Results highlight ADI-001's potential as a best-in-class allogeneic cell therapy for autoimmune disease Webcast featuring Dr. Blake Aftab with accompanying presentation available on Company website REDWOOD CITY, Calif. & BOSTON / Sep 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...Read more
In a Phase 1 in healthy subjects, EDG-7500 was well-tolerated without meaningful changes in left ventricle ejection fraction (LVEF) CIRRUS-HCM single-dose trial of EDG-7500 in obstructive HCM demonstrated robust left ventricular outflow tract (LVOT) gradient reductions without meaningful changes in LVEF Company announced dosing of first patients in CIRRUS-HCM 28-day trial Edgewise to host webcast event on Thursday,...Read more
The first healthy volunteer has been dosed in the first component of the Phase 1 study Initial safety and pharmacokinetic data expected in Q4 2024 Initiation of the second component of the Phase 1 study, in adult DMD patients, expected in Q1 2025 TORONTO / Sep 18, 2024 / Business Wire / Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSX: MSCL) (OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic...Read more
Two patients dosed; several additional patients screened for enrollment Trial to evaluate safety and tolerability of TTX-MC138 in patients with metastatic cancer TTX-MC138 is an antisense oligonucleotide conjugated to TransCode’s proprietary TTX delivery system designed to inhibit microRNA-10b, a known driver of metastasis in multiple cancers Phase 1 clinical trial follows evidence of delivery and pharmacodynamic activity in prior...Read more
Expanded Phase 1 monotherapy study of givastomig, a Claudin 18.2 X 4-1BB bispecific antibody immunostimulant, shows promising single-agent activity in heavily pre-treated patients with gastric cancers expressing Claudin 18.2 at low and high levels The recommended Phase 2 dose for givastomig was determined to be 8-12 mg/kg; givastomig was well tolerated up to the highest study doses A Phase 1b study, evaluating givastomig in...Read more
Early Data Indicate Clinical Activity in Patients with Multiple Solid Tumor Types Prolonged stable disease lasting >11 months demonstrated in Breast Cancer Patient Favorable Pharmacokinetics, Safety and Tolerability Observed Data Presented at the European Society of Medical Oncology on September 14, 2024 SEATTLE WA and LUND, SWEDEN / ACCESSWIRE / September 16, 2024 / Aptevo Therapeutics ("Aptevo") (Nasdaq:APVO) and Alligator...Read more
Of the 20 evaluable ovarian cancer patients, there were 5 PRs Of the 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 3 PRs Biomarker data support proposed mechanism of action of NC410 BELTSVILLE, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class...Read more
Interim safety and biomarker data from the upliFT-D trial in FTD-GRN demonstrated that Dose 1 of PBFT02 achieved robust levels of CSF progranulin in all treated Cohort 1 patients; elevated CSF progranulin levels were sustained up to 12 months post-treatment Dose 1 of PBFT02 continued to be well-tolerated in all patients who received a revised immunosuppression regimen Company to deliver the updated data during a poster presentation at...Read more
TCER® IMA401 is a novel, next-generation, half-life extended bispecific T cell engager directed against an HLA-A*02-presented peptide derived from MAGEA4 and MAGEA8 with high target copy numbers on various solid cancers Data from the first-in-human Phase 1 dose escalation trial demonstrate initial anti-tumor activity and a manageable tolerability profile for TCER® IMA401 monotherapy; patient population includes 35 heavily pre-treated...Read more
23ME-01473 inhibited tumor growth in a patient-derived xenograft mouse model of non-small cell lung cancer Elevated levels of soluble and tumor-bound ULBP6 confirmed in squamous cell carcinomas and a subset of adenocarcinomas, offering potential indications to assess clinical activity Phase 1 trial ongoing with first patient dosed in March 2024 SUNNYVALE, Calif., Sept. 15, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME)...Read more
Updated Phase 1 dose-escalation data from ARROS-1 and ALKOVE-1 clinical trials continue to support potential best-in-class profiles for zidesamtinib and NVL-655 Rapid enrollment in Phase 2 portions of the ARROS-1 and ALKOVE-1 clinical trials; Pivotal data from both ROS1 and ALK programs now anticipated in 2025 Initiation of ALKAZAR Phase 3 randomized, controlled trial of NVL-655 for treatment-naïve patients with advanced ALK-positive...Read more
New antitumor response data from a range of doses and regimens unveiled today at Incyte investor event These results build upon safety and tolerability data presented earlier today during a mini-oral presentation at the European Society of Medical Oncology (ESMO) Congress 2024 Findings support the initiation of a pivotal trial in ovarian cancer, expected to begin in 2025; additional plans to evaluate INCB123667 in combination with other...Read more
Immunocore presents Phase 1 data of brenetafusp, an ImmTAC bispecific targeting PRAME, in patients with ovarian cancer Brenetafusp is clinically active as monotherapy and in combination with chemotherapy in heavily pre-treated, platinum-resistant ovarian cancer patients T cell fitness gene expression signature in blood is an important parameter of clinical activity for tebentafusp in uveal melanoma and for brenetafusp across different...Read more
