Toxic encephalopathy

Schrödinger Highlights Progress of Clinical Programs and Discloses Three New Programs at First Therapeutics Pipeline Investor Event

Retrieved on: 
Thursday, December 14, 2023

The data support continued evaluation of SGR-1505 in the ongoing Phase 1 study in patients with relapsed or refractory B-cell malignancies.

Key Points: 
  • The data support continued evaluation of SGR-1505 in the ongoing Phase 1 study in patients with relapsed or refractory B-cell malignancies.
  • “These data add significantly to our understanding of SGR-1505 and inform our clinical development strategy in hematologic malignancies.
  • Schrödinger is presenting three new proprietary discovery programs at Pipeline Day, targeting EGFRC797S, PRMT5-MTA and NLRP3.
  • Schrödinger is advancing multiple oncology programs designed to exploit the intrinsic vulnerabilities of cancer cells through synthetic lethality and inhibition of DNA-damage repair.

Senti Bio Announces New Strategic Collaboration with Celest Therapeutics for Clinical Development of SENTI-301A in China

Retrieved on: 
Monday, November 6, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced a new strategic collaboration with Celest Therapeutics (Shanghai) Co. Ltd (“Celest”), a China-based biotechnology company, for the clinical development of SENTI-301A to treat solid tumors in China.

Key Points: 
  • Through this collaboration, Celest will lead clinical development, operations, and manufacturing for the advancement of SENTI-301A with technical support from Senti Bio.
  • Celest and Senti Bio have the option to expand clinical development of SENTI-301A to Hong Kong, Macau and Taiwan.
  • Senti Bio will retain all commercialization rights outside of mainland China, Hong Kong, Macau, and Taiwan for SENTI-301A.
  • Senti Bio has shown comprehensive preclinical data demonstrating robust in vitro and in vivo killing of relevant tumor cells with SENTI-301A.

SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Acute Myeloid Leukemia

Retrieved on: 
Tuesday, October 10, 2023

This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

Key Points: 
  • This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
  • “SLS009 is a novel and highly selective CDK9 inhibitor that has already shown a favorable safety profile, strong initial efficacy signals, and evidence of anti-tumor activity.
  • ODD provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs.
  • These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.

Diverse Biotech Announces New Patent Approval for Its PEMBROLIZUMAB Antibody Drug DBT-50201

Retrieved on: 
Wednesday, August 30, 2023

Diverse Biotech has been granted USPTO patent approval of its novel CUSP synthesis platform creating an entirely new class of drugs that are part-antibody and part-cannabinoid in one new molecule.

Key Points: 
  • Diverse Biotech has been granted USPTO patent approval of its novel CUSP synthesis platform creating an entirely new class of drugs that are part-antibody and part-cannabinoid in one new molecule.
  • Starting with DBT-50201, its novel PEMBROLIZUMAB compound, Diverse expects to develop multiple treatments for many diseases with highly unmet needs.
  • According to John Patrick, M.D., Executive Vice President and Chief Medical Officer for Diverse Biotech, “We are very excited about being granted our first patent for our monoclonal antibody class of drugs with our flagship drug DBT-50201 which represents a significant advancement for PEMBROLIZUMAB.
  • Coupled with other potential decreases in toxicity, these results represent a major step forward in the treatment and cure of multiple cancers.”
    About Diverse Biotech: Diverse Biotech Inc .

Fulcrum Therapeutics Signs Exclusive Global License Agreement in Rare Hematology

Retrieved on: 
Monday, July 10, 2023

DBA is a congenital, rare blood disorder that affects an estimated 5,000 individuals worldwide.

Key Points: 
  • DBA is a congenital, rare blood disorder that affects an estimated 5,000 individuals worldwide.
  • DBA is caused by genetic mutations in ribosomal subunits that halt red blood cell maturation and lead to anemia.
  • Fulcrum will assume sole responsibility for research, development, manufacturing and commercialization costs and activities, and will pay tiered royalties on future commercial sales.
  • “By uniting our scientific insights with Fulcrum’s deep expertise in hematology and small molecule development, this agreement will help accelerate the discovery and delivery of ground-breaking therapies for this underserved community.”

Cartesian Therapeutics Announces Landmark Study in The Lancet Neurology of First Successful Clinical Trial of RNA Cell Therapy in Autoimmunity

Retrieved on: 
Thursday, June 22, 2023

Cartesian Therapeutics , a clinical-stage biotechnology company pioneering cell therapies for autoimmune diseases, announced today the publication of a landmark paper in The Lancet Neurology.

Key Points: 
  • Cartesian Therapeutics , a clinical-stage biotechnology company pioneering cell therapies for autoimmune diseases, announced today the publication of a landmark paper in The Lancet Neurology.
  • The study describes Descartes-08, a cutting-edge RNA CAR-T (rCAR-T) therapy administered to patients with generalized myasthenia gravis (MG), a debilitating autoimmune neurological disease.
  • This is the first clinical trial using rCAR-T to treat autoimmunity, and the first successful Phase 2 trial using an engineered cell therapy to treat autoimmunity.
  • Clinical benefit was sustained long-term for most patients, even months after completing the course of therapy.

