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
SOUTH SAN FRANCISCO, Calif. and MIAMI, Fla., April 24, 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, today announced the first cohort of 3 patients have commenced dosing. PAS-004 is being evaluated in a Phase 1...Read more
ALTO-101 demonstrated a favorable pharmacokinetic and tolerability profile; novel transdermal formulation delivered significantly greater drug exposure and fewer adverse events typically associated with PDE4 inhibitors First-in-human achievement of target exposure with proprietary transdermal patch formulation developed in partnership with MEDRx Proof-of-concept study in cognitive impairment associated with schizophrenia...Read more
Phase 1 trial in collaboration with Sant Joan de Déu-Barcelona Children’s Hospital (SJD) determined to have a positive outcome by the study Monitoring Committee Safety and clinical outcomes support the therapeutic potential of VCN-01 in retinoblastoma and emphasize VCN-01’s potential for use in diverse cancer indications ROCKVILLE, Md., April 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified...Read more
Received Fast Track Designations for both inhaled and intratumoral KB707 PITTSBURGH, April 22, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, announced today that the first patient was dosed in its Phase 1 clinical trial (KYANITE-1) evaluating inhaled KB707, a modified HSV-1 vector designed to deliver genes encoding both human interleukin-12 (IL-12) and...Read more
46.2% of patients demonstrated a 1- or 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks in the AXPAXLI arm, compared to 0% in the control arm No patients in the AXPAXLI group experienced worsening in DRSS compared to 12.5% in the control arm at 40 weeks AXPAXLI was generally well tolerated with no inflammation observed Ocular intends to present the Phase 1 HELIOS study at an upcoming...Read more
HOUSTON, April 18, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute...Read more
Phase 1 Clinical Trial Timelines Significantly Accelerated Top-Line Data Readout from Single Ascending Dose Part 1 Now Expected in the Third Quarter of 2024 First Patient Dosed in the Multiple Ascending Dose Part 2 Expected in the Third Quarter of 2024 CAMBRIDGE, Mass., April 17, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic...Read more
The first patient was dosed in the Phase 1 dose escalation trial of CTX-8371.This study is conducted in patients with advanced solid tumors who progressed on at least one prior regimen containing a checkpoint blocker. CTX-8371 is a novel dual checkpoint blocker that simultaneously targets the programmed death receptor PD-1 and its ligand PD-L1. Compass advanced CTX-8371 to the clinic following pre-clinical observations of...Read more
Initiated multiple Phase 1b expansion cohorts to determine the RP2D of ORIC-114 in NSCLC patients with EGFR exon 20, HER2 exon 20, or EGFR atypical mutations Additionally, the company initiated an extension cohort to evaluate ORIC-114 for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC Expect to report updated Phase 1b data in the first half of 2025 SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 15,...Read more
The North Star Ambulatory Assessment (NSAA) remained stable relative to declines reported in Becker natural history studies Significant decreases were observed in circulating levels of creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2), biomarkers associated with skeletal muscle damage Sevasemten was well-tolerated Edgewise leadership to discuss ARCH findings on Tuesday, April 16 at 8:30 a.m. Eastern...Read more
Patients in the Nana-val (nanatinostat in combination with valganciclovir) treatment arm achieved clinically meaningful anti-tumor responses with an overall response rate of 50% and a complete response rate of 20% in the intent-to-treat population (71% and 29% in the efficacy-evaluable population) with a generally manageable safety profile Nana-val demonstrated substantially greater efficacy than nanatinostat monotherapy, further...Read more
WATERTOWN, Mass., April 15, 2024 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven clinical and pre-clinical brain disease programs, today announced that the Phase 1 trial of NMRA-266 has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). NMRA-266 is a positive allosteric modulator (PAM) of the M4 muscarinic...Read more
