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BioNTech Presents Encouraging Phase 1/2 Follow-up Data for CAR-T Candidate BNT211 in Hard-To-Treat Solid Tumors at ESMO

By Dr. Matthew Watson

MAINZ, Germany, September 9, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today presented positive follow-up data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and efficacy of the Company’s novel CAR-T cell therapy candidate, BNT211, in patients with relapsed or refractory advanced solid tumors. The results demonstrated encouraging signs of anti-tumor activity and the safety profile remained manageable for the two tested dose levels. The data were presented in the Investigational Immunotherapy Proffered Paper Session at the European Society for Medical Oncology (ESMO) Congress 2022 by Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany.

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Nykode Therapeutics to present at H.C. Wainwright 24th Annual Global Investment Conference

By Dr. Matthew Watson

OSLO, Norway, Sept. 09, 2022 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced that its Chief Executive Officer, Michael Engsig, and Chief Business Officer & Co-founder, Agnete Fredriksen, will present at the H.C. Wainwright 24th Annual Global Investment Conference on Tuesday, September 13, 2022 at 11:00 a.m. ET / 5:00 p.m. CET and are available for 1:1 investor meetings.

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Orion Corporation: Acquisition of Own Shares 09.09.2022

By Dr. Matthew Watson

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Todos Medical CEO Discusses Long COVID Economic Impact with Moneta Advisory Managing Partner Marc LoPresti

By Dr. Matthew Watson

New York, NY, and Tel Aviv, ISRAEL, Sept. 09, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today released the Nasdaq MarketSite interview between Moneta Advisory Group’s Managing Partner Marc LoPresti and CEO Gerald Commissiong, discussing the impact of Long COVID on the economy and how SARS-CoV-2 viral persistence is damaging population-level immunity leading to the rise of viral outbreaks such as MonkeyPox. A link to the interview can be found at: https://youtu.be/55pv1zKCDgI.

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NexImmune to Present at the H.C. Wainwright 24th Annual Global Investment Conference

By Dr. Matthew Watson

GAITHERSBURG, Md., Sept. 09, 2022 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced that Kristi Jones, Chief Executive Officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference on Monday, September 12 at 11:00 am ET.

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Sana Biotechnology to Present at September 2022 Investor Conferences

By Dr. Matthew Watson

SEATTLE, Sept. 09, 2022 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today announced that it will webcast its presentations at two investor conferences in September. The presentations will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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Atreca to Present at Upcoming Investor Conferences

By Dr. Matthew Watson

SAN CARLOS, Calif., Sept. 09, 2022 (GLOBE NEWSWIRE) -- Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that it will present at the following upcoming investor conferences:

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Chalice Brands Ltd. Announces Termination of Totem Farms & Miracle Greens Transactions

By Dr. Matthew Watson

PORTLAND, Ore., Sept. 09, 2022 (GLOBE NEWSWIRE) -- Chalice Brands Ltd. (CSE: CHAL) (OTCQB: CHALF) (the “Company” or “Chalice Brands”), a premier consumer-driven cannabis company specializing in retail, production, processing, wholesale, and distribution, announced today that it has terminated its previously announced definitive agreements and services agreements (the “Agreements”) dated April 20, 2022, with Miracle Greens, Inc (“Miracle Greens”) and Totem Farms, LLC (“Totem Farms”).

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Novartis Cosentyx® shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa in pivotal Phase III trials

By Dr. Matthew Watson

Basel, September 10, 2022 — Novartis announced the results from two pivotal, Phase III studies (SUNSHINE and SUNRISE), in which Cosentyx® (secukinumab) demonstrated rapid and sustained relief from the common clinical signs and symptoms of moderate-to-severe hidradenitis suppurativa (HS) with a favorable safety profile5,6. The data were presented as a late-breaking abstract at the 31st European Academy of Dermatology and Venereology (EADV) Congress1.

