Syn­dax is hit with a set­back dur­ing the AS­CO pre­view round as lead drug flops in mid-stage study

Let’s add one more big los­er to the lengthy ros­ter of wins and de­feats dur­ing the AS­CO pre­view round.

Syn­dax Phar­ma­ceu­ti­cals shares $SNDX were hit hard af­ter it re­leased ab­stracts fol­lowed by a press re­lease demon­strat­ing that a com­bi­na­tion of their HDAC enti­no­s­tat plus Keytru­da pro­duced an ob­jec­tive re­sponse rate of on­ly 11% in pre-treat­ed can­cer pa­tients — with a pro­gres­sion-free sur­vival rate of on­ly 2.5 months.

Those are lethal num­bers for a mid-stage can­cer study, and their stock tum­bled 23% Thurs­day. It was par­tic­u­lar­ly dis­ap­point­ing af­ter the biotech re­port­ed a year ago that they were track­ing a 31% re­sponse rate in the study.

Brig­gs Mor­ri­son

Syn­dax chief Brig­gs Mor­ri­son, an As­traZeneca vet who made the jump to biotech sev­er­al years ago, has been search­ing for a way out of the box he’s in. And he be­lieves he’s found that by do­ing some post hoc analy­sis that iden­ti­fied a sub­group of pa­tients who did bet­ter.

If you whit­tle the 57 pa­tients re­viewed for this read­out down to 14 with high mono­cyte lev­els, says the com­pa­ny, you’ll get a PFS rate of 5.4 months and an ORR of 29%. And if reg­u­la­tors agree, he wants to fol­low that clue in­to a reg­is­tra­tion study.

It’s not ide­al, but it’s all they have.

Dmit­ry Gabrilovich

“Mono­cyte lev­els may re­flect the abil­i­ty of the im­mune sys­tem to re­spond af­ter elim­i­na­tion of im­mune sup­pres­sion,” said Dmit­ry Gabrilovich from The Wis­tar In­sti­tute. “The da­ta from this PD-1 pre-treat­ed pop­u­la­tion sug­gest that mono­cytes are as­so­ci­at­ed with pos­i­tive clin­i­cal out­come from enti­no­s­tat com­bined with pem­brolizum­ab, and if con­firmed, can po­ten­tial­ly be used for pa­tient se­lec­tion in fu­ture stud­ies.”

The ear­ly roundup of AS­CO da­ta will be fol­lowed in a cou­ple of weeks by the main event. We’re track­ing sev­er­al key drugs in the process and will be on site for the big show in Chica­go. 

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Genen­tech plots $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Genentech has committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Roche’s big South San Francisco hub will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

Am­gen, As­traZeneca speed to­ward fil­ing next-gen an­ti­body for asth­ma af­ter un­cork­ing full late-stage da­ta

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.