Bruce Beutel (Dewpoint)

Af­ter go­ing ‘crazy’ over the sci­ence, Mer­ck signs up a new part­ner in the hunt for an HIV cure

Less than a year af­ter ink­ing a $100 mil­lion li­cens­ing deal with Ger­man gi­ant Bay­er, Dew­point Ther­a­peu­tics has scored an­oth­er big-time con­tract, this time with Mer­ck. And this col­lab­o­ra­tion came to­geth­er in a par­tic­u­lar­ly un­usu­al fash­ion.

Mer­ck and Dew­point have agreed on a part­ner­ship that will pro­vide the phar­ma gi­ant with ac­cess to the Boston-based biotech’s bio­mol­e­c­u­lar con­den­sate tech­nol­o­gy in or­der to de­vel­op treat­ments, and po­ten­tial­ly a cure, for the HIV virus. Dew­point, in turn, will re­ceive up to $305 mil­lion in up­front and mile­stone pay­ments as well as roy­al­ties for any ap­proved prod­uct.

Ann Kwong

Bruce Beu­tel, Dew­point’s COO, worked at Mer­ck for sev­er­al years be­fore join­ing the biotech, and said he kept in touch with his for­mer col­leagues to bring about a sci­en­tif­ic “meet­ing of the minds” be­tween Dew­point ex­ec­u­tive VP Ann Kwong and and Daria Hazu­da, CSO of Mer­ck’s MRL Cam­bridge Ex­plorato­ry Sci­ence Cen­ter.

“[The meet­ing] was ob­vi­ous­ly very suc­cess­ful, and I think what came out of that was the sci­en­tists on both sides re­al­ly were push­ing the busi­ness peo­ple go­ing, ‘You have to find a way to make this work,’” Beu­tel said. “That’s al­ways the best; so of­ten in busi­ness de­vel­op­ment it’s the op­po­site.”

“There was no one from BD on our side but there were two guys from BD on the Mer­ck side in the back of the room,” Kwong added. “Daria and I just sat down at the end of a long ta­ble and we just went crazy for about an hour, hour and a half talk­ing vi­ral­i­ty. It was so much fun.”

Daria Hazu­da

The rap­port shared by the sci­en­tists al­lowed the com­pa­nies to quick­ly iron out their con­tract. Beu­tel said they on­ly need­ed about two and a half months to work every­thing out, mov­ing at a break­neck pace for the phar­ma in­dus­try.

“When I got up from the ta­ble, I turned around and the two BD guys were sit­ting there and their mouths were lit­er­al­ly hang­ing open,” Kwong said with a laugh.

Dew­point it­self fo­cus­es its re­search on bio­mol­e­c­u­lar con­den­sates — droplet-like struc­tures that form dy­nam­i­cal­ly with­in cells when di­verse “com­mu­ni­ties” of pro­teins, RNAs and oth­er bio­mol­e­cules come to­geth­er through phase sep­a­ra­tion. Con­den­sates have been known to sci­en­tists for more than a cen­tu­ry, but Dew­point aims to study how such com­mu­ni­ties in­ter­act and hope­ful­ly cre­ate new treat­ments for dis­eases.

“It’s like when you have oil and vine­gar and you shake it up and you see those lit­tle bub­bles,” Kwong said. “Cells use this to con­cen­trate and sep­a­rate com­mu­ni­ties of bio­mol­e­cules that usu­al­ly in­volve nu­cle­ic acids and dif­fer­ent kinds of pro­teins.”

The deal Dew­point signed with Bay­er, agreed to last No­vem­ber, fo­cused on de­vel­op­ing the biotech’s con­den­sate li­brary and treat­ing car­dio­vas­cu­lar and gy­ne­co­log­i­cal dis­eases.

As for the Mer­ck col­lab­o­ra­tion, mod­ern HIV treat­ments can sup­press vi­ral loads to un­de­tectable lev­els, but the virus re­mains la­tent in cer­tain cells and virus counts will rise if treat­ment is dis­con­tin­ued. Beu­tel and Kwong are keep­ing the sci­en­tif­ic nuts and bolts un­der wraps, but es­sen­tial­ly con­firmed their tech will in some shape or form tar­get la­tent HIV-in­fect­ed cells.

What they will di­vulge is how their tech could po­ten­tial­ly be ap­plied to fight­ing HIV in a gen­er­al sense. By ma­nip­u­lat­ing how com­mu­ni­ties with­in cells in­ter­act, a whole new world of pos­si­bil­i­ties opens up, Beu­tel said.

“In the case of HIV, there will be con­den­sates that are in­volved in the vi­ral life cy­cle, and we’re go­ing to be able to mod­u­late that in a way that pre­vi­ous HIV dis­cov­ery ef­forts sim­ply ig­nored,” Beu­tel said. “That’s go­ing to let you do new things, and hope­ful­ly af­fect a cure like we’re talk­ing about, in a way that you just couldn’t en­vi­sion do­ing when you were fo­cus­ing on the in­di­vid­ual mol­e­c­u­lar tar­gets.”

This kind of re­search in­to bio­mol­e­c­u­lar con­den­sates is still quite new, and Dew­point is years away from pro­duc­ing a clin­i­cal prod­uct, per Beu­tel. But that doesn’t mean they will stop search­ing for that Holy Grail — find­ing the elu­sive cure for HIV.

“You have to deal with the la­tent in­te­grat­ed virus and all of that, so this is re­al­ly the ma­jor fo­cus,” Kwong said.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When Infinity put up duvelisib for a no-money-down instant deal, the biotech was looking for a quick exit from a clinical disaster. AbbVie had walked away from their alliance after looking at how the data stacked up in a crowded field.

And while it was approvable, it wasn’t looking pretty to anyone who thought in commercial terms.

One Big Pharma’s trash, though, was seen as a biotech treasure as a deeply troubled Verastem stepped up to grab the PI3K-delta/gamma — promising to run it across the goal lines at the FDA. And they did just that, only with little to show for it.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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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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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.