Dose

Sana Biotechnology Highlights Preclinical Data Supporting Tumor Control and Immune Evasion Capabilities of Hypoimmune-Modified Allogeneic CAR T Cells in Presentations at the American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 11, 2023
Patient, CIITA, Canadian Aviation Regulations, Treatment, Immune system, GPRC5D, HIP, IND, Biotechnology, CD47, Graft-versus-host disease, MD, Society, Therapy, ASH, B2M, Dose, Escape Room, CD22, Cytolysis, Multiple myeloma, Vaccine

SEATTLE, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced preclinical data supporting the anti-tumor and immune evasion capabilities of allogeneic CAR T cells engineered with Sana’s proprietary hypoimmune (HIP) technology were presented at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, CA.

Key Points: 
  • “HIP-modified allogeneic CAR T cells remain well-tolerated in preclinical models.
  • CD22 HIP CAR T cells were well tolerated with no signs of graft-versus-host disease (GvHD).
  • Sana submitted the investigational new drug (IND) application and intends to begin human testing of SC262 in early 2024.
  • Additionally, these GPRC5D CAR T cells controlled multiple myeloma tumor cells both in vitro and in vivo, demonstrating efficacy that is on par with clinical benchmark GPRC5D CAR T cells.

Century Therapeutics Presents Initial Data from CNTY-101 Phase 1 ELiPSE-1 Trial Supporting the Potential for a Multi-Dosing Strategy for CAR iNK Enabled by Allo-Evasion™ Edits

Retrieved on: 
Saturday, December 9, 2023
Exposition, Tumor microenvironment, Bone marrow, Dose, Cytokine release syndrome, IPSC, Tissue, Pharming, DNA, Society, Therapy, DdPCR, Follicular lymphoma, Serum, Interleukin 2, Event, ASH, Neurotoxicity, Poster, Century, Ink, Cell, Patient, Malignancy, Webcast, Allotransplantation, Lymphoma, Science, Pharmaceutical industry

PHILADELPHIA, Dec. 09, 2023 (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 the presentation of initial clinical data from a single-patient case study which Century believes support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 9-12 in San Diego. The poster, titled, “Multiple Doses of CNTY-101, an iPSC-Derived Allogeneic CD19 Targeting CAR-NK Product, are Safe and Result in Tumor Microenvironment Changes Associated with Response: A Case Study”, is available on the Scientific Resources page of the Company’s website.

Key Points: 
  • “We are thrilled that the initial clinical evidence for CNTY-101 provides support for the potential for Allo-Evasion™ to enable a multi-dosing regimen without the need for continued lymphodepletion.
  • Cycles one and two included three days of lymphodepletion (LD), whereas cycles three through seven were given with no LD.
  • Importantly, tumor microenvironment initial analyses demonstrated a vigorous increase in T cells within 8 days of the 1st CNTY-101 cell infusion.
  • The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website.

Biomea Fusion Announces Acceptance of Three Abstracts for its Novel Menin Inhibitor Highlighting Durable Glycemic Control in Diabetes Patients at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in 2024

Retrieved on: 
Monday, November 27, 2023
Phase, Conference, Dose, ATTD, Type 2 diabetes, Week, Abstract, DSM-IV codes, Cancer, Treatment, Poster, Safety, Osteopathic medicine in Canada, Pharmaceutical industry

These abstracts further validate the mechanism of action of covalently inhibiting menin in people with type 2 diabetes to potentially provide long-term improvement in glycemic control through beta cell regeneration.

Key Points: 
  • These abstracts further validate the mechanism of action of covalently inhibiting menin in people with type 2 diabetes to potentially provide long-term improvement in glycemic control through beta cell regeneration.
  • Biomea will disclose additional information about the presentations in accordance with the ATTD abstract embargo policies.
  • Phase II consists of multiple ascending dose cohorts and dose durations and includes adult patients with type 2 diabetes uncontrolled by current therapies.
  • Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

Passage Bio Reports Third Quarter 2023 Financial Results and Provides Recent Business Highlights

Retrieved on: 
Monday, November 13, 2023
Infant, CNS, Research, Safety, PASG, GRN, Workforce, CSF, Clinical trial, Administration, Patient, FTD, G&A, Granulin, Dose, Frontotemporal dementia, Financial management, R, Research and development, Central nervous system, GM1, Pharmaceutical industry, Medical imaging