Updated Phase 1 data demonstrate a 12-month overall survival (OS) of 71% and 18-month OS of 62% Company plans to discuss encouraging Phase 2 interim results with the FDA Company plans to submit Phase 2 data to a major medical conference in the second half of 2024 LEXINGTON, Mass. / Apr 12, 2024 / Business Wire / Agenus Inc. (NASDAQ: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers,...Read more
National Cancer Institute (NCI)-designated research and treatment center City of Hope, in Duarte, CA, to participate in the University of Minnesota (UMN) Masonic Cancer Center's ongoing Phase 1 trial to determine the maximum tolerated dose of LYMPHIR plus CAR-T therapy CRANFORD, N.J., April 11, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company...Read more
Cohort 1 Exceeds Predetermined Non-Progression Threshold in the Ongoing Phase 1b Study ME-344 in Combination with Bevacizumab was Generally Well-tolerated with no Evidence of Overlapping Toxicity MEI to Continue Advancing ME-344 via Development of a New Formulation with the Potential to Increase Biological Activity, Patient Convenience and Commercial Opportunity SAN DIEGO / Apr 11, 2024 / Business Wire / MEI Pharma,...Read more
Achieved initial cumulative MMR rate of 44% (7/16) by 12 weeks in response-evaluable patients, which compares favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs Achieved initial cumulative MMR rate of 44% (4/9) by 12 weeks in response-evaluable patients who were previously treated with asciminib ELVN-001 was well tolerated with no ≥ Grade 3 treatment-related non-hematologic toxicities reported Company to...Read more
WILMETTE, Ill., April 10, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced that its Phase 1 dosimetry clinical trial for its novel radiopharmaceutical imaging agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) is now active and recruiting patients with advanced cancers. The antibody...Read more
Atopic dermatitis is the first immune disease indication being studied in the clinic for soquelitinib, the Company’s selective ITK inhibitor Corvus anticipates releasing initial clinical data from trial before year-end 2024 BURLINGAME, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced the initiation of the Company’s randomized,...Read more
Clinical data readout expected end of Q3 2024 SER-155 and other Seres microbiome therapeutic candidates have potential to expand microbiome therapeutic franchise into additional medically vulnerable patient populations CAMBRIDGE, Mass. / Apr 09, 2024 / Business Wire / Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announced today that enrollment is complete in the placebo-controlled Cohort 2 of its...Read more
Orexin 2 Receptor Agonist ALKS 2680 Demonstrated Clinically Meaningful and Statistically Significant Improvements from Baseline in Mean Sleep Latency Compared to Placebo at All Doses Tested in Both Narcolepsy Type 2 and Idiopathic Hypersomnia ALKS 2680 Was Generally Well Tolerated at All Doses Tested Dose-Dependent Effects and Pharmacodynamic Profile Support Advancement Into Planned Phase 2 Study DUBLIN,...Read more
Promising early data suggest patients with relapsed/refractory multiple myeloma who progressed after prior BCMA-targeted therapy achieved clinical responses with P-BCMA-ALLO1, which was well tolerated Following efforts to optimize allogeneic CAR-T therapy, Poseida is presenting a new data analysis underscoring the need for higher lymphodepletion chemotherapy doses when treating solid tumors vs. multiple myeloma SAN DIEGO, April...Read more
SOUTH SAN FRANCISCO, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today announced the first patient has been dosed in a Phase 1 dose escalation study (NCT06265688) of CX-2051 in patients with advanced solid tumors. CX-2051 is a masked PROBODY® antibody drug conjugate (ADC) directed toward epithelial cell adhesion molecule...Read more
All pharmacokinetic endpoints were achieved, with a PK profile consistent with drug delivery and absorption in the colon All NaviCap™ devices performed as intended and were well tolerated, with no safety signals observed Multiple-ascending dose (MAD) portion of the trial is underway and progressing well SAN DIEGO, April 04, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining...Read more
Dose escalation in Phase 1b trial completed with no dose-limiting toxicities, no or low-grade cytokine release syndrome and no immune effector cell-associated neurotoxicity syndrome across all patients and early signs of anti-tumor activity Enrollment in Part 2 dose expansion has been initiated LAUSANNE, Switzerland, April 04, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced the completion of dose escalation...Read more