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Novartis Cosentyx® shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa in pivotal Phase III trials

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Anaveon presents updated data from the Phase I/II study of ANV419 during the ESMO Congress 2022

By Dr. Matthew Watson

- ANV419 is well-tolerated at high doses and demonstrates notable safety with strong pharmacodynamic effects and excellent IL-2Rbg selectivity –

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Anaveon presents updated data from the Phase I/II study of ANV419 during the ESMO Congress 2022

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POINT Biopharma Provides Updated Efficacy and Safety Data from the Lead-In Cohort of the Phase 3 SPLASH Trial in mCRPC at ESMO Congress 2022

By Dr. Matthew Watson

Newly published poster on the single-arm 27-patient safety and dosimetry lead-in provides key updates including:

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POINT Biopharma Provides Updated Efficacy and Safety Data from the Lead-In Cohort of the Phase 3 SPLASH Trial in mCRPC at ESMO Congress 2022

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Immatics Presents Comprehensive Preclinical Data Set for TCR Bispecific Candidate IMA402 Targeting PRAME at European Society for Medical Oncology…

By Dr. Matthew Watson

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Elevar Therapeutics Announces Camrelizumab Plus Rivoceranib Significantly Prolonged Overall Survival and Progression-Free Survival Versus Sorafenib in…

By Dr. Matthew Watson

Top-line findings were presented today at the annual European Society for Medical Oncology (ESMO) Congress

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Elevar Therapeutics Announces Camrelizumab Plus Rivoceranib Significantly Prolonged Overall Survival and Progression-Free Survival Versus Sorafenib in...

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Adagene Presents Interim Monotherapy Data at ESMO 2022 Showing Compelling Safety, Anti-Tumor Activity and Pharmacokinetics of Masked, Anti-CTLA-4…

By Dr. Matthew Watson

- Best-in-class profile demonstrated with repeat dosing across dose levels -

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Adagene Presents Interim Monotherapy Data at ESMO 2022 Showing Compelling Safety, Anti-Tumor Activity and Pharmacokinetics of Masked, Anti-CTLA-4...

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Cabaletta Bio Presents New Interim Data from the DesCAARTes™ Phase 1 Trial at the 31st EADV Congress

By Dr. Matthew Watson

PHILADELPHIA, Sept. 10, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of targeted cell therapies for patients with autoimmune diseases, today presented updated clinical and translational data through 6 months of follow-up in cohorts A1 through A4 as well as 28-day safety data and DSG3-CAART persistence data through day 29 for cohorts A1 through A5 from the DesCAARTes™ trial at the 31st European Academy of Dermatology and Venereology (EADV) Congress, which is being held in Milan, Italy from September 7-10, 2022.

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Apexigen Presents New Data from a Phase 2 Trial Evaluating its CD40 Antibody, Sotigalimab, in Combination with Neoadjuvant Chemoradiation in Patients…

By Dr. Matthew Watson

-Sotigalimab in combination with neoadjuvant chemoradiation induced higher pathologic complete response rates, an important predictor of survival, in patients with both adenocarcinoma and squamous cell carcinoma- -Sotigalimab in combination with neoadjuvant chemoradiation induced higher pathologic complete response rates, an important predictor of survival, in patients with both adenocarcinoma and squamous cell carcinoma-

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Presents Positive Safety and Efficacy Data from the Completed Phase 1 Dose Escalation Cohort of ICT01 plus Pembrolizumab in the EVICTION Trial at…

By Dr. Matthew Watson

ImCheck Therapeutics today presented promising updated safety and patient response data from the completed dose escalation combination cohort of its ongoing EVICTION clinical trial during an oral session at the European Society for Medical Oncology (ESMO) Congress currently being held in Paris, France. EVICTION is an open-label Phase I/IIa study evaluating ImCheck’s lead antibody ICT01 as a monotherapy in both solid tumor and hematological cancers, and in combination with pembrolizumab in solid tumors.

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Presents Positive Safety and Efficacy Data from the Completed Phase 1 Dose Escalation Cohort of ICT01 plus Pembrolizumab in the EVICTION Trial at...

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SpringWorks Therapeutics Announces Data from Phase 3 DeFi Trial Evaluating Nirogacestat in Adult Patients with Progressing Desmoid Tumors at the…

By Dr. Matthew Watson

– Nirogacestat Treatment Resulted in Rapid, Sustained and Statistically Significant Improvements in Primary and All Key Secondary Efficacy Endpoints –

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SpringWorks Therapeutics Announces Data from Phase 3 DeFi Trial Evaluating Nirogacestat in Adult Patients with Progressing Desmoid Tumors at the...

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IMAC Holdings, Inc. Announces Completion of Third Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the…

By daniellenierenberg

IMAC Holdings, Inc.

