Neurotoxicity

Nexcella Completes 2nd NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site

Retrieved on: 
Tuesday, September 19, 2023

LOS ANGELES, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced the successful completion of its 2nd CAR-T NXC-201 engineering batch at its U.S. manufacturing site. This represents an important step forward in the planned U.S. expansion of the Company’s ongoing Phase 1b/2a NEXICART-1 (NCT04720313) study of its novel BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.

Key Points: 
  • This represents an important step forward in the planned U.S. expansion of the Company’s ongoing Phase 1b/2a NEXICART-1 (NCT04720313) study of its novel BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.
  • “The completion of our 2nd U.S. engineering batch is a key step towards expanding our NXC-201 clinical trial to the United States,” said Ilya Rachman, M.D.
  • PhD Executive Chairman of Nexcella.
  • “We believe NXC-201 will overcome the neurotoxicity and side effect barrier to expand CAR-Ts into to the remaining 95% of the market.”

Immix Biopharma Subsidiary Nexcella Completes 2nd NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site

Retrieved on: 
Tuesday, September 19, 2023

LOS ANGELES, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced the successful completion of its 2nd CAR-T NXC-201 engineering batch at its U.S. manufacturing site. This represents an important step forward in the planned U.S. expansion of the Company’s ongoing Phase 1b/2a NEXICART-1 (NCT04720313) study of its novel BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.

Key Points: 
  • This represents an important step forward in the planned U.S. expansion of the Company’s ongoing Phase 1b/2a NEXICART-1 (NCT04720313) study of its novel BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.
  • “The completion of our 2nd U.S. engineering batch is a key step towards expanding our NXC-201 clinical trial to the United States,” said Ilya Rachman, M.D.
  • PhD Chief Executive Officer of Immix Biopharma.
  • “We believe NXC-201 will overcome the neurotoxicity and side effect barrier to expand CAR-Ts into to the remaining 95% of the market.”

Nexcella, Immix Biopharma Subsidiary, to Present at the Bank of America 2023 Healthcare Trailblazers Private Company Conference

Retrieved on: 
Thursday, September 7, 2023

LOS ANGELES, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”) a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced that Nexcella NXC-201 clinical data will be presented by Ilya Rachman, MD, PhD, and Gabriel Morris at the Healthcare Trailblazers Private Company Conference Thursday, October 26, 2023.

Key Points: 
  • LOS ANGELES, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”) a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced that Nexcella NXC-201 clinical data will be presented by Ilya Rachman, MD, PhD, and Gabriel Morris at the Healthcare Trailblazers Private Company Conference Thursday, October 26, 2023.
  • At this institutional event, Ilya Rachman and Gabriel Morris will plan on being available to meet institutional investors and potential strategic pharmaceutical partners.
  • “We are delighted to present the clinical progress we are making with our CAR-T, NXC-201, at this premier healthcare conference,” said Ilya Rachman MD PhD, Chief Executive Officer of Immix Biopharma.
  • Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We believe the addressable market of CAR-Ts today is limited by neurotoxicity, which restricts dosing to only 5% of U.S. hospitals.

Nexcella to Present at the Bank of America 2023 Healthcare Trailblazers Private Company Conference

Retrieved on: 
Thursday, September 7, 2023

LOS ANGELES, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that Nexcella NXC-201 clinical data will be presented by Ilya Rachman MD PhD and Gabriel Morris at the Healthcare Trailblazers Private Company Conference Thursday, October 26, 2023.

Key Points: 
  • LOS ANGELES, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that Nexcella NXC-201 clinical data will be presented by Ilya Rachman MD PhD and Gabriel Morris at the Healthcare Trailblazers Private Company Conference Thursday, October 26, 2023.
  • At this institutional event, Ilya Rachman and Gabriel Morris will plan on being available to meet institutional investors and potential strategic pharmaceutical partners.
  • “We are delighted to present the clinical progress we are making with our CAR-T, NXC-201, at this premier healthcare conference,” said Ilya Rachman, MD PhD, Executive Chairman of Nexcella.
  • Gabriel Morris, President of Nexcella added, “We believe the addressable market of CAR-Ts today is limited by neurotoxicity, which restricts dosing to only 5% of U.S. hospitals.

