Backed by Or­biMed and J&J to build pre­ci­sion bac­te­ria-killing tool, Bio­mX adds a slate of in­vestors in $32M Se­ries B

When it comes to tin­ker­ing with the mul­ti­tude of bac­te­ria re­sid­ing in our bod­ies for dis­ease treat­ment, an­tibi­otics has been the go-to for elim­i­nat­ing bad ones while the bur­geon­ing crop of mi­cro­bio­me biotechs aim to add “good” mi­crobes to the mix. But a Weiz­mann In­sti­tute spin­out work­ing out of the Kendall Square of Is­rael is chart­ing a path be­tween those two ap­proach­es with the clin­i­cal stop in sight.

Jonathan Solomon

Bio­mX’s pre­ci­sion tool, which uti­lizes a cus­tomized con­coc­tion of phages to kill spe­cif­ic bac­te­ria as­so­ci­at­ed with dis­ease, has won the back­ing of Or­biMed, J&J and Take­da Ven­tures, among oth­ers, since its ear­ly days. Two years lat­er, the syn­di­cate is com­ing back for more, with a siz­able group of new in­vestors tag­ging along for a $32 mil­lion round as the biotech be­gins test­ing its phage cock­tails in ac­ne and in­flam­ma­to­ry bow­el dis­ease.

Hav­ing nailed down the phage ther­a­py — a top­i­cal gel — for ac­ne and cross-checked the tar­gets with sam­ples from hun­dreds of pa­tients, Bio­mX’s 60-per­son team is look­ing to gath­er some proof-of-mech­a­nism da­ta by the end of the year, CEO Jonathan Solomon tells me.

Ad­di­tion­al­ly, they are cook­ing up treat­ments for can­cer and liv­er dis­ease that should fol­low in the clin­ic soon af­ter the IBD pro­gram al­so be­gins hu­man test­ing in 2020. The grow­ing body of sci­en­tif­ic work elu­ci­dat­ing links of bac­te­ria like He­li­cobac­ter py­lori and Fu­sobac­teri­um nu­clea­tum to gas­tric and col­orec­tal can­cers has dri­ven in­vestors’ in­ter­est in Bio­mX, he says.

“We’re bet­ting that there’s more and more cas­es like that,” he adds, where they could find spe­cif­ic bac­te­ria dri­ving dis­ease and have a pre­ci­sion tool ready “just to take out what we think is the cul­prit.”

As­saf Oron

Down the line, their ap­proach might lend it­self to com­bi­na­tion reg­i­mens where they can team up with oth­er mi­cro­bio­me drugs to add good, pro­tec­tive bac­te­ria af­ter tak­ing out the bad ones. But they would pre­fer to prove one thing at a time.

Bio­mX is al­so work­ing with key in­vestor J&J on bio­mark­er de­vel­op­ment, us­ing the gut mi­cro­bio­me to iden­ti­fy re­spon­ders for one of the phar­ma gi­ant’s key IBD drugs, chief busi­ness of­fi­cer As­saf Oron says.

New back­ers for the round — many of which have been look­ing at the com­pa­ny for a while, ac­cord­ing to Solomon — in­clude RM Glob­al Part­ners, Chong Kun Dang Phar­ma­ceu­ti­cal, Han­dok, KB In­vest­ment and Con­sen­sus Busi­ness Group. Ex­ist­ing in­vestors 8VC, Mi­rae­As­set, Sev­en­ture Part­ners and SBI Japan-Is­rael In­no­va­tion Fund al­so joined in.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Levi Garraway, Roche CMO (Source: Genentech)

UP­DAT­ED: FDA hands out a quick OK for po­ten­tial SMA block­buster ris­diplam, giv­ing Genen­tech and Roche a chance to chal­lenge ri­vals on the price

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.

Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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Elisa Kieback (T-knife)

Ver­sant funds TCR ther­a­py biotech T-knife's $78M+ Se­ries A to boost hu­man­ized T cell mice plat­form

Just a day after announcing the formation of a startup in Switzerland that will develop alternative TCR cell therapies, Versant is keeping its foot on the gas.

The multibillion dollar life sciences VC announced Thursday morning it is leading the Series A funding of T-knife, a German biotech that plans to use its proprietary humanized T cell receptor (HuTCR) mouse platform to treat solid tumors. T-knife raised about $78.4 million in the round and hopes to not only develop its own pipeline but also license out its mice for use by other companies.

UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.