Hedge funds cut NFLX, keep big bets on MSFT, AMZN, add NVDA
DALLAS - The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for Starlight Therapeutics to evaluate STAR-001 in combination with spironolactone for patients with glioblastoma multiforme (GBM) at first progression, according to a press release statement.
Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. (NASDAQ:LTRN), plans to conduct a Phase Ib/2a clinical trial to investigate the safety, tolerability, and preliminary efficacy of this combination therapy for recurrent GBM, which represents approximately 15% of all brain tumors.
GBM is one of the most aggressive forms of brain cancer, with a median survival of approximately 12 months from initial diagnosis and fewer than 5% of patients surviving beyond five years.
STAR-001, also referred to as LP-184 when focused on other solid tumor indications, is described as a synthetically lethal, brain-penetrant DNA-damaging agent. The drug has previously received both FDA Orphan Drug Designation and Fast Track Designation for GBM.
The combination approach pairs STAR-001 with spironolactone, an FDA-approved drug that reportedly enhances STAR-001’s therapeutic effect by inducing degradation of ERCC3, a protein involved in nucleotide excision repair.
A separate Phase 1a trial to determine safety, dosing, and tolerability of STAR-001 across various solid tumors is currently underway and expected to complete enrollment in the current quarter.
Starlight is targeting commencement of the Phase Ib/2a trial in late 2025 or early 2026, subject to additional funding.
The company states that GBM represents an annual market opportunity of $3 to $5 billion globally, with case numbers accelerating worldwide.
Starlight Therapeutics leverages Lantern Pharma’s artificial intelligence drug development platform, RADR, to identify and advance therapeutic combinations for patients with brain and central nervous system cancers.
In other recent news, Lantern Pharma Inc. has completed patient enrollment for its Phase 2 HARMONIC clinical trial in Japan ahead of schedule. The trial focuses on evaluating LP-300 in combination with standard chemotherapy for non-small cell lung cancer patients who have not smoked and have progressed after treatment with tyrosine kinase inhibitors. Additionally, Lantern Pharma reported a significant development in its ongoing Phase 1 clinical trial for the drug LP-284, where a patient with aggressive lymphoma achieved a complete metabolic response after two treatment cycles. The company has also launched a new artificial intelligence module within its RADR platform, aiming to predict the efficacy of cancer treatment combinations involving DNA-damaging agents and DNA repair inhibitors. In corporate developments, Lantern Pharma appointed Lee T. Schalop, M.D., to its board of directors. Dr. Schalop brings over two decades of experience in biotechnology and financial markets, having co-founded Oncoceutics, Inc., which was acquired by Chimerix Inc. in 2021. These recent developments highlight Lantern Pharma’s ongoing efforts in clinical trials and strategic leadership appointments.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.