Shares of Sana Biotechnology Inc. (NASDAQ: SANA) were trading at $4.97, up $3.32, or 201%, on first results from an investigator-sponsored, first-in-human study transplanting UP-421, an allogeneic primary islet cell therapy engineered with the firm’s hypoimmune (HIP) technology, into a patient with type 1 diabetes without immunosuppression. The study was conducted in partnership with Uppsala University Hospital, and results at four weeks after cell transplant show the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker that indicates the transplanted beta cells are making insulin. C-peptide levels also increase with a mixed meal tolerance test, consistent with insulin secretion in response to a meal. MRI scanning also turned up a sustained signal at the site of transplanted cells over time, consistent with graft survival. No safety issues manifested, Seattle-based Sana noted, and the HIP-modified islet cells evaded immune responses. The findings pave the way for development of SC-451, Sana’s HIP-modified, stem cell-derived pancreatic islet cell program.

Early data validate Vir’s newly acquired dual-masked TCE therapies

Vir Biotechnology Inc.’s 2024 deal with Sanofi SA is starting to look like a pretty savvy move. The company, which picked up three clinical-stage dual-masked T-cell engagers (TCEs) and rights to the platform technology as part of a pipeline overhaul, reported phase I data for TCE programs targeting HER2 and PSMA, which showed promising efficacy with a low prevalence of side effects that have hampered other TCE programs. Though still early stage, the results signal a potentially lucrative path forward as Vir advances work on broader TCE efforts. The news also gained attention from Wall Street, as company shares (NASDAQ:VIR) were trading up 72% at midday.

Amid booming market, US FDA advises on obesity drug development

With obesity drugs taking the U.S. and global markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance yesterday to help sponsors develop drugs and biologics for weight reduction and long-term maintenance of body weight. The last time the agency issued a guidance on the subject was 2007 – eight years before the FDA approved the first glucagon-like peptide 1 receptor agonist as an obesity drug. That guidance was never finalized. Whether the new guidance, as well as all the other draft guidances the FDA has rolled out over the past few days, is finalized in a timely manner will depend on the incoming administration.

Jasper posts positive early data as stock drops

Despite positive preliminary data from its early stage study of treating hives, Jasper Therapeutics Inc. saw its stock drop dramatically at midday. Results from the ongoing phase Ib/IIa study of antibody therapy and lead candidate briquilimab in treating chronic spontaneous urticaria, often referred to as hives, showed clinical responses across several of the dosing cohorts. The treatment also displayed a favorable safety profile. The company’s stock (NASDAQ:JSPR) was down 56% at midday, in a drop that one analyst called overdone in the face of evidence efficacy and tolerable safety.

Araris signs $780M deal with Chugai for multi-warhead ADCs

The wheels of the antibody-drug conjugate (ADC) juggernaut keep on turning, with Araris Biotech AG announcing a deal with a headline value of $780 million to apply its multi-payload linker technology to generate novel ADCs for Chugai Pharmaceutical Co. Ltd. Other than the headline figure, few terms were disclosed, with no details of the targets, up-front payment, or timescale of the research collaboration and licensing option agreement. However, the deal is a testimony to Araris’ ability to attach any drug to a specific site at glutamine residue 295 on any native antibody, without the need for any engineering, and in a way that does not affect the pharmacokinetics or effector functions of the antibody. The peptide linkers allow more than one drug payload to be attached at the same site, and because glutamine residue 295 is occluded, payloads are not vulnerable to enzymatic detachment outside a cell, limiting cleavage before the ADC is internalized in the tumor.

