Initiation of Phase 1 clinical trial marks Entrada’s transition into a clinical company Data anticipated in the second half of 2024 BOSTON, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today announced that the first...Read more
52 Relapsed and Refractory Lymphoma Patients Enrolled: 96% Alive at Last Assessment Indicating Favorable Survival Benefit Responses Observed Across Dose Levels with a 14.7% Clinical Response Rate Overall, 35.3% Overall Disease Control Rate, and 36.4% Clinical Response Rate in PTCL Patients Decrease in MCL1 and/or MYC Biomarkers Observed in 100% of Patients in a Dose-Dependent Manner in Once Per Week Administration...Read more
SAN DIEGO / Sep 21, 2023 / Business Wire / Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, announces the full enrollment of 40 subjects with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed leptomeningeal metastases (LM) in the feasibility phase of its prospective FORESEE clinical trial (NCT0414123). This trial is evaluating the performance of Biocept’s...Read more
Based on a novel human cytomegalovirus vector platform, VIR-1388 was designed with the goal of creating a novel HIV vaccine Phase 1 trial supported by the Bill & Melinda Gates Foundation, the National Institute of Allergy and Infectious Diseases and conducted by the HIV Vaccine Trials Network SAN FRANCISCO, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first...Read more
Statistically significant increase in urinary polycystin 1(PC1) after treatment with RGLS8429 Urinary polycystin exhibits anticipated pharmacokinetics/pharmacodynamics (PK/PD) correlation in patients with ADPKD Company to hold conference call at 8:30 a.m. EDT today SAN DIEGO, Sept. 20, 2023 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative...Read more
The Phase 1b Clinical Trial Focuses on Assessing the Safety and Efficacy of the Two-Drug Combination in a Cancer Associated with Longer Survival to Immunotherapy When Genetically Deficient in PP2A PASADENA, CA, Sept. 20, 2023 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”), today announced a Phase 1b collaborative clinical trial to assess whether adding Lixte’s LB-100 to GSK’s programmed death...Read more
KRASG12D(ON) Inhibitor with highly differentiated mechanism of action being evaluated in patients with cancers harboring the KRASG12D mutation, the most common driver of RAS-addicted human cancers REDWOOD CITY, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced the first patient was dosed in its...Read more
NEW YORK, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”) announces dosing of the first patient in the second cohort of patients to receive a single dose of Decoy20 in the INDP-D101 trial. This cohort dose is a dose reduction from the previous cohort based on the significant pharmacodynamic effect seen with the first cohort and anticipated optimal Decoy20 safety profile for both...Read more
Investigational VVD-130037 is highly specific, potent Kelch-like ECH Associated Protein 1 (KEAP1) activator developed for treatment of advanced solid tumors Major milestone for Vividion’s chemoproteomics innovative technology platform First-in-class clinical candidate to target cancers with activation of KEAP1-NRF2 pathway Berlin, Germany, San Diego, CA, USA, September 18, 2023 – Vividion Therapeutics, Inc. (Vividion), announced...Read more
TORONTO, ON / ACCESSWIRE / September 18, 2023 / FSD Pharma Inc. (NASDAQ:HUGE) (CSE:HUGE) (FRA:0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders, today announced that an interim report has been received for the first-in-human ("FIH") single ascending dose Phase I clinical...Read more
Preliminary Data Support Progression to Phase 2a Proof of Concept Trials in T cell-mediated Autoimmune Diseases WAYNE, Pa., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the...Read more
Topline results from this study are expected in early Q1 2024 Celltrion has a right of first negotiation for RT-111 following positive Phase 1 results SAN JOSE, Calif., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced the initiation of a Phase 1 clinical...Read more
Encinitas, California--(Newsfile Corp. - September 18, 2023) - Kiora Pharmaceuticals (NASDAQ: KPRX) today announced the completion of the final patient's last endpoint evaluation from the ABACUS study of KIO-301. KIO-301 is A molecular photoswitch being evaluated in a Phase 1B clinical trial for vision restoration in late-stage Retinitis Pigmentosa (RP). Topline study results will be reported November 4 at the upcoming American Academy of...Read more
