BNT316/ONC-392 is a next-generation anti-CTLA-4 monoclonal antibody candidate jointly developed by BioNTech and OncoC4 as monotherapy or combination therapy in a range of solid tumor indications, including non-small cell lung cancer (NSCLC) Interim data of BNT316/ONC-392 from the ongoing Phase 1/2 trial to be presented at this year’s ASCO Annual Meeting demonstrate encouraging signs of clinical anti-tumor activity and a manageable...Read more
Topline Phase 1 monotherapy and initial combination data expected in 2024 BOSTON, June 01, 2023 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced that the first patient has been dosed in its Phase 1/2 clinical trial evaluating SNS-101 for the treatment of advanced...Read more
Data from the four patients treated with the highest dose of pegtibatinase showed a clinically meaningful 67.1% mean relative reduction in total homocysteine from baseline Pegtibatinase has been generally well-tolerated to date The Company is engaging with regulators and expects to initiate a pivotal Phase 3 Study by year-end 2023 Company to host conference call and webcast today at 8.30 a.m. ET SAN DIEGO, May 31, 2023 (GLOBE...Read more
SAR’579/IPH6101, ANKET® platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi Preliminary data published show SAR’579 was well tolerated and induced 3 complete responses in the 8 patients at 1 mg/kg as highest dose Phase 1/2 data will be presented as an oral presentation at the ASCO 2023 Annual...Read more
THE-630 demonstrates encouraging safety profile through Cohort 6 (18 mg), supportive of continued dose escalation Dose-dependent reductions observed in ctDNA KIT-mutant allele fractions for both major classes of KIT resistance mutations at exposures consistent with preclinical predictions observed in Predictive Resistance Assay™ Evidence of clinical activity observed in heavily pre-treated patient population at exposures...Read more
Potent and durable target engagement observed across cohorts, including with 10 mg doses administered every 12 weeks which were also generally safe and well-tolerated WVE-004 did not show clinical benefit compared with placebo; additionally, poly(GP) reductions did not correlate with clinical outcomes -- Wave to discontinue development of WVE-004 Wave to host investor conference call at 8:30 a.m. ET today CAMBRIDGE, Mass., May 23,...Read more
MINNEAPOLIS, May 22, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced it has entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC). The initial goal of the Phase I trial will be to ascertain the...Read more
Tel Aviv, Israel / Vancouver, Canada, May 22, 2023 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced the selection of its first U.S. site for the company’s Phase I/IIa clinical trial of its proprietary MEAI-based CMND-100...Read more
8 AL Amyloidosis patients relapsed/refractory to DARZALEX®-based regimens were treated with CAR-T NXC-201 100% (8/8) overall response rate and 63% (5/8) complete response (MRD 10-5) was demonstrated by NXC-201 with zero ICANs, zero grade 4 CRS 62% (5/8) had NYHA classification III or IV heart failure prior to treatment with NXC-201 Best responder duration of response was 16.5 months with response ongoing as of the data cutoff date of...Read more
First clinical trial reporting results of an mRNA therapeutic for intracellular protein replacement To date, mRNA-3927 has been generally well-tolerated at the doses administered, with encouraging early signs of dose-dependent pharmacology and potential clinical benefits No occurrence of dose-limiting toxicities or study discontinuations due to drug-related treatment-emergent adverse events (TEAEs) More than 280 doses of mRNA-3927...Read more
NOVATO, Calif., May 17, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) has reviewed and agreed to a protocol amendment to the Phase 1/2 study of GTX-102 in pediatric patients with Angelman syndrome that enables the company to harmonize dose ranges in the U.S. with those being used in ex-U.S. cohorts of the study. Outside of the U.S., the Phase 1/2...Read more
OP-1250 in combination with palbociclib was well-tolerated in patients with ER+/HER2- metastatic breast cancer, with no dose-limiting toxicities, and no observed drug-drug interaction Overall tolerability profile of the combination is consistent with the FDA-approved label of palbociclib plus an endocrine agent Tumor responses have been observed in patients previously treated with CDK4/6 inhibitors SAN FRANCISCO, May 11, 2023...Read more
Prior data provide clinical proof-of-concept for narazaciclib’s mechanism of action in endometrial cancer Preliminary data from trial’s Phase 1 portion expected in 4Q 2023 NEWTOWN, Pa., May 11, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the first...Read more