Yuhan, Oscotec stock gains as J&J hits ‘gold standard’ in NSCLC

Yuhan Corp., Oscotec Inc. and Genosco Inc. were three companies with Asian ties to reap benefit from Johnson & Johnson’s stellar top-line Mariposa study results, wherein J&J’s Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) combo regimen beat out Astrazeneca plc’s standard of care in non-small-cell lung cancer (NSCLC). Announced Jan. 7, J&J reported that Rybrevant plus Lazcluze met the final prespecified secondary endpoint of overall survival (OS), the “gold standard endpoint” in cancer treatment, and demonstrated clinically meaningful and statistically significant improvement in OS versus the current standard of care, Tagrisso (osimertinib). Lazertinib is being touted as the first Korea-made cancer drug to win FDA approval after being licensed out to a multinational pharmaceutical company. Yuhan first gained rights to lazertinib from Genosco, which is an R&D spinoff of South Korea’s Oscotec.

Wuxi Bio licenses trispecific T-cell engager to Candid for $925M

Wuxi Biologics Co. Ltd. is licensing a preclinical trispecific T-cell engager to Candid Therapeutics Inc. in a deal worth up to $925 million plus royalties. Under the terms, San Diego-based Candid gains exclusive global rights to the trispecific T-cell engager discovered via Wuxi’s Wuxibody antibody platform. In exchange, Shanghai-headquartered Wuxi is eligible to receive an up-front payment, and development and sales milestones totaling up to $925 million plus royalties. 

New AI-based models better than humans at diagnosing ovarian cancer

Artificial intelligence (AI)-based models developed by a team of international researchers were able to identify ovarian cancer in ultrasound images more accurately than humans. Results from a study published in Nature Medicine showed that the AI models achieved an accuracy rate of 86.3%, compared to 82.6% for the experts and 77.7% for the non-expert examiners. “This suggests that neural network models can offer valuable support in the diagnosis of ovarian cancer, especially in difficult-to-diagnose cases and in settings where there’s a shortage of ultrasound experts,” said Elisabeth Epstein, a professor at the Department of Clinical Science and Education, Södersjukhuset (Stockholm South General Hospital), at Karolinska Institutet and senior consultant at the hospital’s Department of Obstetrics and Gynecology.

Drugs to Watch 2025: 11 potential blockbusters in the making

The 2025 edition of Clarivate’s Drugs to Watch features 11 candidates or approved therapeutics, including two vaccines and several cancer treatments, that may well become blockbusters. Radiopharmaceuticals for precision cancer treatment also are among the picks as are obesity medications. The 12^th-annual report has a strong track record. Twelve of the 13 drugs from the 2024 Drugs to Watch report have been approved and launched. The report features recently launched drugs or those poised for approval that have the potential to become therapeutics or those likely to rise to $1 billion in annual sales, boosting them to blockbuster status in the next five years.

2024 BioWorld Year in Review

BioWorld’s staff recaps the therapeutic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as biopharma forges ahead in 2025.

2024 BioWorld MedTech Year in Review

BioWorld MedTech’s staff recaps the med-tech and diagnostic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as med tech forges ahead in 2025.

2024 BioWorld Science Year in Review

Taking a look back at the achievements in research this year, including brain maps, pandemic breakthroughs and advances in pregnancy health.

Also in the news

4SC, Acellera, Acelyrin, Achieve, Actio, Aeon, Aicuris, Alebund, Alivegen, Alltrna, Antag, Argobio, Aviceda, Avidity, Brainchild, Calico, Candid, Capsida, Cardurion, Centessa, Commit, Corrixr, Esphera, Eyepoint, Denali, Dizal, Gain, Generation, Glycotope, GSK, Hoth, Hummingbird, Imbrium, Immuneering, Immunome, Interius, Inverna, Johnson & Johnson, Kailera, Kuros, MBX, Medtronic, Merck, Metsera, Mitocarex, Neuraxpharm, Noema, Novo Nordisk, Odyssey, Orion, Pentixapharm, Pepticom, Pharmaessentia, Quris-Ai, Raphael, Restem, Rycarma, Scisparc, Sionna, Stoke, Tarsier, Trisalus, Unnatural Products, Variant, Vergent, Vor, Wuxi, Xylocor