J&J tells End­points News that a bis­pe­cif­ic an­ti­body it is part­nered on with Gen­mab for acute myeloid leukemia has been put on clin­i­cal hold af­ter pa­tients in the tri­al suf­fered se­ri­ous ad­verse events.

The drug, JNJ-63709178, tar­gets both CD3 and CD123 and was in an ear­ly stage study when the hold was in­sti­tut­ed, forc­ing in­ves­ti­ga­tors to sus­pend pa­tient re­cruit­ment, ac­cord­ing to the clin­i­cal­tri­als.gov web site. The com­plete hold, which should stop dos­ing, fol­lowed.

A spokesper­son for J&J con­firmed the news, but de­clined to say just what ad­verse events were seen in the study.

“Janssen R&D tem­porar­i­ly sus­pend­ed the study on Aug 8; the FDA put it on com­plete clin­i­cal hold ef­fec­tive Aug 16,” says the com­pa­ny spokesper­son.  “We’re work­ing with the FDA now to ad­dress rec­om­mend­ed changes to the study.  At this point, we don’t have any ad­di­tion­al de­tails to share.  We’re hop­ing to re­sume the study with ap­pro­pri­ate guid­ance from the FDA.”

News of the clin­i­cal hold was first raised in a tweet from Eval­u­ate Phar­ma’s Ja­cob Pli­eth.

Se­vere ad­verse event -> sus­pen­sion of $JNJ $GEN CD123 bis­pe­cif­ic JNJ-63709178. (H/t Nordea) $NVS $XN­CR $MGNX $CLLS pic.twit­ter.com/4q2bTAhv2d

— Ja­cob Pli­eth (@Ja­cob­Pli­eth) Sep­tem­ber 19, 2016

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Aridis Pharmaceuticals’ monoclonal antibody missed the bar in a Phase III test in ventilator-associated pneumonia caused by the gram-positive bacteria S. aureus, the company announced Wednesday. 

But Aridis is planning for a second Phase III study anyway once it discusses the findings with the FDA and the European Medicines Agency. Execs blamed recruitment challenges stemming from Covid-19 and Russia’s invasion of Ukraine for the miss, cutting their enrollment target in half.

XyloCor Therapeutics says patients with heart disease who got its gene therapy could exercise for longer and had fewer chest pain attacks. The biotech announced it completed a Phase I/II trial of the gene therapy Thursday morning, and plans to move forward with a pivotal trial.

In the Phase II portion of the trial, 28 patients with angina (or chest pain) caused by coronary artery disease and who had no other treatment options were enrolled and were given the highest tested dose from the first part of the trial. Patients were followed for six months.