Registered Phase-1b 12-week study will investigate safety, diabetes control, and weight loss KELOWNA, BC / ACCESSWIRE / December 19, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has begun dosing in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study"). The Study is designed mainly to determine whether Lexaria's...Read more
NPM-115 clinical program utilizes a miniature, GLP-1 (exenatide) implant designed to provide comparable efficacy to semaglutide, with twice-yearly administration Study represents the first clinical application of NanoPortal™, the Company’s proprietary drug implant platform technology ALAMEDA, Calif. / Dec 19, 2024 / Business Wire / Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative biopharmaceutical company...Read more
APOLLO study investigating MT-601 in patients with relapsed lymphoma: 78% of patients achieved objective response rates, with 44.4% demonstrating complete response (CR) MT-601 was observed to be well tolerated in all study participants with no observation of immune-effector cell associated neurotoxicity syndrome (ICANS) HOUSTON, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage...Read more
A-005 was well tolerated and demonstrated ability to cross blood-brain barrier Maximal TYK2 inhibition achieved with favorable pharmacokinetic profile in CNS and periphery Data support advancement to Phase 2 clinical trial in multiple sclerosis, anticipated in 2H 2025 SOUTH SAN FRANCISCO, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical stage biopharmaceutical company developing...Read more
Phio's Lead Compound PH-762 demonstrates encouraging safety profile in 2nd cohort with recommendation to escalate to next dose concentration Marlborough, Massachusetts--(Newsfile Corp. - December 19, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company that develops therapeutics using its INTASYL® siRNA gene silencing technology to make the body's immune cells more effective in killing cancer...Read more
Enrollment underway for patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) Company expects to share preliminary Phase 1 clinical data in the first half of 2025 REDWOOD CITY, Calif. & BOSTON / Dec 19, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today...Read more
Regulatory Approval Showcases Clinical Advancement of Linea DNA™ as a Rapid and Effective Means of Producing CAR-T cell Therapies STONY BROOK, NY / ACCESSWIRE / December 18, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, announced that the State Institute for Drug Control of the Czech Republic (SÚKL) approved an application for a Phase I clinical trial...Read more
This open-label Phase 1 study measures safety, peripheral and central inflammation, effects on Treg cell populations, and FTD progression; Five of the 8 planned FTD subjects have been enrolled to date; Results of study will inform Coya’s randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD HOUSTON / Dec 18, 2024 / Business Wire / Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage...Read more
Approval given after Safety Review Committee (SRC) review of safety data from the three patients comprising Cohort 2 No significant safety or dose limiting toxicities reported in Cohort 2 New patients currently being evaluated for eligibility in Cohort 3 PK and PD data from Cohort 1 patients consistent with preclinical and Phase 0 trial results BOSTON, Dec. 18, 2024 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the...Read more
JERSEY CITY, N.J., Dec. 18, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company’s second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal...Read more
Preliminary clinical data in post-anti-PD-1 NSCLC patients demonstrated a 27% ORR and 73% DCR in monotherapy trial Monotherapy activity with inhaled KB707 provides further evidence of successful repeat administration of HSV-1 based inhaled lung gene delivery and builds on recent clinical data update for CF and AAT deficiency respiratory disease programs PITTSBURGH, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the...Read more
Data from lowest dose level cohorts demonstrate a favorable safety and efficacy profile Data includes complete results from cohort 1 and initial results from cohort 2 Early exercise of common stock warrants from stockholder generates cash proceeds of approximately $12.7 million Company to host conference call and webcast today at 8:00 a.m. ET / 5:00 a.m. PT BURLINGAME, Calif., Dec. 18, 2024 (GLOBE NEWSWIRE) --...Read more
Approval in Hong Kong marks the first clinical trial application clearance of an in vivo gene editing approach for chronic hepatitis B in Hong Kong and the second CTA approval for PBGENE-HBV in 2024 ELIMINATE-B is a global, multi-site study now actively recruiting patients; expected to report clinical data as it matures throughout 2025 U.S. investigational new drug (IND) anticipated in 2025 DURHAM, N.C. / Dec 18, 2024 / Business Wire...Read more