PALO ALTO, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC)(“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported that the first patient has been dosed in the Phase 1 trial evaluating VIP943 in patients with relapsed/refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS), and...Read more
DVX201, a first-ever allogeneic, cord-blood derived, natural killer (NK) cell therapy, has been administered to 16 patients with no dose limiting toxicities, cytokine release syndrome or infusion toxicities to date at all dose levels WEXFORD, Pa., Sept. 14, 2023 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for...Read more
EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator that has the potential to benefit a broad spectrum of HCM and other cardiomyopathy patients BOULDER, Colo. / Sep 14, 2023 / Business Wire / Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced initial dosing in a Phase 1 trial of EDG-7500. EDG-7500 is a first-in-class oral, selective, cardiac...Read more
New Statistically Significant Results Reported for Clinical Efficacy Endpoints of BSA, DLQI and POEM from Phase 1b Study New Phase 2a Study Also Being Planned for Rezpegaldesleukin in Alopecia Areata SAN FRANCISCO, Sept. 13, 2023 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced new data for rezpegaldesleukin in patients with atopic dermatitis, including new clinical efficacy endpoints from the Phase 1b study....Read more
SAN DIEGO, Sept. 13, 2023 /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 in the second cohort of patients in the ongoing Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. "The completion of enrollment in our second cohort is...Read more
Fort Lee, NJ, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), 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 announced the initiation of a Phase 1a dose escalation clinical trial of NXP900, its novel inhibitor of the SRC/YES1 kinase family (“SFK”)....Read more
First drug candidate identified with Gain’s proprietary computational drug discovery platform SEE-Tx® to enter clinical development phase BETHESDA, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that the Company has received approval...Read more
Progressing development of hepatitis B virus (HBV) compounds imdusiran (AB-729) and AB-101, an oral PD-L1 inhibitor Discontinuing all coronavirus and oral RNA destabilizer programs, including AB-343 and AB-161 Extending cash runway through Q3 2025 WARMINSTER, Pa., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its...Read more
Complete topline results confirm treatment was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic) at 66%, comparable to pembrolizumab/neoadjuvant chemotherapy (NAC) Planned Phase 2 study in early-stage TNBC to determine if CKM including Ampligen may be a safe and effective alternative to pembrolizumab or in addition to pembrolizumab/NAC Results now available...Read more
SAN DIEGO, Sept. 11, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117570 in healthy adult participants. NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective dual agonist that may have the potential to treat neurological...Read more
SAD data confirm best-in-class potential for INF904 as orally administered C5aR inhibitor: Safety and tolerability with no signals of concern over entire dose range Pharmacokinetics (PK): favorable dose-proportional systemic exposure with overall PK profile confirming pre-clinical data Desired blocking activity (>90%) of C5a-induced neutrophil activation at disease relevant C5a levels 24 hours post administration for doses of 30...Read more
Initiated IDE161 Phase 1 expansion based on preliminary tumor shrinkage observed in multiple HRD solid tumor patients, including an endometrial cancer subject with a first imaging assessment of a partial response and an 87% reduction of the CA-125 tumor marker Phase 1 expansion focus in ER+, Her2(-), HRD+ breast cancer representing ~10% to ~14% of breast cancer as well as HRD+ ovarian cancer and other HRD-associated solid...Read more
Company to present BDTX-1535 dose escalation data in NSCLC at the AACR-NCI-EORTC Conference in October 2023 CAMBRIDGE, Mass. and NEW YORK, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced the first patients dosed in mutation...Read more
Marker Therapeutics reports clinical updates in APOLLO trial for the treatment of lymphoma patients who have relapsed after anti-CD19 CAR T cell therapy Patient with Non-Hodgkin’s Lymphoma who relapsed after anti-CD19 CAR T cell therapy tolerated initial dose level well and achieved complete response after MT-601 treatment HOUSTON, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR) is a clinical-stage...Read more
