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Latest Phase 1/2 Clinical Trials Stock News

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eFFECTOR Therapeutics Announces New Positive Interim Data from Dose Escalation and Phase 2 Expansion Cohorts of Zotatifin in ER+ Metastatic Breast Cancer Patients

December 8
Last Trade: 0.52 -0.05 -9.02

Median progression free survival (mPFS) of 7.4 months in the ZFA expansion cohort evaluating zotatifin in combination with fulvestrant and abemaciclib in heavily pretreated patients Zotatifin generally well tolerated as dose escalation continues; Currently enrolling at 0.28 mg/kg in the ZF doublet evaluating zotatifin combined with fulvestrant and at 0.1 mg/kg in the ZFA triplet SOLANA BEACH, Calif. and REDWOOD CITY, Calif.,...Read more

Regeneron Pharmaceuticals: Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma

December 7
Last Trade: 840.14 -9.04 -1.06

71% objective response rate, with 46% achieving a complete response or better after 11 months of median follow-up Data to be submitted to regulatory authorities, with Biologics License Application on track to be submitted to the FDA this year Regeneron to host virtual investor event to discuss results alongside updates across its hematology portfolio on Thursday, December 14 at 8:30 a.m. ET TARRYTOWN, N.Y., Dec. 07, 2023 (GLOBE...Read more

Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers

December 5
Last Trade: 7.29 -0.31 -4.08

RP1 in combination with cemiplimab demonstrated clinically meaningful improvements in complete response rate and duration of response compared to cemiplimab in the CERPASS clinical trial, but did not meet either of the two primary endpoints Positive data update for full 140 patients in the IGNYTE clinical trial cohort of RP1 in anti-PD1 failed melanoma reinforces durable benefit; biologics license application (BLA) submission planned...Read more

Viracta Therapeutics Announces Interim Data from Phase 1b/2 Clinical Trial of Nana-val in Patients with Epstein-Barr Virus-Positive Solid Tumors that Show Confirmed Tumor Responses at Higher Dose Levels

December 4
Last Trade: 0.50 0.01 2.39

Confirmed partial responses without dose-limiting toxicities during dose escalation along with new preclinical data support the opportunity to further enhance efficacy through a novel split daily dosing regimen at higher dose levels of Nana-val Enrollment is underway for the sixth dose cohort of the Phase 1b dose escalation portion of the study with plans to initiate a recommended Phase 2 dose-optimization cohort as part of the study’s...Read more

Jasper Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Study of Briquilimab in Chronic Spontaneous Urticaria

November 30
Last Trade: 0.51 -0.01 -1.94

REDWOOD CITY, Calif., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell-driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), as well as lower to intermediate risk myelodysplastic syndromes (LR-MDS) and novel stem cell transplant...Read more

Benitec Biopharma Announces First Subject Dosed in Phase 1b/2a Clinical Trial for Gene Therapy Candidate BB-301 for the Treatment of Oculopharyngeal Muscular Dystrophy

November 30
Last Trade: 3.27 -0.07 -2.10

HAYWARD, Calif., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or the “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference ("ddRNAi") platform, today announced the first subject has been dosed in the BB-301 Phase 1b/2a Clinical Treatment Study. BB-301 is the Company’s...Read more

REGENXBIO Announces Dose Escalation in AFFINITY DUCHENNE® Trial

November 29
Last Trade: 19.58 -1.02 -4.95

First patient received dose level 2 of RGX-202, a potential one-time AAV Therapeutic for the treatment of Duchenne that includes an optimized transgene for a novel microdystrophin On track for pivotal dose determination and initiation of pivotal program in 2024  ROCKVILLE, Md., Nov. 29, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the first patient received RGX-202 at dose level 2 in the Phase I/II...Read more

BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

November 29
Last Trade: 0.28 0.0008 0.28

BX004 showed clinically meaningful improvement in pulmonary function as measured in FEV11 and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain in a predefined subgroup of patients with reduced lung function2 Treatment with BX004 also achieved P. aeruginosa culture conversion to negative at end of 10 days of treatment in 3 patients (14%) versus none for placebo3 In a prespecified subgroup of patients on background use...Read more

Ambrx Biopharma Provides Update On APEX-01, an On-Going Phase 1 / 2 Dose Escalation Study Evaluating ARX517, a Proprietary PSMA-Targeting ADC, in Metastatic Castration-Resistant Prostate Cancer

November 28
Last Trade: 13.34 0.69 5.45

Cohort 9 Following completion of the 21-day observation period at 3.4 mg/kg (Cohort 9), no dose limiting toxicities (DLTs) or serious adverse events (SAEs) were observed Two patients in Cohort 9 experienced rapid PSA reduction at three weeks post-treatment following the first ARX517 dose Cohort 8 The cohort (2.88 mg/kg) is now fully enrolled with 20 patients Recommended phase 2 dose expected by early next year SAN DIEGO,...Read more

Perspective Therapeutics Completes Initial Dose Escalation Cohort for Second Novel Targeted Alpha Therapy

November 16
Last Trade: 0.25 -0.0055 -2.15

SEATTLE, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), today announced the completion of cohort 1 dosing in the Phase 1/2a clinical trial of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-expressing neuroendocrine tumors (NETs). This milestone follows the recent completion of the first dose escalation cohort for Perspective’s melanoma therapeutic...Read more

Ocugen Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410ST—Modifier Gene Therapy—for Stargardt Disease

November 10
Last Trade: 0.39 -0.0009 -0.23

MALVERN, Pa., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in its Phase 1/2 GARDian clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease, a...Read more

Vaxcyte Doses First Participants in Phase 1/2 Clinical Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease in Adults

November 9
Last Trade: 56.67 -0.11 -0.19

VAX-31, a 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate, is the Broadest-Spectrum PCV to Enter the Clinic Topline Safety, Tolerability and Immunogenicity Data Expected in Second Half of 2024 VAX-31 is Designed to Provide Coverage for Approximately 95% of Invasive Pneumococcal Disease Circulating in the U.S. Adult Population SAN CARLOS, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine...Read more

Oncolytics Biotech Announces the Anal Cancer Cohort of the GOBLET Phase 1/2 Study of Pelareorep and Atezolizumab Has Met the Success Criteria for Efficacy

