Nev­er too late: For­bion pitch­es $100M SPAC; Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

Dutch VC For­bion is hop­ping on the ever-length­en­ing SPAC train.

To be led by Jasper Bos, who joined For­bion Growth as a gen­er­al part­ner back in May just af­ter the fund closed at $428 mil­lion, For­bion Eu­ro­pean Ac­qui­si­tion will tar­get late-stage op­por­tu­ni­ties in the life sci­ences in­dus­try in Eu­rope to merge with and bring on­to Nas­daq.

Cyril Less­er, se­nior con­troller at For­bion, will be the CFO while Bos serves as CEO.

Af­ter a record year for biotech SPACs, the craze for blank check com­pa­nies ap­pears to be in a bit of a lull re­cent­ly, al­though it’s clear­ly not stop­ping ex­pe­ri­enced in­vestors who think they will be able to spot a de­cent pri­vate com­pa­ny to flip pub­lic.

As is stan­dard with these types of deals, For­bion Eu­ro­pean Ac­qui­si­tion is pen­cil­ing in a $100 mil­lion raise by sell­ing shares at $10 apiece — a pitch cen­tered around the man­age­ment team’s ex­pe­ri­ence, net­work and ex­per­tise. It may raise an­oth­er $20 mil­lion “at the clos­ing of an ac­qui­si­tion,” the com­pa­ny added. — Am­ber Tong

Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

On­col­o­gy biotech Kro­nos Bio an­nounced da­ta from its on­go­ing Phase I/II clin­i­cal tri­al of its oral CDK9 in­hibitor KB-0742, which is be­ing de­vel­oped to treat MYC-am­pli­fied sol­id tu­mors.

Among the 12 pa­tients treat­ed in the tri­al, KB-0742 had a ter­mi­nal half-life of 24 hours, with ap­prox­i­mate­ly 2 to 2.5-fold ac­cu­mu­la­tion be­tween days 1 and 10. Ac­cord­ing to Kro­nos, this long plas­ma half-life sup­ports the biotech’s ap­proach to defin­ing a ther­a­peu­tic win­dow for CDK9 in­hi­bi­tion.

Fur­ther dose es­ca­la­tion — the first part of the two-stage tri­al — is re­quired to reach de­sired lev­els of CDK9 in­hi­bi­tion.

The na­ture and sever­i­ty of the ad­verse events ob­served have been con­sis­tent with what is typ­i­cal­ly seen among heav­i­ly pre­treat­ed pa­tients with ad­vanced can­cer in Phase I tri­als, and Kro­nos Bio is con­tin­u­ing to en­roll in the tri­al.

“These ear­ly da­ta are en­cour­ag­ing, and we look for­ward to con­tin­u­ing the tri­al and es­tab­lish­ing a rec­om­mend­ed Phase II dose,” said Kro­nos Bio CEO and pres­i­dent Nor­bert Bischof­berg­er.

While the first stage is de­ter­min­ing safe­ty of the drug and find­ing a dosage lev­el for pa­tients, the sec­ond stage of the tri­al will en­roll pa­tients with MYC-am­pli­fied or over-ex­press­ing tu­mors, as well as oth­er tran­scrip­tion­al­ly ad­dict­ed tu­mor types, to as­sess the an­ti-tu­mor ac­tiv­i­ty of KB-0742 at the rec­om­mend­ed Phase II dose. — Paul Schloess­er

Gilead goes with Ama­zon Web Ser­vices as its cloud provider

Gilead had de­cid­ed on Ama­zon for its cloud ser­vices.

Gilead an­nounced this morn­ing that it is go­ing with Ama­zon Web Ser­vices as its cloud provider — cit­ing AWS’s on­line port­fo­lio for in­fra­struc­ture and oth­er ser­vices.

Ac­cord­ing to Gilead, AWS’ ca­pa­bil­i­ties in ma­chine learn­ing and an­a­lyt­ics fu­el de­ci­sion mak­ing across the phar­ma — from bio­mark­er dis­cov­ery to man­u­fac­tur­ing and clin­i­cal tri­al re­cruit­ment.

“With AWS as our pre­ferred cloud provider, our re­searchers can use AWS’s port­fo­lio of ser­vices to gain the in­sights, agili­ty, and se­cu­ri­ty need­ed to de­liv­er new med­i­cines at speed,” said Gilead SVP and CIO Marc Berson in a pre­pared state­ment.

In ad­di­tion, Gilead has moved more than 50% of its da­ta cen­ter foot­print to AWS over the past year through an ac­cel­er­at­ed cloud mi­gra­tion pro­gram with AWS Pro­fes­sion­al Ser­vices. The com­pa­ny al­so plans to mi­grate hun­dreds of ap­pli­ca­tions to AWS, which in­clude ap­pli­ca­tions that sup­port in­dus­try good prac­tice guide­lines and reg­u­la­tions in ar­eas like drug man­u­fac­tur­ing, stor­age and dis­tri­b­u­tion.

As a re­sult, Gilead will be ac­cel­er­at­ing its plans to up­grade its IT op­er­a­tions with AWS, while avoid­ing up­front costs to re­fresh hard­ware and the sus­tained costs of run­ning an “al­ways on,” on-premis­es IT land­scape pro­vi­sioned for peak use. — Paul Schloess­er

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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