Decision Follows Review of Comprehensive Safety Data Package Submitted by the Company Salarius Plans to Meet with FDA to Discuss Future Development and Potential Registration Pathways HOUSTON, May 09, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment...Read more
Initial Phase 1 part started with multivalent modified mRNA influenza vaccine candidates Candidates developed in collaboration with GSK within broad infectious disease vaccine program encode for antigens covering four WHO-recommended flu strains TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / May 8, 2023 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines...Read more
After completing enrollment in 5 dose cohorts, and with no dose-limiting safety signals observed to date by the independent DSMB, the Phase 1/2 trial of mRNA-3927 advances to the dose-expansion phase to determine a recommended dose CAMBRIDGE, MA / ACCESSWIRE / May 3, 2023 / Moderna,Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that an abstract reporting on...Read more
100% Tumor Shrinkage at 2-months in advanced metastatic colorectal cancer was demonstrated by IMX-110 + BeiGene / Novartis anti-PD-1 Antibody Tislelizumab combination in the first, lowest dose cohort (two out of two first evaluable patients) in its ongoing phase 1b/2a dose escalation clinical trial IMMINENT-01 We believe results bolster scientific basis for IMX-110 in unlocking the immune system’s ability to fight cancer LOS...Read more
Preliminary results demonstrate a durable complete response at starting dose level in elderly subject Positive results from first cohort allows Company to progress to second cohort in Phase 1b portion of the Phase 1b/2 trial with 230 mg/m2 dose of Annamycin HOUSTON, May 2, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline,...Read more
Positive randomized data with TPST-1120 combined with atezolizumab + bevacizumab compared head-to-head with atezolizumab + bevacizumab The addition of TPST-1120 resulted in a clinically-meaningful improvement in both confirmed and unconfirmed RECIST responses The number of patients on treatment and on study markedly favors the TPST-1120 arm Company to host webcast conference call today at 8:30 a.m. ET BRISBANE, Calif., April 28,...Read more
Topline data presented at AAN annual meeting showed AOC 1001 achieved directional improvements in multiple functional endpoint assessments - myotonia (vHOT), measures of strength (total QMT) and mobility (10mWRT, Timed Up and Go) AOC 1001 data demonstrate favorable safety/tolerability profile with most adverse events mild or moderate Topline AOC 1001 data identify dose range for pivotal study; Avidity continues to work to resolve...Read more
YONKERS, N.Y., April 26, 2023 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announces the first patient has been dosed in the Phase 1b/2 of exebacase in the setting of an...Read more
Preliminary Evidence of Durable Anatomical and Functional Improvements Following Administration of OpRegen Cells Extensive OpRegen Surgical Bleb Coverage of Areas of GA May Be Critical for Optimizing Patient Outcomes OCT Imaging With Segmentation Analysis is Advantageous in Assessment of Retinal Integrity Post-Treatment CARLSBAD, Calif. / Apr 26, 2023 / Business Wire / Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a...Read more
Interim Results from Ongoing ARO-RAGE Phase 1/2 Study Demonstrate up to 90% Serum sRAGE Reduction with Mean Maximum Reduction of 80% after Two Doses Further Data to be Presented at Upcoming R&D Day PASADENA, Calif. / Apr 25, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced interim results from an ongoing Phase 1/2 clinical study of ARO-RAGE, the company’s investigational RNA interference (RNAi)...Read more
Topline data anticipated in mid-2024 SIGNAL-AD builds on promising data from the Phase 2 SIGNAL Study in Huntington’s Disease ROCHESTER, N.Y., April 25, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced that it has completed enrollment goal in the...Read more
First clinical trial seeking to determine if the potentiation of cytotoxic chemotherapy by LB-100 occurs in cancer patients as has been shown in multiple animal studies across a spectrum of cancers PASADENA, CA, April 24, 2023 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”) a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, announced that the...Read more
AUSTIN, Texas, April 19, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced the completion of enrollment of the original three patients required in Cohort 8 of the ReSPECT-GBM Phase 1/2a dose escalation clinical trial of rhenium (186Re)...Read more
