First patient in Cohort four has been treated with TTX-MC138 Ten patients have been treated with TTX-MC138 at escalating dose levels Additional patients being evaluated for eligibility for expanded enrollment No significant safety or dose limiting toxicities have been reported BOSTON, March 27, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer...Read more
Preclinical data demonstrates that SPY003 is highly potent and has potential for quarterly or biannual dosing, suggesting opportunity for improved efficacy and convenience over first-generation anti-IL-23 monoclonal antibodies Interim pharmacokinetic and safety data from healthy volunteers for SPY003 anticipated in the second half of 2025 Subject to interim results, Spyre expects to incorporate SPY003 into its...Read more
Positive Topline Data from the Fourth Cohort of Patients Consistent demonstration of polycystin (PC) biomarker impact confirming 300 mg fixed dose selection to achieve optimal kidney exposure Patients receiving 300 mg farabursen demonstrated a mean halting of height-adjusted total kidney volume (htTKV) growth over 4 months Exploratory analysis of patients from high-dose cohorts demonstrates statistical significance...Read more
SON-1010 is being studied as a combination therapy with trabectedin (Yondelis®), the first FDA-approved treatment for two types of advanced soft tissue sarcoma after failure of standard chemotherapy, due to the potential for immune mechanism synergies and enhancement of progression-free survival (PFS) The Safety Review Committee found no unexpected toxicities in early dosing of SON-1010 in the first 7 patients at the maximum tolerated...Read more
SAN DIEGO and LOS ANGELES, March 26, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, and City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, are pleased to jointly announce progress from a phase 1 clinical trial utilizing Calidi’s...Read more
AGOURA HILLS, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or “Our”), ”), a leader in RNA-based therapeutics, announced today the successful completion of a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101,an antisense therapeutic targeting...Read more
Clinical Complete Responses Observed with Single Low-Dose of Bel-sar in Patients with Intermediate and High-Risk NMIBC with Robust Cell-Mediated Immunity and Urothelial Field Effect Favorable Safety Profile; Only Grade 1 Drug-Related Adverse Events Reported in Less Than 10% of Patients Data Supports Potential for a Paradigm Shifting Approach in the Front-Line Treatment of patients with NMIBC Aura Hosting Virtual Urologic Oncology...Read more
NEW YORK, March 20, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, today provided an update on key pharmacodynamic findings from the weekly dosing cohort of its ongoing Phase 1 trial of Decoy20. As announced in last week’s earnings release, the Company has now enrolled more than 20 patients in the weekly...Read more
Weekly subcutaneous administration of sabirnetug was well-tolerated in the Phase 1 study Systemic exposure following subcutaneous administration supports further clinical development Development of sabirnetug delivered subcutaneously has the potential for decreased treatment burden and increased patient convenience NEWTON, Mass., March 19, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage...Read more
OCU200 has a very favorable safety and tolerability profile No serious adverse events related to the study drug have been reported Dosing of the second cohort has been approved MALVERN, Pa., March 18, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Data and Safety Monitoring Board (DSMB) for the...Read more
Antitumor activity observed with confirmed partial responses in 50% of patients at highest dose tested to date, across multiple tumor types PLN-101095 was generally well tolerated across all doses SOUTH SAN FRANCISCO, Calif., March 17, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced data from the first three of five potential cohorts of its ongoing Phase 1 dose escalation clinical trial evaluating...Read more
Positive preliminary data from all five single ascending dose (SAD) cohorts and first three completed multiple ascending dose (MAD) cohorts support safety and tolerability of PALI-2108 No serious adverse events (SAEs) and no treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs seen to date On track to report topline data in first half of 2025 Carlsbad, CA, March 14, 2025 (GLOBE NEWSWIRE) -- Palisade Bio,...Read more
BETHESDA, Md., March 14, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the dosing of the first participant with Parkinson’s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company’s lead allosteric small molecule in development...Read more
Long-lasting in vivo antibody production: DMAb levels remained stable for 72 weeks in all participants (n=24) who have reached that timepoint No anti-drug antibodies (ADA): no immune rejection of the DMAbs was detected across ~1,000 blood samples, unlike other gene-based antibody delivery approaches where ADA formation has been a challenge Well-tolerated: most common side effects were mild, temporary injection site reactions...Read more
