PYX-201 achieved a confirmed 50% ORR by RECIST 1.1 including one Complete Response and 100% Disease Control Rate in six heavily pretreated HNSCC patients, supporting differentiated mono and front-line combo therapy expansion trials to begin dosing 1Q25 Overall, 26% ORR across all six Solid Tumor Types of Interest (n=31) with Dose Dependent Responses Observed, Supporting First-In-Concept Mechanism with Novel Extracellular Targeting...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
SRC recommended that the trial escalate to the next dose level of 15mg capsule No dose-limiting toxicities (DLTs) observed to date No rash observed to date MIAMI, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis...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
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
Six sites across the U.S. are now engaged in Phase1b study Marlborough, Massachusetts--(Newsfile Corp. - November 19, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company exploring new pathways towards a cancer-free future, today announced it has completed the enrollment of its second patient cohort in its PH-762 Phase 1b dose-escalating clinical trial, and added a sixth clinical site in San...Read more
First gamma delta CAR T cell therapy with the potential to address solid tumors entering clinical trials Preliminary Phase 1 clinical data expected in the first half of 2025 REDWOOD CITY, Calif. & BOSTON / Nov 18, 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 announced the...Read more
Third cohort dose is one million CAR positive cells; ten times higher than the first cohort dose SAN JOSE, Calif., Nov. 18, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has dosed its first patient in the third cohort in the ongoing Phase 1 clinical trial of its novel chimeric antigen...Read more
27-year-old African American-Asian Woman with Active Lupus Nephritis Achieved DORIS Clinical Remission; Patient Remains On-study, in Clinical Remission, and Free of All Immunosuppressive Therapies Patient Treated with Fludarabine-free Conditioning and Single-dose FT819; Favorable Safety Profile with No Grade ≥3 Adverse Events and No Events of CRS, ICANS, or GvHD Reconstituted B Cell Compartment Predominantly Consists of Naïve,...Read more
Significant correlation shown between blood levels and symptom relief; TH104 was well tolerated with no unexpected treatment-emergent adverse events Phase 2 preliminary data for chronic pruritus in primary biliary cholangitis expected in 2025 BRIDGEWATER, NJ / ACCESSWIRE / November 18, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic...Read more
CARMEL, Ind., Nov. 18, 2024 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced the completion of the last subject’s last visit in its Phase 1 single and multiple ascending dose trial of MBX 1416, the Company’s long-acting glucagon-like peptide...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
Treatment with nomlabofusp modified gene expression and lipid profiles in addition to increasing frataxin (FXN) levels in study participants with Friedreich’s ataxia (FA) Modeling and simulation predict that, in most patients with FA, 50 mg of nomlabofusp administered daily is likely to achieve FXN levels that are ≥50% of levels observed in healthy controls and similar to mean FXN levels reported in asymptomatic heterozygous...Read more
Single Dose of Nucresiran 300mg or Higher Led to Rapid Knockdown of Mean TTR Levels of Greater than 90% by Day 15 that was Sustained at Six Months At These Doses, Peak Reduction of Mean TTR Levels of Greater than 96% were Achieved by Day 29 Data Support Potential for Biannual or Annual Subcutaneous Dosing, Representing a New Paradigm in the Treatment of ATTR Amyloidosis Encouraging Safety and Tolerability Observed Alnylam Continues to...Read more
Consistently rapid, deep and durable reduction in serum TTR accompanied by evidence of disease stabilization or improvement after a one-time treatment of nex-z, supporting the hypothesis that greater TTR reduction may lead to a greater clinical benefit in ATTR amyloidosis Favorable trends consistently observed across multiple markers of cardiac disease progression at month 12 compared to baseline in an ATTR-CM population with a high...Read more
Media Release Mature data in patients with a minimum follow-up of 22 months (N=21) shows excellent results, well above historical controls and exceeding expectations: Median Overall Survival is 32.9 months, with median Progression Free Survival reaching 12.7 months, and a 24-month Overall Survival rate of 81.0% Data from all evaluable patients to date (N=40) demonstrates significant improvement of Overall Response Rate compared...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
