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Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery and development company focused on creating novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that through its discovery work, it has identified three additional families of highly novel, non-tryptamine, next-generation psychedelic compounds.

Mindset's ambition since its formation has been to lead the medical psychedelic space in drug discovery by pushing the boundaries of known psychedelic drugs to create the broadest portfolio of varied and differentiated drug candidates. While much of the industry focus has been on classic psychedelic drugs, Mindset has purposefully expanded its discovery efforts beyond the tryptamine drug class (i.e. psilocybin and DMT) into new, innovative chemical structures in order to develop superior neuropsychiatric medications.

Using a fragment-based drug discovery (FBDD) method combined with a highly focused medicinal chemistry strategy, Mindset's scientists designed and developed three new, chemically distinct, small molecule non-tryptamine scaffolds, Families 6, 7 and 8. Mindset has filed provisional patent applications on these families, with favorable FTO searches. Approximately forty novel drug-like lead compounds were synthesized and evaluated in in-vit ro hydroxy tryptamine (5-HT) subtype receptors and in in-vit ro absorption, distribution, metabolism, and excretion (ADME) studies. To date, pre-clinical screening has shown significantly enhanced receptor functional potency and selectivity. In addition, some of the new compounds have the potential for greater central nervous system (CNS) penetration, oral activity and efficacy.

"Mindset's leading drug discovery engine continues to yield innovations with the potential to help patients across the world with neuropsychiatric and neurological disorders. The discovery of new Families 6, 7 and 8 demonstrates our commitment to expanding our Research & Development and strengthening our Intellectual Property (IP) portfolio beyond the classical tryptamines in the psychedelic field," said James Lanthier, CEO of Mindset Pharma. "The discovery of these new families further expands our rich pipeline and provides a unique serotonergic receptor profile supporting our goal to design new and elegant drug candidates with increased receptor selectivity and potency profiles. Pre-clinical screening of the new families has shown promising results thus far and we are eagerly looking forward to advancing Mindset's continued innovations into these new, chemically distinct drug families."

About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin in addition to its own proprietary compounds. The company has a co-development agreement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for its short-duration compounds, Mindset Families 2 and 4.

For further information on Mindset, please visit our website at www.mindsetpharma.com .

For more information, please contact:

Investor Contact:
Allison Soss
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267

Media Contact:
McKenna Miller
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 949-606-6585

Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com

Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094

Forward-Looking Information
This news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate", "may", "will", "would", "potential", "proposed" and other similar words, or statements that certain events or conditions "may" or "will" occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company's business are contained under the heading "Risk Factors" in the Company's annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.



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Mindset Pharma Receives Scientific Advice from UK Regulator Facilitating Advancement of Phase 1 First-In-Human Clinical Trial Plan for Its Lead Clinical Candidate, MSP-1014

Mindset Pharma Receives Scientific Advice from UK Regulator Facilitating Advancement of Phase 1 First-In-Human Clinical Trial Plan for Its Lead Clinical Candidate, MSP-1014

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that the Company has received Scientific Advice from the UK Medicines and Healthcare products Regulatory Agency ("MHRA") on a range of points to finalize its Phase 1 first-in-human clinical trial plan evaluating its lead psychedelic drug candidate MSP-1014 for the treatment of Major Depressive Disorders (MDD) .

In a meeting with the MHRA, Mindset discussed its plans for Phase 1 first-in-human clinical development of MSP-1014, a novel and patented, second-generation psilocybin-like drug candidate within Family 1, in collaboration with a specialized psychedelic UK-based Contract Research Organization (CRO), Clerkenwell Health. The MHRA has agreed with the Company's position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time. The MHRA has also provided specific valuable guidance on potential clinical trial design regarding dosing, patient selection criteria, and safety endpoints.

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Mindset Pharma Files National Patents Protecting Family 1 Application in 16 Different Countries

Mindset Pharma Files National Patents Protecting Family 1 Application in 16 Different Countries

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery and development company focused on creating novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced the filing of 16 different national applications for the protection of one of four of the Company's key Families of novel, next-generation psychedelics with differentiated characteristics.

Included within these applications are several drug candidates that the Company classifies as belonging to "Family 1", which are described as second-generation psilocybin analogs, with potential improvements in effect size, safety, safety, and manufacturing compared to psilocin and psilocybin. Mindset's Family 1 scaffold includes the first elected Mindset clinical candidate, MSP-1014, which is the Company's most advanced drug candidate, a psilocybin-like chemical entity that has the potential to be a best-in class psychedelic treatment, and more effective alternative. MSP-1014 has demonstrated improved efficacy, with reduced potential side effects, and safety profile compared to the first-generation drug candidate, psilocybin, in preclinical studies. Mindset filed national applications in 16 different countries altogether, including the principal South East Asian markets.

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Mindset Pharma to Participate in the H.C. Wainwright 24th Annual Global Investment Conference on September 12-14, 2022

Mindset Pharma to Participate in the H.C. Wainwright 24th Annual Global Investment Conference on September 12-14, 2022

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery and development company focused on creating novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that James Lanthier, CEO, and Joseph Araujo, CSO of Mindset, will participate in the H.C. Wainwright 24 th Annual Global Investment Conference to be held at the Lotte New York Palace Hotel in New York City on September 12-14, 2022.

Mr. Lanthier and Mr. Araujo will participate in a fireside chat with Patrick Trucchio, H.C. Wainwright Research Analyst, on Tuesday, September 13 th at 9:30 a.m. ET. To attend, please register here .

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Mindset Pharma CEO, James Lanthier, Issues Letter to Shareholders

Mindset Pharma CEO, James Lanthier, Issues Letter to Shareholders

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery and development company focused on creating novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today issued a letter to shareholders from James Lanthier, Chief Executive Officer of Mindset.