In Phase 1b Study, Patients Treated in First-Line Demonstrated a Confirmed Objective Response Rate of 65% THOUSAND OAKS, Calif., Sept. 10, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced exciting data from a study arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS® (sotorasib) with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These...Read more
Extended follow-up in the Actimab-A + CLAG-M trial showed median overall survival in patients proceeding to bone marrow transplant of 24 months in all patients and 30 months in patients who received prior venetoclax treatment Actimab-A shown to enhance the anti-leukemic activity of FLT3 inhibition of approved therapies gilteritinib and midostaurin preclinically, supporting the clinical evaluation of Actimab-A combinations with...Read more
GMI-1687, a highly potent E-selectin antagonist, is being developed as a potential point-of-care treatment for inflammatory diseases with initial focus on sickle cell disease (SCD) Single ascending dose study is expected to randomize approximately 40 healthy volunteers on GMI-1687 vs placebo with endpoints for safety, tolerability, and pharmacokinetics Initial results expected by end Q1 2024 ROCKVILLE, Md. / Sep 06, 2023 / Business...Read more
78% of patients reported that their overall health had improved since starting BioLexa as compared to 22% stating that there was no change in their health, or their health was worse. DLQI found that BioLexa use led to a 46% improvement in patient quality of life whereas placebo had no effect. NEW YORK, Sept. 6, 2023 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced...Read more
Examination of EEG in healthy subjects administered single doses of BHV-7000 confirmed central nervous system (CNS) activity consistent with effects observed with other antiseizure medications. EEG results demonstrated dose-dependent and time-dependent effects of BHV-7000 on CNS target engagement in study subjects: At the lowest dose studied of 10 mg, subjects with targeted drug concentrations ≥EC50 showed a mean increase in...Read more
SALT LAKE CITY, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced it has completed the Phase 1 study for REC-3964 in healthy volunteers. The study achieved its primary objectives of assessing the safety, tolerability and pharmacokinetic profile of REC-3964. REC-3964 has been well tolerated with no serious adverse events...Read more
Data support utility of AUTO1/22 approach in preventing antigen evasion in pediatric B-ALL Complete responses observed in patients with CD19 negative disease No antigen negative relapse seen in responding patients LONDON, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces a publication on...Read more
First-In-Human Single Ascending Dose Clinical Data for RLYB116 Demonstrated a Reduction in Free C5 Greater than 99% at 24 Hours for the 100 mg dose and at 12, 24, and 72 Hours for the 300 mg dose in Healthy Participants Mean Estimated Elimination Half-Life for RLYB116 was > 300 Hours No Severe or Serious Adverse Events with Single-Dose Administration of RLYB116 Phase 1 Multiple Ascending Dose Study of RLYB116 Ongoing; Preliminary...Read more
Group 2 data available to date support primary safety and feasibility endpoints of single-day bolus dosing of CT-0508 New translational analyses combining group 1 & group 2 continue to support CAR-M mechanism of action, demonstrating a correlation between biomarkers and best overall response PHILADELPHIA, Sept. 1, 2023 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage...Read more
CAMBRIDGE, Mass., Aug. 31, 2023 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious disease by correcting abnormal gene expression, today announced the first patient has been dosed in the Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory acute myelogenous leukemia (AML). “Based on...Read more
MONTREAL, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that all five of the U.S.-based clinical sites participating in the conduct of the Phase 1 clinical trial of the Company’s lead investigational peptide drug conjugate, sudocetaxel...Read more
Anti-tumor activity in patients with NRAS Q61X melanoma and KRAS Q61X NSCLC supports tissue agnostic development in RAS Q61X solid tumors Initial Phase 1b combination data from SEACRAFT-1 expected in Q2-Q4 2024 Dosing of first patient in pivotal SEACRAFT-2 trial in NRAS-mutant melanoma expected in H1 2024 SAN DIEGO, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly...Read more
