PASADENA, Calif. / Apr 24, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced today that it has dosed the first subjects in a Phase 1/2a clinical trial (NCT06209177) of ARO-CFB, the company’s investigational RNA interference (RNAi) therapeutic, in up to 66 healthy volunteers and patients with complement mediated kidney disease. James Hamilton, M.D., MBA, Chief of Discovery and Translational Medicine at...Read more
Phase 1 part of combined Phase 1/2 study initiated as part of pandemic preparedness against highly pathogenic avian influenza (H5N1) virus, considered to be potential future pandemic threat Study will assess monovalent vaccine candidate, encoding an influenza A H5-antigen using proprietary second-generation mRNA backbone Avian influenza is latest program progressing to clinical trials under broad infectious disease collaboration...Read more
Nes-Ziona, Israel, April 22, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first two patients have been dosed in the Company’s multi-country, randomized, controlled Phase I/II trial evaluating AllocetraTM in up to 160 patients with moderate to severe knee osteoarthritis. The Phase I/II multi-center trial is...Read more
MALVERN, Pa., April 19, 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 and vaccines, today announced that dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an...Read more
Primary safety endpoint met; VTP-200 was generally well-tolerated, with no treatment-related grade 3 or higher adverse events (AEs) or serious AEs (SAEs). Positive trends in clearance rate for both high-risk (hr)HPV (60%, Group 2) and cervical lesions (67%,Groups 2 and 5), were observed in the groups receiving the highest ChAdOx dose. Pooled data from the five different active dose groups demonstrated no statistically significant...Read more
SAN DIEGO, April 18, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the first patient has been dosed in the fourth cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors...Read more
First efficacy signals demonstrated for a gene therapy under development for Oculopharyngeal Muscular Dystrophy (OPMD) which affects ~15,000 patients worldwide BB-301 facilitated improvements across multiple measures of swallowing function in the first Phase 1b/2a clinical study subject as compared to pretreatment assessments conducted during the observational natural history portion of the study Virtual R&D Day being held today...Read more
Expansion Cohorts showed rapid, clinically meaningful improvement across multiple domains; improvements consistent or exceeding Dose-escalation Cohorts data at Day 170 Additional long-term data in Dose-escalation Cohorts showed increasing and sustained clinical benefit through Day 758 Company will host investor call at 8:00 a.m. ET NOVATO, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE)...Read more
STARMAP (Study Treating Acquired Resistance: MAPK Amplifications) is a first-in-human, 3-part, Phase 1/2 study of BBI-825 as a single agent and in combination with select targeted cancer therapies BBI-825 is a novel, oral, selective ribonucleotide reductase (RNR) inhibitor and Boundless Bio’s second extrachromosomal DNA (ecDNA)-directed therapy (ecDTx) to enter clinical development Preclinically, BBI-825 has demonstrated tumor growth...Read more
Povetacicept administered subcutaneously once every four weeks continues to be well tolerated in IgA nephropathy, with UPCR reductions of greater than 60% observed at 36 weeks, associated with remission, resolution of hematuria, and stable renal function (eGFR) Company reports successful end of phase 2 meeting with FDA, supporting advancement to a registrational, placebo-controlled phase 3 study of povetacicept in IgA nephropathy,...Read more
Twenty patients with indolent (n=18) and aggressive (n=2) R/R B-NHL received evorpacept plus standard rituximab and lenalidomide (“R2”) Evorpacept plus R2 was well tolerated with a safety profile similar to historical R2 The combination achieved promising initial activity with a best overall response rate (“ORR”) of 94% and a complete response rate (“CRR”) of 83% in patients with indolent R/R B-NHL (R2 historical CRR benchmark is...Read more
Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program PRINCETON, N.J. / Apr 08, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI® (adagrasib) in combination with cetuximab for the...Read more