Robust balance sheet to support achievement of meaningful clinical milestones, with cash runway into Q4 2025

Key Points: 
  • Robust balance sheet to support achievement of meaningful clinical milestones, with cash runway into Q4 2025
    PHILADELPHIA, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for central nervous system (CNS) disorders, today reported financial results for the third quarter ended September 30, 2023, and provided recent business highlights.
  • "Our team remains focused on execution, and this past quarter marked another stride toward achieving key milestones across our two lead clinical programs.
  • Initial data focused on safety and CSF progranulin levels from three Cohort 1 patients is expected in the fourth quarter of 2023.
  • Present initial safety and biomarker data from three Cohort 1 patients in upliFT-D clinical trial for FTD in Q4 2023.

Camallergy and OnDosis Announce a Groundbreaking Partnership to Revolutionize Food Allergy Treatment

Retrieved on: 
Wednesday, November 29, 2023
Managed Care, Hospitals, Pharmaceutical, Health, Immune system, US Foods, MHRA, Patient, Multimedia, Medicine, FDA, OIT, Food and Drug Administration, University, MD, Partnership, Peanut allergy, Health care, Food, Physician, Food allergy, Dose, Pharmaceutical industry, Vaccine

View the full release here: https://www.businesswire.com/news/home/20231129814223/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231129814223/en/
    This partnership is set to transform the way food allergies (including peanut allergy) are treated, combining Camallergy's innovative therapies with OnDosis' cutting-edge Dosage Manager device technology.
  • The drug-device combination aims to address the challenges physicians face in offering oral immunotherapy, making the treatment more accessible for patients.
  • The collaboration between Camallergy and OnDosis aims to dramatically reduce the treatment burden associated with traditional oral immunotherapy.
  • Sherden Timmins, CEO of Camallergy: "This partnership with OnDosis represents a pivotal moment in our mission to tackle food allergies.

Century Therapeutics to Present Initial Clinical Data Supporting the Potential for a Multi-Dosing Strategy for CAR iNK Enabled by Allo-Evasion™ Edits at the 65th ASH Annual Meeting and Exposition

Retrieved on: 
Thursday, November 2, 2023
Detail, CAR, Lymphoma, IPSC, CD19, 65th National Film Awards, Society, ASH, Century, Allotransplantation, Kinetics, Ink, Safety, Therapy, Patient, Toxicity, Vaccine, Pharmaceutical industry, Dose, Neoplasm

PHILADELPHIA, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immune-oncology, today announced the upcoming presentation of initial data from its ongoing first-in-human Phase 1 ELiPSE-1 trial of CNTY-101 in relapsed/refractory CD19 positive B-cell lymphomas. The data, which support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits, will be featured during a poster session at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023 in San Diego.

Key Points: 
  • The data, which support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits, will be featured during a poster session at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023 in San Diego.
  • CNTY-101 is the Company’s first allogeneic cell therapy product candidate engineered with multiple complementary functionalities designed to enhance its product profile.
  • Pharmacokinetic measurements demonstrated that CNTY-101 cells were detected after each infusion with comparable kinetics, with a limited duration in circulation.
  • The Company believes these preliminary data support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits.

Xencor Presents Preclinical Data from Multiple XmAb® Research Programs at the SITC Annual Meeting

Retrieved on: 
Friday, November 3, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, CD3, Poster, NKG2D, Ovarian cancer, CD28, MICB, Antigen, Cytokine, PD-1, Dose, CLDN6, SITC, Immunotherapy, IL18BP, FIH, NK, Antibody, Cancer, Tumor microenvironment, Society, Patient, Ghyslaine Nke, MICA, Vaccine, NCR1

We are also developing additional CD3 and CD28 T cell engaging bispecific antibodies against solid tumor targets.”

Key Points: 
  • We are also developing additional CD3 and CD28 T cell engaging bispecific antibodies against solid tumor targets.”
    Posters will be available in the poster hall and virtually to registrants of the SITC Annual Meeting.
  • In the poster hall, odd-numbered posters will be displayed on Friday, November 3, and even-numbered posters will be displayed on Saturday, November 4.
  • Xencor’s posters will be archived under "Events & Presentations" in the Investors section of the Company's website located at www.xencor.com .
  • To enhance the anti-tumor activity, Xencor engineered multi-specific NK cell-engaging antibodies that simultaneously target MICA/B antigens and an orthogonal activating receptor on NK cells, NKp46.