November 9
Last Trade: 1.40 0.00 0.00

Pelareorep-atezolizumab combination data exceeds historical control trials with a 37.5% objective response rate, including a complete response SAN DIEGO and CALGARY, Alberta, Nov. 9, 2023 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the presentation of positive, interim results from the Phase 1/2 GOBLET study evaluating the...Read more

Perspective Therapeutics Announces First Patient Dosed in Phase 1/2a Study of [(212)Pb]VMT-α-NET for Treatment of Advanced SSTR2-Positive Neuroendocrine Tumors

November 8
Last Trade: 0.25 -0.0055 -2.15

SEATTLE, Nov. 08, 2023 (GLOBE NEWSWIRE) --  Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), announced today that the first patient was dosed at Washington University in St Louis in the Company’s Phase 1/2a trial evaluating the safety and efficacy of [212Pb]VMT-α-NET, a targeted alpha-particle therapy (TAT), in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)...Read more

Medicenna Therapeutics Announces Promising Single-Agent Response and Durability of MDNA11 in the Phase 1/2 ABILITY Study During Dose Escalation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

November 6
Last Trade: 0.46 0.02 4.60

MDNA11 continues to demonstrate encouraging single-agent activity from the dose escalation and evaluation portion of the ABILITY-1 Study including deep ongoing partial responses with 100% reduction of target lesions in one pancreatic and 70% reduction of target lesion in one melanoma cancer patient MDNA11 also showed durable stable disease in 3 melanoma patients for at least 5 months to 18 months with concomitant shrinkage of tumor...Read more

23andMe Announces Updated Safety and Preliminary Efficacy Data From the Phase 1/2a Study of 23ME-00610, an Investigational Antibody Targeting CD200R1

November 6
Last Trade: 0.87 0.03 3.17

23andMe presented data from the now completed dose escalation phase, and pharmacokinetic / pharmacodynamic (PK/PD) cohorts at the Society for Immunotherapy of Cancer Annual Meeting 2023 Dosing with 23ME-00610 monotherapy in 28 patients with advanced solid tumors up to 1400 mg every three weeks (Q3W) showed tolerability consistent with expectation for on-target effects Peripheral pharmacodynamic data demonstrate that 23ME-00610...Read more

AAO Late-Breaking: Kiora's Small Molecule Photoswitch Demonstrates Meaningful Vision Improvements in Blind Patients with Retinitis Pigmentosa

November 4
Last Trade: 0.54 -0.005 -0.93

Topline Phase I/II First-in-Human Results Presented at AAO 2023 Significant improvement in visual field, in concordance with trended improvements in visual acuity and functional vision Functional MRI demonstrates increased brain activity in visual cortex Novel small molecule photoswitch is safe and tolerable Company presentation available on IR website (ir.kiorapharma.com) Encinitas, California--(Newsfile Corp. - November 4,...Read more

Replimune Presents Updated Interim Results from ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Skin Cancers During Oral Presentation at 38th Annual Meeting of Society for Immunotherapy of Cancer...

November 3
Last Trade: 7.29 -0.31 -4.08

WOBURN, Mass., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced updated interim results from ARTACUS, a Phase 1/2 clinical trial evaluating RP1 monotherapy for the treatment of skin cancers in patients who have had solid organ or hematopoietic cell transplants. The data were presented...Read more

Xilio Therapeutics Announces Initial Monotherapy Safety and Anti-Tumor Activity Data for XTX202, a Tumor-Activated, Engineered, Beta-Gamma IL-2, in Late Line Patients with Advanced Solid Tumors

November 3
Last Trade: 0.85 -0.07 -7.89

Initial evidence of dose-dependent disease control rate with 50% disease control rate at higher doses (≥2.8 mg/kg) and 31% disease control rate across all dose levels in a range of solid tumor types, including cold tumors Treatment-related adverse events primarily Grade 1-2 at doses up to 4 mg/kg administered once every three weeks in outpatient setting, with no reported signs or symptoms of vascular leak syndrome Two patients...Read more

Sensei Biotherapeutics Reports Favorable Clinical Data for SNS-101 at 2023 SITC Annual Meeting

November 3
Last Trade: 0.68 -0.04 -5.44

Clinical dose escalation data for SNS-101 monotherapy show well tolerated safety profile, potentially best-in-class pharmacokinetics, and encouraging cytokine release profile across multiple dose cohorts First VISTA-blocking antibody administered at a dose anticipated to be therapeutically relevant without eliciting dose-limiting toxicity Monotherapy data from Phase 1/2 study to be presented in a late-breaking poster presentation at...Read more

Kronos Bio Presents Positive Preliminary Data from the Phase 1 Dose Escalation Portion of the Ongoing Phase 1/2 KB-0742 Study at the Connective Tissue Oncology Society Annual Meeting

November 2
Last Trade: 1.41 0.14 11.02

Brian Van Tine, M.D., of Washington University School of Medicine, shares data from the ongoing phase 1/2 KB-0742 clinical study that clearly corresponds with the findings from the pre-clinical studies at leading international sarcoma meeting KB-0742 demonstrated on-mechanism, single agent anti-tumor activity and a manageable safety profile in heavily pre-treated patients with transcriptionally addicted solid...Read more

4D Molecular Therapeutics Gains Alignment with FDA on Plan to Lift Clinical Hold on Phase 1/2 INGLAXA Clinical Trial for 4D-310 for Fabry Disease Cardiomyopathy

October 30
Last Trade: 14.94 0.36 2.47

Initiated single non-human primate (NHP) safety study evaluating intravenous 4D-310 combined with rituximab/sirolimus (R/S) immunosuppressive regimen Amended INGLAXA protocol to minimize risk of atypical hemolytic uremic syndrome (aHUS) associated with intravenous (IV) AAV dosing, including addition of R/S immunosuppressive regimen 4D-310 combines a novel, targeted next generation AAV vector (C102) and GLA transgene for a single low...Read more

Sernova Announces Positive Ongoing Interim Phase 1/2 Clinical Data for the Cell Pouch System™ for Type 1 Diabetes Trial at the 2023 IPITA, IXA, and CTRMS Joint Congress

