REC-617, a precision designed molecule, demonstrated dose-linear pharmacokinetics (PK) with rapid absorption and robust pharmacodynamic (PD) biomarker modulation, suggesting substantial target engagement Confirmed partial response (PR) observed during monotherapy dose-escalation in a patient with platinum-resistant ovarian cancer, treated with 4 lines of prior therapy in advanced setting, durable response ongoing after more than 6...Read more
The pivotal Phase 3 inMIND trial met its primary endpoint of progression-free survival (PFS) and key secondary endpoints in patients with relapsed or refractory follicular lymphoma (FL) treated with tafasitamab (Monjuvi®) in combination with lenalidomide and rituximab Positive data featured in a late-breaking oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting support the planned U.S. filing of a...Read more
Analyses pooling data from IMerge Phase 2, Phase 3 and the QTc substudy suggest patients who were ESA ineligible or who had prior treatment with luspatercept or lenalidomide experienced clinical benefit from imetelstat similar to prior results from the IMerge pivotal trial Data from the QTc substudy reinforce imetelstat as a second-line treatment option for LR-MDS patients with transfusion-dependent anemia regardless of prior therapies,...Read more
In the dose escalation Part 1 of the study, no dose-limiting toxicities were observed and the PK profiles were similar to those reported for previous monotherapy studies of imetelstat and ruxolitinib Based on the safety profile, imetelstat 9.4 mg/kg dosed every four weeks with ruxolitinib was the selected dose for the dose expansion Part 2 of the study, which is currently enrolling patients Geron is also evaluating the potential of...Read more
Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity (clinical benefit rate: 62.5%; overall response rate: 26.7%) in patients previously treated with a CDK4/6 inhibitor Safety and tolerability of the combination is generally consistent with the profile of abemaciclib and what has been observed in other clinical trials of vepdegestrant; no significant drug-drug interaction was observed between...Read more
Data from Phase 1b/2 clinical trial to be presented at 2024 San Antonio Breast Cancer Symposium (SABCS) show encouraging clinical activity in patients with heavily pretreated HER2-positive breast cancer who had received multiple HER2-targeted agents, including fam-trastuzumab deruxtecan-nxki (ENHERTU®) Combination therapy was well tolerated with a manageable safety profile consistent with prior experience with each investigational...Read more
BASKING RIDGE, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced the successful completion of patient enrollment in all three cohorts of the Phase 1b/2a CENDIFOX trial. This investigator-initiated trial, led by Dr. Anup Kasi at The...Read more
Based on more than six months of additional monitoring, data show continued improvement in overall survival (OS) in intent-to-treat (ITT) population of women newly diagnosed with advanced ovarian cancer Median OS increased from 11 to 13 months in IMNN-001 treatment group based on latest data analysis No change in IMNN-001 favorable safety profile including no reports of serious immune-related adverse events IMUNON remains on track to...Read more
32% objective response rate (ORR) in evaluable patients at the 5.2 mg/kg starting dose – the selected dose for randomized portion (Part 2) of ongoing registrational REFRαME-O1 trial These data confirm luvelta’s robust response rate in patients with late-stage ovarian cancer expressing a broad range of folate receptor alpha (FRα) Neutropenia well-managed; no new safety findings Luvelta is positioned for an...Read more
Company continuing to work with the U.S. FDA on potential for accelerated approval pathway Novavax intends to partner on both candidates to advance to filing and commercialization GAITHERSBURG, Md., Dec. 10, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza...Read more
LEXINGTON, Mass., Dec. 10, 2024 /PRNewswire/ -- Curis, Inc. ("Curis") (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, yesterday presented data from the TakeAim Leukemia study (CA-4948-102) in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) at the 66th ASH annual meeting. The additional data presented include data for 21 patients with...Read more
SAN DIEGO, Dec. 10, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the outcome of a third, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™...Read more
SYDNEY, AUSTRALIA, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the initiation of the pivotal TACTI-004 Phase III clinical trial for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC). “The receipt of regulatory approval from...Read more