NXP800 demonstrated single agent activity New dosing schedule successfully minimized thrombocytopenia Fort Lee, NJ, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today reported encouraging data from the Phase 1b study evaluating...Read more
DehydraTECH clinical test article manufacturing has been completed KELOWNA, BC / ACCESSWIRE / November 13, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX, LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ("HREC") approval that was required before dosing can begin in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4,...Read more
High-dose LTI-03 (5 mg BID), a Caveolin-1 related peptide, reduced expression of multiple profibrotic proteins in both pathological basal-like cells and fibroblasts and decreased the expression of a biomarker indicative of epithelial health and lung function decline, suggesting potential therapeutic effect Positive trend observed in seven out of eight IPF biomarkers in Cohort 2, with four biomarkers statistically significant in the...Read more
SPY001 was well tolerated with a favorable safety profile consistent with the anti-α4β7 class SPY001 pharmacokinetics exceeded expectations with a ~4-fold increase relative to vedolizumab, supporting potential Q6M maintenance dosing with a single subcutaneous (SC) injection Planned Phase 2 induction regimen targets drug concentrations in quartile 4 of vedolizumab's exposure-response relationship, which has the potential to...Read more
Aptevo Therapeutics and Alligator Bioscience report favorable safety, tolerability and evidence of biological activity of ALG.APV-527, more than half of evaluable patients achieved stable disease Colon cancer patient achieved stable disease and remained on study for more than six months, breast cancer patient remained on study for more than 11 months Biomarker analysis confirms immune activation in the tumor microenvironment Data...Read more
Advancement of Fast Skeletal Muscle Troponin Activator Expands Pipeline of Muscle-Directed Drug Candidates SOUTH SAN FRANCISCO, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-4015089 (CK-089) in healthy human...Read more
GENEVA, SWITZERLAND / ACCESSWIRE / November 11, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF) (OTCQB:RLFTF) (OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced positive final results from its proof-of-concept, investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of epidermolysis...Read more
Objective response rate (ORR) of 46%, 12-month overall survival (OS) of 91.3% and a median overall survival (mOS) of 21.8 months in first line (1L) HPV+ R/M HNSCC patients treated with CUE-101 and KEYTRUDA® (pembrolizumab) ORR of 50% in 1L patients treated with CUE-101 and pembrolizumab with low PD-L1 expression (combined positive score (CPS) 1-19) 67% overall disease control rate (DCR) in late-stage pancreatic cancer patients...Read more
Data continues positive trend as additional patients are enrolled in 3 cohorts Vaccine was safe and well tolerated by participants in all 3 cohorts Protocol defined immune responses were exhibited in over 70% of patients A Phase 2 study evaluating the vaccine in the neoadjuvant setting is planned to commence in 2025 SAN JOSE, Calif., Nov. 8, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a...Read more
Preliminary data demonstrate durable and dose-dependent T cell responses targeting KRAS mutations and induced responses to patient-specific neoantigens Correlation observed between disease-free survival (“DFS”) and T cell response ELI-002 Phase 1 safety and tolerability profile remains favorable ELI-002 Phase 2 interim event-driven DFS analysis expected in H1 2025 BOSTON, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics,...Read more
BDC-4182 demonstrated compelling anti-tumor activity and an acceptable safety profile in preclinical studies BDC-4182 outperformed cytotoxic claudin 18.2 ADCs in syngeneic model Learnings from BDC-1001 data suggest Boltbody™ ISACs with enhanced immune activation could offer greater efficacy, warranting further testing REDWOOD CITY, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage...Read more
Phase 1 TRAVERSE Trial Demonstrated a Single Infusion of ALLO-316 Can Yield an Overall Response Rate of 50% and Confirmed Response Rate of 33% in Patients with CD70 Tumor Proportion Score (TPS) of Greater than 50% TRAVERSE Trial Highlights the Ability of CD70 Dagger® Technology to Promote Robust Expansion and Persistence of ALLO-316 with Standard Lymphodepletion, Validating its Potential as the Next...Read more