October 27
Last Trade: 0.73 0.00 0.00

All six patients in the first cohort (Cohort A) were successfully implanted with the 8-channel Cell Pouch System with post-transplant follow-up periods ranging from 6 months to 3.5 years; 5 of 6 patients in Cohort A discontinued insulin therapy (insulin independent) following islet transplantation into the Cell Pouch and modest islet top-up via portal vein. All 6 patients achieved HbA1c values in the non-diabetic range (<6.5%); In...Read more

Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19

October 26
Last Trade: 28.78 0.15 0.52

Lead formulations evaluated in the Phase 1/2 study demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains Safety profile of the mRNA-based combination vaccine candidates consistent with the companies’ COVID-19 vaccine The companies plan to start a pivotal Phase 3 trial in the coming months NEW YORK & MAINZ, GERMANY / Oct 26, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq:...Read more

Regeneron Pharmaceuticals Shares Preliminary Results Showing Gene Therapy Improves Auditory Responses in Child with Profound Genetic Hearing Loss

October 26
Last Trade: 840.14 -9.04 -1.06

Global Phase 1/2 CHORD trial investigating otoferlin gene therapy (DB-OTO) represents Regeneron’s first auditory program and is currently enrolling patients DB-OTO is part of a growing pipeline of genetic medicines for hearing loss and other therapeutic areas that are being advanced by the company TARRYTOWN, N.Y., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced preliminary, positive...Read more

BioNTech Presents Positive Phase 1/2 Data Update for CAR-T Cell Therapy Candidate BNT211 in Advanced Solid Tumors at ESMO Congress 2023

October 23
Last Trade: 103.43 1.51 1.48

BNT211 combines two innovative approaches in one regimen with first-in-class potential: an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (“CARVac”) Data presented at ESMO Congress 2023 demonstrates that the application of CARVac increases the persistence of the adoptively transferred autologous CAR-T cells BNT211 continues to show encouraging...Read more

Merus’ Zeno Interim Data Continues to Demonstrate Robust and Durable Responses in NRG1+ Cancer

October 23
Last Trade: 23.93 -0.83 -3.35

37% ORR and 14.9 months median DOR in 78 evaluable NRG1+ NSCLC patients 42% ORR and 9.1 months median DOR in 33 evaluable NRG1+ PDAC patients Sufficient clinical data expected in 1H24 to support potential BLA submissions UTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative,...Read more

Potential of Arvinas’ PROTAC® AR Degraders Reinforced by 11.1 months rPFS with Bavdegalutamide and Updated Positive Interim Data from Second Generation ARV-766 in mCRPC

October 22
Last Trade: 34.16 1.47 4.50

Data presented at the European Society for Medical Oncology from the Phase 1/2 trial with bavdegalutamide showed 11.1 months radiographic progression free survival in mCRPC patients with tumors harboring AR 878/875 mutations Interim data from the Phase 1/2 trial of Arvinas’ second PROTAC AR degrader, ARV-766, showed robust efficacy in a broader mCRPC patient population with a tolerability profile well-suited to both early- and...Read more

Harpoon Therapeutics Announces Updated Interim Tolerability and Response Data from Phase 1/2 Clinical Trial of T Cell Engager HPN328 at ESMO Congress 2023

October 21
Last Trade: 8.94 -1.06 -10.60

Confirmed response rate 35% (11/31), across all tumor types and patient cohorts treated with 1 mg priming dose, including three confirmed, complete responses 32% (6/19) confirmed response rate in patients with small cell lung cancer (SCLC), including one confirmed complete response 42% (5/12) confirmed response rate in other neuroendocrine tumor types, including two confirmed complete responses Generally well tolerated;...Read more

IMUNON Announces First Patient enrolled in Phase 1/2 Clinical Trial of IMNN-001 in Combination with bevacizumab in Advanced Ovarian Cancer

October 18
Last Trade: 0.84 -0.04 -4.43

The MRD trial will evaluate the effect of this treatment combination on minimal residual disease. LAWRENCEVILLE, N.J., Oct. 18, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that the first patient in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab...Read more

Bolt Biotherapeutics Announces First Patient Dosed in Phase 1/2 Study of BDC-3042 in Patients with Advanced Cancers

October 17
Last Trade: 0.90 -0.25 -21.73

BDC-3042, a novel Dectin-2 agonistic antibody that stimulates the innate immune system, is being evaluated in a Phase 1/2 dose-escalation and expansion study in patients with a broad range of solid tumors REDWOOD CITY, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced that the first...Read more

Monte Rosa Therapeutics Announces Interim PK/PD and Clinical Data for MRT-2359 in Phase 1/2 Trial for MYC-Driven Solid Tumors

October 17
Last Trade: 4.33 0.66 17.98

Optimal levels of degradation of GSPT1 in peripheral blood mononuclear cells and tumors observed at all doses, consistent with preclinical studies Tumor size reductions observed in patients with biomarker-positive tumors Safety profile supports further clinical development of MRT-2359 Conference call and webcast at 8:00 a.m. ET today BOSTON, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, a clinical-stage biotechnology...Read more

Kineta Announces First Patient Dosed in Phase 1/2 VISTA-101 Clinical Trial of KVA12123 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Solid Tumors

October 17
Last Trade: 4.29 -0.18 -4.03

The Combination Arm (Part B) of the Phase 1/2 Clinical Trial Builds Upon the Initial Safety, Tolerability and Pharmacokinetic Data of KVA12123 in the Monotherapy Arm (Part A) Initial Combination Therapy Clinical Data Anticipated in Q2 2024 SEATTLE, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer...Read more

Kura Oncology Announces Positive Results from Registration-Directed Study of Tipifarnib in Patients with HRAS Mutant HNSCC

October 17
Last Trade: 10.81 -0.49 -4.34

Meaningful antitumor activity observed in recurrent/metastatic HRAS mutant HNSCC, including CR Data validate activity of farnesyltransferase inhibitors and support rapid advancement of KO-2806 into combinations with targeted therapies in large solid tumor indications Results to be presented in late-breaking oral session at 2023 ESMO Congress on Saturday SAN DIEGO, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq:...Read more

