Aerie’s dry eye disease drug may not have met the primary endpoints it’s chosen for a Phase IIb study, but that’s not stopping the biotech from powering through Phase III — and steering toward a field with plenty of rivals.

“While we did not achieve statistical significance at our pre-determined primary endpoints at Day 28, as a reminder, this is a Phase 2b study where selecting primary endpoints are not required,” CEO Vicente Anido said in a statement.

Roche’s Herceptin has long stood as standard of care across multiple advanced cancers, but a suite of next-gen players are looking to beat the aging giant at its own game. In HER2-expressing esophageal cancer, BeiGene partner Zymeworks thinks its bispecific antibody could have the juice to get it done.

Zymeworks’ bispecific antibody zanidatamab, combined with one of two chemotherapy regimens, posted an overall response rate of 75% in patients with advanced gastroesophageal adenocarcinoma (GEA) who had not previously received a HER2-targeted cancer therapy, the Vancouver-based biotech said Thursday.

Can the antibody-drug conjugate model be applied to an off-the-shelf NK cell therapy? Acepodia uncorked preliminary Phase I data at #ESMO21 that suggest the answer may be yes.

Private biotech Acepodia’s lead “antibody cell conjugation” (ACC) candidate ACE1702 was well-tolerated in seven patients with advanced HER2 tumors who received lower doses of the drug, CEO Sonny Hsiao announced early Thursday. The patients who received the first four dose levels showed no signs of cytokine release syndrome, neurotoxicity or graft versus host disease — and one of them achieved a confirmed partial response; not earth-shattering, but a positive sign.

The FDA has cleared a company trying to use CRISPR gene-editing to cure HIV to begin clinical trials.

The study, run by the startup Excision BioTherapeutics, will likely begin early next year, CMO Lisa Danzig said, after final details are hashed out. It will involve three groups of three healthy HIV patients, with each group given a sequentially higher dose as the company tests the safety of the new therapy.

The one international science conference I always enjoyed attending most has been ESMO. You mix some high-octane cancer R&D news with one of the best collection of global experts in the field. It was education, breaking news and a great European location all built into one packed weekend.

ASCO is great — but the ESMO package has been phenomenal.

We’ve lost the location, for now, but everything else is still in place for a big weekend. Managing editor Kyle Blankenship is leading the coverage on the news front, with the rest of the team pitching in to help. And we’ll have the full lineup of stories from the conference in a special report on Monday, Sept. 20. Be sure to check it out. And follow us on Twitter through the weekend for breaking news.

Just weeks after a J&J candidate failed its first trial in an effort to build a vaccine against HIV, that same vaccine technology scored the company a victory in the fight against a virus that has emerged yet again, and threatens to cause havoc in Africa if left unchecked alongside Covid-19.

A two-dose vaccine regimen from J&J to fight Ebola was long-lasting during trials in adults and children, the company said Monday, as the immune response lasts in adults for at least two years.

A little over a year after flopping out of the chronic cough game and leaving Merck as the sole player, Bellus Health is saying it’s back in contention.

The Canadian biotech touted a Phase IIb interim analysis Monday morning it described as positive, saying that “at least one dose” of its experimental chronic cough drug posted a clinically meaningful reduction in placebo-adjusted 24-hour cough frequency after four weeks. It’s a result that comes roughly 15 months after another Phase II trial reported a miss on all four doses, sending shares $BLU down more than 75% at the time.