4.3 mg/kg of luveltamab tazevibulin (luvelta) in combination with standard dose of bevacizumab (15 mg/kg) every 3 weeks resulted in a 56% objective response rate in patients with late-stage ovarian cancer and was selected to be the recommended phase 2 dose (RP2D) Luvelta in combination with bevacizumab demonstrated encouraging preliminary antitumor activity (35% response rate) across all explored dose ranges Expansion at RP2D is...Read more
Encouraging signs of anti-tumor activity including objective responses observed in patients with SMARCA4-mutated non-small cell lung cancer (NSCLC) and esophageal cancer in early PRT3789 monotherapy dose escalation At doses studied to date, PRT3789 was generally well-tolerated with no dose-limiting toxicities or study drug-related serious adverse events Company to host investor conference call and webcast on Friday,...Read more
Preliminary immunogenicity results demonstrate induction of cancer antigen-specific T-cell responses in 77% of evaluable patients following CVGBM monotherapy 84% of immune responses were de novo, observed in patients without pre-existingT-cell activity against encoded cancer antigens CVGBM was generally well tolerated up to the highest tested dose level of 100 µg with no dose-limiting toxicities Most common adverse...Read more
SAN DIEGO, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT) (the “Company”) today announced its decision to discontinue its clinical trials evaluating ONCT-534, its dual action androgen receptor inhibitor for the treatment of patients with metastatic castration resistant cancer, and ONCT-808, its ROR1-targeting autologous CAR T program for the treatment of patients with aggressive B-cell lymphoma, and to...Read more
VYN202 was generally well tolerated with no drug-related adverse events Pharmacokinetic results demonstrated dose-dependent exposure of VYN202 in blood Pharmacodynamic activity observed on target engagement and inflammatory biomarkers Dosing has begun in the MAD portion of the trial with results expected in Q4 2024 BRIDGEWATER, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the...Read more
WILMETTE, Ill., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced positive early data from its ongoing open-label MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial confirming MNPR-101-Zr’s tumor targeting ability in humans. MNPR-101 is Monopar’s proprietary first-in-class humanized...Read more
SER-155 administration was associated with a significant reduction in both bacterial bloodstream infections (BSIs) and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia, as compared to placebo through day 100 post HSCT Demonstrated generally well tolerated safety profile and confirmed drug bacteria strain engraftment; no treatment-related serious adverse events Company to seek Breakthrough Therapy...Read more
2.5 mg dose restored normative wakefulness with mean sleep latency of 32 minutes as measured by the Maintenance of Wakefulness Test (MWT) Favorable safety and tolerability profile with no observations of frequently reported on-target adverse events (AEs) associated with other OX2R agonists, visual disturbances or hepatotoxicity as of the data cutoff date 1 PK profile supports once-daily dosing Company plans to rapidly initiate Phase...Read more
Mosliciguat is a potential first-in-class, inhaled soluble Guanylate Cyclase (sGC) activator with targeted delivery to the lungs via once-daily administration, which may have broad applicability across the spectrum of pulmonary hypertension (PH) In the Phase 1b ATMOS study, presented today at the European Respiratory Society (ERS) Congress, a single dose of inhaled mosliciguat in PH patients (N=38) led to sustained, clinically...Read more
81.8% ORR by BICR and 63.6% confirmed ORR by BICR at the 240 mg dose; 46.2% confirmed ORR in CNS Metastases 90.9% (n = 20/22) of patients with confirmed responses remained on study with a median duration of response not yet reached at time of analysis ArriVent to host virtual webinar on these interim analyses of Phase 1b data for firmonertinib in EGFR PACC mutant NSCLC on September 9, 2024 at 4:30 pm ET NEWTOWN SQUARE, Pa., Sept....Read more
DeLLphi-303 Study Results Show Potential for IMDELLTRA in Combination with a PD-L1 Inhibitor as First-Line Maintenance Therapy in ES-SCLC DeLLphi-301 Long-Term Follow-up Data Demonstrate Sustained Safety and Efficacy for IMDELLTRA THOUSAND OAKS, Calif., Sept. 9, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data showcasing IMDELLTRATM (tarlatamab-dlle), a first-in-class delta-like ligand 3...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, today announced that the first patient has been dosed with CX-801 monotherapy in a Phase 1 study (NCT06462794) in patients with solid tumors. CX-801 is a dually-masked interferon alpha-2b PROBODY® cytokine with potential broad applicability in both...Read more
Phase 1 healthy volunteer study of half-life extended anti-TL1A antibody XmAb942 to dose first subject in Q4 2024, with data anticipated in the first half of 2025 XmAb® T-cell engagers plamotamab (CD20 x CD3) and XmAb657 (CD19 x CD3) to be evaluated in autoimmune diseases, with respective Phase 1b/2a and Phase 1 studies to initiate in 2025 Ongoing Phase 1 dose escalation of XmAb819 (ENPP3 x CD3) in advanced clear cell renal...Read more
Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024 SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data from the Phase 1 study of CK-4021586 (CK-586) were presented in a poster session at the American College of Clinical Pharmacology (ACCP) Annual Meeting in Bethesda, MD. The study met...Read more
