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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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