The End­points 11 cel­e­brates bio­phar­ma's most promis­ing star­tups. Live event on Sep­tem­ber 30

Next month John Car­roll and the End­points ed­i­to­r­i­al team con­tin­ue a proud tra­di­tion of pro­fil­ing a stand­out group of 11 star­tups that just might be head­ed for great­ness. And we’re adding a new, live el­e­ment that we want to share with all of you — and we’re ask­ing for just one hour of your time.

Please mark your cal­en­dars for a 1-hour main event on Sep­tem­ber 30 at 4pm ET. The agen­da will ex­pand in the com­ing weeks, and we’ll have more than one hour’s worth of con­tent for you. But the cen­ter­piece of the 2020 End­points 11 is a one-hour live-streamed event.

It will start at 4pm ET / 1pm PT, and you can sign up with this link.

Our goal is to cel­e­brate bold sci­ence in the pur­suit of new biotech drugs, and that’s a lot eas­i­er said than done. When it comes to pick­ing pri­vate com­pa­nies, we’re deal­ing with in­com­plete and im­per­fect in­for­ma­tion. And the lim­its of our cur­rent un­der­stand­ing of bi­ol­o­gy can frus­trate the most ex­pe­ri­enced sci­en­tif­ic teams armed with tremen­dous fi­nan­cial back­ing. Re­gard­less, we’re go­ing to make our picks and ar­gue our case for them. The com­pa­nies that are in our sight are all swing­ing for the fences. Some will fail, but they each rep­re­sent a trend in new biotech com­pa­ny cre­ation. And they emerge from a his­tor­i­cal back­drop, with the pan­dem­ic fo­cus­ing the world’s at­ten­tion on bio­phar­ma like nev­er be­fore.

This year we’re spon­sored by Catal­ent, a com­pa­ny that has sup­port­ed our in­de­pen­dent mis­sion at End­points from the start. This year, part of our agen­da fea­tures my co-founder and End­points ed­i­tor John Car­roll pre­sent­ing the awards live to the win­ners along­side Catal­ent CEO John Chimin­s­ki. Both “John C”s have a fun his­to­ry of this kind of work, which we last saw at JP Mor­gan this year in San Fran­cis­co. It’s go­ing to be a lot of fun and I hope you all can be a part of it.

Feel­ing Zoomed out? That’s un­der­stand­able, and we’ll be work­ing to keep your at­ten­tion. There is a gen­uine need to con­tin­ue the kind of cel­e­bra­to­ry events that would bring us to­geth­er in a nor­mal year — and we think this is worth your time. There’s more than one hour’s worth of con­tent to share with you all, but the ex­pe­ri­ence will be shaped in a way where the live show is the cen­ter­piece. Every­thing else is on-de­mand. And there’s no cost to at­tend. You can sign up here.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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