Favorable safety and immunogenicity profile in ABCC6 Deficiency, with clinical improvements in vascular pathology, visual function and patient reported outcomes (PROs) Natural history study highlights stroke as common feature among patients with early-onset ABCC6 Deficiency Favorable safety, immunogenicity and clinical outcome data were maintained through 48 weeks in Cohorts 1-3 in ENPP1 Deficiency; Data from Cohort 4...Read more
SAN DIEGO, April 07, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced the presentation of interim results from ARTACUS, a Phase 1/2 clinical trial evaluating RP1 monotherapy for the treatment of skin cancers in patients who have had solid organ or hematopoietic cell transplants, by Michael R....Read more
Established Low Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial DSMB Approval to Proceed with Medium Dose Cohort Dosing Malvern, Pa., April 05, 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 and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the...Read more
Improved VELOS™ manufacturing process delivering higher cNeT doses Protocols updated to evaluate the benefit of enhanced host conditioning, with further data expected in 2H 2024 First three patients dosed in CHIRON and THETIS with enhanced host chemo-conditioning, along with IL-2 aligned to standard TIL therapy, show improved cNeT persistence and engraftment LONDON, April 04, 2024 (GLOBE NEWSWIRE) -- Achilles...Read more
Conducted initial pivotal study interactions with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA); Company has clear registration path for 4D-710 for treatment of cystic fibrosis (CF) lung disease in people with CF (pwCF) who are ineligible for or cannot tolerate approved CF modulator therapies AEROW clinical trial Phase 2 Expansion Cohort dose selection and initiation expected in Q2 2024, with...Read more
Deep Cyclic Inhibitor of the MAPK pathway demonstrated strong tumor growth inhibition in preclinical studies of RAF or RAS mutant tumors, both as monotherapy and in combination Phase 1 portion of the Phase 1/2a trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of IMM-6-415 and establish a candidate recommended Phase 2 dose (RP2D) Initial PK, PD and safety data expected in...Read more
Phase 1/2a End of Study Data: 70mg doses demonstrated substantial and sustained reductions in convulsive seizure frequency on top of the best available anti-seizure medicines; Median reductions of 85% (n=10) at 3 months and 74% (n=9) at 6 months after last dose Open Label Extension Studies: Durable reductions in seizures and clinically meaningful improvements in multiple measures of cognition and behavior were maintained over 12...Read more
STAR-0215 Dosed Once or Twice Over 6 Months Reduced Monthly Attack Rates by 90-96%, Supporting Chronic Dosing 2 or 4 Times Per Year 92-100% Decrease in Moderate or Severe Attacks and 91-95% Reduction in Attacks Requiring Rescue Medications with STAR-0215 Very Well-Tolerated with No Serious Adverse Events and No Discontinuations Phase 3 Initiation on Track for Q1 2025, with Top-Line Results Expected by Year End...Read more
Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 60% (50% CR) in 2nd line AML subjects AnnAraC has potential to fill significant unmet need and expected to increase 2nd line AML CRs more than double over existing 2nd line therapies All 82 Annamycin subjects (in multiple studies) continue to show no signs of cardiotoxicity during study; Lower toxicity profile than traditional intensive therapy Annamycin is...Read more
Rapid improvements demonstrated for proptosis, clinical activity scores, and diplopia versus placebo with a favorable safety profile Phase 2b/3 trial to be initiated in the second half of 2024 Conference call to review these data to be held at 8:30 a.m. ET today LOS ANGELES, March 20, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery...Read more
REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of...Read more
NUV-1511 is the Company’s first drug-drug conjugate (DDC) to enter the clinic NEW YORK / Mar 14, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic. “Dosing...Read more
IMM-1-104 has been well-tolerated, demonstrating the potential for a differentiated safety profile 100% suppression of acquired RAS alterations was observed in evaluable patients profiled for ctDNA and treated with IMM-1-104, supporting goal of Universal-RAS activity Target lesion regression observed in over half of patients treated with IMM-1-104 at 320mg or 240mg QD, with best individual lesion regression of -35.7% and...Read more
Vancouver, Canada, March 13, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a clinical- stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced that it has received approval from the Israeli Ministry of Health to commence its phase I/IIa clinical trial for alcohol use...Read more
