EDINBURGH, Scotland, Dec. 20, 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 announced 3 patients have now completed the full-dose regimen in the ACHIEVE Phase 2b trial in the UK with no drug-related Adverse Events seen in any of the...Read more
JENA, Germany, Dec. 20, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the first patient has been dosed in its Phase 2a basket study in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), investigating the Company’s oral C5aR inhibitor, INF904. Camilla Chong, MD, Chief...Read more
NOVATO, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the first patient has been dosed in the pivotal Phase 3 Aspire study (NCT06617429) evaluating the efficacy and safety of GTX-102, its investigational antisense oligonucleotide (ASO) for Angelman syndrome. "Initiation of patient dosing in our Phase 3 Aspire study represents an important step forward in the development of...Read more
Registered Phase-1b 12-week study will investigate safety, diabetes control, and weight loss KELOWNA, BC / ACCESSWIRE / December 19, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has begun dosing in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study"). The Study is designed mainly to determine whether Lexaria's...Read more
Enrollment underway for patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) Company expects to share preliminary Phase 1 clinical data in the first half of 2025 REDWOOD CITY, Calif. & BOSTON / Dec 19, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today...Read more
JERSEY CITY, N.J., Dec. 18, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company’s second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal...Read more
The Phase 1/2 trial will assess the safety and clinical activity of IMC-R117C, as a monotherapy and in combination with standards of care, in patients with advanced cancers expressing PIWIL1 First immunotherapy program to target PIWIL1, a cancer-testis antigen overexpressed in a range of cancers, including colorectal cancer (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 17 December 2024) Immunocore...Read more
Phase 1b trial will evaluate receptor occupancy of PIPE-791 in the brain and lungs of patients in multiple cohorts using a PET tracer of the LPA1 receptor Topline data readout planned for the second quarter of 2025 SAN DIEGO / Dec 16, 2024 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the first patient has been dosed in the Company’s phase 2 trial evaluating petosemtamab monotherapy in heavily pretreated (3L+) metastatic colorectal cancer (mCRC). Petosemtamab...Read more
Dose-finding clinical trial in China designed to evaluate safety and preliminary anti-tumor activity of SN301A (SENTI-301A manufactured in China) in hepatocellular carcinoma (“HCC”) SOUTH SAN FRANCISCO, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit...Read more
Voyage is the first-ever Phase 3 study of lysergide D-tartrate (LSD) with the primary endpoint measuring the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score at week 12 for MM120 Orally Disintegrating Tablet (ODT) 100 µg vs placebo Study builds on positive Phase 2b study results presented at the American Psychiatric Association’s Annual Meeting in May 2024 Topline data from the 12-week double-blind...Read more
Twice daily (BID) dosing regimen expected to maximize clinical benefit for patients by optimizing the activity of Aprea’s experimental drug, ATRN-119, over a 24-hour daily cycle New regimen potentially optimizes clinical outcomes and strengthens the clinical path forward ATRN-119 is the first macrocyclic ATR inhibitor to enter clinical trials DOYLESTOWN, Pa., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq:...Read more
Marks successful completion of full enrollment of SAD cohorts and the first two MAD cohorts in the healthy volunteer study Up to 10 adult participants with genetically confirmed Duchenne Muscular Dystrophy (“DMD”) to be enrolled in the now ongoing Phase 1b trial in DMD patients Phase 1 data to be presented at major medical conference in Q1 2025 TORONTO / Dec 11, 2024 / Business Wire / Satellos Bioscience Inc. (TSX: MSCL, OTCQB:...Read more
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2H 2025 APG777 + APG333 can potentially address key drivers of respiratory diseases more broadly versus monotherapy Preclinical proof-of-concept achieved for APG777 + APG333 combination with clinical trial planning underway in asthma and COPD SAN FRANCISCO and WALTHAM, Mass., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc.,...Read more
First patient dosed with combination of IDE161, IDEAYA's investigational, potential first-in-class PARG inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy The IDEAYA-sponsored Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer Selected initial...Read more
NORWOOD, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, today announced the dosing of the first patient in the Phase 1 portion of the clinical study of CRB-601 for the treatment of patients with advanced solid tumors (NCT06603844). CRB-601 is a monoclonal antibody targeting latent TGFβ...Read more
WILMETTE, Ill., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the first patient ever dosed with MNPR-101-Lu. This novel therapeutic radiopharmaceutical combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR),...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced initiation of dosing in a global Phase 2a clinical study, BEACON, of the investigational drug leucine-rich repeat kinase 2 (LRRK2) inhibitor BIIB122 (DNL151) in participants with LRRK2-associated Parkinson’s disease (LRRK2-PD). LRRK2 inhibition is a potential therapeutic approach that may slow progression of Parkinson’s...Read more
