Topline results demonstrated a favorable safety profile and tolerability across four ascending dose levels in healthy volunteers and showed dose dependent levels of PMN310 antibody in Cerebrospinal fluid (CSF) suggestive of its potential for target engagement in Alzheimer’s disease patients CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 26, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a biotechnology...Read more
10 of 12 patients treated in HER2 expressing solid tumor Phase 1b trial were breast cancer patients Dose selected for ongoing Phase 2b clinical trial in Osteosarcoma was shown to be well tolerated in breast cancer patients Preclinical breast cancer efficacy models showed positive data to prevent breast cancer metastases to the brain, reduce tumor growth by over 90% in combination with HER2-targeted antibodies, and prevent the formation...Read more
Safety, tolerability, pharmacokinetic and pharmacodynamic profile of VG-3927 supports continued development as potential once-daily oral therapy for Alzheimer’s disease (AD) VG-3927 achieved robust decrease of sTREM2 in CSF demonstrating clinical proof-of-target engagement New preclinical and clinical data from SAD cohorts to be presented at upcoming 2024 Alzheimer’s Association International Conference (AAIC) Company...Read more
SOUTH SAN FRANCISCO, Calif., July 24, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced that researchers at Columbia University Irving Medical Center (CUIMC) have initiated an investigator-sponsored trial (“IST”) of NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy in patients with systemic...Read more
CAMBRIDGE, Mass., July 22, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). "HER2...Read more
Pharmacokinetic and tissue data confirm NaviCap platform delivers topically through the entire colon, with lower systemic concentrations, as desired Data modeling suggests tofacitinib tissue concentrations greater than IC90 through at least 16 hours after dosing SAN DIEGO, July 18, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, presented supplemental data from...Read more
BOTHELL, Wash., July 18, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) today reported favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 study in healthy volunteers with CDI-988, its potent, oral, pan-viral protease inhibitor. CDI-988 was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery...Read more
After four weeks of treatment, CT-996 demonstrated clinically meaningful weight loss of -7.3% (weight loss in placebo -1.2%; p < 0.001)1 Pharmacokinetic data supports a once-daily oral dosing regimen for CT-9961 The safety and tolerability profile was consistent with other oral GLP-1 receptor agonists and no unexpected safety signals were observed1 SOUTH SAN FRANCISCO, Calif. / Jul 17, 2024 / Business Wire /...Read more
WILMETTE, Ill., July 09, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced the enrollment of the first patient in its first-in-human Phase 1 dosimetry and imaging clinical trial of MNPR-101-Zr. This novel radiopharmaceutical imaging agent combines MNPR-101, Monopar’s antibody that selectively targets the...Read more
GT-02287 Well Tolerated With No Serious Adverse Events or Other Safety Signals Reported Additional Topline Data To Be Presented Mid-August GT-02287 on Track To Initiate Clinical Trial in Parkinson’s Disease Patients in Q4 2024 BETHESDA, Md., July 09, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next...Read more
Five sites across the U.S. are now participating in the Phase 1b study Marlborough, Massachusetts--(Newsfile Corp. - July 8, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company whose proprietary INTASYL® siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced the addition of the University of Pittsburgh Medical Center (UPMC)...Read more
Positive Phase 1 Clinical Data of MTX110 in DMG Brain Cancer Demonstrating Increased Survival Presented at ISPNO 2024 After Only Two Infusions and Two Patients at Optimal Dose, Median Overall Survival Across all Patients was 16.5 Months (vs 10.0 Months in Historical Reference Cohort) JULY 2 -- Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical...Read more
Novel arenaviral therapeutic vaccine, developed in collaboration with Gilead Sciences, Inc. (Gilead), to be evaluated as a potential component of a curative regimen for human immunodeficiency virus (HIV) HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion...Read more