Perspective Therapeutics Completes Recruitment for First Patient Cohort in Phase 1/2a Dose Escalation Trial of VMT01 in Malignant Melanoma

October 16
Last Trade: 0.25 -0.0055 -2.15

SEATTLE, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), today announced the completion of recruitment for the first patient cohort in its Phase 1/2a dose escalation study of 212Pb-VMT01 (clinicaltrials.gov identifier NCT05655312), its targeted alpha-particle therapy, in development for the treatment of MC1R-positive metastatic melanoma. “We are encouraged by...Read more

Verastem Oncology Announces Initial Results of RAMP 203 Trial of Avutometinib and LUMAKRAS™ (sotorasib) in KRAS G12C-Mutant Non-Small Cell Lung Cancer

October 14
Last Trade: 7.36 -0.23 -3.03

Avutometinib + Sotorasib Combination Demonstrated Preliminary Efficacy with Confirmed Responses in both KRAS G12C Inhibitor Resistant and Naïve Patients No New Safety Signals Observed in Combination; Most Treatment-Related Adverse Events Mild to Moderate Enrollment of Patients Naïve to or Previously Treated with a KRAS G12C Inhibitor Ongoing in Expansion Phase BOSTON / Oct 14, 2023 / Business Wire / Verastem Oncology (Nasdaq: VSTM)...Read more

Puma Biotechnology Announces Presentation of Findings from a Phase I/II Study of Alisertib and Pembrolizumab for Rb-Deficient Head and Neck Squamous Cell Carcinomas at the 2023 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting

October 14
Last Trade: 4.13 -0.05 -1.20

LOS ANGELES / Oct 14, 2023 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the poster presentation of a Phase I/II trial of alisertib plus pembrolizumab for the treatment of patients with Rb-deficient head and neck squamous cell carcinoma (Clinicaltrials.gov identifier NCT04555837) at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston,...Read more

Coherus BioSciences Announces Toripalimab Data at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

October 14
Last Trade: 2.22 -0.08 -3.48

Data demonstrate preclinical potent T cell activation and differentiated mechanism of action and enhanced clinical efficacy irrespective of PD-L1 status when administered in combination with chemotherapy Toripalimab demonstrated twelve-fold higher binding affinity to PD-1 compared to pembrolizumab In vitro studies show significantly higher activation of T cells compared to pembrolizumab in multiple assay systems REDWOOD CITY,...Read more

Kronos Bio Presents Positive Preliminary Data from Phase 1 Dose Escalation Portion of Phase 1/2 KB-0742 Study at AACR-NCI-EORTC

October 13
Last Trade: 1.41 0.14 11.02

Demonstrated on-mechanism, single agent anti-tumor activity in heavily pre-treated patients with transcriptionally addicted solid tumors Showed manageable safety profile, with no grade 3/4 neutropenia, dose proportional exposure, dose-dependent target engagement, and 24-hour plasma half-life Dose escalation continues; dosing of patients at the 80 mg dose level is ongoing Enrollment ongoing in dose expansion phase in...Read more

SELLAS Life Sciences Announces First Patient Dosed in Phase Ib/II Trial of SLS009 (GFH009) in Relapsed/Refractory Peripheral T-cell Lymphomas

October 11
Last Trade: 1.07 0.06 5.94

NEW YORK, Oct. 11, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that its partner GenFleet Therapeutics (Shanghai), Inc. has dosed the first patient in a Phase Ib/II trial evaluating SLS009 (GFH009) in relapsed/refractory Peripheral...Read more

PDS Biotech Announces Interim Safety and Immune Response Data from Phase 1/2 Clinical Trial Evaluating Novel Antibody Drug Conjugate PDS0301 Combined with Docetaxel to Treat Metastatic Prostate Cancer

October 11
Last Trade: 5.15 0.03 0.59

First study of patients with metastatic prostate cancer to evaluate standard-of-care chemotherapy (docetaxel) combined with an antibody drug conjugate (PDS0301). Decrease in prostate specific antigen (PSA) levels was seen in all patients at all three tested doses of PDS0301. The combination was well-tolerated at all tested dose levels. Data to be presented by National Cancer Institute as an oral presentation at Cytokines...Read more

Eupraxia Pharmaceuticals Announces Initiation of Second Cohort in Phase 1b/2a Clinical Trial in Eosinophilic Esophagitis

October 11
Last Trade: 5.86 0.11 1.91

Preliminary data from the first cohort demonstrates that EP-104GI was well tolerated with no drug-related adverse events reported VICTORIA, BC, Oct. 11, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology, today announced the initiation of the second cohort for its Phase 1b/2a clinical trial in eosinophilic...Read more

Tempest Therapeutics Releases New Data Demonstrating Superiority of TPST-1120 Arm Across Multiple Study Endpoints in Randomized First-Line HCC Study

October 11
Last Trade: 3.20 -0.05 -1.54

New data package reveals improvements in multiple categories for TPST-1120 combined with atezolizumab + bevacizumab versus standard of care atezolizumab + bevacizumab in a global Phase 1b/2 study 30% confirmed ORR achieved in TPST-1120 arm compared to 13.3% for atezolizumab + bevacizumab in the control arm, a substantial increase specific to the TPST-1120 arm compared to the previous data cut of 17.5% versus 10.3% in the control...Read more

Creative Medical Technology Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of StemSpine® using AlloStem™ ("CELZ-201-DDT") Novel Cell Therapy to Treat Chronic Lower Back Pain

October 10
Last Trade: 4.46 0.09 2.12

Company reaches next clinical trial milestone for the intramuscular treatment of Chronic Lower Back Pain with the first novel allogenic cellular therapy in the United States PHOENIX, Oct. 10, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") (NASDAQ: CELZ), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and...Read more

Oncternal Therapeutics Announces First Patient Dosed in Phase 1/2 Study of Dual-Action AR Inhibitor, ONCT-534, in Patients with Metastatic Castration-Resistant Prostate Cancer

October 5
Last Trade: 0.43 0.09 24.78

SAN DIEGO, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the first patient has been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-534, the company’s dual-action androgen receptor inhibitor. “The dosing of the first patient with ONCT-534 is an important milestone for...Read more