Topline data for Phase 3 pivotal program anticipated in 2026 WATERTOWN, Mass., Dec. 04, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that the first patient has been dosed in the LUCIA trial, the Company’s second global Phase 3 clinical trial of...Read more
First program to result from end-to-end use of OS to identify a novel target and new chemical matter, which moved from target ID to IND enabling studies in under 18 months with ~200 compounds synthesized REC-1245 is a potent and selective RBM39 degrader with a potential first-in-class profile in Solid tumors and Lymphoma >100,000 patients in the US and EU5 initially addressable SALT LAKE CITY, Dec. 03, 2024 (GLOBE NEWSWIRE) --...Read more
REDWOOD CITY, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today announced that the first patient has been dosed in Jasper’s Phase 1b/2a...Read more
Spyre is concurrently advancing two anti-TL1A molecules into first-in-human studies Preclinical data for both SPY002 molecules demonstrate picomolar potency and potential for quarterly or twice-yearly dosing, suggesting opportunity for improved efficacy and convenience over first-generation anti-TL1As which are dosed every two to four weeks Interim pharmacokinetic, pharmacodynamic, and safety data from healthy volunteers for both...Read more
GAITHERSBURG, Md., Nov. 26, 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 first patient enrollment and dosing at the UVA Cancer Center in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with...Read more
Landmark Overdose Protection Clinical Trial of PF614-MPAR Expects Early Interim Data in 1Q 2025 SAN DIEGO, CA / ACCESSWIRE / November 26, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has treated its first group of...Read more
TN-401 AAV9-based Gene Therapy Designed to Deliver Fully Functional PKP2 Gene with the Aim of Increasing Protein Levels to Address Underlying Disease RIDGE-1 Currently Enrolling at Six Centers; Observational Natural History and Seroprevalence Study of PKP2-associated ARVC Adults Continues Enrollment at 20 Clinical Sites in the U.S., UK and Europe Initial Clinical Data for RIDGE-1 Anticipated in 2025 SOUTH SAN FRANCISCO, Calif.,...Read more
Phase 1/2 dose escalation study to evaluate BriaCell’s personalized next generation immunotherapy treatment in metastatic breast cancer Bria-OTS™ to be studied as monotherapy and in combination with BeiGene’s anti-PD-1 antibody PHILADELPHIA and VANCOUVER, British Columbia, Nov. 21, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) a clinical-stage biotech company that develops novel...Read more
LEXINGTON, Mass. and AMSTERDAM, Nov. 21, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the first patient has been dosed in the GenTLE Phase I/IIa clinical trial of AMT-260 for the treatment of refractory mesial temporal lobe epilepsy (MTLE). “The dosing of the first patient in our Phase I/II trial in...Read more
Potential to redefine frontline AML treatment being evaluated in clinic: Mipletamig, CD3 x CD123 bispecific, in combination with standard of care, offers a multi-mechanism strategy for potential improved patient outcomes Favorable early safety, efficacy, tolerability and durability of remission data informed Aptevo's ongoing RAINIER Phase 1b/2 trial SEATTLE, WA / ACCESSWIRE / November 20, 2024 / Aptevo Therapeutics ("Aptevo")...Read more
HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF)...Read more
SINGAPORE, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Further to an announcement on October 7, 2024, CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of blood and solid cancers, is pleased to announce that the first patient has been dosed in...Read more
Ten clinical trial sites across Japan and Taiwan are actively screening patients, with additional sites expected to also begin patient enrollment in the coming months U.S. clinical sites continue to actively screen and dose patients in both the LP-300 combination arm and the standard-of-care control arm of the Harmonic trial Non-small cell lung cancer (NSCLC) in never smokers occurs at rates 2 to 3 times higher in East Asian countries...Read more
SAN CARLOS, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint-resistant cancers, and a subsidiary of Grifols, announced today that the first patient has been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of the first recombinant polyclonal drug candidate, GIGA-2339, for the treatment...Read more
Alignment achieved with FDA on AFFINITY DUCHENNE® pivotal program and access to accelerated approval; BLA expected in 2026 Pivotal trial of RGX-202 is enrolling ambulatory patients aged 1 and above with first patient dosed Phase I/II data show RGX-202 recipients exceeding external natural history and established benchmarks for clinical outcomes Functional improvements seen in all patients treated with dose level 1 and dose...Read more
Enrollment underway for lupus nephritis (LN) patients Preliminary clinical data in LN anticipated in 1H25 Initiation of patient enrollment in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) expected in 1Q25; patient enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) expected in 2H25 REDWOOD CITY, Calif. &...Read more