MALVERN, Pa., March 13, 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 and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an...Read more
Partial response and stable disease reported in combination cohort, and durable stable disease observed in monotherapy cohorts No dose limiting toxicities observed at any dose level Cleared fifth of six monotherapy cohorts and second of four combination cohorts Kineta is actively exploring strategic alternatives to maximize value for all stakeholders SEATTLE, March 12, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a...Read more
Safety in the Phase 1b part of Sonnet's double-blind, randomized, controlled trial of SON‑080 was reviewed by the study's Data Safety Monitoring Board (DSMB) The adverse event profile and tolerability of SON-080 was consistent with data from previous IL-6 candidates, meeting the Phase 1b safety objective Sonnet will leverage this safety data to support initiation of a Phase 2 clinical trial in Diabetic Peripheral Neuropathy (DPN), a...Read more
- Preclinical data show ARO-DM1 reduces muscular DMPK expression and corrects spliceopathies, which could lead to improved muscle strength and function PASADENA, Calif. / Mar 08, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced today that it has dosed the first subjects in a Phase 1/2a double-blinded, placebo-controlled, dose-escalating study (NCT06138743) to evaluate single and multiple ascending doses...Read more
Insertion of a functional OTC gene through ARCUS in vivo gene editing may provide lasting clinical benefit for children with OTC deficiency who are in dire need for effective treatments CTA approval for ECUR-506 in the United Kingdom provides further regulatory support for Precision BioSciences’ ARCUS in vivo gene editing platform DURHAM, N.C. / Mar 06, 2024 / Business Wire / Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced...Read more
Phase 1/2 study is evaluating IPH6501, a first-in-class CD20-targeting tetraspecific natural killer cell engager, from ANKET® platform, for the treatment of CD20-expressing B-cell Non-Hodgkin's Lymphomas. MARSEILLE, France / Mar 06, 2024 / 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 1/2 multicenter trial...Read more
New three-month assessment in first patient at dose level 2 demonstrates robust microdystrophin expression Patient aged 12 years at dosing had expression level at 75.7% of control Early evidence of strength and motor function improvement observed On track to initiate pivotal trial in second half of 2024 Webcast this morning, Tuesday, March 5, 8:30 a.m. ET, with principal investigator ROCKVILLE, Md., March 5, 2024...Read more
US$5M grant supports study of pelareorep in combination with modified FOLFIRINOX +/- atezolizumab Testing with the most common therapies could facilitate broad use of pelareorep in pancreatic cancer patients SAN DIEGO and CALGARY, AB, March 5, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced it has submitted an amendment to...Read more
Ongoing Phase 1/2 clinical trial for NGN-401 to include additional patients in Cohort 1 and a dose-escalation cohort Both previously planned updates are expected to provide a more robust dataset to inform future registrational trial design Removal of staggered dosing in Cohort 1 expected to enable the anticipated completion of Cohort 1 dosing in the second half of 2024 Third patient dosed in Cohort 1 NEW YORK / Mar 04, 2024 /...Read more
Avidity accelerates global Phase 3 HARBOR™ study initiation to Q2 2024 following regulatory agreement on study design; primary endpoint is video hand opening time (vHOT) and secondary endpoints include muscle strength and activities of daily living Delpacibart etedesiran (AOC 1001) demonstrated consistent and durable improvements in myotonia, muscle strength and activities of daily living in people with DM1 in long-term data from...Read more
REVEAL adolescent and adult trial will proceed to high dose cohort following Independent Data Monitoring Committee approval of Company’s request to initiate dose escalation; dosing of first patient in cohort two (high dose, n=3) expected in Q2 2024 REVEAL adolescent and adult trial will now expand into the U.S. following submission to FDA (age 12+ protocol) Dosing of second patient in cohort one (low dose) of REVEAL pediatric trial...Read more
Trial will evaluate the effect of this combination therapy on minimal residual disease LAWRENCEVILLE, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2...Read more