FG-3246 demonstrated efficacy in adenocarcinoma selected cohorts receiving biologically active doses of FG-3246 at ≥ 1.2 mg/kg in heavily pre-treated, biomarker unselected patients: Median radiographic progression free survival of 8.7 months PSA50 response in 36% of patients Confirmed radiographic objective response rate of 20%, with a median duration of response of 7.5 months FG-3246 demonstrated an acceptable safety profile;...Read more
Trial’s Safety Monitoring Committee Recommends Maintaining Initial Cell Dose Level for Next Cohort of Patients HOUSTON / Apr 02, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports early efficacy results showing tumor stabilization in the third patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel™ (KB-GDT-01), Kiromic’s allogeneic,...Read more
Study enrolling patients with metastatic urothelial cancer (mUC) and other Nectin-4 enriched tumors Emerging clinical profile from CSPC’s Phase 1 China study indicates differentiation from PADCEV NORWOOD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, announced today the first patient in the U.S....Read more
Heart-1 clinical trial demonstrated LDL-C reduction of up to 73% at 0.45 mg/kg of VERVE-101 Company to pause enrollment in Heart-1 clinical trial following asymptomatic Grade 3 transient ALT elevation and thrombocytopenia seen in the sixth participant enrolled in 0.45 mg/kg dose cohort Verve to prioritize development of VERVE-102, which uses a different LNP delivery system than VERVE-101; Clinical Trial Applications have been cleared...Read more
BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes The first two type 1 diabetes patients enrolled in COVALENT-112 both demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219 BMF-219 has been well tolerated by both patients Open label portion of Phase II COVALENT-112...Read more
Phase 1a trial demonstrated acceptable safety and tolerability with no reported serious adverse events Phase 1a data demonstrated target engagement, a pharmacodynamic effect and effects on liver function Initiating Phase 1b proof-of-concept trial in severe alcohol-associated hepatitis Expect to Present Safety, PD and PK Data for SZN-043 at Upcoming Medical Meeting in 2024 SOUTH SAN FRANCISCO, Calif., April 01, 2024 (GLOBE...Read more
Topline data delivered to Ono Pharmaceutical, representing the first of two data sets that will trigger Ono’s option exercise decision for itolizumab Itolizumab continues to show clinically meaningful response in highly proteinuric subjects More than 80% of subjects achieved >50% reduction in urine protein creatinine ratio (UPCR) Itolizumab demonstrated a favorable safety and tolerability profile LA JOLLA, Calif. / Apr 01, 2024 /...Read more
Revita aims to be the first approved therapeutic option for durable weight maintenance after discontinuation of GLP-1 based drugs, as an adjunct to diet and exercise With this FDA IDE approval, Fractyl Health will initiate the Remain-1 randomized, double blind pivotal study and begin providing updates on the open label cohort, which we refer to as the Reveal-1 cohort, in the second half of 2024 BURLINGTON, Mass., April 01, 2024...Read more
Topline Results For Progression-Free Survival Expected In Q2 2024 CARDIFF, UK / ACCESSWIRE / March 28, 2024 / Biodexa Pharmaceuticals (NASDAQ:BDRX) ("Biodexa"), an acquisition-focused biopharmaceutical company, is developing MTX110 for the treatment of Diffuse Midline Glioma (DMG) in pediatric patients and for Recurrent Glioblastoma (rGBM) in adults; two aggressive brain cancers with universally poor prognoses. The company says...Read more
Up to 3.3% Placebo-Adjusted Mean Weight Loss (5.3% from Baseline) Observed After 28 Days VK2735 Shown to be Safe and Well-Tolerated in 28-Day Study with Low Rates of GI-Related Adverse Events Phase 2 Trial in Obesity Planned for 2H24 Conference Call Scheduled for 8:00 a.m. ET Today SAN DIEGO, March 26, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused...Read more
CAMBRIDGE, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced the clearance of its clinical trial authorisation (CTA) application by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency for BEAM-302, an in vivo base editor, as a potential treatment for patients with alpha-1 antitrypsin...Read more
