BOCA RATON, Fla., Sept. 17, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, today announced that results of additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease (AD) trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical...Read more
BRAINTREE, Mass., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial, enrolling and completing the follow up of 50% of the patients participating in the trial to evaluate the LIBERTY® Endovascular Robotic Surgical System. The Company...Read more
BASKING RIDGE, N.J., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced treatment of the first patient in the second-line cholangiocarcinoma (“CCA”) cohort of the BOLSTER trial. This follows the recently announced successful...Read more
Early observations suggest that the vehicle-treated Alzheimer's mice exhibit a larger population of reactive astrocytes, while the HT-ALZ treated groups show fewer reactive astrocytes, pointing to a potential breakthrough in the treatment of Alzheimer's. NEW YORK, Sept. 17, 2024 /PRNewswire/...Read more
CRANBURY, N.J. / Sep 17, 2024 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that all patients have been enrolled in the global, pivotal Phase 2 clinical trial evaluating RP-A501 to treat male patients with Danon disease. After the two-patient safety run-in,...Read more
Two patients dosed; several additional patients screened for enrollment Trial to evaluate safety and tolerability of TTX-MC138 in patients with metastatic cancer TTX-MC138 is an antisense oligonucleotide conjugated to TransCode’s proprietary TTX delivery system designed to inhibit microRNA-10b, a known driver of metastasis in multiple cancers Phase 1 clinical trial follows evidence of delivery and pharmacodynamic activity in prior...Read more
WAYNE, Pa., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that the first patient has been dosed in Aclaris' Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3, for the...Read more
Daiichi Sankyo and Merck’s patritumab deruxtecan demonstrates a statistically significant progression-free survival improvement in this EGFR-mutated non-small cell lung cancer population with high unmet need following prior EGFR TKI treatment Discussions with global regulatory authorities to be initiated BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 17, 2024 / Business Wire / The HERTHENA-Lung02 phase 3 trial evaluating patritumab...Read more
Expanded Phase 1 monotherapy study of givastomig, a Claudin 18.2 X 4-1BB bispecific antibody immunostimulant, shows promising single-agent activity in heavily pre-treated patients with gastric cancers expressing Claudin 18.2 at low and high levels The recommended Phase 2 dose for givastomig was determined to be 8-12 mg/kg; givastomig was well tolerated up to the highest study doses A Phase 1b study, evaluating givastomig in...Read more
GAITHERSBURG, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today it has entered into agreements with two additional site locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment...Read more
Cabozantinib continues to demonstrate a significant improvement in progression-free survival versus placebo in patients with advanced neuroendocrine tumors, including across key subgroups Findings were the basis for the supplemental New Drug Application filed with the U.S. Food and Drug Administration for cabozantinib for advanced neuroendocrine tumors ALAMEDA, Calif. / Sep 16, 2024 / Business Wire / Exelixis, Inc....Read more
QUEENSBURY, N.Y. / Sep 16, 2024 / Business Wire / Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced the presentation of new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM). The data were presented by Dr. Matthew Wheater from University Hospital...Read more
SOUTH JORDAN, Utah, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced positive 6-month findings from the randomized arteriovenous (AV) fistula arm of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The data were shown at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) during a FIRST@CIRSE...Read more
A key aspect of Parkinson’s disease (PD) pathophysiology is decreased systemic regulatory T cell (Treg) function with associated neuroinflammation in the nigrostriatal pathway of the brain, including the presence of reactive astrocytes and microglia that have an initiating and progressing role in PD; Subcutaneous injection of COYA 302, an anti-inflammatory, Treg-enhancing combination biologic (comprising low dose interleukin-2 and CTLA-4...Read more
Early Data Indicate Clinical Activity in Patients with Multiple Solid Tumor Types Prolonged stable disease lasting >11 months demonstrated in Breast Cancer Patient Favorable Pharmacokinetics, Safety and Tolerability Observed Data Presented at the European Society of Medical Oncology on September 14, 2024 SEATTLE WA and LUND, SWEDEN / ACCESSWIRE / September 16, 2024 / Aptevo Therapeutics ("Aptevo") (Nasdaq:APVO) and Alligator...Read more