The Phase 1 study for OV888/GV101 capsule met its objective, demonstrating a favorable safety and tolerability profile with no serious adverse events Secondary endpoint results indicate that the target pharmacokinetic profile was achieved at the targeted clinical dose, supporting once daily dosing OV888/GV101 capsule was shown to be biologically active in participants and elicited dose-dependent pharmacodynamic effects within the...Read more
Drug-device combination leverages Biora’s NaviCap™ platform to deliver tofacitinib directly to colonic tissue as a potential treatment for ulcerative colitis BT-600 was well tolerated and met all trial objectives, demonstrating the NaviCap platform’s ability to deliver therapeutics directly to the colon Drug absorption in colonic tissue extended to distal colon, suggesting pan-colonic delivery Company to host virtual event with key...Read more
BOSTON, June 27, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced new preliminary data from the ongoing AMPLIFY-7P Phase 1a study of its off-the-shelf investigational therapeutic cancer vaccine candidate, ELI-002 7P. The preliminary data showed patients...Read more
Patient screening underway in Ntrust-1, the first U.S.-based clinical trial of an engineered NK cell therapy for the treatment of lupus nephritis IND cleared for Ntrust-2, a clinical trial for NKX019 for the treatment of systemic sclerosis, myositis and vasculitis Clinical data from Ntrust-1 and Ntrust-2 planned for 2025 SOUTH SAN FRANCISCO, Calif., June 27, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical...Read more
Overall response of 18.2% in heavily pretreated patients across gastrointestinal tumors with target alterations regardless of prior irinotecan exposure Prolonged clinical benefit in patients with CRC, with 40% of irinotecan-naïve patients receiving treatment for greater than nine months Preliminary RP2D established as 60mg BID lunresertib continuous plus standard FOLFIRI Safety profile of combination consistent with FOLFIRI...Read more
Top-Line Data Readout From the Single Ascending Dose Part 1 Expected in the Third Quarter of 2024, and From the Multiple Ascending Dose Part 2 in the First Quarter of 2025 Planned Part 3 Will Assess Total Weight Loss at 24 Weeks, Exploring Maximum Titratable Dose and Dietary Changes; Interim Data Readout Expected Mid-2026 with Top-Line Data in the Second Half of 2026 Recent Financing of up to $70 million Will Fund the Ongoing...Read more
Dose-dependent antitumor clinical activity in ROR1+ relapsed/refractory triple-negative breast cancer; 40% objective response rate and 60% clinical benefit rate at the highest dose cleared to date (150 x 106 CAR T cells) First demonstration that CAR T cells enhanced with anti-exhaustion technology can both expand and infiltrate into solid tumors No significant safety signal related to LYL797 observed in patients without lung...Read more
AK006 achieved serum concentrations consistent with levels demonstrating inhibitory activity in preclinical experiments Skin biopsies from subjects treated with AK006 show high receptor occupancy AK006 was well-tolerated with a favorable safety profile SAN CARLOS, Calif., June 25, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a biotechnology company developing AK006 for the treatment of mast cell-driven...Read more
Data demonstrate that administration of WTX-330 reached therapeutically relevant exposure levels of systemically delivered IL-12 prodrug with an improved tolerability profile over historical data for rhIL-12 Early WTX-330 dose-escalation data demonstrated encouraging clinical activity and evidence of immune biomarker activity including an unconfirmed partial response in a metastatic melanoma patient Expansion arms open to checkpoint...Read more
First-Patient-In (FPI) for Phase 1 combination treatment with IDE397, IDEAYA's MAT2A inhibitor, and Trodelvy®, Gilead's Trop-2 directed antibody-drug conjugate (ADC) The global Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with Trodelvy MTAP-deletion is found in approximately 26% of patients with bladder cancer SOUTH SAN FRANCISCO, Calif.,...Read more
Gemini administration induced statistically significant, dose dependent changes in key biomarkers of activity Gemini was safe and well tolerated at pharmacologically active doses Phase 1 results enable further development across multiple indications SAN DIEGO / Jun 24, 2024 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on...Read more
This patient is expected to be the final patient in the second dosage cohort of the trial SAN JOSE, Calif., June 24, 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 treated the sixth patient in the ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for...Read more
