Cancer

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

The US precision medicine company hopes its drug response predictor technology will enhance responses to the chemotherapy Ixempra on the basis of promising data from a handful of breast cancer patients in a Phase II trial, marking a positive turn in its journey to date.  

Tumor infiltrating lymphocyte therapies show promise for solid tumors, with a first FDA approval, but face manufacturing and access challenges as development continues.

The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

Ordspono, a bispecific antibody newly approved in the EU to treat follicular lymphoma and diffuse large B-cell lymphoma, joins Libtayo in Regeneron’s growing oncology portfolio.

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

Attendees at this year's European Society for Medical Oncology meeting in Barcelona can look forward to a range of interesting datasets, from Phase III trials of established products in new settings to preliminary studies of novel products coming through the pipeline.  

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

Francesco Hofmann, head of R&D at the mid-sized French group, tells Scrip that its strategy of not playing in the spaces that are dominated by big pharma is paying off.

Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.

The German group is spinning off from Eckert & Ziegler and listing in Frankfurt, though a leap to the NASDAQ will likely follow once it has more data on a lymphoma theranostic.

J&J acquired Taris in 2019 to gain access to TAR-200 and its drug delivery platform. Now, early clinical data suggest the product could delay or remove the need for cystectomy in several bladder cancer settings and the US healthcare giant is eyeing multi-blockbuster sales.    

Recent ODACs suggest FDA is moving towards focusing not just on applications with pending approval decisions but on refining trials designs and drug labels for their competitors as well.

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

The Barcelona meeting saw early data from two candidates from Incyte and Pfizer which suggest some progress for a new drug mechanism that has so far underwhelmed.    

New Phase II data for the bispecific antibody show promise in colorectal cancer as the company seeks to spread the bispecific antibody’s wings. Phase III trials are on the horizon, where it will need to go up against standard of care.    

AstraZeneca’s NIAGARA trial of perioperative Imfinzi in bladder cancer was positively received at the ESMO meeting but its design did not distinguish the contributions of each treatment portion to the overall effect – something that the US FDA is likely to have a view on.    

Persistence has paid off for Incyte’s Zynyz in anal cancer with a Phase III win that should make up for a previous disappointment at the FDA and give a boost to the firm’s pipeline prospects for a post-Jakafi era.    

The second instalment of In Vivo’s three-part series delves into the therapeutic categories that will propel forecast pharmaceutical sales growth for 2025, focusing on blood malignancies, skin conditions and generalized cardiovascular disease.