QW

ACELYRIN, INC. Provides Business Update and Highlights Key Upcoming Milestones

Retrieved on: 
Donnerstag, Mai 9, 2024
Psoriatic arthritis, Hyperglycemia, Graves' ophthalmopathy, Abscess, Huber loss, Risk, QW, Hidradenitis suppurativa, Conference, Webcast, Suicidal ideation, Development, MRCP, Disease, Patient, Fungus, LOS, SLRN, Diplopia, FRCP, IL-17A, POC, CAS, Quality of life, Exophthalmos, Behavior, Infection, Pharmaceutical industry

LOS ANGELES, May 09, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today provided an update on various corporate milestones.

Key Points: 
  • This Phase 2b/3 trial, designed to be the first of two registrational trials in TED, is planned to be initiated in the second half of 2024.
  • Izokibep in Uveitis (UV): ACELYRIN expects to complete enrollment in the ongoing Phase 2b/3 trial this month and top line data are anticipated by year-end 2024.
  • ACELYRIN expects to report cash, cash equivalents, and short-term marketable securities of $678.5 million at March 31, 2024.
  • Gil Labrucherie, who serves as ACELYRIN’s Chief Financial Officer, has also been named Chief Business Officer in addition to Chief Financial Officer.

ACELYRIN, INC. Reports Full Year 2023 Financial Results and Recent Highlights

Retrieved on: 
Donnerstag, März 28, 2024
Research, IL-17A, Strategic planning, Cell, Exophthalmos, Disease, Infection, Fungus, Risk, Inflammation, SLRN, Patient, Psoriatic arthritis, Acquisition, Doctor of Philosophy, MD, Quality of life, CAS, Senior, IPR, Eye, NeoGenomics, Graves' ophthalmopathy, Suicidal ideation, Behavior, Hidradenitis suppurativa, QW, Drug development, LOS, Corporate communication, Abscess, Diplopia, Pharmaceutical industry

LOS ANGELES, March 28, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today reported financial results for the full year ended December 31, 2023 and highlighted recent corporate updates and upcoming milestones.

Key Points: 
  • R&D Expenses: Research and development expenses were $355.9 million for the full year ended December 31, 2023, as compared to $55.6 million for 2022.
  • G&A Expenses: General and administrative expenses were $66.2 million for the full year ended December 31, 2023, as compared to $13.5 million for 2022.
  • Net Loss: Net loss for the full year ended December 31, 2023 was $381.6 million, compared to $64.8 million for 2022.
  • In December 2023, the Company announced the appointment of Lynn Tetrault to its Board of Directors.

TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma

Retrieved on: 
Dienstag, Februar 20, 2024
QW, CD3, RRMM, Physician, FDA, Food, BCMA, Patient, Multiple myeloma, B-cell maturation antigen, Pharmaceutical industry

HORSHAM, Pa., Feb. 20, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months.1 There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • TECVAYLI® has been prescribed to more than 3,600 patients in the U.S. since approval.3
    This approval is based on results from the Phase 1/2 MajesTEC-1 study ( Phase 1: NCT03145181 ; Phase 2: NCT04557098 ).
  • Today's approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules," said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine.
  • "As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, TECVAYLI is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma."

ACELYRIN, INC. Provides Update on Izokibep Clinical Development Program

Retrieved on: 
Montag, November 27, 2023
8-K, Quality of life, Conference, Contract research organization, Hidradenitis suppurativa, Arm, Physician, SLRN, Disease, MD, Doctor of Philosophy, Clinical trial, QW, Part, American College, Patient, Safety, Psoriatic arthritis, Pharmaceutical industry

LOS ANGELES, Nov. 27, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis (“PsA trial”).

Key Points: 
  • LOS ANGELES, Nov. 27, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis (“PsA trial”).
  • In September 2023, ACELYRIN disclosed top-line results from Part B of its Phase 2b/3 trial evaluating izokibep for the treatment of moderate-to-severe Hidradenitis Suppurativa (“HS trial”).
  • The CRO does not conduct any trials on behalf of ACELYRIN beyond the izokibep clinical program.
  • ACELYRIN’s team recently identified clinical trial execution errors involving its CRO and one of the vendors engaged by the CRO.

