Palm Beach, FL –– October 12, 2022 – FinancialNewsMedia.com News Commentary – The COVID pandemic has not only had a negative effect on most markets but it has also spurred growth in several worldwide markets. The COVID-19 pandemic has impacted the whole drug industry’s inventory network. It will also increase interest in the global central nervous system disorders therapeutics market due to the link between neurological illnesses like anxiety, depression, and others and COVID-19 contamination. As indicated by an article distributed by the Clinical Preliminary Field in January 2021, around 84% of patients experiencing extreme COVID-19 disease are accounted for to encounter a mental debilitation like mental disarray of some sort or another. This study reveals that COVID-19 patients are at a higher risk of developing a neurological problem like dementia or Alzheimer’s infection. Individuals experiencing intense COVID-19 contamination might foster disarray, ridiculousness, and misery of awareness. People who experience the ill effects of post-intense episodes of COVID-19 frequently experience issues with concentration and memory issues, in some cases alluded to as “mind haze.” This weakening is a typical side effect in individuals with serious exhaustion. A report from Coherent Market Insights projected that the Central Nervous System Disorders Therapeutics Market is Estimated to Size $ 159,583.2 Million, Growing at a CAGR Of 7.4% by 2028. It said expanding item dispatches and administrative endorsements for focal sensory system issues therapeutics are supposed to drive the development of the global central nervous system disorders therapeutics market over the conjectured timeframe (2028). Active Biotechs in the markets today include: Pasithea Therapeutics Corp. (NASDAQ: KTTA), AstraZeneca PLC (NASDAQ: AZN), Cardiff Oncology, Inc. (NASDAQ: CRDF), SpringWorks Therapeutics, Inc. (NASDAQ: SWTX), Day One Biopharmaceuticals (NASDAQ: DAWN).
The report continued: “Additionally, business methodologies such as associations and coordinated efforts to support the innovative work of therapeutics for the treatment of neurodegenerative CNS problems by vital participants are likewise expected to help with the development of the global central nervous system disorders therapeutics market over the conjectured timeframe. The global central nervous system disorders therapeutics market is supposed to show a CAGR of 7.4% during the conjecture timeframe, due to rising innovative work and coordinated effort by drug organizations, as would be considered normal to support the development of the market. Among districts, North America assessed to represent the biggest share in the global central nervous system disorders therapeutics market in 2021. Expanding predominance of focal sensory system problems in the district is supposed to reinforce the market development over the conjecture timeframe.”
Pasithea Therapeutics Corp. (NASDAQ: KTTA) Breaking News: Pasithea Therapeutics Acquires AlloMek Therapeutics — Expands CNS Product Portfolio with Addition of CIP-137401, a Macrocyclic, Next-Generation MEK Inhibitor – Pasithea Therapeutics Corp. (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders, today announced that it acquired AlloMek Therapeutics, LLC (“AlloMek”), a privately-held biotechnology company. AlloMek’s lead therapeutic candidate, CIP-137401, is a potential best-in-class macrocyclic mitogen-activated protein kinase kinase 1/2 (MEK) inhibitor for use in a range of CNS-related indications, including neurofibromatosis type 1 (NF1) and Noonan syndrome, as well as potential synergy with our existing multiple sclerosis (MS) development program. The closing of the acquisition occurred on October 11, 2022.
CIP-137401 is a small molecule allosteric inhibitor of MEK 1/2, a key kinase in the Ras-Raf-MEK-ERK signaling pathway. Existing MEK inhibitors are marketed for a range of diseases, providing evidence for the value of regulating MEK as a drug target, however, they suffer from limitations. Unlike other MEK inhibitors, CIP-137401 is macrocyclic, which displays improved drug-like properties, such as an optimal pharmacokinetic (PK), safety (tolerability) and potency profile, offering potential benefits over other MEK inhibitors. CIP-137401 was designed to limit toxicities and overcome poor pharmacokinetic profiles such as short half-lives and the formation of major metabolites, which result in the limited exposure and stability of known MEK inhibitors.
“The acquisition of AlloMek represents the successful continuation of our business development strategy. Expanding our CNS-focused drug development pipeline with near-term clinical opportunities addressing rare RASopathies, while also positioning us for long-term growth opportunities with potential synergy with our existing tolerizing program that we believe will yield the greatest results for patients, the healthcare community and stockholders,” stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “CIP-137401 was designed to impart optimum drug-like properties potentially allowing for higher exposure, improved efficacy and less frequent dosing which can drive better outcomes as well as improved patient compliance to address issues with existing MEK inhibitors. In addition, we would like to welcome Connecticut Innovation Fund (CI), a venture capital firm as a long term focused institutional stockholder who has supported the development of CIP-137401 to our stockholder registry.”
CIP-137401 has displayed efficacy in a range of mouse models of various diseases and has completed pre-clinical testing and animal toxicology studies to support an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). CIP-137401 has already received orphan-drug designation from the FDA for NF1. The Company plans to initially focus clinical development of CIP-137401 on NF1 followed by Noonan syndrome, both rare diseases with significant unmet clinical needs.