Favourable safety profile for world’s first LAG-3 agonist, IMP761, with no treatment related adverse events to date Additional safety data and assessment of PK/PD relationships to follow in first half of CY2025 IMP761 is designed to enhance the “brake” function of LAG-3 on T cells to restore balance to the immune system and address the underlying cause of many autoimmune diseases SYDNEY, AUSTRALIA, Dec. 17, 2024 (GLOBE NEWSWIRE) --...Read more
In 33 heavily pretreated NSCLC EGFR wild-type (EGFRwt) patients the combination of AFM24 and atezolizumab shows an overall response rate (ORR) of 21% (6 confirmed responses, 1 response awaiting confirmatory scan) and a disease control rate (DCR) of 76%; tumor shrinkage was observed in 48% of patients; preliminary median progression free survival (PFS) is 5.6 months and 36% of patients remain on treatment In 17 heavily pretreated NSCLC...Read more
Phase 1b trial will evaluate receptor occupancy of PIPE-791 in the brain and lungs of patients in multiple cohorts using a PET tracer of the LPA1 receptor Topline data readout planned for the second quarter of 2025 SAN DIEGO / Dec 16, 2024 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule...Read more
BHV-1300 achieved deep lowering of targeted IgG, with reductions > 60% in the lowest subcutaneous dose tested in the MAD. Subcutaneous BHV-1300 achieved rapid and progressive lowering of IgG within hours of each weekly dose administration, and pharmacodynamic effects were sustained relative to baseline over the four-week period. The optimized subcutaneous formulation also showed substantially less inter-patient variability in...Read more
Heavily-pretreated patients on lunresertib and camonsertib combination achieved 25.9% overall response rate (ORR) in endometrial cancer and 37.5% in platinum-resistant ovarian cancer Nearly half of patients with gynecologic cancers maintained progression-free survival at 24 weeks, comparing favorably to current standard of care Company plans to initiate a registrational Phase 3 trial of lunresertib in combination with camonsertib in...Read more
Two of three patients achieved both complete remission and MRD-negative status High response rates observed in earlier studies continue in ongoing mipletamig trial Cohort 2 enrollment commencing SEATTLE, WA / ACCESSWIRE / December 12, 2024 / Aptevo Therapeutics ("Aptevo") (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel bispecific immune-oncology therapeutics based on its proprietary ADAPTIR® and...Read more
HOUSTON / Dec 12, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable ongoing efficacy results from the eight-month follow-up visit for the fourth patient enrolled in its Deltacel-01 Phase 1 clinical trial, and provides additional updates on the first and seventh patients. This trial is evaluating Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT)...Read more
Clear evidence of SERPINA1 gene delivery and AAT expression following KB408 administration in AATD patients Both KB408 for AATD patients and KB407 for patients with cystic fibrosis were safe and well tolerated at all dosing regimens evaluated to date Conditional sanctioning of the KB407 Phase 1 CF Study CORAL-1 protocol by CFF TDN Investor call and webcast to be held December 12 at 8:30 am ET to discuss data update PITTSBURGH,...Read more
ZYNLONTA in combination with glofitamab demonstrated clinically meaningful benefit with 94% best ORR and 72% CR rate Safety data show no dose-limiting toxicities (DLTs), no high-grade cytokine release syndrome (CRS) or high-grade immune effector cell-associated neurotoxicity syndrome (ICANS) across all patients Company to host conference call today at 8:30 a.m. EST LAUSANNE, Switzerland, Dec. 11, 2024 /PRNewswire/ -- ADC...Read more
PRT2527 demonstrated activity across a range of relapsed/refractory lymphoid malignancies, including patients who received prior CAR-T therapy Prelude plans to seek a partner for future development of PRT2527 in hematologic malignancies WILMINGTON, Del., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD) (“Prelude” or the “Company”), a clinical-stage precision oncology company, today announced the...Read more
Marks successful completion of full enrollment of SAD cohorts and the first two MAD cohorts in the healthy volunteer study Up to 10 adult participants with genetically confirmed Duchenne Muscular Dystrophy (“DMD”) to be enrolled in the now ongoing Phase 1b trial in DMD patients Phase 1 data to be presented at major medical conference in Q1 2025 TORONTO / Dec 11, 2024 / Business Wire / Satellos Bioscience Inc. (TSX: MSCL, OTCQB:...Read more
