Data presented at plenary session of Society of Gynecologic Oncology Meeting Patients treated suffered from platinum resistant/refractory ovarian cancer Previous PD-(L)1/CTLA-4 combinations have reported only 3-10% responses in comparable patient populations1,2 Findings consistent with botensilimab/balstilimab benefit in cold and refractory tumors across 9 different solid tumor cancers LEXINGTON, Mass. / Mar 27, 2023 /...Read more
BBP-398, an investigational SHP2 inhibitor, is a potentially best-in-class therapy for use in combination approaches, which is shown by preclinical findings demonstrating its safety profile, continuous, once-daily dosing regimen and synergistic efficacy to treat cancers driven by KRAS mutations If successful, the combination of investigational therapy BBP-398 and OPDIVO has the potential to address the serious unmet need for patients...Read more
A confirmed complete response was observed in the first patient in the lowest-dose cohort of the Phase 1 SQZ-AAC-HPV-101 clinical trial Following review and recommendation by the Study Safety Committee, the Company is advancing SQZ-AAC-HPV-101 trial to the highest-dose cohort Strong enrollment rates; Anticipate initial clinical data from the highest-dose cohort in the fourth quarter of 2023 WATERTOWN, Mass. / Mar 22, 2023 / Business...Read more
TORONTO / Mar 22, 2023 / Business Wire / 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 for the treatment of challenging neurodegenerative, inflammatory and metabolic disorders, today announced that its Australian entity, FSD Pharma Australia Pty Ltd. received the certificate of approval from The...Read more
MOMENTUM Phase 2 Obesity Trial (Week 24 Interim Analysis of 160 Subjects) Mean weight loss of 10.7% (placebo-adjusted 9.7%) at 2.4 mg dose at Week 24 Mean weight loss of 11.9% (placebo-adjusted 11.1%) in subjects weighing 115 kg or less at baseline at 2.4 mg dose at Week 24 Approximately 50% of subjects achieved 10% or more weight loss and approximately 20% of subjects achieved 15% or more weight loss at the 1.8 mg and 2.4 mg doses...Read more
HAMILTON, ON and BOSTON, March 20, 2023 /CNW/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the first patient has been dosed in the Phase 1 study evaluating [225Ac]-FPI-2059 (FPI-2059). FPI-2059 is a small molecule targeted alpha therapy (TAT) designed to deliver actinium-225 to tumor...Read more
CAPE CANAVERAL, Fla., March 20, 2023 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced that the first subjects have been dosed in a randomized, double-blind, placebo-controlled Phase 1 clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor contributing to heart...Read more
Company anticipates that the combination of pan-TKI dovitinib and PARP inhibitor stenoparib may generate synergistic anti-cancer activity Program initiation marks key milestone in Allarity’s clinical strategy shift towards combination therapies BOSTON, Mass - March 20, 2023 — Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity” or the “Company”), a clinical-stage pharmaceutical company developing novel oncology therapeutics...Read more
Milestone marks transition of Pyxis Oncology to a clinical-stage company Preliminary data anticipated in early 2024 CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, today announced dosing of the first subject in a Phase 1 trial of PYX-201. PYX-201 is a novel antibody-drug...Read more
Subjects completed 16-week treatment with no significant safety issues Topline results expected in the first half of 2023 SCOTTSDALE, Ariz., March 16, 2023 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage biopharmaceutical company that focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions, today announced...Read more
Initial data expected in the second half of 2023 WARMINSTER, Pa., March 16, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced that the first subject has been dosed in the Phase 1 clinical trial evaluating the safety, tolerability, and...Read more
Reduction in neutrophil extracellular traps (NETs) markers Potential association between patient survival and CEACAM1 positive lymphocytes REHOVOT, Israel, March 16, 2023 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies that harness the power of the tumor microenvironment (TME) to overcome tumor immune...Read more