Continued mechanistic dose response observed following completion of 3 mg/kg dose level based on urinary biomarker analyses Percent change from baseline in PC1 and PC2 demonstrated a dose response across all doses tested, with statistical significance seen at 3 mg/kg compared to placebo Exploratory imaging analyses indicated reduction in total kidney volume in 70% of patients dosed with 3 mg/kg Fourth cohort enrollment...Read more
ENTR-601-44 was well-tolerated in healthy volunteers with no serious adverse events, no drug-related adverse events and no clinically significant changes or trends noted in vital signs, ECGs, physical exams or laboratory assessments ENTR-601-44 demonstrated significant plasma concentration, muscle concentration and exon skipping, at levels that suggest the potential for a clinically meaningful starting dose in planned upcoming...Read more
Follow-up Findings Show Stable Disease FDA and IRB Approve IND for a Single-Use, Single-Patient Treatment with Deltacel Fast Track Designation Request Submitted to FDA Complete Enrollment in Trial’s Second Cohort Expected in July HOUSTON / Jun 20, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports follow-up results from the second, third and fourth patients enrolled in its Deltacel-01...Read more
Demonstrating pelareorep's synergy with modified FOLFIRINOX +/- atezolizumab in pancreatic cancer could expand the number of patients it may benefit Funding for the study comes from the US$5 million Therapeutic Accelerator Award from PanCAN SAN DIEGO, and CALGARY, AB, June 20, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology,...Read more
NMRA-511 is a highly potent and selective, best-in-class, antagonist of the vasopressin 1a receptor, which is known to play a role in regulation of aggression, stress and anxiety response NMRA-511 was generally well-tolerated at all dose levels in Phase 1 single ascending dose / multiple ascending dose study, with no serious adverse events reported to date Alzheimer’s disease agitation is associated with increased morbidity and...Read more
SOUTH SAN FRANCISCO, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the first participant has been dosed in the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator (CAM) candidate in development for the treatment of chronic hepatitis B virus (HBV) infection. Chronic...Read more
Preclinical data for SPY001 demonstrate the potential for improved dosing over standard of care, including the potential for dosing every eight or twelve weeks compared to dosing every two weeks for subcutaneous vedolizumab Interim subcutaneous pharmacokinetic and safety data from healthy volunteers anticipated by year-end 2024 SPY002, an extended half-life anti-TL1A antibody designed for enhanced potency to both TL1A monomers and...Read more
APR-1051 is a highly selective and potentially best-in-class oral WEE1 inhibitor Phase 1 ACESOT-1051 clinical trial is evaluating APR-1051 as monotherapy treatment in patients with significant unmet medical need Dosing of the first patient in the ACESOT-1051 study represents a key advancement in Aprea’s clinical pipeline DOYLESTOWN, Pa., June 17, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”,...Read more
SOUTH SAN FRANCISCO, Calif., June 17, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants. “We are conducting this Phase 1 bridging study to characterize the pharmacokinetics of aficamten in healthy Japanese adults and to...Read more
KT-333 demonstrated initial clinical proof of concept across multiple hematological malignancies, including complete responses in two patients with Hodgkin’s lymphoma Robust STAT3 knockdown and positive immunomodulatory effect achieved in blood and tumor KT-333 was well-tolerated with Phase 1 dose escalation ongoing and additional data expected in the second half of 2024 WATERTOWN, Mass., June 14, 2024 (GLOBE NEWSWIRE) -- Kymera...Read more
Observed 67% Objective Response Rate (ORR) in frontline HR-MDS patients, primarily with TP53 mutations; initial complete remission (CR)/marrow complete remission (mCR) rate of 58% and median overall survival had not yet been reached Observed 43% ORR in frontline TP53m AML patients, 33% CR/complete remission with incomplete hematologic recovery (CRi) and median overall survival had not yet been reached SL-172154 demonstrated a...Read more
Top-line data forthcoming SAN DIEGO / Jun 13, 2024 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, announced today that it has completed enrollment and dosing of its first in human Phase 1 clinical study (RVL-HV02). The study, which was conducted...Read more