89bio Announces New Positive Long-Term Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH)

Retrieved on: 
Montag, November 27, 2023
Patient, Liver, NASH, Fatty liver disease, SAN, Cirrhosis, QW, Inflammation, Week, FGF21, Fibrosis

SAN FRANCISCO, Nov. 27, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced positive topline data from the blinded extension phase of its Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH). At week 48, both the 30mg weekly (QW) and 44mg every-two-week (Q2W) dosing schedules of pegozafermin demonstrated statistically significant improvements across key markers of liver health. The benefits observed at week 48 were consistent with the results observed at week 24, indicating sustained benefits over time.

Key Points: 
  • The benefits observed at week 48 were consistent with the results observed at week 24, indicating sustained benefits over time.
  • A subset of patients in the placebo arm of the Main Study (n=19) were re-randomized to receive pegozafermin 30mg weekly (QW) during the Extension Phase.
  • The efficacy endpoints assessed in the Extension Phase included liver fat, non-invasive markers of fibrosis and inflammation, and metabolic markers.
  • Extension Phase Data at Week 48: Liver NITs Results [marker of]

Live from ESMO 2023 | Oral Report Featuring Latest Data of Pelcitoclax (APG-1252) Combined with Osimertinib Demonstrates Potential as a New Treatment Option for TP53-and EGFR-Mutant NSCLC

Retrieved on: 
Montag, Oktober 23, 2023
TKI, Bone marrow, PRS, NSCLC, Notifiable disease, Mini, Aes, ESMO, TP53, QW, Hepatitis, Congress, PFS, European Society for Medical Oncology, CHB, Pharmacokinetics, Disease, Oncology, ORR, Safety, Cancer, Apoptosis, Patient, Prognosis, Cohort, EGFR, Pharmaceutical industry

The clinical data presented at the ESMO Congress this year demonstrated promising therapeutic utility of pelcitoclax combined with osimertinib in patients with EGFR-mutant NSCLC.

Key Points: 
  • The clinical data presented at the ESMO Congress this year demonstrated promising therapeutic utility of pelcitoclax combined with osimertinib in patients with EGFR-mutant NSCLC.
  • Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "Currently, there are many challenges in the treatment of NSCLC.
  • At the ESMO 2023, we presented the latest clinical data that continued to suggest encouraging therapeutic potential of pelcitoclax combined with osimertinib in EGFR-TKI-naïve patients with TP53- and EGFR-mutant NSCLC.
  • In earlier studies, pelcitoclax combined with osimertinib demonstrated clinical potential for the treatment of patients with EGFR-mutant advanced NSCLC resistant to EGFR-TKIs.

SELLAS Announces Positive Topline Data in Lymphoma Cohort from SLS009 Phase 1 Dose-Escalation Trial, Supporting Advancement to Phase 2 Clinical Study; Primary and Secondary Endpoints Met

Retrieved on: 
Donnerstag, September 21, 2023
Pharmacodynamics, Lymphoma, PTCL, MYC, Index, Peripheral T-cell lymphoma, PD, Relapse, Trae tha Truth, Pharmacokinetics, Cmax, Biomarker, Acute myeloid leukemia, Plasma, QW, AML, Doctor of Science, SLS, MD, Patient, Hypokalemia, Bilirubin, AUC, MCL1, MTD, Bone marrow, Toxic leukoencephalopathy, CDK9, BIW, Safety, Vaccine, Pharmaceutical industry, Generic drug

All primary and secondary study objectives, including safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD), were successfully achieved.

Key Points: 
  • All primary and secondary study objectives, including safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD), were successfully achieved.
  • A dose-limiting toxicity occurred in one out of five patients treated at the 100 mg dose level.
  • No dose-limiting toxicities were observed at any other dose level, and there were no unexpected toxicities across the study.
  • For more information on the Phase 1 study of SLS009 in r/r AML and r/r lymphomas, please visit ClinicalTrials.gov and reference Identifier NCT04588922 .

