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

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.