WALTHAM, Mass., March 15, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) today announced that data from the Phase 1 portion of the ongoing Phase 1/2 AUGMENT-101 trial of revumenib in patients with nucleophosmin mutant (mNPM1) and KMT2A-rearranged (KMT2Ar) relapsed/refractory (R/R) acute leukemia and an analysis describing MEN1 mutations observed in the study have been published in the journal Nature. Revumenib is...Read more
San Diego, California--(Newsfile Corp. - March 15, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, reports that the human research ethics committee ("HREC") in Australia has approved the initiation of the multiple ascending dose ("MAD") arm of Skye's Phase 1 study of SBI-100 Ophthalmic Emulsion ("OE"). Skye expects...Read more
WALTHAM, Mass., March 14, 2023 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced that the first patient has been dosed in its Phase 1 umbrella trial of TSC-100 and TSC-101 targeting minor histocompatibility antigens (MiHA) HA-1 and HA-2,...Read more
SOUTH SAN FRANCISCO, Calif., March 14, 2023 /PRNewswire/ -- ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative ("Quantum Leap") today announced that the first patient has been dosed in the I-SPY-P1-TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and...Read more
SOUTH SAN FRANCISCO, Calif., March 13, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Quantum Leap Healthcare Collaborative (“Quantum Leap”) today announced that the first patient has been dosed in the I-SPY-P1-TRIAL for the treatment of patients with unresectable or metastatic HER2-positive and...Read more
BASEL, Switzerland, March 13, 2023 (GLOBE NEWSWIRE) -- VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, and Asahi Kasei Pharma Corporation (“Asahi Kasei Pharma”) today announced the start of a Phase 1 study investigating the pharmacokinetics, pharmacological action, safety, and tolerability of apraglutide when a single...Read more
NEW YORK, March 13, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces that Atlanta, Ga.-based Emory Winship Cancer Institute (“Emory”) has become a new clinical trial site for INDP-D101. INDP-D101 is the Company’s first-in-human, open label, dose escalation and expansion,...Read more
CAMBRIDGE, Mass., March 13, 2023 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that the Phase 1 trial of XMT-2056 has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). This action follows the...Read more
Enrollment continuing to progress toward an interim analysis, planned when 30-50% of subjects reach the primary endpoint expected mid-year 2023 HOUSTON, March 9, 2023 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that the first...Read more
FRTX-02 was generally safe and well tolerated within the potential therapeutic dose range, meeting the study’s primary objectives Plasma concentrations within the potential therapeutic dose range were consistent with efficacious exposure levels established in nonclinical disease models and support once-daily oral dosing Reduction in disease-relevant cytokines was observed in exploratory ex-vivo LPS-stimulated whole blood...Read more
BICX104 was Well Tolerated with No Serious Adverse Events Reported and Achieved 84 Days of Therapeutic Naltrexone Plasma Concentrations BICX104 Subjects Experienced Better 84-Day Treatment Adherence Than Vivitrol® Subjects Company Seeking FDA Approval for Immediate Expanded Access “Compassionate Use” of BICX104 for Over 10 Million Americans with Opioid Use Disorder BioCorRx Applying for Fast Track Designation and Also Seeking FDA...Read more
NEW YORK, March 07, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces the dosing of the first subject in INDP-D101. INDP-D101 is the Company’s first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in...Read more
Dosing of all patients was completed at the end of February No Serious Adverse Events (SAE’s) have been reported Phase 1 clinical initial safety and antibody response update expected in Q2, 2023 JUPITER, Fla., March 07, 2023 (GLOBE NEWSWIRE) -- Dyadic International, Inc. ("Dyadic", "we", "us", "our", or the "Company") (NASDAQ: DYAI), a global biotechnology company focused on building innovative...Read more
San Diego, California--(Newsfile Corp. - March 7, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma and ocular hypertension, has completed dosing of the third cohort of eight healthy participants in its Phase 1 clinical trial of its lead product candidate, SBI-100 Ophthalmic Emulsion ("OE"), a cannabinoid receptor...Read more
ST. LOUIS, March 06, 2023 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, today announced that its lead drug candidate, lasofoxifene, improved vaginal/vulvar symptoms while fulvestrant worsened them in a study of postmenopausal women with locally advanced or metastatic...Read more