TORONTO, ON / ACCESSWIRE / December 10, 2024 / Quantum BioPharma Ltd. (NASDAQ:QNTM) (CSE:QNTM) (FRA:0K91) ("Quantum BioPharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, HUGE Biopharma Australia Pty Ltd., that the safety review committee recommends commencing dosing of the second cohort in its trial entitled "A Phase...Read more
ACI-24.060 was generally safe and well tolerated in individuals with Down syndrome with no serious adverse events related to the study drug No cases of amyloid-related imaging abnormalities observed in this study population Based upon these findings, AC Immune plans to open the high-dose cohort in ABATE in individuals with Down syndrome Lausanne, Switzerland, December 10, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage...Read more
INB-100 continues to demonstrate durable complete remissions (CR) with no relapses observed in any acute myeloid leukemia (AML) patients including those with high-risk disease after a median follow-up of 19.7 months. Data highlights INB-100’s long-term impact, exhibiting durable in vivo expansion and persistence of allogeneic gamma-delta T cells 365 days following a single administration of INB-100, demonstrating the first-ever durable...Read more
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2H 2025 APG777 + APG333 can potentially address key drivers of respiratory diseases more broadly versus monotherapy Preclinical proof-of-concept achieved for APG777 + APG333 combination with clinical trial planning underway in asthma and COPD SAN FRANCISCO and WALTHAM, Mass., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc.,...Read more
OKI-219 is well-tolerated across all doses, and no dose interruptions, delays, reductions, or discontinuations were reported Initial patient data show exposures of OKI-219 exceeding levels associated with robust antitumor activity in preclinical models Data support the initiation of Part 1b of PIKture-01 evaluating OKI-219 in combination with fulvestrant; first patients dosed, and initial data are expected in 2H-2025 Management to...Read more
Achieved primary endpoint of LS mean reduction vs placebo in LDL-C on top of maximally tolerated lipid modifying therapies at day 84 with statistically significant reduction (p<0.0001) 21% observed reduction in major adverse cardiovascular events favoring obicetrapib at one year Observed to be well-tolerated with safety results comparable to placebo NewAmsterdam to host conference call at 8:00 a.m. ET...Read more
Neflamapimod did not demonstrate statistically significant effects versus placebo on primary and secondary endpoints at 16 weeks Favorable safety and tolerability results with no new safety signal identified Target plasma drug concentrations not achieved during 16-week double-blind phase of the trial Trial participants continue to receive neflamapimod during open-label extension BOSTON, Dec. 10, 2024 (GLOBE NEWSWIRE) -- CervoMed...Read more
First patient dosed with combination of IDE161, IDEAYA's investigational, potential first-in-class PARG inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy The IDEAYA-sponsored Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer Selected initial...Read more
Initial results from randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care in RAS-mut mCRC demonstrated 64% ORR in the 30mg onvansertib dose arm versus 33% ORR in the control arm In the experimental arms, 30mg dose of onvansertib demonstrated a higher ORR compared to 20mg dose of onvansertib (64% vs. 50%) with deeper tumor regression in the 30mg arm Onvansertib was well tolerated at both...Read more
Therapeutically relevant levels of Factor VIII (FVIII) activity sustained in ongoing nonhuman primate (NHP) study through more than sixteen months of follow up MGX-001 bioengineered FVIII construct exhibited higher FVIII activity at similar integration rates compared to wild type FVIII construct in preclinical studies; program on track for IND filing in 2026 EMERYVILLE, Calif., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Metagenomi, Inc....Read more
Objective response rate (ORR) of 94% and a complete response (CR) rate of 71% demonstrated after IMPT-314 treatment in CAR T-naïve patients with large B-cell lymphoma who had received at least 2 prior lines of therapy Manageable safety profile with no high-grade cytokine release syndrome (CRS) and low rates of Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS); adverse events were resolved with standard treatment...Read more
5-year follow-up from SEQUOIA study demonstrated treatment with BRUKINSA reduced the risk of progression or death by 71% compared to bendamustine-rituximab in patients with treatment-naïve CLL, further solidifying its position as the leader in new patient starts in both frontline and relapsed/refractory (R/R) CLL with the broadest label of any BTK inhibitor At a median follow-up of 1.5 years, promising data from the 320 mg expansion...Read more
