RRMM

Gracell Biotechnologies Doses First Patient in Phase 1b/2 Clinical Trial in U.S. Evaluating GC012F for Treatment of Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Tuesday, September 26, 2023
IIT, CD19, European Hematology Association, Multiple myeloma, Survival, Cancer, Pharmacokinetics, Trial of the century, ASCO, American Society of Clinical Oncology, Patient, Graceling, SAN, Autoimmune disease, EHA, RRMM, Society, Neurotoxicity, ORR, BCMA, Safety, Pharmaceutical industry, Medical device

The Phase 1b portion of the open-label multi-center trial has been initiated and will be conducted at several top medical centers in the United States.

Key Points: 
  • The Phase 1b portion of the open-label multi-center trial has been initiated and will be conducted at several top medical centers in the United States.
  • The Phase 2 portion is intended to evaluate the efficacy of GC012F in RRMM patients and further characterize the safety of GC012F.
  • “Gracell has amassed a body of compelling evidence supporting the dual-targeting approach of GC012F for treatment of RRMM.
  • “Dosing the first patient in the Phase 1b portion of the U.S. trial is another important step toward validating this treatment for RRMM patients.

Gracell Biotechnologies’ CEO Dr. William Cao Named to Prestigious PharmaVoice 100, Honoring Most Inspiring Life Science Leaders

Retrieved on: 
Tuesday, September 19, 2023
IIT, Drug development, Multiple myeloma, Cancer, EDT, Sutro Biopharma, Patient, Graceling, SAN, Autoimmune disease, Industry Dive, BCMA, Bone marrow, Pharmaceutical industry, RRMM

“I am deeply honored and humbled to receive recognition from our industry’s most prominent leaders,” Dr. Cao said.

Key Points: 
  • “I am deeply honored and humbled to receive recognition from our industry’s most prominent leaders,” Dr. Cao said.
  • With more than 30 years of experience in the life science industry, Dr. Cao has led Gracell since its founding in 2017.
  • In 2022, FasTCAR was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Award for its potential to address major industry obstacles.
  • The event will bring together newsmaking leaders from across pharma and biotech for keynote presentations, panels and fireside chats.

Bristol Myers Squibb Highlights Advancing Pipeline and Differentiated Research Platforms to Support Long-Term Sustainable Growth at R&D Day

Retrieved on: 
Thursday, September 14, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Bristol Myers Squibb, Janssen Pharmaceuticals, Lupus, Ruxolitinib, Probability, Eosinophilic esophagitis, Drug development, LPA1, Doctor of Philosophy, CD3, Target protein, Atrial fibrillation, GPRC5D, Cell therapy, Acute coronary syndrome, Medicine, BMY, Pulmonary fibrosis, BET, CAR, Neuroscience, NEX, Patient, Hematology, ROS1, IND Queens Boulevard Line, Biology, Canadian Aviation Regulations, Growth, Johnson & Johnson, Research and development, RRMM, BMS, R, FDA, NYSE, Idiopathic pulmonary fibrosis, BCMA, Disease, Fine chemical, Pharmaceutical industry, Vaccine

Bristol Myers Squibb (NYSE: BMY) is today holding a Research and Development (R&D) Day in New York to discuss the company’s R&D strategy and capabilities and to provide insight into its robust pipeline supporting long-term sustainable growth.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) is today holding a Research and Development (R&D) Day in New York to discuss the company’s R&D strategy and capabilities and to provide insight into its robust pipeline supporting long-term sustainable growth.
  • “We are further enhancing our R&D engine to strengthen scientific leadership, accelerate our promising pipeline and drive increased productivity.
  • Key pipeline updates for the newly anticipated registrational assets include:
    CD19-directed NEX T cell therapy BMS-986353, expanding into clinical trials for immunologic diseases, including severe, refractory systemic lupus erythematosus.
  • “Our research strategy will enable us to increase the number and quality of potentially transformational early-stage candidates, leveraging our differentiated research platforms, and accelerate the path from proof-of-concept to regulatory approval.”
    R&D Day takes place at 9 a.m.