VYN202 has been designed to achieve class-leading potency and BD2-selectivity Trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202 in healthy volunteers; top-line data expected in 2H’24 BRIDGEWATER, N.J., June 13, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and...Read more
MIAMI, June 13, 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 type 1 (NF1) and other indications, announced today that an independent Safety Review Committee (SRC) has completed its safety review of data from the first dose cohort (2mg) treated...Read more
Eight of 12 evaluable patients (66.7%) had progression-free survival (PFS) ranging from 5 to 11 months At the highest NGC-Cap dose, all three evaluable patients had PFS with two partial responses (PR) and one stable disease (SD) For all NGC-Cap doses, 5-Fluorouracil (5-FU) exposure was greater and fluoro-beta-alanine (FBAL) exposure was lower with a better or similar side-effect profile than monotherapy capecitabine HANOVER,...Read more
BOTHELL, Wash., June 11, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that it has completed the first cohort of healthy volunteers in its ongoing, first-in-human, dose escalation Phase 1 clinical study evaluating ATH-1105, an oral, small molecule positive modulator of...Read more
Phase 1a study portion of single ascending dosing in healthy participants will inform the development of ABI-5366 with interim data expected in Q3 2024 Phase 1b study portion of multiple ascending weekly doses in participants with recurrent genital herpes on track to initiate by end of year with interim data expected in 1H 2025 SOUTH SAN FRANCISCO, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc....Read more
ARCT-032 is safe and well tolerated with no serious adverse events (SAEs) in 36 study participants, including 4 adults with cystic fibrosis (CF) Phase 1b interim data includes a CF participant with Class 1 mutations and three participants with F508del mutations being treated with Trikafta® Early trend of improved lung function with an average absolute response of +4.0% (ranging up to +9%) and relative change of +5.8% FEV1 on Day 8,...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China. The first patient received their first dose on May 31, 2024. This is a Phase I, multicenter, open-label clinical study to evaluate the safety,...Read more
Favorable Follow-up Findings Include Stable Disease and a 13% Decrease in Tumor Size HOUSTON / Jun 06, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable six-month follow-up results from the first patient enrolled in the Deltacel-01 Phase 1 clinical trial. This trial is evaluating Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in...Read more
Primary endpoint data shows 12-month overall response rate (ORR) of 33.6% Biologics license application (BLA) submission intended for 2H 2024; first patient expected to be enrolled in IGNYTE-3 confirmatory trial in Q3 2024 Company to host conference call and webcast today at 8:00 a.m. ET WOBURN, Mass., June 06, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the...Read more
DNA vaccine proof-of-concept study expected to demonstrate an “mRNA better” platform LAWRENCEVILLE, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform’s potential as a next-generation vaccine, announces that the first participants have been treated in the IMNN-101 Phase 1 clinical trial....Read more
SZN-043 is a novel hepatocyte-specific R-spondin mimetic bispecific fusion protein targeting ASGR1 Anticipate potential proof-of-concept data available in the first half of 2025 SOUTH SAN FRANSCISO, Calif., June 04, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today...Read more
TuHURA's lead candidate, IFx-2.0, was safe and well tolerated at once weekly dosing for 3 weeks Eighty percent (80%) of ICI naïve patients with advanced MCC who failed to respond to pembrolizumab or avelumab therapy achieved a durable Complete Response (CR), pathologic CR or Partial Response (PR) following IFx-2.0 therapy and rechallenge with an anti-PD(L)-1 checkpoint inhibitor Data presented at the 2024 American Society of Clinical...Read more
Latest data from first and second cohorts support Company’s 'pulse-prime' approach, demonstrating rapid clearance, broad immune activation, and encouraging safety profile Poster Presented at American Society of Clinical Oncology Annual Meeting NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection...Read more
Evorpacept in combination with PADCEV®, an approved antibody-drug conjugate (“ADC”), demonstrated promising activity and was generally well tolerated Company to host conference call and webcast with Samuel A. Funt, M.D., of Memorial Sloan Kettering Cancer Center on Friday, June 7, 2024, at 1:00 PM ET SOUTH SAN FRANCISCO, Calif., June 02, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq:...Read more