89 percent of evaluable patients achieved minimal residual disease (MRD) negativity with CARVYKTI® after three-year follow-up in CARTITUDE-4 study; the majority in less than 2 months Results add to the overall survival (OS) benefit recently reported making CARVYKTI® the first and only cell therapy to significantly extend OS versus standard therapies in multiple myeloma Landmark Phase 3 CARTITUDE-4 study data featured as an oral...Read more
Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter administration...Read more
89 percent of patients evaluable for MRD assessment were MRD negative, with the majority reaching MRD negativity in less than 2 months Results add to the overall survival (OS) benefits recently presented, as the first and only cell therapy to significantly extend OS versus standard therapies in multiple myeloma SAN DIEGO, Dec. 9, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today new results from the...Read more
Elritercept demonstrated a durable transfusion independence in lower-risk myelodysplastic syndromes, including in patients with high transfusion burden, with a median duration of response of 134.1 weeks Durable clinical responses were associated with improvements in patient-reported measures of fatigue in MDS patients early, and with continued improvement over time Data from ongoing Phase 2 clinical trial in myelofibrosis continue to...Read more
Durable responses are rapid and deepen on treatment as demonstrated by an initial 75.5% Objective Response Rate which increased to 84.2% in patients with at least two disease assessments Treatment responses observed in heavily pre-treated population with mutations associated with poor prognosis and/or resistance to BTK inhibitors, including patients with CNS involvement Favorable safety profile across all doses tested Nurix will...Read more
Results from BRUIN CLL-321 show Lilly's pirtobrutinib reduced the risk of disease progression or death by 46% compared to idelalisib plus rituximab or bendamustine plus rituximab Pirtobrutinib prolonged the time to next treatment or death by a median of 23.9 months compared to 10.9 months in the control arm BRUIN CLL-321 is the first randomized Phase 3 study in CLL ever conducted exclusively in patients previously treated with a BTK...Read more
ZUMA-5 Analysis Shows Median Progression-Free Survival of 62.2 Months and Median Duration of Response of 60.4 Months After Median Follow-Up of More Than Five Years Over Half of Patients Alive at Time of Analysis, with No Need for Subsequent Therapy and Rare Instances of Late Disease Progression, Indicating Curative Potential SANTA MONICA, Calif. / Dec 09, 2024 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced...Read more
To date, event-free survival strongly favors the treatment arm (HR=0.30; p=0.04), and treatment-arm patients trend towards lower probability of relapse (HR=0.28; p=0.14) No dose-limiting toxicities observed and infusions of TSC-100 and TSC-101 were well-tolerated across all three dose levels Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10, 2024, at 8:00 a.m. ET WALTHAM, Mass., Dec. 09,...Read more
54% of patients experience more than 2.5 years of durable hematocrit (Hct) control (<45%), decreased phlebotomy use, long-term tolerability, and improvements in patient-reported outcomes in patients with polycythemia vera NEWARK, CA / ACCESSWIRE / December 9, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced details from a poster presentation with final data from the rusfertide Phase 2 REVIVE study....Read more
All Three Patients Treated in First Dose Cohort Administered Fludarabine-free Conditioning and Show Rapid, Deep, and Sustained B-cell Depletion with Favorable Safety Profile First Patient to Reach 6-Month Follow-up Remains in DORIS Clinical Remission and Free of All Immunosuppressive Therapies Company Plans to Initiate Dose Expansion at First Dose Level of 360M Cells SAN DIEGO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics,...Read more
Preliminary data supports BMF-500’s potential as a transformative therapy for patients with FLT3 mutated relapsed or refractory (R/R) acute leukemia BMF-500 showed a favorable safety and tolerability profile, with no dose-limiting toxicities observed across all dose levels Pharmacokinetic and pharmacodynamic data confirmed on-target FMS-like tyrosine kinase 3 (FLT3) inhibition, demonstrating dose-proportional activity and good...Read more
AFM28, a bispecific, tetravalent innate cell engager (ICE®) targeting CD123 and CD16A, achieved a 40% composite complete remission rate (CRcR) at the highest dose level (300 mg) in heavily pretreated R/R AML patients AFM28 demonstrates a favorable safety profile: Grade 1 and 2 Infusion related reactions (IRRs) were the main related side effect, occurring in 45% of patients; no signs of neurotoxicity or immune-related side effects were...Read more
R289 was generally well tolerated and demonstrated signs of preliminary clinical activity in elderly heavily pretreated LR-MDS patients RBC-TI/HI-E responses occurred in 40% of evaluable TD patients receiving R289 doses ≥500 mg QD SOUTH SAN FRANCISCO, Calif., Dec. 9, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today...Read more