Statistically significant mean weight loss up to 5.5% over 28 days (4.9% placebo adjusted) Well-tolerated with no treatment-related dose interruptions, reductions, or discontinuations even with rapid dose titration Distinct drug properties support potential to be a leading GLP-1R agonist Plans to initiate Phase 2 clinical trial in 2025 Company to host conference call today at 8:00 am ET FOSTER CITY, Calif., Sept. 09, 2024...Read more
9.2-month median PFS in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer at RP2D 33% ORR across all patients & 53% ORR in patients with kinase mutations at RP2D Favorable overall tolerability profile; at RP2D, only 2 patients discontinued treatment due to adverse events & only 1 patient experienced Grade 3 hyperglycemia Data support planned initiation of 2L pivotal study in 2025 Triplet...Read more
NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, provides an update regarding key clinical advancements. The independent Safety Review Committee overseeing the Company’s Phase 1 clinical trial convened in August to review the safety data at the higher...Read more
ARQ-255 is a topical Janus kinase 1 (JAK1) inhibitor suspension formulated as a potential topical treatment for alopecia areata Proprietary Deep Dermal Drug Delivery (4D) technology formulated to deliver drug deep into the skin to the base of the hair follicle where alopecia areata inflammation occurs Phase 1b results expected first half of 2025 WESTLAKE VILLAGE, Calif., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics,...Read more
ROCKVILLE, Md. & EDMONTON, Alberta / Sep 05, 2024 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) announced today that the first participant has been dosed in a Phase 1a single ascending dose (SAD) study of AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). The SAD study...Read more
WALTHAM, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced dosing of the first participants in the Phase 1 healthy volunteer clinical trial of VYD2311, a next generation monoclonal antibody (mAb) candidate for COVID-19. VYD2311 is a mAb with high in vitro neutralization potency shown against...Read more
Descartes-15 observed to achieve an approximately ten-fold increase relative to Descartes-08 in CAR expression and selective target-specific killing in preclinical studies GAITHERSBURG, Md., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the first patient has been dosed in...Read more
Results Include Safety, Tolerability, Pharmacokinetics, and Target Engagement GT-02287, in Development for GBA1 Parkinson’s Disease, on Track to Initiate Phase 1b Trial in Patients in Q4 2024 BETHESDA, Md., Aug. 29, 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...Read more
BRANFORD, Conn. / Aug 28, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR), a precision dermatology company, announced that it has initiated dosing the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days, with primary endpoints focusing on safety and tolerability, and secondary...Read more
Décolleté indication selected for Phase 2 study expected to start next year Conference call to discuss results scheduled for Wednesday, August 28, 2024 at 4:30 p.m. ET PITTSBURGH, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. (“Jeune”), a wholly owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) leveraging Krystal’s clinically validated gene-delivery platform to fundamentally address – and reverse – the...Read more
PASADENA, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) (“LIXTE” or the “Company”), today announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. (“Roche”) for treatment of unresponsive (MSI Low) metastatic colorectal cancer. As part of the clinical trial (NCT06012734,...Read more
First Solid Tumor Patient Treated with Second, Higher Dose in Phase 1/1b BP1001-A Clinical Trial Experienced Tumor Reduction and Continued Stable Disease Reports Continued Patient Progress from Phase 2 Triple Combination Study of Prexigebersen in Acute Myeloid Leukemia (AML) Supportive Safety and Efficacy Data from Two Assets Validate Potential of DNAbilize® Platform Technology to Treat Most Vulnerable Cancer Patients HOUSTON,...Read more
BRANFORD, Conn. / Aug 20, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR), a precision dermatology company announced that it has successfully screened the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The patient is scheduled to initiate treatment by the end of the month. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days,...Read more
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025 Initiation of the first clinical trial of APG777 and APG990 combination expected to commence in 2025 with the potential for greater efficacy in atopic dermatitis and across I&I diseases SAN FRANCISCO and WALTHAM, Mass., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology...Read more
MRT-6160, a potent and highly selective VAV1-directed molecular glue degrader, represents a potential novel therapeutic approach for systemic and neurological autoimmune and inflammatory diseases Initial Phase 1 clinical results, including biomarker data to demonstrate pharmacodynamic effects, anticipated in Q1 2025 BOSTON, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology...Read more