Lineage Cell Therapeutics: RG6501 (OpRegen®) Phase 1/2a Results Show Evidence of Rapid Improvement of Outer Retinal Structure in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

October 5
Last Trade: 1.04 -0.03 -2.80

CARLSBAD, Calif. / Oct 05, 2023 / Business Wire / Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that the results of imaging analyses demonstrating rapid improvement in outer retinal structure from patients enrolled in a Phase 1/2a clinical study of RG6501 (OpRegen) (ClinicalTrials.gov Identifier:...Read more

Moderna Announces Positive Phase 1/2 Data from mRNA-1083, the Company's Combination Vaccine Against Influenza and COVID-19

October 4
Last Trade: 80.32 0.37 0.46

mRNA-1083 showed strong immunogenicity against influenza and COVID-19, with an acceptable reactogenicity and safety profile, compared to licensed standalone vaccines Company to begin Phase 3 trial of mRNA-1083 in adults 50 years and above CAMBRIDGE, MA / ACCESSWIRE / October 4, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced positive interim results from the Phase 1/2 trial of mRNA-1083, an investigational combination vaccine...Read more

Freeline Therapeutics Reports Positive Initial Clinical Data from First Cohort of Phase 1/2 GALILEO-1 Trial of FLT201, Its Novel Gene Therapy Candidate, in Gaucher Disease

October 4
Last Trade: 6.33 0.00 0.00

Robust increases of up to 700-fold over baseline in plasma GCase enzyme activity in first two patients treated with FLT201 Normalization of leukocyte GCase in both patients demonstrates cellular uptake from plasma FLT201 has been well tolerated, with no serious adverse events Company to host conference call today at 8 a.m. ET LONDON, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today...Read more

BiomX Announces Completion of Patient Dosing in Part 2 of the Phase 1b/2a Study Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

October 4
Last Trade: 0.28 0.0008 0.28

Company remains on track to report Part 2 results from the study in November 2023 Part 1 data of the Phase 1b/2a study accepted for oral presentation at upcoming IDWeek 2023 CAMBRIDGE, Mass. and NESS ZIONA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria,...Read more

Vertex Pharmaceuticals Presents Positive, Updated VX-880 Results From Ongoing Phase 1/2 Study in Type 1 Diabetes at the European Association for the Study of Diabetes 59th Annual Meeting

October 3
Last Trade: 350.15 -3.80 -1.07

All patients treated with VX-880 in Parts A and B have follow-up data beyond Day 90 and have demonstrated islet cell engraftment and glucose-responsive insulin production All patients showed improvement across all measures of glucose control, including decreases in HbA1c, increases in blood glucose time-in-range, and reduction or elimination of insulin use The two patients with at least 1 year of follow-up met the criteria for the...Read more

Purple Biotech Reports Positive Interim and Preliminary Results from NT219 Phase 1/2 Study in R/M Head & Neck Cancer

October 3
Last Trade: 1.11 0.03 2.78

Anti-tumor activity noted in the highest dose cohort of NT219 in combination with cetuximab;  2 out of 4 SCCHN patients at the highest dose cohort demonstrated a confirmed partial response NT219 exposure at the highest dose level reaching human equivalent dose for efficacy based on animal models Target engagement was confirmed in patients’ tissue biopsies Phase 2 study of NT219 in combination with cetuximab in 2L SCCHN, is...Read more

Kineta Announces Positive KVA12123 Monotherapy Safety and Biomarker Data from its Ongoing Phase 1/2 VISTA-101 Clinical Trial

October 3
Last Trade: 4.29 -0.18 -4.03

Cleared First Three Monotherapy Cohorts with No Dose Limiting Toxicity and No Consistent Pattern of Adverse Events at any Dose Level >90% VISTA Receptor Occupancy Observed in the 30 mg Dosing Cohort VISTA Blocking KVA12123 Engineered to Provide Strong Single Agent Anti-Tumor Activity While Minimizing Cytokine Related Adverse Events Clinical Trial is Advancing to Higher Monotherapy Dose Levels and in Combination with Pembrolizumab...Read more

Immix Biopharma Announces Complete Response in 9th Relapsed/Refractory AL Amyloidosis Patient in NXC-201 Clinical Trial at IMS 20th Annual Meeting

October 3
Last Trade: 4.80 -0.19 -3.81

100% (9/9) overall response rate and 67% (6/9) complete response rate (MRD 10-5) observed in heavily pre-treated patients with daratumumab relapsed/refractory AL Amyloidosis as of the September 20, 2023 data cutoff 100% (4/4) overall response rate and 75% (3/4) complete response rate observed in t(11;14) relapsed/refractory AL Amyloidosis Best responder duration of response was 19.2 months with response ongoing; median follow-up of...Read more

Syndax Pharmaceuticals Announces Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Meets Primary Endpoint and Stopped Early for Efficacy Following Protocol-Defined Interim Analysis

October 2
Last Trade: 16.65 -0.15 -0.89

Trial met its primary endpoint with a CR/CRh rate of 23% at interim analysis of the pooled KMT2Ar AML and ALL cohorts (p-value = 0.0036); an additional 14% of patients proceeded to transplant without achieving CR/CRh  65% (32/49) overall response rate in KMT2Ar AML; CR/CRh rate of 24.5%  50% (7/14) of transplanted patients have initiated, and 21% (3/14) of transplanted patients could initiate revumenib as post-transplant...Read more

IMUNON Reports Interim Progression-Free Survival and Overall Survival Data in Phase 1/2 OVATION 2 Study in Advanced Ovarian Cancer

September 28
Last Trade: 0.84 -0.04 -4.43

Intent-to-treat population shows 9-month OS improvement over control arm Subgroup of patients treated with IMNN-001 + PARPi shows meaningful PFS and OS trend compared with control arm Continued follow-up is indicated to confirm initial observations LAWRENCEVILLE, N.J., Sept. 28, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company focused on developing DNA-mediated immunotherapies and...Read more

Sensei Biotherapeutics Announces Initiation of Combination Arm for Phase 1/2 Clinical Study of SNS-101 with Regeneron’s Libtayo®