Combination of vilastobart and atezolizumab demonstrated encouraging early evidence of anti-tumor activity, including unconfirmed partial responses observed in two patients with difficult-to-treat, immunologically “cold” tumors Complete resolution of a metastatic liver lesion observed in a patient with microsatellite stable colorectal cancer (MSS CRC) Safety data indicated combination of vilastobart and atezolizumab was generally...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
Up to 6.8% Placebo-Adjusted Mean Weight Loss (8.2% from Baseline) After 28 Days of Dosing with Oral Tablet of VK2735 Encouraging Tolerability Through 100 mg Daily Dosing with Oral VK2735; Mild GI-Related Adverse Event Profile Updated Results from VENTURE Phase 2 Study of Subcutaneous VK2735 Show Durable Effects and Support Potential Monthly Dosing Regimen SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Viking...Read more
Met primary objective demonstrating nintedanib DPI was safe and well tolerated Participants did not experience adverse events typically reported with oral nintedanib Expect to meet with the FDA in 1H 2025 to advance MNKD-201 into the next phase of development DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization...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
TH104, the Company's lead candidate for moderate-to-severe pruritus in chronic liver disease, showed no opioid withdrawal effects, reinforcing safety profile TH104 was well tolerated with no unexpected treatment-emergent adverse events, supporting further clinical development Company expects Phase 2 topline data for chronic pruritus in primary biliary cholangitis (PBC) patients in 2025 BRIDGEWATER, NJ / ACCESSWIRE / October 28,...Read more
WATERTOWN, Mass., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today presented positive additional data from an ongoing Phase 1b study of DISC-0974 in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and anemia,...Read more
~33% ORR by RECIST 1.1: 1 CR + 8 PRs out of 27 evaluable heavily pre-treated (median 2-3 prior lines, ranging from 1-7) MTAP-deletion UC and NSCLC patients 9 of 9 responses have confirmed by RECIST 1.1 (5 confirmed responses out of 18 evaluable patients reported on July 8, 2024, IDE397 webcast) MTAP-deletion UC: 40% (4 of 10) confirmed ORR and 3 pts on treatment >250 days MTAP-deletion SqNSCLC: ~38% (3 of 8) confirmed ORR and 4...Read more
INZ-701 was well-tolerated and significantly increased plasma pyrophosphate (PPi) levels in patients with end-stage kidney disease (ESKD) undergoing hemodialysis; low PPi levels are associated with calciphylaxis, a rare, life-threatening complication of ESKD Company plans to initiate a registrational trial in calciphylaxis in 2025 subject to regulatory alignment and sufficient funding BOSTON, Oct. 24, 2024 (GLOBE NEWSWIRE) --...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
Pharmacokinetic data up to 9 months continue to support potential best-in-class profile, including a half-life of approximately 75 days, approximately three to five times that of currently approved treatments for moderate-to-severe AD Key biomarker data from single doses of APG777 show near complete inhibition of pSTAT6 and sustained TARC inhibition up to 9 months Proof-of-concept data from the ongoing APG777 Phase 2 clinical trial in...Read more
Objective response rate of 34% (2 responses pending confirmation) and 25% (confirmed) in the 100mg daily dose expansion cohort (n=32) of ARC-20, a Phase 1/1b study of casdatifan in metastatic clear cell renal cell carcinoma (ccRCC) Low rate of primary progression (19%) and high rate of disease control (81%) was observed in the 100mg expansion cohort with many of those patients still on treatment Arcus will host a conference call...Read more
Interim data from ongoing trial of PRT3789 showed additional clinical activity at higher doses in patients with non-small cell lung cancer (NSCLC) First safety data presented from combination study of PRT3789 and docetaxel demonstrated an acceptable safety profile First preclinical proof-of-concept data presented from precision antibody drug conjugate program deploying a novel SMARCA2/4 dual degrader payload WILMINGTON, Del., Oct....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
Objective response rate (ORR) of 74% across all tested dose levels of ZL-1310 in patients with recurrent extensive-stage small cell lung cancer (SCLC) Favorable pharmacokinetics (PK) and safety profile support continued evaluation of ZL-1310 as a single agent and in combination for the treatment of extensive-stage SCLC in recurrent and first-line therapy Zai Lab to host conference call and webcast to discuss data on October 24, 2024, at...Read more
Data presented at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics CAMBRIDGE, Mass. & MONTREAL / Oct 23, 2024 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today presented updated data highlighting the benefits of its individualized schedule for the management of anemia in the Phase 1 MYTHIC clinical trial treating...Read more