In the dose escalation Part 1 of the study, no dose-limiting toxicities were observed and the PK profiles were similar to those reported for previous monotherapy studies of imetelstat and ruxolitinib Based on the safety profile, imetelstat 9.4 mg/kg dosed every four weeks with ruxolitinib was the selected dose for the dose expansion Part 2 of the study, which is currently enrolling patients Geron is also evaluating the potential of...Read more
Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity (clinical benefit rate: 62.5%; overall response rate: 26.7%) in patients previously treated with a CDK4/6 inhibitor Safety and tolerability of the combination is generally consistent with the profile of abemaciclib and what has been observed in other clinical trials of vepdegestrant; no significant drug-drug interaction was observed between...Read more
TORONTO, ON / ACCESSWIRE / December 10, 2024 / Quantum BioPharma Ltd. (NASDAQ:QNTM) (CSE:QNTM) (FRA:0K91) ("Quantum BioPharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, HUGE Biopharma Australia Pty Ltd., that the safety review committee recommends commencing dosing of the second cohort in its trial entitled "A Phase...Read more
INB-100 continues to demonstrate durable complete remissions (CR) with no relapses observed in any acute myeloid leukemia (AML) patients including those with high-risk disease after a median follow-up of 19.7 months. Data highlights INB-100’s long-term impact, exhibiting durable in vivo expansion and persistence of allogeneic gamma-delta T cells 365 days following a single administration of INB-100, demonstrating the first-ever durable...Read more
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2H 2025 APG777 + APG333 can potentially address key drivers of respiratory diseases more broadly versus monotherapy Preclinical proof-of-concept achieved for APG777 + APG333 combination with clinical trial planning underway in asthma and COPD SAN FRANCISCO and WALTHAM, Mass., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc.,...Read more
OKI-219 is well-tolerated across all doses, and no dose interruptions, delays, reductions, or discontinuations were reported Initial patient data show exposures of OKI-219 exceeding levels associated with robust antitumor activity in preclinical models Data support the initiation of Part 1b of PIKture-01 evaluating OKI-219 in combination with fulvestrant; first patients dosed, and initial data are expected in 2H-2025 Management to...Read more
First patient dosed with combination of IDE161, IDEAYA's investigational, potential first-in-class PARG inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy The IDEAYA-sponsored Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer Selected initial...Read more
Durable responses are rapid and deepen on treatment as demonstrated by an initial 75.5% Objective Response Rate which increased to 84.2% in patients with at least two disease assessments Treatment responses observed in heavily pre-treated population with mutations associated with poor prognosis and/or resistance to BTK inhibitors, including patients with CNS involvement Favorable safety profile across all doses tested Nurix will...Read more
To date, event-free survival strongly favors the treatment arm (HR=0.30; p=0.04), and treatment-arm patients trend towards lower probability of relapse (HR=0.28; p=0.14) No dose-limiting toxicities observed and infusions of TSC-100 and TSC-101 were well-tolerated across all three dose levels Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc., on Tuesday, December 10, 2024, at 8:00 a.m. ET WALTHAM, Mass., Dec. 09,...Read more
All Three Patients Treated in First Dose Cohort Administered Fludarabine-free Conditioning and Show Rapid, Deep, and Sustained B-cell Depletion with Favorable Safety Profile First Patient to Reach 6-Month Follow-up Remains in DORIS Clinical Remission and Free of All Immunosuppressive Therapies Company Plans to Initiate Dose Expansion at First Dose Level of 360M Cells SAN DIEGO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics,...Read more
Preliminary data supports BMF-500’s potential as a transformative therapy for patients with FLT3 mutated relapsed or refractory (R/R) acute leukemia BMF-500 showed a favorable safety and tolerability profile, with no dose-limiting toxicities observed across all dose levels Pharmacokinetic and pharmacodynamic data confirmed on-target FMS-like tyrosine kinase 3 (FLT3) inhibition, demonstrating dose-proportional activity and good...Read more
AFM28, a bispecific, tetravalent innate cell engager (ICE®) targeting CD123 and CD16A, achieved a 40% composite complete remission rate (CRcR) at the highest dose level (300 mg) in heavily pretreated R/R AML patients AFM28 demonstrates a favorable safety profile: Grade 1 and 2 Infusion related reactions (IRRs) were the main related side effect, occurring in 45% of patients; no signs of neurotoxicity or immune-related side effects were...Read more
