microspheres containing GA, administered intramuscularly (IM) once every 28 days.
  • Mapi Pharma partnered with Viatris (NASDAQ: VTRS) for GA Depot in an agreement under which Viatris was granted an exclusive license to commercialize the GA Depot injection product for relapsing forms of multiple sclerosis.
  • Mapi Pharma was founded by Ehud Marom who serves as Chairman & CEO of Mapi Pharma and Stem Cell Medicine.

Clene Receives $3 Million Loan from State of Maryland to Support Development of Commercial Manufacturing Facility

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Thursday, May 19, 2022
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SALT LAKE CITY, May 19, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that the Maryland Board of Public Works has finalized a $3 million loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Key Points: 
  • The loan was provided by the states Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.
  • This non-dilutive loan for capital equipment purchases will support the expansion of Clenes operations in Cecil County, Maryland, at a new commercial manufacturing facility for production of its lead drug candidate, CNM-Au8, a gold nanocrystal suspension.
  • This expansion is aligned with Clenes anticipation of the potential commercialization of CNM-Au8 as a treatment for amyotrophic lateral sclerosis (ALS).
  • We appreciate the continued financial support from the state of Maryland, the town of Elkton, and Cecil County.

Autobahn Therapeutics Announces Emerging Preclinical Data Demonstrating Ability of CNS-Delivered Thyromimetics to Promote Remyelination

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Wednesday, May 18, 2022
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We are excited to share new data with LL-341070, an analog of ABX-002, in partnership with these esteemed academic centers and leaders in neurodegeneration and remyelination in myelin-mediated diseases, said Kevin Finney, Chairman and CEO of Autobahn.

Key Points: 
  • We are excited to share new data with LL-341070, an analog of ABX-002, in partnership with these esteemed academic centers and leaders in neurodegeneration and remyelination in myelin-mediated diseases, said Kevin Finney, Chairman and CEO of Autobahn.
  • These findings further support our hypothesis that CNS-delivered thyromimetics can promote myelin regeneration and offer potentially disease-altering treatments for indications such as multiple sclerosis.
  • Details of the respective preclinical data presentations are as follows:
    Meeting Forum: 2022 Myelin Gordon Research Conference being held May 22-27, 2022, in Barga, Italy.
  • Our findings are highly encouraging and suggest that treatment with thyromimetics can lead to robust remyelination in the CNS, resulting in neurologic recovery.

INmune Bio, Inc. Presents Data Demonstrating XPro™ Promotes Remyelination in Gray Matter at 3rd European Conference on Neuroinflammation

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Tuesday, May 10, 2022
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Boca Raton, Florida, May 10, 2022 (GLOBE NEWSWIRE) --  Inmune Bio, Inc. (NASDAQ: INMB) (“INMB” or “the Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease is pleased to announce that Professor Lesley Probert Ph.D., head of the department of Immunology at the Hellenic Pasteur Institute in Athens, Greece will be presenting data on the effects of tumor necrosis factor (TNF) in MS at the 3rd European Conference on Neuroinflammation concluding in London today. 

Key Points: 
  • Professor Probert has been researching the role of TNF in promoting demyelination (destruction of myelin) for more than a decade.
  • When the myelin sheath is damaged, nerve cells cannot transmit signals efficiently and, if the damage persists, the cells undergo neurodegeneration and die.
  • The data presented today show that XProTM also promotes remyelination within the gray matter of the brain by inducing the brains natural repair mechanisms.
  • Neutralization of soluble TNF with XProTM activates pro-microglial and pro-astroglial responses to clear (phagocytize) degenerated myelin and promote remyelination in cortical areas.

Clene Reports First Quarter 2022 Financial Results and Recent Operating Highlights

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Monday, May 9, 2022
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Additional data from the RESCUE-ALS open-label extension were presented in a late breaker session at the American Academy of Neurology Annual Meeting (April 2022).

Key Points: 
  • Additional data from the RESCUE-ALS open-label extension were presented in a late breaker session at the American Academy of Neurology Annual Meeting (April 2022).
  • Unblinded data from the VISIONARY-MS Phase 2 clinical trial data are targeted for the third quarter of 2022.
  • Clene expects that its cash as of March 31, 2022, will be sufficient to fund its operations into the second quarter of 2023.
  • Research and development expenses were $8.6 million for the quarter ended March 31, 2022, compared to $6.3 million for the same period in 2021.

Frequency Therapeutics Provides Business Updates and First Quarter 2022 Financial Results

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Wednesday, May 4, 2022
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Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate regenerative potential to restore function, today announced business updates and financial results for the first quarter ended March 31, 2022.

Key Points: 
  • Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate regenerative potential to restore function, today announced business updates and financial results for the first quarter ended March 31, 2022.
  • Frequency continues to make important progress executing our pipeline of therapeutic programs for hearing loss and remyelination in multiple sclerosis (MS).
  • FX-345 is being evaluated in IND-enabling studies and Frequency anticipates filing an IND application for FX-345 in the second half of 2022.
  • Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2022, were $124.8 million (excluding restricted cash).

Updated Interim Data from Clene Nanomedicine’s RESCUE-ALS Open-Label Extension Study to be Presented in Emerging Science Program at 2022 AAN Annual Meeting

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Friday, April 1, 2022
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Featured in the Emerging Science Program on April 5, the data demonstrate a 70% survival benefit among ALS patients who entered the open-label extension of RESCUE-ALS (n=36, 90% of those eligible).

Key Points: 
  • Featured in the Emerging Science Program on April 5, the data demonstrate a 70% survival benefit among ALS patients who entered the open-label extension of RESCUE-ALS (n=36, 90% of those eligible).
  • Furthermore, CNM-Au8 was shown to be well-tolerated with no safety signals identified over 96 weeks of treatment.
  • RESCUE-ALS was a proof of concept study intended to establish that treatment of neuronal energetic failure can provide disease-modifying effects in ALS.
  • The slide presentation from the Emerging Science session will be available in the Scientific Posters & Presentations section of the Clene website on the afternoon of April 5.