NT219 was well tolerated Anti-tumor activity at relevant higher dose levels observed with 29% Objective Response Rate (ORR) and 71% Disease Control Rate (DCR) REHOVOT, Israel, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune...Read more
For the first time, patients with alcohol use disorder will receive the company's unique and proprietary psychedelic - MEAI Vancouver, Canada, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, is pleased to announce it...Read more
MALVERN, Pa., Feb. 22, 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 and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease. Stargardt...Read more
MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer...Read more
John W. Day, MD, PhD, Professor of Neurology and Pediatrics, and Director, Division of Neuromuscular Medicine, Stanford University School of Medicine and a principal investigator in END-DM1, ongoing natural history study will join Avidity management to present data from MARINA-OLE™ Avidity to host Volume 8 of investor and analyst event series via webcast March 4, 2024, at 8:00 a.m. ET SAN DIEGO, Feb. 15, 2024 /PRNewswire/...Read more
On track to complete enrollment of the chronic cohort in Q2 2024 Data readout from chronic cohort expected in Q3 2024 Planning underway to make NVG-291 available to placebo-treated subjects following cohort completion Vancouver, British Columbia--(Newsfile Corp. - February 15, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of...Read more
Presentations will Highlight Initial Data Announced in January 2024 Demonstrating Proof-of-Concept in its DM1 and DMD Programs, Validating the Promise of the FORCE™ Platform and Targeted Delivery to Muscle Additional Data from ACHIEVE and DELIVER Trials Expected in the Second Half of 2024 WALTHAM, Mass., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company...Read more
OCALA, Fla., Feb. 14, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the first subject has been dosed at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC Study”). The...Read more
BOSTON, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 1b/2 clinical trial evaluating the combination of samuraciclib (CT7001), an investigational oral and first-in-class inhibitor of CDK7, and vepdegestrant (ARV-471), an investigational oral PROTAC®...Read more
The ABILITY-1 Study is evaluating MDNA11, a highly selective long-acting IL-2 Superkine, in combination with KEYTRUDA® (pembrolizumab) for treatment of patients with advanced solid tumors MDNA11 continues to demonstrate encouraging single-agent activity from the monotherapy dose escalation portion of the ABILITY-1 Study Company expects to report results from both the monotherapy expansion and combination escalation and expansion arms...Read more
4D-310 demonstrated clinically meaningful cardiac endpoint improvements through 12-24 months in contractility (echocardiography), peak VO2 (cardiopulmonary exercise testing) and/or cardiac quality of life (KCCQ) in all five evaluable patients Cardiac biopsies were obtained from a patient at week 6 and 24 and showed robust and durable delivery, transgene expression and clearance of Gb3 substrate in cardiomyocytes No new...Read more
Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-655 of 150 mg once daily Phase 2 Designed with Registrational Intent for TKI Pre-Treated Patients with ALK-Positive NSCLC and Enables Preliminary Evaluation in the TKI-naïve Setting CAMBRIDGE, Mass., Feb. 12, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted...Read more
MILAN, Italy and NEW YORK, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a clinical-stage immuno-oncology (I/O) company developing a cell-based platform harnessing the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors, today announced that: We have successfully dosed the first of three patients in Cohort 8 (Temferon™ at 4x10^6/kg), the last cohort of the Phase 1 dose-ranging...Read more
Completed enrollment in cohort 2 of the Phase I/II AFFINITY DUCHENNE® trial of RGX-202, a potential one-time AAV Therapeutic for the treatment of Duchenne that includes an optimized transgene for a novel microdystrophin New three-month assessment in third patient at dose level 1 demonstrates largest increase in microdystrophin expression Patient aged 6.6 years old had expression level at 83.4% of control On track to initiate...Read more
NEW YORK, Feb. 06, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced the publication of results in Nature Communications from a phase 1/2 study of agenT-797 in patients with...Read more