Encouraging progression-free survival and overall survival profile Safety findings consistent with previously reported data, no new safety signals observed Investor webcast to be held Friday, October 25 at 12:00 p.m. Eastern Time (ET) REDWOOD CITY, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today...Read more
Global Phase 1 clinical trial will evaluate the safety and tolerability of ZW171 in treatment of ovarian cancer, non-small cell lung cancer (NSCLC), and other mesothelin (MSLN) expressing cancers VANCOUVER, British Columbia, Oct. 21, 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...Read more
Clinical Complete Responses Observed in 4 out of 5 Patients in Subset of Patients with Low Grade Disease; Evidence of Bladder Urothelial Field Effect in Non-Target Tumors Favorable Safety Profile Observed; Only Grade 1 Drug-Related Adverse Events Reported in Less Than 10% of Patients Aura Hosting Virtual Urologic Oncology Investor Event with Key Opinion Leaders at 4.30 pm ET Today BOSTON, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Aura...Read more
First safety data anticipated before year end with assessment of PK/PD relationships to follow in H1’CY2025 SYDNEY, AUSTRALIA, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the first part (Part A, single dose) of the placebo-controlled,...Read more
NORWOOD, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, announced today that it has completed enrollment of the dose escalation part of its bridging Phase 1 clinical trial of CRB-701 (SYS6002). The dose escalation part of this open label study (NCT06265727) is being conducted in the US and the UK. The...Read more
Demonstrated Favorable Safety Profile of REQORSA AUSTIN, Texas, Oct. 15, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that it has completed the 0.09 mg/kg dose group of the Phase 1 dose escalation portion of the Acclaim-3 clinical trial of Reqorsa® Gene Therapy...Read more
Patient showed clinical activity after initial treatment, with necrosis, inflammation, and T cell infiltration observed in tumor biopsy from the lowest dose SAN JOSE, Calif., Oct. 15, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has administered the second dose of its CAR-T therapy to an...Read more
NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, provides an update regarding key clinical advancements in its Phase 1 trial of lead drug candidate Decoy20. The Safety Review Committee examined weekly administration data at the lower Decoy20 dose and cleared...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
Subcutaneously administered AK006 showed approximately 77% bioavailability and prolonged receptor occupancy on mast cells Subcutaneous AK006 was well-tolerated with a favorable safety profile Top-line Phase 1 results of Intravenous AK006 in patients with CSU are expected in early Q1 of 2025 SAN CARLOS, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a biotechnology company developing AK006...Read more
Quantitative Electroencephalogram (qEEG) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid (NAS), confirmed GABAA modulation Rapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone Promising results support continued development of oral brexanolone for the treatment of neuropsychiatric disorders SALT LAKE CITY, Oct. 10, 2024 /PRNewswire/ --...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
Patients currently remain on study for continued treatment with TTX-MC138 No significant safety or dose limiting toxicities reported TTX-MC138, an antisense oligonucleotide conjugated to TransCode’s proprietary TTX delivery system, is designed to inhibit microRNA-10b, a known driver of metastasis in multiple cancers microRNA technology was recognized with the 2024 Nobel Prize in Physiology and Medicine TransCode is the...Read more
Company to host conference call and webcast today, October 10, at 9:00 am EDT/3:00 pm CEST Company announces updated Phase 1b clinical data on ACTengine® IMA203 targeting PRAME in 28 heavily pretreated metastatic melanoma patients with substantially enhanced maturity compared to the last data update in May 2024 and provides the first report on progression-free survival (PFS) and overall survival (OS) Based on the Phase 1b data, the...Read more
LOS ALTOS, Calif., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the successful completion of the UNI-494 Phase 1 study in healthy volunteers. “We are pleased to announce the successful completion of the UNI-494 Phase 1 study that informs our next steps for...Read more
