Mark Timney, Blade Therapeutics chairman (Blade)

Small biotech chaired by ex-Pur­due CEO Mark Tim­ney jumps in­to the SPAC lane

The lat­est biotech SPAC has land­ed, and it’s one fea­tur­ing Pur­due Phar­ma’s for­mer CEO, Mark Tim­ney.

Blade Ther­a­peu­tics an­nounced its plans Mon­day to re­verse merge with the blunt­ly named Biotech Ac­qui­si­tion Com­pa­ny in a $254.3 mil­lion deal. Tim­ney, who cur­rent­ly serves as Blade’s ex­ec­u­tive chair­man, will re­tain the same role once the com­bined com­pa­ny com­pletes the merg­er in the first quar­ter of 2022.

Most of the funds — $230 mil­lion — come from the SPAC’s bank ac­count with the re­main­ing $24.3 mil­lion stem from a PIPE fi­nanc­ing that has a blue-chip slate of back­ers, in­clud­ing Deer­field, the VC arms of Pfiz­er and Bris­tol My­ers Squibb, MPM Cap­i­tal and Os­age Uni­ver­si­ty Part­ners.

As to what the SPAC cash will fund, Blade said in a press re­lease it ex­pects to push for­ward “clin­i­cal, man­u­fac­tur­ing and pre­clin­i­cal ac­tiv­i­ties” for its lead pro­grams with the new mon­ey.

Lit­tle ink has been spilled about Blade, but the South San Fran­cis­co-based biotech is aim­ing to bring oral small-mol­e­cule drugs to mar­ket. The lead pro­gram is known as cud­e­tax­e­s­tat, which Blade de­scribes as a “non-com­pet­i­tive, re­versible in­hibitor of au­to­tax­in.” It’s ex­pect­ed to en­ter a Phase II study in the first half of next year for id­io­path­ic pul­monary fi­bro­sis, Blade said.

Cud­e­tax­e­s­tat al­so re­cent­ly be­gan an­oth­er Phase I study last month to in­ves­ti­gate how it works in com­bi­na­tion with oth­er ap­proved ther­a­pies in IPF. It’s ex­pect­ed to wrap up be­fore April 2022.

The biotech al­so has three pre­clin­i­cal can­di­dates cur­rent­ly un­der de­vel­op­ment, each of which are cal­pain in­hibitors. Blade’s lead pre­clin­i­cal pro­gram is BLD-2184, which it’s de­vel­op­ing to treat a range of neu­rode­gen­er­a­tive dis­or­ders such as Hunt­ing­ton’s dis­ease, spin­ocere­bel­lar atax­ia type 3, Parkin­son’s dis­ease and Lewy body de­men­tia, among oth­ers.

Blade says it’s plan­ning a Phase I tri­al for BLD-2184 in the first half of 2022. The biotech’s oth­er two pre­clin­i­cal pro­grams are be­ing de­vel­oped for lung and liv­er fi­bro­sis, re­spec­tive­ly.

De­spite be­ing named in dozens of law­suits for his role in the opi­oid epi­dem­ic at Pur­due, Tim­ney has not found him­self lack­ing job op­por­tu­ni­ties. He pre­vi­ous­ly joined The Med­i­cines Com­pa­ny as CEO in De­cem­ber 2018, earn­ing an $84 mil­lion wind­fall in the biotech’s near­ly $10 bil­lion sale to No­var­tis the next year. And ear­li­er this year, Tim­ney joined At­tralus Ther­a­peu­tics as CEO in his next stop.

SPACs con­tin­ue chug­ging along fol­low­ing a mas­sive boom ear­li­er this year, lead­ing to more than $300 bil­lion across all mar­ket sec­tors by the end of the first quar­ter. Af­ter reg­u­la­tors asked fi­nan­cial in­sti­tu­tions to vol­un­tar­i­ly pro­vide doc­u­men­ta­tion on how they were in­ter­nal­ly polic­ing the blank-check com­pa­nies, ac­tiv­i­ty slowed, but it’s since picked back up as the year moved on.

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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