Nes-Ziona, Israel, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the completion of the dosing and initial follow-up period for the first patient in its Phase I clinical trial evaluating the safety, tolerability and potential therapeutic effect of Allocetra™ following injection into an affected joint in...Read more
REL-P11 is a proprietary, low-dose, modified-release psilocybin formulation Single-Ascending Dosing (SAD) study to evaluate safety and pharmacokinetics in obese and normal weight subjects With positive results, Phase 2a proof-of-concept study expected to begin in H1 2025 CORAL GABLES, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology company...Read more
MINNEAPOLIS / Nov 13, 2024 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for severe ischemic diseases, today announced that the first patient has been dosed in DiaMedica’s investigator-sponsored Phase 2 trial of DM199 for the treatment of preeclampsia (PE). DiaMedica anticipates top line data for Part 1A in the first half of 2025 which is...Read more
Phase 2b ACCESS study designed to evaluate multiple doses up to 120 mg of GSBR-1290 over 36 weeks Comprehensive development program also includes Phase 2 ACCESS II study to evaluate even higher doses of GSBR-1290 over 36 weeks; first patient expected to be dosed by end of 2024 Topline data from both ACCESS and ACCESS II studies expected in the fourth quarter of 2025 Company to host conference call today at 4:30 p.m....Read more
Nes-Ziona, Israel, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the enrollment and dosing of the first 10 patients in the randomized Phase II stage of the Company’s multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis. The initiation of patient dosing follows the...Read more
TORONTO, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing have begun in Canada for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The clinical team at the University of Calgary Cumming School of Medicine has started screening...Read more
Orphan Drug Designation has been granted lately by US FDA RAMAT GAN, Israel, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announces the dosing of the first patient in the Phase IIa clinical trial in patients with advanced pancreatic...Read more
Phase 3 single-arm, baseline-controlled trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) currently enrolling participants at leading vascular anomaly centers across the U.S. Microcystic LMs is a chronically debilitating and lifelong genetic disease affecting an estimated more than 30,000 diagnosed patients in the U.S. QTORIN™ rapamycin...Read more
Carlsbad, CA, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that it dosed its first subject in its Phase 1 clinical study of PALI-2108, an orally administered PDE4 inhibitor prodrug that is...Read more
WATERTOWN, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced its partner Betta Pharmaceuticals has dosed the first patient in the Phase 1 clinical trial of CFT8919, an orally bioavailable allosteric degrader of EGFR L858R for non-small cell lung cancer (NSCLC), in Greater China. “We...Read more
VANCOUVER, British Columbia, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that the first patient has been dosed in the company’s first-in-human Phase 1 trial (NCT06555744) to evaluate the safety and tolerability of the...Read more
PASADENA, Calif. / Nov 04, 2024 / Business Wire / Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, today announced that it has initiated dosing of healthy volunteers in the first-in-human study of XmAb®942, an investigational high-potency extended half-life anti-TL1A antibody. Xencor continues to expect initial data from the...Read more
Testing the efficacy and safety of Intensity's lead drug candidate, INT230-6, when combined with Standard-of-Care versus Standard-of-Care alone The endpoint is the change in pathological complete response rates SHELTON, Conn. and BERN, Switzerland, Oct. 31, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and...Read more
Study done in collaboration with Memorial Sloan Kettering and led by Dr. Winston Wong, Head and Neck Oncologist and Dr. Alan Ho, Chief of the Head and Neck Oncology Service IIT will evaluate eseba-vec in patients who are HPV16+ after treatment for curative intent Potential to expand the eseba-vec HNSCC opportunity into adjuvant care Initial safety and efficacy data from IIT expected in 2026 NEW YORK and VIENNA, Oct. 30, 2024...Read more
GAITHERSBURG, Md., Oct. 29, 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 that the first three patients in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma have been...Read more
TORONTO, ON / ACCESSWIRE / October 29, 2024 / Quantum BioPharma Ltd. (NASDAQ:QNTM)(CSE:QNTM)(FRA:0K91) ("Quantum BioPharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, HUGE Biopharma Australia Pty Ltd., that sentinel dosing has started for its trial entitled "A Phase 1, Randomised, Double-Blind, Placebo-Controlled,...Read more
Company’s first clinical trial studying CAR-NK (CD19 t-haNK) cellular therapy in liquid tumors First natural killer cell-based cellular therapy study conducted in the continent of Africa Complete enrollment currently expected in Q1 2025 CULVER CITY, Calif. / Oct 24, 2024 / Business Wire / Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX), announced today that the first patients have been dosed in an initial trial studying the...Read more
Second Phase 3 LUCIA pivotal trial first patient dosing expected by end of 2024 Topline data anticipated in 2026 WATERTOWN, Mass., Oct. 24, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that the first patient has been dosed in the Phase 3...Read more