Salarius Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Thursday, August 10, 2023
Lymphoma, Workforce, Abstract, Drug development, Probability, Follicular lymphoma, European Hematology Association, Venetoclax, Multiple myeloma, Survival, Disclosure, Clinical trial, Lenalidomide, NHL, Dose, Salinicola salarius, PBMC, Bortezomib, Market, Azacitidine, Acquisition, Patient, Neoplasm, Ewing sarcoma, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Cryptocurrency, Pharmaceutical industry, Vaccine

HOUSTON, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today reported financial results for the three and six months ended June 30, 2023 and provided a business update.

Key Points: 
  • Research and development expenses declined to $2.4 million for the second quarter of 2023 from $2.9 million for the second quarter of 2022, primarily due to lower spending on seclidemstat offset by higher spending on SP-3164.
  • Spending associated with seclidemstat and SP-3164 for the second quarter of 2023 was $1.1 million and $1.3 million, respectively, compared with $2.1 million and $0.8 million, respectively, for the second quarter of 2022.
  • General and administrative expenses were $1.6 million for the second quarter of 2023, compared with $1.8 million for the second quarter of 2022, with the decline due to lower annual shareholder meeting expenses and overall compensation and benefit costs.
  • As of June 30, 2023, Salarius had cash, cash equivalents and restricted cash of $11.5 million, compared with $12.1 million as of December 31, 2022.

Passage Bio Reports Second Quarter 2023 Financial Results and Provides Recent Business Highlights

Retrieved on: 
Monday, August 7, 2023
PASG, Central nervous system, Natural history, Dose, GRN, Survival, Glycogen storage disease, Clinical trial, G&A, Research, DSM-IV codes, GM1, AAV, CNS, Administration, Infant, Genetic distance, Patient, Frontotemporal dementia, Weill Cornell Medicine, CSF, Research and development, R, FTD, Safety, Vaccine, Pharmaceutical industry, Cohort

“We continued to make steady progress advancing our lead clinical programs in the second quarter and further improved our financial strength, extending our cash runway into the fourth quarter of 2025.

Key Points: 
  • “We continued to make steady progress advancing our lead clinical programs in the second quarter and further improved our financial strength, extending our cash runway into the fourth quarter of 2025.
  • Additionally, we are thrilled to have already dosed the first patient at Dose 3, demonstrating effective execution across the program.
  • In FTD, we are excited by emerging data from initial treated patients, which indicates translation from preclinical models into the clinic.
  • General and Administrative (G&A) Expenses: G&A expenses were $8.1 million for the quarter ended June 30, 2023, as compared to $13.0 million as of June 30, 2022.

Passage Bio Announces Promising Interim Clinical Data from First Eight Patients with GM1 Gangliosidosis in Imagine-1 Study

Retrieved on: 
Monday, August 7, 2023
GLB1, PASG, Central nervous system, Natural history, ICM, Cohort, Dose, Survival, GM1, Biomarker, CNS, Infant, Patient, CSF, Safety, Disease, Pharmaceutical industry

Imagine-1 is a Phase 1/2, global, open-label, dose-escalation study of the AAVhu68 gene therapy PBGM01 delivered by intra-cisterna magna (ICM) injection in six cohorts of pediatric subjects with early and late infantile GM1 Gangliosidosis (GM1).

Key Points: 
  • Imagine-1 is a Phase 1/2, global, open-label, dose-escalation study of the AAVhu68 gene therapy PBGM01 delivered by intra-cisterna magna (ICM) injection in six cohorts of pediatric subjects with early and late infantile GM1 Gangliosidosis (GM1).
  • GM1 is a rare, fatal lysosomal storage disease in which mutations in the GLB1 gene result in very low activity of the enzyme beta-galactosidase (β-Gal).
  • "We are highly encouraged by the compelling data emerging from our Imagine-1 study, with results underscoring the potential of PBGM01 to be a transformative therapy for GM1 patients,” said William Chou, M.D., president and chief executive officer of Passage Bio.
  • The amended study protocol has been approved at several clinical trial sites, including in Brazil, Canada, Turkey and the United States.