CNS

ORIC Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Updates

Retrieved on: 
Monday, March 11, 2024

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter and year ended December 31, 2023.

Key Points: 
  • Presented preclinical data for ORIC-114 at ESMO Congress 2023, demonstrating potent activity across atypical mutations in EGFR, thus expanding the potential eligible patient population.
  • Presented initial data from the Phase 1b trial of ORIC-533 in patients with relapsed/refractory multiple myeloma at the 2023 ASH Annual Meeting.
  • Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $235.0 million as of December 31, 2023.
  • There were no such expenses for the year ended December 31, 2023.

Plus Therapeutics Completes Dosing in Cohort 5 of ReSPECT-LM Phase 1 Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases

Retrieved on: 
Monday, March 11, 2024

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 completed dosing in Cohort 5 of the ReSPECT-LM Phase 1 dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors.

Key Points: 
  • Three patients were dosed as part of Cohort 5, bringing the total to 18 patients dosed in the ReSPECT-LM trial to date.
  • There have been no dose limiting toxicities observed to date with administered radiation doses up to 66.14 millicuries in Cohort 5, a ten-fold increase over Cohort 1.
  • The Company plans to initiate dosing in Cohort 6 in the second quarter of 2024, pending Data Safety Monitoring Board (DSMB) approval.
  • In addition, five new clinical trial sites were added to this trial over the last year, bringing the total number of sites to seven.

Monte Rosa Therapeutics Announces Initiation of IND Enabling Studies for MRT-8102, A First-in-Class NEK7 Directed Molecular Glue Degrader and NLRP3/IL-1β Pathway Inhibitor

Retrieved on: 
Monday, March 11, 2024

BOSTON, March 11, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced a novel development candidate, MRT-8102, a potent, highly selective and orally bioavailable NIMA related kinase 7 (NEK7)-directed MGD. MRT-8102 is expected to be developed for the treatment of inflammatory diseases driven by interleukin-1β (IL-1β) and the NLRP3 inflammasome, which are critical elements of the inflammatory process. This is the first development candidate to be declared from the Company’s NEK7 development program.

Key Points: 
  • This is the first development candidate to be declared from the Company’s NEK7 development program.
  • “In preclinical non-human primate studies, MRT-8102 has demonstrated potent and selective degradation of NEK7, reducing downstream IL-1β.
  • We believe MRT-8102 has the potential to be developed in multiple inflammatory diseases, including gout, pericarditis and other cardiovascular diseases.
  • IND-enabling studies are underway, and we plan to file our first IND for the program in the first quarter of 2025.

Reviva to Present at the UBS Virtual CNS Day

Retrieved on: 
Monday, March 11, 2024

CUPERTINO, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will participate in a Fireside Chat at the UBS Virtual CNS Day, taking place virtually March 18, 2024.

Key Points: 
  • CUPERTINO, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will participate in a Fireside Chat at the UBS Virtual CNS Day, taking place virtually March 18, 2024.

Mustang Bio Announces Publication in Nature Medicine of Data from Phase 1 Trial Evaluating MB-101 IL13Rα2-targeted CAR T-Cells in High-Grade Glioma

Retrieved on: 
Thursday, March 7, 2024

WORCESTER, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced Phase 1 clinical data were published in Nature Medicine that demonstrated the promising safety and clinical activity of Mustang’s MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of patients with recurrent and refractory malignant glioma, including glioblastoma.

Key Points: 
  • MB-101 was developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Mustang.
  • Central nervous system (CNS) increases in inflammatory cytokines, including IFNγ, CXCL9, and CXCL10, were associated with CAR T-cell administration and bioactivity.
  • Primary endpoints were safety and feasibility, with secondary endpoints measuring therapy-related cytokine dynamics, CAR T-cell persistence and clinical outcomes.
  • Dr. Brown has a financial interest in Mustang and has previously been a paid consultant for the company.

Reviva to Present at the 36th Annual ROTH Conference

Retrieved on: 
Thursday, March 7, 2024

CUPERTINO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will present at the 36th Annual ROTH Conference, taking place March 17-19, 2024, in Dana Point, CA.