SNK01 autologous NK cell therapy demonstrated a positive effect on cerebral spinal fluid (“CSF”) and plasma Tau proteins in Alzheimer’s patients. The additional Phase 1 SNK01 trial data suggest clinical activity regarding cognitive function in patients with advanced Alzheimer’s disease in addition to previously disclosed positive effects on amyloid protein and neuroinflammation biomarkers. SANTA ANA, Calif., March 25, 2024 (GLOBE...Read more
Three-part study to evaluate safety, tolerability and pharmacokinetics now underway RM-718 showed potential to reduce body weight and hyperphagia, no hyperpigmentation observed in preclinical studies BOSTON, March 25, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare...Read more
Plus’ CSF-01 cancer cell enumeration test is a sensitive and specific diagnostic test for the presence of adenocarcinoma and melanoma cancer cells in the leptomeninges CSF-01 testing is used as an exploratory endpoint in the ReSPECT-LM trials Controlled clinical trial data evaluating the utility of CSF-01 in clinical decision-making is anticipated to be released in Q2/Q3 2024 AUSTIN, Texas, March 25, 2024 (GLOBE NEWSWIRE) --...Read more
Preclinical data with APG808 demonstrate the potential for improved dosing over other treatment options in development, including the potential for dosing every six- or eight- weeks compared to dosing every two weeks for other biologics in development Second product candidate to enter the clinic following positive interim results from Phase 1 Healthy Volunteer Trial for APG777, which exceeded all of its trial objectives Interim...Read more
Medical Review Committee approved initiation of recruitment of next cohort of patients, in alignment with dose optimization protocol First patient out of six already enrolled and treated with initial dose of 2.50 mg/kg/dose MONTREAL, March 21, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and...Read more
LOS ANGELES, CA, March 20, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases, today announced Memorial Sloan Kettering Cancer Center as lead clinical site for its NXC-201 relapsed/refractory AL Amyloidosis multi-site clinical trial. “We are looking forward to...Read more
23ME-01473 (‘1473) seeks to restore anti-tumor immunity through NK and T cells by blocking the immunosuppressive effects of soluble ULBP6 ‘1473 also induces Fc receptor-mediated killing of ULBP6-expressing cancer cells through enhanced effector function SOUTH SAN FRANCISCO, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME), a leading human genetics and biopharmaceutical company, today announced the...Read more
Favorable Safety and Tolerability also Observed HOUSTON / Mar 19, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports early efficacy results showing primary lung tumor stabilization and the complete disappearance of brain metastases in the second patient in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel™ (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf,...Read more
LP-284 is in a Phase 1 clinical trial, having been developed with guidance from Lantern’s AI platform, RADR®, as a potential therapy for relapsed or refractory non-Hodgkin’s lymphoma and other solid tumors. LP-284 is the second of Lantern’s synthetic-lethal franchise of molecules that have been shown to be synthetically lethal in DNA damage repair deficient cancers and has entered into first-in-human clinical trials. LP-284 is the third...Read more
33% Response Rate and 100% Disease Control Rate Observed in Patients Evaluated for Efficacy Complete Response of Non-Target Tumor Also Observed Platinum-Resistant Ovarian Cancer is a Devastating Serious Condition of Unmet Medical Need with a Median Life Expectancy of Approximately One Year Fort Lee, NJ, March 14, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) today announced preliminary data from the ongoing Phase 1b...Read more
MARLBOROUGH, Mass., March 13, 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 the addition of three clinical trial sites for its Phase 1b study of PH-762: The George Washington University—Medical Faculty Associates in Washington,...Read more
Mechanistic dose response observed at a 2mg/kg dose level based on urinary biomarker analyses Encouraging exploratory results of imaging-based biomarkers with greatest reductions in total kidney volume seen in patients with the highest increases in PC1 and PC2 Cohort 3 fully enrolled with data readout anticipated in mid-2024; Cohort 4 screening to start in 2Q 2024 Company to hold conference call at 8:30am ET today SAN DIEGO, March...Read more
