Take­da part­ners with an up­start drugs-from-bugs mi­cro­bio­me play­er in­spired by a fe­cal trans­plan­ta­tion biz


Back when Mark Smith was work­ing on his PhD at MIT about 6 years ago, his girl­friend’s cousin was in­fect­ed with C.diff. Af­ter 7 re­oc­cur­rences fol­low­ing treat­ment with van­comycin, though, the cousin fi­nal­ly beat it by get­ting a fe­cal trans­plant, with his room­mate as the donor.

That in­ci­dent both in­trigued him and in­spired Smith’s first jump in­to a start­up, Open­Bio­me, which us­es screened fe­cal sam­ples for a more sys­tem­at­ic ap­proach in cre­at­ing a safe, re­li­able sup­ply of trans­plants to a grow­ing mar­ket.

Smith’s sec­ond start­up was a nat­ur­al ex­ten­sion of the first ven­ture: Finch Ther­a­peu­tics, a mi­cro­bio­me com­pa­ny which is de­vel­op­ing new drugs-from-bugs — an ap­proach which has helped in­spire a ros­ter of star­tups over the last two years. And to­day, the low-pro­file biotech — which has mush­roomed overnight in Somerville, MA in­to a 65-em­ploy­ee com­pa­ny that’s deeply en­gaged in man­u­fac­tur­ing work and fo­cus­ing on two de­vel­op­ment pro­grams – is un­veil­ing its first in­dus­try part­ner­ship.

Take­da, the Japan­ese phar­ma com­pa­ny with a grow­ing Boston R&D op­er­a­tion, is pay­ing $10 mil­lion up front on a very ear­ly-stage deal to part­ner on FIN-524, a pre­clin­i­cal pro­gram for IBD.

Work­ing with col­leagues at MIT, Smith has been work­ing on a “suite of al­go­rithms to ap­ply to da­ta on fe­cal trans­plan­ta­tion, to re­verse en­gi­neer ef­fec­tive ther­a­pies, then iden­ti­fy with com­pu­ta­tion­al ap­proach­es which bugs dri­ve clin­i­cal re­spons­es.”

“The core of our com­pa­ny is built around hu­man-first dis­cov­ery,” says Smith. While ri­vals look to an­i­mal mod­els to val­i­date their ideas, Finch li­censed a data­base de­rived from 22,000 pa­tients at Open­Bio­me dosed with fe­cal trans­plan­ta­tion. If they see an in­ter­est­ing phe­no­type, they can “se­quence the sam­ple, look at the or­gan­isms gen­er­at­ing a re­sponse, and go back to the freez­er and pull the strain.”

You start with some­thing that works, like fe­cal trans­plan­ta­tion, says Smith, and then work back­wards to get a drug. That is how they came up with the lead pro­gram for C.diff, now head­ed in­to a Phase II study.

Why 65 work­ers at this stage? Smith ex­plains that 40 staffers in­volved in man­u­fac­tur­ing at Open­Bio­me came over to the spin­out.

Ten mil­lion dol­lars isn’t a huge amount of cash in the biotech busi­ness. But Smith has man­aged to start a com­pa­ny and get in­to pipeline build­ing with­out hand­ing over a lot of eq­ui­ty to the VCs. He start­ed with an­gel mon­ey, then raised $5.5 mil­lion in an A round, and is now work­ing on a siz­able se­ries B. That $10 mil­lion from Take­da — along with an un­de­fined pack­age of mile­stones — goes a long way to fund their growth.

The Take­da pro­gram prob­a­bly has two-and-a-half to three years to go be­fore they hit the clin­ic, Smith adds, tar­get­ing ul­cer­a­tive col­i­tis.

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.

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.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

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.