ELREXFIO™ (elranatamab-bcmm), Now Available from Onco360

Retrieved on: 
Wednesday, September 13, 2023
FDA, Health, Pharmaceutical, Clinical Trials, Oncology, REMS, Cytokine release syndrome, Malignancy, US FDA, Mitigation, CD3, CRS, Multiple myeloma, Immunomodulatory imide drug, Cancer, Bone marrow, National Cancer Institute, Cohort study, Pharmacy, CAR, US, Specialty pharmacy, Patient, B cell, SEER, ADC, Diagnosis, RRMM, Caregiver, Phase, ORR, BCMA, Pfizer, Disease, Vaccine, Pharmaceutical industry, Epidemiology

Onco360®, the nation’s leading independent Specialty Pharmacy will be a pharmacy provider for Elrexfio™ (elranatamab-bcmm).

Key Points: 
  • Onco360®, the nation’s leading independent Specialty Pharmacy will be a pharmacy provider for Elrexfio™ (elranatamab-bcmm).
  • This indication is approved under accelerated approval based on response rate and durability of response.
  • Multiple myeloma, a rare malignancy, accounts for 1.8% of all new cancer cases in the United States.
  • The five-year overall survival (OS) for patients with multiple myeloma is 59.8%.3
    ELREXFIO is commercialized by Pfizer.

Gracell Biotechnologies Reports Second Quarter 2023 Unaudited Financial Results and Provides Corporate Update

Retrieved on: 
Monday, August 14, 2023
Janus, Exercise, Lender option borrower option, IIT, RA, CD19, SCR, HLA, OrbiMed, DLBCL, ADS, Multiple myeloma, Cancer, Research, Commencement at Central Connecticut State University, ASCO, Patient, Investment, Graceling, B-ALL, SAN, TME, EHA, Webcast, BCMA, RRMM, SMART, ORR, Conference, Pharmaceutical industry, Security (finance), Vaccine, Cryptocurrency, Broadcasting

ET today

Key Points: 
  • ET today
    SAN DIEGO and SUZHOU, China and SHANGHAI, China, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune diseases, today reported second quarter unaudited financial results for the period ended June 30, 2023, and provided corporate updates.
  • “We are delighted with the significant milestones achieved in the past few months across our reprioritized pipeline.
  • The Phase 1b part of the RRMM US IND trial has commenced as patient screening is underway.
  • Financial Results for Second Quarter Ended June 30, 2023
    As of June 30, 2023, the Company had RMB1,188.0 million (US$163.8 million) in cash and cash equivalents and short-term investments.

2seventy bio Reports Second Quarter Financial Results and Recent Operational Progress

Retrieved on: 
Monday, August 14, 2023
Biotechnology, General Health, Health, Oncology, Abstract, Maintenance, Communication, Partnership, Gene, European Hematology Association, Regeneron Pharmaceuticals, Multiple myeloma, American Society of Clinical Oncology, Cancer, Toxicity, Bristol Myers Squibb, American Society of Gene and Cell Therapy, Trial of the century, TCR, ASCO, Congress, AML, SAE, Investigational New Drug, Patient, S12, EHA, Annual general meeting, Root cause analysis, PDUFA, Webcast, Cell, BMS, RRMM, Research, FDA, Ovarian cancer, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, IND, Food, Pharmaceutical industry, Rare-earth element, Vaccine, Cryptocurrency, Idecabtagene vicleucel

(Nasdaq: TSVT), a leading immuno-oncology cell therapy company, today reported financial results and recent highlights for the second quarter ended June 30, 2023.

Key Points: 
  • (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, today reported financial results and recent highlights for the second quarter ended June 30, 2023.
  • The Company ended the second quarter of 2023 with cash, cash equivalents and marketable securities of $307 million.
  • 2seventy bio believes that this cash position, combined with growing Abecma cashflow and disciplined expense management, provides financial runway into 2026.
  • ET to discuss 2Q 2023 financial results and recent business highlights.

SpringWorks Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, August 2, 2023
KRAS, Plantar fibromatosis, Marketing, Neoplasm, New Drug Application, Janssen, G&A, MEK, Cycle, Pain, Congress, Nirogacestat, RAS, Patient, Janssen Pharmaceuticals, Research and development, R, Prescription Drug User Fee Act, European Hematology Association, Multiple myeloma, MAPK, Decentralized finance, Research, GSK plc, PDUFA, Growth, Teclistamab, FDA, Common, RAF, NRAS, Solar cycle 10, GSK, AACR, CD3, Cancer, American Association for Cancer Research, BRAF, Solar cycle 2, TEAD, Administration, RRMM, Therapy, NDA, ASCO, American Society of Clinical Oncology, Annual general meeting, EHA, Mouse, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Food, BCMA, Pharmaceutical industry

STAMFORD, Conn., Aug. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported second quarter financial results for the period ended June 30, 2023 and provided an update on recent company developments.