Trial will evaluate IDE161, IDEAYA's investigational PARG inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with MSI-high and MSS endometrial cancer Potential first-in-class PARG inhibitor, in combination with anti-PD-1 therapy, targets two complementary mechanisms of anti-tumor immune response in endometrial cancer IDEAYA will sponsor the clinical trial and Merck will...Read more
TORONTO, ON / ACCESSWIRE / March 11, 2024 / FSD Pharma Inc. (NASDAQ:HUGE) (CSE:HUGE)(FRA:0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, today announces the submission of the Company's Clinical Trial Application (CTA) for a planned Phase-1b clinical trial to Assess the Safety and Efficacy of...Read more
A total of 18 patients have been dosed in the trial to date Company anticipates moving into Cohort 6 in Q2 2024 following standard safety review AUSTIN, Texas, March 11, 2024 (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 (CNS) cancers, today announced it has...Read more
SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the U.S. Phase 1a/1b study evaluating NX-2127 in adults with relapsed/refractory B-cell...Read more
LISBON, Portugal, March 07, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ: VAXX), a U.S. company pioneering the development of a new class of medicines, announced positive clinical data from its UB-312 program in Parkinson’s disease (PD) presented by Jean-Cosme Dodart, PhD, SVP of Research at Vaxxinity in an oral session at the AD/PD™ 2024 International Conference on Alzheimer’s and Parkinson’s Disease, held virtually and in Lisbon,...Read more
Initial interim data show favorable drug exposure and confirm ALG.APV-527 biological activity Early promising signs of clinical activity in heavily pretreated patients Dose-escalation trial data on track for readout 2H 2024 LUND, SWEDEN and SEATTLE WA / ACCESSWIRE / March 7, 2024 / Alligator Bioscience AB ("Alligator") (ATORX) and Aptevo Therapeutics ("Aptevo") (Nasdaq:APVO) today announced positive interim data from the dose...Read more
Company anticipates dosing of KO-2806 in combination with adagrasib in KRASG12C-mutant NSCLC next quarter Dose escalation of KO-2806 as a monotherapy continues in parallel SAN DIEGO, March 06, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced dosing of the first patient...Read more
Study delivers first clinical safety and pharmacokinetic data as proof of concept for the use of multispecific antibodies in humans Candidate showed similar half-life to standard monoclonal antibodies and minimal anti-drug antibodies WESTON, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), today announced results from a Phase 1 clinical study of SAR441236, its trispecific...Read more
TORONTO, ON / ACCESSWIRE / March 5, 2024 / FSD Pharma Inc. (NASDAQ:HUGE) (CSE:HUGE) (FRA:0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announced its participation in Americas Committee for Treatment and Research in Multiple Sclerosis ("ACTRIMS") 2024 Forum held during Feb. 29 - Mar 2, 2024, in West Palm Beach, Florida. ACTRIMS was...Read more
BEIJING and LUND, Sweden, March 5, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer...Read more
Pharmacokinetic data support potential best-in-class profile with potential for improved clinical responses from greater exposures in induction than currently available biologic therapies and maintenance dosing of every 3- or 6-months Single dose showed deep and sustained inhibition of key atopic dermatitis biomarkers pSTAT6 and TARC for ~3 months (longest follow-up available with inhibition still ongoing at time of data cut) APG777...Read more
Top-line data including safety, tolerability, and biomarker activity anticipated this summer This Phase 1 clinical study data will support further development across multiple indications SAN DIEGO / Mar 04, 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...Read more
The Phase 1b trial of VLS-01 investigates the pharmacokinetics, pharmacodynamics, safety and tolerability of atai’s proprietary, optimized oral transmucosal formulation of DMT VLS-01 is being developed as a rapid-acting and durable antidepressant for treatment resistant depression, which affects approximately 100 million people globally VLS-01 is designed to induce a short psychedelic experience, allowing for a total in-clinic...Read more
Positive data following completion of second cohort of Phase 1 trial of Decoy 20 leads independent Safety Review Committee to recommend initiating multi-dosing cohort Single dose cohort data expected to be published at a scientific conference in 2024 NEW YORK, March 04, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral...Read more