Quantum Machines and QuantWare Partner to Offer Pre-integrated Control and QPU Solutions

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Dienstag, Juni 13, 2023
Partnership, OPX, QM, Electronics, QPU, Research, TEL, QW, Running, Investment, HPC, Algorithm, QUA, Calibration, Contralto, Quantum machine learning, Microscope

TEL AVIV, Israel and DELFT, Netherlands, June 13, 2023 /PRNewswire/ -- Quantum Machines (QM), the provider of breakthrough quantum control solutions that accelerate the development and implementation of quantum computers, and QuantWare, the leading provider of superconducting quantum processors (QPUs) today announced a partnership aimed at enabling companies as well as researchers, to dramatically accelerate their development. The partnership will offer customers a QPU that's pre-integrated with a control system out-of-the-box. Additionally, as part of this partnership, QuantWare (QW) is using OPX+, QM's control system, for their own lab infrastructure, while QM is using QW's QPUs to build Israel's first functional quantum computer.

Key Points: 
  • The partnership between Quantum Machines and QuantWare now makes it possible to quickly and seamlessly go from a QPU to a working quantum computer that is capable of running advanced quantum algorithms.
  • Quantum Machines and QuantWare deliver a large-scale QPU and a state-of-the-art control system that are already integrated ahead of time.
  • "We provide the ideal quantum control systems that make it seamless to realize the potential of any QPU our customers have," said Itamar Sivan, CEO of Quantum Machines.
  • "Achieving useful quantum computation is a huge challenge that requires collaboration - like the one we are currently establishing with Quantum Machines," said Matthijs Rijlaarsdam, CEO of QuantWare.

Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma

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Samstag, Juni 3, 2023
Infection, Maintenance, Dysgeusia, Arm, University, CRS, GPRC5D, University of Arkansas for Medical Sciences, DOR, Aes, Multiple myeloma, Safety, B-cell maturation antigen, OS, Survival, Vanderbilt University Medical Center, Hope, Janssen, Associate, PFS, Assistant, Fungal infection, ASCO, Incidence, QW, American Society of Clinical Oncology, Cytokine release syndrome, Patient, Division, B cell, Janssen Pharmaceuticals, Immunoglobulin G, CR, Johnson & Johnson, Daratumumab, RRMM, Abstract, Society, ORR, BCMA, Pharmaceutical industry, Copper, Vaccine, Medicine, Hyaluronidase

CHICAGO, June 3, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the pivotal Phase 1/2 MonumenTAL-1 study of the investigational bispecific antibody talquetamab in the treatment of patients with relapsed or refractory multiple myeloma (RRMM).1 Data from the MonumenTAL-1 study highlight safety and efficacy results (Abstract #8036) and an analysis of infections and parameters of humoral immunity in patients with RRMM treated with talquetamab (Abstract #8020).1,2 These data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2 Additional data from the Phase 2 TRiMM-2 study, evaluating talquetamab in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), were presented (Abstract #8003) at the meeting.3

