Stem cell

Cell BioEngines Enters Agreement with Miltenyi Bioindustry to Manufacture Hematopoietic Cell Therapy Clinical Program

Retrieved on: 
Friday, December 29, 2023
Hematopoietic stem cell transplantation, GM, Bone marrow, Cell, CMC, Good manufacturing practice, Blood, MBA, MD, Doctor of Philosophy, HSC, GMP, Stem cell, HSCT, Patient, Vaccine

NEW YORK, Dec. 29, 2023 (GLOBE NEWSWIRE) -- Cell BioEngines, Inc., a clinical-stage biotechnology company focused on delivering novel, innovative stem cell and immune cell therapies to address blood and solid cancers, today announced an agreement with Miltenyi to develop and manufacture its expanded hematopoietic stem cell transplantation (HSCT) product for clinical use in hematology-oncology.

Key Points: 
  • NEW YORK, Dec. 29, 2023 (GLOBE NEWSWIRE) -- Cell BioEngines, Inc., a clinical-stage biotechnology company focused on delivering novel, innovative stem cell and immune cell therapies to address blood and solid cancers, today announced an agreement with Miltenyi to develop and manufacture its expanded hematopoietic stem cell transplantation (HSCT) product for clinical use in hematology-oncology.
  • Cell BioEngines’ proprietary stem cell expansion technology provides an ‘off-the-shelf’ curative treatment for blood cancer patients who need a bone marrow transplant.
  • Under the terms of the agreement, Miltenyi will begin development leading towards Good Manufacturing Practices (GMP) manufacturing of the Phase 1 clinical trial batches of Cell BioEngines’ CBE-101 clinical program.
  • "Working with Miltenyi enables us to avoid the need to invest time, resources and capital in constructing our own CMC development and manufacturing capabilities.

MIMEDX Provides AXIOFILL® Update & Reiterates 2023 Full Year Net Sales and Fourth Quarter Adjusted EBITDA Margin Outlook

Retrieved on: 
Friday, December 29, 2023
Classification, Physician, ECM, FDA, Letter, Public Health Service Act, Stem cell, RFD, Growth, Safety, Patient

MARIETTA, Ga., Dec. 29, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today provided the following update regarding AXIOFILL and reiterated its outlook for 2023 full year net sales growth and fourth quarter adjusted EBITDA margin.

Key Points: 
  • Receipt of FDA Warning Letter for AXIOFILL Classification; Not Related to Safety
    MARIETTA, Ga., Dec. 29, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today provided the following update regarding AXIOFILL and reiterated its outlook for 2023 full year net sales growth and fourth quarter adjusted EBITDA margin.
  • However, on December 21, 2023, MIMEDX received a Warning Letter from FDA reiterating the agency’s position on AXIOFILL.
  • MIMEDX plans to provide commentary about this matter during its upcoming fourth quarter and year end 2023 conference call in late-February.
  • As such, we are also reiterating our expectations for full year 2023 net sales in the high-teens and fourth quarter adjusted EBITDA margin above 20%.

BrainStorm Granted Patents for Allogeneic Exosome Platform-Product in Neurological Disorder Treatments

Retrieved on: 
Tuesday, December 26, 2023
Brainstorm, Acquisition, Patent, Stem cell, Exosome, European Patent Convention, ALS, Therapy, Pharmaceutical industry

The European Patent office granted patent No.

Key Points: 
  • The European Patent office granted patent No.
  • 3105587 titled 'Method of Qualifying of Cells' for a method of qualifying whether a cell population is a suitable therapeutic for treating ALS.
  • The patent also grants claims for an isolated population of mesenchymal stem cells for use in treating ALS.
  • Securing this European patent, alongside our existing patents in the US, Canada, Israel, Brazil, and Japan, enhances our capability to forge new global commercial partnerships, further expanding the reach of NurOwn."

BioLineRx Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease

Retrieved on: 
Thursday, December 21, 2023
SCD, Lead, Sickle cell disease, Division, Collection, FDA, G-CSF, TEL, Filgrastim, Multiple myeloma, MD, Doctor of Philosophy, Natalizumab, HSC, Stem cell, Patient, Safety, Health, Pharmaceutical industry

TEL AVIV, Israel, Dec. 21, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD). The proof-of-concept trial, which plans to enroll five patients diagnosed with SCD, is being conducted in collaboration with Washington University School of Medicine in St. Louis and will assess the safety and tolerability of the two regimens.