Miniature, twice-yearly GLP-1 (exenatide) implant under development for chronic weight management NPM-115 has demonstrated comparable preclinical weight loss to injections of semaglutide, the active ingredient in Ozempic®/Wegovy® Rapid full study enrollment with all 24 subjects initiating the 8-week run-in period within four weeks; top-line study results expected in mid-2025 ALAMEDA, Calif. / Mar 13, 2025 / Business Wire / Vivani...Read more
Phase 1 Data Indicate Potential for Use of Once-Yearly Lenacapavir for HIV Prevention, with Plans to Launch a Phase 3 Trial in 2H 2025 Also at CROI: New PURPOSE 1 Data Showcasing Preference for Twice-Yearly Lenacapavir vs. Once-Daily Orals and In-Depth Look at Adolescent Pharmacokinetic, Safety and Efficacy Data FOSTER CITY, Calif. / Mar 11, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first data...Read more
Represents first ever triplet combination using targeted radiotherapy as a backbone therapy in AML with initial clinical data expected in 2H:2025 Expansion into frontline setting greatly expands potential addressable patient opportunity for Actimab-A Triplet combination supported by previously completed Phase 1 trials of Actimab-A + Venetoclax and Actimab-A + CLAG-M demonstrating Actimab-A's mutation agnostic and...Read more
Topline data expected as early as mid-2025 SOUTH SAN FRANCISCO, Calif., March 11, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. “We are pleased to initiate a Phase 1 trial for our oral bivalent norovirus vaccine,...Read more
BOTHELL, Wash. / Mar 10, 2025 / Business Wire / Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC. “Immunome is developing differentiated ADCs that we believe can greatly benefit cancer patients,” said Bob Lechleider, M.D., Chief...Read more
Enrollment completed ahead of schedule in the first dose expansion cohort Momentum continues with first patient dosed in the second expansion cohort Topline results from the 40-patient dose expansion study expected in 1H 2026 Phase 1b dose escalation data expected to be presented in 2H 2025 ROCKVILLE, Md., March 07, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on...Read more
Marlborough, Massachusetts--(Newsfile Corp. - March 5, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio announced today that it has fulfilled the required enrollment for safety in its third dose cohort in its Phase 1b dose escalating...Read more
SAN DIEGO, March 5, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of investigational compound NBI-1140675 in healthy adult participants. NBI-1140675 is an investigational, oral, selective second-generation small molecule inhibitor of the vesicular monoamine transporter 2 (VMAT2) in...Read more
Exploratory phase 1b trial will evaluate safety, tolerability and effect on pain intensit Topline data readout planned for early 2026 SAN DIEGO / Mar 04, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today initiated patient...Read more
MIAMI, FL / ACCESS Newswire / March 4, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced the approval and upcoming initiation of its Phase 1 clinical trial for Ketamir-2, the Company's novel oral ketamine analog in development for neuropathic pain, with subject recruitment scheduled to begin in Q1...Read more
SAN DIEGO & COPENHAGEN, Denmark / Mar 03, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) and Saniona (OMX: SANION) today announced the successful completion of the two originally planned cohorts in their Phase 1 multiple-ascending-dose MAD study (EUCT: 2024-514514-12-00) of ACP-711, formerly SAN711, in healthy volunteers. In the study, ACP-711 was safe and generally well tolerated across all dosing cohorts. There...Read more
Nes-Ziona, Israel, March 03, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive interim six-month efficacy data from the Phase I stage of its randomized, multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis. Key highlights: Statistically significant 47.0%...Read more
Optimized subcutaneous administration of BHV-1300 achieved rapid, deep and sustained lowering of IgG, differentiating Biohaven's new small molecule class of degraders from the monoclonal antibody FcRn-targeting competition. Up to 84% reduction of total IgG was observed with a median reduction of 80% after subcutaneous weekly 1000 mg dosing in the ongoing Phase 1 study. Subcutaneous BHV-1300 achieved progressive reductions in IgG...Read more
Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately 60-day half-life APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by successful completion of preclinical combination toxicology studies and positive APG990 interim Phase 1 results; trial planned to initiate this year with readout expected in second half of 2026 Webcast...Read more
BERWYN, Pa. / Feb 27, 2025 / Business Wire / Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, would like to congratulate Nanomerics on completing a human study using the Molecular Envelope Technology (MET) and showing no moderate to...Read more