September 27
Last Trade: 0.68 -0.04 -5.44

Eleven patients enrolled overall in trial to date, with enrollment progressing faster than anticipated  Monotherapy arm has advanced to a fourth cohort, with initial monotherapy PK and safety data expected in the fourth quarter of 2023 and topline monotherapy data expected in 2024  New guidance for initial combination PK and safety data expected in the first quarter of 2024, with preliminary anti-tumor activity data expected...Read more

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

September 26
Last Trade: 5.14 0.01 0.19

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing  innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the first patient has been dosed in a Phase 1b/2 clinical trial evaluating its...Read more

Inozyme Pharma Announces Positive Interim Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE)

September 26
Last Trade: 3.81 -0.13 -3.18

Data from ongoing trial suggest clinical benefit for ENPP1 Deficiency, including improvement in key biomarkers, patient reported outcomes (PROs) and functional outcomes  Improvement in the Global Impression of Change (GIC) observed in all three dose cohorts in ABCC6 Deficiency (PXE) trial  INZ-701 was generally well tolerated and exhibited a favorable safety and immunogenicity profile in both trials  Company to host...Read more

Omega Therapeutics Announces Promising Preliminary Clinical Data for OTX-2002 from Ongoing MYCHELANGELO™ I Trial

September 26
Last Trade: 2.29 0.10 4.57

All 8 patients treated with OTX-2002 in initial two cohorts achieved highly specific on-target genomic engagement, intended epigenetic state change and robust downregulation in expression of c-MYC, a historically ‘undruggable’ target First-known clinical observation of pre-transcriptional gene modulation using a programmable epigenomic mRNA candidate Clinical proof-of-platform established; potential applicability across a broad range...Read more

Armata Pharmaceuticals Announces First Patient Dosed in the Phase 2a Portion of the Phase 1b/2a 'diSArm' Study of AP-SA02 in Adults with Bacteremia Due to Staphylococcus aureus

September 26
Last Trade: 2.70 -0.09 -3.23

Initiation of the Phase 2a portion follows DRC review of positive safety and tolerability data from recently completed Phase 1b portion Study being conducted in partnership with the U.S. Department of Defense LOS ANGELES, Sept. 26, 2023 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for...Read more

Taysha Gene Therapies Announces Second Patient Dosed with TSHA-102 in the REVEAL Phase 1/2 Adult Trial for the Treatment of Rett Syndrome

September 26
Last Trade: 1.79 0.09 5.29

Available clinical data from the two adult patients dosed with TSHA-102 in the first cohort (low dose) to be discussed during upcoming quarterly earnings call following Independent Data Monitoring Committee (IDMC) review Dosing of third adult patient and completion of enrollment in the low-dose cohort expected in the fourth quarter of 2023 Dosing of first pediatric Rett syndrome patient expected in the first quarter of 2024 DALLAS,...Read more

Cantex Pharmaceuticals and Allegheny Health Network Announce Initiation of a Phase 1/2 Study of Azeliragon in Patients Refractory to First-Line Treatment of Metastatic Pancreatic Cancer

September 26
Last Trade: 11.46 -0.12 -1.04

Initiation of Clinical Study at Allegheny Health Network Seeks to Provide Treatment Options to Pancreatic Cancer Patients WESTON, Fla. and PITTSBURGH, Sept. 26, 2023 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, and Allegheny Health Network...Read more

NervGen Pharma Announces First Subject Dosed in Landmark Phase 1b/2a Clinical Trial for NVG-291 in Spinal Cord Injury

September 25
Last Trade: 1.66 -0.02 -1.19

Chronic spinal cord injury cohort results expected in mid-2024 Subacute spinal cord injury cohort results expected in late 2024/early 2025 Vancouver, British Columbia--(Newsfile Corp. - September 25, 2023) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced the first subject has been dosed in the...Read more

Moleculin Biotech Announces Completion of Enrollment in U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB107)

September 21
Last Trade: 0.55 0.03 5.34

Data readouts expected before year end Previously reported preliminary efficacy data on its Phase 1B/2 clinical trial with Annamycin in monotherapy treatment of STS lung mets with >60% of the subjects exhibiting stable disease after two cycles of treatment Annamycin has Fast Track Status and Orphan Drug Designation from FDA for the treatment of soft tissue sarcoma HOUSTON, Sept. 21, 2023 /PRNewswire/ -- Moleculin Biotech, Inc.,...Read more

Protara Therapeutics Announces Dosing of First Patient in Phase 1b/2 ADVANCED-2 Trial of TARA-002 in NMIBC Patients with High Grade Carcinoma in Situ

September 20
Last Trade: 1.60 0.23 16.79

NEW YORK, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that dosing is now underway in its Phase 1b/2 ADVANCED-2 trial evaluating intravesical instillation of TARA-002, the Company’s investigational cell-based therapy, for the treatment of high-grade non-muscle invasive bladder...Read more

Arcturus Therapeutics: Study Shows Novel sa-mRNA Vaccines Offer Robust, Broad, Enduring Protection Against COVID-19 Variants

September 19
Last Trade: 23.79 -0.23 -0.96

Late-breaking data presented at 9th ESWI Influenza Conference in Valencia SAN DIEGO / Sep 19, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the results of a phase 1/2 study showing that...Read more

BioNTech and CEPI Announce Partnership to Advance mRNA Mpox Vaccine Development and Support CEPI’s 100 Days Mission

September 18
Last Trade: 103.43 1.51 1.48

BioNTech is initiating a Phase 1/2 clinical trial of the mRNA-based mpox vaccine program, BNT166 The Coalition for Epidemic Preparedness Innovations (CEPI) commits funding of up to $90 million for the development of vaccine candidates Data generated by this partnership will contribute to CEPI’s 100 Days Mission, a global effort to accelerate the development of well-tolerated and effective vaccines against future viral threats with...Read more

Harpoon Therapeutics Announces First Patients with Small Cell Lung Cancer Dosed in HPN328 Combination Cohort

September 15
Last Trade: 8.94 -1.06 -10.60

SOUTH SAN FRANCISCO, Calif., Sept. 15, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, today announced dosing of the first patients with small cell lung cancer (SCLC) in an ongoing Phase 1/2 trial of HPN328, a DLL3 targeting TriTAC®, in combination with atezolizumab (Tecentriq®). Harpoon previously entered a Master Clinical Supply Agreement with...Read more