Allogeneic iNKTs, agenT-797, administered alone or in combination with anti-PD-1 therapy, shows activity in patients with refractory solid tumor cancers. In a patient with metastatic gastric cancer who had no response to treatment with pembrolizumab and nivolumab/FOLFOX, agenT-797 induced a partial response with 42% tumor shrinkage, which continues beyond 9 months. AgenT-797 was administered without toxic lymphodepletion, persists for...Read more
Camonsertib PARPi combinations demonstrated 48% CBR in patients with unmet medical needs, across tumor types, and regardless of PARPi partner or platinum resistance, with a favorable safety and tolerability profile Combination results showed most benefit in late-line ovarian cancer demonstrating 32% overall response, 58% CBR and mPFS of approximately 7 months Early ctDNA molecular responses in 66% of evaluable patients confirms...Read more
The iLSTA Trial is the first study combining LSTA1 with standard-of-care chemotherapy and immunotherapy WARPNINE to provide funding and local trial management BASKING RIDGE, N.J. and SUBIACO, Australia, April 18, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other...Read more
All 10 patients with late stage melanoma who completed EVX-02 treatment demonstrated robust and treatment-specific immune responses and were relapse-free at their last assessment Results further validate predictive potential of proprietary AI technology and pave the way for advancement of EVX-03, a next-generation DNA-based personalized cancer immunotherapy, into the clinic in Q4 COPENHAGEN, Denmark, April 18, 2023 (GLOBE NEWSWIRE)...Read more
37% overall response rate (ORR) observed in 43 evaluable patients 6 months median duration of response as of Feb. 1, 2023 data cutoff date End-of-phase meeting with U.S. Food & Drug Administration provides clarity to potential registration path in HNSCC Investor call on April 17, 2023 at 6:30 p.m. ET UTRECHT, The Netherlands and CAMBRIDGE, Mass., April 17, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the...Read more
VTP-200 was generally well-tolerated and was administered with no product-related grade 3 unsolicited adverse events and no product-related serious adverse events (SAEs) in women with low grade human papillomavirus-related cervical lesions Interim data showed encouraging initial immunogenicity results, particularly in relation to the E1, E2 and E6 antigens OXFORD, United Kingdom, April 17, 2023 (GLOBE NEWSWIRE) -- Vaccitech plc...Read more
First clinical results to be presented at the AACR Annual Meeting 2023 showed 23ME-00610 demonstrated an acceptable safety and tolerability profile, with favorable pharmacokinetics and peripheral CD200R1 saturation in patients with advanced solid malignancies Recommended dose selected for evaluation of anti-tumor activity in the ongoing Phase 2a portion of the Phase 1/2a study ORLANDO, Fla., April 14, 2023 (GLOBE NEWSWIRE) --...Read more
Favorable safety and tolerability profile related to OCU400 investigational product candidate Initial clinical data from low and medium dose cohorts indicates positive trend in Multi-luminance mobility testing and Best-Corrected Visual Acuity scores for OCU400 treated eyes 71.4% (5/7) of OCU400 treated eyes in low and medium dose cohorts experienced at least 1 Lux luminance level improvement in mobility test from baseline 66.7% (2/3)...Read more
Results from Cohorts 1 and 2 Showed a Dose-Dependent Reduction in Total Homocysteine Levels Results from Cohort 3 Indicated Additional Dose Exploration and Data from Longer Treatment Duration May be Needed AUSTIN, Texas, April 12, 2023 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing human enzyme therapeutics to benefit people with rare metabolic diseases, today...Read more
VISTA blocking immunotherapy engineered to address immunosuppression in the tumor microenvironment (TME) Phase 1 initial data readout anticipated by end of 2023 SEATTLE, April 12, 2023 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today the first patient has been dosed in a Phase...Read more
UCART22 is currently the most advanced allogeneic CAR T-cell product in development for relapsed or refractory B-cell acute lymphoblastic leukemia The BALLI-01 study (evaluating UCART22) is actively enrolling patients with relapsed or refractory B-cell ALL after FCA lymphodepletion NEW YORK, April 11, 2023 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company...Read more