Results of IMNN-101 Proof-of-Concept study demonstrate persistent immunogenicity in trial participants and further validate PlaCCine® technology IMNN-101 induced 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4 IMNN-101 continues to show an acceptable safety profile LAWRENCEVILLE, N.J., Feb. 26, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on...Read more
SAN JOSE, Calif., Feb. 26, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced has it has dosed its final patient in the third cohort of its ongoing Phase 1 clinical trial evaluating its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer. The study is being conducted through a...Read more
Phase 1a study will evaluate single and multiple ascending doses of ABI-6250 in healthy participants with data expected in Q3 2025 Biomarker of ABI-6250 target engagement, serum bile acids, will be assessed in addition to safety and pharmacokinetic measures SOUTH SAN FRANCISCO, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics...Read more
Safety Review Committee Found No Safety Concerns Following Milestone Trial TORONTO, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), today announced that it has completed its trial entitled “A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy...Read more
AUSTIN, Texas, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced the completion of the ReSPECT-LM Phase 1 single-dose escalation trial, having determined an RP2D. The ReSPECT-LM single-dose escalation trial...Read more
Topline data expected Mid-Year SAN DIEGO / Feb 26, 2025 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on rebalancing inflammation to optimize health, announced dosing of the first patient in the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of intravenous single ascending doses of Gemini in...Read more
Rapid Enrollment and Dosing of First Patients Encouraging and Underscores Unmet Need for Better Treatment Options for Alzheimer’s Disease Six-month Interim Results Expected in 1H 2026 with Topline Results Anticipated in 2H 2026 CAMBRIDGE, Massachusetts, Feb. 25, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody...Read more
Significant mean splicing correction of 29.1% following a single dose of PGN-EDODM1 at 10 mg/kg PGN-EDODM1 observed to have favorable emerging safety profile Conference call scheduled today at 8:00 a.m. ET BOSTON / Feb 24, 2025 / Business Wire / PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of...Read more
ABI-1179 was well-tolerated, with a half-life of approximately four days and high exposure across the dose range evaluated supporting the potential for once-weekly oral administration at a low dose Assembly Bio to move ABI-1179 directly into Phase 1b portion of the ongoing Phase 1a/b study in participants with recurrent genital herpes Phase 1b to run concurrently with ongoing Phase 1b study for ABI-5366, with interim data...Read more
Oral, once-daily doses of VYN202 being evaluated in subjects with moderate-to-severe plaque psoriasis Top-line data from the 12-week double-blind trial expected by year-end 2025 Phase 1b trial designed to provide key insights into VYN202’s potential across a range of chronic, immune-mediated diseases BRIDGEWATER, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a...Read more
ELIMINATE-B Phase 1 dose finding study for chronic Hepatitis B executing on schedule with completion of first dose administration for cohort 1 (n=3 patients) PBGENE-HBV, the first LNP gene editing technology studied for Hepatitis B, was safe and well tolerated PBGENE-HBV demonstrated substantial antiviral activity measured by reduction of Hepatitis B surface antigen (HBsAg) after one administration at the lowest dose level First...Read more
HOUSTON / Feb 18, 2025 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports continued favorable efficacy results from the 10-month follow-up visit for the fourth patient enrolled in its Deltacel-01 Phase 1 clinical trial and provides an enrollment update. 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...Read more
NEW YORK, Feb. 14, 2025 (GLOBE NEWSWIRE) -- February 14, 2025 – IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, yesterday presented Phase 1 data on its allogeneic gamma-delta T cell therapy, INB-100, at the 2025 Transplantation & Cellular Therapy (TCT) Meetings in Hawaii. The data, previously announced, reinforce INB-100’s potential to significantly...Read more
First Solid Tumor Patient Treated with Second, Higher Dose in Phase 1/1b BP1001-A Clinical Trial Experienced Tumor Reduction and Continued Stable Disease Reports Continued Patient Progress from Phase 2 Triple Combination Study of Prexigebersen in Acute Myeloid Leukemia (AML) HOUSTON, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize®...Read more
Study Progresses to Fourth Higher 90 mg/m2 Dose Cohort Compelling Patient Response Highlighted by Stable Disease and Significant Reduction in Blast Count After One Treatment Cycle HOUSTON, Feb. 12, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity...Read more
100% of acute myeloid leukemia (AML) patients across both original and expansion cohorts remain in complete remission (CR), with a median follow-up of 20.1 months AML patients treated demonstrated one-year progression-free survival (PFS) and overall survival (OS), exceeding real-world control groups Patients treated with INB-100 demonstrating prolonged and durable remissions supported by gamma-delta T cell persistence beyond one...Read more
