Hematopoietic stem cell transplantation

Innate Pharma to Host Virtual KOL Event on Lacutamab

Retrieved on: 
Monday, November 27, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Euronext Paris, Annual general meeting, CTCL, Bone marrow, Progression-free survival, ASH, Cutaneous T-cell lymphoma, Cutaneous lymphoma, Patient, Hematopoietic stem cell transplantation, Division, IPH, Blood, Lymphoma, ORR, Doctor of Philosophy, Society, Skin, IPHA, KOL, PTCL, ITT, Education, Pharmaceutical industry

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that it will host a virtual KOL (Key Opinion Leader) event on lacutamab, a first-in-class anti-KIR3DL2 antibody currently in development for cutaneous T-cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL), on Tuesday, December 12, 2023, at 7:00AM PST (4:00PM CET).

Key Points: 
  • Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that it will host a virtual KOL (Key Opinion Leader) event on lacutamab, a first-in-class anti-KIR3DL2 antibody currently in development for cutaneous T-cell lymphoma (CTCL) and peripheral T cell lymphoma (PTCL), on Tuesday, December 12, 2023, at 7:00AM PST (4:00PM CET).
  • Prof. Porcu is a Lymphoma-focused hematologic oncologist with a long track record of advocacy and education for patients with cutaneous lymphoma.
  • Sonia Quaratino, M.D., PhD, Chief Medical Officer of Innate Pharma, will host the call.
  • In the Intention to treat population (ITT), the global confirmed objective response rate (ORR) was 37.5% (21/56).

MaaT Pharma Provides Third Quarter 2023 Business Update and Reports Financial Results

Retrieved on: 
Thursday, November 9, 2023
Biotechnology, Pharmaceutical, Health, Bone marrow, Annual general meeting, Charcot disease, European Medicines Agency, Maat, ICI, HSCT, Randomized controlled trial, CFO, ASH, Artificial intelligence, EMA, Patient, DSMB, PICASSO, Medi-Cal Access Program, Aryl hydrocarbon receptor, Hematopoietic stem cell transplantation, Immunotherapy, EUR, Therapy, Symantec Endpoint Protection, ORR, Cancer, Survival, MET, SITC, ARES, CGMP, Development, Society, Pharmaceutical industry, Vaccine, ALS

We are proud to achieve these milestones and we will continue to work on generating value for our shareholders,” stated Siân Crouzet, CFO of MaaT Pharma.

Key Points: 
  • We are proud to achieve these milestones and we will continue to work on generating value for our shareholders,” stated Siân Crouzet, CFO of MaaT Pharma.
  • MaaT Pharma reported revenues from its compassionate access program of EUR 0.4 million for the quarter ended September 30, 2023 comparable with the third quarter of 2022.
  • 2 The Company would like to correct a clerical error that was present in its Q2 results press release of July 27, 2023.
  • The EUR 0.9 million figure was the difference in revenue between H1 2023 and H1 2022 (EUR 1.4 million vs. EUR 0.5 million).

Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor

Retrieved on: 
Friday, December 1, 2023
CNS, NYSE, Food, Arrhythmia, Toxicity, BTK, MCL, HSCT, University, Cytopenia, Disease, Tablet, Bleeding, Patient, SLL, Infection, Hematopoietic stem cell transplantation, FDA, DOR, Acalabrutinib, Lymphocytosis, LLY, Chronic lymphocytic leukemia, Eli Lilly and Company, ORR, IRC, Accelerated approval (FDA), CLL, HIV disease progression rates, Lymphoma, Pharmaceutical industry, Pirtobrutinib

INDIANAPOLIS, Dec. 1, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Jaypirca was approved under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from the open-label, single-arm, multicohort, international, Phase 1/2 BRUIN trial.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

Key Points: 
  • The labeling for Jaypirca contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity.
  • "The treatment landscape for CLL has been dramatically improved by the introduction of covalent BTK inhibitors and BCL-2 inhibitors.
  • Patients with active central nervous system (CNS) involvement by lymphoma or allogeneic hematopoietic stem cell transplantation (HSCT) within 60 days were excluded.
  • Patients in the efficacy-eligible population had received a median of five prior lines of therapy (range: 2 to 11).

Smart Immune to Present Details of Pioneering Clinical Study at the American Society of Hematology (ASH) Annual Meeting 2023

Retrieved on: 
Thursday, November 2, 2023
Neoplasm, Cyclophosphamide, Graft-versus-host disease, MD, Doctor of Philosophy, Infection, Haplo, Poster, Society, ASH, Immune system, Risk, Leukemia, Transplant, Safety, Patient, American Society for Investigative Pathology, Hematopoietic stem cell transplantation, Vaccine, EU

Six days after the transplantation, the patients will receive an infusion of SMART101, produced in Paris, from the same healthy donor.