Key Points: 
  • CUPERTINO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will present at the 36th Annual ROTH Conference, taking place March 17-19, 2024, in Dana Point, CA.
  • Please contact your ROTH representative to register for the conference and schedule a one-on-one meeting with Reviva management.

Olema Oncology Announces Publication of Data Highlighting Palazestrant’s Ability to Inhibit Wild-Type and Mutant ER+ Breast Cancer Both as Monotherapy and in Combination with CDK4/6 Inhibitors

Retrieved on: 
Wednesday, March 6, 2024

The paper, titled “Palazestrant (OP-1250), a Complete Estrogen Receptor Antagonist, Inhibits Wild-type and Mutant ER-positive Breast Cancer Models as Monotherapy and in Combination”, describes the scientific background underlying the design, discovery and optimization of palazestrant.

Key Points: 
  • The paper, titled “Palazestrant (OP-1250), a Complete Estrogen Receptor Antagonist, Inhibits Wild-type and Mutant ER-positive Breast Cancer Models as Monotherapy and in Combination”, describes the scientific background underlying the design, discovery and optimization of palazestrant.
  • “What’s even more exciting is to see how faithfully the pre-clinical research predicted the behavior of palazestrant now that it is in late-stage clinical development.
  • In mouse xenograft models, palazestrant demonstrated excellent pharmacokinetics, was well tolerated, showed synergy with CDK4/6 inhibitors, and was highly effective at reducing tumor growth in both wild-type and ESR1-mutant ER+ breast cancer.
  • In addition, in an ESR1-mutant intercranial xenograft model, palazestrant inhibited tumor growth and improved survival of animals with CNS metastases, even after stopping drug treatment.

Intra-Cellular Therapies to Participate in Three Upcoming Investor Conferences

Retrieved on: 
Wednesday, March 6, 2024

NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will participate in three upcoming investor conferences:

Key Points: 
  • NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it will participate in three upcoming investor conferences:
    A live and achieved webcast of the Company’s presentation at the Leerink Partners Global Biopharma Conference can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com.
  • Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

Nurix Therapeutics Announces Presentations at the American Association for Cancer Research (AACR) 2024 Annual Meeting

Retrieved on: 
Tuesday, March 5, 2024

SAN FRANCISCO, March 05, 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 Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, is invited as a featured speaker in two sessions at the American Association for Cancer Research (AACR) 2024 Annual Meeting, which will be held from April 5-10, 2024, in San Diego, CA.

Key Points: 
  • SAN FRANCISCO, March 05, 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 Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, is invited as a featured speaker in two sessions at the American Association for Cancer Research (AACR) 2024 Annual Meeting, which will be held from April 5-10, 2024, in San Diego, CA.
  • Dr. Hansen’s presentation “NX-5948, a brain-penetrant BTK degrader with clinical activity in B-cell malignancies including CNS lymphoma” will be featured in the Major Symposium session: Molecular Glues, PROTACs, and Next-Gen Degraders: Discovery and Early Preclinical Advances that will be held from 10:15 -11:45 a.m. PT on Tuesday, April 9, 2024.
  • Dr. Hansen is also a featured presenter in the Educational session: Chemistry to the Clinic Part 1 of 3: Targeted Protein Degraders: Delivering Degraders to the Site of Action that will be held from 4:45 - 6:15 p.m. PT on Friday, April 5, 2024.

Praxis Precision Medicines Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024

Fourth Quarter and Full Year 2023 Financial Results:

Key Points: 
  • Fourth Quarter and Full Year 2023 Financial Results:
    As of December 31, 2023, Praxis had $81.3 million in cash and cash equivalents, compared to $100.5 million in cash, cash equivalents and marketable securities as of December 31, 2022.
  • Research and development expenses were $18.4 million for the fourth quarter of 2023, compared to $28.3 million for the fourth quarter of 2022.
  • General and administrative expenses were $9.9 million for the fourth quarter of 2023, compared to $13.1 million for the fourth quarter of 2022.
  • Praxis incurred a net loss of $26.9 million for the fourth quarter of 2023, including $5.7 million of stock-based compensation expense, compared to $41.2 million for the fourth quarter of 2022, including $6.4 million of stock-based compensation expense.