Key Points: 
  • "This is an exciting area of clinical research with the potential to meaningfully increase patients' access to stem-cell based gene therapies."
  • Approved gene therapies rely on the collection of significant quantities of CD34+ hematopoietic stem cells to enable therapeutic manufacturing and backup storage.
  • However, available mobilization regimens may not reliably yield desired numbers of HSCs for gene therapy, and the common mobilization agent G-CSF is contraindicated in patients with SCD.
  • Difficulties in obtaining target quantities of HSCs may extend patient treatment journeys and increase patient and caregiver burdens.

Dx&Vx co-develops a bio-healthcare big data platform with LG CNS

Retrieved on: 
Wednesday, December 20, 2023
Cloud, Google Cloud, Single-frequency network, Stem cell, Digital, Digital therapeutics, Medicine, CVS, Drug development, Research, CDSS, Disease, Blood, Tissue, DNA, Cancer, CDX, AI, GSK, Artificial intelligence, LG CNS, Biomarker, Therapy, LG, Medical device

SEOUL, South Korea, Dec. 20, 2023 /PRNewswire/ -- Dx&Vx will develop a bio-healthcare big data platform utilizing AI technology provided by LG CNS.

Key Points: 
  • Dx&Vx recently announced on the 18th that it has signed a contract with LG CNS to jointly develop a bio-healthcare big data platform utilizing AI technology provided by LG CNS.
  • Dx&Vx is set to introduce an AI-driven digital medical and clinical data platform through its collaboration with LG CNS.
  • LG CNS will provide the AI and big data technologies needed to build the platform.
  • Starting with the joint development, Dx&Vx plans to strengthen its collaboration with LG CNS to develop innovative bio-healthcare solutions based on its biomedical big data platform.

NextCure Publishes Non-Clinical Data Defining the Mechanism of Action for NC525, a Novel LAIR-1 Antibody for AML

Retrieved on: 
Wednesday, November 15, 2023
Safety, Health, Acute myeloid leukemia, Patient, Thrombocytopenia, Journal, SOC, Neutropenia, Cell death, Cancer, Survival, AML, Stem cell, Manuscript, Pharmaceutical industry

The data demonstrate that NC525 induces cell death in acute myeloid leukemia (AML) blast cells and leukemic stem cells (LSCs) through leukocyte-associated immunoglobin-like receptor-1 (LAIR-1) agonism by driving a unique apoptotic signaling pathway.

Key Points: 
  • The data demonstrate that NC525 induces cell death in acute myeloid leukemia (AML) blast cells and leukemic stem cells (LSCs) through leukocyte-associated immunoglobin-like receptor-1 (LAIR-1) agonism by driving a unique apoptotic signaling pathway.
  • NC525 is a humanized monoclonal antibody (mAb) that specifically binds to LAIR-1 and kills LSCs, while sparing healthy hematopoietic stem cells (HSCs).
  • The publication details a novel mechanism for the potential treatment of AML, as the expression level of the LAIR-1 receptor on leukemic cells acts as a key regulator.
  • Thus, NC525 holds great promise as an important and novel treatment for patients with resistant and refractory AML (R/R AML).

Orion Research Foundation grants EUR 1,112,000 for research in 2024

Retrieved on: 
Wednesday, November 15, 2023
Helena Lewyn, Insulin resistance, Chemistry, Senior, DNA, Phenotype, Osteoarthritis, Patient, Pharmacy, Infection, Biology, National Institutes of Health, Seminal vesicles, Mitochondrion, Doctor of Philosophy, Veterinary medicine, Stem cell, Bangladesh Technical Education Board, Inflammation, Birgitta, Synovial fluid, Prevalence, Prenatal development, Carcinoma, Functional, Alzheimer's disease, Orion Corporation, Pancreatic serous cystadenoma, Ageing, Adipose tissue, Medicine, Sensitive, Physics, Pathology, FT, CALR, Colitis, Drug resistance, Oklahoma Medical Research Foundation, ELT, Obesity, Research, Trial of the century, EUR, Cystoscopy, Chronic lymphocytic leukemia, BMI, Turku University Hospital, Horse, Neoplasm, CLL, Pharmaceutical industry, Medical imaging, Dietary supplement, Vaccine

Orion Research Foundation sr is distributing EUR 1,112,000 in research grants based on applications for 2024.

