Jason Lettmann, Lightstone Ventures

Light­stone Ven­tures un­veils $375M third fund, this time ex­pand­ing its wish­list in blos­som­ing CNS field

Neu­ro­science is hav­ing a mo­ment right now, and one VC firm strad­dling the line be­tween biotech and medtech is look­ing to cap­i­tal­ize on the field’s rapid growth.

Light­stone Ven­tures has raised $375 mil­lion for its third ven­ture fund with an eye on ex­pand­ing its fo­cus in CNS dis­ease, the firm said Tues­day.

The newest raise brings Light­stone’s to­tal to more than $850 mil­lion since the firm was found­ed back in 2012. So far, that trea­sure chest has led to in­vest­ments in around 30 com­pa­nies split across the biotech and medtech spaces. With its third and largest fund, Light­stone is ex­pect­ing much the same as be­fore — most­ly in­vest­ments in seed-stage to Se­ries A com­pa­nies with an eye on “break­throughs” in pa­tient care, gen­er­al part­ner Ja­son Lettmann told End­points News.

What is new, Lettmann said, is a broad­er fo­cus on CNS star­tups, which con­tin­ues Light­stone’s piv­ot in­to that space dat­ing back to the firm’s sec­ond fund. But the team is al­so keep­ing the door open in oth­er ther­a­peu­tic ar­eas.

“Look­ing for­ward, we are plan­ning to spend a lot of time (in CNS),” Lettman said. “We re­al­ly do be­lieve CNS is the next fron­tier. We’re go­ing to try to spend more time in the un­der­ap­pre­ci­at­ed ar­eas, whether that’s au­toim­mune, im­munol­o­gy, etc. That’s where we’ll prob­a­bly look.”

In terms of tar­get­ed deal size or how many com­pa­nies are on the hit list, Lettman was mum, say­ing Light­stone will look at deals of rough­ly the same size and de­vel­op­ment stage, this time with more cap­i­tal flex­i­bil­i­ty, and re­main open to “op­por­tunis­tic” late-stage fly­ers.

In ear­ly-stage in­vest­ment, one of the biggest de­bates among VCs is the prod­uct-vs-plat­form par­a­digm, and Lettmann had some thoughts on ex­act­ly how his firm thinks about that di­vide. Light­stone tar­gets what it calls plat­form plays in both the biotech and medtech space but asks com­pa­nies to quick­ly nar­row the fo­cus around a sin­gle or clutch of prod­ucts.

“We don’t in­vest in plat­forms just for the sake of a plat­form,” Lettman said. “I think one of the things we’re most proud of is how many of our com­pa­nies have ul­ti­mate­ly de­vel­oped ther­a­pies that have been ap­proved in pa­tients. So I think our strat­e­gy is to find things where there are mul­ti­ple shots on goal but re­al­ly quick­ly piv­ot to a prod­uct fo­cus.”

Get­ting in ear­ly at the seed stage for com­pa­nies af­fords Light­stone a chance to help en­tre­pre­neurs shape their com­pa­ny’s tra­jec­to­ry mov­ing in­to the fu­ture. For Lettmann, the ide­al part­ner en­tre­pre­neurs are “op­er­a­tors” with ex­pe­ri­ence in the space and with star­tups, but the firm still takes a hands-on ap­proach when deal­ing with com­pa­nies.

“I think one of the ad­van­tages of a fund of our size is the abil­i­ty to re­al­ly fo­cus and spend the time to launch those com­pa­nies,” he said. “We do re­al­ly try to roll up our sleeves.”

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

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For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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