R289 was generally well tolerated and demonstrated signs of preliminary clinical activity in elderly heavily pretreated LR-MDS patients RBC-TI/HI-E responses occurred in 40% of evaluable TD patients receiving R289 doses ≥500 mg QD SOUTH SAN FRANCISCO, Calif., Dec. 9, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today...Read more
Additional new profiling of patient responses from the optimized lymphodepletion arm (Arm C) show consistent P-BCMA-ALLO1 cellular expansion and persistence across subgroups New preclinical data supports P-CD19CD20-ALLO1's strong anti-cancer profile and the ongoing Phase 1 clinical trial Case study demonstrates reactivation of an autologous Poseida CAR-T therapy with a T-cell engager in patient with relapsed multiple myeloma,...Read more
SOLANA BEACH, Calif., Dec. 09, 2024 (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, dermatologic, and neurological conditions, today announced the presentation of preliminary data on ART27.13, the Company’s benzimidazole derivative, being studied for cancer-related anorexia. The...Read more
The maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg, without dose-limiting toxicity or evidence of cytokine release syndrome at any dose level Stable disease (SD) at four months post-initiation of dosing was seen in 10 of 21 (48%) evaluable monotherapy patients, and importantly included one patient dosed at the MTD who had a partial response (PR) by RESIST criteria (a 45% decrease from baseline) Together, these data...Read more
No dose-limiting toxicities reported in two different weekly doses in heavily pre-treated patients Preliminary evidence of dose response includes significant tumor shrinkage and one patient with complete resolution of a liver lesion MONTREAL, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Thera technologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and...Read more
NORWOOD, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, today announced the dosing of the first patient in the Phase 1 portion of the clinical study of CRB-601 for the treatment of patients with advanced solid tumors (NCT06603844). CRB-601 is a monoclonal antibody targeting latent TGFβ...Read more
Demonstrated durable hematologic response across all patient subgroups, regardless of baseline transfusion status and concomitant JAK inhibitor therapy Phase 2 study in MF anemia has been initiated, enrolling a broad range of patient types WATERTOWN, Mass., Dec. 08, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of...Read more
In Multiple Myeloma, Cemsidomide in Combination with Dexamethasone at Highest Dose Level Explored to Date Achieved 36 Percent Overall Response Rate (ORR) and 45 Percent Clinical Benefit Rate (CBR); Responses Seen Across All Dose Levels Multiple Myeloma Arm Demonstrated Well-Tolerated Safety Profile; On-Target Neutropenia Was Manageable With Low Rates of Febrile Neutropenia and Infections; No Treatment Emergent Adverse Events Leading to...Read more
WILMETTE, Ill., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the first patient ever dosed with MNPR-101-Lu. This novel therapeutic radiopharmaceutical combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR),...Read more
Nes-Ziona, Israel, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive interim 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. The multi-center Phase I/II clinical trial consists of two stages. The first...Read more
First three Single Ascending Dose cohorts demonstrated no treatment related adverse events Carlsbad, CA, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune, inflammatory, and fibrotic diseases, today announced preliminary results from its first three single ascending...Read more
Compelling molecular responses starting at lowest dose level in heavily pre-treated patients with high baseline BCR-ABL transcript levels Encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations, or dose reductions across three dose escalation cohorts High levels of target coverage achieved with once daily dosing at all doses Completion of dose escalation and initiation of dose...Read more
Emerging JANX007 data demonstrated substantial clinical activity in 5L mCRPC patients, supporting clinical development plan directed at pre-PLUVICTO® 2L / 3L patients In 16 patients JANX007 displayed: High PSA response rates: 100% achieved best PSA50 declines Deep PSA declines: 63% achieved best PSA90 declines; 31% achieved best PSA99 declines Durable PSA response at ≥ 12 weeks: 75% maintained PSA50 declines; 50% maintained PSA90...Read more
Spyre is concurrently advancing two anti-TL1A molecules into first-in-human studies Preclinical data for both SPY002 molecules demonstrate picomolar potency and potential for quarterly or twice-yearly dosing, suggesting opportunity for improved efficacy and convenience over first-generation anti-TL1As which are dosed every two to four weeks Interim pharmacokinetic, pharmacodynamic, and safety data from healthy volunteers for both...Read more