KT-621, an oral degrader, is the first STAT6 targeted medicine to enter clinical development, with the potential to address multiple immuno-inflammatory diseases KT-621 has demonstrated dupilumab-like activity and was well tolerated in a wide variety of preclinical models of TH2 diseases Phase 1 healthy volunteer data expected to be reported in the first half of 2025 WATERTOWN, Mass., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Kymera...Read more
OK-101 is the first drug candidate to enroll patients specifically diagnosed with Neuropathic Corneal Pain (NCP) in a clinical trial The Phase 2 trial is designed as a randomized, placebo-controlled, double-masked study to treat 48 NCP patients OK-101 is the first IND granted by FDA to treat patients with NCP LONDON and NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an...Read more
VIRO-25 trial to assess efficacy & safety of olvimulogene nanivacirepvec (Olvi-Vec) & platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in recurrent non-small cell lung cancer Trial represents second indication in the clinic for Olvi-Vec via systemic administration Interim readout expected mid-2025 WESTLAKE VILLAGE, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Genelux...Read more
REC-3964 is Recursion’s first new chemical entity developed using the RecursionOS. REC-3964 represents a novel, non-antibiotic approach with a unique mechanism of action that binds and blocks catalytic activity of the toxin's innate glucosyltransferase in order to inhibit the toxin produced by C. diff. in the gastrointestinal tract. There are up to 175,000 cases of recurrent C. diff. each year and more than 29,000 patients die in the...Read more
REDWOOD CITY, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the first patient has been dosed in RASolute 302, a Phase 3 registrational study of RMC-6236, a RAS(ON) multi-selective inhibitor, in patients with previously treated, metastatic pancreatic ductal adenocarcinoma...Read more
LEXINGTON, Mass. and AMSTERDAM, Oct. 15, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the first patient has been dosed in the Phase I/II clinical trial of AMT-162 for the treatment of amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1), a rare, inherited and...Read more
CAMBRIDGE, Mass. & MONTREAL / Oct 14, 2024 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced the first patient has been dosed in the Company’s Phase 1 (POLAR) clinical trial evaluating RP-3467, a Polθ ATPase inhibitor, alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. RP-3467 is Repare’s fourth...Read more
First patient dosed two quarters ahead of original timelines in Acrivon Phase 1 study to assess safety and tolerability of ACR-2316 ACR-2316 was internally discovered and advanced in 15 months from initial lead to Phase 1 trial initiation uniquely enabled by AP3 ACR-2316 was rationally designed by AP3 to deliver complete tumor regression and pro-apoptotic tumor cell death through potent activation of CDK1, CDK2, and...Read more
Primary target patient population for the FHD-909 Phase 1 trial is non-small cell lung cancer (NSCLC) Lilly leads the clinical development of the Phase 1 trial Foghorn’s selective SMARCA2 oncology program is part of a U.S. 50/50 co-development and co-commercialization collaboration with Lilly CAMBRIDGE, Mass., Oct. 10, 2024 (GLOBE NEWSWIRE) -- October 10, 2024 -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage...Read more
JERUSALEM, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today that its first patient with recurrent lung cancer has been treated, in a clinical trial at Hadassah Medical Center in Jerusalem, Israel. The trial is designed to treat up to ten patients with recurrent tumors in the...Read more
Global study in approximately 180 adults with hidradenitis suppurativa to assess the efficacy and safety of two dose regimens of AVTX-009 compared to placebo Topline data expected in 2026 WAYNE, Pa. and ROCKVILLE, Md., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced that the first patient has been dosed in the Company’s Phase 2 LOTUS trial of AVTX-009 in hidradenitis suppurativa (HS)....Read more
Phase 2 trial is an adaptive designed randomized study comparing NGC-Cap to monotherapy capecitabine Results from this Phase 2 trial will evaluate NGC-Cap’s safety-efficacy profile and help to define the optimal dosage regimen in patients with metastatic breast cancer HANOVER, Md., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company...Read more
Anticipated advantages of UGN-103 include a shorter manufacturing process and a simpler reconstitution procedure PRINCETON, N.J. / Oct 02, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the first patient was dosed in the Phase 3 clinical trial of investigational drug UGN-103...Read more
LYON, France, October 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patients have been treated in a Phase I/II study evaluating the Company’s proprietary Focal One® robotic high-intensity focused ultrasound (HIFU) technology for the treatment of benign prostatic hyperplasia (BPH). “We’ve been offering targeted HIFU ablation to prostate cancer patients for more...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5,...Read more