THB335 Phase 1 data support advancement into Phase 2 clinical trial in chronic spontaneous urticaria (CSU) Company initiating process to leverage balance sheet strength to maximize shareholder value Cash and cash equivalents of approximately $285 million as of December 31, 2024 (unaudited) Management to hold conference call/webcast today Tuesday, February 11, 2025, at 8:00 a.m. EST to discuss clinical results and...Read more
Company remains on track to report Phase 1a data from both the Single- and Multiple-Ascending Dose (SAD and MAD) cohorts in the healthy volunteer portion of the study in 1Q 2025 at an upcoming major medical meeting The Phase 1b portion of the trial, in DMD patients, is underway with the intention of enrolling up to 10 adult volunteers with genetically confirmed DMD during 1Q 2025 Phase 2 IND filing on track to be submitted by end of 1Q...Read more
WVE-007 is a novel, long-acting GalNAc-siRNA targeting INHBE mRNA – a genetically validated target that provides a new approach for healthy, sustainable weight loss (fat loss with muscle preservation) Proof-of-concept clinical data from INLIGHT are expected in 2025 CAMBRIDGE, Mass., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad...Read more
No significant safety or dose limiting toxicities reported PK data from Cohorts 1 and 2 consistent with preclinical and Phase 0 trial results BOSTON, Feb. 6, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced that Cohort 3 of its Phase 1 clinical trial enrolled three patients and all have been dosed with...Read more
Results from the Phase 1 single ascending dose study support proceeding to develop a Phase 2 trial for the prevention of kidney transplant rejection TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses TNX-1500 showed mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses supporting monthly dosing for future efficacy trials TNX-1500 was generally...Read more
SRC recommended that the trial escalate to the next dose level of 22mg capsule No dose-limiting toxicities (DLT’s) or rash observed to date in either capsule or tablet formulations MIAMI, Feb. 05, 2025 (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...Read more
SYDNEY, Jan. 30, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) an oncology-focused drug development company, is pleased to announce the regulatory approval and launch of a clinical trial evaluating the combination of paxalisib and immunotherapy in patients with advanced breast cancer. This novel treatment combination offers what is believed to be a unique approach to targeting this highly aggressive and...Read more
HB-500 is a next-generation therapeutic vaccine being developed in collaboration with Gilead Sciences, Inc. (Gilead) as a potential component of a curative regimen for human immunodeficiency virus (HIV) Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial Primary completion expected H2 2025 NEW YORK and VIENNA, Jan. 30, 2025 (GLOBE NEWSWIRE) --...Read more
SAN MATEO, Calif., Jan. 29, 2025 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, and Oqory, Inc., a private biopharmaceutical company dedicated to developing next-generation antibody drug conjugates (ADCs) for the treatment of cancer, today highlighted Phase 1a/1b data for Oqory’s anti-TROP2 ADC,...Read more
Topline data from an interim analysis of the fourth cohort of its Phase 1b Multiple-Ascending Dose (MAD) clinical trial showed continued mechanistic dose response Exploratory results of imaging-based biomarkers continued to show reduction in height-adjusted total kidney volume (htTKV) growth rate Successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) with agreement on key components of a Phase 3 single...Read more
AK006 did not demonstrate therapeutic activity in CSU Allakos will discontinue further development of AK006, reduce workforce by 75% and explore strategic alternatives Management to host conference call and webcast today at 8:30 am E.T. SAN CARLOS, Calif., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Allakos Inc. (Company) (Nasdaq: ALLK), today announced topline results from its phase 1 clinical trial of AK006 in chronic...Read more
Initial data from the Phase 1 trial expected in 2025 SAN FRANCISCO, CALIFORNIA, Jan. 27, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE® platform, today announced that the first patient was dosed in a Phase 1 trial evaluating GTB-3650, its...Read more
IPH4502 is a novel and differentiated topoisomerase I inhibitor ADC conjugated to exatecan targeting Nectin-4 MARSEILLE, France / Jan 27, 2025 / Business Wire / Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the first patient was dosed in its Phase 1 study (NCT06781983), investigating the safety and tolerability of IPH4502, an innovative Antibody-Drug Conjugate (ADC),...Read more
Early Proof-of-Concept Results from the Phase 1a Trial Anticipated in Q3 2025 BOSTON / Jan 23, 2025 / Business Wire / Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced initiation of a Phase 1a clinical trial of STAR-0310 in healthy subjects. STAR-0310, a high affinity monoclonal antibody OX40 antagonist that...Read more