2 of 3 patients achieved MRD negative CR in the first dose level evaluated in the trial with a generally well-tolerated preliminary safety profile Dose escalation is continuing with additional response and durability data expected in 2025 Conference call scheduled on December 3 at 7:30am ET SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or...Read more
TN-401 AAV9-based Gene Therapy Designed to Deliver Fully Functional PKP2 Gene with the Aim of Increasing Protein Levels to Address Underlying Disease RIDGE-1 Currently Enrolling at Six Centers; Observational Natural History and Seroprevalence Study of PKP2-associated ARVC Adults Continues Enrollment at 20 Clinical Sites in the U.S., UK and Europe Initial Clinical Data for RIDGE-1 Anticipated in 2025 SOUTH SAN FRANCISCO, Calif.,...Read more
Single intrathecal dose of Rhenium (186Re) Obisbemeda shows a favorable response rate and median overall survival in leptomeningeal metastases (LM) patients Achieves up to 8x absorbed radiation dose to the CNS subarachnoid space vs. standard of care external beam radiation Receives FDA agreement to initiate the ReSPECT-LM Phase 1 multiple administration dose escalation trial of Rhenium (186Re) Obisbemeda for LM AUSTIN, Texas, Nov....Read more
50% of patients who received repeated doses (n=10) remained alive and in remission beyond the expected median overall survival (OS) from standard-of-care Stupp regimen while none of the patients who received a single dose (n=3) achieved this outcome. Biopsy results confirmed the presence and persistence of gamma-delta T cells along with CD3+ and CD8+ T cells within the brain tumor microenvironment in two patients following treatment...Read more
PYX-201 achieved a confirmed 50% ORR by RECIST 1.1 including one Complete Response and 100% Disease Control Rate in six heavily pretreated HNSCC patients, supporting differentiated mono and front-line combo therapy expansion trials to begin dosing 1Q25 Overall, 26% ORR across all six Solid Tumor Types of Interest (n=31) with Dose Dependent Responses Observed, Supporting First-In-Concept Mechanism with Novel Extracellular Targeting...Read more
HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF)...Read more
SRC recommended that the trial escalate to the next dose level of 15mg capsule No dose-limiting toxicities (DLTs) observed to date No rash observed to date MIAMI, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis...Read more
SINGAPORE, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Further to an announcement on October 7, 2024, CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of blood and solid cancers, is pleased to announce that the first patient has been dosed in...Read more
SAN CARLOS, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immunodeficiencies, infectious diseases and checkpoint-resistant cancers, and a subsidiary of Grifols, announced today that the first patient has been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of the first recombinant polyclonal drug candidate, GIGA-2339, for the treatment...Read more
Six sites across the U.S. are now engaged in Phase1b study Marlborough, Massachusetts--(Newsfile Corp. - November 19, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company exploring new pathways towards a cancer-free future, today announced it has completed the enrollment of its second patient cohort in its PH-762 Phase 1b dose-escalating clinical trial, and added a sixth clinical site in San...Read more
First gamma delta CAR T cell therapy with the potential to address solid tumors entering clinical trials Preliminary Phase 1 clinical data expected in the first half of 2025 REDWOOD CITY, Calif. & BOSTON / Nov 18, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the...Read more
Third cohort dose is one million CAR positive cells; ten times higher than the first cohort dose SAN JOSE, Calif., Nov. 18, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has dosed its first patient in the third cohort in the ongoing Phase 1 clinical trial of its novel chimeric antigen...Read more
27-year-old African American-Asian Woman with Active Lupus Nephritis Achieved DORIS Clinical Remission; Patient Remains On-study, in Clinical Remission, and Free of All Immunosuppressive Therapies Patient Treated with Fludarabine-free Conditioning and Single-dose FT819; Favorable Safety Profile with No Grade ≥3 Adverse Events and No Events of CRS, ICANS, or GvHD Reconstituted B Cell Compartment Predominantly Consists of Naïve,...Read more
Significant correlation shown between blood levels and symptom relief; TH104 was well tolerated with no unexpected treatment-emergent adverse events Phase 2 preliminary data for chronic pruritus in primary biliary cholangitis expected in 2025 BRIDGEWATER, NJ / ACCESSWIRE / November 18, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic...Read more