Dear Fellow Shareholders:

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Mindset Pharma Receives Allowance for Patent Application Covering its Short-Duration Novel Psychedelic Medications for The Treatment of Central Nervous System Disorders

Mindset Pharma Receives Allowance for Patent Application Covering its Short-Duration Novel Psychedelic Medications for The Treatment of Central Nervous System Disorders

Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, announced today that the United States Patent and Trademark Office ("USPTO") has granted allowance for Mindset's patent application number 17387,864, titled "3-Pyrrolidine-Indole Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders." Included within this application are drug candidates that the Company classifies as belonging to Family 2, which are novel analogues of psilocybin that exhibit a range of pharmacokinetic and pharmacodynamic improvements in pre-clinical studies.

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Cybin to Participate in Upcoming Scientific and Investor Conferences

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Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics TM , is pleased to announce its participation in the following upcoming conferences:

Interdisciplinary Conference on Psychedelic Research, Psychedelic Science, Ethics & Business Event, September 21, 2022 in Haarlem, Amsterdam

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Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

Clene Nanomedicine Presents Updated Long-Term Survival Data from RESCUE-ALS Participants at 2022 AANEM Scientific Conference

  • Treatment with CNM-Au8 significantly improved long-term survival with approximately a 70% decreased risk of mortality vs. original placebo randomization
  • Comparable survival benefits were also shown compared to ENCALS predicted median survival
  • C NM-Au8 treatment was well-tolerated, and there were no significant safety findings reported

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 diseases, today announced presentation of updated survival results from the Phase 2 RESCUE-ALS trial open-label extension (OLE) at the 2022 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Clinical & Scientific Conference, taking place September 21-24 in Nashville, Tennessee.

The poster titled, " Evidence for a Potential Survival Benefit in Amyotrophic Lateral Sclerosis with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS trial Long-Term Open Label Extension ," provides ongoing evidence supporting the clinical benefits of Clene's lead drug candidate, CNM-Au8 ® , a catalytically active gold nanocrystal suspension that holds promise as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Specifically, the poster evaluated the survival benefit associated with long-term CNM-Au8 treatment. Updated interim analyses of all-cause mortality with up to 137 weeks of follow-up from randomization comparing participants originally randomized to CNM-Au8 to participants originally randomized to placebo demonstrated a significant survival benefit with CNM-Au8 treatment, resulting in approximately a 70% decreased risk of death (HR = 0.29, p=0.01). Sensitivity analyses of observed survival compared to predicted median survival derived from the published ENCALS prediction model based on each participant's baseline study characteristics, with a data cutoff of August 31, 2022, also demonstrated a significant survival benefit with CNM-Au8 treatment (HR = 0.36, p=0.003). CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported during the OLE .

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Cybin Achieves Research and Development Milestones Ahead of Projected Timelines

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-- Completion of Adelia milestones marks promising path toward clinical drug development --

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Renee Wegrzyn Slated to Lead New Advanced Research Projects Agency for Health

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The White House today announced that President Biden intends to appoint Renee Wegrzyn PhD, as the first Director of the Advanced Research Projects Agency for Health ( ARPA-H ). Dr. Wegrzyn is currently the Vice President for Business Development at Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming. ARPA-H was established in March 2022 to drive transformative health breakthroughs that cannot readily be accomplished through traditional research or commercial activity.

(PRNewsfoto/Ginkgo Bioworks)

"I am deeply honored to have the opportunity to shape ARPA-H's ambitious mission and foster a vision and approach that will improve health outcomes for the American people, including President Biden's Cancer Moonshot," said Dr. Wegrzyn. "Some of the problems we face every day - especially in health and disease - are so large they can seem insurmountable. I have seen firsthand the tremendous expertise and energy the U.S. biomedical and biotechnological enterprise can bring to solve some of the toughest health challenges. ARPA-H will create the transformative and collaborative space that is required to support the next generation of moonshots for health—not only for complex diseases like cancer, but also systemic barriers like supply chain gaps and equitable access to breakthrough technologies and cures for everyone."

Dr. Wegrzyn holds a PhD and BS in Applied Biology from the Georgia Institute of Technology , was a Fellow in the Center for Health Security Emerging Leaders in Biosecurity Initiative (ELBI), and completed her postdoctoral training as an Alexander von Humboldt Fellow in Heidelberg, Germany . Early in her career, she led research and development teams in private industry in the areas of biosecurity, gene therapies, emerging infectious disease, neuromodulation, synthetic biology, and diagnostics. She served as Program Manager in the Biological Technologies Office (BTO) of the Defense Advanced Research Projects Agency (DARPA), where she leveraged the tools of synthetic biology and gene editing to enhance biosecurity, support the domestic bioeconomy, and thwart biothreats. Since joining Ginkgo in August 2020 , she has built out its innovation pipeline for biosecurity, developing and scaling new tools to combat infectious disease and other biological threats through broad community access.

"This is a really great moment for health and biomedical innovation. Dr. Wegrzyn stands out as a thoughtful, innovative, and practical leader," said Matt McKnight , General Manager for Biosecurity at Ginkgo. "She understands the health innovation ecosystem from every angle—from early-stage research and development to commercialization and community impact, across the public, private, and academic sectors. In her time at Ginkgo, she has been an incredible leader, and her work has shaped the emerging biosecurity industry for years to come. Renee uniquely understands what is needed in the next era of invention, and ARPA-H will benefit tremendously from being shaped by her vision."

About Ginkgo Bioworks

Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.

MEDIA CONTACT:

press@ginkgobioworks.com

INVESTOR CONTACT:

investors@ginkgobioworks.com

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SOURCE Ginkgo Bioworks

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How to Invest in Life Science (Updated 2022)

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