biotechnology55.815 min read
Oral microbial metabolite prodrug reprograms T cells to boost cancer immunotherapy
14 days ago•Source: Nature
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48.975 min•1 month ago
AI-Designed Universal Vaccine Enters Human Trials with Early Safety Signals
Researchers at the University of Cambridge used AI to identify stable features across the sarbecovirus family and developed a DNA vaccine intended as a broad-spectrum, potentially universal shot. In the first human trial, the vaccine was safe and elicited antibodies recognizing diverse sarbecoviruses, and its needle-free delivery and stability could aid distribution. However, immune responses were modest, and duration of protection, optimal dosing, and real-world efficacy require larger trials; the goal of a universal vaccine remains years away.
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MethylScan: A Low-Cost Blood Test for Early, Multi-Disease Detection
SciTechDaily•4 months ago
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FDA Rejects Replimune’s Engineered Virus for Melanoma Again, Sparking Regulatory Debate
statnews.com•4 months ago
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Lab-grown esophagus in pigs restores swallowing, signaling pediatric repair prospects
Scientists grew lab-made oesophagi from pig stem cells on scaffolds and implanted them into eight recipient pigs. Over two months the grafts developed into functional tissue with nerves, muscle, and blood vessels, and five pigs survived six months, regaining the ability to swallow. While some initial scar tissue affected swallowing, it diminished over time, suggesting a path toward treating conditions like long-gap oesophageal atresia in children or muscular damage in adults, though human trials are still future work.
Moderna Roivant patent deal caps biotech patent fight at $2.25B
Moderna will pay Roivant up to $2.25 billion to settle patent infringement claims over its Covid-19 vaccine, while The Readout highlights Prime Medicine’s gene-therapy work and FDA warnings to telehealth firms over compounded GLP-1s.
Lab-grown liver assembloids edge toward miniaturized human livers
Researchers combine multiple donor liver cell types to form in vitro liver assembloids that recapitulate periportal tissue, moving toward miniature human livers for faster drug testing and personalized therapies.
ImmunityBio Pursues FDA Path to Resubmission for ANKTIVA in Papillary NMIBC
ImmunityBio announced a productive Type B End‑of‑Phase meeting with the FDA regarding its supplemental Biologics License Application for ANKTIVA plus BCG in BCG‑unresponsive papillary NMIBC. The FDA asked for additional information (not new trials) to support a potential resubmission, which ImmunityBio will provide within 30 days. Long‑term QUILT‑3.032 data in 80 patients show about 96% bladder cancer‑specific survival at 36 months and high cystectomy‑free survival (roughly 82–93% at 12–36 months), underscoring a bladder‐sparing, chemo‑free approach. ANKTIVA is already approved for CIS in the US, UK, and Saudi Arabia, with EU conditional status for CIS and ongoing EMA discussions to extend labeling to papillary disease if US approval is achieved.
Biotech Stocks Drop Sharply After Disappointing Bone Disease Drug Trials
Shares of Ultragenyx and Mereo BioPharma plummeted after their Phase 3 trial for the brittle-bone disease treatment setrusumab failed to meet primary endpoints, despite secondary improvements in bone density, leading to significant market value losses and cautious outlooks from analysts.
Rocket Pharmaceuticals' Gene Therapy Trial for Danon Disease Faces FDA Hold After Patient Death
Rocket Pharmaceuticals announced an update on its Phase 2 trial of RP-A501 for Danon disease after a patient experienced a serious adverse event and subsequently passed away, leading to a clinical hold by the FDA. The company is investigating the cause, working with regulators and stakeholders, and has paused dosing to ensure patient safety. The trial aims to evaluate the efficacy of RP-A501, a gene therapy targeting cardiac function in Danon disease, with ongoing efforts to resume the study.
Arrakis CEO Discusses Challenges in Developing RNA-Targeting Cancer Drugs
Arrakis, a biotech startup led by Michael Gilman, is tackling the challenge of targeting the Myc oncogene, which is implicated in 70% of cancers and is difficult to target due to its "intrinsically disordered" protein structure. Instead of targeting the protein directly, Arrakis aims to intercept the mRNA responsible for its production, a novel approach in drug development.
Radiopharmaceutical Growth Stalled by Talent Shortage
The rise of radiopharmaceuticals, a new cancer treatment that targets cancer cells with radioactive isotopes, is facing a significant talent shortage. This innovative approach has attracted numerous biotech startups and substantial investments, with several companies being acquired for over $1 billion. However, the industry's growth is threatened by a lack of skilled professionals needed to develop and implement these therapies.
Summit Therapeutics' Stock Skyrockets After Cancer Drug Outperforms Keytruda in Phase 3 Trial
Summit Therapeutics' stock surged after the company announced that its cancer drug outperformed Keytruda in a Phase 3 trial, just ahead of a major cancer conference in Chicago.
Intellia Withdraws from Hemophilia Collaboration with Regeneron
Intellia has exited a partnership with Regeneron to develop a factor IX gene editing therapy for hemophilia B, opting out of a deal that was signed in 2020. Despite this, Intellia remains eligible for up to $320 million in future milestones and still holds a 35% stake in a factor XIII insertion program for hemophilia A.