Of the 20 evaluable ovarian cancer patients, there were 5 PRs Of the 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 3 PRs Biomarker data support proposed mechanism of action of NC410 BELTSVILLE, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class...Read more
Aethlon's Trial is a Safety, Feasibility, and Dose Finding Study of the Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies SAN DIEGO, Sept. 16, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced that the Cancer Clinical Trial Unit at Royal Adelaide Hospital was...Read more
Preclinical Study Highlight the Potential of Elraglusib in Overcoming FOLFIRINOX-induced Chemoresistance Through Downregulation of Epithelial to Mesenchymal Transition (EMT) Initial Data Demonstrates Early Evidence of Increased Clinical Activity of Combining FOLFIRINOX with Elraglusib and Losartan in Patients with Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Deep, Durable Responses Observed in 3/6 patients with...Read more
Durable Clinical Benefit Observed Beyond a Year on Treatment in Heavily Pre-Treated Patients Boston (September 16, 2024) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that two patients enrolled in its Phase 2 clinical trial of stenoparib for advanced, recurrent ovarian cancer have now exceeded...Read more
Results delivered in prestigious Proffered Paper oral presentation at ESMO Congress 2024 In patients with any PD-L1 expression (CPS ≥1), efti in combination with KEYTRUDA outperformance is largest in CPS ≥20 with 31.0% ORR (34.5% ORR including partial response after data cut-off) versus 18.5% ORR for KEYTRUDA Efti in combination with KEYTRUDA led to a high durability of response of 17.5 months in patients with any PD-L1 expression and...Read more
An ongoing complete response (CR) with an overall response rate (ORR) of 32% achieved across two dosing regimens Underscores ozuriftamab vedotin’s activity in a high unmet need SCCHN patient population The conditionally binding ADC targeting ROR2 was notably well tolerated The Company intends to meet with the FDA to discuss a SCCHN potential registrational trial in 2H 2024 SAN DIEGO, Sept. 16, 2024 (GLOBE NEWSWIRE) -- BioAtla,...Read more
WALTHAM, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the presentation of longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”) during the European Society for Medical...Read more
5-year survival rate of 82.6% and 73% reduction in overall risk of death (hazard ratio of 0.27) are the strongest Multikine efficacy results reported to date, reflecting results in patients who met the CEL-SCI confirmatory Registration Study target population criteria and were deemed at low risk for recurrence, therefore not recommended per NCCN guidelines to receive chemotherapy post-surgery Data provide further evidence that the...Read more
Phase 2 updated results for zanidatamab in HER2-positive mGEA included a confirmed objective response rate (cORR) of 84%, duration of response (DoR) of 18.7 months, median progression-free survival (mPFS) of 15.2 months and a Kaplan-Meier–estimated overall survival (OS) of 59% at 30 months DUBLIN, Sept. 16, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced updated data, including median...Read more
Longest survival follow-up ever reported for a Phase III immunotherapy trial in this setting WILMINGTON, Del. / Sep 16, 2024 / Business Wire / Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not...Read more
TransCon CNP demonstrated AGV superior to placebo with LS mean treatment difference of 1.49 cm/year at Week 52 (p<0.0001) For children aged 5-11 years TransCon CNP demonstrated a change from baseline AGV superior to placebo with LS mean treatment difference of 1.78 cm/year at Week 52 (p<0.0001) Other endpoints supportive that TransCon CNP may provide benefits beyond linear growth TransCon CNP was generally well-tolerated, with...Read more
FLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, today presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy, with financial support from Merck &...Read more
11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate 15 out of the 16 patients had a reduction of their tumors (target lesions) 79% of EVX-01’s vaccine targets triggered a targeted immune response, which compares very favorably to what is seen with other approaches A positive correlation was observed between the AI-Immunology™ platform predictions and neoantigen immune response...Read more