Additional new profiling of patient responses from the optimized lymphodepletion arm (Arm C) show consistent P-BCMA-ALLO1 cellular expansion and persistence across subgroups New preclinical data supports P-CD19CD20-ALLO1's strong anti-cancer profile and the ongoing Phase 1 clinical trial Case study demonstrates reactivation of an autologous Poseida CAR-T therapy with a T-cell engager in patient with relapsed multiple myeloma,...Read more
Preliminary data demonstrate that CTX112™ has the potential to provide meaningful clinical benefit with a well-tolerated safety profile using a standard lymphodepletion protocol Company announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX112 for the treatment of certain relapsed or refractory (R/R) CD19-positive B-cell malignancies CTX112 is also in a Phase...Read more
SOLANA BEACH, Calif., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic, and neurological conditions, today announced the presentation of preliminary data on ART27.13, the Company’s benzimidazole derivative, being studied for cancer-related anorexia. The...Read more
Based on successful Phase 2a data, Company set to initiate Phase 2b sarcopenia study in early 2025; currently securing centers of excellence to begin enrollment First oral TNF-α inhibitor, if approved, would offer potential patient benefit in an approximate $40 billion TNF inhibitor market BALTIMORE / Dec 09, 2024 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical...Read more
- Median Overall Survival (mOS) Not Yet Reached, Now Exceeds 7.7. Months at Latest Follow-Up in the 30 mg BIW Cohort in Patients Relapsed or Refractory to Venetoclax-Based Regimens - - Overall Response Rate (ORR) of 56% Achieved to Date in Patient with Acute Myeloid Leukemia with Myelodysplasia Related Changes (AML MRC) Prospectively Enrolled in Two Expansion Cohorts; Exceeding Prespecified Target Response Rate of 33% - NEW YORK,...Read more
The maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg, without dose-limiting toxicity or evidence of cytokine release syndrome at any dose level Stable disease (SD) at four months post-initiation of dosing was seen in 10 of 21 (48%) evaluable monotherapy patients, and importantly included one patient dosed at the MTD who had a partial response (PR) by RESIST criteria (a 45% decrease from baseline) Together, these data...Read more
Multiple clinical trial sites across Taiwan are actively screening patients, following successful site initiation visits. Expansion into Taiwan is particularly significant as over 50% of lung cancer cases in Taiwan occur in never-smokers. DALLAS / Dec 09, 2024 / Business Wire / Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR® AI platform, today...Read more
Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-2 flexible-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 261 Trial also met its key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score at week 261 Positive results across all three Phase 3 TEMPO...Read more
Subgroup analyses from Ph 2 protocol-defined R/R mNPM1 AML efficacy population (N=64) show responses across all major subgroups, including heavily pretreated patients 26% CR+CRh (20/77) and 48% ORR (37/77) in all enrolled patients who met the efficacy evaluable criteria in Ph 2 R/R mNPM1 AML cohort 100% ORR (37/37) and 95% CRc (35/37) in BEAT AML trial exploring revumenib in combination with venetoclax/azacitidine in...Read more
Preliminary data suggests improved relapse-free survival compared to published groups of acute myeloid leukemia (AML) patients at high risk of relapse post-transplant Trem-cel + Mylotarg continue to demonstrate engraftment, shielding, and broadened therapeutic window Company has received supportive feedback from the FDA regarding a registrational clinical trial design CAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Vor Bio...Read more
No dose-limiting toxicities reported in two different weekly doses in heavily pre-treated patients Preliminary evidence of dose response includes significant tumor shrinkage and one patient with complete resolution of a liver lesion MONTREAL, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Thera technologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and...Read more
MIAMI, Dec. 09, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the first patient has been enrolled in the company’s CGUARDIANS II clinical trial evaluating its CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach. The patient...Read more
56% mean improvement in Total Symptom Score (TSS) at 24 weeks with 76% of patients achieving at least a 50% reduction in TSS 89% of patients had >50% decrease in serum tryptase by four weeks of treatment and 95% of patients with elevated baseline tryptase achieved serum tryptase levels <20 ng/ml by week 24 SUMMIT Part 2 enrollment completed early; surpassing original enrollment target with 179 patients enrolled, top-line...Read more