Ocugen Announces Positive Clinical Study Update from the Phase 1/2 Trial of OCU400, a Modifier Gene Therapy Product Candidate, for the Treatment of Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA)

September 13
Last Trade: 0.39 -0.0009 -0.23

Favorable safety and tolerability profile of OCU400 investigational drug product in RP and LCA subjects to date Clinical study update suggests continued positive trends in Best-Corrected Visual Acuity (BCVA) and Multi-Luminance Mobility Testing (MLMT), as well as positive trends in Low-Luminance Visual Acuity (LLVA) among treated eyes 83% (10/12) of subjects demonstrated stabilization or improvement in treated eye either on BCVA or...Read more

aTyr Pharma Presents Efzofitimod Data Demonstrating Statistically Significant Improvements in Time to Relapse, FVC and Patient Reported Outcomes

September 11
Last Trade: 1.20 -0.01 -0.83

Post-hoc analysis from Phase 1b/2a study in pulmonary sarcoidosis presented at the European Respiratory Society (ERS) International Congress 2023. 7.7% of patients in the 3.0 and 5.0 mg/kg efzofitimod group relapsed following steroid taper, compared to 54.4% in the placebo and efzofitimod 1.0 mg/kg group (p=0.017). Rate of change for forced vital capacity (FVC) was significantly improved for the 3.0 and 5.0 mg/kg efzofitimod group...Read more

Beam Therapeutics Announces First Patient Dosed in Phase 1/2 Trial of BEAM-201 in Relapsed, Refractory T-ALL/T-LL

September 5
Last Trade: 26.40 -2.35 -8.17

CAMBRIDGE, Mass., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that in August, the first patient was treated with BEAM-201, a quadruplex-edited allogeneic CAR-T cell investigational therapy. BEAM-201 is being evaluated in a Phase 1/2 clinical study for the treatment of relapsed/refractory T-cell acute...Read more

Plus Therapeutics Initiates Part B of ReSPECT-LM Phase 1/2a Trial for Leptomeningeal Metastase

September 5
Last Trade: 2.12 -0.11 -4.93

AUSTIN, Texas, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced treatment of the first patient in Part B (Cohort 4) of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of...Read more

Nuvalent Initiates the Phase 2 Portion of ARROS-1 Clinical Trial for Patients with ROS1-Positive NSCLC and other Solid Tumors

September 5
Last Trade: 70.66 -0.17 -0.24

Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-520 of 100 mg daily CAMBRIDGE, Mass., Sept. 5, 2023 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the initiation of the Phase 2 portion of ARROS-1, its Phase 1/2 clinical trial of...Read more

Alpine Immune Sciences Announces Initiation of Dosing in 240 mg IgA Nephropathy Cohort of Povetacicept Clinical Study (RUBY-3)

August 30
Last Trade: 16.84 0.32 1.94

SEATTLE / Aug 30, 2023 / Business Wire / Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the successful initiation of the second IgA nephropathy (IgAN) dose cohort in RUBY-3, a phase 1b/2a study in autoimmune glomerulonephritis. Safety Monitoring Committee (SMC) review has determined that repeat...Read more

Denali Therapeutics Announces New Interim Data from Phase 1/2 Study of DNL310 (ETV:IDS) in MPS II (Hunter Syndrome) at SSIEM 2023

August 30
Last Trade: 18.37 -0.37 -1.97

Additional biomarker data up to two years of treatment continue to demonstrate rapid and sustained normalization of CSF heparan sulfate to normal healthy levels and improvement in lysosomal function biomarkers Additional safety data up to two years of treatment continue to demonstrate that DNL310 is generally well tolerated Previously reported data showed robust and statistically significant reduction of NfL, a marker of neuronal...Read more

Longboard Pharmaceuticals Completes Enrollment of Phase 1b/2a PACIFIC Study Evaluating LP352 for the Treatment of Developmental and Epileptic Encephalopathies

August 23
Last Trade: 4.54 -0.12 -2.58

Enrolled 52 participants with Developmental and Epileptic Encephalopathies (DEEs) into the PACIFIC Study Participants have a broad range of DEEs including Lennox-Gastaut syndrome, Dravet syndrome, SCN2A-related epilepsies, CDKL5 deficiency disorder, among others PACIFIC topline results remain on track for around year-end 2023 LA JOLLA, Calif. / Aug 23, 2023 / Business Wire / Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a...Read more

Pieris Pharmaceuticals Announces Milestone Achievement for Boston Pharmaceuticals' Initiation of Phase 1/2 Study of BOS-342, a 4-1BB/GPC3 Immuno-Oncology Bispecific

August 17
Last Trade: 0.20 0.0041 2.13

BOSTON, MA / ACCESSWIRE / August 17, 2023 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company focused on novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases and cancer, today announced that the Company has achieved an undisclosed milestone payment from Boston Pharmaceuticals. The milestone is based on dosing the first patient in a Boston...Read more

Bristol-Myers Squibb: Updated Data from TRIDENT-1 Trial Show Durable Efficacy Benefits with Repotrectinib for Patients with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

August 16
Last Trade: 50.31 0.15 0.30

Repotrectinib continued to demonstrate high response rates and durable responses, including robust intracranial responses, in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer who were TKI-naïve or previously treated with one TKI and no chemotherapy Median duration of response and progression-free survival to be disclosed for the first time in the pooled Phase 1/2 population alongside updated results...Read more

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

August 16
Last Trade: 1.54 -0.01 -0.65

Initial data show clinical responses from four of four indolent lymphoma patients, including complete response in follicular lymphoma patient previously treated with CD19 CAR-T cell therapy Aligns with ongoing results from investigator-sponsored trial at Fred Hutch that show ongoing complete remission for more than three years Update on data presented at 5th iwCAR-T, Scottsdale, AZ Safety Review Committee unanimously approved...Read more

Taysha Gene Therapies Reports Initial Clinical Data from First Adult Rett Syndrome Patient Dosed in REVEAL Phase 1/2 Trial and Provides Corporate Update with Second Quarter 2023 Financial Results

