Seres dou­bles down on a mi­cro­bio­me do-over as the FDA clears a make-or-break study

Seres CEO Roger Pomer­antz

Seres CEO Roger Pomer­antz says he’s back on track.

Eight months af­ter the biotech in­dus­try’s lead­ing mi­cro­bio­me pro­gram de­railed in a dis­as­trous Phase II, Seres’ chief says he and his team per­suad­ed reg­u­la­tors at the FDA to sign off on a new study that could pro­vide piv­otal da­ta on his top pro­gram. And now he’ll dou­ble down on a tri­al that will once again roll the dice on a cut­ting-edge ef­fort to de­vel­op a gut-lev­el ther­a­py that can right a chal­leng­ing health wrong.

Back last Ju­ly, Seres was ham­mered hard af­ter the com­pa­ny said its Phase II study of SER-109 failed to demon­strate ef­fi­ca­cy in re­duc­ing the re­cur­rence of Clostrid­i­um dif­fi­cile in­fec­tion. The ther­a­py bare­ly sep­a­rat­ed from a place­bo, crush­ing the biotech’s share price.

The key dif­fer­ence be­tween this new “piv­otal wor­thy” study and Seres’ failed tri­al is a dose that is 10 times as high as what it start­ed out with. And the CEO — a long­time Mer­ck vet — is con­vinced that the biotech has it right.

This time around Seres will re­cruit 320 pa­tients “at mul­ti­ple sites in the US and Cana­da,” says the CEO, “to make it as piv­otal­ly ro­bust as pos­si­ble…We’ve got­ten pret­ty good at this.” And the tri­al will get un­der­way lat­er this year, with a plan to line up CMC man­u­fac­tur­ing and more to be ready for an OK and com­mer­cial­iza­tion.

Bold words and big plans.

Pomer­antz has ex­plained all this to me once be­fore, which I wrote up. But the come­back case has had vir­tu­al­ly no ef­fect on his stock price, which has con­tin­ued to re­side in biotech’s dog house. Now he’ll get a chance to re­deem him­self and the com­pa­ny, ei­ther end­ing up on the thresh­old of a land­mark OK or mir­ing the com­pa­ny so deep in the muck that it may nev­er get out.

Nestlé Health Sci­ence, which paid $120 mil­lion up­front to part­ner on CDI at the be­gin­ning of 2016, al­so has a lot rid­ing on this. Their pact in­clud­ed some $2 bil­lion in mile­stones for four pro­grams, along with a com­mit­ment to help pay for late-stage de­vel­op­ment.

When you dou­ble down on suc­cess, the con­se­quences of a po­ten­tial fail­ure aren’t easy to ig­nore. And the out­come will have sig­nif­i­cant im­pli­ca­tions for all the star­tups in the mi­cro­bio­me field — whether they like it or not.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

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Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.