Reductions in Very Long-Chain Fatty Acids and Plasma Lipid Levels Observed After 28 Days of Once Daily Dosing VK0214 Shown to be Safe and Well-Tolerated in 28-Day Study SAN DIEGO, Oct. 9, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced positive data from the...Read more
MALVERN, Pa., Oct. 09, 2024 (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 U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the investigational new drug application for the Phase 1 clinical trial evaluating OCU200, a recombinant...Read more
Kineta has completed enrollment in the monotherapy cohorts of the Phase 1 VISTA-101 clinical trial. The ongoing Phase 1 study is now enrolling patients into cohorts evaluating KVA12123 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The company will present additional scientific data in 2024 at an upcoming scientific meeting. SEATTLE, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (OTC Pink: KANT)...Read more
HOUSTON / Oct 08, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable ongoing efficacy results from follow-up visits for Patient 4 and Patient 6 in its Deltacel-01 Phase 1 clinical trial. This trial is evaluating Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who...Read more
SAN DIEGO, Oct. 8, 2024 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced it has completed enrollment of 26 patients in the fourth cohort in the Phase 1b MAD study of RGLS8429 for the treatment of ADPKD. "The completion of enrollment of our final cohort marks an...Read more
Investigational agent in development as a one dose treatment or prevention of seasonal and pandemic influenza A dose ranging, Phase 1 study in healthy volunteers demonstrated positive tolerability results and plasma levels in the predicted therapeutic window, enabling selection of Phase 2 dose Preclinical data showed potent inhibition of drug-resistant and bird influenza viruses Phase 2 study expected to begin in H1 2025 Improved...Read more
BENGALURU, India & HYDERABAD, India / Oct 08, 2024 / Business Wire / Aurigene Oncology Limited, a wholly-owned subsidiary of Dr. Reddy’s Laboratories Limited and a clinical stage biotech committed to bringing in novel and effective therapeutics for the treatment of cancer, has announced the Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) from the SWASTH study – India’s first trial for a novel autologous BCMA directed CAR-T cell...Read more
GENEVA, SWITZERLAND / ACCESSWIRE / October 8, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF) (OTCQB:RLFTF) (OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced promising preliminary results from its proof-of-concept, investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of epidermolysis...Read more
VIP943 demonstrates promising safety and tolerability and achieves two complete responses to date in Phase 1 dose-escalation study, reinforcing the program’s potential and validating the VersAptx™ Platform technology Vincerx focusing resources on continued development of VIP943 Expected cash runway into early 2025 Management to host webcast and Q&A today at 5:00 PM EDT to review pipeline and corporate updates, followed by...Read more
WILMETTE, Ill., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced that the Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) is now active and recruiting patients with advanced cancers. The Phase 1a trial is an open-label...Read more
Results of the Phase I clinical trial, presented at the bi-annual Contrast Media Research symposium in Oslo, Norway, conclude that this novel macrocyclic manganese-based contrast agent was well tolerated with no serious adverse events, dose-limiting toxicities or clinically relevant findings reported. If approved, this agent could provide an alternative to gadolinium-based contrast agents and address the potential impact of post-patient...Read more
Treatment with 45mg paxalisib and radiotherapy demonstrated 67% partial response (PR) Over two-thirds of the patients at maximum tolerated dose (MTD) achieved intracranial response which compares favorably to historical response rates for whole brain radiation therapy alone SYDNEY, Oct. 2, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, announced the presentation of data...Read more
Potential best-in-class targeted treatment for Netherton syndrome is company’s first protein therapeutic to advance to the clinic Initial data from trial expected by end of 2025 RESEARCH TRIANGLE PARK, N.C., Oct. 02, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the enrollment of the first participant in a Phase 1 trial evaluating BCX17725, a potent and selective investigational...Read more
HOUSTON / Oct 01, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports good safety and favorable ongoing efficacy results from the 10-month follow-up visit of the first patient treated in its Deltacel-01 Phase 1 clinical trial. This trial is evaluating Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small...Read more