First patient administered in dose-confirmation Part B of Phase 1 study with mRNA-based, multiepitope cancer vaccine candidate CVGBM Part B expected to include up to 20 patients to generate extended data on safety, tolerability, and immunogenicity of CVGBM TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / August 15, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of...Read more
Two clinical trial sites activated Patient enrollment expected this quarter Trial designed to evaluate the safety and preliminary anti-tumor activity of TTX-MC138 BOSTON, Aug. 15, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced initiation of its Phase 1 multicenter, open-label, clinical study of its...Read more
Overall response rate (“ORR”) of 25% and 50% disease control rate ("DCR") observed in first four evaluable patients treated with TIDAL-01 with advanced CRC Complete response achieved in heavily pre-treated late line patient with progression free survival extending beyond one year Favorable tolerability profile and demonstrated manufacturing success Product characterization and translational data support biological hypothesis for...Read more
Media Release 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 Safety data from this first-in-human study anticipated by year-end and pharmacokinetics and pharmacodynamics data in first half CY2025 SYDNEY, AUSTRALIA, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the...Read more
WILMETTE, Ill., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, today announced the successful dosing of the first patient in its open-label Phase 1 imaging and dosimetry clinical trial of its uPAR-targeted imaging radiopharmaceutical MNPR-101-Zr. MNPR-101-Zr was well-tolerated with no serious adverse...Read more
No Significant Issues Encountered During the Single Ascending Dose (SAD) Study, Allowing for Previously Reported Accelerated Start to Multiple Ascending Dose (MAD) Part 2 Top Line Data Readout from SAD Part 1 Expected in the Third Quarter of 2024, and from the MAD Part 2 in the First Quarter of 2025 CAMBRIDGE, Mass., Aug. 13, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company...Read more
VLS-01 is designed to induce a short psychedelic experience, allowing for a total in-clinic treatment of 2-hours, consistent with an established commercial paradigm in interventional psychiatry VLS-01 reached peak plasma concentration within 30-45 minutes and was shown to induce a short psychedelic experience, with subjective effects generally resolving within 90-120 minutes VLS-01 demonstrated a favorable safety profile and was well...Read more
Received FDA guidance on the registrational path for INB-100 in acute myeloid leukemia (AML), an investigational allogeneic gamma-delta T cell therapy, with IND submission anticipated in Q1 2025. Early clinical data from investigator sponsored trials demonstrates prolonged relapse-free survival across both AML and glioblastoma (GBM) programs, compared to current standard-of-care, with both programs advancing to Phase 2 clinical...Read more
Respect-LM dosing shows continued feasibility and safety of up to 44 mCi of intrathecal Rhenium (186Re) Obisbemeda High absorbed radiation doses, mean circulating tumor cell reductions, and median overall survival of 12 months continue to show clinical promise AUSTIN, Texas, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing...Read more
Phase 1 human clinical study of PALI-2108 for the treatment of Ulcerative Colitis (UC) on track to commence before year end Based on the modeling and simulations, Palisade has established dose levels and trial design for PALI-2108 Carlsbad, CA, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing...Read more
DALLAS / Aug 07, 2024 / Business Wire / Lantern Pharma (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging artificial intelligence (AI) and machine learning to transform the cost, pace, and timeline of oncology drug discovery and development, today announced a significant advancement demonstrating the preclinical synergy of LP-184 with checkpoint inhibitors and the ability of LP-184 to resensitize tumors that have become...Read more
42.8% confirmed ORR observed in Claudin 18.2-enriched subset of gastric and GEJ cancer EO-3021 demonstrated differentiated safety profile, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy/hypoesthesia Advancing into dose expansion portion of Phase 1 trial; additional monotherapy data expected in 1H 2025 Expect to initiate dosing in combination portion of Phase 1 trial by...Read more
HOUSTON / Aug 01, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”), reports favorable eight-month follow-up results from the first patient enrolled in its 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 patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to...Read more
NEWTON, Mass., July 29, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) in the brain for the treatment of Alzheimer’s disease (AD), today announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug (ACU193) in a Phase 1 pharmacokinetic (PK) comparison...Read more
NEWTON, Mass., July 28, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced new findings from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193). The research highlights the experiences of patients in the clinical trial to...Read more
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
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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