Investigational cellular therapy, bemdaneprocel (BRT-DA01), was well tolerated with no major safety issues in all 12 participants in low dose and high dose cohorts through one year At one-year, exploratory clinical endpoints improved overall, with participants in the high dose cohort showing greater improvement One year assessment of all participants demonstrated feasibility of transplantation, cell survival, and engraftment Planning...Read more
SAN JOSE, Calif., Aug. 28, 2023 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that, in partnership with Moffitt Cancer Center, it has commenced treatment of the third patient in the ongoing clinical trial of Anixa's novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. The study...Read more
SHELTON, CT / ACCESSWIRE / August 21, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's broad-spectrum antiviral drug, is progressing successfully. Healthy Volunteers Recruitment for Phase 1a and Phase 1b is Progressing...Read more
Interim analysis of Phase 1B data suggests Processa’s novel chemotherapy treatment could improve safety and efficacy in more patients by individualizing the dosing regimen for each patient HANOVER, MD, Aug. 17, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the...Read more
SAN DIEGO / Aug 16, 2023 / Business Wire / MEI Pharma, Inc. (NASDAQ: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, today announced the dosing of the first patient in a Phase 1b study evaluating ME-344 in combination with bevacizumab (AVASTIN®) in patients with previously treated metastatic colorectal cancer. ME-344 is a novel mitochondrial inhibitor targeting energy production through the...Read more
10th patient dosed marks achievement of first clinical milestone associated with next tranche of funding Eledon to report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation at ASN Kidney Week in November 2023 IRVINE, Calif., Aug. 16, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the dosing of the 10th patient in the Company’s...Read more
NEW YORK, Aug. 16, 2023 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating EO-3021 in patients with advanced unresectable or metastatic solid tumors...Read more
Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 Study Designed to Support Planned Phase 2 Trial in Prevention of Kidney Transplant Rejection Multiple Possible Indications, Including Bone Marrow Transplantation and Autoimmune Diseases: Potential Pipeline in a Product TNX-1500 is the First of Tonix’s Internally-Developed Biologic Candidates to Reach the...Read more
DT-216 Resulted in a Significant Increase in FXN mRNA Levels in Skeletal Muscle of FA Patients Treatment Generally Well-Tolerated; Injection Site Reactions Attributable to Current Formulation Composition Design Plans to Proceed with an Improved DT-216 Formulation and Initiate a Multiple Dose Phase 1 Clinical Study in the Second Half of 2024 Conference Call and Webcast to be Held Today at 4:30pm ET CARLSBAD, Calif., Aug. 14, 2023...Read more
Cohort 1 patients exhibited a significant immune response consistent with the mechanism of action Safety Review Committee approved continuation to the next cohort of patients NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”) today announced completion of the first cohort of patients who received a single dose in Part 1 of its INDP-D101 trial of Decoy20 and the...Read more
Company's novel NeuroDirectTM topical ketamine formulation to treat PTSD shown to be safe and well-tolerated in first cohort of Phase I trial. MIAMI, FL / ACCESSWIRE / August 10, 2023 / Psycheceutical Bioscience, Inc. ("Psycheceutical" or the "Company") (OTC PINK:BWVI), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, today announced the completion of dosing...Read more
CAMBRIDGE, Mass., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating CLN-978 for the treatment of relapsed/refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL). The study is an open-label, dose-escalation, dose-expansion, and...Read more
NEW YORK and BERLIN, Aug. 08, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced results from Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine). The Phase 1 open-label, 4-period crossover study assessed the safety, tolerability, and pharmacokinetic...Read more
WILMETTE, Ill., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, today provided an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS). Both patients treated to date at the 650 mg/m2 dose level have...Read more