Phase I completed in healthy volunteers with pharmacokinetic data supporting dosing for both therapeutic and further development for bird flu prevention NEWTOWN, Pa., Jan. 23, 2025 /PRNewswire/ -- Traws Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced completion of...Read more
Safety, tolerability, pharmacokinetic, and pharmacodynamic profile supports continued development of VG-3927 as potential once-daily oral therapy for Alzheimer’s disease (AD) Robust and dose-dependent reductions of sTREM2 were achieved demonstrating sustained functional target engagement Company plans to advance VG-3927 into a Phase 2 trial in the third quarter of 2025; Selects 25mg QD oral as a dose that fully engages...Read more
Positive Phase 1b Data Confirms Overdose Protection for Highest Dosage Form of PF614-MPAR SAN DIEGO, CA / ACCESS Newswire / January 22, 2025 / 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 interim data from its second clinical trial to...Read more
SAN DIEGO, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Cullgen Inc. (“Cullgen”), a privately-held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE™ platform to discover and advance therapeutics for the treatment of cancer and other diseases, today announced that it has begun dosing in human subjects to evaluate its potential first-in-class, oral, pan-TRK protein degrader for the treatment of...Read more
SAN DIEGO, Jan. 21, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, today announced preliminary efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma (CRC)....Read more
Company will move forward with trial sites across North America CAMBRIDGE, Mass. / Jan 21, 2025 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the Phase 1 clinical trial of AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for people living with amyotrophic...Read more
Provides Enrollment Update for Phase 1 Study in Late-Stage Non-small Cell Lung Cancer HOUSTON / Jan 21, 2025 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable efficacy results from the 12-month follow-up visit for the first patient and the two-month follow-up visit for the seventh patient enrolled in its Deltacel-01 Phase 1 clinical trial, and provides an enrollment update. This...Read more
Dosing to Commence Mid-February Topline data expected Mid-Year SAN DIEGO / Jan 21, 2025 / 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 treatment of disease, announced today that it has started its PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical...Read more
Company on track to report topline data in first half of 2025 Positive preliminary data from all five single ascending dose (SAD) cohorts ranging from 15mg to 450mg support safety and tolerability of PALI-2108 Continued progress toward Phase 1b/2a of PALI-2108 trial for the treatment of UC Carlsbad, CA, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a...Read more
MALVERN, Pa., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME). “OCU200 has the potential to change the treatment landscape for DME,...Read more
Set to begin larger Phase 2b study in sarcopenia and new trial in GLP-1-induced sarcopenia and frailty Transformative potential for novel TNF-alpha inhibitor drug: Estimated $40 billion TNF inhibitor market and $50 billion GLP-1 agonist market BALTIMORE / Jan 15, 2025 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral...Read more
CTIM-76 Phase 1 trial focused on CLDN6-positive gynecologic and testicular cancers Trial marks key milestone in driving pipeline progress PHILADELPHIA, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating...Read more
Interim data from Cohort 4 expected Q1 2025 MIAMI, Jan. 14, 2025 (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 type 1 (NF1) and other cancer indications, today announced it has opened three clinical trial sites in Eastern Europe. These...Read more
Follows Safety Review Committee (SRC) approval based on safety data from patients in Cohorts 1 and 2 No significant safety or dose limiting toxicities reported in Cohorts 1 and 2 PK data from Cohorts 1 and 2 consistent with preclinical and Phase 0 trial results BOSTON, Jan. 14, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA...Read more
The first selective Fatty Acid Binding Protein 5 inhibitor safely administered to human subjects Initial safety and pharmacokinetic data expected during the first half 2025 SOLANA BEACH, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, or dermatologic and...Read more
Announces encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with mCRPC Entered into clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab for the first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations Expects to report seven data readouts...Read more
Pathologic Complete Response reported for 2 patients with cutaneous Squamous Cell Carcinoma Marlborough, Massachusetts--(Newsfile Corp. - January 13, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio today announced pathologic...Read more