Ault Alliance Congratulates Alzamend Neuro on This Important and Historic Milestone in Clinical Drug Discovery and Development LAS VEGAS / Apr 04, 2023 / Business Wire / Ault Alliance, Inc. (NYSE American: AULT), a diversified holding company (“Ault Alliance” or the “Company”), is proud to announce that Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”) has initiated its Phase I/IIA clinical trial for its immunotherapeutic vaccine...Read more
ATLANTA / Apr 03, 2023 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the initiation of a phase I/IIA clinical trial for its immunotherapy vaccine (ALZN002) to treat...Read more
ATLANTA / Apr 03, 2023 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced receipt of a “Study May Proceed” letter from the U.S. Food and Drug Administration (“FDA”) for...Read more
YONKERS, New York, April 03, 2023 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, announced the initiation of a Phase 1b/2 of exebacase in the setting of an arthroscopic debridement,...Read more
Additional evidence of durable anti-cancer activity with MDNA11 monotherapy seen in latest radiographic scans from first four dose escalation cohorts Continued tumor reduction and complete regression of one of three metastatic lesions in fourth-line pancreatic cancer patient with confirmed partial response Stable disease maintained for more than 70 weeks in patient with metastatic melanoma MDNA11 continues to selectively and...Read more
Company also enrolling ReSPECT-GBM Phase 2 trial Presentation of data from Phase 1/2a and Phase 2 trials planned in 2023 AUSTIN, Texas, March 28, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced the first patient in Cohort eight of...Read more
Completed Phase 1b/2a trial of VTP-300 met its primary and secondary endpoints VTP-300 is the first antigen-specific immunotherapy shown to induce sustained reductions in Hepatitis B surface antigen (HBsAg) Results will be presented at the upcoming European Association for the Study of the Liver (EASL) Congress in June OXFORD, United Kingdom, March 28, 2023 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC), a clinical-stage...Read more
TORONTO, March 28, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s Phase I/II clinical study (the “Study”) (NCT05322954) evaluating the safety and feasibility of oral psilocybin as a potential...Read more
U.S. Food & Drug Administration (FDA) approves enrolling pediatric patients in the ongoing OCU400 Phase 1/2 trial who have: 1) RP associated with NR2E3 and RHO mutations and 2) LCA associated with CEP290 gene mutations Ocugen has completed enrollment of adult RP patients with NR2E3 and RHO mutations in the Phase 1/2 trial and expanded enrollment in LCA patients with CEP290 mutations MALVERN, Pa., March 27, 2023 (GLOBE NEWSWIRE)...Read more
LOS ANGELES, March 23, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”) today announced that NXC-201 treatment continues to demonstrate 100% complete hematologic responses and 100% organ response rate – cardiac, renal, liver response – in a total of 8 AL amyloidosis patients (an additional 2 patients maintaining 100% complete response). Additionally,...Read more
AUSTIN, Texas, March 22, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced treatment of the first patient in Cohort 3 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of...Read more
The study is intended to assess whether pepinemab can reverse the suppressive tumor microenvironment found in PDAC, thereby facilitating the anti-tumor activity of immune checkpoint blockade This Vaccinex-sponsored study will be conducted at the University of Rochester Primary funding support is provided by Gateway Discovery Award, administered by ASCO’s “Conquer Cancer Foundation” ROCHESTER, N.Y., March 21, 2023 (GLOBE NEWSWIRE)...Read more
VTP-200 was generally well-tolerated with no product-related serious adverse events (SAEs) Interim data showed encouraging initial immunogenicity results, particularly in relation to the E1, E2 and E6 antigens used in VTP-200 HPV001 clinical trial will continue as planned to the 12-month primary endpoint OXFORD, United Kingdom, March 20, 2023 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical...Read more
Nes-Ziona, Israel, March 20, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that an independent Data and Safety Monitoring Board (DSMB) has completed an interim data review for the first cohort of patients in the Company’s ongoing Phase I/II clinical trial of Allocetra™ in patients with advanced-stage peritoneal metastasis...Read more
BEDFORD, Mass. / Mar 15, 2023 / Business Wire / Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines, today announced that the FDA will allow the administration of a higher single dose of STK-001 (70mg) in its ongoing Phase 1/2a MONARCH study of children and adolescents with Dravet syndrome. This new 70mg...Read more