VA Oklahoma City Healthcare System Chooses ViewRay's MRIdian® MRI-Guided Radiation Therapy System

Retrieved on: 
Tuesday, June 13, 2023

DENVER, June 13, 2023 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY) announced today that the VA Oklahoma City Healthcare System has selected MRIdian MRI-guided radiation therapy system to expand radiation therapy services at the Oklahoma City VA Medical Center. This will be the first cancer center in Oklahoma and the fourth VA medical center offering Veterans access to MRIdian's advanced MRI-guided radiation therapy to treat cancer. The MRIdian system will enable the Oklahoma City VA Medical Center to provide precision MRI-guided radiation therapy technology to Veterans seeking personalized treatment for a broad range of cancer, including pancreas, prostate, lung, liver, breast, and oligometastatic disease. Other VA medical centers that will be offering MRIdian MRI-guided radiation therapy include Louis Stokes Cleveland Medical Center (VA Northeast Ohio Healthcare System), Lt. Colonel Charles S. Kettles VA Medical Center (VA Ann Arbor Healthcare System), and Michael E. DeBakey Medical Center (VA Houston Healthcare system).

Key Points: 
  • DENVER, June 13, 2023 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY) announced today that the VA Oklahoma City Healthcare System has selected MRIdian MRI-guided radiation therapy system to expand radiation therapy services at the Oklahoma City VA Medical Center.
  • The MRIdian system will enable the Oklahoma City VA Medical Center to provide precision MRI-guided radiation therapy technology to Veterans seeking personalized treatment for a broad range of cancer, including pancreas, prostate, lung, liver, breast, and oligometastatic disease.
  • Other VA medical centers that will be offering MRIdian MRI-guided radiation therapy include Louis Stokes Cleveland Medical Center (VA Northeast Ohio Healthcare System), Lt.
  • Colonel Charles S. Kettles VA Medical Center (VA Ann Arbor Healthcare System), and Michael E. DeBakey Medical Center (VA Houston Healthcare system).

Servier Presents Transformational Data from Pivotal Phase 3 INDIGO Trial of Vorasidenib in Recurrent or Residual Grade 2 IDH-Mutant Diffuse Glioma

Retrieved on: 
Sunday, June 4, 2023

BOSTON, June 4, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing innovative therapies to the patients we serve, today presented results from the pivotal Phase 3 INDIGO clinical trial investigating vorasidenib, an investigational, oral, selective, highly brain-penetrant dual inhibitor of mutant IDH1/2 enzymes in patients with residual or recurrent isocitrate dehydrogenase 1 or 2 (IDH1/2) mutant low-grade glioma who have been treated with surgery only. INDIGO succeeded in meeting its primary endpoint of progression free survival (PFS) per blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis. The data were presented as a late breaking abstract during the plenary session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), and simultaneously published in the New England Journal of Medicine.

Key Points: 
  • We look forward to working with the FDA on its review of vorasidenib as a potential therapy in IDH-mutant diffuse glioma."
  • INDIGO is a registration-enabling Phase 3 global, randomized, double-blinded placebo-controlled study of vorasidenib in patients with residual or recurrent grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation who have undergone surgery as their only treatment.
  • Of the 331 patients, 172 had oligodendroglioma (88 vorasidenib; 84 placebo) and 159 patients had astrocytoma (80 vorasidenib; 79 placebo).
  • Servier is working to determine timelines for submission of a New Drug Application (NDA) for vorasidenib to the FDA.

ViewRay's MRIdian® to be Featured at Leading European Radiation Oncology Meeting

Retrieved on: 
Friday, May 12, 2023

DENVER, May 12, 2023 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY) announced today that the company's MRIdian MRI-guided radiation therapy system will be featured at the Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO) with over 50 presentations and posters highlighting MRIdian clinical and research experience. This year's ESTRO meeting will be held May 12-16, 2023, in Vienna, Austria.

Key Points: 
  • This year's ESTRO meeting will be held May 12-16, 2023, in Vienna, Austria.
  • ViewRay will host a lunch symposium on Saturday, May 13, from 13:00 – 14:00 CEST at the Messe Congress Center, Lehar 1-2-3 titled, "MRIdian A3i™*: Transforming MR-guided Radiation Therapy."
  • MRIdian A3i* introduces the 4th generation of real-time tissue tracking with automatic beam gating, now with multiplanar tracking and gating.
  • Radiation treatments may cause side effects that can vary depending on the part of the body being treated.

Reviva Pharmaceuticals Announces Intent to File an IND for Brilaroxazine in Psoriasis After Promising Preclinical Data

Retrieved on: 
Thursday, May 11, 2023

CUPERTINO, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), respiratory and metabolic diseases, has presented promising preclinical data on the potential of novel serotonin-dopamine stabilizer brilaroxazine for the treatment of psoriasis at the First International Societies for Investigative Dermatology (ISID) Meeting in Tokyo, Japan, May 10-13, 2023. The ISID poster is available at revivapharma.com/publications.

Key Points: 
  • “We were excited to present encouraging preclinical data at ISID 2023 highlighting the therapeutic potential of brilaroxazine lipogel, a novel, proprietary lipogel formulation for the topical treatment of psoriasis.
  • We have filed a composition of matter patent for brilaroxazine-lipogel and a separate patent for its use in psoriasis.
  • Brilaroxazine (RP5063) is a modulator of D and 5-HT receptors with multifaceted activity that may affect underlying psoriasis pathology.
  • Preclinical studies in the imiquimod-induced psoriatic mouse model (BALB/c) were used to evaluate the potential of topical liposomal-gel formulation of brilaroxazine for the treatment of psoriasis.