CARMEL, Ind., Nov. 18, 2024 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced the completion of the last subject’s last visit in its Phase 1 single and multiple ascending dose trial of MBX 1416, the Company’s long-acting glucagon-like peptide...Read more
Enrollment underway for lupus nephritis (LN) patients Preliminary clinical data in LN anticipated in 1H25 Initiation of patient enrollment in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) expected in 1Q25; patient enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) expected in 2H25 REDWOOD CITY, Calif. &...Read more
Treatment with nomlabofusp modified gene expression and lipid profiles in addition to increasing frataxin (FXN) levels in study participants with Friedreich’s ataxia (FA) Modeling and simulation predict that, in most patients with FA, 50 mg of nomlabofusp administered daily is likely to achieve FXN levels that are ≥50% of levels observed in healthy controls and similar to mean FXN levels reported in asymptomatic heterozygous...Read more
Single Dose of Nucresiran 300mg or Higher Led to Rapid Knockdown of Mean TTR Levels of Greater than 90% by Day 15 that was Sustained at Six Months At These Doses, Peak Reduction of Mean TTR Levels of Greater than 96% were Achieved by Day 29 Data Support Potential for Biannual or Annual Subcutaneous Dosing, Representing a New Paradigm in the Treatment of ATTR Amyloidosis Encouraging Safety and Tolerability Observed Alnylam Continues to...Read more
Consistently rapid, deep and durable reduction in serum TTR accompanied by evidence of disease stabilization or improvement after a one-time treatment of nex-z, supporting the hypothesis that greater TTR reduction may lead to a greater clinical benefit in ATTR amyloidosis Favorable trends consistently observed across multiple markers of cardiac disease progression at month 12 compared to baseline in an ATTR-CM population with a high...Read more
Media Release Mature data in patients with a minimum follow-up of 22 months (N=21) shows excellent results, well above historical controls and exceeding expectations: Median Overall Survival is 32.9 months, with median Progression Free Survival reaching 12.7 months, and a 24-month Overall Survival rate of 81.0% Data from all evaluable patients to date (N=40) demonstrates significant improvement of Overall Response Rate compared...Read more
Nes-Ziona, Israel, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the completion of the dosing and initial follow-up period for the first patient in its Phase I clinical trial evaluating the safety, tolerability and potential therapeutic effect of Allocetra™ following injection into an affected joint in...Read more
REL-P11 is a proprietary, low-dose, modified-release psilocybin formulation Single-Ascending Dosing (SAD) study to evaluate safety and pharmacokinetics in obese and normal weight subjects With positive results, Phase 2a proof-of-concept study expected to begin in H1 2025 CORAL GABLES, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology company...Read more
NXP800 demonstrated single agent activity New dosing schedule successfully minimized thrombocytopenia Fort Lee, NJ, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today reported encouraging data from the Phase 1b study evaluating...Read more
DehydraTECH clinical test article manufacturing has been completed KELOWNA, BC / ACCESSWIRE / November 13, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX, LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ("HREC") approval that was required before dosing can begin in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4,...Read more
High-dose LTI-03 (5 mg BID), a Caveolin-1 related peptide, reduced expression of multiple profibrotic proteins in both pathological basal-like cells and fibroblasts and decreased the expression of a biomarker indicative of epithelial health and lung function decline, suggesting potential therapeutic effect Positive trend observed in seven out of eight IPF biomarkers in Cohort 2, with four biomarkers statistically significant in the...Read more
SPY001 was well tolerated with a favorable safety profile consistent with the anti-α4β7 class SPY001 pharmacokinetics exceeded expectations with a ~4-fold increase relative to vedolizumab, supporting potential Q6M maintenance dosing with a single subcutaneous (SC) injection Planned Phase 2 induction regimen targets drug concentrations in quartile 4 of vedolizumab's exposure-response relationship, which has the potential to...Read more
Aptevo Therapeutics and Alligator Bioscience report favorable safety, tolerability and evidence of biological activity of ALG.APV-527, more than half of evaluable patients achieved stable disease Colon cancer patient achieved stable disease and remained on study for more than six months, breast cancer patient remained on study for more than 11 months Biomarker analysis confirms immune activation in the tumor microenvironment Data...Read more