Sustained elevated expression of alpha-galactosidase A (α-Gal A) activity maintained for up to three years for the longest-treated patient as of the data cutoff date. All 12 patients withdrawn from enzyme replacement therapy (ERT) remain off ERT, with sustained elevated α-Gal A activity observed for up to 19 months as of the data cutoff date. Total antibody (Ab) or neutralizing antibody (Nab) titers against α-Gal A decreased markedly in...Read more
No serious or treatment related adverse events in either the first or second cohort Second cohort demonstrated an average 60% reduction in Dysphasia Likert score and an average 80% reduction in Odynophagia Likert score First cohort maintaining signs of efficacy to six months Third cohort now fully dosed at five times the first cohort dose and two-and-a-half times the second cohort dose Results from third cohort are expected in the...Read more
Topline Safety, Tolerability and Immunogenicity Data from VAX-31 Phase 1/2 Study (n=1,015) Expected in Third Quarter of 2024 VAX-31 is Designed to Provide Coverage for Approximately 95% of IPD Circulating in the U.S. Adult Population Company’s Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise, VAX-24 and VAX-31, Intended to Deliver the Broadest-Spectrum of Coverage Against IPD SAN CARLOS,...Read more
PASADENA, CA, Jan. 29, 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 Phase 1b/2 clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma...Read more
MB-106 AML Phase 1B/2 trial (MB-106) preliminary data readout: Reached 67% recruitment MB-106 preliminary results: Intent to Treat CR rate of 40% plus a CR/ CRi rate of 47% (N=15); Dosed Per Protocol CR rate of 46% plus a CR/CRi rate of 54% (N=13) First 1st line AML subject treated and resulted in a CR in MB-106 No CR/CRi's in MB-106 have relapsed to date MB-107 STS Lung Mets Phase 1B/2 trial preliminary data readout: Phase 1B...Read more
OCALA, Fla., Jan. 22, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the first subject has been enrolled at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC...Read more
First patient dosed in company’s second clinical program with initial data expected in second half of 2024 Cash runway extended into second half of 2025 with clinical trials on track CAMBRIDGE, Mass., Jan. 17, 2024 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, announced today it has dosed the first patient in VBP301, its Phase 1/2, multicenter, open-label, first-in-human study of...Read more
Cleared First Four Monotherapy Doses and Initial Combination Cohort with No Dose Limiting Toxicities at any Dose Level KVA12123 Monotherapy Demonstrated Dose Proportional Induction of Pro-inflammatory Biomarkers Required for Strong Anti-tumor Activity Additional Monotherapy Clinical Efficacy Data and Initial Combination Clinical Data Anticipated in Q2 2024 SEATTLE, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a...Read more
AMPLIFY-7P study builds on preliminary positive findings from the 2-peptide formulation of ELI-002 published in Nature Medicine demonstrating tumor biomarker reduction, with strong T cell responses that correlated with reduced risk of relapse and death ELI-002 7P is a 7-peptide formulation of the therapeutic cancer vaccine designed to stimulate an immune response against the seven KRAS mutations that drive 25% of all solid tumors,...Read more
SEATTLE, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), today announced that it began patient recruitment for the second dosing cohorts (Cohort 2) in clinical studies for both of its lead product candidates, [212Pb]VMT-α-NET and [212Pb]VMT01, after the safety monitoring committees for each study unanimously recommended moving forward. In addition, the first patient in cohort 2 of the [212Pb]VMT01...Read more
Second study of Allocetra in knee osteoarthritis, following the on-going Phase I/II trial in pre-surgery, end-stage osteoarthritis, that is continuing to enroll patients Nes-Ziona, Israel, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health (IMOH) authorized the initiation of a...Read more
First enrollment and first subject dosing expected soon at Erasmus Medical Center in Rotterdam, Netherlands Management discusses the announcement and what this means here: video OCALA, Fla., Jan. 10, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that enrollment is open at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen®...Read more
