FDA slaps a par­tial hold on one of As­traZeneca's cru­cial dur­val­um­ab pro­grams

Shares of As­traZeneca $AZN start­ed to slide this morn­ing as the phar­ma gi­ant con­firmed that the FDA has placed a par­tial clin­i­cal hold on a Phase III re­search pro­gram in­volv­ing its check­point in­hibitor dur­val­um­ab, halt­ing new en­roll­ment.

The par­tial hold was in­sti­tut­ed af­ter in­ves­ti­ga­tors tracked bleed­ing events in a Phase III com­bo study for dur­val­um­ab, its top in­ves­ti­ga­tion­al drug, with treme­li­mum­ab for head and neck can­cer. But the com­pa­ny cau­tions that all oth­er stud­ies are pro­ceed­ing as planned, not­ing that such bleed­ing events are not un­usu­al in head and neck can­cer.

That said, As­traZeneca can ill af­ford any de­lays in the de­vel­op­ment of dur­val­um­ab now. The com­pa­ny al­ready de­layed its de­vel­op­ment time­line for the check­point in­hibitor to al­low for com­bi­na­tion stud­ies, which As­traZeneca is count­ing on to make a splash with a late ar­rival in the field.

A set­back here will raise fresh ques­tions for As­traZeneca as it at­tempts to play catch-up to the mar­ket lead­ers in check­point in­hibitors. Dur­val­um­ab is now a dis­tant fourth — or fifth — in the mar­ket, like­ly to fol­low Roche’s $RHH­BY Tecen­triq and well be­hind Mer­ck ($MRK/Keytru­da) and Bris­tol-My­ers Squibb $BMY, which has racked up block­buster sales with Op­di­vo.

As­traZeneca’s shares are down 5%.

The news about the safe­ty is­sue has been per­co­lat­ing in­side As­traZeneca for more than a month.

In a fol­lowup to a query, As­traZeneca said that they took the first step in paus­ing en­roll­ment in mid-Sep­tem­ber, more than a month ago, then fol­lowed up with no­tices to reg­u­la­tors and in­ves­ti­ga­tors. Ac­cord­ing to a spokesper­son:

The FDA re­cent­ly con­firmed their agree­ment with our ac­tion and placed a par­tial clin­i­cal hold on re­cruit­ment of new pa­tients while we com­plete our analy­sis. We sent an up­date to Clin­i­cal­Tri­als.gov with­in the usu­al time­frames. Our analy­sis is now com­plete and has been sub­mit­ted to FDA and un­der their re­view; we hope to re­sume [en­roll­ment] as soon as pos­si­ble.

Here’s the full ini­tial state­ment sent to End­points News:

Fol­low­ing the re­cent up­date on clin­i­cal­tri­als.gov, As­traZeneca con­firms that the US FDA has placed a par­tial clin­i­cal hold on the en­roll­ment of new pa­tients with head and neck squa­mous cell car­ci­no­ma (HN­SCC) in clin­i­cal tri­als of dur­val­um­ab as monother­a­py and in com­bi­na­tion with treme­li­mum­ab or oth­er po­ten­tial med­i­cines. All tri­als are con­tin­u­ing with ex­ist­ing pa­tients.

The par­tial clin­i­cal hold on new pa­tient [en­roll­ment] re­lates on­ly to head and neck can­cer. Tri­als for dur­val­um­ab in dif­fer­ent can­cer types, as monother­a­py or in com­bi­na­tion with treme­li­mum­ab or oth­er po­ten­tial med­i­cines, are pro­gress­ing as planned, with piv­otal da­ta in lung can­cer an­tic­i­pat­ed in the first half of 2017.

The FDA’s de­ci­sion fol­lows vol­un­tary ac­tion by As­traZeneca to pause [en­roll­ment] of new HN­SCC pa­tients while a de­tailed analy­sis is con­duct­ed of ad­verse events re­lat­ed to bleed­ing that were ob­served as part of rou­tine safe­ty mon­i­tor­ing of the Phase III KESTREL and EA­GLE tri­als. Bleed­ing is a known com­pli­ca­tion in treat­ments of head and neck can­cers pri­mar­i­ly due to the na­ture of the un­der­ly­ing dis­ease, the prox­im­i­ty of tu­mours to ma­jor blood ves­sels and use of pri­or can­cer ther­a­pies, which may in­volve surgery and ra­di­a­tion.