Clinical trial part of long-term growth strategy for motixafortide across multiple potential therapeutic areas TEL AVIV, Israel, March 6, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced a collaboration with Washington University School of Medicine in St. Louis to advance a Phase 1 clinical trial that will evaluate the safety...Read more
NEW HAVEN, Conn. / Mar 06, 2023 / Business Wire / Rallybio Corporation (Nasdaq: RLYB) today announced that clinical proof-of-concept has been achieved in a Phase 1b study for RLYB212, an anti-HPA-1a monoclonal antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). Results show that one week after a single subcutaneous dose, RLYB212 was able to rapidly and completely eliminate transfused, HPA-1a positive...Read more
NEW YORK & LONDON & PARIS / Mar 03, 2023 / Business Wire / Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company, announces the completion of an end of Phase 1 (EOP1) meeting with the US Food and Drug Administration (“US FDA”). SACT-1 is a repurposed small molecule drug formulated in oral suspension targeting neuroblastoma in pediatric patients and...Read more
NORTH PALM BEACH, FL / ACCESSWIRE / February 28, 2023 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in the brain cancer space, announced today that the Company has completed and closed its Phase I clinical trial evaluating safety and tolerance for Pritumumab ("PTB") as a treatment for Primary and Metastatic Brain Cancers. Previous...Read more
Vancouver, British Columbia--(Newsfile Corp. - February 27, 2023) - Defence Therapeutics Inc. (CSE: DTC) (FSE: DTC) (OTC Pink: DTCFF) ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, is pleased to update its stakeholders on its completed achievements as well as outlining the future milestones set for 2023. Over the last three...Read more
Rapid, profound and durable responses across multiple dosing groups with favorable safety profile observed—positioning barzolimab as a potential best-in-class addition to a historically limited treatment landscape At week 12, 56% of all patients in the 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups had complete response and 76% had well-controlled disease (UAS7/UCT) At week 24, 53% of all patients in the 1.5 mg/kg and 3.0 mg/kg dose...Read more
BOSTON / Feb 24, 2023 / Business Wire / Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, presented new STAR-0215 data in two poster presentations at the American Academy of Allergy, Asthma, and Immunology Annual Meeting in San Antonio, Texas that demonstrate early...Read more
WTX-330 is designed as systemically delivered, conditionally activated IL-12 therapy Phase 1 Study of WTX-330 is intended to evaluate the safety, tolerability, and clinical activity of WTX-330 in Patients with Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma Second clinical stage program of a new class of systemically delivered, conditionally activated INDUKINE™ therapeutics developed by Werewolf WATERTOWN, Mass.,...Read more
REDWOOD CITY, Calif., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, and Nestlé Health Science, a leader in the science of nutrition, today announced interim results from a Phase 1 study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of CDX-7108. CDX-7108 is a lipase variant specifically engineered to overcome the limitations of existing...Read more
Next-generation gamma-delta T cell CAR technology targets tumors while sparing healthy tissue. Greater than 15x difference in killing between tumor cells and healthy B cells with the non-signaling gamma-delta CAR-T platform (nsCAR) utilizing the validated target of CD19 as proof-of-concept. Leveraging the unique properties of gamma-delta T cells supports the potential to broaden the utilization of CAR technology for previously...Read more
Results highlight the favorable profile for bemnifosbuvir related to low risk for drug-drug interactions BOSTON, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that data from three Phase 1 studies suggest a favorable drug-drug interaction profile. No dosage adjustment is needed for CYP3A substrates or for drugs that are sensitive...Read more
San Diego, California--(Newsfile Corp. - February 23, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has received a positive recommendation following a pre-specified data review by the safety review committee ("SRC") based on dosing of the second cohort of eight healthy participants of its Phase 1 study of SBI-100...Read more