Key Points: 
  • Six days after the transplantation, the patients will receive an infusion of SMART101, produced in Paris, from the same healthy donor.
  • An improvement in allo-HSCT clinical outcomes is expected from this first-of-a-kind thymus-empowered approach, leading to better overall survival and lower co-morbidity rates.
  • If the primary endpoints are met as anticipated, the study will also show the biological activity of SMART101 to reverse thymic involution.
  • By expediting T cell reconstitution post-transplant, we expect to improve the overall clinical outcomes and increase the benefit/risk ratio of haploidentical transplant.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer

Retrieved on: 
Wednesday, November 1, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Survival, Patient, Colitis, Nephritis, Cholangiocarcinoma, Incidence, Hypothyroidism, Pneumonitis, NYSE, Food, Progression-free survival, Fatigue, Medicine, Itch, DOR, AST, Pembrolizumab, Cisplatin, Head, Gastrointestinal cancer, MRK, PFS, Fever, University of California, Bile, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HIV disease progression rates, Administration, Rash, Disease, Ascending cholangitis, Merck & Co., Risk, Immunotherapy, ORR, University, Anemia, RECIST, BTC, Hepatitis, Biliary tract, Lymphocyte, ALT, OS, Death, Toxicity, Hematopoietic stem cell transplantation, CI, Pharmaceutical industry, Vaccine, Merck

Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.

Key Points: 
  • Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • For gemcitabine, treatment could be continued beyond eight cycles, while for cisplatin, treatment could be administered for a maximum of eight cycles.
  • There was a difference of ≥5% incidence in laboratory abnormalities between patients who received KEYTRUDA plus chemotherapy versus placebo plus chemotherapy for decreased lymphocytes (69% vs. 61%).

Rigel Announces Poster Presentations at the 65th American Society of Hematology Annual Meeting and Exposition

Retrieved on: 
Thursday, November 2, 2023
CR, IVO, VEN, Haematopoiesis, Constipation, Platelet, Acute myeloid leukemia, CRC, Prior, Thrombocytopenia, Vomiting, MDS, Diarrhea, Treatment, Rigel, Fostamatinib, Bone marrow, Hematopoietic stem cell transplantation, CRH, CRi, Inflammation, Azacitidine, Nausea, Society, Progress, ASH, Poster, Myelodysplastic syndrome, Cell death, Relapse, ITP, SAN, ORR, University, Safety, Venetoclax, IRAK, Cellular, MD Anderson Cancer Center, Cytopenia, Transplant, Neutropenia, AML, HSCT, Fatigue, Pharmaceutical industry, Dentistry, Dietary supplement, Bookkeeping, Vaccine, Patient, Cancer

SOUTH SAN FRANCISCO, Calif., Nov. 2, 2023 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the upcoming presentation of four posters highlighting data from their commercial and clinical-stage hematology-oncology portfolio at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, California and virtually.

Key Points: 
  • "We are also excited by the compelling data in patients with mIDH1 MDS and look forward to evaluating this potential opportunity further.
  • On top of the olutasidenib data, we are delighted to share other updates and data across our development portfolio, demonstrating our presence in the hematology-oncology space."
  • These results support the use of fostamatinib as a second-line treatment in patients with primary ITP.
  • To learn more about Rigel Pharmaceuticals and their clinical and commercial hematology/oncology portfolio visit Booth #2805 during ASH 2023.

Garuda Therapeutics Announces the Appointment of Panteli Theocharous, Ph.D., FRCPath as Chief Therapeutics Officer

Retrieved on: 
Wednesday, October 25, 2023
Biotechnology, Pharmaceutical, Health, Stem Cells, Medical Affairs Bureau, PPD, Hematology, University, Royal Free Hospital, Cell, Malignancy, Gene, HSC, Royal College of Pathologists, Thermo Fisher Scientific, Haematopoietic system, Therapy, Patient, Hematopoietic stem cell transplantation, MS, Pharmaceutical industry, Medical device, Garuda

Garuda Therapeutics (Garuda), a company creating off-the-shelf, durable blood stem cell-based cellular therapies, today announced the appointment of Panteli Theocharous, Ph.D., FRCPath as Chief Therapeutics Officer.

