A year and a half gone, two HIV vaccine studies shut down. That’s the case at the Janssen Pharmaceutical Companies of Johnson and Johnson as the phase III Mosaico study of the company’s HIV vaccine regimen was not effective in preventing infection compared to placebo. Based on a data and safety monitoring board’s report, Janssen discontinued the study. The regimen comprised a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four visits over one year, with a mix of soluble proteins (Clade C/Mosaic gp140, adjuvanted with aluminum phosphate) administered at visits three and four. In August 2021, Janssen’s placebo-controlled Imbokodo study enrolled 2,637 young women in five sub-Saharan Africa countries was stopped because the vaccine, similar to that used in the Mosaico study, provided insufficient protection.

US GAO: HHS needs to improve oversight of pathogen research

The U.S. Department of Health and Human Services (HHS) received low marks on its latest Government Accountability Office (GAO) report card for its oversight of high-risk research involving potential pandemic pathogens. While HHS policy requires its funding agencies, such as the NIH, to refer proposed research that is “reasonably anticipated to create, transfer or use enhanced potential pandemic pathogens” to the department for additional review, the GAO found that the policy fails to objectively define “reasonably anticipated.” As a result, some research that should be subject to more oversight could be falling through the cracks.

Iaso Bio nets ¥500M as it eyes China nod for CAR T therapy

Iaso Biotherapeutics Inc. raised ¥500 million (US$75 million) in a series C1 round as looks for its first drug approval by China after its NDA was accepted for what is claimed to be the first B-cell maturation antigen-targeting CAR T-cell therapy in China. Iaso Bio plans to use the funds to develop its pipeline, as well as make preparation for the commercialization of its lead product, equecabtagene autoleucel (CT-103A). Eleven investors participated in this round, including Shanghai Guoxin Investment Development Co. Ltd., Shenzhen Efung Investment Management Co. Ltd., Shanghai Waigaoqiao Free Trade Zone Group Co. Ltd. and Nanjing Jiangbei New Area State-owned Asset Management Co. Ltd., among others. 

Initiative aims at improving trial access across the EU

In the absence of a European framework that defines conditions for cross-border clinical trials, industry is stepping up with an initiative to develop recommendations to enable cross-border access to clinical trials for patients across the EU. As part of their EU-X-CT Initiative, the European Federation of Pharmaceutical Industries and Associates and the European Forum for Good Clinical Practice have set up a multi-stakeholder consortium of patient organizations, academia, research networks and industry, tasking it with developing those recommendations. “The project will be vital in bringing groundbreaking trials to patients in countries who previously had no access and could revolutionize treatment options for those with rare diseases,” the two groups said.

Newco news: Pulmobiotics is developing cell therapy for lung diseases, but with a twist

Pulmobiotics Ltd., which was founded in 2019, is developing cell therapy for lung diseases, including lung cancer. But unlike other cell therapies for cancer, this one is based not on harnessing T cells, but on engineering bacteria. The team has engineered Mycoplasma pneumoniae to deliver various therapeutic proteins to the lung, depending on the therapeutic indication. “We are not the first in engineering bacteria,” Maria Lluch, chief scientific officer at Pulmobiotics and a principal investigator at the International University of Catalonia, told BioWorld. “But we are the first in the lung.”

Also in the news

2seventy, Abbisko, Advaxis, Algernon, Asher, Atyr, Avidity, Ayala, Beigene, Bluebird, Boehringer Ingelheim, Briacell, Cardiol, Ceruvia, Concert, Cyrano, Deciphera, Deuteroncology, Dong-A, Dyadic, Edesa, Editas, Everest, Exegenesis, Foundation Medicine, Horizon, Hutchmed, Irlab, Junshi, Keymed, Krystal, Medigene, Moderna, Monopar, Neophore, Neurosense, Novavax, Orphagen, Oryzon, Paratek, Pharmather, Plus, Repare, Sanofi, Scisparc, Servier, Shoreline, Sun, Takeda, Trefoil