RGX-121, a potential one-time gene therapy for the treatment of MPS II, continues to be well-tolerated with no drug-related SAEs across three dose levels Additional data from patients in Cohort 3 using pivotal program dose level continue to demonstrate largest reductions in CSF GAGs, continuing to approach normal levels at 48 weeks New, longer-term clinical measures demonstrated continued improvement in neurodevelopmental and daily...Read more
FOSTER CITY, Calif. / Feb 22, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced data evaluating lenacapavir in combination with broadly neutralizing antibodies (bNAbs) teropavimab and zinlirvimab as a potential long-acting treatment regimen with twice-yearly dosing. Results from the Phase 1b clinical trial demonstrated the investigational combination was generally well tolerated with high efficacy in select...Read more
Immunocore announces initial Phase 1 safety and pharmacodynamic activity data with first soluble TCR therapy for people living with HIV Data from the single ascending dose part of the Phase 1 trial shows IMC-M113V is well tolerated Expected markers of T cell activation observed in half of participants at 15-mcg dose; plasma viral load remained suppressed throughout dosing and follow-up The multiple ascending dose part of the trial is...Read more
SAN DIEGO, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the start of a Phase 1 study evaluating its development program targeted at treating primary dysmenorrhea by delivering the active pharmaceutical ingredient diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), in a novel way. Daré’s investigational product, DARE-PDM1, will deliver diclofenac...Read more
Kinnate to retain Kinnjiu’s cash, intellectual property and other assets, including key personnel and legal entity structure Kinnate’s cash runway still expected to fund current operations into mid-2024 Trial sites open in People's Republic of China (PRC) and Taiwan for ongoing Phase 1 clinical trial evaluating exarafenib, a pan-RAF inhibitor Kinnate to maintain strategic presence in PRC, Hong Kong, Macau and Taiwan SAN FRANCISCO...Read more
SOLANA BEACH, Calif. and REDWOOD CITY, Calif., Feb. 21, 2023 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today announced top-line results from its Phase 1b clinical trial of zotatifin for the treatment of COVID demonstrating favorable safety results as well as positive trends in several measures of antiviral...Read more
BOSTON, Feb. 21, 2023 (GLOBE NEWSWIRE) -- Aileron Therapeutics (Nasdaq: ALRN) today announced that a review of initial data from its Phase 1b chemoprotection trial of ALRN-6924 in patients with p53-mutated breast cancer showed that patients in the trial experienced severe neutropenia (Grade 4) and alopecia. The primary endpoint of the Phase 1b open-label trial, which was evaluating ALRN-6924 in patients with breast cancer receiving...Read more
CAMBRIDGE, Mass. / Feb 17, 2023 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the first patient has been dosed in Study SRP-9003-102. Also known as VOYAGENE, Study 9003-102 is a phase 1 study of SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy Type 2E/R4 (LGMD2E). VOYAGENE is a U.S.-only study enrolling...Read more
Oral Presentation, Abstract #59: 12 out of 12 AML in complete remission patients with full 1-year follow-up achieved successful neutrophil engraftment at a median of 19 days after conditioning with briquilimab in combination with fludarabine and low dose irradiation Oral Presentation, Abstract #86: All 12 patients at Stanford receiving briquilimab-based conditioning and donor cell infusion in an outpatient setting were discharged from...Read more
SOUTH SAN FRANCISCO, Calif., Feb. 16, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the first patient has been dosed in the ASPEN-07 study evaluating evorpacept, a next generation CD47 blocker, in combination with PADCEV® (enfortumab vedotin-ejfv), an antibody drug conjugate (“ADC”),...Read more
Biochemical and radiographic responses reported in first two cohorts of dose escalation in heavily pre-treated metastatic castration-resistant prostate cancer (mCRPC) patients PSA50 or greater responses in 50% of patients Responses observed in patients with visceral, nodal and bone involvement HOUSTON, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular...Read more
