Grade 2

Gracell Biotechnologies Presents Updated Clinical Data from FasTCAR-T GC012F Demonstrating Deep and Durable Responses in Newly Diagnosed Multiple Myeloma at ASH 2023

Retrieved on: 
Tuesday, December 12, 2023
Autoimmune disease, Plasmacytoma, Cytokine release syndrome, Grade 2, International, Data, IIT, Multiple myeloma, SAN, Society, Cancer, SCR, ASH, Neurotoxicity, CRS, Patient, Safety, PFS, Pharmaceutical industry

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 11, 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 updated results from the clinical investigator-initiated trial (IIT) of GC012F for treatment of newly diagnosed multiple myeloma (NDMM) as an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place in San Diego, California and online.

Key Points: 
  • GC012F demonstrated a 100% overall response rate (ORR) and 95% MRD- sCR rate among 22 transplant-eligible, high-risk NDMM patients as of the data cutoff date of October 1, 2023.
  • The data included longer-term follow-up from the initial 16 patients, for whom earlier results were presented at the 2022 American Society for Hematology (ASH) Annual Meeting, plus six additional patients that were enrolled and treated later.
  • The data also showed that GC012F was well-tolerated with no new safety signals observed in this frontline application of CAR-T therapy.
  • “We are delighted to announce the updated data of FasTCAR-T GC012F for the treatment of multiple myeloma patients in the frontline setting.

Brii Bio Presents New Data Highlighting Progress Towards Achieving HBV Functional Cure at AASLD's The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
Hepatology, Grade 2, FAS, Plasma, AASLD, Biotechnology, Vaccination, Patient, HBV, EOT, Enzyme inhibitor, Week, Liver, Health, Liver cancer, CHB, MD, Trial of the century, PPS, Seroconversion, Hepatitis, Pharmaceutical industry, Vaccine, HBsAg, Boston

DURHAM, N.C. and BEIJING, Nov. 13, 2023 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today shared three posters at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in Boston, MA, two of which were accepted as late-breakers providing new data from two Phase 2 assets, BRII-179 (VBI-2601) and BRII-835 (VIR-2218), within the chronic hepatitis B (CHB) clinical program.

Key Points: 
  • "We are pleased to share these data at The Liver Meeting that demonstrate the versatility of our HBV portfolio and critical insight in our search for a cure for HBV," said David Margolis, MD, Chief Medical Officer of Brii Bio.
  • "The important connection between HBsAg loss and antibody response provides a clear direction in further improving the functional cure rate and identifying patients who will most likely respond to curative treatments.
  • Highlights include:
    The PK characteristics of BRII-835 in patients with chronic HBV infection are generally similar to those in healthy volunteers.
  • In addition, Vir Biotechnology, Inc. ("Vir") is also investigating VIR-2218 and/or VIR-3434 for the treatment of HBV/HDV co-infection.

Seagen to Highlight Overall Survival Data for PADCEV® and TIVDAK® during Presidential Symposium at ESMO Congress 2023

Retrieved on: 
Monday, October 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, Fatal, Weakness, Female, Skin, PD-L1, Creatinine, DKA, Nausea, Swelling, Keratitis, Pneumonia, Birth, PD-1, Hair, Neutrophil, Male, Peripheral neuropathy, Lipase, Acute kidney injury, Blood, Stevens–Johnson syndrome, Toxic epidermal necrolysis, Diabetic neuropathy, Toxicity, Bulla, Temperature, Appetite, Itch, SJS, Fetus, Cornea, Conjunctivitis, Hyperglycemia, Dermatitis, Evaluation, Hypoxia, Pain, Diabetic ketoacidosis, Pembrolizumab, ILD, Risk, Liver, Lymphocyte, Grade 2, Rash, Erythema, Fatigue, Acral lentiginous melanoma, Pneumonitis, Papule, Incidence, Dysgeusia, Anemia, Cough, Urinary tract infection, Diarrhea, Erythroderma, Periodic breathing, TEN, Patient, MUC, PN, Drug eruption, Septic shock, Pharmaceutical industry, Medical imaging, Palladium

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.

Key Points: 
  • Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.
  • When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate.
  • Skin reactions occurred in 72% (all grades) of the 121 patients treated with PADCEV in combination with pembrolizumab in clinical trials.
  • The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash.

Gracell Biotechnologies Reports Updated Clinical Data for FasTCAR-T GC012F for High-Risk, Newly Diagnosed Multiple Myeloma, Demonstrating 100% Stringent Complete Response Rate

Retrieved on: 
Wednesday, September 27, 2023
IIT, ASH, CD19, SCR, International, CRS, Multiple myeloma, DOR, B-cell maturation antigen, Cancer, MRD, Cytokine release syndrome, Patient, Graceling, IMS, Autoimmune disease, Poster, Rollcage Stage II, Society, III, ORR, BCMA, Safety, Grade 2, Vaccine, Pharmaceutical industry, Medical device, Hematology

The abstract (P-136) was presented as a poster at the 20th International Myeloma Society (IMS) Annual Meeting in Athens, Greece.