BRENTWOOD, Tenn., Sept. 09, 2022 (GLOBE NEWSWIRE) -- IMAC Holdings, Inc. (Nasdaq: BACK) (IMAC or the Company), today announces it has completed the third cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinsons disease.

The third cohort consists of five patients with bradykinesia due to Parkinsons disease receiving an intravenous infusion of a high concentration stem cell treatment. The third and final cohort of the Phase 1 clinical trial was completed on Tuesday, September 6, 2022.

About IMACs Phase 1 Clinical Trial

The Phase 1 clinical trial, consisting of a 15-patient dose escalation safety and tolerability study, is being conducted at three of IMACs clinical centers in Chesterfield, Missouri, Paducah, Kentucky, and Brentwood, Tennessee. The trial is divided into three groups: 1) five patients with bradykinesia due to Parkinsons disease received a low concentration dose, intravenous infusion of stem cells, 2) five received a medium concentration intravenous dose, 3) and five received a high concentration intravenous dose. All groups will be subsequently tracked for 12 months. IMACs medical doctors and physical therapists at the clinical sites have been trained to administer the treatment and manage the therapy. Ricardo Knight, M.D., M.B.A., who is medical director of the IMAC Regeneration Center of Chicago, is the trials principal investigator.

The Institute of Regenerative and Cellular Medicine serves as the trials independent investigational review board, while Regenerative Outcomes provides management of the study. Further details of the trial can be found at clinicaltrials.gov.

About Bradykinesia Due to Parkinsons Disease

In addition to unusually slow movements and reflexes, bradykinesia may lead to limited ability to lift arms and legs, reduced facial expressions, rigid muscle tone, a shuffling walk, and difficulty with repetitive motion tasks, self-care, and daily activities. Parkinsons disease is the typical culprit of bradykinesia, and as it progresses through its stages, a persons ability to move and respond declines.

Story continues

According to Zion Market Research, the global Parkinsons disease therapeutics market was $2.61 billion in 2018 and is expected to grow to $5.28 billion by 2025. The Parkinsons Disease Foundation estimates that nearly 10 million people are suffering from Parkinsons disease, and almost 60,000 new cases are reported annually in the U.S.

About IMAC Holdings, Inc.

IMAC Holdingsowns and manages health and wellness centers that deliver sports medicine, orthopedic care, and restorative joint and tissue therapies for movement restricting pain and neurodegenerative diseases.IMACis comprised of three business segments: outpatient medical centers, The Back Space, and a clinical research division. With treatments to address both young and aging populations,IMAC Holdingsowns or manages outpatient medical clinics that deliver regenerative rehabilitation services as a minimally invasive approach to acute and chronic musculoskeletal and neurological health problems. IMACs The Back Company retail spinal health and wellness treatment centers deliver chiropractic care within Walmart locations. IMACs research division is currently conducting a Phase I clinical trial evaluating a mesenchymal stem cell therapy candidate for bradykinesia due to Parkinsons disease. For more information visitwww.imacholdings.com.

# # #

Safe Harbor Statement

This press release contains forward-looking statements. These forward-looking statements, and terms such as anticipate, expect, believe, may, will, should or other comparable terms, are based largely on IMAC's expectations and are subject to a number of risks and uncertainties, certain of which are beyond IMAC's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the skills and experience necessary to meet customers requirements, and its ability to protect its intellectual property. IMAC encourages you to review other factors that may affect its future results in its registration statement and in its other filings with the Securities and Exchange Commission. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this press release will in fact occur.

IMAC Press Contact:

Laura Fristoe

lfristoe@imacrc.com

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Spinal Muscular Atrophy: Causes and importance of early diagnosis for proactive management – Firstpost

By daniellenierenberg

A person with SMA may find it challenging to stand up, walk, control their head movements, and in some cases, even breathe and swallow

Spine. Image courtesy Pearson Scott Foresman/Wikimedia Commons

Spinal muscular atrophy (SMA) is a severe genetic condition that targets motor neurons in the central nervous system (CNS), resulting in progressive muscle atrophy, weakness, and paralysis. It is a group of genetic disorders in which a person cannot control the movement of their muscles due to a loss of nerve cells in the spinal cord and brain stem. A person with SMA may find it challenging to stand up, walk, control their head movements, and in some cases, even breathe and swallow. Some forms of SMA are present at birth, while others develop over time. Some have an impact on life expectancy.