Extended follow-up data reaching over two years in the earliest patients dosed reinforce the potential of NTLA-2002 to be a functional cure for people living with hereditary angioedema (HAE) Eight of 10 patients remain completely attack-free following the 16-week primary observation period through the latest follow-up, including patients with the most severe disease Single dose of NTLA-2002 led to a 98% mean reduction in monthly HAE...Read more
KT-253 demonstrates initial clinical proof of concept in patients with tumor types shown to be sensitive in preclinical models, including responses in MCC and AML Evidence of target engagement and potent upregulation of p53 pathway biomarkers even at the lowest dose levels in solid tumor and AML patients KT-253 was generally well tolerated without hematologic adverse events seen with traditional MDM2 small molecule inhibitors KT-253...Read more
Mechanism of action supported by observed MP0317 localization and immune cell activation in the tumor microenvironment Favorable and manageable safety profile observed at all tested dose levels Weekly and three-weekly dosing schedules established, supported by pharmacokinetics and pharmacodynamics Data support further clinical evaluation of MP0317 in combination settings ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., June 01,...Read more
Monotherapy brenetafusp (IMC-F106C) in late-line cutaneous melanoma demonstrated promising disease control (partial response and stable disease), progression free survival (PFS), and ctDNA molecular response Clinical activity was enriched in PRAME positive patients with 58% disease control rate and 4.2 months median PFS Peripheral blood T cell fitness was associated with increased brenetafusp clinical activity and was higher in...Read more
Scans of this first patient in the second cohort show 8.5% reduction in tumor size HOUSTON / May 29, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable safety and tolerability, and early efficacy in the fourth patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel™ (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta...Read more
Top-line Phase 1 CSU results expected at year end 2024 SAN CARLOS, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a biotechnology company developing AK006 for the treatment of mast cell-driven diseases, today announced that the first patient with chronic spontaneous urticaria (CSU) has been dosed in a randomized, double-blind, placebo-controlled Phase 1 trial of AK006. The Phase 1 trial is designed to...Read more
No Clinically-Relevant Adverse Events Reported in Single Dose Portion, Multiple Dose Portion to Commence Investor Call Scheduled for today, Wednesday, May 22, at 10:00 am ET to Discuss Potential Impact on PTSD, Depression, Anxiety, Addiction, and Obesity NEW YORK, NY / ACCESSWIRE / May 22, 2024 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a leader in biopharmaceutical innovation, today announced the complete safety data set from...Read more
First-in-human trial confirms “Pulse-Prime” hypothesis targeting stimulation of innate and adaptive immune systems Investigational package of broad immune agonists derived from Gram-negative bacteria which induces dozens of cytokines/chemokines that are quickly cleared from the body Identification of tolerable single dose in Phase 1a, recommended for multi-dosing, will be presented at ASCO NEW YORK, May 22, 2024 (GLOBE NEWSWIRE) --...Read more
Novel and proprietary CAR-T approach holds potential to be first effective CAR-T therapy for solid tumors SAN JOSE, Calif., May 21, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced that treatment has commenced for the fifth patient in its ongoing Phase 1 clinical...Read more
The SON-1010 studies have together enrolled 61 subjects, to date, as dose escalation continues in SB101 and SB221 at higher levels Patients have received up to 25 cycles of SON-1010 as monotherapy and 10 cycles of SON-1010 with atezolizumab (Tecentriq®) without dose-limiting toxicity at any dose level Cytokine data reveals about 10-fold extended half-life for SON-1010 compared with rhIL-12 that induces prolonged and controlled IFNγ...Read more
CT-0525 is the first CAR-Monocyte to be evaluated in humans in the solid tumor setting Initial data expected by year-end 2024 PHILADELPHIA, May 16, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that the first patient was dosed in its Phase 1 clinical...Read more