Key Points: 
  • The abstract (P-136) was presented as a poster at the 20th International Myeloma Society (IMS) Annual Meeting in Athens, Greece.
  • GC012F demonstrated a 100% overall response rate (ORR) and a 100% MRD- sCR rate among 19 transplant-eligible, high-risk NDMM patients as of the data cutoff date of August 1, 2023.
  • The data also showed that GC012F was well-tolerated with no new safety signals observed in this frontline application of CAR-T therapy.
  • We are delighted to report that in this study, all 19 NDMM patients treated by GC012F achieved MRD- sCR with favorable safety.

Mustang Bio Announces First Data from Ongoing Multicenter Phase 1/2 Clinical Trial Evaluating MB-106 CAR-T Cell Therapy

Retrieved on: 
Wednesday, August 16, 2023
Lymphoma, International Workshop on Lung Health, Waldenström macroglobulinemia, US Foods, University, CD19, Chronic lymphocytic leukemia, Follicular lymphoma, CRS, Fred Hutchinson Cancer Research Center, University of Washington, Clinical trial, Immunoglobulin M, Bone marrow, NHL, PET-CT, Immunotherapy, Associate, Translation, Regenerative medicine, WM, Patient, Cancer, CR, Orphan, Diagnosis, Trial of the century, Hairy cell leukemia, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mustang, DSM-IV codes, Food, Safety, Disease, Grade 2, Medical imaging, Vaccine, Pharmaceutical industry

WORCESTER, Mass., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced the first data from the indolent lymphoma cohort of the Company’s ongoing multicenter Phase 1/2 clinical trial evaluating MB-106, a first-in-class CD20-targeted, autologous CAR-T cell therapy for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHL”) and chronic lymphocytic leukemia (“CLL”), demonstrating clinical responses as well as safety and efficacy consistent with the ongoing Phase 1/2 clinical trial taking place at Fred Hutchinson Cancer Center (“Fred Hutch”).

Key Points: 
  • The multicenter data also show persistence of CAR-T cells at 6+ months and favorable safety data with only Grade 1 cytokine release syndrome (“CRS”) reported to date.
  • Additionally, the data from the ongoing clinical trial at Fred Hutch continue to demonstrate a high rate of complete and durable responses.”
    Dr. Shadman also presented data from the ongoing Fred Hutch Phase 1/2 clinical trial, specific to two B-NHL cohorts, follicular lymphoma (“FL”) and WM.
  • Furthermore, Mustang anticipates requesting regenerative medicine advanced therapy (RMAT) designation for WM from the FDA in 2024.
  • Finally, data from the Fred Hutch clinical trial also support the potential of MB-106 to be administered as outpatient therapy and provide a best-in-class immunotherapy option for patients treated previously with CD19-directed CAR-T cell therapy.

Ayala Pharmaceuticals Announces Updated RINGSIDE Phase 2 Results at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Thursday, May 25, 2023
Abstract, Keratitis, Plantar fibromatosis, Diarrhea, Aes, Clinical trial, RECIST, Vanderbilt University Medical Center, First grade, Grade 2, Woman, Research, Part, Doctor of Philosophy, GSI, QD, ASCO, BD, American Society of Clinical Oncology, MD, Patient, Stomatitis, Sarcoma, Annual general meeting, OTCQX, ALT, Thomas Jefferson National Accelerator Facility, Neoplasm, Poster, ITT, Society, BIW, Safety, Ovarian disease, Medical imaging, Nursing, Pharmaceutical industry

REHOVOT, Israel and MONMOUTH JUNCTION, N.J., May 25, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced updated results from Phase 2 (Part A segment) of the RINGSIDE study evaluating AL102 in desmoid tumors. The results are summarized in an abstract published today for the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. More detailed results will be featured in a poster session at ASCO on Saturday, June 3. AL102 is a once-daily, potent, selective, oral gamma-secretase inhibitor (GSI).

Key Points: 
  • REHOVOT, Israel and MONMOUTH JUNCTION, N.J., May 25, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced updated results from Phase 2 (Part A segment) of the RINGSIDE study evaluating AL102 in desmoid tumors.
  • The results are summarized in an abstract published today for the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • There have been no new safety signals, and the safety results appear consistent with the GSI class.
  • A copy of the poster will be available on the Ayala corporate website, under Events & Presentations, following the presentation at ASCO.

