Month: May 2023

– IND application cleared within 30 days for clinical trial of CABA-201 in patients with LN and SLE and Fast Track Designation granted by the FDA for CABA-201 to deplete CD19-positive B cells and improve disease activity in patients with LN and SLE – – Phase 1/2 trial planned to evaluate CABA-201 in six patients with active LN and six patients with SLE without renal involvement in parallel cohorts at an initial dose of 1.0 x 106 cells/kg in each cohort – – Invited, oral presentation on CD19-CAR T in SLE and poster presentations for CABA-201 and DSG3-CAART to be presented at the upcoming ASGCT 26th Annual Meeting – PHILADELPHIA, May 11, 2023 (GLOBE NEWSWIRE) — Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with...

Camsirubicin Phase 1b Dose­Escalation Trial Enrolling 5th Dose­Level Cohort (650 mg/m2) MNPR-101 RIT Shows Promising Imaging and Therapeutic Preclinical Study Results WILMETTE, Ill., May 11, 2023 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical­stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced first quarter 2023 financial results and summarized recent developments. Recent Developments Camsirubicin – Phase 1b Dose­Escalation Trial, Currently Enrolling Fifth Dose­Level CohortPhase 1b data to date show an improvement in median progression free survival in patients with advanced soft tissue sarcoma (ASTS) from what was observed in the prior camsirubicin Phase 2 trial...

Initiation of the IMPACT Phase 2b trial of pemvidutide in non-alcoholic steatohepatitis (NASH) expected mid-2023 Top-line 48-week results from the MOMENTUM Phase 2 obesity trial expected Q4 2023 Top-line results from the Phase 2 trial of HepTcell™ in chronic hepatitis B (CHB) expected Q1 2024 Webcast to be held today, May 11, 2023, at 8:30 am EDT GAITHERSBURG, Md., May 11, 2023 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three months ended March 31, 2023, and provided a business update. “We are on course for mid-year initiation of IMPACT, our Phase 2b biopsy trial of pemvidutide in subjects with NASH,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “In our previous trials in subjects with non-alcoholic...

– Progressing Phase 1/1b clinical trial for IL-2 INDUKINE WTX-124 in advanced or metastatic solid tumors; initial first-in-human clinical data from monotherapy dose-escalation arm expected in 4Q 2023 – – Progressing Phase 1 clinical trial for IL-12 INDUKINE WTX-330 in patients with advanced or metastatic solid tumors or lymphoma; preclinical data published in Cancer Immunology Research – – First preclinical data for new candidate WTX-712, a conditionally active IL-21 INDUKINE molecule targeting oncology indications, presented at AACR Annual Meeting – WATERTOWN, Mass., May 11, 2023 (GLOBE NEWSWIRE) — Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate...

ATLANTA, May 11, 2023 (GLOBE NEWSWIRE) — Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”), today announced financial results for the first quarter ended March 31, 2023. Key HighlightsThe Company proposed a Phase 3 program for its lead development candidate IMC-1 to the U.S. Food & Drug Administration (“FDA”) as a treatment for FM consisting of four primary components: two adequate and well-controlled clinical studies, one of which would be a full factorial design with each of the individual components of IMC-1 (famciclovir and celecoxib) as separate comparator arms, a long-term safety trial, and a preceding pharmacokinetic/food effect study. Based on data...

– Phase 2b ODYSSEY Trial of CLS-AX in Wet AMD Expected to Open Enrollment in Q2 2023 – – Positive Safety Data, Duration and Biologic Effect of CLS-AX Over 6 Months in OASIS Phase 1/2a Extension Study Highlighted in Presentations at Recent Medical Meetings – – Management to Host Webcast and Conference Call Today at 8:30 A.M. ET – ALPHARETTA, Ga., May 11, 2023 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update. “We have delivered a productive start to 2023 as we continue executing on our near-term plan to advance CLS-AX (axitinib injectable suspension)...

HOOKIPA on track to report Phase 2 data on HB-200 for head and neck cancer in combination with pembrolizumab in 2Q 2023Phase 1 clinical trials initiated for two programs (HB-300 for advanced prostate cancer and Gilead-partnered HB-400 for chronic hepatitis B)HB-700 for KRAS-mutated cancers achieved $10 million milestone payment in Roche collaborationNEW YORK and VIENNA, May 11, 2023 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today reported financial results and business highlights for the first quarter of 2023. “We are happy to report continued progress across our oncology and infectious disease portfolios, as our HB-300 program for advanced prostate cancer and Gilead-partnered HB-400 program for the...

RL-007: First patient dosed in the Phase 2b study of RL-007 in Cognitive Impairment Associated with Schizophrenia. GRX-917: Presented PD data from the completed Phase 1 study, which suggest the potential for anxiolytic effects without the significant sedative effects seen with benzodiazepines. VLS-01: Well-tolerated in Parts 1 (IV) and 2 (OTF) of the on-going Phase 1 study. Amended protocol to expand study into Part 3, which is expected to further optimize the PK and PD of our proprietary OTF formulation. COMPASS Pathways announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the Phase 3 program in TRD, with topline data from Pivotal Trial 1 now expected in the summer of 2024. The Company’s $250M cash position and committed term loan funding is expected to fund operations into 1H 2026.NEW YORK and BERLIN, May 11, 2023...

BROOKFIELD, NEWS, May 11, 2023 (GLOBE NEWSWIRE) — Brookfield Reinsurance (NYSE, TSX: BNRE) today announced financial results for the quarter ended March 31, 2023. Sachin Shah, CEO of Brookfield Reinsurance, stated, “Our results for the quarter were strong and reflect the significant growth of our business and investment portfolio redeployment activities over the past year. We continue to prioritize sourcing high value investment opportunities, whilst scaling the overall business. Our high levels of liquidity give us substantial flexibility in that regard.”UnauditedAs at and for the periods ended March 31(US$ millions, except per share amounts) Three Months Ended    2023       2022  Total assets1 $         44,951     $         11,648  Adjusted equity1,2           4,721               1,576  Distributable operating...