SMA can be clinically divided into five subtypes. The most severe type is SMA type 0, appearbefore birth, can be fatal before or after birth within the first year of life. Type 1 SMA also called infantile-onset, is the most common type of SMA, accounting for 60% cases, which appears in infants and causes them to die or become dependent on a ventilator by the age of two. Children with SMA type 2 are sitters, while those with type 3 can walk on their own for a while before becoming wheelchair-bound. SMA type 4 develops in adults and causes later-life progressive weakness.

SMA is the most frequent cause of death in the infantile age group, occurring in one in 10,000 live births. However, the SMA carrier frequency was 1 in 38 in a recent Indian study. Children with SMA can currently receive supportive care in India that includes assisted ventilation, feeding, physiotherapy, orthotics, and spine stabilization.

What causes SMA?

SMA is caused by a very specific genetic mutation in a gene called theSMN1 gene. SMN is that protein that play a critical role in the survival of the nerve cells that control muscles. (SMN) protein keeps motor neurons healthy and functioning normally. The loss of motor neurons in the spinal cord caused by SMA patients, and insufficient levels of the SMN protein results in skeletal muscle weakness and wasting.

SMA patients gradually lose their ability to control their muscles movement and strength. The muscles closest to the torso and neck are frequently severely affected by the disease. Some SMA patients never sit, stand, or walk. Other signs of SMA include tongue fasciculation, a bell-shaped chest (caused by muscle weakness), weak cough, difficulty breathing , choking or trouble swallowing, weak sucking and labored breathing during feeding.

How is SMA diagnosed?

The diagnosis of spinal muscular atrophy depends on the type of SMA a person has and age of onset. The path to diagnosis for infants and children with more severe forms of SMA frequently starts when a parent or medical professional notices unusual muscle weakness (hypotonia). People with adult-onset SMA types, such as type 4, might begin the diagnosis process after observing minor symptoms like hand tremors.

Physical exam

A physical examination is required to identify the presence of symptoms like muscle weakness or a lack of reflexes in cases where a new-born is not screened for SMA at birth. A primary care physician or a neurologist could perform this.

Family medical history

As part of your or your childs physical examination, a thorough review of the patients family history is necessary to determine whether there have ever been any instances of neuromuscular disease in the family. If the physical examination and family history raise suspicion of SMA, genetic testing will likely be the next step.

Genetic testing

Through molecular genetic testing, which requires a blood sample, SMA is identified. A single gene is examined for mutations linked to a genetic disease in molecular genetic testing.

Importance of early diagnosis

A patient with SMA must first undergo a higher level of cognitive evaluation. The clinician should assess the patient for weakness before concentrating solely on SMA. A muscle biopsy could be the next step in the evaluation to more precisely distinguish between muscle weakness and nerve weakness. Finally, the clinician would probably identify this patients SMA based on the results of the combined muscle biopsy and electrode diagnostics.

If a diagnosis is made early, the individual has access to the tools and the resources that medical science has developed over the last number of years to assist optimal functioning.

The standard method for diagnosing SMA is molecular genetic testing. SMA should be given early consideration in any infant with weakness or hypotonia due to the effectiveness of molecular testing and high frequency of SMA in the hypotonic infant. All other infant causes of hypotonic weakness are included in the differential diagnosis of severe forms of SMA.

SMA is inherited in an autosomal recessive manner. Each pregnancy of a couple who have had a child with SMA has an approximately 25 per cent chance of producing an affected child. Carrier testing for at-risk relatives and prenatal testing for pregnancies at increased risk are possible if the diagnosis of SMA has been confirmed by molecular genetic testing in an affected family member.

Currently, there are several SMA treatments that have received FDA approval including Risdiplam (Evrysdi), Onasemnogene abeparvovec-xioi (Zolgensma) and Nusinersen (Spinraza). These targeted treatments may prevent the development or slow the progression of some features of SMA.

The severity of the disease varies depending on the type of SMA, with more severe subtypes needing more aggressive treatment. Proactive care and treatment decision-making by the multidisciplinary team and family are of paramount importance.

The author is MBBS, DCH, MRCPCH, Fellowship Pediatric Genetics, Consultant Clinical Geneticist, Salem Genetics Centre. Views are personal.

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