As­traZeneca has sub­mit­ted its analy­sis of the ob­served bleed­ing events to the FDA for re­view and is work­ing close­ly with the Agency, pro­vid­ing the re­quired in­for­ma­tion to re­sume new pa­tient [en­roll­ment] as soon as pos­si­ble.

Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Ludwig Hantson, Alexion CEO

Why pay $4B for a steady di­et of dis­ap­point­ment? Porges turns thumbs down on Alex­ion’s M&A strat­e­gy, of­fers some point­ers

When Alexion announced recently that it was paying $1.4 billion to bag Portola and its underperforming Factor Xa inhibitor reversal agent, you could hear the head-scratching going on around virtual Wall Street.

Why was Alexion going down the discount lane for new products? And why something like this? Analysts have been urging Alexion to get serious about M&A for years if it was serious about diversifying the company beyond Soliris and its successor drug. But this wasn’t the kind of heavy-impact deal they were looking for.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,200+ biopharma pros reading Endpoints daily — and it's free.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,200+ biopharma pros reading Endpoints daily — and it's free.

Cy­to­ki­net­ics nabs Chi­nese part­ner, up to $450M as CV be­comes com­pa­ny fo­cus

Cytokinetics’ ALS programs may have seen better days, but its cardiovascular division has attracted well-backed partners, including Amgen and Royalty Pharma, who, in 2017 paid $90 million in exchange for a 4.5% royalty on their lead heart drug.

Now a Chinese drugmaker and a major investor are signing onto their second cardiovascular candidate, an experimental drug known as CK-274 and designed to treat hypertrophic cardiomyopathies — genetic conditions that cause heart muscles to become abnormally and potentially dangerously thick. Ji Xing Pharmaceuticals will pay Cytokinetics $25 million upfront for the rights to commercialize the drug in China and certain neighboring regions, along with $200 million in potential milestones.

President Trump (left) and NIAID chief Anthony Fauci in the White House press room, April 22, 2020 (Michael Reynolds/Sipa via AP Images)

White House tries to dis­cred­it An­tho­ny Fau­ci — could he be on his way out?

For two months in late winter and early spring, Anthony Fauci and President Trump stood in uneasy co-existence at White House briefings — an unlikely truce between an infectious disease official who had helped combat AIDS and Ebola and a president who repeatedly denied the danger of a virus that would go on to kill 100,000 Americans, repeatedly rejected masks and certain social distancing efforts, and promoted a drug with little scientific basis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,200+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sanofi keeps foot on the gas, agree­ing to five-year col­lab­o­ra­tion with MD An­der­son

Just four months after scoring its first cancer drug approval in a decade, Sanofi is staying on the oncology offensive.

The French pharma is planning to accelerate the development of potential treatments, partnering with the University of Texas MD Anderson Cancer Center in a five-year collaboration. By combining Sanofi’s pipeline with MD Anderson’s top-notch clinical trial program in oncology, the pair will launch biomarker-driven clinical studies to better understand which drug cocktails can effectively curb cancer progression.

Bil­lions of dol­lars worth of SPACs are rid­ing on the biotech IPO boom

Billionaire hedge fund manager Bill Ackman’s push to raise $4 billion for his blank check company, Pershing Square Tontine Holdings, is casting a spotlight on the SPACs. And amid a historic SPAC boom, biotechs are setting several records on what some observers say is shaping up to be a third major track — besides IPO and M&A — to go public.

“SPACs were approximately 3% of the IPO market back in 2014, now they are almost 35% of all new listings,” Jay Heller, the Nasdaq’s head of capital markets, told Endpoints News.

Andrew Allen, Gritstone Oncology CEO

A neoanti­gen pi­o­neer says its tech is work­ing great. So what wrecked the share price?

Gritstone Oncology was one of the original neoantigen upstarts, raising cash and planning to disrupt the immuno-oncology field with a bold new approach to fighting cancer with a new brand of vaccines.

On Monday, the crew in charge ran out a full display of what they’ve been seeing in a Phase I study. And everything seems to be working perfectly with one big exception: It didn’t significantly shrink tumors, let alone eradicate them.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.