Key Points: 
  • Garuda Therapeutics (Garuda), a company creating off-the-shelf, durable blood stem cell-based cellular therapies, today announced the appointment of Panteli Theocharous, Ph.D., FRCPath as Chief Therapeutics Officer.
  • To the role, Dr. Theocharous brings experience leading multiple hematology and oncology assets into and through clinical development and beyond.
  • He previously served as Global Head, Cell and Gene Therapy Strategy Lead at PPD, part of Thermo Fisher Scientific.
  • “As Garuda continues to advance our off-the-shelf durable blood stem cell and immune cell programs, Dr. Theocharous’ experience driving HSC-based cellular therapies across all phases of development will be invaluable,” said Dhvanit Shah, Ph.D., President and Chief Executive Officer of Garuda.

SELLAS Announces Positive Initial Topline Phase 2a Data of SLS009 in Acute Myeloid Leukemia

Retrieved on: 
Monday, October 16, 2023
UAB, Survival, Food, CRC, Azacitidine, MD, Venetoclax, CDK9, Safety, University, AML, EFS, MOS, Acute myeloid leukemia, DOR, Associate, Assistant, Patient, Doctor of Science, Hematopoietic stem cell transplantation, PD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Quality of life, SLS, Nursing, Pharmaceutical industry, Treatment, Medicine

NEW YORK, Oct. 16, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced positive initial topline data at the 45 mg (safety) dose level from its ongoing Phase 2a clinical trial of its novel and highly selective CDK9 inhibitor, SLS009, in combination with venetoclax and azacitidine (aza/ven) in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) who did not respond or stopped responding to venetoclax-based therapies. Topline data for the recommended Phase 2 dose (60 mg) is expected later this quarter.

Key Points: 
  • Topline data for the recommended Phase 2 dose (60 mg) is expected later this quarter.
  • A total of five patients with r/r AML who failed venetoclax-based therapies have been enrolled to date at the 45 mg dose level.
  • All patients enrolled were alive at the time of their last follow-up and four continue treatment.
  • Among the 31 Phase 1 AML patients, 29 out of 31 (94%) patients were alive as of their May 2023 follow-up.

IN8bio Completes Dose Escalation in Phase 1 Trial of INB-100, a Potential First-in-Class Gamma-Delta T Cell Therapy for the Treatment of Leukemias, and Initiates Enrollment for the Phase 2 Trial of INB-400 in Newly Diagnosed Glioblastoma

Retrieved on: 
Thursday, October 12, 2023
ASH, GBM, Glioblastoma, ORR, Cleveland Clinic, OS, Society, University of Louisville School of Medicine, Safety, University, HSCT, FDA, Brain, Clinical trial, Immune system, Leukemia, PFS, EBMT, TTP, Hematopoietic stem cell transplantation, European Society for Medical Oncology, Graft-versus-host disease, Progression-free survival, Patient, Pharmaceutical industry, Medical imaging

“Our novel, synergistic immunotherapy approach has demonstrated promising early clinical results in patients with unmet medical needs.

Key Points: 
  • “Our novel, synergistic immunotherapy approach has demonstrated promising early clinical results in patients with unmet medical needs.
  • The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of graft versus host disease (GvHD), relapse rate and OS.
  • The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients.
  • INB-400 was granted Orphan Drug Designation by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation.

FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment After Surgery

Retrieved on: 
Tuesday, October 17, 2023
Oncology, Health, FDA, Surgery, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Congress, III, Hepatitis, HIV disease progression rates, Immunosuppression, MRK, NYSE, Lung cancer, Food, Platinum, American Joint Committee on Cancer, Pembrolizumab, The New England Journal of Medicine, AJCC, OS, PD-L1, Colitis, EGFR, Stanford University, Medicine, Pemetrexed, Patient, ESMO, Merck & Co., Steroid, EFS, II, Carboplatin, TPS, Pneumonitis, Paclitaxel, History, Head, International Association, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Society for Medical Oncology, Neoplasm, Hematopoietic stem cell transplantation, European Society of Gynaecological Oncology, T2A, ALK, Nephritis, Pharmaceutical industry, Vaccine, NSCLC, Merck

With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.

Key Points: 
  • With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.
  • The EFS results, which were from the first interim analysis, were published in June 2023 in the New England Journal of Medicine.
  • Adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single agent adjuvant treatment, were generally similar to those occurring in patients across tumor types receiving KEYTRUDA in combination with chemotherapy.
  • Eighty-one percent of patients in the KEYTRUDA in combination with platinum-containing chemotherapy arm had definitive surgery compared to 76% of patients in the placebo in combination with platinum-containing chemotherapy arm.