Interim safety and biomarker data from the upliFT-D trial in FTD-GRN demonstrated that Dose 1 of PBFT02 achieved robust levels of CSF progranulin in all treated Cohort 1 patients; elevated CSF progranulin levels were sustained up to 12 months post-treatment Dose 1 of PBFT02 continued to be well-tolerated in all patients who received a revised immunosuppression regimen Company to deliver the updated data during a poster presentation at...Read more
Median Overall Survival remains at 30 months; Objective Response Rate of 36% and Disease Control Rate of 77% 11/53 (21%) of patients experienced 90-100% tumor shrinkage VERSATILE-003 Phase 3 clinical trial planned to begin this year PRINCETON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the...Read more
FLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, presented final data on Dublin-3 study (2L/3L EGFR wild-type NSCLC) focusing on safety outcomes on September 14, 2024 at European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Full data on Dublin-3 study...Read more
Two Oral Presentations Featured Updated Ivonescimab Data from Phase II Studies in CRC and TNBC in Addition to Poster Presentation on HNSCC Encouraging Phase II Data Supports the Continuing Expansion of the Clinical Development of Ivonescimab Outside of Metastatic Non-Small Cell Lung Cancer MIAMI / Sep 16, 2024 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for the...Read more
TCER® IMA401 is a novel, next-generation, half-life extended bispecific T cell engager directed against an HLA-A*02-presented peptide derived from MAGEA4 and MAGEA8 with high target copy numbers on various solid cancers Data from the first-in-human Phase 1 dose escalation trial demonstrate initial anti-tumor activity and a manageable tolerability profile for TCER® IMA401 monotherapy; patient population includes 35 heavily pre-treated...Read more
Confirmed partial responses (PRs) doubled to four since ASCO GI in MSS CRC patients without liver and peritoneal metastases for overall response rate (ORR) of 24% (4/17) with ADG126 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab Median progression-free survival of 8.5 months observed in patients without liver and peritoneal metastases at the ADG126 10 mg/kg Q3W dose At the 10 mg/kg dose level, 12-month...Read more
TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrence BARCELONA, Spain, Sept. 16, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the...Read more
Late-breaking results selected for presentation during a Presidential Symposium session and an official Press Briefing at the European Society for Medical Oncology Congress 2024 and simultaneous publication in the New England Journal of Medicine KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival as pre-operative (neoadjuvant) treatment...Read more
These data represent the longest reported median overall survival from a Phase 3 advanced melanoma trial; data selected for official ESMO press conference At ten years, more than 40% (43%) of patients treated with Opdivo plus Yervoy were alive; a decade ago, this patient population faced a survival rate of around 25% after only one year Data to be presented today as a mini oral and simultaneously published in The New England Journal of...Read more
Treatment with rinatabart sesutecan (Rina-S) showed encouraging response rate in heavily pretreated patients with ovarian cancer in dose expansion cohort Responses with Rina-S were observed across FRα expression levels Phase 3 trial will further evaluate the safety and efficacy of Rina-S at 120 mg/m2 in patients with advanced ovarian cancer COPENHAGEN, Denmark / Sep 15, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today...Read more
ALAMEDA, Calif. / Sep 15, 2024 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced detailed final overall survival (OS) results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (Tecentriq®) compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who...Read more
At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab RAHWAY, N.J. / Sep 15, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced long-term overall survival (OS) data from the pivotal Phase 3 KEYNOTE-006 trial, evaluating KEYTRUDA® (pembrolizumab), Merck’s...Read more
Findings are from ancillary study of phase 3 STAMPEDE trial Data support company’s plan to expand Decipher Prostate test to patients with metastatic disease SOUTH SAN FRANCISCO, Calif. / Sep 15, 2024 / Business Wire / Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that new data from a phase 3 trial of the multi-center, randomized STAMPEDE clinical trial show that its Decipher Prostate Genomic...Read more