Palette Life Sciences Announces Transaction With Global Healthcare Investor OrbiMed

Retrieved on: 
Tuesday, March 21, 2023
OrbiMed, Silicon Valley Bank, Incontinence, Hyaluronic acid, Prostate, Strategy, Grade 2, JAMA Oncology, Radiation, Rectum, Patient, Randomized controlled trial, Corporation, Science, FDA, Oncology, Prostate cancer, Financial services, Bank, Nursing, Pharmaceutical industry, EU

SANTA BARBARA, Calif. and STOCKHOLM, Sweden, March 21, 2023 (GLOBE NEWSWIRE) -- Palette Life Sciences, a global life sciences company, today announced that it has entered into a debt financing facility for up to $75 million (“debt facility”) with OrbiMed, an investor in the healthcare industry. The non-dilutive capital provides further financial flexibility to support global commercial and product development activities across its product portfolio.

Key Points: 
  • Capital infusion will assist global expansion of Palette’s product portfolio, including Barrigel in the United States
    SANTA BARBARA, Calif. and STOCKHOLM, Sweden, March 21, 2023 (GLOBE NEWSWIRE) -- Palette Life Sciences, a global life sciences company, today announced that it has entered into a debt financing facility for up to $75 million (“debt facility”) with OrbiMed, an investor in the healthcare industry.
  • Under the terms of the debt facility, Palette Life Sciences can borrow up to $75 million based on the achievement of certain milestones and other specified conditions, including $50 million immediately available at closing.
  • Per Langö, CEO and Board Director of Palette Life Sciences, said “Securing this credit facility is a significant step forward for Palette Life Sciences.
  • James Leech, VP of Strategy & Corporate Development at Palette Life Sciences, stated “This debt financing provides Palette Life Sciences with important growth capital as we continue to progress our product portfolio into expanded indications and drive continued revenue growth globally.

Palette Life Sciences Announces Transaction With Global Investment Leader OrbiMed

Retrieved on: 
Tuesday, March 21, 2023
OrbiMed, Silicon Valley Bank, Incontinence, Hyaluronic acid, Prostate, Strategy, Grade 2, JAMA Oncology, Radiation, Rectum, Patient, Randomized controlled trial, Corporation, Science, FDA, Oncology, Prostate cancer, Financial services, Bank, Nursing, Pharmaceutical industry, EU

SANTA BARBARA, Calif. and STOCKHOLM, Sweden, March 21, 2023 (GLOBE NEWSWIRE) -- Palette Life Sciences, a global life sciences company, today announced that it has entered into a debt financing facility for up to $75 million (“debt facility”) with OrbiMed, a leading investor in the healthcare industry. The non-dilutive capital provides further financial flexibility to support global commercial and product development activities across its product portfolio.

Key Points: 
  • The non-dilutive capital provides further financial flexibility to support global commercial and product development activities across its product portfolio.
  • Under the terms of the debt facility, Palette Life Sciences can borrow up to $75 million based on the achievement of certain milestones and other specified conditions, including $50 million immediately available at closing.
  • Per Langö, CEO and Board Director of Palette Life Sciences, said “Securing this credit facility is a significant step forward for Palette Life Sciences.
  • James Leech, VP of Strategy & Corporate Development at Palette Life Sciences, stated “This debt financing provides Palette Life Sciences with important growth capital as we continue to progress our product portfolio into expanded indications and drive continued revenue growth globally.

Lilly Announces Details of Presentations at 2023 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Tuesday, March 14, 2023
Dehydration, Breast cancer, Patient, HER2, Infection, Tamoxifen, Loperamide, Toxicity, Hospital, Febrile neutropenia, Recurrence, Grade 2, Fulvestrant, HIV disease progression rates, Diarrhea, Pharmaceutical industry, Neutropenia, Abemaciclib

Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio.

Key Points: 
  • Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio.
  • A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio.
  • Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
  • Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors.

BioVie Announces the Pausing of Patient Enrollment in Ascites Phase 2b Trial, Encouraging Efficacy Data is Announced, Initiating FDA Discussions to Conduct Pivotal Registrational Trial

Retrieved on: 
Monday, March 13, 2023
Paracentesis, Terlipressin, Liver, Publication, Nature Reviews Gastroenterology & Hepatology, Ascites, Cirrhosis, Abdomen, Temperature, Patient, Incidence, SOC, Standard of care, FDA, Grade 2, Cancer, Pharmaceutical industry, Hepatology, Medicine, Gastroenterology

This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05).

Key Points: 
  • This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05).
  • Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid (p=0.001), which was significantly different from those treated with SOC (p=0.007).
  • The current trial (NCT04112199) evaluates the efficacy of BIV201 combined with standard-of-care (SOC), compared to SOC alone, for the treatment of refractory ascites.
  • “Compelling data from the first 15 patients led us to pause enrollment,” commented Cuong Do, BioVie’s President and CEO.