Lit­tle Abi­vax sees volatile shares rock­et up on a (very ear­ly-stage) re­port of an HIV break­through

Linos Van­dek­er­ck­hove, Uni­ver­si­ty of Ghent

Abi­vax is wit­ness­ing the lat­est gy­ra­tion in its stock price af­ter claim­ing it’s gath­ered ev­i­dence of suc­cess in elim­i­nat­ing a sig­nif­i­cant amount of the reser­voirs of HIV that linger in pa­tients. But it’s ear­ly days yet for this drug and a com­pa­ny that has seen plen­ty of ups and downs over the last year.

The Paris-based biotech {$AB­VX.PA} says that in a small study with 30 HIV pa­tients — split 3-1 on drug and place­bo — ABX464 was com­bined with their cur­rent an­ti­retro­vi­ral reg­i­men to test its ef­fect af­ter 28 days.

Check­ing to­tal HIV DNA de­tect­ed in pe­riph­er­al blood mononu­clear cells, re­searchers re­port­ed that among the 14 evalu­able pa­tients in the study, 7 had a mean change of -40%, rang­ing from -27% to -67%, hit­ting the mark for a qual­i­fied re­sponse of at least -25%. None of the place­bo pa­tients re­spond­ed sim­i­lar­ly.

Shares jumped more than 150% on the re­port.

This isn’t the first wild roller coast­er ride for this stock. It’s seen a num­ber of highs and lows, first with a set­back on its lead pro­gram for hep B and then with news about the HIV pro­gram. The stock dropped by half last sum­mer when the biotech said that the Phase III hep B pro­gram was head­ed to a fail­ure. And it brought the price back up by fo­cus­ing on HIV and a pro­gram that it claims can pro­vide a “func­tion­al cure” for HIV.

Red flags should be not­ed on the small num­ber of pa­tients re­port­ed out, the ear­ly stage of the work, the size of the prob­lem and the fact that the biotech was al­ready boast­ing about its po­ten­tial well ahead of any da­ta.

HIV pa­tients keep the virus in check these days with cock­tails of very ef­fec­tive ther­a­pies. Elim­i­nat­ing the HIV that lurks in pa­tients, al­ways threat­en­ing to re­bound, has been a Holy Grail in this field for decades.

“This is the first time we see a sig­nal with any ther­a­peu­tic can­di­date that it may be pos­si­ble to re­duce HIV reser­voirs in pa­tients,” said Pro­fes­sor Linos Van­dek­er­ck­hove, Head HIV Cure Re­search Cen­ter at the De­part­ment of In­ter­nal Med­i­cine, at the Uni­ver­si­ty of Ghent, Bel­gium, a prin­ci­pal in­ves­ti­ga­tor in­volved in the study. ‘’Now we are look­ing for­ward to learn how this drug can be op­ti­mized to be part of a mul­ti­tar­get ap­proach to fur­ther re­duce the vi­ral reser­voir.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

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.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

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.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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