Friend-Shoring Trend Trickles to Biopharma Manufacturing

The rationale behind site decisions is nuanced and varies by product. For example, recombinant microbial fermentation is driving most of the U.S. capacity growth. One company not headquartered in the U.S. said it is looking to diversify/de-risk its manufacturing options by having a U.S.-based site. The U.S. growth rate is expected to grow 6.4% between 2022 and 2027 (up from 2% between 2017 and 2022).

Growing Cells in Hydrogels

Hydrogels can be used to grow a range of cell types, including a variety of immune system cells. In a human-derived hydrogel, cells receive signals that are similar to what they experience inside the body. Hydrogels also might find applications in early development of therapies through large-scale manufacturing. In addition, hydrogels could be used as promising approach in clinical trials as a patient-stratification mechanism.

New Techniques for Predicting Antibody Stability During Storage

When native antibodies unfold, the aggregation-prone parts of the protein are exposed and can form aggregates. These aggregates can increase the risk of immune reactions in patients or, if they become large enough to form visible particles, they can lead to the drug batch being discarded. One research team has developed new methods for predicting the aggregation of antibodies during storage in a faster manner.

First-In-Class Immune Checkpoint Therapy Unlocks NK Cell Attack on Tumors

Scientists at Albert Einstein College of Medicine developed a first-in-class monoclonal antibody-based immunotherapy that blocks an immune checkpoint receptor, KIR2DL5, on NK cells, which PVR cancer proteins use to suppress immune attack. The researchers’ studies in mouse models of human cancers confirmed that blocking KIR2DL5 reduced tumor growth and improved survival. The team believes the novel immunotherapy “has great potential to move into clinical trials involving various types of cancer.”

Stress Test: ProJenX’s Oral Drug Shows Early Promise vs. ALS

During a platform presentation at the recent 21st Annual Meeting of the Northeast ALS Consortium, as well as in an abstract published in Muscle & Nerve, the researchers reported no moderate or severe adverse events, and identified no abnormalities or general trends in any safety assessments in patients given four dose levels of prosetin, from 0.03 to 0.24 mg/kg. Plasma levels of prosetin increased in a predictable manner.

BioNTech Acquires mRNA Manufacturing Facility in Singapore

BioNTech says its Singapore mRNA manufacturing facility will create regional manufacturing capacities to support BioNTech’s pipeline of mRNA-based vaccines and therapeutics across Asia the Pacific region for both commercial and clinical scale, with the potential to expand the production to other drug classes. The facility will be initially equipped to manufacture a range of mRNA-based products and authorized vaccines and therapeutics for infectious diseases.

Somatic Cell Copy Number Changes in HNSC Cancer Predict Immunotherapy Response

A study led by researchers at NYU Grossman School of Medicine and UC San Diego Moores Cancer Center found that patients with HPV-negative head and neck squamous-cell cancers who exhibited an increased somatic dosage of 9p24.1 in their cancer cells lived for 30 months on average after anti-PD-1 checkpoint inhibitor immunotherapy, while those with a lower 9p24.1 dosage survived for 11 months on average. The claim their findings reveal 9p24.1 as “a genetically defined axis that promises to determine for the first time whether HNSC patients will do well or poorly on a checkpoint inhibitor.”

From Good to Great: Bonum Therapeutics Raises $93M Series A with...

Bonum Therapeutics, a biopharmaceutical startup that uses allosteric control to develop conditionally active and less toxic medications, has announced a $93-million Series A funding round. Bonum spun off from Good Therapeutics, which was acquired by Roche in August 2022 for a $250-million upfront payment with future milestone payments. In addition to the internal efforts on immuno-oncology and cytokines, Bonum is interested in collaborations with other companies.

COVID-19 and Cancer May Have Common Drug Target in GRP78

The chaperone protein GRP78 is known to play an essential role in the spread of SARS-CoV-2. Now, a new study suggests that blocking the production of GRP78, or inhibiting its activity with a new targeted drug, greatly reduced the replication of SARS-CoV-2. This suggests that this drug could potentially offer a new type of protection against COVID-19, one that might remain effective even as new strains develop.

Melanoma Maneuvers Mortality by Maintaining Telomeres

Melanoma cells avoid normal cellular aging and death by acquiring mutations that activate expressions of telomerase and a peptidase called tripeptidyl peptidase 1 (TPP1). Mutations in TPP1 and telomerase synergistically lengthen the protective caps at chromosomal ends (telomeres), preventing the normal process of replicative senescence which allows cells to age with every cycle of replication and eventually die due to shortened telomeres. The discovery increases our understanding of immortalization strategies in cancer and has the potential to improve treatments.