CAMBRIDGE, Mass. & MONTREAL / Sep 30, 2024 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported data highlighting the clinical benefits of camonsertib, a potential best-in-class oral small molecule ATR inhibitor, combined with palliative radiation for the treatment of metastatic tumors harboring an ataxia-telangiectasia-mutated (ATM)...Read more
Data Revealed Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics (PK) Top-Line Data Readout from the MAD Part 2 Expected in the First Quarter of 2025 Planned Phase 1 Part 3 Will Evaluate Early Proof of Concept CAMBRIDGE, Mass., Sept. 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced...Read more
Achieves primary endpoint showing a linear relationship between adherence to PoNS Therapy® in Phase 2 and improvement in DGI scores from Phase 1 to end of treatment at week 14 Confirms the therapeutic benefits of PoNS Therapy for gait deficit improvement in people with MS NEWTOWN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company...Read more
Ratutrelvir was well-tolerated for 10 days and achieved consistent plasma levels in the predicted therapeutic window, without the need for co-administration of ritonavir Phase 2a study expected to begin in H1 2025 in patients with COVID Improving COVID care is an ongoing need, with approximately 50,000 US deaths in 2023 NEWTOWN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or...Read more
Activated clinical sites for Phase 1 trial of ADI-001 in autoimmune diseases, including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) Enrollment open for patients with LN; enrollment in SLE, SSC, and AAV expected to open in the fourth quarter of 2024 REDWOOD CITY, Calif. & BOSTON / Sep 30, 2024 / Business Wire /...Read more
Updated Phase 1 data presented at ESH-iCMLf 26th Annual John Goldman Conference Reported cumulative MMR rate of 44% (8/18) by 24 weeks, with stable or deepening responses between weeks 12 and 24, which continues to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs ELVN-001 remains well-tolerated with no dose reductions reported with 39 patients enrolled and a median treatment duration of 20 weeks at...Read more
Data showed a 91% ORR with P-BCMA-ALLO1 in an optimized lymphodepletion arm, including a 100% ORR in BCMA-naïve patients, and an 86% ORR in those who had received at least one prior BCMA- and/or GPRC5D-targeting treatment modality Differentiated P-BCMA-ALLO1 safety results with no dose-limiting toxicities, low rates of CRS and ICANS all Grade 2 or less and no graft vs. host disease or Parkinsonism P-BCMA-ALLO1 was recently...Read more
Updated data show 100 percent overall response rate with 56 percent of patients achieving complete response or better with weekly dosing, supporting the combinability of the GPRC5D bispecific antibody Safety profile, including infection rates, similar to TALVEY® and DARZALEX FASPRO® monotherapies RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced updated results from the...Read more
BOTHELL, Wash., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces dosing of the first subjects in the multiple-ascending dose (MAD) portion of the Phase 1 study with CDI-988, its potent, broad-spectrum, oral pan-viral protease inhibitor. Topline study results are expected in late 2024 or early 2025. CDI-988 was specifically designed and developed using Cocrystal’s proprietary...Read more
Single patient in 2mg cohort with stage 3 colon cancer who received 4 prior lines of therapy achieves prolonged stable disease and remains on drug into 6th dosing cycle No treatment-related adverse events (TRAEs) or dose-limiting toxicities (DLTs) observed to date, including no rash or gastrointestinal (GI) AEs Systemic exposure at steady-state enables constant target inhibition while avoiding peak plasma...Read more
Investigational immunotherapy candidate, VTP-1000, seeks to address significant unmet need in people with celiac disease. An estimated one in 100 people globally suffer from celiac disease, for which no approved treatments currently exist. The first-in-human Phase 1 trial aims to evaluate the safety and tolerability in adults with celiac disease. OXFORD, United Kingdom, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics...Read more
SAN DIEGO / Sep 24, 2024 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, today announced statistically significant, dose dependent increases of interleukin-10 (IL-10) in response to Gemini treatment, using a high sensitivity analysis. This additional...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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