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Vicente Anido, Aerie CEO (University of West Virginia via YouTube)

Who needs pri­ma­ry end­points any­way? Aerie touts sil­ver lin­ings from failed PhI­Ib, plots PhI­II in dry eye dis­ease

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.

Ali Tehrani, Zymeworks CEO

Zymeworks squares up with Her­ceptin af­ter HER2 bis­pe­cif­ic aces mid-stage test in esophageal can­cer

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.

Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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Sonny Hsiao, Acepodia CEO

Ace­po­dia un­corks a very ear­ly win for its an­ti­body-nat­ur­al killer cell con­ju­gates in HER2 tu­mors

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.

FDA ap­pears un­con­vinced by Pfiz­er's case for Covid-19 boost­er in lead up to ad­comm

At around 9 a.m. on Wednesday morning, the FDA released Pfizer’s detailed case to the agency and its outside advisors for authorizing Covid-19 booster doses. Three hours later, the FDA released its own analysis.

For most of the documents, it is as if the agency and the company are having two different conversations.

The documents provide a prelude for an advisory committee hearing that will debate whether the agency should approve booster shots. The issue has proven deeply polarizing. President Biden has promised to authorize boosters based on data from Israel and elsewhere, angering some public health officials in and outside the FDA, who fear the president is interfering in the agency’s independence and argue that existing data don’t support such shots, especially when much of the world remains unvaccinated.

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Kamel Khalili, Excision BioTherapeutics

FDA clears first-of-its-kind tri­al to see if CRISPR gene edit­ing can cure HIV

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.

Back-to-back piv­otal fail­ures force Ther­a­vance to lay off 270 staffers, prune R&D fo­cus

If it all went well, Q3 was supposed to be harvest time for Theravance.

Both of its lead drugs — the pan-JAK inhibitor izencitinib and blood pressure drug ampreloxetine — were slated for crucial readouts. The biotech was, as SVB Leerink analyst Geoffrey Porges put it, “entering the most important period of validation events in its history.”

Instead, izencitinib flopped a key Phase IIb trial in ulcerative colitis, putting the J&J partnership around it in jeopardy. A month later, Theravance is reporting that the Phase III trial testing ampreloxetine in symptomatic neurogenic orthostatic hypotension is also a failure, imploding the company’s entire pipeline and forcing a rethink on R&D strategy.

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#ES­MO21 is loom­ing, and we have a great group of ex­perts lined up to help make sense of the news

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.

Paul Stoffels, J&J CSO (Andrew Harnik/AP Images)

Ebo­la vac­cine built on same tech­nol­o­gy as Covid-19 jab from J&J shows long-last­ing suc­cess

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.

Roberto Bellini, Bellus Health CEO

UP­DAT­ED: Bel­lus says its Mer­ck cough ri­val passed a PhI­Ib test af­ter ear­li­er flop, but in­vestors can't make up their minds

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.