Complete Remission rate of 64% and Overall Response Rate of 73% demonstrated in highly refractory patients Durability of clinical activity achieved 67% Overall Survival and 42% Progression Free Survival at One Year FLORHAM PARK, N.J., March 04, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of...Read more
First Patient Expected to be Randomized in the Second Quarter of 2024 CAMBRIDGE, Mass., Feb. 29, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has received first site Institutional Review Board (IRB) approval for Alexander Prezioso, M.D., Investigator, Clinical Pharmacology of Miami, in Hialeah,...Read more
Topline results expected in the third quarter of 2024; planning a Phase 2 Trial for prevention of kidney transplant rejection Anti-CD40L has multiple possible indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product Sanofi recently published results on their Fc-modified humanized anti-CD40L mAb, frexalimab, for multiple sclerosis in the New England Journal of...Read more
BETHESDA, Md., Feb. 27, 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 the initiation of the Multiple Ascending Dose (MAD) part of the Phase 1 clinical trial of GT-02287, Gain’s lead drug candidate for the treatment of GBA1 Parkinson’s...Read more
Oral presentation on March 7, 2024 will review positive safety and efficacy data for novel BET inhibitor VYN201 BRIDGEWATER, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that Dr. Iain Stuart, Chief...Read more
WILMETTE, Ill., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced that the internationally recognized radiopharmaceutical physician, Professor Rodney Hicks, will be the lead investigator for Monopar’s MNPR-101-Zr Phase 1 dosimetry clinical trial in advanced cancer patients. Professor Hicks...Read more
Emerging JANX007 data illustrate a potential best-in-class profile: promising efficacy with favorable safety profile in heavily pretreated subjects with late-stage mCRPC 83% (5/6) of subjects achieved PSA50 declines with first step dose ≥ 0.2mg 56% (10/18) of subjects achieved PSA50 declines with first dose ≥ 0.1mg No CRS greater than Grade 2 was observed in any cohort Early JANX008 data display differentiated safety and...Read more
Data expected to be shared during March corporate update With SAD cohorts complete, MAD cohorts to begin dosing in March SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced completion of the single-ascending dose (SAD) cohorts for its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is...Read more
KOMET-008 is evaluating ziftomenib in combination with gilteritinib, FLAG-IDA or LDAC in patients with relapsed/refractory NPM1-mutant or KMT2A-rearranged AML SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patient has been dosed in...Read more
All eight (100%) treatment-arm patients are relapse-free and have achieved and maintained complete donor chimerism following treatment with TSC-100 or TSC-101 Patient with high-risk, TP53-mutated MDS is relapse-free for over one year following treatment with TSC-101 Patient with AML converted from detectable to undetectable disease following treatment with TSC-101 Data presented at TANDEM meeting suggests complete donor chimerism is...Read more
Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) Biodexa Announces Positive Top Line Phase I Clinical Trial Results for Diffuse Midline Glioma and Provides R&D Update Median Overall Survival of 16.5 Months vs 10.0 months in Comparable Cohort CARDIFF, United Kingdom, February 23, 2024 (GLOBE NEWSWIRE) – Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of...Read more
On track to provide update from ongoing Phase 1 clinical trial in mid-2024; additional data expected in 1H 2025 BOSTON, Feb. 22, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that it has expanded its ongoing...Read more
Oral presentation to explore drug effect of sabirnetug (ACU193) on key cerebrospinal fluid biomarkers in early AD Poster presentation to showcase method used to develop a first-of-its-kind assay to measure target engagement of an AβO-selective antibody On track to initiate a Phase 2 trial evaluating sabirnetug in the first half of 2024 Sabirnetug is the nonproprietary name for ACU193 now accepted by the United States Adopted Name...Read more
Paxalisib plus Radiotherapy Data Shows Promise for Treating Patients with PI3K Pathway Mutation Brain Metastases SYDNEY, Feb. 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specializing in oncology, today announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial. This investigator-initiated trial...Read more