Study met its primary endpoint, demonstrating significant improvement in radiographic progression-free survival Overall Response Rate was 38.1% vs. 12.0% for the ARPI switch arm, including 9.3% Complete Responses Patients demonstrated statistically significant improvement in time to reduction of health-related quality of life (HRQoL) as measured by Functional Assessment of Cancer Therapy—Prostate (FACT-P) Interim Overall Survival...Read more
23ME-01473 inhibited tumor growth in a patient-derived xenograft mouse model of non-small cell lung cancer Elevated levels of soluble and tumor-bound ULBP6 confirmed in squamous cell carcinomas and a subset of adenocarcinomas, offering potential indications to assess clinical activity Phase 1 trial ongoing with first patient dosed in March 2024 SUNNYVALE, Calif., Sept. 15, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME)...Read more
23ME-00610 monotherapy demonstrates preliminary evidence of clinical benefit in clear-cell renal-cell carcinoma, with one confirmed partial response Higher tumor expression of CD200 and human genetics correlated with increased clinical benefit, suggesting potential value as patient selection biomarkers Greater response in “cold” tumors suggests opportunity in patients unable to benefit from PD-1/PD-L1 checkpoint...Read more
Encouraging antitumor activity demonstrated with vobra duo as measured by 6-month landmark rPFS rate and ORR Patients remained on vobra duo through a median of 6 doses (ranging up to 12), representing an extension of treatment duration as compared to Phase 1 mCRPC dose expansion cohort Company expects to have mature median rPFS no later than early 2025 MacroGenics to host an investor call to review key data presented at ESMO and...Read more
Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive BARCELONA, Spain, Sept. 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200...Read more
Study met primary endpoint of change from baseline in body weight for ponsegromab compared to placebo across all ponsegromab doses tested, reaching 5.6% mean increase at the highest dose evaluated at 12 weeks; ponsegromab was generally considered safe and well-tolerated at all dose levelsi At the highest dose evaluated, improvements were seen from baseline in appetite and cachexia symptoms, physical activity, and muscle massi Based on...Read more
In the Phase 3 LEAP-012 trial, KEYTRUDA plus LENVIMA in combination with TACE reduced the risk of disease progression or death by 34% compared to TACE alone Late-breaking first interim analysis results are being presented during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 RAHWAY, N.J. & NUTLEY, N.J. / Sep 14, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the...Read more
Phase 3 POD1UM-303/InterAACT2 trial met primary endpoint of progression-free survival and demonstrated improvement across secondary endpoints in patients with squamous cell anal carcinoma (SCAC) taking retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel) Late-breaking data presented at the European Society for Medical Oncology (ESMO) Congress 2024 support the planned U.S. filing of a supplemental...Read more
KEYNOTE-A18 is the first Phase 3 study of an immunotherapy in combination with CRT to demonstrate a statistically significant and clinically meaningful improvement in overall survival versus CRT alone in these patients Results were selected for the official press briefing and presentation during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 and published simultaneously in The...Read more
Updated Phase 1 dose-escalation data from ARROS-1 and ALKOVE-1 clinical trials continue to support potential best-in-class profiles for zidesamtinib and NVL-655 Rapid enrollment in Phase 2 portions of the ARROS-1 and ALKOVE-1 clinical trials; Pivotal data from both ROS1 and ALK programs now anticipated in 2025 Initiation of ALKAZAR Phase 3 randomized, controlled trial of NVL-655 for treatment-naïve patients with advanced ALK-positive...Read more
KEYTRUDA is the first anti-PD-1/L1 therapy in combination with trastuzumab and chemotherapy to demonstrate a statistically significant improvement in OS in this patient population Results from the final analysis of KEYNOTE-811 are being presented during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) Congress 2024 and published simultaneously in the New England Journal of Medicine In the U.S., KEYTRUDA, in...Read more
Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease New results show potential of RYBREVANT® beyond lung cancer BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new data from the Phase 1b/2 OrigAMI-1 study, which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy (mFOLFOX6 [FOLFOX] or FOLFIRI)...Read more
Post-progression outcomes showed significant and sustained improvement for RYBREVANT® plus standard of care versus chemotherapy alone BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced updated results from the Phase 3 MARIPOSA-2 study which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy led to consistent benefit across post-progression outcomes in adult patients with...Read more
