FDA forces trou­bled Ad­vax­is to halt en­roll­ment on its PhI­II study for lead drug ax­al­imo­gene

A lit­tle more than a month af­ter Am­gen qui­et­ly walked away from its $65 mil­lion up­front to part­ner with Ad­vax­is $ADXS on ax­al­imo­gene filolis­bac, the biotech is re­port­ing that the FDA has slapped the pro­gram with a par­tial hold or­der­ing a stop to new en­roll­ment in the Phase III. And this isn’t the first time.

Ac­cord­ing to the com­pa­ny’s re­lease, reg­u­la­tors trig­gered the hold on their study for cer­vi­cal can­cer due to “re­quests for ad­di­tion­al in­for­ma­tion per­tain­ing to cer­tain AX­AL chem­istry, man­u­fac­tur­ing and con­trols (CMC) mat­ters.” No new safe­ty is­sues were iden­ti­fied, ac­cord­ing to the biotech.

Now a pen­ny stock biotech, Ad­vax­is shares closed at just 31 cents to­day, down 10%. And the shares dropped 15% more af­ter the news hit.

Ad­vax­is is ad­vanc­ing ther­a­pies that use live at­ten­u­at­ed Lis­te­ria mono­cy­to­genes which are en­gi­neered to se­crete anti­gen/ad­ju­vant fu­sion pro­teins. And they’re not sim­ple to de­vel­op. The ther­a­py us­es bac­te­ria to kick up an im­mune re­sponse by trig­ger­ing a T cell at­tack on can­cer cells.

Ken­neth Berlin

“FDA’s re­view of the AX­AL In­ves­ti­ga­tion­al New Drug (IND) ap­pli­ca­tion was prompt­ed by our pro­pos­al to mod­i­fy the AIM2CERV tri­al’s analy­sis plan to in­clude, among oth­er things, al­lowance for a sec­ond for­mal in­ter­im analy­sis for both safe­ty and ef­fi­ca­cy,” said Ken­neth Berlin, Ad­vax­is’ CEO. “The pri­ma­ry fo­cus of the items raised by the Agency re­lates to pro­vid­ing ad­di­tion­al clar­i­fy­ing de­tails for CMC in­for­ma­tion pre­vi­ous­ly pro­vid­ed in sup­port of Phase 3 de­vel­op­ment and which will help sup­port a fu­ture Bi­o­log­ics Li­cense Ap­pli­ca­tion. We have al­ready be­gun ef­forts to ad­dress the Agency’s re­quests for in­for­ma­tion and are work­ing to re­spond as prompt­ly as we can.”

That event fol­lows an ear­li­er clin­i­cal hold on their lead pro­gram in com­bi­na­tion with As­traZeneca’s PD-L1 check­point Imfinzi fol­low­ing a pa­tient death, though the hold was lat­er lift­ed. Af­ter a months-long holdup in H1 2018, re­searchers came up with new guide­lines aimed at pre­vent­ing any fu­ture in­stances of acute res­pi­ra­to­ry fail­ure that killed the pa­tient.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Joan Butterton, Merck Research Laboratories VP of global clinical development, infectious diseases (Merck)

Mer­ck­'s ex­per­i­men­tal HIV drug is­la­travir hits with a PhI­II com­bo win and FDA fil­ing plans

Back in March, Merck and Gilead agreed to a partnership to challenge GlaxoSmithKline on long-acting HIV meds — by combining one drug from both Merck and Gilead that had shown potential. While Gilead brought its capsid inhibitor lenacapavir, Merck brought islatravir into the deal — a small molecule that the pharma acquired in 2012 from a small Japanese firm.

While that partnership is ongoing, islatravir is coming out of 2 Phase III pivotal trials with back-to-back successes and plans to beat a quick advance to the FDA.

Gil Beyen, Erytech CEO

A transat­lantic biotech flags a painful PhI­II can­cer flop, wav­ing a white flag

More than 4 years after little Erytech inflated some rare passion for its stock with upbeat Phase IIb data for their lead drug in pancreatic cancer, they’ve let the air out of the party balloons.

The transatlantic biotech $ERYP put the word out Monday morning that its drug eryaspase flopped in a Phase III pivotal for second line metastatic pancreatic cancer, slamming its stock, which plunged more than 30%.

Preston Klassen, Metacrine CEO

An­oth­er NASH play­er re­treats from bat­tered field af­ter tox­i­col­o­gy study flags po­ten­tial de­lay

NASH, the notorious liver disease afflicting an increasing number of Americans, has always been the focus at Metacrine ever since serial entrepreneur Rich Heyman unveiled the first round of financing all the way back in 2015.

Not anymore.

The San Diego-based biotech is halting its NASH program and choosing instead to prioritize its effort in pushing the same FXR agonist, MET642, into a Phase II trial for inflammatory bowel disease.