Advancement of Fast Skeletal Muscle Troponin Activator Expands Pipeline of Muscle-Directed Drug Candidates SOUTH SAN FRANCISCO, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-4015089 (CK-089) in healthy human...Read more
GENEVA, SWITZERLAND / ACCESSWIRE / November 11, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF) (OTCQB:RLFTF) (OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced positive final results from its proof-of-concept, investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of epidermolysis...Read more
Objective response rate (ORR) of 46%, 12-month overall survival (OS) of 91.3% and a median overall survival (mOS) of 21.8 months in first line (1L) HPV+ R/M HNSCC patients treated with CUE-101 and KEYTRUDA® (pembrolizumab) ORR of 50% in 1L patients treated with CUE-101 and pembrolizumab with low PD-L1 expression (combined positive score (CPS) 1-19) 67% overall disease control rate (DCR) in late-stage pancreatic cancer patients...Read more
Data continues positive trend as additional patients are enrolled in 3 cohorts Vaccine was safe and well tolerated by participants in all 3 cohorts Protocol defined immune responses were exhibited in over 70% of patients A Phase 2 study evaluating the vaccine in the neoadjuvant setting is planned to commence in 2025 SAN JOSE, Calif., Nov. 8, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a...Read more
Preliminary data demonstrate durable and dose-dependent T cell responses targeting KRAS mutations and induced responses to patient-specific neoantigens Correlation observed between disease-free survival (“DFS”) and T cell response ELI-002 Phase 1 safety and tolerability profile remains favorable ELI-002 Phase 2 interim event-driven DFS analysis expected in H1 2025 BOSTON, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics,...Read more
BDC-4182 demonstrated compelling anti-tumor activity and an acceptable safety profile in preclinical studies BDC-4182 outperformed cytotoxic claudin 18.2 ADCs in syngeneic model Learnings from BDC-1001 data suggest Boltbody™ ISACs with enhanced immune activation could offer greater efficacy, warranting further testing REDWOOD CITY, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage...Read more
Phase 1 TRAVERSE Trial Demonstrated a Single Infusion of ALLO-316 Can Yield an Overall Response Rate of 50% and Confirmed Response Rate of 33% in Patients with CD70 Tumor Proportion Score (TPS) of Greater than 50% TRAVERSE Trial Highlights the Ability of CD70 Dagger® Technology to Promote Robust Expansion and Persistence of ALLO-316 with Standard Lymphodepletion, Validating its Potential as the Next...Read more
Combination of vilastobart and atezolizumab demonstrated encouraging early evidence of anti-tumor activity, including unconfirmed partial responses observed in two patients with difficult-to-treat, immunologically “cold” tumors Complete resolution of a metastatic liver lesion observed in a patient with microsatellite stable colorectal cancer (MSS CRC) Safety data indicated combination of vilastobart and atezolizumab was generally...Read more
Carlsbad, CA, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced that it dosed its first subject in its Phase 1 clinical study of PALI-2108, an orally administered PDE4 inhibitor prodrug that is...Read more
WATERTOWN, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced its partner Betta Pharmaceuticals has dosed the first patient in the Phase 1 clinical trial of CFT8919, an orally bioavailable allosteric degrader of EGFR L858R for non-small cell lung cancer (NSCLC), in Greater China. “We...Read more
VANCOUVER, British Columbia, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that the first patient has been dosed in the company’s first-in-human Phase 1 trial (NCT06555744) to evaluate the safety and tolerability of the...Read more
Up to 6.8% Placebo-Adjusted Mean Weight Loss (8.2% from Baseline) After 28 Days of Dosing with Oral Tablet of VK2735 Encouraging Tolerability Through 100 mg Daily Dosing with Oral VK2735; Mild GI-Related Adverse Event Profile Updated Results from VENTURE Phase 2 Study of Subcutaneous VK2735 Show Durable Effects and Support Potential Monthly Dosing Regimen SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Viking...Read more
Met primary objective demonstrating nintedanib DPI was safe and well tolerated Participants did not experience adverse events typically reported with oral nintedanib Expect to meet with the FDA in 1H 2025 to advance MNKD-201 into the next phase of development DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization...Read more
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...
CLICK TO LEARN MORE