BRAFTOVI + MEKTOVI continued to show substantial antitumor activity after a minimum follow up of approximately three years, corresponding to the longest duration of response and progression-free survival in treatment-naïve patients compared to historical outcomes Results support BRAFTOVI + MEKTOVI as a standard of care option for this population NEW YORK / Sep 14, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced...Read more
Updated data show consistent objective response rate of 40% and manageable safety profile in patients with non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutations treated with zipalertinib who progressed on or after prior amivantamab treatment Enrollment of pivotal Phase 2b trial complete ahead of schedule CAMBRIDGE, Mass., Sept. 14, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc....Read more
New antitumor response data from a range of doses and regimens unveiled today at Incyte investor event These results build upon safety and tolerability data presented earlier today during a mini-oral presentation at the European Society of Medical Oncology (ESMO) Congress 2024 Findings support the initiation of a pivotal trial in ovarian cancer, expected to begin in 2025; additional plans to evaluate INCB123667 in combination with other...Read more
Confirmed overall response rate (ORR) = 62.5% (95% CI, 30.4-86.5) observed in prospectively-selected ACR-368 OncoSignature-positive (BM+) patients with endometrial cancer Achieved statistically significant segregation of responders in BM+ vs BM- subgroups based on OncoSignature patient selection (p-value = 0.009) ACR-368 endometrial cohort data maturing with all responders still on therapy; mDoR not yet reached (~6 months at time of...Read more
Tumors shrank in 89% of taletrectinib-treated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were TKI-pretreated in the study Taletrectinib demonstrated durable responses and prolonged progression-free survival (PFS) with long-term follow up; median duration of response (DOR) and median PFS in TKI-naïve patients were 44 months and 46...Read more
BARCELONA, Spain, Sept. 14, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) presented final data from the Phase 2 NuTide:701 study at the ESMO Congress on NUC-7738 in combination with pembrolizumab for patients with metastatic melanoma who were refractory to or had relapsed on prior PD-1 inhibitor therapy. In this cohort of 12 patients, most of whom had received at least two prior lines of PD-1 inhibitor therapy, nine (75%) achieved...Read more
Updated monotherapy data for Nectin-4 targeting zelenectide pevedotin in metastatic urothelial cancer (mUC) showed a promising 45% overall response rate (ORR), 11.1 months median duration of response and a generally well-tolerated safety profile EphA2-targeting BT5528 demonstrated an emerging differentiated safety profile and antitumor activity in patients with advanced solid tumors, including a 45% ORR in mUC 6.5 mg/m2 every two weeks...Read more
Immunocore presents Phase 1 data of brenetafusp, an ImmTAC bispecific targeting PRAME, in patients with ovarian cancer Brenetafusp is clinically active as monotherapy and in combination with chemotherapy in heavily pre-treated, platinum-resistant ovarian cancer patients T cell fitness gene expression signature in blood is an important parameter of clinical activity for tebentafusp in uveal melanoma and for brenetafusp across different...Read more
4.3 mg/kg of luveltamab tazevibulin (luvelta) in combination with standard dose of bevacizumab (15 mg/kg) every 3 weeks resulted in a 56% objective response rate in patients with late-stage ovarian cancer and was selected to be the recommended phase 2 dose (RP2D) Luvelta in combination with bevacizumab demonstrated encouraging preliminary antitumor activity (35% response rate) across all explored dose ranges Expansion at RP2D is...Read more
Study Meets Overall Response Rate Primary Endpoint, Encouraging Secondary Endpoint Progression-Free Survival Data in Squamous Cell Carcinoma of the Head and Neck Cohort No New Safety Signals or Added Systemic Safety Concerns Observed Data Presented at the European Society for Medical Oncology (ESMO) Congress NEW YORK, Sept. 14, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing...Read more
Clinically meaningful objective response rate (ORR) of 63.3-76.7% observed with belrestotug + dostarlimab combinations, with confirmed ORR (cORR) at ~60% for every dose >30% cORR difference between belrestotug + dostarlimab vs dostarlimab monotherapy Belrestotug + dostarlimab safety profile broadly consistent with known safety profile of checkpoint inhibitor combinations GALAXIES Lung-301, global Phase 3 registration study,...Read more
