A vir­tu­al biotech in­cu­ba­tor is launch­ing with the help of Evotec and Sam­sara, look­ing for a few good sci­en­tists in need of seed cash for spin­outs

By any mea­sure, mon­ey has been pour­ing in­to the bio­phar­ma R&D field for more than 5 years now, with every stage of de­vel­op­ment crowd­ed with in­vestors look­ing for the next big thing in ther­a­peu­tics.

Val­ue in­flec­tion points are the guid­ing star of that multi­bil­lion-dol­lar busi­ness.

But a busy Sam­sara Bio­Cap­i­tal, the fam­i­ly fund KCK and the big Eu­ro­pean CRO Evotec are back­ing the play of a pair of in­vestors who have staked out a field where there doesn’t seem to be quite so much den­si­ty.

Tom No­vak and Michelle Kim-Dane­ly are launch­ing a vir­tu­al in­cu­ba­tor called Au­to­bahn Labs, which is at the be­gin­ning stages of ink­ing deals with aca­d­e­m­ic labs to seed spin­out com­pa­nies for their dis­cov­er­ies. Sam­sara and KCK are pro­vid­ing up to $5 mil­lion per op­er­a­tion, with Evotec on board to lend its ex­ten­sive con­tract plat­form sup­port to the fledg­lings that sign on. And the sci­en­tists can al­so tap Au­to­bahn’s ad­vi­so­ry group as they steer their lit­tle com­pa­nies through pre­clin­i­cal de­vel­op­ment.

Tom No­vak

“Our plan,” No­vak tells me, “is to en­ter in­to part­ner­ships with ma­jor uni­ver­si­ties and find pro­grams that are at very ear­ly stage, 3 to 4 years ahead of the clin­ic.”

And the rare few that make it to launch can look to one of their in­vestors to take the lead on an A round.

To get start­ed, Au­to­bahn has signed up UCLA on kind of a mas­ter con­tract that lays out the terms cov­er­ing IP and eq­ui­ty and so on — and no, they aren’t de­tail­ing the par­tic­u­lars of the con­tract to me.

For sci­en­tists with­out se­lect VCs on speed di­al, that might look quite ap­peal­ing. And now No­vak and Kim-Dane­ly are look­ing to repli­cate the UCLA deal, pri­mar­i­ly along the West Coast but al­so back east as well as Eu­rope.

Michelle Kim-Dane­ly

Both of the prin­ci­pals at Au­to­bahn are re­al­is­tic about the like­li­hood of fail­ure. They es­ti­mate that 85% to 90% of their seed plays won’t make it to the clin­ic and that next lev­el of de­vel­op­ment. But get­ting 1 out of 10 small in­vest­ments to pay off could work out well. No­vak says they have enough mon­ey for 8 on­go­ing projects at a time.

“It’s im­por­tant to have dif­fer­ent mod­els, dif­fer­ent sweet spots,” says Kim-Dane­ly. “For uni­ver­si­ties it’s an­oth­er ar­row in their quiv­ers.”

As for dis­ease ar­eas and tech, the two say they are com­plete­ly ag­nos­tic.

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.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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