SAN DIEGO / Feb 16, 2023 / Business Wire / Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM) today announced encouraging initial data from its ongoing Phase 1 trial (APEX-01 (NCT04662580)) investigating ARX517, Ambrx’s proprietary anti-PSMA ADC, in prostate cancer patients. APEX-01 is a Phase 1, first-in-human, open label dose escalation and dose expansion trial enrolling patients with advanced prostate cancer whose tumors have progressed on at...Read more
VANCOUVER, British Columbia, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “AGN Pharma”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to advise that its subsidiary Algernon NeuroScience (AGN Neuro), has completed dosing of the first cohort in its Phase 1 clinical study of an intravenous formulation of AP-188...Read more
MONTREAL, Feb. 16, 2023 (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 an update on the plan to amend and optimize the protocol of its Phase 1 oncology clinical trial with the goal of a timely re-submission to the United States Food and Drug Administration...Read more
SPL028 is a proprietary deuterated DMT candidate with multi-layered IP protection Phase I study will compare two routes of SPL028 administration; intravenous and intramuscular LONDON, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, today confirms that the...Read more
VYN201 was generally well-tolerated with no clinically relevant treatment emergent adverse events from all dose cohorts, meeting the primary objective of the study Topline Phase 1b results in vitiligo patients expected in mid-2023 BRIDGEWATER, N.J., Feb. 15, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated...Read more
Completed NVG-291 dosing of subjects in Phase 1 clinical trial Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury planned to start in Q3 2023 NVG-291 has been demonstrated in preclinical studies to promote repair mechanisms in the nervous system, including axonal regeneration, remyelination and plasticity Vancouver, British Columbia--(Newsfile Corp. - February 14, 2023) - NervGen Pharma Corp. (TSXV: NGEN)...Read more
WILMETTE, Ill., Feb. 14, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced the following update on its currently enrolling open-label Phase 1b camsirubicin Maximum Tolerated Dose (MTD) trial in patients with advanced soft tissue...Read more
Twelve of 42 patients (28.6%) in metastatic castration-resistant prostate cancer (mCRPC) cohort achieved ≥ 50% prostate-specific antigen (PSA) reduction (PSA50), including 9 (21.4%) who achieved ≥ 90% PSA reduction (PSA90) Nine of 35 patients (25.7%) with measurable mCRPC achieved confirmed partial responses Manageable overall safety profile observed across multiple expansion cohorts Company plans to initiate Phase 2 study in mCRPC...Read more
CHARLOTTESVILLE, Va. and CARMEL, Ind., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), 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 the completion of enrollment in its Phase 1 INTERCEPT-AD trial of ACU193 in patients with early...Read more
Trial to Evaluate Safety, Tolerability and Clinical Activity in Solid Tumors Expressing 5T4 LUND, SWEDEN and SEATTLE, WA / ACCESSWIRE / February 13, 2023 / Alligator Bioscience AB ("Alligator") (Nasdaq Stockholm: ATORX) and Aptevo Therapeutics ("Aptevo") (NASDAQ:APVO) today announced the dosing of the first patient in the companies' Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors expressing the tumor-associated...Read more
Results align with the overall safety profile of Annamycin Final cohort demonstrated an 80% overall response rate (ORR) in elderly subjects (≥60 years old) No cardiotoxicity demonstrated in any study subject The median number of prior therapies for all subjects was 4 HOUSTON, Feb. 13, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a...Read more
San Diego, California--(Newsfile Corp. - February 13, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma and ocular hypertension, has completed dosing of the second cohort of eight healthy participants in its Phase 1 clinical trial of its lead product candidate, SBI-100 Ophthalmic Emulsion ("OE"), a cannabinoid...Read more
All OTX-TKI treated subjects who were rescue-free at the Month 7 interim analysis remained rescue-free, extending the 73% rescue-free rate up to Month 10 CSFT and BCVA measurements at 10 months were comparable between OTX-TKI treated subjects and aflibercept treated subjects OTX-TKI continued to be generally well tolerated with no drug-related serious adverse events through Month 10 Conference call to discuss results to be held on...Read more
