Palm Beach, FL –– August 11, 2022 – FinancialNewsMedia.com News Commentary – Multiple Sclerosis (MS) is an immune-mediated disease affecting the central nervous system. It is characterized by demyelination, inflammation, degenerative changes such as progressive brain and spinal cord atrophy and neuroaxonal loss. According to the Multiple Sclerosis International Federation, the number of people with multiple sclerosis across the globe increased from 2.3 million in 2013 to 2.8 million in 2020. The increasing prevalence of this disease has increased the demand for effective diagnosis and treatment of multiple sclerosis globally. Hence, the government is actively supporting the treatment of multiple sclerosis. A report from Fortune Business Insights said that: “The global multiple sclerosis drugs market size was valued at USD 23.68 billion in 2021. The market is projected to grow from USD 25.43 billion in 2022 to USD 33.17 billion by 2029, exhibiting a CAGR of 3.9% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with multiple sclerosis drugs experiencing lower-than-anticipated demand across all regions compared to pre pandemic levels. Based on our analysis, the market exhibited a slow growth of 1.2% in 2020 as compared to 2019.  The multiple sclerosis drugs market growth is attributed to the increasing focus on R&D to develop innovative drugs by major market players. For instance, in December 2020, Adamas Pharmaceuticals Inc. announced results from the phase 3 clinical study on ADS-5102, an investigational amantadine agent for treating MS patients. Furthermore, new product launches, increasing government initiatives to improve the accessibility of care & treatment, and the rising prevalence of multiple sclerosis are expected to contribute to the expansion of the market.”  Active Biotechs in the markets today include:  Pasithea Therapeutics Corp. (NASDAQ: KTTA), BioNTech SE (NASDAQ: BNTX), Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX}, SIGA Technologies, Inc. (NASDAQ: SIGA), Moderna, Inc. (NASDAQ: MRNA).

Fortune Business Insights added: “The increased market penetration, rapid adoption of immunosuppressive drugs, and advancements in the production of monoclonal antibody drugs have resulted in the increased use of monoclonal antibodies. This is poised to drive the global multiple sclerosis drugs market growth during the forecast period.  The market is witnessing substantial clinical research and R&D investment attraction. Most of the pharmaceutical companies have increased their focus on developing novel therapies for the treatment of MS.  Increased research on various novel candidates has resulted in strengthening the pipeline portfolio of leading and small-scale pharmaceutical companies. The expected launch of these pipeline candidates is likely to drive the multiple sclerosis treatment market growth in the coming years.”

Pasithea Therapeutics Corp. (NASDAQ: KTTA) Breaking News: Pasithea Therapeutics Announces Results of Preclinical Study Demonstrating Tolerizing Vaccine Efficacy in Relapsing-Remitting Model of Multiple Sclerosis – Pasithea Therapeutics Corp. (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research and development of new and effective treatments for psychiatric and neurological disorders, today announced positive results from a preliminary preclinical proof of concept study of PAS002, its tolerizing vaccine program in multiple sclerosis (“MS”).

Earlier this year, a study in Nature, the world’s leading science journal, showed that a molecule called GlialCAM found in the brain’s white matter is attacked in MS. GlialCAM shares a component of its protein structure that mimics an identical component of the Epstein Barr Virus (“EBV”) Nuclear Antigen-1, which plays a critical role in triggering MS.

In this proof of concept study, relapsing paralysis was established in a mouse model of relapsing-remitting experimental autoimmune encephalomyelitis (“EAE”), the standard animal model of MS. In three groups, a proprietary DNA cassette was engineered to encode GlialCAM and injected to potentially block acute disease and its relapse. These DNA molecules were designed to protect against paralytic disease by tolerizing the immune system so it would not attack myelin in the brain and spinal cord. The engineered DNA molecule creates tolerance, working like an ‘inverse vaccine’, and was administered intra-muscularly at days 0, 3, 7, 10, and 14. The study had a standard duration of 32 days.

The data showed that the engineered DNA plasmids provide a high level of efficacy in reducing disease severity and incidence of relapse when administered prophylactically in the EAE model, a widely used relapsing-remitting model of MS.

Key findings from the study include:

• treatment with a DNA tolerizing ‘inverse vaccine’ delayed the onset of paralysis when compared to vehicle (p<001);
• a statistically significant reduction in disease severity, when compared to vehicle (p=0.002);
• a statistically significant reduction in relapse severity, when compared to vehicle (p<001);
• treatment with a DNA vaccine prevented disease in approximately 50% of the mice, when compared to vehicle (p=0.004);

The study was conducted at Hooke Laboratories, an independent full-service Contract Research Organization with deep experience in EAE animal model of MS.