CAMBRIDGE, MA / ACCESSWIRE / September 30, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the first participant in the U.S. has been dosed in the Nova 301 Trial, a pivotal Phase 3 randomized clinical trial evaluating the efficacy, safety, and immunogenicity of an investigational norovirus vaccine, mRNA-1403. Global recruitment for the Nova 301 trial has also begun. "Norovirus is a significant public health concern that affects...Read more
SAN DIEGO, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the first subjects dosed in the Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure...Read more
The first healthy volunteer has been dosed in the first component of the Phase 1 study Initial safety and pharmacokinetic data expected in Q4 2024 Initiation of the second component of the Phase 1 study, in adult DMD patients, expected in Q1 2025 TORONTO / Sep 18, 2024 / Business Wire / Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSX: MSCL) (OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic...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
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
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
Phase 2/3 of the DRAGON II trial will evaluate the efficacy, safety, and tolerability of Tinlarebant in approximately 60 adolescent STGD1 subjects across the U.S., U.K., and Japan Phase 1b of DRAGON II trial to evaluate pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese subjects was recently completed Tinlarebant granted Orphan Drug and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1 Pivotal...Read more
Investigator-initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin Funding for study provided by NIH and BrainUp® Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune memory in glioblastoma animal models HOUSTON, Sept. 9, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, today announced that the first patient has been dosed with CX-801 monotherapy in a Phase 1 study (NCT06462794) in patients with solid tumors. CX-801 is a dually-masked interferon alpha-2b PROBODY® cytokine with potential broad applicability in both...Read more
Outcomes is the third study in the Phase 3 SYNCHRONY clinical trial program SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported the first patient was dosed in the Phase 3 SYNCHRONY Outcomes trial. The study...Read more
SAN DIEGO, Sept. 06, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced that the first patient has been dosed in a Phase 2a trial of VTX3232 in patients with early Parkinson’s disease. “We are excited to initiate this trial...Read more
ROCKVILLE, Md. & EDMONTON, Alberta / Sep 05, 2024 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) announced today that the first participant has been dosed in a Phase 1a single ascending dose (SAD) study of AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). The SAD study...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, announced the first patients have been dosed in an arm of the randomized UMBRELLA phase 1/2 clinical study partnered with Sanofi that is evaluating evorpacept in combination with SARCLISA®...Read more
WALTHAM, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced dosing of the first participants in the Phase 1 healthy volunteer clinical trial of VYD2311, a next generation monoclonal antibody (mAb) candidate for COVID-19. VYD2311 is a mAb with high in vitro neutralization potency shown against...Read more
Descartes-15 observed to achieve an approximately ten-fold increase relative to Descartes-08 in CAR expression and selective target-specific killing in preclinical studies GAITHERSBURG, Md., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the first patient has been dosed in...Read more
BRANFORD, Conn. / Aug 28, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR), a precision dermatology company, announced that it has initiated dosing the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days, with primary endpoints focusing on safety and tolerability, and secondary...Read more
PASADENA, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) (“LIXTE” or the “Company”), today announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. (“Roche”) for treatment of unresponsive (MSI Low) metastatic colorectal cancer. As part of the clinical trial (NCT06012734,...Read more
Complete enrollment currently expected in 3Q 2024 Topline results expected in 1Q calendar year 2025 Additional studies under assessment for multiple metabolic conditions CRANBURY, N.J., Aug. 22, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that...Read more
SEATTLE, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) and Quantum Leap Healthcare Collaborative™ (QLHC), today announced the first patient has been dosed in their clinical trial evaluating Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, as a neoadjuvant treatment in...Read more
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025 Initiation of the first clinical trial of APG777 and APG990 combination expected to commence in 2025 with the potential for greater efficacy in atopic dermatitis and across I&I diseases SAN FRANCISCO and WALTHAM, Mass., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology...Read more
MRT-6160, a potent and highly selective VAV1-directed molecular glue degrader, represents a potential novel therapeutic approach for systemic and neurological autoimmune and inflammatory diseases Initial Phase 1 clinical results, including biomarker data to demonstrate pharmacodynamic effects, anticipated in Q1 2025 BOSTON, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology...Read more
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...
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