BMB-101 is a highly selective and potent 5-HT2C agonist being developed for the treatment of refractory epilepsies and other indications, such as psychosis, addiction, and impulse control disorders qEEG study was conducted in healthy individuals in Cohort 4 of the Multiple Ascending Dose arm of the study Proof of Mechanism and target engagement in the brain was established using blood biomarkers and qEEG In qEEG, BMB-101 demonstrated...Read more
First dual coronavirus-norovirus oral antiviral is scheduled for Phase 1 in healthy volunteers In vitro studies show broad-spectrum activity against noroviruses including GII.4 pandemic strains No approved treatments or vaccines for norovirus infection BOTHELL, Wash., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biopharmaceutical company dedicated to...Read more
Preclinical data with APG777 demonstrate the potential for significantly improved dosing over standard of care, including the potential for every two- or three-month dosing Initial subcutaneous pharmacokinetic and safety data from healthy volunteers anticipated in mid-2024 First product candidate to enter the clinic from the company’s strategic collaboration with Paragon Therapeutics, Inc., an innovative discovery engine developing...Read more
Composite qEEG measure showed change from placebo after first dose of 5 mg Effect in the composite qEEG measured through 10-day treatment period Ongoing PRAX-628 Phase 2 Photo-Paroxysmal Response (PPR) expected to read out in 2H 2023 BOSTON, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for...Read more
SAN JOSE, Calif., Aug. 7, 2023 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that its partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the Company's breast cancer vaccine with Keytruda® (pembrolizumab). An expansion of the ongoing Phase 1 dose...Read more
EASI-Related and PASI-Related Clinical Efficacy Endpoints in Atopic Dermatitis and Psoriasis Studies Were Incorrectly Calculated by Lilly and Were Reported Erroneously at EADV 2022 SAN FRANCISCO, Aug. 7, 2023 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that efficacy data previously generated by Eli Lilly & Company for rezpegaldesleukin (REZPEG) that were presented at the September 2022 EADV Congress were...Read more
SHANGHAI, China and PRINCETON, N.J., Aug. 03, 2023 (GLOBE NEWSWIRE) -- LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced the first patient has been dosed in its Phase 1 clinical trial of BBP-398, an investigational SHP2 inhibitor, in combination with AstraZeneca’s osimertinib, an epidermal growth factor receptor (EGFR)...Read more
Company continued to see rapid progression and acceleration of enrollment with 180 patients enrolled to date across 46 clinical trial sites, globally Completion of enrollment of study expected by end of 2023 Company has documented the necessary number of patients reaching the primary efficacy endpoint (overall survival) to conduct pre-planned interim analysis Topline data from interim analysis expected before year end HOUSTON, TX...Read more
First participant is expected to be dosed in September 2023 with data anticipated in the second half of 2024 Cash runway extended through the end of 2025 BOSTON, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today...Read more
NEW YORK, July 28, 2023 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® technology platform, announced today that the University of California Davis Comprehensive Cancer Center has dosed the first patient in its investigator-initiated trial which aims to evaluate IO102-IO103, the company’s investigational immune-modulating...Read more
Company Selects Refractory Advanced Genitourinary Malignancies including Renal Cell Cancer as Second Indication MILAN, Italy and NEW YORK, July 28, 2023 (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: the Phase 1...Read more
Participant 1 Achieved Clinically Meaningful Reduction in Plasma Phe of Up to 99% Change from Baseline and Below the U.S. PKU Treatment Guideline Threshold (<360 μmol/L)*; At 31 Weeks Post-Dose, Phe Level 319 μmol/L With a 59% Reduction from Baseline, Even After Dietary Protein Supplementation Participant 2 Plasma Phe Level Reduction of 49% Change from Baseline at 17 Weeks Post-Dose HMI-103 Has Been Generally...Read more
55% objective response rate; 23% complete response rate in locally advanced cSCC 50% objective response rate; 13% complete response rate in metastatic cSCC Cosibelimab continues to demonstrate a favorable safety profile Biologics License Application currently under review by U.S. FDA; PDUFA goal date of January 3, 2024 WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a...Read more
