Company on track to report topline data in first half of 2025 Positive preliminary data from all five single ascending dose (SAD) cohorts ranging from 15mg to 450mg support safety and tolerability of PALI-2108 Continued progress toward Phase 1b/2a of PALI-2108 trial for the treatment of UC Carlsbad, CA, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a...Read more
MALVERN, Pa., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME). “OCU200 has the potential to change the treatment landscape for DME,...Read more
Set to begin larger Phase 2b study in sarcopenia and new trial in GLP-1-induced sarcopenia and frailty Transformative potential for novel TNF-alpha inhibitor drug: Estimated $40 billion TNF inhibitor market and $50 billion GLP-1 agonist market BALTIMORE / Jan 15, 2025 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral...Read more
CTIM-76 Phase 1 trial focused on CLDN6-positive gynecologic and testicular cancers Trial marks key milestone in driving pipeline progress PHILADELPHIA, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating...Read more
Interim data from Cohort 4 expected Q1 2025 MIAMI, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced it has opened three clinical trial sites in Eastern Europe. These...Read more
Follows Safety Review Committee (SRC) approval based on safety data from patients in Cohorts 1 and 2 No significant safety or dose limiting toxicities reported in Cohorts 1 and 2 PK data from Cohorts 1 and 2 consistent with preclinical and Phase 0 trial results BOSTON, Jan. 14, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA...Read more
The first selective Fatty Acid Binding Protein 5 inhibitor safely administered to human subjects Initial safety and pharmacokinetic data expected during the first half 2025 SOLANA BEACH, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, or dermatologic and...Read more
Announces encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with mCRPC Entered into clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab for the first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations Expects to report seven data readouts...Read more
Pathologic Complete Response reported for 2 patients with cutaneous Squamous Cell Carcinoma Marlborough, Massachusetts--(Newsfile Corp. - January 13, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio today announced pathologic...Read more
BURLINGAME, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data, which include previously reported results from cohort 1 of the trial and new data covering...Read more
Updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab continue to show promising anti-tumor activity and a differentiated safety profile in first-line cisplatin-ineligible metastatic urothelial cancer NECTIN4 gene amplification development strategy underway for zelenectide pevedotin in breast cancer, lung cancer and multiple tumors, with several Phase 1/2 trials planned to start in 2025 Emerging...Read more
Company also announces strong enrollment progress for REMAIN-1 weight maintenance pivotal study High demand from patients and physicians indicates significant interest in REMAIN-1 study and GLP-1 discontinuation; mid-point analysis on-track and anticipated in Q2 2025 BURLINGTON, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering pattern...Read more
CB-010 GALLOP Phase 1 trial initiated in lupus CB-012 AMpLify Phase 1 trial in r/r AML completes dose level 3 with no DLTs; enrolling patients at dose level 4 CB-010 ANTLER 2L LBCL and CB-011 CaMMouflage r/r MM Phase 1 clinical data expected in H1 2025 Sri Ryali appointed chief financial officer Caribou to present at 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, at 10:30 am PST BERKELEY, Calif., Jan. 12,...Read more
LAVA-1266 is a potent and selective bispecific anti-CD123 Gammabody® First-in-human study enrolling adult patients with CD123-expressing AML or MDS Initial Phase 1 data read-out expected by year-end 2025 UTRECHT, The Netherlands and PHILADELPHIA, Jan. 10, 2025 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, “LAVA,” “the Company”), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody®...Read more
LUNAR-H5N1 becomes the third STARR® mRNA vaccine candidate to enter clinic First Phase 1 participant injected December 2024 Interim Phase 1 data expected H2 2025 SAN DIEGO / Jan 10, 2025 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory...Read more
BELTSVILLE, Md., Jan. 10, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers. “Dosing the first patient in...Read more
CAMBRIDGE, Massachusetts, Jan. 10, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on developing precision therapies for neurodegenerative diseases, today announced the initiation of its Phase 1b clinical trial (PRECISE-AD) evaluating its lead therapeutic candidate, PMN310, in Alzheimer’s disease (AD). PMN310, a humanized IgG1 antibody, is engineered to selectively target...Read more
Emiltatug ledadotin observed to be generally well tolerated with differentiated safety and tolerability profile Promising clinical activity observed in patients with triple-negative breast cancer (TNBC) previously treated with topoisomerase-1 inhibitor (topo-1) ADCs; confirmed responses observed across all enrolled tumor types First expansion cohort initiated in patients with TNBC previously treated with at least one topo-1 ADC; dose...Read more