NORWOOD, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, today announced the dosing of the first patient in the Phase 1 portion of the clinical study of CRB-601 for the treatment of patients with advanced solid tumors (NCT06603844). CRB-601 is a monoclonal antibody targeting latent TGFβ...Read more
KEYTRUDA® (pembrolizumab) plus chemotherapy followed by maintenance with LYNPARZA® (olaparib), with or without bevacizumab, demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone The study did not reach its secondary endpoint of overall survival RAHWAY, N.J. / Dec 09, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...Read more
Observed an antiviral effect for the primary and secondary virology endpoints in the overall population, with a viral load decline of 1.4 log at the end of treatment in Part 2 Demonstrated a viral load decline of 1.2 log compared to placebo at the end of treatment in prespecified analysis of patients randomized within 3 days of symptom onset Zelicapavir was well-tolerated with a favorable safety profile Conference call and webcast to...Read more
Results from Arm 1 of the EPCORE® NHL-2 trial show treatment with epcoritamab combination led to an overall response rate (ORR) of 100 percent and a complete response (CR) rate of 87 percent in high-risk patients with previously untreated diffuse large B-cell lymphoma (DLBCL) Extended follow-up data from EPCORE® NHL-1 trial demonstrates durability of responses and long-term safety of epcoritamab monotherapy for patients with...Read more
Data presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH) NORTH CHICAGO, Ill., Dec. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new results from two ongoing clinical trials evaluating epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, in adult patients with diffuse large B-cell lymphoma (DLBCL) at the 66th Annual Meeting and Exposition of...Read more
Preliminary results from 86 patients enrolled in the Phase 2 pivotal iMMagine-1 study of anito-cel demonstrated 97% ORR and 62% CR/sCR at a median follow-up of 9.5 months No delayed neurotoxicities have been observed to date with anito-cel, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome in more than 150 patients dosed across the Phase 1 and iMMagine-1 studies 30.2-month median...Read more
Demonstrated durable hematologic response across all patient subgroups, regardless of baseline transfusion status and concomitant JAK inhibitor therapy Phase 2 study in MF anemia has been initiated, enrolling a broad range of patient types WATERTOWN, Mass., Dec. 08, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of...Read more
New analysis from Phase 3 CEPHEUS study demonstrates 85 percent of patients who achieved MRD negativity (10-6) with DARZALEX FASPRO® were progression free at 4.5 years Subgroup analysis from Phase 3 AURIGA study show higher rates of MRD-negative conversion in patient populations disproportionately impacted by multiple myeloma SAN DIEGO, Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data...Read more
Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate RAHWAY, N.J. / Dec 08, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, Merck’s investigational antibody drug conjugate (ADC) that targets receptor...Read more
Scemblix demonstrated sustained superior major molecular response (MMR) vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%), meeting both ASC4FIRST 96-week key secondary endpoints1 Scemblix showed a clinically relevant 15.1% higher MMR rate vs. second generation (2G) TKIs (72.0% vs. 56.9%)1 96-week data extend favorable safety and tolerability profile for Scemblix vs. imatinib and 2G TKIs, with...Read more
ENERGIZE-T Study Achieved Primary and All Key Secondary Endpoints in Adult Patients with Transfusion-Dependent Alpha- or Beta-Thalassemia ENERGIZE-T is First Phase 3 Study to Demonstrate Efficacy of an Oral, Disease-Modifying Treatment for Transfusion-Dependent Alpha- and Beta-Thalassemia Company Filed for Regulatory Approval of Mitapivat (PYRUKYND®) for the Treatment of Adult Patients with Non-Transfusion-Dependent and...Read more
100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy SAN DIEGO, Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new frontline data featuring TECVAYLI® (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance...Read more
Exploratory long-term follow-up analysis of the Phase III POLARIX study indicated a positive trend in overall survival in favor of Polivy in combination with R-CHP for people with first-line diffuse large B-cell lymphoma (DLBCL) Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems These encouraging five-year results continue to...Read more