UPLIFT clinical trial did not meet its primary endpoint Company realigns focus and significantly reduces expenses to extend cash runway into 2026 Conference call today at 8:00 a.m. ET CAMBRIDGE, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas...Read more
NEW HAVEN, Conn., July 27, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced multiple updates on key programs including: preliminary EEG data from its lead investigational agent, BHV-7000, from the Kv7...Read more
Patients enrolled were diagnosed with refractory, metastatic or locally advanced, non-small cell lung cancer (NSCLC), for whom there were no other suitable treatment options Five of eight patients treated (62.5%) had a best response of immune-related stable disease, and three (37.5%) demonstrated immune-related progressive disease No patients had treatment emergent serious adverse events and all patients completed per protocol...Read more
Initial topline data from COVALENT-101 trial revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients carrying menin-dependent mutations treated at Dose Level 4 Dose Level 4 exposure correlates with initial activity seen in BMF-219’s pre-clinical studies Safety profile of BMF-219 supports further dose escalation; enrollment for Dose Level 5 has commenced to explore the optimal biological dose BMF-219, the first...Read more
Dosing of patients completed at the end of February Data Safety Monitoring Board conducted analysis of Day 29 data No major vaccine-related safety concerns for either of the two dose levels No Serious Adverse Events (SAE’s) or Adverse Events of Special Interest reported DYAI-100 RBD COVID-19 booster vaccine produced immune response at both dose levels Phase 1 full study report expected in Q4, 2023 JUPITER, Fla., July 24,...Read more
MENLO PARK, Calif., July 20, 2023 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences,” or the “Company”), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients’ lives, today announced the six-month results from the SAHARA randomized controlled trial (RCT). The trial successfully met its primary endpoint and the data reported...Read more
BMB-101 is a highly selective and potent 5-HT2C agonist being developed for the treatment of refractory epilepsies and other indications, such as psychosis, addiction, and impulse control disorders BMB-101 demonstrated an excellent safety and tolerability profile in single ascending dose, multiple ascending dose and food effects study -BMB-101 demonstrated central target engagement and predictable plasma pharmacokinetics VANCOUVER,...Read more
Phase 2 Trials in Relapsed/Refractory and Frontline Settings Planned, APVO436 to be administered in Combination with Emerging Standard of Care New Data Adds to Growing Body of Clinical Evidence in Support of APVO436 Clinical Potential SEATTLE, WA / ACCESSWIRE / July 18, 2023 / Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (Nasdaq;APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology...Read more
Phase 1b study demonstrates that miricorilant, a selective cortisol modulator, effectively reduces liver fat, improves liver health and key metabolic and lipid measures and is well-tolerated Corcept will initiate a Phase 2b study in the fourth quarter MENLO PARK, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of...Read more
First Clinical Study of a Central Nervous System-Administered RNAi Therapeutic Showed Rapid and Robust Target Engagement with Sustained Effect Over 6 Months with a Single Dose ALN-APP Continues to Demonstrate an Encouraging Clinical Safety and Tolerability Profile Multiple-dose Portion of Study, Part B, Being Initiated in Approved Regions CAMBRIDGE, Mass. / Jul 17, 2023 / Business Wire / Alnylam Pharmaceuticals,...Read more
Multiple patients treated with PSMA-TRACTr JANX007 have achieved meaningful PSA drops coupled with manageable safety and CRS PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008 have been generally well tolerated at levels above the projected maximum tolerable dose of the parental T cell engagers JANX007 preliminary data showed encouraging safety results consistent with on-tumor activity with no dose-limiting toxicities PK exposure...Read more
Continued favorable safety and tolerability profile for all dose levels tested Serum samples from all dose levels tested showed robust neutralization activity against Omicron XBB.1.5, one of the dominant SARS-CoV-2 variants circulating globally Ongoing analysis of serum neutralizing activity and pharmacokinetic data expected to support rapid anticipated transition to pivotal clinical trial WALTHAM, Mass., July 17, 2023 (GLOBE...Read more