MARLBOROUGH, Mass., Feb. 10, 2023 /PRNewswire/ -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced that an independent Data Monitoring Committee (DMC) completed its prespecified review of interim safety data in the Company's Phase 1b clinical trial of PH-762 for the...Read more
CAMBRIDGE, Mass. / Feb 08, 2023 / Business Wire / Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that enrollment in Cohort 2 in its SER-155 Phase 1b study is underway. SER-155, an investigational oral microbiome therapeutic, is designed to reduce the incidence of gastrointestinal (GI) infections, bloodstream infections, and graft versus host disease (GvHD) in individuals undergoing...Read more
CNTY-101 is the first cell therapy product candidate engineered with six precision gene edits including a CD19-CAR, Allo-Evasion™ technology, IL-15 cytokine support and a safety switch ELiPSE-1 trial to test multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits designed to resist 3 major pathways of rejection PHILADELPHIA, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc., (NASDAQ: IPSC), an...Read more
Enrollment continuing to progress toward an interim analysis, planned when 30-50% of subjects reach the primary endpoint expected mid-year 2023 HOUSTON, Feb. 7, 2023 /PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that the...Read more
NEW YORK, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces the addition of Morristown Medical Center, part of the Atlantic Health System, as a new clinical trial site for INDP-D101. INDP-D101 is the Company’s first-in-human, open label, dose escalation and...Read more
VANCOUVER, British Columbia, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), an end-to-end Canadian-based drug manufacturer and formulator licensed by Health Canada to produce and supply natural, GMP-grade psilocybin, synthetic psychedelic substances, and high-quality functional mushrooms, is pleased to announce the submission of its clinical trial application (CTA)...Read more
Seelos is conducting a Phase I ethnobridging study in healthy Japanese and non-Asian subjects to evaluate the safety and pharmacokinetic profiles of SLS-002. NEW YORK, Feb. 6, 2023 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that it has dosed the first patients...Read more
Media Release 20 patients with 1st line non-small cell lung cancer (1L NSCLC) now enrolled in the first triple combination therapy study of efti with standard-of-care combination of anti-PD-1 therapy and chemotherapy Promising initial efficacy results showing a 72.7% response rate and 90.9% disease control rate reported at SITC 2022 Additional data is expected throughout calendar year 2023 and will further inform our next steps in 1L...Read more
INO-4201 found to be well-tolerated in the trial Humoral responses were boosted in 100% (36 of 36) of treated participants PLYMOUTH MEETING, Pa., Feb. 2, 2023 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases, today announced positive results from a Phase 1b clinical trial...Read more
SOLANA BEACH, Calif., Feb. 02, 2023 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced that enrollment in the final cohort of the Phase 1b stage of its Cancer Appetite Recovery Study (CAReS) is now complete. The first stage of...Read more
EXS4318 is the first immunology & inflammation candidate designed by Exscientia and its fourth molecule to enter the clinic Exscientia invented a potentially first-in-class potent and selective PKC theta inhibitor Eligible for pre-commercial milestone payments and, if approved, tiered royalties on net product sales OXFORD, England / Feb 02, 2023 / Business Wire / Exscientia plc (Nasdaq: EXAI) today announced...Read more
Marks first ever trial to evaluate deuterated DMT in humans Based on preclinical studies CYB004 demonstrated superior bioavailability compared to IV DMT which may support less invasive dosing methods CYB004 is a patented proprietary molecule protected through 2041 TORONTO / Feb 01, 2023 / Business Wire / - Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing...Read more
CAMBRIDGE, Mass., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that patient dosing is underway in the expansion portion of its UPGRADE-A clinical trial of UpRi in combination with carboplatin in...Read more
AUSTIN, Texas, Feb. 01, 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 completion of enrollment in Cohort 2 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal...Read more
