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.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,600+ biopharma pros reading Endpoints daily — and it's free.

Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.

Jonathan Symonds [via HSBC]

GSK to tap Jonathan Symonds as chair­man, lever­ag­ing Big Phar­ma ex­pe­ri­ence for con­sumer biz deal

Six months into its search for a new board chairman, GlaxoSmithKline has apparently found the perfect candidate in a seasoned executive groomed at AstraZeneca and Novartis. Jonathan Symonds is in the final stages of being appointed, Bloomberg reports.

In January Sir Philip Hampton announced his intention to step down and make way for a new leader to oversee the consumer health joint venture GSK is setting up with Pfizer. The deal — announced a month prior — would spin out the unit formerly headed by GSK CEO Emma Walmsley and merge it with the equivalent division at Pfizer to create a new entity to be listed separately.

UP­DAT­ED: Am­gen, No­var­tis scrap Alzheimer's stud­ies — is BACE fi­nal­ly dead or will Bio­gen and Ei­sai car­ry on?

The BACE theory of controlling Alzheimer’s died with failed pivotal projects at Merck, Eli Lilly and their partners at AstraZeneca. Now Amgen and Novartis have come along to bulldoze it under a mound of safety threats — leaving only Biogen and Eisai to carry on with a less than zero chance of success — with the notable addition that they may actually be doing harm to patients.

After the market closed Thursday, Amgen and Novartis announced that they were dumping two pivotal programs underway with the Banner Alzheimer’s Institute on their BACE drug CNP520 (umibecestat) after an independent review of the data indicated that patients’ cognitive abilities were actually worsening at a faster pace than the placebo arm.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,600+ biopharma pros reading Endpoints daily — and it's free.

Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Fresh out of Eli Lil­ly, Christi Shaw sur­faces as Daniel O'­Day's new CEO at CAR-T pi­o­neer Kite

Well, that didn’t take long. 

We found out Thursday evening that Christi Shaw has given up her top post as the head of the Bio-Medicines group at Eli Lilly for the helm at CAR-T pioneer Kite. New Gilead CEO Daniel O’Day, a Roche veteran, had made finding a Kite CEO a top priority on his arrival at Gilead. And he went right for a headliner.

O’Day was clearly excited about the coup.

“We conducted an extensive search for a new leader at Kite and we believe that Christi’s unique set of skills will allow us to continue to build on our leadership position in cell therapy,” he said in a prepared statement. “Christi’s vast experience across complex therapeutic areas, and particularly in oncology, will serve Kite very well. She is clearly a leader who will bring teams and individuals together and I am confident she will build upon the entrepreneurial spirit at Kite as we seek to help more people with cancer around the world.”

Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Eli Lil­ly's Christi Shaw bows out of top post at the Bio-Med­i­cines unit

Less than 3 years after Eli Lilly CEO David Ricks recruited Novartis vet Christi Shaw to run their big Bio-Medicines business, she’s out.

In a statement put out Thursday morning, Lilly said that Shaw’s last day will come at the end of August. Patrik Jonsson, currently president and general manager of Lilly Japan, will succeed Shaw once he gets the paperwork sorted out.

Lilly’s shares dropped 4% on the news.

Jeff Poulton

Al­ny­lam’s Maraganore switch­es ‘per­haps the best CFO in mid-cap biotech’ with Shire vet Jeff Poul­ton

There’s a new CFO taking charge of the numbers at RNAi pioneer Alnylam.

Alnylam chief John Maraganore says that CFO Manmeet S. Soni is leaving in the proverbial pursuit of new opportunities. And he’s being replaced by ex-Shire CFO Jeff Poulton, not long after the Takeda takeover obliterated that position.

Endpoints News

Basic subscription required

Unlock this story instantly and join 54,600+ biopharma pros reading Endpoints daily — and it's free.