“The results of this study show that this technology has the potential to tolerize to GlialCAM, a myelin molecule that has molecular similarity to the Epstein Barr Virus that triggers MS.” stated Pasithea’s Chairman, National Academy of Sciences Professor Lawrence Steinman, a world recognized leading authority in MS. Prof. Steinman’s research led to the development of the drug Tysabri, which is approved to treat patients with MS and Crohn’s disease. “Remarkably the piece of GlialCAM protein shared between EBV and white matter in the brain, is also found in the pox viruses, including monkeypox.  Monkeypox is rarely associated with brain inflammation, and this new technology may prove useful for brain inflammation caused in certain viral infections.”  CONTINUED…  Read the Pasithea Therapeutics full press release by going to:  https://ir.pasithea.com/

In other biotech news in the markets this week: 

BioNTech SE (NASDAQ: BNTX) recently reported financial results for the three and six months ended June 30, 2022 and provided an update on its corporate progress.  “In the first half of 2022, we achieved important milestones as we have further strengthened our COVID-19 vaccine leadership and have expanded our broad pipeline and accelerated its maturation. Our COVID-19 product pipeline includes variant-adapted and next-generation vaccine candidates, aimed at prolonged and broad protection,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “In oncology, we have presented encouraging data updates for our individualized mRNA cancer vaccine candidate BNT122 in pancreatic cancer and our novel CAR-T cell therapy candidate BNT211 in solid tumors, leading to our first PRIME designation by EMA. We drive toward the preparation of registrational trials as well as the delivery of our first BioNTainers to Africa, aiming to provide access to novel medicines.”

“With our strong performance year to date, we believe to be well on track to achieve our previous financial guidance for the ongoing financial year,” said Jens Holstein, CFO of BioNTech. “With our initiatives around variant-adapted COVID-19 vaccine candidates, we expect an uptake in demand in our key markets in the fourth quarter of 2022, subject to regulatory approval. We will continue to invest heavily in research and development in 2022 and beyond and remain focused on furthering our oncology pipeline as well as driving our leadership in COVID-19 vaccine development. We are driving toward potential launches of multiple innovative products to address diseases with high unmet medical need in the coming three to five years.”

Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) recently announced that ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine) is now commercially available in Canada for people living with amyotrophic lateral sclerosis (ALS). ALBRIOZA (also known as AMX0035) is an oral fixed-dose combination therapy that may reduce neuronal cell death as a stand-alone therapy or when added to existing treatments. In a clinical trial, ALBRIOZA significantly slowed disease progression and loss of functional decline in people living with ALS.

“We have remained steadfast in our commitment to ensure ALBRIOZA would be available in Canada as quickly as possible following Health Canada’s decision to approve ALBRIOZA, with conditions, in June,” said Margaret Olinger, Chief Commercial Officer at Amylyx. “We are pleased that starting this week, we are ready to fill prescriptions for ALBRIOZA.”

SIGA Technologies, Inc. (NASDAQ: SIGA), a commercial-stage pharmaceutical company, recently announced the exercise of procurement options under its 75A50118C00019 (19C) contract with the U.S. Department of Health and Human Services for the delivery to the U.S. government of intravenous (IV) formulation of TPOXX treatment courses valued at approximately $26 million . These option exercises represent the first procurement option exercises for IV TPOXX under the 19C contract. Product deliveries of IV TPOXX in connection with these contract options are targeted for 2023. IV TPOXX is an important option for those who are unable to swallow.

“These option exercises for the procurement of IV formulation of TPOXX as well as the funding of a post-marketing field study for IV TPOXX highlight the growing importance of a broad-based response to the substantial risks posed by the orthopox family of viruses, including smallpox and monkeypox,” said Phil Gomez, CEO of SIGA. “The exercised options are among many procurement options under the 19C contract that remain to be exercised and, as such, we will continue to coordinate with the U.S. government toward future procurements of oral TPOXX and IV TPOXX.”

Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, recently reported financial results and provided business updates for the second quarter of fiscal year 2022.

“Today’s earnings represent a strong second quarter performance, with $10.8 billion in revenue for the first half of the year. We continue to have advance purchase agreements for expected delivery in 2022 of around $21 billion of sales. Given our strong financial position and commercial momentum, we are announcing today that the Board of Directors has approved a new share repurchase program for $3 billion,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Despite the slowing economy and challenges in the biotech industry, Moderna is in a unique position: a platform to drive scale and speed in research of new medicines, a strong balance sheet with $18 billion of cash and an agile, mission-driven team of over 3,400 people and growing. We will continue to invest and grow as we have never been as optimistic about Moderna’s future. Right now, we have four infectious disease vaccines in Phase 3 trials, and later this year, we expect important data from proof-of-concept studies in rare diseases and immuno-oncology. Our teams are actively working to prepare these new product launches to help patients and drive growth. This is an exciting time for Moderna as we continue to see significant scientific and business momentum.”

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