Key Points: 
  • CHICAGO, June 3, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the pivotal Phase 1/2 MonumenTAL-1 study of the investigational bispecific antibody talquetamab in the treatment of patients with relapsed or refractory multiple myeloma (RRMM).1 Data from the MonumenTAL-1 study highlight safety and efficacy results ( Abstract #8036 ) and an analysis of infections and parameters of humoral immunity in patients with RRMM treated with talquetamab ( Abstract #8020 ).1,2 These data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2 Additional data from the Phase 2 TRiMM-2 study, evaluating talquetamab in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), were presented ( Abstract #8003 ) at the meeting.3
    Patients in the Phase 1/2 MonumenTAL-1 study (n=339) were treated with subcutaneous (SC) talquetamab at the recommended Phase 2 dose (RP2D) of 0.8 mg/kg biweekly (Q2W) or 0.4 mg/kg weekly (QW) with step-up doses.1 The overall response rate (ORR) to talquetamab was similar across both doses.1 With a median follow-up of 12.7 months, 71.7 percent (104/145) of response-evaluable patients treated with the 0.8 mg/kg Q2W dose achieved a response, 60.7 percent achieved a very good partial response (VGPR) or better, nine percent achieved a complete response (CR), and 29.7 percent achieved a stringent complete response.1 With a median follow-up of 18.8 months, 74.1 percent (106/143) of response-evaluable patients treated with the 0.4 mg/kg QW dose achieved a response, 59.4 percent achieved a VGPR or better, 9.8 percent achieved a CR, and 23.8 percent achieved a stringent CR.1 In a separate cohort of patients treated with prior T-cell redirection therapy, 64.7 percent (33/51) achieved a response, and 54.9 percent achieved a VGPR or better, with a median follow-up of 14.8 months.1
    "The updated results from the MonumenTAL-1 study continue to show the encouraging potential of talquetamab for heavily pretreated patients with multiple myeloma, including those who may have been exposed to prior T-cell redirection therapy," said Carolina Schinke, M.D., Associate Professor of Medicine at the Myeloma Center at the University of Arkansas for Medical Sciences and principal investigator.† "With a high overall response rate among relapsed or refractory patients, the results underscore the efficacy of talquetamab as a novel option for later-line patients who otherwise face a poor prognosis, including patients with high-risk disease."
  • The safety profile was clinically manageable with low rates of Grade 3/4 infections (0.8 mg/kg Q2W dose, 25.5 percent; 0.4 mg/kg QW dose, 21.4 percent) and talquetamab discontinuations (1.5 percent).3 Almost all patients (95.4 percent) received antibacterial, antifungal or antiviral prophylaxis.
  • No new safety signals were observed with longer term follow-up.3 The most common non-hematologic AEs at the 0.8 mg/kg Q2W dose and 0.4 mg/kg QW dose cohorts were CRS (80 percent and 71 percent, respectively; all Grade 1/2), skin-related AEs (84 percent and 71 percent, respectively; Grade 3/4: eight percent and 14 percent, respectively) and nail-related AEs (69 percent and 57 percent, respectively; Grade 3/4: two percent and zero percent, respectively).3
    "The updated findings from MonumenTAL-1 and data from the TRiMM-2 study are exciting, as they demonstrate the continued promise of T-cell redirecting therapies as single agents or in combination with standard-setting treatments in multiple myeloma," said Chris Heuck, M.D., Global Medical Head, Oncology, Janssen Research & Development, LLC.
  • "At Janssen, we recognize that the future of multiple myeloma treatment lies in harnessing the power of combination therapies to target this complex disease, and the talquetamab results seen to date offer new hope to patients in need of additional treatment options."

eFFECTOR Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Dienstag, Mai 9, 2023
Abstract, PRS, Metastatic breast cancer, American Society of Clinical Oncology, Cancer, Fulvestrant, STRI Group, G&A, Net operating loss, MNK, NSCLC, Effector, Lung cancer, Messenger, Cell, Assistant, Science, ASCO, QW, Expense, Patient, Investment, Administration, KICKSTART, Stanford University School of Medicine, Artificial intelligence, Research and development, R, Research, Pembrolizumab, Therapy, Safety, PD-L1, Society, ER, Breast cancer, Pharmaceutical industry, Vaccine, Cryptocurrency, Medicine, Genetics

SOLANA BEACH and REDWOOD CITY, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update.

Key Points: 
  • Clinical data for zotatifin-based combination regimens in ER+ breast cancer have been selected for presentation at ASCO Annual Meeting 2023.
  • Management also intends to host a conference call to discuss results and further development of zotatifin during ASCO 2023.
  • Research and Development (R&D) Expenses: R&D expenses were $6.6 million for the quarter ended March 31, 2023, compared to $3.1 million for the same quarter of 2022.
  • Other expense in the quarter ended March 31, 2023 consisted primarily of interest expense associated with the company’s term loans.