LEXINGTON, Mass., May 16, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that the first participants were dosed in a Phase 1a single ascending dose (SAD) trial of VY-TAU01, an investigational anti-tau antibody developed to inhibit the spread of pathological tau in Alzheimer’s disease. The objective of the randomized, double-blind,...Read more
After six months of additional follow-up, clinical benefit rate (63%), overall response rate (41.9%), median progression-free survival (11.2 months), and safety profile of vepdegestrant in combination with palbociclib were consistent with data previously reported at SABCS in December 2023 At the recommended Phase 3 dose of 200 mg vepdegestrant in combination with palbociclib, patients achieved a median progression-free survival...Read more
Over 24 weeks, a once-weekly subcutaneous injection of CT-388 achieved a clinically meaningful and statistically significant mean placebo-adjusted weight loss of 18.8% (p < 0.001) At week 24, 100% of CT-388 treated participants achieved >5% weight loss, 70% achieved >15% and 45% achieved >20% weight loss In a subgroup with pre-diabetes at baseline, CT-388 treatment normalized glycemia in all patients, indicating...Read more
PH-762 is Phio’s lead product candidate Screening on the next cohort is on-going MARLBOROUGH, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced progress on its Phase 1b clinical study for their lead compound...Read more
Expects to Initiate the Phase 2 Expansion Study in the Second Half of 2024 Acclaim-3 Study Supported by FDA Orphan Drug and Fast Track Designations AUSTIN, Texas, May 14, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the first patient has been enrolled and...Read more
Proof-of-concept study for Imunon’s first vaccine utilizing its proprietary PlaCCine platform is now open for enrollment Topline results expected this year LAWRENCEVILLE, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, today announced that DM Clinical Research in Philadelphia is the...Read more
SENTI-202 is a potential first-in-class Logic Gated off-the-shelf CAR-NK cell therapy Initial clinical efficacy data expected by year-end 2024 and durability data expected in 2025 SOUTH SAN FRANCISCO, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today...Read more
SAN DIEGO, May 9, 2024 /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-1076986 in healthy adult participants. NBI-1076986 is an investigational, oral, M4 subtype-selective muscarinic acetylcholine receptor antagonist for the potential treatment...Read more
Pre-treatment Sample of Patient’s Blood Showed Rapid and Potent Depletion of CD19+ B Cells in Ex Vivo Cytotoxicity Assay with FT819 Translational Data from FT819 Phase 1 B Cell Malignancies Study Support Key Therapeutic Mechanisms of Activity for B Cell-mediated Autoimmune Diseases Initial Clinical Observations of FT522 CAR NK Cell Program in Phase 1 B Cell Lymphoma Study Show Rapid, Deep, and Sustained B Cell Depletion and Enhanced...Read more
Patient dosed with TSC-203-A0201 targeting cancer-associated antigen PRAME On-track to report initial data from the solid tumor clinical trial in 2024 WALTHAM, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that...Read more
CX-904 demonstrated a favorable safety profile with no cytokine release syndrome (CRS) of any grade observed in step-dosing cohorts and no grade >1 CRS observed overall Encouraging initial signs of efficacy observed for CX-904 in advanced pancreatic cancer, including 2 of 6 patients (33%) with a confirmed partial response and all 6 patients (100%) with disease control Preliminary pharmacokinetic and pharmacodynamic...Read more
SAN DIEGO, May 8, 2024 /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-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of...Read more
Data Support Advancement to Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024 Full Data from the Phase 1 Study to be Presented at a Medical Congress in 2H 2024 SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced topline data from the Phase 1 study of CK-4021586 (CK-586). The study met its primary...Read more
VERVE-102 is an investigational in vivo base editing medicine designed to permanently inactivate the PCSK9 gene in the liver to durably reduce blood low-density lipoprotein cholesterol Heart-2 enrolling patients with heterozygous familial hypercholesterolemia or premature coronary artery disease BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care...Read more
SAN DIEGO, May 6, 2024 /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, after review of all available safety data, the Company initiated screening in the of the fourth cohort of patients in the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. Patients in the...Read more