Initiation of REVEAL pediatric trial in the U.S. broadens the clinical evaluation of TSHA-102 to female patients 5-8 years old with stage three Rett syndrome MHRA authorized the CTA for TSHA-102 in pediatric patients with Rett syndrome, enabling expansion of ongoing U.S. REVEAL pediatric trial into the U.K. TSHA-102 clinical program now includes broad evaluation across pediatric, adolescent and adult patients in three countries...Read more
The ABILITY-1 Study will evaluate MDNA11, a highly selective long-acting IL-2 Superkine, in combination with KEYTRUDA® (pembrolizumab) for treatment of patients with advanced solid tumors MDNA11 continues to demonstrate encouraging single-agent activity from the dose escalation portion of the ABILITY-1 Study MDNA11 is generally well tolerated with no dose-limiting toxicities or vascular leak syndrome reported in any of the dose...Read more
Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype (wt) non-small cell lung cancer (NSCLC) expansion cohort Follow-up shows three of the initially reported responses have now been confirmed (1 CR, 2 PR) and one still awaiting a confirmatory scan Study to be expanded to a total of 40 EGFRwt NSCLC patients Enrollment in the EGFR-mutant (mut) NSCLC cohort is...Read more
SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the fourth patient has now been enrolled into its Phase 1/2 study of ONCT-534, its dual-action androgen receptor inhibitor, for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved...Read more
Company Doses First Participants in Phase 2 Portion of Ongoing VAX-31 Phase 1/2 Study in Adults Following Independent Review of Phase 1 Safety and Tolerability Data; Topline Safety, Tolerability and Immunogenicity Data Expected in Third Quarter of 2024 Following Successful End-of-Phase 2 Meeting with FDA, Company Planning for Initiation of VAX-24 Adult Phase 3 Pivotal, Non-Inferiority Study in Second Half of 2024; Topline...Read more
Therapy Demonstrated Safety, Stabilization/Shrinkage of Treated Tumors Expanded Development for Monotherapy and Combination Therapy Anticipated ATLANTA, GA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the closure of patient enrollment for the Phase 1/2 clinical study...Read more
STOCKHOLM, Jan. 4, 2024 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that Medivir's licensee, Tango Therapeutics (NASDAQ: TNGX; Tango), has dosed the first patient with TNG348, a novel USP1 inhibitor. Tango received U.S. Food and Drug Administration clearance on its Investigational New Drug...Read more
HOUSTON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that the hematologic cancer Phase 1/2 clinical trial being conducted at the University of Texas MD Anderson Cancer Center (MDACC or MD Anderson) is now listed as active and recruiting on clinical trials.gov – trial NCT04734990. Salarius also announces that an additional Ewing sarcoma patient treated with seclidemstat, topotecan and...Read more
NOVATO, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, today announced the completion of patient enrollment in its Phase 1/2 clinical trial of GTX-102 for the treatment of pediatric patients with Angelman syndrome (AS). The dose-expansion cohorts (Cohorts...Read more
BOSTON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the phase 1/2 trial evaluating TNG348 as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant or other HRD+ (homologous...Read more
In Phase 1/2 ACHIEVE Trial, DYNE-101 Demonstrated Dose-Dependent Splicing Correction, Muscle Delivery and DMPK Knockdown All Evaluable Patients in the 3.4 mg/kg Cohort Treated with DYNE-101 Q4W Demonstrated Consistent Splicing Correction with a 19% Mean Improvement Across 22-Gene Panel at 3 Months Improvement in Myotonia (vHOT) as well as Fatigue (MDHI) Observed in Lowest Dose ACHIEVE Cohort at 6 Months In Phase 1/2...Read more
Topline data remains on track for second quarter of 2024 MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced that all patients have been enrolled in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal...Read more
Bexicaserin achieved a median seizure reduction of 53.3% in countable motor seizures compared to 20.8% in the placebo group across the DEE study population A median seizure reduction of 72.1% in Dravet Syndrome (DS), 48.1% in Lennox-Gastaut Syndrome (LGS) and 61.2% in DEE Other was achieved Favorable safety and tolerability results Longboard is rapidly moving forward with preparations for its global Phase 3 program Conference call and...Read more
Boca Raton, Florida, Jan. 02, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, dosed the first patient in the Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC) on December 27, 2023. INKmune™ is a biologic therapy given as...Read more