August 14
Last Trade: 1.79 0.09 5.29

Data from first adult patient dosed in REVEAL Phase 1/2 trial showed TSHA-102 was well-tolerated with no treatment-emergent serious adverse events (SAEs) as of six-week assessment and improvement in key efficacy measures, including Clinical Global Impression – Improvement (CGI-I), Clinical Global Impression – Severity (CGI-S) and Rett Syndrome Behavior Questionnaire (RSBQ), four weeks post-treatment Principal Investigator (PI) observed...Read more

Perspective Therapeutics Announces First Patient Dosed in Phase 1/2a Dose Escalation Trial of VMT01 of its Targeted Alpha-Particle Therapy (TAT), for Treatment of MC1R-positive Metastatic Melanoma

August 11
Last Trade: 0.25 -0.0055 -2.15

First patient with MC1R-positive metastatic melanoma treated with 212Pb-VMT01 Preliminary data readout from dose escalation study expected Q4 2023 RICHLAND, Wash. & CORALVILLE, Iowa, Aug. 11, 2023 (GLOBE NEWSWIRE) --   Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), announces the first patient was dosed at the University of Wisconsin in the Company’s Phase 1/2a dose...Read more

Immatics Initiates Phase 1/2 Clinical Trial to Evaluate PRAME TCR Bispecific IMA402 in Patients with Advanced Solid Tumors

August 10
Last Trade: 9.25 0.06 0.65

TCER® IMA402 is the first next-generation, half-life extended TCR Bispecific targeting PRAME to enter the clinic Patient enrollment for IMA402 Phase 1/2 trial underway The trial will evaluate safety, tolerability, and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors First clinical data expected in 2024   Tuebingen, Germany and Houston, Texas, August 10, 2023 – Immatics N.V. (NASDAQ:...Read more

Medicenna Therapeutics Completes MDNA11 Dose Escalation and Commences Monotherapy Dose Expansion in the Phase 1/2 ABILITY Study

August 9
Last Trade: 0.46 0.02 4.60

Durable anti-cancer activity was observed during monotherapy dose escalation without dose-limiting toxicities Late-stage pancreatic cancer patient achieved 80% tumor shrinkage with complete regression observed in two of three metastatic lesions in the liver in response to single-agent MDNA11 Immune pharmacodynamic data continues to support a differentiated mechanism with preferential expansion of potent cancer-fighting immune...Read more

NervGen Pharma to Proceed with Landmark Phase 1b/2a Clinical Trial for NVG-291 in Spinal Cord Injury Having Completed FDA Review and Received IRB Approval

August 8
Last Trade: 1.66 -0.02 -1.19

Recruitment of individuals with spinal cord injury (SCI) initiated at Shirley Ryan AbilityLab in Chicago Chronic SCI cohort results expected in mid-2024 and subacute SCI cohort results in late 2024/early 2025 Vancouver, British Columbia--(Newsfile Corp. - August 8, 2023) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous...Read more

Passage Bio Announces Promising Interim Clinical Data from First Eight Patients with GM1 Gangliosidosis in Imagine-1 Study

August 7
Last Trade: 0.65 0.0071 1.11

Interim safety data up to 28 months showed Dose 1 and 2 of PBGM01 were well tolerated and had a favorable safety and immunological profile Dose 2 resulted in substantial improvements in key CSF biomarkers and was able to achieve normal levels of CSF β-Gal activity and GM1 gangliosides, similar to healthy controls Dose 2 biomarker responses demonstrated durability up to 12 months after treatment Imagine-1 study participants showed...Read more

Oncternal Therapeutics Receives FDA Study May Proceed Letter for ONCT-534, its Novel Dual-action Androgen Receptor Inhibitor, for the Treatment of Patients with Advanced Prostate Cancer

August 3
Last Trade: 0.43 0.09 24.78

SAN DIEGO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced the receipt of a Study May Proceed letter from the U.S. Food and Drug Administration (FDA), for a Phase 1/2 dose escalation study of ONCT-534, a novel dual-action androgen receptor inhibitor (DAARI), in patients with metastatic...Read more

IDEAYA Biosciences and Amgen Achieve First-Patient-In for Clinical Evaluation of IDE397 (MAT2A) and AMG 193 (PRMT5(MTA)) Combination in MTAP(-/-) Tumors

August 2
Last Trade: 30.89 -0.37 -1.18

First patient dosed with combination of IDE397, the IDEAYA MAT2A inhibitor, and AMG 193, the Amgen MTA-cooperative PRMT5 inhibitor, in Amgen-sponsored Phase 1/2 clinical trial ­Global clinical trial will evaluate IDE397 and AMG 193 combination as potential first-in-class synthetic lethality combination in MTAP-deletion patients with planned expansion in NSCLC ­Earlier reported unconfirmed partial response for...Read more

Taysha Gene Therapies Announces Positive Recommendation from Independent Data Monitoring Committee of REVEAL Phase 1/2 Trial in Rett Syndrome

July 31
Last Trade: 1.79 0.09 5.29

Independent Data Monitoring Committee recommended REVEAL Phase 1/2 trial continuation and proceeding with dosing of second patient based on encouraging initial clinical data from the first adult with Rett syndrome dosed with investigational gene therapy TSHA-102 Initial clinical update from the first patient dosed with TSHA-102 planned for forthcoming quarterly earnings call Dosing of second patient expected in the third quarter of...Read more

4D Molecular Therapeutics Presents Additional Positive Interim Data from Intravitreal 4D-150 Phase 1/2 PRISM Clinical Trial in Patients with Wet AMD at ASRS 2023

July 29
Last Trade: 14.94 0.36 2.47

Dose response demonstrated in favor of highest tested dose of 3E10 vg/eye, including 100% reduction in supplemental anti-VEGF injections (4 of 4 evaluable patients injection-free) and a clinically meaningful reduction in mean central subfield thickness (CST) at 36 weeks in patient population with high anti-VEGF need Assessment of outcomes beyond 36 weeks in the 3E10 vg/eye dose cohort showed a durable reduction in supplemental anti-VEGF...Read more

Avenue Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)

July 27
Last Trade: 0.15 -0.0015 -0.97

MIAMI, July 27, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that the first patient has been dosed in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's...Read more

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Astria Therapeutics

Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...