Disease-modifying candidate UB-312 demonstrated target engagement of aggregated alpha-synuclein in cerebrospinal fluid of Parkinson’s patients Data provide validation of the Vaxxinity platform’s ability to selectively target aggregated, toxic forms of neurodegenerative proteins CAPE CANAVERAL, Fla., July 17, 2023 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of...Read more
HOUSTON, July 17, 2023 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced completion of the first dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1001-A (liposomal Grb2) in patients with solid tumors, including ovarian,...Read more
CB-010 allogeneic CAR-T cell therapy data rival response rates and safety profile of approved autologous CAR-T cell therapies 94% overall response rate (ORR), 69% complete response (CR) rate, and 44% CR rate at ≥6 months following a single dose of CB-010; 24 months is the longest CR maintained to date LBCL patient subgroup had a 50% CR rate at ≥6 months; 18 months is the longest LBCL subgroup CR maintained to...Read more
Psycheceutical's clinical trial program is the first ever to test the topical application of ketamine for use in treating a mental health disorder through the company's NeuroDirect™ delivery system. MIAMI, FL / ACCESSWIRE / July 13, 2023 / Psycheceutical Bioscience, Inc ("Psycheceutical" or the "Company") (OTC PINK:BWVI), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health...Read more
Skye preparing to start Phase 2a glaucoma clinical trial in Q3 San Diego, California--(Newsfile Corp. - July 13, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, reports that the safety review committee ("SRC") for its Phase 1 clinical trial of SBI-100 Ophthalmic Emulsion ("OE") has reviewed data from the...Read more
Analysis of MRI scans in participants from an open label Phase 1b study demonstrates that CDM®, a novel gray matter biomarker, is improved following three months of treatment with XPro1595TM Boca Raton, Florida, July 11, 2023 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that...Read more
CULVER CITY, Calif. / Jul 10, 2023 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced findings from a Phase 1 study showing that allogeneic cytokine-induced memory-like (CIML) natural killer (NK) cells used in combination with ImmunityBio’s IL-15 superagonist N-803 may induce tumor regression associated with persistent CIML NK cell expansion in advanced head-and-neck cancer patients....Read more
Biodexa Ltd (a wholly owned subsidiary of Biodexa Pharmaceuticals PLC, Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain, is pleased to announce completion of enrolment and treatment of nine paediatric patients into the ongoing investigator-sponsored Phase I study of MTX-110 in newly diagnosed DMGs (NCT 04264143). All of the patients (age...Read more
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., July 09, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase I study in China of HMPL-415, an investigational novel selective allosteric inhibitor targeting Src homology-2 domain-containing protein tyrosine phosphatase-2 (“SHP2”). The first patient received their first dose on July 6, 2023. The...Read more
PITTSBURGH, July 03, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with debilitating diseases, announced today that the first patient has been dosed at the Cystic Fibrosis Institute of Chicago in the Company’s Phase 1 CORAL-1/US study evaluating KB407, an engineered HSV-1-based, aerosol-delivered, mutation...Read more
Median Overall Survival of 20.9 Months for Patients Without Active Liver Metastases Surpasses the Recently Reported 12.9-Month Benchmark with Standard of Care in this Population LEXINGTON, Mass. / Jun 30, 2023 / Business Wire / Immuno-oncology leader, Agenus (Nasdaq: AGEN), shared promising data today from its Phase 1b trial on the botensilimab and balstilimab combination at a late-breaking session at the 2023 ESMO World Congress on...Read more
Data from Phase 1 clinical trial in healthy volunteers show comparable pharmacokinetic, pharmacodynamic and safety profile between U.S. and Japanese healthy subjects Initiating Phase 1b clinical trial in gout patients in the U.S. and expect to begin pivotal clinical trials in 2024 MIAMI, June 29, 2023 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”)...Read more
Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic immunoassay tests and microarrays. Surmodics is pursuing highly differentiated whole-product solutions that are designed to address...
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