NKGen Biotech’s autologous clinical program product candidate, SNK01, demonstrated improvement in neuroinflammation and cognitive function in patients with Alzheimer’s Disease (“AD”) in its Phase 1 dose-escalation safety trial. SNK01 consists of a non-genetically modified NK cell product with enhanced cytotoxicity and activating receptor expression for the treatment of moderate AD. Initial patient in this Phase 1/2a trial received 6...Read more
NKGen’s SNK01 program continues to show positive progress with the FDA IND clearance in October 2023, and now the CTA clearance by Health Canada for a phase 1/2a clinical trial in moderate Alzheimer’s Disease patients Based on data generated from its Phase I dose escalation safety trial, presented at the recent CTAD conference in October 2023, NKGen is optimistic that the Phase 1/2a clinical trial could demonstrate more...Read more
SAN DIEGO, Dec. 26, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today updated the status of its dose escalation/dose expansion Phase 1/2 Study ONCT-808-101, evaluating the company’s ROR1-targeting autologous CAR T cell therapy ONCT-808 for the treatment of patients with relapsed or refractory aggressive B-cell...Read more
PASADENA, Calif. / Dec 21, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-CFB, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for complement mediated renal disease, such as immunoglobulin A nephropathy (IgAN), which is the most common glomerular...Read more
Expands clinical development of GC012F in rSLE following FDA IND clearance for Phase 1/2 trial in the United States Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in rSLE, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells FasTCAR-T GC012F has demonstrated a favorable safety profile in clinical investigator-initiated trials in 60 patients with multiple myeloma and...Read more
PHOENIX, AZ / ACCESSWIRE / December 20, 2023 / Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ), a biotechnology company has received clearance from the FDA to conduct a phase 1/2 clinical trial using their innovative StemSpine® treatment known as AlloStem™. This study aims to determine the safety, efficacy and tolerability of CELZ-201-DDT, a proprietary, ready-to-use cell line developed by the company. The trial will focus on...Read more
Dose 1 of PBFT02 achieved supraphysiologic CSF progranulin levels in each of the first three treated patients at 30 days after treatment Elevated progranulin levels were sustained at up to six months post-treatment Dose 1 of PBFT02 was generally well-tolerated in patients who received an enhanced steroid regimen for immunosuppression Pipeline to focus on continued advancement of PBFT02 in FTD-GRN and explore PBFT02 in multiple...Read more
Thirty additional patients with advanced neuroendocrine and advanced ovarian cancer will be enrolled in the study of 23ME-00610, an investigational antibody targeting CD200R1 A second potentially efficacious dose level to characterize safety and efficacy will be evaluated to identify the optimal dose in alignment with recently published regulatory guidance SOUTH SAN FRANCISCO, Calif., Dec. 19, 2023 (GLOBE NEWSWIRE) -- 23andMe...Read more
Patients treated with AMT-130 continue to show evidence of preserved neurological function with potential dose-dependent clinical benefits relative to an inclusion criteria-matched natural history of the disease Mean CSF NfL continue to demonstrate favorable trends with low-dose patients below baseline at 30 months and high-dose patients near baseline at 18 months AMT-130 continues to be generally well-tolerated...Read more
SUNNYVALE, Calif., Dec. 19, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced that the first patient was enrolled and treated in its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial for the treatment of patients with New York Heart Association Class II and III ischemic heart failure...Read more
Nectin-4 portfolio comprised of BT8009 and BT7480 represents potential opportunity to become leader in treating Nectin-4-driven cancers, starting with metastatic urothelial cancer (mUC) Updated BT8009 clinical data continue to support promising response and differentiated safety profile in mUC as well as emerging clinical activity in additional tumor types beyond bladder EphA2 portfolio led by BT5528 could be the first to address a...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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