San Diego, California--(Newsfile Corp. - January 31, 2023) - Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has received a positive recommendation following a pre-specified data review by the safety review committee ("SRC") based on dosing of the first cohort of eight healthy participants of its Phase 1 study of SBI-100...Read more
SAN DIEGO / Jan 31, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, “Arcturus Therapeutics”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that the Clinical Trial Application (CTA) for ARCT-032, an inhaled investigational mRNA...Read more
NORTH PALM BEACH, FL / ACCESSWIRE / January 25, 2023 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company developing monoclonal antibodies that target various cancer types, announced the completion of the dosing period of their Phase I Clinical Trial evaluating the safety and dose tolerance of Pritumumab ("PTB") as a treatment for Brain Cancer. The completion of...Read more
CAMBRIDGE, Mass., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced the initiation of patient dosing in its Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen product candidate. XMT-2056 is a...Read more
Repeated administrations of PRGN-2012 were well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 Clinical data show strong response in RRP patients with 50% of patients in Complete Response, requiring no post-treatment surgeries, following PRGN-2012 treatment at Dose Level 2; All complete responders remain surgery-free post-treatment with a minimum follow up of 12 months PRGN-2012...Read more
Small U.S. Phase 1 trial with newly optimized formulation to confirm favorable safety profile from three previous clinical trials and facilitate Phase 2B development of PH10 as a stand-alone treatment for major depressive disorder SOUTH SAN FRANCISCO, Calif. / Jan 24, 2023 / Business Wire / Vistagen (NASDAQ: VTGN) a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living...Read more
JUPITER, Fla., Jan. 24, 2023 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on building innovative microbial protein production platforms today announced that, in line with the timing announced during management’s Q3 earnings call, it has initiated dosing in its Phase 1 clinical trial to demonstrate clinical safety and antibody response...Read more
Hunt Valley, MD, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO), proudly celebrates a first-in-human Phase I clinical study for Skye Bioscience, Inc.’s (SKYE: OTCQB) proprietary, synthetic cannabinoid derivative, SBI-100 Ophthalmic Emulsion (OE), which has been designed to advance a new mechanism of action with potential as a treatment for...Read more
Overall response rate (ORR) of 23% and disease control rate (DCR) of 76% in expanded cohort of 70 heavily pre-treated patients; data suggest superior benefit compared to what has been reported for standard of care and other investigational therapies Responses have been durable with 69% ongoing at data cut-off; median overall survival not reached Global, randomized Phase 2 trials of botensilimab/balstilimab in MSS CRC and other...Read more
24 healthy volunteers have been dosed in study SB102 to assess the safety, PK, and PD of SON-1010 without the background of prior chemotherapy PK data shows an extended half-life of SON-1010 of approximately 112 hours, compared to 12 hours for rhIL-12 Simulation of the controlled and prolonged induction of IFNg and minimal related adverse events suggest that dose escalation can continue PRINCETON, NJ / ACCESSWIRE / January 19, 2023...Read more
ANAHEIM, CA, Jan. 19, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance use and related disorders, today announced an update from the Phase I clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), which is being developed under BioCorRx Pharmaceuticals, Inc., the...Read more
In the race to create faster-acting, safer antidepressants, Vistagen (NASDAQ: VTGN) is starting the year strong as it gets ready to launch a Phase 1 Trial of its novel pherine nasal spray for Major Depressive Disorder (MDD). The trial, involving the Company’s newly optimized formulation of PH10, is intended to confirm the favorable safety profile of PH10 established in three previous clinical studies conducted in Mexico, including a...Read more
WILMETTE, Ill., Jan. 18, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced the positive recommendation from its safety review committee to advance to the fifth dose level (650 mg/m2) in its camsirubicin Phase 1b trial in patients with advanced...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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