Take­da-part­nered Finch Ther­a­peu­tics grabs $36M and looks to leapfrog the pack in mi­cro­bio­me R&D

Close to a year af­ter Seres de­clared that it had jumped back on track af­ter a trou­bling set­back with its lead mi­cro­bio­me drug for Clostrid­i­um dif­fi­cile in­fec­tions, a dark horse in the pack is chal­leng­ing it for the lead in the emerg­ing field.

Four months af­ter merg­ing with Cresto­vo, Finch Ther­a­peu­tics has raised $36 mil­lion in Se­ries B mon­ey to hus­tle ahead with a mid-stage study of CP101 that got un­der­way last sum­mer. The “full spec­trum mi­cro­bio­ta” prod­uct was the main at­trac­tion for the merg­er, Finch CEO Mark Smith tells me, and re­placed their own ri­val ther­a­py in the pipeline.

The com­bi­na­tion of the two biotechs al­so came with new sup­port from Cresto­vo sup­port­er Chris Shumway of Shumway Cap­i­tal, who helped bring the syn­di­cate to­geth­er. Wil­lett Ad­vi­sors, Mor­gan No­ble and Avenir Growth Cap­i­tal all stepped in for the round, which brings Finch’s to­tal haul to $77 mil­lion.

Alexan­der Kho­ruts

Cresto­vo’s aca­d­e­m­ic col­lab­o­ra­tors, Alexan­der Kho­ruts and Michael Sad­owsky, ran an open-la­bel study in 49 pa­tients that they deemed a suc­cess, with 88% of the pa­tients not see­ing a re­cur­rence of C diff over two months. The Cam­bridge, MA-based com­pa­ny then start­ed to re­cruit 240 pa­tients for a piv­otal tri­al of the ther­a­py.

Smith says that the FDA has al­so come through with fast track des­ig­na­tion — not a high hur­dle, typ­i­cal­ly, but he’s hap­py to have it. And af­ter talks with reg­u­la­tors, he says, they’re drop­ping the low-dose arm that had been planned, fo­cus­ing on two dos­es in a study that will now be capped with 200 pa­tients.

Michael Sad­owsky

That is enough to get what the CEO says is po­ten­tial­ly reg­is­tra­tional da­ta, though the FDA will have the fi­nal say in whether they need to do a mir­ror study to con­firm their re­sults be­fore or af­ter an ap­proval.

“We think that this da­ta we’re gen­er­at­ing in Phase II could sup­port a BLA,” Smith tells me. “We think it’s the first prod­uct to re­al­ly cap­ture what works well with fe­cal trans­plan­ta­tion.”

And it’s an oral dose, which Smith be­lieves is an­oth­er added ad­van­tage for the com­pa­ny, part­nered with Take­da. He’s been build­ing the biotech on the foun­da­tion pro­vid­ed by Open­Bio­me, a fe­cal trans­plant com­pa­ny he found­ed.

C diff, though, is the big ini­tial fo­cus in the mi­cro­bio­me field, and Finch will have to beat out some se­ri­ous ri­vals.

Seres was ham­mered hard back in 2016, 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. But they ral­lied, putting to­geth­er a new “piv­otal wor­thy” study with a dose that is 10 times as high as what it start­ed out with.

Finch will need to get great re­sults to es­tab­lish a lead here. Smith isn’t say­ing just how long it will be be­fore the da­ta read out. But he does note that it shouldn’t be too long now, with the com­pa­ny fo­cused on build­ing out the man­u­fac­tur­ing need­ed to back up a prod­uct.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.