Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

Af­ter fly­ing high on Wall Street for the last few months of a pan­dem­ic, Biond­Vax’s stock and dreams of get­ting ap­proval for its uni­ver­sal flu vac­cine hit the wind­shield.

The Jerusalem-based biotech an­nounced on Fri­day that its on­ly clin­i­cal can­di­date, M-001, failed both pri­ma­ry and sec­ondary end­points in a Phase III study. There was no sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in re­duc­tion of flu ill­ness and sever­i­ty be­tween the vac­cine and place­bo groups, ac­cord­ing to the com­pa­ny. The vac­cine did prove safe, if in­ef­fec­tive, Biond­Vax said.

The news sent Biond­Vax’s stock plum­met­ing 85%, clos­ing at $5.20 per share. The day be­fore, shares closed at $37.88 apiece. For the last few years, the biotech’s share val­ue lin­gered around $5 to $7 per share. Prices be­gan to rise in Jan­u­ary, then surged from April to Ju­ly, like­ly due to the pan­dem­ic. On Ju­ly 14, they peaked at $48.25 apiece. Ever­core ISI an­a­lyst Josh Schim­mer pre­dict­ed back in March that all vac­cine de­vel­op­ers — not just those fo­cused on Covid-19 — would prof­it from the health cri­sis, list­ing $BVXV among the po­ten­tial win­ners.

Biond­Vax’s Phase III tri­al in­clud­ed 12,463 adults ages 50 and up: “the group most ur­gent­ly in need of im­proved pro­tec­tion from the flu,” CSO Tamar Ben-Yedidia said in a state­ment. The can­di­date, de­signed as a com­mon de­nom­i­na­tor to in­fluen­za A and B virus­es, was stud­ied over the course of two flu sea­sons, be­gin­ning in 2018. Each par­tic­i­pant was mon­i­tored for just one flu sea­son.

Ron Babecoff

There was no sug­ar-coat­ing the find­ings. “We are dis­ap­point­ed with these re­sults …” founder, pres­i­dent and CEO Ron Babecoff said be­fore he went on to thank the team for 15 years of “ded­i­ca­tion and pas­sion.”

“Un­for­tu­nate­ly, this study did not have the ef­fi­ca­cy out­comes that we an­tic­i­pat­ed for M-001 on a stand­alone ba­sis. We have ob­served in sev­en pre­vi­ous stud­ies that M-001 safe­ly pro­voked an im­mune re­sponse to a broad range of flu strains, but ul­ti­mate­ly this was not suf­fi­cient on a stand­alone ba­sis to show pro­tec­tion,” Babecoff said in the state­ment.

It’s not look­ing good for the biotech, which said it’s “ex­am­in­ing op­tions to max­i­mize the val­ue” of its as­sets, in­clud­ing IP and a state-of-the-art man­u­fac­tur­ing fa­cil­i­ty.

Back in June, Biond­Vax met both pri­ma­ry end­points in a Phase II tri­al sup­port­ed by the NI­AID. The com­pa­ny had an­nounced that the can­di­date “in­duced sig­nif­i­cant poly­func­tion­al T cell re­spons­es” — but it wasn’t enough to clear Phase III.

Oth­er play­ers in search of the Holy Grail in­clude Vac­citech, which be­gan dos­ing par­tic­i­pants in a Phase IIb study last June, and the NIH, which un­veiled a can­di­date head­ed for the clin­ic last April.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty upfront payments attached, and the promise of big biobucks if a program works out. Not this one.

Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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