Alzheon Reports Industry-Leading Biomarker, Brain Preservation and Clinical Benefits Following 24 Months of Treatment in Phase 2 Trial of Oral ALZ-801 (Valiltramiprosate) in Patients with Early Alzheimer’s Disease

Retrieved on: 
Wednesday, September 13, 2023

“We are pleased with the growing body of evidence that supports ALZ-801’s potential as the first oral disease modifying therapy for Alzheimer’s disease.

Key Points: 
  • “We are pleased with the growing body of evidence that supports ALZ-801’s potential as the first oral disease modifying therapy for Alzheimer’s disease.
  • In mechanism of action studies, ALZ-801 fully blocked the formation of neurotoxic soluble beta amyloid (Aβ) oligomers at the Phase 3 clinical dose.
  • In November 2022, Alzheon reported positive study results from a pre-specified analysis following 52 weeks of treatment with ALZ-801.
  • An ongoing long-term extension of the trial evaluates ALZ-801 for an additional 52 weeks of treatment for a total of 156 weeks.

’Negative Evidence’ for Neurological Complications of COVID Vaccines Explored in Journal of American Physicians and Surgeons (AAPS)

Retrieved on: 
Tuesday, September 5, 2023

TUCSON, Ariz., Sept. 05, 2023 (GLOBE NEWSWIRE) -- The occurrence of neurological adverse events following COVID vaccines is generally acknowledged, but their significance is downplayed, writes Jane Orient , M.D., in the fall issue of the Journal of American Physicians and Surgeons.

Key Points: 
  • TUCSON, Ariz., Sept. 05, 2023 (GLOBE NEWSWIRE) -- The occurrence of neurological adverse events following COVID vaccines is generally acknowledged, but their significance is downplayed, writes Jane Orient , M.D., in the fall issue of the Journal of American Physicians and Surgeons.
  • The devastating complications such as paralysis that are accepted as known side effects of vaccines are said to be exceedingly rare.
  • Between 2020 and 2023, 73 review papers were published describing sizable case-series of neurological complications of COVID-19 vaccines, but only three articles containing original research examining potential mechanisms.
  • “The highly publicized and coercive ‘lifesaving measures’ now look like a ticking time bomb.”
    The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS) , a national organization representing physicians in all specialties since 1943.

Acer Therapeutics Reacquires Worldwide Development, Commercialization and Economic Rights to OLPRUVA™ from Relief Therapeutics, Excluding the Geographical Europe

Retrieved on: 
Wednesday, August 30, 2023

OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).

Key Points: 
  • OLPRUVA™ is approved in the U.S. for the treatment of certain urea cycle disorders (UCDs).
  • Acer and Relief have now agreed to terminate the CLA, where Acer is no longer required to pay Relief 60% of OLPRUVA™ net profits in the Acer territories and have regained all development and commercialization rights in rest of the world, excluding the Geographical Europe.
  • Additionally, Acer and Relief have entered into a new Exclusive License Agreement (ELA) in which Relief will retain development and commercialization rights for OLPRUVA™ in the Geographical Europe, where Acer will have the right to receive a royalty of up to 10% of the net sales of OLPRUVA™.
  • For additional Important Safety Information, see full Prescribing Information , Patient Package Insert and discuss with your doctor.

WaveBreak Presents New Preclinical Data at MDS 2023 Demonstrating the Efficacy of its First-in-Class, Small-Molecule Inhibitors of Toxic Oligomers for Blocking Progression of Both α-Synuclein Oligomers and Aggregates in Models of Parkinson's Disease

Retrieved on: 
Wednesday, August 30, 2023

BOSTON, Aug. 30, 2023 /PRNewswire/ -- WaveBreak announced today the presentation of new preclinical data for its first-in-class, oral inhibitors of α-synuclein oligomer generation demonstrating efficacy for blocking the progression of both α-synuclein oligomers and aggregates in cell and mouse models of Parkinson's disease.

