Inflammation

Century Therapeutics Presents New Preclinical Data Highlighting iPSC-derived Cell Therapy Platform Technology at the 2024 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Monday, April 8, 2024

PHILADELPHIA, April 08, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced that preclinical data from the Company’s iPSC-derived cell therapy platform was presented at the AACR Annual Meeting 2024.

Key Points: 
  • PHILADELPHIA, April 08, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced that preclinical data from the Company’s iPSC-derived cell therapy platform was presented at the AACR Annual Meeting 2024.
  • This novel CAR was engineered and tested in iPSC-derived gamma-delta T cells, showing in vitro tumor cell cytotoxicity.
  • These findings support the continued examination of a CD19xCD22 bispecific CAR for off-the-shelf allogeneic cell therapy to expand patient access beyond CD19 CAR-T cell therapies.
  • In these preclinical studies, Century identified novel single-domain antibodies (VHH) that bind to multiple epitopes on the NECTIN4 extracellular domain.

Celularity to Present Data Showing Senescent Cell Elimination by Off-the-Shelf Natural Killer Cells Derived from Human Placental Cells

Retrieved on: 
Monday, April 8, 2024

The preclinical data, which suggest that Celularity’s placenta-derived unmodified natural killer (NK) cells (CYNK-001) and genetically modified NK cells (CYNK-201) may serve as potent and selective senolytic agents for use in addressing age-related diseases, will be presented on May 9, 2024.

Key Points: 
  • The preclinical data, which suggest that Celularity’s placenta-derived unmodified natural killer (NK) cells (CYNK-001) and genetically modified NK cells (CYNK-201) may serve as potent and selective senolytic agents for use in addressing age-related diseases, will be presented on May 9, 2024.
  • Senescent cells are key drivers in the process of age-related cellular corruption at the heart of degenerative diseases, cancer and immuno-senescence (the progressive decline in immune function that occurs with age).
  • Moreover, if not eliminated, these cells impair the normal regenerative process that restores function to organs and tissues.
  • Celularity believes these preclinical data demonstrate the potential of its assets to target and selectively remove damaged and abnormal cells expressing stress ligands, such as senescent, virally infected and cancer cells.

Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial Opportunities

Retrieved on: 
Monday, April 8, 2024

In conjunction with the strategic process and focus on its late stage MicroPine asset, Eyenovia reiterated its immediate commercialization opportunities and corporate savings intended to reduce operating expenses while continuing to support meaningful value generation from the company's two FDA-approved products.

Key Points: 
  • In conjunction with the strategic process and focus on its late stage MicroPine asset, Eyenovia reiterated its immediate commercialization opportunities and corporate savings intended to reduce operating expenses while continuing to support meaningful value generation from the company's two FDA-approved products.
  • “The pediatric progressive myopia market represents a significant opportunity for Eyenovia both in the United States and China.
  • This disease, for which there are no FDA-approved pharmaceutical treatments, has been called an epidemic by several medical and optometric organizations.
  • Eyenovia does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved.

Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24

Retrieved on: 
Monday, April 8, 2024

These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials.

Key Points: 
  • These findings indicate that the net benefits of a high intensity statin and EPA, compared to statin alone, on expression of detoxification proteins during inflammation may contribute to reduced atherothrombotic risk in outcome trials.
  • The beneficial effects of a high intensity statin and EPA on endothelial dysfunction may contribute to reduced atherothrombotic risk in outcome trials.
  • Elevated Lp(a) levels are an independent and causal risk factor for cardiovascular (CV) disease with limited treatments available.
  • The potent antioxidant actions of EPA may contribute to reduced CV events in REDUCE-IT, including among those subjects with elevated Lp(a).

Positive Results from Phase 3 OPTIMIZE-1 Trial of Once Daily OCS-01 for the Treatment of Inflammation and Pain Following Cataract Surgery Presented at the 2024 American Society of Cataract and Refractive Surgery Annual Meeting

Retrieved on: 
Monday, April 8, 2024

Dr. Donnenfeld presented the “Once Daily OCS-01, an OPTIREACH® Formulation of High Concentration Dexamethasone Eye Drop, for Inflammation and Pain Following Cataract Surgery – a Phase 3, Double-Masked, Vehicle-Controlled Study” on Sunday, April 7th.

Key Points: 
  • Dr. Donnenfeld presented the “Once Daily OCS-01, an OPTIREACH® Formulation of High Concentration Dexamethasone Eye Drop, for Inflammation and Pain Following Cataract Surgery – a Phase 3, Double-Masked, Vehicle-Controlled Study” on Sunday, April 7th.
  • The results showed that 57.2% of patients treated with OCS-01 were inflammation free (i.e.
  • absence of anterior chamber cells) at Day 15 (vs. 24.0% with vehicle, p
  • The two Phase 3 OPTIMIZE trials are expected to support an NDA submission.