SYDNEY, May 1, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce that the Safety Review Team (SRT) of the EVT801 Phase 1 clinical trial has concluded that the primary and secondary objectives of stage 1 of the trial have successfully been met. Consisting of the trial's lead investigators, independent medical monitor, and key members from Kazia...Read more
Low-dose LTI-03 (2.5 mg BID), a Caveolin-1 related peptide, reduced expression of multiple profibrotic proteins in both pathological basal-like cells and fibroblasts and increased the expression of a biomarker indicative of epithelial health, suggesting potential therapeutic effect Positive trend was observed in seven of eight IPF biomarkers evaluated Low-dose LTI-03 was well-tolerated, with no safety signal observed Data from Cohort...Read more
Antibody rise observed in lactating mothers and in their breast milk Long-term goal is to provide protection to infants through passive antibody transfer SOUTH SAN FRANCISCO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it has completed the topline analysis for the Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate. The trial was focused on...Read more
Boca Raton, Florida, April 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, is pleased to share an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro™ for treatment of Alzheimer’s Disease (AD) for more than three...Read more
Dosing of all patients in the trial has been successfully completed Final results are expected to be available in late Q2 2024 SAN DIEGO, April 30, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced completion of dosing for the multiple-ascending dose cohorts for its clinical study of BT-600, a drug-device combination consisting of the...Read more
Part 2 of REFRαME-O1, the registration-directed study of luvelta for patients with platinum-resistant ovarian cancer (PROC), is open for enrollment Planned 50 patients in Dose-Optimization (Part 1) of REFRαME-O1 have been enrolled and are in follow up SOUTH SAN FRANCISCO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering...Read more
MONTREAL & LAUSANNE, Switzerland / Apr 30, 2024 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, and Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, today announced that the first patient has been dosed in Module 4 of...Read more
LAUSANNE, Switzerland & MONTREAL / Apr 30, 2024 / Business Wire / Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, and Repare Therapeutics Inc. (“Repare”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, announced that the first patient has been dosed in Module 4 of the ongoing Phase 1/1b...Read more
SHELTON, CT / ACCESSWIRE / April 30, 2024 / NanoViricides, Inc. (NYSE Amer:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, reports that the Phase I Clinical Trial of NV-387 is completed successfully and data lock is expected soon. The Phase 1 clinical trial, protocol number KM-NVCoV2-001, which received approval from the regulatory agency in India for healthy as well as COVID-19 participants, was closed...Read more
First-in-human study to evaluate safety, tolerability and pharmacokinetics (PK) in healthy volunteers Enrollment of first study participant anticipated in June 2024 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan...Read more
Ability to dose TERN-701 without regard to food represents a key potential differentiator within the allosteric BCR-ABL inhibitor class Pharmacokinetic data show no clinically significant difference in exposure between fed and fasted dosing Phase 1 CARDINAL trial evaluating TERN-701 in 2L+ CML patients remains ongoing, with interim data from initial cohorts anticipated in second half of 2024 FOSTER CITY, Calif., April 29, 2024...Read more
BETHESDA, Md., April 24, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, announces positive results from the single ascending dose (SAD) part of its Phase 1 study. GT-02287 was generally well tolerated up to and including the highest planned dose level, and...Read more
Follow-up Scans Show Continued Stable Disease in First Patient Cohort Company to Apply for FDA Fast Track Designation HOUSTON / Apr 24, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces consistent favorable safety, tolerability, and efficacy from follow-up visits of the first cohort of three patients enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is...Read more
Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
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