Dr. Marques added, “We look forward to bringing CIP-137401 into the clinic rapidly. We currently anticipate filing an IND in the second half of 2023 following GMP manufacturing of CIP-137401, which is needed for the IND-submission and initiation of human clinical trials. Our clinical strategy is to pursue the development of CIP-137401 in NF1 followed by Noonan syndrome, which may also offer the potential for a rare pediatric disease priority review voucher (PRV) from the FDA.”
Dr. Uday Khire, Chief Executive Officer of AlloMek, noted, “We are excited to work with the esteemed team at Pasithea to get CIP-137401 into patients. We strongly believe in our lead molecule, CIP-137401, which has shown a unique combination of potency, tolerability and PK profile in preclinical settings and could prove to be a sweet spot among MEK kinase inhibitors.”
“We have worked with the drug candidate in our laboratory in a mouse model of a rare inherited heart disease with increased cardiac ERK activity,” added Howard J. Worman, M.D., Professor of Medicine and Pathology and Cell Biology at Columbia University and Chair of AlloMek’s Scientific Advisory Board. “In our model, CIP-137401 was very effective in controlling cardiac fibrosis, extremely potent in reducing tissue ERK activity in vivo and well-tolerated by the animals.”
Lawrence Steinman MD, Professor of Neurology and Neurological Sciences at Stanford University and Chairman of the board of directors at Pasithea, concluded, “AlloMek’s programs are potentially transformative for unmet needs in neurologic diseases, including NF1, Noonan syndrome and may synergize with Pasithea’s program in MS. Pasithea has experimental data on tolerizing the immune system to unwanted responses to a molecule called GlialCAM, which is similar (molecular mimicry) to Epstein-Barr virus and to members of the Poxvirus family. Published research in Nature showed that kinases are critical for facilitating pathological cross-reaction by adding phosphate residues (phosphorylation) to key amino acids. CIP-137401 has the potential to block phosphorylation of the molecular mimic, and by doing so, help to ameliorate the pathology that triggers MS.” CONTINUED… Read the Pasithea Therapeutics full press release by going to: https://ir.pasithea.com/
In other biotech news in the markets this week:
AstraZeneca PLC (NASDAQ: AZN) Alexion, AstraZeneca Rare Disease, recently announced that it has entered a definitive agreement to acquire Lexington, Mass.-based LogicBio® Therapeutics, Inc. (NASDAQ: LOGC), a pioneering genomic medicine company. The proposed acquisition aims to rapidly accelerate Alexion’s growth in genomic medicines through LogicBio’s unique technology, experienced rare disease R&D team, and expertise in pre-clinical development.
“The proposed acquisition of LogicBio is a significant development for our growing research in genomic medicine,” said Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease. “LogicBio’s people, experience and platforms provide new scientific capabilities by adding best-in-class technology and expertise to our genomic medicine strategy. The scientific collaboration between Alexion and AstraZeneca has been a substantial area of focus since last year’s acquisition and the addition of LogicBio will expand this foundational work.”
Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced plans to conduct a randomized Phase 2 trial of onvansertib in combination with standard-of-care (SoC) FOLFIRI/bevacizumab in second-line RAS-mutated mCRC, durability of responses from its ongoing Phase 1b/2 clinical trial in KRAS-mutated mCRC and additional business updates.
“We designed our next clinical program in mCRC, a randomized Phase 2 trial we have named ONSEMBLE, to accelerate and de-risk our lead indication,” said Mark Erlander, PhD, chief executive officer of Cardiff Oncology. “Chief among ONSEMBLE’s objectives is to generate a randomized dataset to demonstrate the contribution of onvansertib over standard-of-care alone, validating the Phase 1b/2 trial results. These results show patients with different KRAS mutations experiencing durable responses to treatment with onvansertib plus standard-of-care, with an objective response rate and median progression-free survival that are well above historical benchmarks. In line with the FDA’s Project Optimus initiative, the ONSEMBLE trial will also seek to confirm the optimal dose of onvansertib in mCRC. We believe achieving these objectives could position onvansertib for a possible accelerated approval opportunity, though this would ultimately depend on the strength of the ONSEMBLE trial results.”
SpringWorks Therapeutics, Inc. (NASDAQ: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, recently announced that the first patient has been dosed in a Phase 2 trial evaluating nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, as a monotherapy in patients with recurrent ovarian granulosa cell tumors.
Ovarian granulosa cell tumors account for approximately 5% of all ovarian cancers and are the most common subtype of ovarian sex cord tumors, representing 70% of all cases. Nearly all ovarian granulosa cell tumors harbor a mutation in the FOXL2gene and preclinical studies have demonstrated that ovarian granulosa cell tumor cell lines are susceptible to gamma secretase inhibition.
Day One Biopharmaceuticals (NASDAQ: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, recently announced the appointment of Garry Nicholson as chairman of its board of directors. Mr. Nicholson brings more than 30 years of pharmaceutical and biotech oncology experience and previously served as president of Pfizer Oncology where he led its global oncology franchise. Day One co-founder Julie Grant, who served as board chair since 2021, will continue to serve as a member of the board of directors.
“Garry is an accomplished leader in the development and commercialization of new cancer therapies and we are thrilled to welcome him as chairman of our board of directors,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Garry’s expertise and guidance will be critical as tovorafenib continues to advance in our pivotal FIREFLY-1 trial towards potential commercialization for relapsed pediatric low-grade glioma and as our other ongoing clinical trials continue to progress.”
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