Key Points: 
  • STAMFORD, Conn., Aug. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported second quarter financial results for the period ended June 30, 2023 and provided an update on recent company developments.
  • In May 2023, SpringWorks announced full enrollment of the Phase 2 trial evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors.
  • SpringWorks expects to file an Investigational New Drug Application for SW-682 in the fourth quarter of 2023.
  • Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $77.9 million, or $1.25 per share, for the second quarter of 2023.

First Patient Dosed in SAR’514 / IPH6401 Phase 1/2 Clinical Trial in Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Tuesday, July 11, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, CD16, FACP, Cancer, Pharmacokinetics, NK, Cross, Euronext Paris, IPH, MD, Patient, IPHA, Master of Science, RRMM, Safety, News, BCMA, Pharmaceutical industry, Vaccine, Innate lymphoid cell, NCR1, Sanofi

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical trial ( NCT05839626 ), evaluating SAR’514 / IPH6401 in relapsed/refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)1.

Key Points: 
  • Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical trial ( NCT05839626 ), evaluating SAR’514 / IPH6401 in relapsed/refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)1.
  • SAR’514 is a trifunctional anti-BCMA NKp46xCD16 NK cell engager, using Sanofi’s proprietary CROSSODILE® multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format.
  • It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform.
  • Our first patient dosed with SAR’514 / IPH6401 is indeed welcome news.

IASO Bio Receives FDA Approval of IND Application for IASO-782 for Treatment of Autoimmune Disease

Retrieved on: 
Saturday, June 17, 2023
Biotechnology, ITP, Ryan Murphy, Investigational New Drug, Patient, SAN, Injection, RRMM, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry

SHANGHAI and NANJING, China and SAN JOSE, Calif., June 17, 2023 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its IASO-782 Injection for use in U.S. clinical trials for Autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).

Key Points: 
  • SHANGHAI and NANJING, China and SAN JOSE, Calif., June 17, 2023 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its IASO-782 Injection for use in U.S. clinical trials for Autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).
  • The IND approval of IASO-782 Injection in the U. S. follows closely on the heels of IASO's in-house developed CT103A for relapsed/refractory multiple myeloma (RRMM) receiving FDA approval for clinical trials within just six months and is a significant milestone in IASO Bio's internationalization process.
  • With a focus on expanding overseas clinical trial programs, IASO Bio will accelerate its overseas clinical trials and the development and implementation of innovative immunotherapy drugs to benefit more patients globally.

Gracell Biotechnologies Presents Longer-Term Results for FasTCAR-T GC012F in B-Cell Non-Hodgkin’s Lymphoma at EHA2023, Highlighting 100% Overall Response Rate

Retrieved on: 
Saturday, June 10, 2023
IIT, CD19, SCR, European Hematology Association, CRS, DLBCL, B-cell maturation antigen, NHL, Cancer, SLE, B-cell lymphoma, MRD, Congress, Patient, Graceling, SAN, Autoimmune disease, Cytokine release syndrome, EHA, CR, Phenotype, ORR, BCMA, Safety, April 12, Vaccine, Pharmaceutical industry, Tanning (leather), Medical imaging, RRMM

SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China, June 10, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today presented longer-term follow-up data from a first-in-human study evaluating GC012F, a CD19 and B-cell maturation antigen (BCMA) dual-targeted autologous CAR-T therapeutic candidate, in patients with relapsed/refractory B-cell non-Hodgkin’s Lymphoma (r/r B-NHL) as an oral presentation (abstract #S234) at the European Hematology Association (EHA2023) Congress.

Key Points: 
  • GC012F is manufactured through a novel next-day FasTCAR process and demonstrated a younger phenotype of CAR-T cells and highly effective tumor killing activity in preclinical animal models.
  • In the single-arm, open label investigator-initiated trial (IIT), nine r/r B-NHL patients were enrolled and treated with GC012F, and completed at least three months of follow-up.
  • All patients’ lymphoma samples expressed CD19, and samples from seven out of eight tested patients expressed BCMA.
  • GC012F also continued to show a favorable safety profile:
    Cytokine release syndrome (CRS) was mostly Grade 1 (56%; 5/9).