Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
World’s first lung cancer vaccine enters clinical trials
In a world-first, Cancer Research UK is backing a clinical trial of an experimental vaccine designed to prevent lung cancer in people at high risk. The vaccine, called LungVax, was developed by researchers at the University of Oxford and University College London and uses similar technology to the Oxford/AstraZeneca COVID-19 vaccine to train the immune system to spot and destroy abnormal lung cells before they can turn cancerous. Lung cancer is the leading cause of cancer-related deaths worldwide, responsible for one in five cancer deaths. With funding of up to £2.06 million, supported by the CRIS Cancer Foundation, scientists will launch a four-year Phase 1 trial in 2026 to test dosing and safety in people who have already been treated for early-stage lung cancer or identified as high risk through National Health Service screening programs. “LungVax is our chance to actively prevent this disease,” said Sarah Blagden, an oncologist at the University of Oxford and cofounder of the LungVax project, in the news release. – Bree Foster
FDA approves first siRNA therapy for rare FCS patients
Arrowhead Pharmaceuticals has received FDA approval for Redemplo (plozasiran), a therapy for adults with familial chylomicronemia syndrome (FCS), a rare genetic condition that causes dangerously high triglyceride levels and increases the risk of acute pancreatitis. Redemplo, the first and only FDA-approved siRNA treatment for people living with FCS, works by targeting the liver protein apoC-III (apolipoprotein C-III) to lower triglycerides. The approval follows positive results from the Phase 3 PALISADE trial, where patients receiving Redemplo experienced a median 80 percent reduction in triglycerides compared with 17 percent in the placebo group, alongside a lower incidence of pancreatitis. The therapy, which can be self administered via injection once every three months, marks Arrowhead’s first FDA-approved medicine and represents a milestone for the company’s proprietary TRiM platform. In the press release, Lindsey Sutton, copresident of the FCS Foundation, called the approval “a pivotal moment” for patients, offering new hope for a disease that has long been overlooked and misunderstood. Redemplo is expected to be available in the US by the end of the year. – Bree Foster
Moderna secures $1.5B credit line as revenue slump pressures pipeline plans
Moderna has secured a five-year, $1.5 billion credit facility from Ares Management to strengthen its balance sheet and give the company more financial flexibility as it advances its mRNA pipeline. The non-dilutive loan is structured across three tranches, including an initial $600 million term loan and two delayed-draw facilities — one for $400 million available through 2027 and another for $500 million tied to future regulatory milestones through 2028. The move comes amid a sharp decline in revenue following the pandemic-era rush for its COVID-19 vaccine, which has forced Moderna to scale back costs, cut jobs, and face investor concerns about cash burn and the need for more capital. Analysts have flagged the company’s net losses and shrinking cash reserves as warning signs. The company reiterated the financial outlook it shared on its Q3 earnings call, including a target to reach cash breakeven by 2028, saying the new financing offers added room to maneuver without changing its near-term plans. – Andrea Corona
Scientists create fully synthetic brain tissue model for animal-free drug testing
Scientists at the University of California, Riverside have engineered what they describe as the first fully synthetic, animal-free brain tissue model — a porous polyethylene glycol-based scaffold that supports donor-derived brain cells without relying on biological coatings. The material, detailed in Advanced Functional Materials, enables neurons to organize into functional networks and could provide a more controlled alternative to animal brains for studying traumatic injuries, neurodegenerative diseases, and drug responses. The work aligns with ongoing efforts to reduce animal use in preclinical research and comes as thousands of researchers gathered at the Society for Neuroscience (SfN) meeting this week, where more reliable human-relevant models remain a major focus across sessions and exhibitor discussions. – Andrea Corona
Johnson & Johnson acquires Halda Therapeutics for $3.05B
On Monday, Johnson & Johnson announced their acquisition of Connecticut-based biotech Halda Therapeutics. Key to the deal is Halda’s regulated induced proximity targeting chimera (RIPTAC) platform, which is designed to force an interaction between two proteins to selectively kill cancer cells, even in tumors that have developed resistance to standard treatments. The company plans to use the platform to design oral targeted therapies for solid tumors like prostate cancer. The $3.05 billion deal also includes Halda’s lead candidate, HLD-0915, an oral RIPTAC drug. In October, Halda released results of the drug’s first-in-human results, reporting a favorable safety profile and anti-tumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC). “Many therapies lose effectiveness over time due to resistance. Halda’s innovative technology is designed to work even when cancers no longer respond to standard treatments using a novel mechanism that enables the selective killing of cancer cells,” said John C. Reed, Executive Vice President, Innovative Medicine, R&D at Johnson & Johnson in the press release. – Allison Whitten
Roche trial shows positive results for early-stage breast cancer drug
In a Phase 3 trial, Roche’s oral drug, giredestrant, was shown to significantly improve disease-free survival compared to standard-of-care endocrine therapy in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer at the early stages. Roche said in the press release that the new data makes giredestrant the first selective estrogen receptor degrader (SERD) to show success in the adjuvant setting. The results also mark the second successful readout for the drug, as Roche recently announced positive results for giredestrant when combined with everolimus, an mTOR (mammalian target of rapamycin) inhibitor, in patients with ER-positive advanced breast cancer. “Today’s results underscore the potential of giredestrant as a new endocrine therapy of choice for people with early-stage breast cancer, where there is a chance for cure,” said Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, in the release. – Allison Whitten
