Novartis AG’s radioligand therapy, Pluvicto, a bestseller for the company that has been restructuring itself, continues to show strong growth in the third quarter of 2023, according to its most recent financial results. Sales were up 217% from the same quarter in 2022. Adding to the momentum was new data from the phase III PSMAfore study of Pluvicto, which hit its primary endpoint of radiographic progression-free survival (rPFS) in treating prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen receptor pathway inhibitor therapy. Also, the data showed Pluvicto more than doubled the median rPFS, to 12 months, in study patients. The company said it continues to collect overall survival data from the study, with a regulatory filing expected now in 2024 instead of this year. The radioligand therapy was approved in March 2022 for treating PSMA-positive mCRPC for patients already treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
ESMO: Immutep’s LAG-3 immunotherapy shows 35.5 months overall in NSCLC
Immutep Ltd.’s lead candidate, eftilagimod (IMP-321, efti), a lymphocyte activation gene-3 (LAG-3) fusion protein and major histocompatibility complex class II agonist, delivered an overall survival benefit of 35.5 months in the TACTI-002 trial that combined efti with Merck & Co. Inc.’s Keytruda (pembrolizumab) as first-line treatment of non-small-cell lung cancer at two years follow-up. For comparison, Immutep added 12 months of survival compared to historical data from the current best option of pembrolizumab combined with doublet chemotherapy.
$85M series A fuels Rampart’s efforts in DNA-based drugs
Rampart Bioscience Inc. pulled down $85 million in a series A financing for work on DNA-based medicines. The La Jolla, Calif.-based firm’s platform called Halo is designed to produce potent, durable, and redosable therapies, Rampart said. Leading the pipeline is a program for hypophosphatasia, a rare, often fatal genetic disease that prevents bone mineralization.
Newco news: Aiolos’ $245M series A advances asthma drug with twice-a-year dosing
With one of the higher series A rounds for 2023, the newly launched Aiolos Bio Inc. pulled in $245 million to advance its lead product, AIO-001, an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody set to enter a phase II trial for moderate to severe asthma. It is the third largest series A financing this year, only topped by two Cambridge, Mass.-based companies, Renagade Therapeutics Inc., which raised $300 million in May, and Orbital Therapeutics Inc., which raised $270 million in April. San Francisco and London-based Aiolos gained global exclusive development and commercialization rights, outside of greater China, from Jiangsu Hengrui Pharmaceuticals Co. Ltd. two months ago. The TSLP antibody has a differentiated potency and long half-life, allowing it to be dosed every six months.
Biosimilar maker breaks new ground in lifecycle approach
The time was when innovators took a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when competition was on the horizon. Now a biosimilar maker, Celltrion USA, is traveling that route, scoring the first U.S. FDA approval of a subcutaneous formulation of its infliximab biosimilar for a new indication. Celltrion’s Zymfentra was approved this week on the 351(a) BLA path for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following treatment with an infliximab product administered intravenously. Celltrion’s Inflectra was approved in 2016 as a biosimilar to Johnson & Johnson’s Remicade (infliximab) and licensed to Pfizer Inc.)
Sanders decries NIH’s ‘become-a-billionaire program’
U.S. Sen. Bernie Sanders (I-Vt.) is calling for an investigation into the NIH’s proposed grant of an exclusive patent license for a late-stage cervical cancer drug to a small company linked to a former NIH researcher. Characterizing the proposal as part of NIH’s “how-to-become-a-billionaire program,” Sanders said there is no justification for “granting a monopoly for a treatment that was invented, manufactured and tested by the NIH, is already in late-stage trials and could potentially enrich a former NIH employee who was one of the major government researchers of this treatment.”