HOUSTON, March 14, 2023 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), today announced its decision to discontinue its ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients. The trials for BPX-601 and BPX-603 are being discontinued following the Company’s assessment of the risk/benefit...Read more
Interim analysis will be performed when the last of these patients has completed a tumor assessment scan approximately 9 weeks after initiating treatment The open-label Phase 1b/2 KEYNOTE B-84 study is evaluating the use of pepinemab in combination with Merck’s KEYTRUDA (pembrolizumab) in R/M HNSCC ROCHESTER, N.Y., March 09, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a...Read more
Third patient now implanted with higher capacity, 10-chamber Cell Pouch Company anticipates first interim data from second cohort in Q4 2023 LONDON, Ontario, March 08, 2023 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the...Read more
AP-PA02 is well-tolerated and data supports progression to Phase 2b Also announces first subject dosed in Phase 2 'Tailwind' clinical trial of inhaled AP-PA02 in patients with Non-Cystic Fibrosis Bronchiectasis (NCFB) NCFB represents Armata's third active clinical program MARINA DEL REY, Calif., March 6, 2023 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company...Read more
Broad response demonstrated through deep cyclic inhibition of MAPK pathway, independent of specific RAS mutation Phase 1/2a clinical trial with IMM-1-104 underway in patients with advanced solid tumors harboring RAS mutations CAMBRIDGE, Mass., March 05, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim...Read more
HOUSTON, March 1, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced the first subject has been treated in Italy in the Company's Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are...Read more
TORONTO / Feb 28, 2023 / Business Wire / Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics® today announced significant progress updates for its two lead clinical development programs: CYB003, its proprietary deuterated psilocybin analog for the potential treatment of Major Depressive Disorder and CYB004, its proprietary deuterated...Read more
SOUTH SAN FRANCISCO, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human genetics and biopharmaceutical company, with a mission to help people access, understand and benefit from the human genome, dosed the first patient in the Phase 2a portion of its Phase 1/2a (Phase 2a) study evaluating 23ME-00610, an investigational antibody targeting CD200R1, in patients with advanced solid...Read more
Robust enrollment of up to 5 patients per month continues in ongoing Phase 1b/2a next-generation CAR-T NXC-201 clinical trial in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis Nexcella on track to present 50-patient cohort multiple myeloma data later this year at a premier scientific forum Los Angeles, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”), a biopharmaceutical company...Read more
The study will be partially funded by Break Through Cancer through the Ovarian Minimal Residual Disease Team Lab LAWRENCEVILLE, NJ and CAMBRIDGE, MA, Feb. 27, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, and Break Through Cancer, a public foundation dedicated to empowering outstanding researchers and clinicians to both intercept and find cures for some of the most difficult-to-treat...Read more
RGX-111 is an investigational AAV Therapeutic for the treatment of severe MPS I that is part of REGENXBIO's clinical-stage pipeline of neurodegenerative disease programs RGX-111, a potential one-time gene therapy for MPS I, continues to be well-tolerated across two dose levels, with no drug-related serious adverse events New biomarker and neurodevelopmental data continue to indicate encouraging CNS profile in patients dosed with...Read more
Additional interim biomarker and efficacy data from first six patients continue to demonstrate both the high and low dose of PBGM01 led to a biological effect in patients PBGM01 administration resulted in stabilization of MRI severity scores in all treated patients through 6 to twelve months of follow-up PHILADELPHIA, Feb. 24, 2023 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company...Read more
Nes-Ziona, Israel, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company’s Phase I/II of AllocetraTM in patients with advanced solid malignancies. The clearance of the Phase I/II by the AEMPS follows recent...Read more