BURLINGAME, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data, which include previously reported results from cohort 1 of the trial and new data covering...Read more
Updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab continue to show promising anti-tumor activity and a differentiated safety profile in first-line cisplatin-ineligible metastatic urothelial cancer NECTIN4 gene amplification development strategy underway for zelenectide pevedotin in breast cancer, lung cancer and multiple tumors, with several Phase 1/2 trials planned to start in 2025 Emerging...Read more
Company also announces strong enrollment progress for REMAIN-1 weight maintenance pivotal study High demand from patients and physicians indicates significant interest in REMAIN-1 study and GLP-1 discontinuation; mid-point analysis on-track and anticipated in Q2 2025 BURLINGTON, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering pattern...Read more
CB-010 GALLOP Phase 1 trial initiated in lupus CB-012 AMpLify Phase 1 trial in r/r AML completes dose level 3 with no DLTs; enrolling patients at dose level 4 CB-010 ANTLER 2L LBCL and CB-011 CaMMouflage r/r MM Phase 1 clinical data expected in H1 2025 Sri Ryali appointed chief financial officer Caribou to present at 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, at 10:30 am PST BERKELEY, Calif., Jan. 12,...Read more
LAVA-1266 is a potent and selective bispecific anti-CD123 Gammabody® First-in-human study enrolling adult patients with CD123-expressing AML or MDS Initial Phase 1 data read-out expected by year-end 2025 UTRECHT, The Netherlands and PHILADELPHIA, Jan. 10, 2025 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, “LAVA,” “the Company”), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody®...Read more
LUNAR-H5N1 becomes the third STARR® mRNA vaccine candidate to enter clinic First Phase 1 participant injected December 2024 Interim Phase 1 data expected H2 2025 SAN DIEGO / Jan 10, 2025 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory...Read more
BELTSVILLE, Md., Jan. 10, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers. “Dosing the first patient in...Read more
CAMBRIDGE, Massachusetts, Jan. 10, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on developing precision therapies for neurodegenerative diseases, today announced the initiation of its Phase 1b clinical trial (PRECISE-AD) evaluating its lead therapeutic candidate, PMN310, in Alzheimer’s disease (AD). PMN310, a humanized IgG1 antibody, is engineered to selectively target...Read more
Emiltatug ledadotin observed to be generally well tolerated with differentiated safety and tolerability profile Promising clinical activity observed in patients with triple-negative breast cancer (TNBC) previously treated with topoisomerase-1 inhibitor (topo-1) ADCs; confirmed responses observed across all enrolled tumor types First expansion cohort initiated in patients with TNBC previously treated with at least one topo-1 ADC; dose...Read more
New SER-155 Phase 1b study biomarker data in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients demonstrate that SER-155 promoted epithelial barrier integrity and decreased systemic inflammatory biomarkers compared to placebo; data support the broader potential of Seres’ live biotherapeutics to target inflammatory and immune diseases SER-155 clinical results accepted for 2025 TANDEM Meeting oral presentation in...Read more
In the PET trial, RAP-219 achieved and exceeded target receptor occupancy, increasing support for the dosing regimen utilized in the ongoing Phase 2a trial in focal epilepsy; restricted neuroanatomical expression of TARP8 was confirmed In the MAD-2 trial, RAP-219 was observed to be generally well tolerated with faster titration and higher exposures than in the initial MAD trial Data underscore the potential broad therapeutic index of...Read more
Data show favorable safety and tolerability with dosing up to 800 mg for 10 days Plans to initiate human challenge study in 2025 in norovirus-infected subjects BOTHELL, Wash., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces favorable safety and tolerability results at dosing up to 800 mg per day for 10 consecutive days from the multiple-ascending dose (MAD) portion of...Read more
Compelling early clinical response signals for VIR-5818 and VIR-5500 in heavily pretreated patients with various solid tumors VIR-5818: In patients receiving doses ≥400 µg/kg, tumor shrinkage observed in 50% (10/20) of participants with various HER2-expressing cancers; confirmed partial responses in 33% (2/6) of participants with HER2-positive CRC VIR-5500: PSA declines in 100% (12/12) and PSA50 response confirmed in 58% (7/12)...Read more
Successfully dosed 6 patients in safety run-in segment, now accelerating enrollment Positive data from first four patients announced December 2024 NXC-201 is the only one-time CAR-T therapy in development for AL Amyloidosis Next program update Q1 2025 AL Amyloidosis is a life-threatening disorder of plasma cells in the bone marrow affecting ~33,000 patients in the U.S. LOS ANGELES, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Immix...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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