Results demonstrate rapid and sustained suppression of free TL1A, confirming target engagement of anti-TL1A (TEV-’574)1 Anti-TL1A (TEV-’574) was shown to be safe and well-tolerated, with a low incidence of antidrug antibodies2 Data support the ongoing Phase 2b clinical investigation of anti-TL1A (TEV-’574) in inflammatory bowel disease3 TEL AVIV, Israel & PARSIPPANY, N.J. / Feb 20, 2024 / Business Wire / Teva Pharmaceuticals, a...Read more
Positive safety/tolerability profile achieved with TH104 showing self-resolving, mild side effect profile aligned with previous studies Phase 1 clinical trial compared oral transmucosal delivery of TH104 to injectable reference approved drug completed Company fully funded into 2025 with Phase 2 moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC) study on-track and expected to initiate in 2024 BRIDGEWATER, NJ /...Read more
WILMETTE, Ill., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced it has received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 dosimetry trial of its novel radiopharmaceutical MNPR-101-Zr. The MNPR-101-Zr Phase 1 dosimetry clinical trial will enroll...Read more
ARV-102 is a novel oral PROTAC® protein degrader designed to cross the blood-brain barrier and target leucine-rich repeat kinase 2 (LRRK2) The Phase 1 trial of ARV-102 will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers NEW HAVEN, Conn., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on...Read more
The Clinical Study Report Also Describes Efficacy in 6 Participants Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Medicus Pharma Ltd. (TSXV: MDCX) (FSE: N46) ("Medicus" or the "Company") is pleased to announce that it has published the abbreviated clinical study report (CSR) from the SKNJCT-001 Phase 1 safety and tolerability study. SKNJCT-001 is an open-label, dose-escalation, placebo-controlled trial to evaluate dose...Read more
Study milestone further extends momentum for Company’s lead PDC candidate and oncology clinical development program MONTREAL, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced completion of enrollment of the first six participants in Part 3 of its...Read more
RP-1664 is a Potential First-in-Class, Selective, PLK4 Inhibitor CAMBRIDGE, Mass. & MONTREAL / Feb 15, 2024 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced the first patient has been dosed in the Company’s Phase 1 LIONS (PLK4 Inhibitor in Advanced Solid Tumors) clinical trial evaluating RP-1664, a potential first-in-class,...Read more
Second Patient Completed Treatment and Third Patient Dosed in Phase 1 Study Evaluating Deltacel™ for the Treatment of Non-Small Cell Lung Cancer HOUSTON / Feb 14, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces continued encouraging clinical findings from the most recent follow-up visit of the first patient enrolled in Deltacel-01, the Company’s Phase 1 clinical trial evaluating...Read more
TScan’s abstract selected by the Tandem Meetings to receive a Best Abstracts Award Company to discuss the potential implications of initial data from a large prospective clinical trial assessing the relationship between donor chimerism and risk of relapse WALTHAM, Mass., Feb. 14, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor...Read more
Activation of four U.S. sites for Phase 1 clinical trial of PAS-004 to evaluate safety, dose, key biomarker data and preliminary efficacy Plans to open three additional sites in Eastern Europe in the coming months Preliminary interim data expected in 2H 2024 SOUTH SAN FRANCISCO, Calif. and MIAMI, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a...Read more
Dose escalation for fourth patient follows successful completion of first cohort SAN JOSE, Calif., Feb. 12, 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 fourth patient in the ongoing Phase 1 clinical trial of its novel chimeric...Read more
Biodexa Reports 12 Month Survival in MAGIC-G1 Study of MTX110 in Recurrent Glioblastoma Patients CARDIFF, United Kingdom, February 8, 2024 (GLOBE NEWSWIRE) -- Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs including Type 1 diabetes and rare/orphan brain...Read more
WALTHAM, Mass. and BOULDER, Colo., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its upcoming posters for bezuclastinib at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) being held in Washington, D.C. from February 23-26, 2024. The company will host a...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
CLICK TO LEARN MORE