Combination of masofaniten plus enzalutamide continues to be well tolerated with durable reductions in PSA in patients with mCRPC Phase 2 dose expansion currently underway at the RP2CDs of masofaniten 600 mg BID in combination with enzalutamide 160 mg QD Across all dosing cohorts, 88% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved PSA <0.2ng/mL. After 15.2 months of...Read more
Encouraging signs of anti-tumor activity including objective responses observed in patients with SMARCA4-mutated non-small cell lung cancer (NSCLC) and esophageal cancer in early PRT3789 monotherapy dose escalation At doses studied to date, PRT3789 was generally well-tolerated with no dose-limiting toxicities or study drug-related serious adverse events Company to host investor conference call and webcast on Friday,...Read more
Anti-tumor clinical responses were observed in 29% (4/14) of efficacy-evaluable patients with PROC treated with TransCon IL-2 β/γ in combination with chemotherapy Initial data suggest clinical activity in heavily pre-treated PROC patients and that TransCon IL-2 β/γ in combination with chemotherapy was generally well-tolerated COPENHAGEN, Denmark, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today...Read more
Preliminary immunogenicity results demonstrate induction of cancer antigen-specific T-cell responses in 77% of evaluable patients following CVGBM monotherapy 84% of immune responses were de novo, observed in patients without pre-existingT-cell activity against encoded cancer antigens CVGBM was generally well tolerated up to the highest tested dose level of 100 µg with no dose-limiting toxicities Most common adverse...Read more
BOSTON, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, versus placebo for the treatment of COVID-19. The trial did not meet...Read more
Second Phase 2 Study for Luvadaxistat Fails to Meet Primary Endpoint as Potential Treatment for Cognitive Impairment Associated with Schizophrenia Results Confounded by Variability in Cognition Measures Across Population Studied and Potential Imbalance in Baseline Characteristics of Enrolled Subjects Neurocrine Biosciences to Focus Resources on Phase 3 Clinical Development of NBI-1117568 for Schizophrenia and NBI-1065845 for Major...Read more
In Phase 2a arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel, complete or partial responses have been observed in the first two patients (2/5) to date, for an initial response rate of 40% and an initial disease control rate of 80%, with all five patients continuing on treatment Initial data are at 240 mg QD (safety lead-in dose) of IMM-1-104; additional patients have now been dosed at 320 mg QD...Read more
SAN DIEGO, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT) (the “Company”) today announced its decision to discontinue its clinical trials evaluating ONCT-534, its dual action androgen receptor inhibitor for the treatment of patients with metastatic castration resistant cancer, and ONCT-808, its ROR1-targeting autologous CAR T program for the treatment of patients with aggressive B-cell lymphoma, and to...Read more
99.9% of Participants Did Not Acquire HIV Infection in the Lenacapavir Group, with 2 Incident Cases Among 2,180 Participants PURPOSE 2 Trial Results for Cisgender Men and Gender-Diverse People Add to the Body of Evidence for the Investigational Use of Lenacapavir for HIV Prevention Gilead Stopped the Blinded Phase of the Trial at Interim Analysis and Will Offer Open-Label Lenacapavir to All Participants FOSTER CITY,...Read more
No TCB008-related Adverse Events seen in any of the re-start patients 6 Patients received second dose, 3 Patients received third dose, 1 Patient received fourth dose EDINBURGH, Scotland, Sept. 12, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today...Read more
Two of the first three patients in the Phase 1 cohort of the Phase 1/2a clinical trial, treated at the highest dose of 6 billion cells per treatment, were found to have improved CDR-SB cognitive scores, resulting in a clinical upgrade from moderate AD to mild AD after only three months on therapy. First patient dosed in the Phase 2 cohort of the trial, continuing at the highest dose of 6 billion cells per treatment. With the...Read more
Bright Minds Biosciences announces Phase 2 Clinical trial to evaluate BMB-101 in a group of drug-resistant epilepsy disorders with high unmet needs BMB-101 is a novel highly selective 5-HT2C agonist. Its G-protein biased agonism provides an improved mechanism of action for chronic dosing Financial runway extending into 2026 enabling key data readout Conference call & KOL Event – will be held as a webcast on September...Read more
