An up­start jumps al­most overnight from pre­clin­i­cal to PhI with a $35M Take­da deal and a buy­out op­tion

In­grid Swan­son Pultz

Here’s a non­tra­di­tion­al way to set up a biotech com­pa­ny and shoot straight at a buy­out.

About six years ago, In­grid Swan­son Pultz ad­vised a group of stu­dents at the Uni­ver­si­ty of Wash­ing­ton who took on the chal­lenge of us­ing 3D struc­ture pro­tein de­sign tech to de­vel­op a new ther­a­py for celi­ac dis­ease, marked by a se­vere re­ac­tion to gluten.

Start­ing out with an en­zyme that could with­stand the harsh, acidic en­vi­ron­ment of the stom­ach, they en­gi­neered it specif­i­cal­ly to go af­ter frag­ments of gluten that trig­ger a gut re­ac­tion. And they did well, win­ning a pres­ti­gious com­pe­ti­tion.

But Pultz didn’t stop there.

She con­tin­ued to work on the en­zyme dur­ing her post­doc days and then as a fac­ul­ty mem­ber at the In­sti­tute for Pro­tein De­sign at the Uni­ver­si­ty of Wash­ing­ton. Grant mon­ey was avail­able to go far be­yond the usu­al bound­aries that can lim­it an aca­d­e­m­ic project, she tells me, tak­ing it right up to the clin­ic. A cou­ple of months ago her ther­a­py — now called Ku­ma­Max — was spun out in a start­up dubbed PvP Bi­o­log­ics. And to­day Take­da is an­nounc­ing that it is putting up $35 mil­lion to cov­er a Phase I proof of con­cept study, with an op­tion to buy the new­ly cre­at­ed com­pa­ny for an undis­closed pack­age of fees and mile­stones.

PvP is a sin­gle-as­set play with a small team, five peo­ple in San Diego, where Adam Simp­son is pres­i­dent and CEO. And Swan­son re­mains in Seat­tle with a team of three.

Guid­ing them through a lot of this has been their chair­man, Tadata­ka “Tachi” Ya­ma­da, a part­ner at Fra­zier Health­care and the for­mer chief med­ical and sci­en­tif­ic of­fi­cer at Take­da, which has been un­der­go­ing a top-to-bot­tom over­haul over the past year.

Pultz’s work here is just the lat­est of sev­er­al ex­am­ples of aca­d­e­mics who are bust­ing through some old bar­ri­ers and mov­ing new ther­a­pies in­to or close to the clin­ic. Re­cent­ly a Van­der­bilt team took an Alzheimer’s drug in­to Phase I. Stan­ford’s Irv Weiss­man, us­ing CIRM grants, al­so went in­to ear­ly stage work with grant mon­ey and lat­er start­ed Forty Sev­en, a can­cer drug com­pa­ny. And Har­vard’s Blavat­nik Bio­med­ical Ac­cel­er­a­tor took a promis­ing pre­clin­i­cal AML pro­gram from the lab of Matthew Shair and sold it to Mer­ck for $20 mil­lion up­front last spring.

Pultz may do bet­ter than any of them, in less time. The Take­da deal puts her new com­pa­ny on a short track to a po­ten­tial ac­qui­si­tion, and the PvP team will get through Phase I with­out rais­ing a tra­di­tion­al round from a ven­ture group.

Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Sanofi teams up with Mer­ck to pair Keytru­da with a next-gen IL-2 can­di­date from the Syn­thorx buy­out

Nearly a year after snapping up a next-gen immuno-oncology candidate in its $2.5 billion Synthorx buyout, Sanofi is joining forces with Merck to pair the drug with blockbuster Keytruda.

The pharmas are planning a Phase II trial of Sanofi’s non-alpha IL-2 candidate THOR-707 in combination or sequenced administration with Keytruda for various cancers. While the companies are keeping mum about the financial terms and targets, they said the trials will be Sanofi-sponsored.

CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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Kevin Lind (L) and Amit Munshi

Are­na's Amit Mun­shi spins out his neu­ro sub in­to a biotech start­up, with $56M for the bap­tism

Back in January, Arena Pharma $ARNA CEO Amit Munshi turned up at JP Morgan with ambitious plans for 2020. Near the top of the to-do list was news that he was creating a new neuro subsidiary that would focus on microglial neuroinflammation.

Now, he’s taking the sub and spinning it out into a new biotech with $56 million in funding and a syndicate of its own to back up their work. And Munshi — who’s been successful running the market cap up to the $5 billion mark — will take his value from the 33% equity stake that Arena retains in the spinout.

Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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Managing partner Stefan Fischer (TVM)

Eli Lil­ly part­ner TVM Cap­i­tal rais­es $478M for their new life sci­ences fund, a 'sub­stan­tial' over­sub­scrip­tion

A German-Canadian VC fund and high-profile Eli Lilly partner has nearly half a billion dollars in new cash to play with.

TVM Capital Life Science, based out of Munich and Montreal, announced the closing of its second and latest fund Tuesday with $478 million in hand. That total represents a “substantial” oversubscription, managing partner Stefan Fischer said, and a good 36.5% more than the $350 million initially expected.