Key Points: 
  • BOSTON, Aug. 30, 2023 /PRNewswire/ -- WaveBreak announced today the presentation of new preclinical data for its first-in-class, oral inhibitors of α-synuclein oligomer generation demonstrating efficacy for blocking the progression of both α-synuclein oligomers and aggregates in cell and mouse models of Parkinson's disease.
  • The data were presented in a poster presentation today at the MDS International Congress of Parkinson's Disease and Movement Disorders® taking place August 27–31 in Copenhagen.
  • Highlights of the presentation follow, and the poster is available on WaveBreak's website:
    A WaveBreak oral, small-molecule inhibitor of α-synuclein oligomer generation—WTX-A—demonstrated potent reduction of α-synuclein oligomers and aggregates in cell and mouse models of Parkinson's disease.
  • WaveBreak's technology platform enables analysis of the inhibition of the source mechanisms that produce oligomer intermediates in complex disease processes.

How bees can monitor pollution for us – everything from toxic metals to antimicrobial resistance

Retrieved on: 
Thursday, August 24, 2023

This often makes it hard to pin down the spread of different contaminants throughout them.

Key Points: 
  • This often makes it hard to pin down the spread of different contaminants throughout them.
  • Our two new studies have used backyard bees to better monitor contamination in urban environments.
  • Read more:
    Bees can do so much more than you think – from dancing to being little art critics

The buzz behind biomonitoring

    • While foraging for nectar, pollen and water, bees are constantly picking up contaminants from their environment.
    • European honey bees have long been used as sentinel species to monitor for pests and diseases, including Varroa mites and chemicals at airports.
    • As the popularity of urban beekeeping has grown, there has been more research on honey bee biomonitoring of a range of contaminants, including metals, pesticides and so-called “forever chemicals”, known as PFAS, in honey.

How bees help us map pollution

    • In Nouméa, we used honey bees to map impacts from the local nickel smelter.
    • However, comparing the data from bees to soil and dust samples revealed bees were the most sensitive and effective marker of smelter contamination.
    • By mapping trace metals in honey bees in Sydney we could look at the specific factors contributing to metal pollution within their foraging range.
    • We also examined how bees can help us understand emerging concerns such as the spread of antimicrobial resistance (AMR) genes.

How do contaminants affect bees?

    • Our analyses showed contaminants build up within the bee over time and were not present on their exterior.
    • We compared metal concentrations in matched samples of washed and unwashed bees and they were no different, indicating contaminants were inside the bee.
    • Research has shown exposure to contaminants including metals and neonicotinoid insecticides can impair honey bee development, foraging ability and survival.

And what’s in their honey?

    • While we previously identified some commercial honeys are adulterated with sugar syrups, this new work focused on potentially toxic trace metals in the honey.
    • The good news is we found trace metals in honey at very low levels that do not pose a concern.

Bees aren’t the only biomonitors

    • The lessons from this work have led the Environment Protection Authority (EPA) Victoria, with which we are all affiliated, to explore the use of biomonitors (honey bees, house sparrows and birds of prey) in its ongoing environmental contaminant research.
    • Earth is facing a multitude of interlacing environmental challenges including biodiversity loss, climate change, population growth and pervasive chemical pollution.
    • More comprehensive monitoring, including surveillance using bees, will allow us to respond more quickly and effectively to environmental health challenges.

ImmPACT Bio Announces FDA Clearance of IND Application for Bispecific CD19/CD20 CAR T Therapy IMPT-514 for the Treatment of Refractory Systemic Lupus Erythematosus

Retrieved on: 
Tuesday, August 15, 2023

WEST HILLS, Calif., Aug. 15, 2023 /PRNewswire/ -- ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for IMPT-514, a bispecific CD19/CD20 CAR T therapy for the treatment of active, refractory systemic lupus erythematosus (SLE).

Key Points: 
  • "FDA clearance to initiate clinical development of IMPT-514, the first bispecific CD19/CD20 CAR T therapy being investigated for the treatment of systemic lupus erythematosus, marks a pivotal milestone for our autoimmune disease clinical program," said Sumant Ramachandra, M.D., Ph.D., president and chief executive officer of ImmPACT Bio.
  • This offers the potential for a one-time treatment administration capable of resetting the immune response for durable remission."
  • The Phase 1 dose escalation cohort is limited to patients with active, biopsy-proven, proliferative lupus nephritis.
  • Additional patients with and without active proliferative nephritis will be enrolled during the Phase 2 portion of the clinical trial.