Over 49 weeks of DNL310 (ETV:IDS) treatment in the Phase 1/2 study, positive changes across measures of exploratory clinical outcomes including VABS-II (adaptive behavior) and BSID-III (cognitive capabilities) scores and global impression scales were observed Interim Phase 1/2 data also suggest that DNL310 improves hearing, as assessed by auditory brainstem response testing Additional biomarker data out to 49 weeks continue to...Read more
All three patients with 12 months of follow-up demonstrated improvement in multiple FDA-recommended cardiac endpoints at relatively low dose of 1E13 vg/kg Cardiac biopsy demonstrated selective and widespread transgene expression within ~50% of cardiomyocytes Engaging with FDA to lift clinical hold and resume enrollment with updated exclusion criteria and highly effective rituximab/sirolimus immunosuppressive regimen to reduce risk of...Read more
BRISBANE, Calif. / Feb 22, 2023 / Business Wire / Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced updated preliminary data as of the October 20, 2022 cutoff date from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease. These data, which present new biomarker data and results from the first...Read more
BX004 therapy safe and well-tolerated across all patients and dose levels Preliminary signals of efficacy also observed, with notable reductions in bacterial burden Dosing in patients in Part 2 initiated, results expected in Q3 23 Company to host webcast/cc to discuss Part 1 data today at 9:00 am ET CAMBRIDGE, Mass. and NESS ZIONA, Israel, Feb. 22, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the...Read more
CLS-AX OASIS Results Show Favorable Safety Data, Durability and Biologic Effect Over 6 Months in Treatment-Experienced Anti-VEGF Sub-Responders SCS Microinjector® Featured in Favorable Data Presentations Related to Multiple Therapies in Clinical Development ALPHARETTA, Ga., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of...Read more
Both Fanconi Anemia patients treated with briquilimab successfully engrafted with neutrophil engraftment within 11 days 100% total donor chimerism was achieved through six months for the first patient and through three months for the second patient Both patients are doing well post-transplant with briquilimab-based conditioning REDWOOD CITY, Calif., Feb. 17, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR)...Read more
Data presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Analysis of patients receiving meropenem suggest that SYN-004 is well-tolerated with HCT and was not observed in blood samples from the majority of the evaluable patients ROCKVILLE, Md., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage...Read more
Trem-cel exhibited robust engraftment five months post-transplant through three cycles of Mylotarg Mylotarg treatment enriched CD33-negative donor hematopoiesis Second patient successfully received trem-cel transplant and achieved neutrophil engraftment and platelet recovery CAMBRIDGE, Mass., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, presented clinical data from...Read more
Rapid, significant, and sustained increase in plasma pyrophosphate (PPi) observed and encouraging patient reported outcome data in all dose cohorts in ENPP1 Deficiency trial Rapid and significant increase in PPi observed in all dose cohorts with sustained increase observed in highest dose cohort in ABCC6 Deficiency (PXE) trial INZ-701 was generally well-tolerated and exhibited a favorable safety profile in both...Read more
10 of 11 patients (91%) had a reduction in number of surgical interventions, measured from Day 0 to one year following initial treatment; 4 of the 10 patients did not need any surgery Treatment with INO-3107 achieved statistical significance based on clinical endpoint of reduction in overall number of surgical interventions compared with previous year INO-3107 was well-tolerated and immunogenic, with efficacy and safety results for...Read more
Favorable safety profile to date, with no occurrence of high-grade (>2) cytokine release syndrome or dose-limiting toxicities Preliminary signs of anti-tumor activity were observed, with iRECIST stable disease (iSD) in 8 out of 14 evaluable patients at week 8 and PSA levels stabilizing or decreasing in heavily pre-treated patients Dose escalation is ongoing UTRECHT, The Netherlands and PHILADELPHIA, Feb. 16, 2023 (GLOBE...Read more
First two sickle cell disease participants have achieved 100% donor myeloid chimerism through 100 days follow-up Third sickle cell disease participant has now achieved 100% donor myeloid chimerism through 30 days follow-up All three participants have increased their hemoglobin at last follow-up relative to baseline REDWOOD CITY, Calif., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a...Read more