In Multiple Myeloma, Cemsidomide in Combination with Dexamethasone at Highest Dose Level Explored to Date Achieved 36 Percent Overall Response Rate (ORR) and 45 Percent Clinical Benefit Rate (CBR); Responses Seen Across All Dose Levels Multiple Myeloma Arm Demonstrated Well-Tolerated Safety Profile; On-Target Neutropenia Was Manageable With Low Rates of Febrile Neutropenia and Infections; No Treatment Emergent Adverse Events Leading to...Read more
MP0533 phase 1/2a dose escalation study continues with overall acceptable safety profile to date as well as initial antileukemic and pharmacodynamic activity Clinical protocol amendment in process with optimized dosing scheme to overcome target-mediated drug disposition and test the full potential of MP0533 Switch-DARPin MP0621 demonstrates intended mechanism in vivo, achieving killing of cKit+ cells while reducing off-target effects...Read more
52% ORR per mIWG criteria, including 83% ORR for patients receiving 100 mg BID 88% ORR per PPR criteria, including 100% ORR for patients receiving 100 mg BID Median time to response 2.2 months with median duration of response and median PFS not yet reached Top-line data from APEX Part 2 on-track for mid-2025 Cogent to host investor webcast on Monday, December 9 at 8:00 a.m. ET WALTHAM, Mass. and BOULDER, Colo., Dec. 08, 2024...Read more
First and only subcutaneous anti-CD38 therapy demonstrating potential to prevent end-organ damage, and extend progression-free survival and overall survival based on findings from Phase 3 AQUILA study SAN DIEGO, Dec. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data from the Phase 3 AQUILA study showing that DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) significantly delayed progression from...Read more
CALQUENCE plus venetoclax with obinutuzumab reduced the risk of disease progression or death by 58% versus standard of care in this setting CALQUENCE plus venetoclax poised to become first all-oral fixed-duration regimen of a second-generation BTK inhibitor plus venetoclax in 1st-line CLL WILMINGTON, Del. / Dec 08, 2024 / Business Wire / Positive results from the AMPLIFY Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib)...Read more
COPENHAGEN, Denmark / Dec 08, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB): Preliminary analyses from the EPCORE® CLL-1 trial demonstrates overall response rate (ORR) of 61 percent and complete response (CR) rate of 39 percent in heavily pretreated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) who received epcoritamab monotherapy In the study, 75 percent of evaluable responders achieved undetectable...Read more
Data presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH) NORTH CHICAGO, Ill., Dec. 7, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating fixed-duration investigational epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with...Read more
COPENHAGEN, Denmark / Dec 07, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB): Results show 96 percent overall response rate (ORR), 87 percent complete response (CR), and 80 percent 21-month progression-free survival (PFS) in patients with relapsed or refractory (R/R) follicular lymphoma (FL) following treatment with epcoritamab plus lenalidomide + rituximab (R2) Long-term follow-up results demonstrated strong and durable efficacy,...Read more
Head-to-head exploratory cohort of a Phase 3 trial showed first-in-class poze-cemdi combination treatment helped patients achieve and maintain greater disease control, as measured by lactate dehydrogenase (LDH) levels, compared to standard-of-care ravulizumab Five patients receiving ravulizumab did not achieve meaningful LDH control compared to one patient receiving poze-cemdi; after switching to the combination, four of the five...Read more
New data demonstrate the actionability of clonoSEQ for tailoring treatment decisions in patients with MCL, CLL, MM and ALL Studies show depth of response at 10-6 provides more accurate assessment of treatment responses SEATTLE, Dec. 07, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical...Read more
73% of the NKTR-255 treatment group compared to 50% of the placebo group achieved a complete response at 6 months NKTR-255 enhanced CAR T-cell kinetics with improved CD8+ CAR-T area under the curve (AUC) 0-15 days post-administration being 5.8-fold greater than placebo-controls SAN FRANCISCO, Dec. 7, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced results of its Phase 2 proof-of-concept study evaluating...Read more
NEW YORK, Dec. 07, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the presentation of CD38-SADA in Non-Hodgkin Lymphoma (NHL) preclinical data and trial in progress posters at the 66th...Read more
All Seven Patients Treated with BEAM-101 Achieved Hemoglobin F (HbF) Induction of >60%, Hemoglobin S (HbS) Reduction to <40%, and Resolution of Anemia Post-BEAM-101 Treatment Initial Safety Profile Consistent with Busulfan Conditioning and Autologous Hematopoietic Stem Cell Transplantation All Seven Patients Dosed Achieved Target Cell Dose with One or Two Mobilization Cycles and Experienced Rapid Neutrophil and Platelet...Read more
Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96% THOUSAND OAKS, Calif., Dec. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data demonstrating that adding BLINCYTO® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of...Read more
Phase 3 POD1UM-304 trial met primary endpoint of overall survival (OS) and all secondary endpoints in patients with previously untreated metastatic non-small cell lung cancer (NSCLC) Data presented at the European Society for Medical Oncology (ESMO) Asia Congress 2024 support the planned 2025 filing of a supplemental Biologics License Application (sBLA) in the U.S. for retifanlimab in NSCLC WILMINGTON, Del. / Dec 07, 2024 / Business...Read more
Petosemtamab in combination with pembrolizumab in 1L r/m PD-L1 expressing HNSCC ongoing with clinical data update planned for 2025 Petosemtamab in mCRC evaluation expanded to include 1L and 3L+; initial clinical data planned for 2025 – Conference Call on Saturday, December 7th at 9:00 a.m. ET UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 07, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our),...Read more
BOTHELL, Wash., Dec. 06, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today presented preclinical data highlighting target engagement and neuroprotective effects of ATH-1105 in human motor neurons at the Motor Neurone Disease Association’s 35th International Symposium on ALS/MND, taking...Read more
Decision follows observations of liver transaminitis without clinically significant symptoms in some subjects on azelaprag Company will evaluate data from patients enrolled to date and share updated plans for azelaprag in Q1 2025 In parallel to evaluating azelaprag, Company will continue to advance earlier platform-derived programs, including IND submission for CNS penetrant NLRP3 inhibitor anticipated in the second half of...Read more
Substantial and durable reductions in convulsive seizure frequency observed in patients treated with 2 or 3 doses of 70mg followed by 45mg maintenance dosing on top of the best available anti-seizure medicines Patients experienced continuous improvements in multiple measures of cognition and behavior with ongoing treatment through 2 years Data support proposed Phase 3 registrational study regimen; Update anticipated before...Read more
TORONTO and HAIFA, Israel, Dec. 06, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) ("NurExone" or the "Company"), a biopharmaceutical company developing exosome-based regenerative therapies, has announced significant findings from an expanded preclinical study of the potential of its portfolio drug, ExoPTEN, for repairing optic nerve damage. Conducted in collaboration with the Goldschleger Eye...Read more
LA JOLLA, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announces the study update and interim analysis results from the Company’s COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) will be presented at the 35th...Read more
WILMETTE, Ill., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the first patient ever dosed with MNPR-101-Lu. This novel therapeutic radiopharmaceutical combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR),...Read more
UGN-102 demonstrated 82.3% duration of response (DOR) at 12 months in patients who achieved complete response at 3 months 79.6% complete response rate at 3 months in patients treated with UGN-102 Safety profile consistent with prior clinical trials of UGN-102 PRINCETON, N.J. / Dec 05, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat...Read more
Data confirm previous results showing that ProSense® cryoablation is highly effective for kidney tumors < 3 cm and a safe procedure for kidney tumors < 5 cm in people ineligible for surgery Interim results presented at the Israeli Urological Association Conference in Eilat, Israel ProSense® is approved for benign and malignant kidney tumors in the U.S., Europe and numerous other countries CAESAREA, Israel, Dec. 5, 2024...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced initiation of dosing in a global Phase 2a clinical study, BEACON, of the investigational drug leucine-rich repeat kinase 2 (LRRK2) inhibitor BIIB122 (DNL151) in participants with LRRK2-associated Parkinson’s disease (LRRK2-PD). LRRK2 inhibition is a potential therapeutic approach that may slow progression of Parkinson’s...Read more
70-year-old patient with advanced chemo-refractory anal cancer achieves complete response (CR) in 8 weeks when treated with MDNA11 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) Complete regression of all tumors in two CPI-resistant patients in monotherapy arms continue to show durability with a patient with melanoma remaining tumor free at week 63 while a patient...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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