Abundant, richly vascularized and functioning islets observed throughout all chambers of Sernova’s Cell Pouch more than 5 years after islet transplantation Histological data confirmation of healthy beta, alpha and delta cells secreting insulin, glucagon, and somatostatin in all Cell Pouch Chambers Sernova’s Cell Pouch safely contains its therapeutic cells and provides full retrievability using conventional instruments and...Read more
On track to announce topline results from ORIGIN 3 trial in Q2 2025 Expect to present 96-week data from ORIGIN Phase 2b clinical trial of atacicept in IgAN in Q4 2024 BRISBANE, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today...Read more
VYN202 was generally well tolerated with no drug-related adverse events Pharmacokinetic results demonstrated dose-dependent exposure of VYN202 in blood Pharmacodynamic activity observed on target engagement and inflammatory biomarkers Dosing has begun in the MAD portion of the trial with results expected in Q4 2024 BRIDGEWATER, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the...Read more
WILMETTE, Ill., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced positive early data from its ongoing open-label MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial confirming MNPR-101-Zr’s tumor targeting ability in humans. MNPR-101 is Monopar’s proprietary first-in-class humanized...Read more
Phase 2 data demonstrated positive immune responses to A and B strains, with acceptable safety and reactogenicity profile, meeting all pre-defined study endpoints Vaccine candidate based on CureVac's proprietary second-generation mRNA backbone GSK confirmed data support advancing program to Phase 3; dosing of first Phase 3 participant is associated with a significant milestone payment for CureVac In July 2024, GSK...Read more
CAMBRIDGE, Massachusetts and TORONTO, Ontario, Sept. 12, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that preclinical data supporting the...Read more
SER-155 administration was associated with a significant reduction in both bacterial bloodstream infections (BSIs) and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia, as compared to placebo through day 100 post HSCT Demonstrated generally well tolerated safety profile and confirmed drug bacteria strain engraftment; no treatment-related serious adverse events Company to seek Breakthrough Therapy...Read more
Losmapimod failed to show an improvement in relative surface area (RSA), a measure of reachable workspace (RWS), versus placebo at week 48 Fulcrum to suspend future losmapimod development Robust cash position enables Fulcrum to continue its mission to develop therapies addressing diseases of high unmet need including pociredir for the treatment of sickle cell disease (SCD) CAMBRIDGE, Mass., Sept. 12, 2024 (GLOBE...Read more
Bel-sar Demonstrated 80% Tumor Control Rate, 90% Visual Acuity Preservation, and a Highly Favorable Safety Profile Aura to Host a Virtual Ocular Oncology Investor Event Featuring Key Opinion Leaders Today at 8:00 am ET BOSTON, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today...Read more
SAN DIEGO, Sept. 11, 2024 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today provided a corporate and REM-001 clinical study update. Corporate Updates In April 2024, Kintara and TuHURA Biosciences, Inc. ("TuHURA") entered into definitive merger agreement (the "Merger Agreement"), pursuant to which Kayak Mergeco, Inc.,...Read more
TEL AVIV, Israel, Sept. 11, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced positive findings regarding the compatibility of sutures in human clinical trials of its lead product, PRF-110. PRF-110 is designed to provide extended, non-opiate, post-surgical pain relief. The...Read more
Folate receptor alpha targeting drug conjugate & hexa silanol exatecan (FRA-H) payloads tested in animal models of ovarian cancer Strong efficacy for FRA-H in KB and IGROV-1 mouse models of ovarian cancer Strong safety profile for FRA-H with no loss of bodyweight as compared with control in animal models Success of tADC proof-of-concept study paves way for creating multiple potential therapeutic candidates for...Read more
Median overall survival of 15.6 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint inhibitor OS of 15.6 months compares favorably with 6.7-9.3 months reported for similar patients in the literature Ongoing Phase 3 study investigating Bria-IMT™ in similar metastatic breast cancer population No drug related discontinuations to date PHILADELPHIA and VANCOUVER, British Columbia, Sept. 11, 2024...Read more
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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