Nexcella, Inc. initiates process of bringing NXC-201 to the United States by entering into an agreement with a well-known GMP cell therapy manufacturer that will supply Phase 1b/2 NXC-201 clinical trial material NXC-201 is in development for the treatment of patients with relapsed or refractory multiple myeloma and light chain (AL) amyloidosis Nexcella believes recently reported Phase 1b data from the ongoing Phase 1b/2 clinical trial...Read more
CAMBRIDGE, England & BOSTON / Feb 14, 2023 / Business Wire / Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced monotherapy Phase I dose escalation results of the ongoing Phase I/II trial of BT8009, a novel BTC™ targeting Nectin-4. The results will be presented at the 2023 American...Read more
CAMBRIDGE, Mass., Feb. 10, 2023 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC) today announced that the U.S. Food and Drug Administration (FDA) verbally informed the company on February 8, 2023 that it has placed a partial clinical hold on the Phase 1/2 VELA trial of BLU-222 due to visual adverse events (AEs) observed in a limited number of patients. Patients currently enrolled in the trial are continuing on study drug at...Read more
SANTA MONICA, Calif. / Feb 09, 2023 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced the three-year follow-up results from the pivotal ZUMA-3 study of the CAR T-cell therapy Tecartus® (brexucabtagene autoleucel). Results from the analysis showed a median overall survival (OS) of 26 months and demonstrated that responses remained durable in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R...Read more
BOSTON / Feb 08, 2023 / Business Wire / Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced the initiation of the ALPHA-STAR Phase 1b/2 clinical trial of STAR-0215 in people living with HAE. Initial proof-of-concept results in HAE patients from...Read more
Company reaches next clinical trial milestone for treatment of Type 1 Diabetes with the first novel allogenic cellular therapy in the dorsal artery of the pancreas in the United States PHOENIX, Feb. 8, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a biotechnology company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced...Read more
IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab combination designed to enhance response to solid tumors by turning immunologically “cold” tumors “hot” Initial data anticipated in 1H 2023 LOS ANGELES, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and...Read more
Phase 1/2 Trial Now Active at Stanford, Emory, and Thomas Jefferson Universities ATLANTA, GA, Feb. 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today its clinical trial of Gedeptin® for patients with recurrent head and neck cancers is now actively enrolling patients at three major...Read more
Newly-published data shows a strong link between tumor DNA circulating in blood and patient responses to investigational neoadjuvant treatment with immune therapies FT. MYERS, FL / ACCESSWIRE / February 6, 2023 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of oncology testing and global contract research services, today announced results of a new study of the RaDaR® assay in patients with muscle-invasive bladder cancer...Read more
PASADENA, Calif. / Feb 02, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) announced today that it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-MMP7, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce the expression of matrix metalloproteinase 7 (MMP7) as a potential treatment for idiopathic pulmonary fibrosis (IPF). “MMP7 is thought to play multiple roles in IPF...Read more
Suprachoroidal CLS-AX Resulted in Favorable Safety Data, Durability and Biologic Effect Over 6 Months in Treatment-Experienced Anti-VEGF Sub-Responders 67% of Extension Study Participants Went at Least 6 Months Without Needing Additional Treatment Extension Participants Experienced a 77 - 85% Reduction in Treatment Burden Over 6 Months Webcast and Conference Call Today at 8:30 A.M. ET Hosted by...Read more
WATERTOWN, Mass., Jan. 30, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that the first patient has been dosed in its Phase 1/2 clinical trial of CFT1946, an orally bioavailable mutant-selective BiDAC™...Read more
• AML Patients Receive Tuspetinib Monotherapy to Kick Off APTIVATE Phase 1/2 Trial• New Response Emerges with 40 mg Tuspetinib in FLT3 Wildtype AML Patient• Aptose Elucidates Rationale for Tuspetinib’s Superior Safety Profile SAN DIEGO and TORONTO, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS) today announced the 120 mg monotherapy dosing of patients in the...Read more
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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