New SER-155 Phase 1b study biomarker data in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients demonstrate that SER-155 promoted epithelial barrier integrity and decreased systemic inflammatory biomarkers compared to placebo; data support the broader potential of Seres’ live biotherapeutics to target inflammatory and immune diseases SER-155 clinical results accepted for 2025 TANDEM Meeting oral presentation in...Read more
In the PET trial, RAP-219 achieved and exceeded target receptor occupancy, increasing support for the dosing regimen utilized in the ongoing Phase 2a trial in focal epilepsy; restricted neuroanatomical expression of TARP8 was confirmed In the MAD-2 trial, RAP-219 was observed to be generally well tolerated with faster titration and higher exposures than in the initial MAD trial Data underscore the potential broad therapeutic index of...Read more
Data show favorable safety and tolerability with dosing up to 800 mg for 10 days Plans to initiate human challenge study in 2025 in norovirus-infected subjects BOTHELL, Wash., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces favorable safety and tolerability results at dosing up to 800 mg per day for 10 consecutive days from the multiple-ascending dose (MAD) portion of...Read more
Compelling early clinical response signals for VIR-5818 and VIR-5500 in heavily pretreated patients with various solid tumors VIR-5818: In patients receiving doses ≥400 µg/kg, tumor shrinkage observed in 50% (10/20) of participants with various HER2-expressing cancers; confirmed partial responses in 33% (2/6) of participants with HER2-positive CRC VIR-5500: PSA declines in 100% (12/12) and PSA50 response confirmed in 58% (7/12)...Read more
Successfully dosed 6 patients in safety run-in segment, now accelerating enrollment Positive data from first four patients announced December 2024 NXC-201 is the only one-time CAR-T therapy in development for AL Amyloidosis Next program update Q1 2025 AL Amyloidosis is a life-threatening disorder of plasma cells in the bone marrow affecting ~33,000 patients in the U.S. LOS ANGELES, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Immix...Read more
Epstein-Barr virus (EBV) causes infectious mononucleosis and is associated with several types of cancer and multiple sclerosis There are no current treatments or vaccines for EBV First participant dosed with novel investigational EBV vaccine targeting multiple viral proteins in Phase I study WESTON, Mass., Jan. 07, 2025 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), announces dosing of the first...Read more
Phase 1 results support proceeding to Phase 2 in patients with post-bariatric hypoglycemia (PBH), which is expected to begin in 2H 2025 Phase 1 trial in healthy volunteers showed MBX 1416 was generally well-tolerated with a favorable safety profile Pharmacokinetic results demonstrated sustained dose-dependent exposure and support once-weekly dosing Company to host conference call to discuss results today at 8:30 am ET CARMEL,...Read more
ABI-4334 was well-tolerated with a favorable safety profile and half-life supporting once-daily oral dosing observed In the first 150 mg dose cohort, ABI-4334 showed strong antiviral activity with a mean reduction of 2.9 log IU/mL in plasma HBV DNA over 28 days of treatment Enrollment in final cohort of 400 mg ongoing with data anticipated in 1H 2025 SOUTH SAN FRANCISCO, Calif., Dec. 26, 2024 (GLOBE NEWSWIRE) -- Assembly...Read more
Promising results support VYN202’s potential as a novel, once-daily oral treatment for a broad range of immune-mediated disorders Consistent with Phase 1a SAD results, VYN202 demonstrated a favorable safety and tolerability profile with no drug-related adverse events historically associated with earlier generation, less selective BET inhibitors VYN202 demonstrated robust pharmacodynamic activity including evidence of target engagement...Read more
The Company has received approval to begin enrollment of the Phase 1b clinical trial in Australia Phase 1b clinical trial will assess safety and tolerability along with biomarkers during three months of dosing with GT-02287 in people diagnosed with Parkinson’s disease Phase 1b clinical trial follows successful Phase 1 study in which GT-02287 was safe and well tolerated while demonstrating GCase target engagement BETHESDA, Md.,...Read more
Investigational agent in development for treatment or prevention of H5N1 Bird Flu Phase 1 dosing completed in healthy volunteers Potent inhibition of drug-resistant and bird flu viruses in vitro In vivo study in mice, with H5N1 isolated from an infected dairy worker, showed potent protection and suppression of virus replication in lungs Phase 2 study expected to begin in H1 2025 Traws Pharma is expanding its...Read more
IMC-P115C (PRAME-HLE-A02) targets the same peptide and has the same CD3 effector and TCR specificity as brenetafusp, and is designed with extended half-life The Phase 1 trial will assess the safety and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with advanced solid tumors that express PRAME (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, 23 December 2024) Immunocore...Read more
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
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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