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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC deal in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Derek Chalmers, Cara Therapeutics CEO

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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