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
LEXINGTON, Mass. and AMSTERDAM, Aug. 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 a Phase I/IIa clinical trial of AMT-191 for the treatment of Fabry disease, a rare, inherited genetic disease. The Phase I/IIa study is a multi-center, open-label trial being conducted...Read more
Media Release IMP761 is designed to enhance the “brake” function of LAG-3 on T cells to restore balance to the immune system and address the underlying cause of many autoimmune diseases Safety data from this first-in-human study anticipated by year-end and pharmacokinetics and pharmacodynamics data in first half CY2025 SYDNEY, AUSTRALIA, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the...Read more
WOBURN, Mass., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that the first patient has been randomized and dosed in the IGNYTE-3 study – a global Phase 3 clinical trial assessing the efficacy and safety of RP1 (vusolimogene oderparepvec) plus nivolumab in patients with advanced...Read more
PITTSBURGH, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us,” “we” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces the dosing of the first two patients with LP-310 in its Phase 2a clinical trial in Oral Lichen Planus (OLP) patients. Lipella’s Phase 2a trial is a multicenter, dose-ranging study involving...Read more
DUBLIN, July 31, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the first patient has been dosed in REVITALYZ, a Phase 3 study evaluating LUMRYZ as a potential treatment for idiopathic hypersomnia (IH). "IH is a debilitating sleep disorder characterized by profound sleep inertia, or difficulty waking up and...Read more
NEWTON, Mass., July 29, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) in the brain for the treatment of Alzheimer’s disease (AD), today announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug (ACU193) in a Phase 1 pharmacokinetic (PK) comparison...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 24, 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
KB-0742 cleared 80mg four-days-on, three-days-off dosing schedule in dose escalation Company expects to provide an efficacy update on this expansion cohort in 1H 2025 SAN MATEO, Calif. and CAMBRIDGE, Mass., July 23, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today...Read more
LB54640 has shown targeted effect on MC4R without hyperpigmentation BOSTON, July 23, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that the first patients have been dosed in the Company’s Phase 2 clinical trial evaluating LB54640, an...Read more
CAMBRIDGE, Mass., July 22, 2024 /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 HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). "HER2...Read more
Pure Biologics’ exploratory Phase 0 study to evaluate pharmacodynamic activity of PBA-0405 in solid tumors SOUTH SAN FRANCISCO, Calif. / Jul 18, 2024 / Business Wire / Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study...Read more
GenFleet’s IND in China was cleared in June 2024; this is the first discovery program from the collaboration Verastem announced in 2023 to advance into human clinical trials Verastem plans to initiate development studies outside of China after evaluating initial dose escalation data from the Phase 1 study in China BOSTON / Jul 12, 2024 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to...Read more
Testing the efficacy and safety of our lead product candidate, INT230-6, as Monotherapy Compared with Systemic U.S. Standard-of-Care Chemotherapy SHELTON, Conn., July 9, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies...Read more
Lead site Memorial Sloan Kettering Cancer Center (MSKCC) Timing of milestone in-line with mid-2024 guidance Data from ex-US clinical trial reported at ASGCT 2024 showed a 92% overall response rate LOS ANGELES, July 08, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and autoimmune...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 08, 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 2 trial evaluating petosemtamab in combination with standard chemotherapy in second line (2L)...Read more
WATERTOWN, Mass. and GOSSELIES, Belgium, July 08, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced the dosing of the first patient in GALAXIES Lung-301, a global, randomized, double-blind Phase 3 registrational clinical trial of belrestotug +...Read more
GAITHERSBURG, Md., July 02, 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 its Phase 2 open-label clinical trial evaluating Descartes-08 in patients with systematic lupus erythematosus (SLE). Descartes-08, Cartesian’s lead mRNA cell therapy candidate...Read more
Novel arenaviral therapeutic vaccine, developed in collaboration with Gilead Sciences, Inc. (Gilead), to be evaluated as a potential component of a curative regimen for human immunodeficiency virus (HIV) HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion...Read more
EMERYVILLE, Calif., June 27, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the first participant has been dosed in a Phase 1/2 clinical trial evaluating the safety, tolerability, and immunogenicity of Z-1018, the company's investigational vaccine candidate being developed for the prevention of...Read more
Top-Line Data Readout From the Single Ascending Dose Part 1 Expected in the Third Quarter of 2024, and From the Multiple Ascending Dose Part 2 in the First Quarter of 2025 Planned Part 3 Will Assess Total Weight Loss at 24 Weeks, Exploring Maximum Titratable Dose and Dietary Changes; Interim Data Readout Expected Mid-2026 with Top-Line Data in the Second Half of 2026 Recent Financing of up to $70 million Will Fund the Ongoing...Read more
NEW YORK, June 26, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. Expanded access...Read more
CAMBRIDGE, Mass., June 26, 2024 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced the first patient was treated with BEAM-302, an investigational in vivo base editing medicine designed to precisely correct the underlying cause of severe alpha-1 antitrypsin deficiency (AATD), that is currently being evaluated in a Phase 1/2...Read more
SOUTH SAN FRANCISCO, Calif. / Jun 25, 2024 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today announced that the first patient has been dosed in the company’s Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial to evaluate the...Read more
First-Patient-In (FPI) for Phase 1 combination treatment with IDE397, IDEAYA's MAT2A inhibitor, and Trodelvy®, Gilead's Trop-2 directed antibody-drug conjugate (ADC) The global Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with Trodelvy MTAP-deletion is found in approximately 26% of patients with bladder cancer SOUTH SAN FRANCISCO, Calif.,...Read more
First patient dosed with AllocetraTM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people Thumb osteoarthritis currently has no FDA-approved therapy and no effective long-term treatments Ness-Ziona, Israel, June 24, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
CLICK TO LEARN MORE