Ocugen Announces Positive Data and Safety Monitoring Board Review and Initiation of Enrollment in Medium Dose for OCU410—a Modifier Gene Therapy—in Phase 1/2 ArMaDa Study for Geographic Atrophy

Retrieved on: 
Friday, April 5, 2024

Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.

Key Points: 
  • Three subjects with geographic atrophy (GA) were dosed in the Phase 1/2 clinical trial to date.
  • An additional three subjects will be dosed with the medium dose (Cohort 2) and three patients with the high dose (Cohort 3) of OCU410 in the dose-escalation phase.
  • “The DSMB has recommended moving forward to medium dose for dosing subjects with GA,” said Dr. Peter Chang, MD, FACS, DSMB Chair for the OCU410 clinical trial.
  • Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)].

Contineum Therapeutics Announces Pricing of Initial Public Offering

Retrieved on: 
Friday, April 5, 2024

All of the shares are being offered by Contineum.

Key Points: 
  • All of the shares are being offered by Contineum.
  • The gross proceeds to Contineum from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Contineum, are expected to be $110.0 million.
  • In addition, Contineum has granted the underwriters a 30-day option to purchase up to an additional 1,031,250 shares of its Class A common stock at the initial public offering price, less underwriting discounts and commissions.
  • Goldman Sachs & Co. LLC, Morgan Stanley, Stifel, and RBC Capital Markets are acting as joint book-running managers for the offering.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Hut 8, Ventyx, and Anavex and Encourages Investors to Contact the Firm

Retrieved on: 
Friday, April 5, 2024

In November 2023, Hut 8 formed following the merger of Hut 8 Mining Corp. (“Legacy Hut”) and U.S. Data Mining Group, Inc. d/b/a US Bitcoin Corp. (“USBTC”) (the “Merger”).

Key Points: 
  • In November 2023, Hut 8 formed following the merger of Hut 8 Mining Corp. (“Legacy Hut”) and U.S. Data Mining Group, Inc. d/b/a US Bitcoin Corp. (“USBTC”) (the “Merger”).
  • USBTC held a 50% interest in a joint venture bitcoin mining facility, located in King Mountain, Texas (the “King Mountain JV”), which was acquired in the Merger.
  • In addition, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • For more information on the Anavex class action go to: https://bespc.com/cases/AVXL

Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus

Retrieved on: 
Thursday, April 4, 2024

BERKELEY, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.

Key Points: 
  • The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.
  • CB-010 targets CD19, a protein on the surface of B cells, and has a PD-1 knockout (KO) that reduces CAR-T cell exhaustion.
  • CB-010 holds the potential for deep depletion of disease-causing B cells which could reset the immune system, leading to sustained drug-free remission.
  • Instead, the chRDNA technology allows for precise insertion of the CAR at an intended location within the T cell genome.

ANI Pharmaceuticals Recognizes Sarcoidosis Awareness Month and Patients Living with Sarcoidosis

Retrieved on: 
Thursday, April 4, 2024

BAUDETTE, Minn., April 04, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) https://www.anipharmaceuticals.com/ (Nasdaq : ANIP) is proud to support the Foundation for Sarcoidosis Research’s (FSR) commitment to sarcoidosis patients and efforts to increase disease awareness during April’s Sarcoidosis Awareness Month.

Key Points: 
  • BAUDETTE, Minn., April 04, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) https://www.anipharmaceuticals.com/ (Nasdaq : ANIP) is proud to support the Foundation for Sarcoidosis Research’s (FSR) commitment to sarcoidosis patients and efforts to increase disease awareness during April’s Sarcoidosis Awareness Month.
  • During the month of April, members of the ANI organization are raising awareness of sarcoidosis by wearing “Say Sarcoidosis” pins offered through FSRs National Awareness Campaign, “Say Sarcoidosis.” In addition, ANI members will also be wearing purple on April 13th in honor of “World Sarcoidosis Awareness Day.”
    According to the FSR, sarcoidosis is a rare inflammatory disease characterized by the formation of granulomas predominately in the lungs and, to a lesser extent, in other organs of the body.
  • “We applaud the Foundation for Sarcoidosis Research’s Awareness Campaign – “Say Sarcoidosis” and their ongoing education and support of people who live with sarcoidosis.
  • “We are grateful for ANI Pharmaceuticals’ commitment to increasing awareness and education about those living with sarcoidosis,” said Mary McGowan, Chief Executive Officer of the FSR.