Key Points: 
  • Orion Research Foundation sr is distributing EUR 1,112,000 in research grants based on applications for 2024.
  • Orion Reaserch Foundation awards grants of max EUR 50,000 for 17 researchers for postdoctoral research and max EUR 6,000 for 95 young researchers for doctoral dissertation work.
  • One of the postdoctoral grants was distributed from Maritza and Reino Salonen’s Fund which is administered by Orion Research Foundation.
  • Orion Research Foundation sr is annually distributing its return on investment and donations from Orion Corporation as grants for young researchers for doctoral dissertation work and postdoctoral research.

IBN Announces Latest Episode of The Bell2Bell Podcast featuring Wa’el Hashad, CEO of Longeveron Inc.

Retrieved on: 
Tuesday, November 14, 2023
Duloxetine, B cell, Longevity, David Berry (inventor), IBN, Ventricular septal defect, Therapy, Boehringer Ingelheim, Patient, HLHS, Hypoplastic left heart syndrome, Eli Lilly, Dabigatran, Eli Lilly and Company, Interview, University, Stem cell, Splenic infarction, Podcast, Amgen, Pharmaceutical industry, Empagliflozin, Evolocumab, Shimaa Hashad

The Bell2Bell Podcast delivers informative updates and exclusive interviews with executives operating in fast-moving industries.

Key Points: 
  • The Bell2Bell Podcast delivers informative updates and exclusive interviews with executives operating in fast-moving industries.
  • Bell2Bell’s latest podcast features Wa’el Hashad, CEO of Longeveron Inc. (NASDAQ: LGVN) , a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty.
  • The latest installment of The Bell2Bell Podcast continues to reinforce IBN’s commitment to the expansion of its robust network of brands, client partners, followers, and the growing IBN Podcast Series .
  • For more than 17 years, IBN has leveraged this commitment to provide unparalleled distribution and corporate messaging solutions to 500+ public and private companies .

Vittoria Biotherapeutics Secures Over $15 Million in Private Financing Round to Support the Development of Novel CAR-T Cell Therapies

Retrieved on: 
Tuesday, November 14, 2023
Safety, Engineering, Hope, Leukemia & Lymphoma Society, University, Stem cell, Leukemia, New York Blood Center, Investment, Patient, T-cell lymphoma, Genetic engineering, CD5, Joseph Vittoria, Cancer, Lymphoma, LLS, Pharmaceutical industry

PHILADELPHIA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Vittoria Biotherapeutics today announced it has secured over $15 million in a private financing round.

Key Points: 
  • PHILADELPHIA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Vittoria Biotherapeutics today announced it has secured over $15 million in a private financing round.
  • The funds will be used to continue advancing Vittoria’s lead candidate, VIPER-101, an autologous, dual population CD5-knockout CAR-T cell therapy for T-cell Lymphoma, into the clinic.
  • The additional capital will support Vittoria’s clinical development initiatives and advance its next-generation cell therapies that strengthen efficacy, improve safety, and broaden therapeutic applicability for patients with cancer and autoimmune diseases.
  • By acting on the fundamental biology of T cells, Senza5 can be widely utilized to improve the efficacy of engineered T-cell therapies.

KALA BIO Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
Sale, Eye, Stargardt, Three Months, Protease, Acquisition, Research, Safety, Retinitis pigmentosa, Food, BLA, D, Commercial, Chair, CIRM, Stem cell, Patient, Secretome, FDA, CHASE, MSC, Infection, Stargardt disease, R, Nine Months, Paratriathlon, Biologics license application, Contingency, Pharmaceutical industry, Cryptocurrency, Vaccine, Clothing, Video game, Fine chemical, Life insurance, Security (finance), Drug, Alcon

ARLINGTON, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research and development of innovative therapies for rare and severe diseases of the eye, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • Cash Position: As of September 30, 2023, KALA had cash and cash equivalents of $56.1 million, compared to $70.5 million as of December 31, 2022.
  • R&D Expenses: For the quarter ended September 30, 2023, research and development (R&D) expenses were $5.6 million, compared to $5.4 million for the same period in 2022.
  • Operating Loss: For the quarter ended September 30, 2023, loss from operations was $8.8 million, compared to $14.6 million for the same period in 2022.
  • The weighted average number of shares used to calculate net loss/income per share was 2.6 million for the quarter ended September 30, 2023 and 1.5 million for the quarter ended September 30, 2022.