Gary Glick (Scorpion Therapeutics)

UP­DAT­ED: Se­r­i­al en­tre­pre­neur Gary Glick sells an­oth­er one of his star­tups for $229M — this time to an un­like­ly buy­er

Gary Glick has proven him­self, time and again, a nifty start­up artist. Af­ter sell­ing Lyc­era to Cel­gene, he held a streak for IFM Ther­a­peu­tics — carv­ing a plate of in­flam­ma­tion pro­grams each time and turn­ing the re­sult­ing sub­sidiary over to Big Phar­ma, while keep­ing the core dis­cov­ery unit — and more re­cent­ly lined up $270 mil­lion for pre­ci­sion on­col­o­gy work at Scor­pi­on.

James Sapirstein

His lat­est deal, though, looks a bit dif­fer­ent.

Glick has sold First Wave Bio to Azur­Rx, a pen­ny stock biotech un­til a re­verse stock split on Fri­day pushed shares $AZRX back up. The stock has since slid down 11.76% to $4.81. The ma­jor­i­ty of the $229 mil­lion deal is in stock — with on­ly $18 mil­lion in cash — and as a re­sult, he will hand over the name, as­sets and con­trol to Azur­Rx CEO James Sapirstein.

Still, it ap­pears to be a good enough deal for Glick. The on­ly Form D First Wave has filed, dat­ed 2018, shows it set out to raise at most $5 mil­lion and had sold at least $2.6 mil­lion worth of eq­ui­ty pri­vate­ly.

First Wave was start­ed around the same time as IFM, Glick told End­points News, based on his old­er aca­d­e­m­ic work on im­mune me­tab­o­lism.

“So the com­pa­ny, un­like the oth­er com­pa­nies I start­ed, was not ven­ture-backed,” he said. “This is a com­pa­ny that was some­what self-fi­nanced with the group of in­di­vid­u­als who have helped start all of my com­pa­nies, and the goal was to run a very lean op­er­a­tion, very fo­cused op­er­a­tion, vir­tu­al­ly. There were nev­er any em­ploy­ees in the com­pa­ny, there were a few of us that con­sult­ed for the com­pa­ny and (got) eq­ui­ty as well.”

At the heart of the re­verse merg­er are the new for­mu­la­tions that First Wave has de­vised for niclosamide, an an­tipar­a­sitic drug ap­proved by the FDA to treat tape­worm in­fes­ta­tions. These small mol­e­cule for­mu­la­tions are gut-re­strict­ed, open­ing up a range of ap­pli­ca­tions in­clud­ing in­flam­ma­to­ry bow­el dis­ease — and they had some pos­i­tive clin­i­cal re­sults to back it up.

That caught the at­ten­tion of Azur­Rx, which spe­cial­izes in tar­get­ed, non-sys­temic ther­a­pies for gas­troin­testi­nal dis­eases.

“We have been talk­ing to First Wave for a very long time,” said Sapirstein, who not­ed he’s known Glick since their col­lege days.

Then came the Covid-19 pan­dem­ic, and sci­en­tif­ic find­ings out of Ko­rea that niclosamide — a wide­ly avail­able drug list­ed by the WHO as an es­sen­tial med­i­cine — may be a “game chang­er” as an an­tivi­ral. The serendip­i­tous de­vel­op­ment meant the val­ue of First Wave’s pro­grams bal­looned so much that Azur­Rx couldn’t quite af­ford the deal it was orig­i­nal­ly en­vi­sion­ing.

So this Jan­u­ary, the com­pa­nies set­tled for a li­cens­ing deal around two in­di­ca­tions: Covid-19 re­lat­ed GI in­fec­tions and im­mune check­point in­hibitor-as­so­ci­at­ed col­i­tis and di­ar­rhea in ad­vanced stage can­cer pa­tients.

James Pen­ning­ton

Four months in­to the Covid-19 study, Azur­Rx made the de­ci­sion to just snap it all up — and change its name to First Wave. Its pipeline will now ex­pand to in­clude three clin­i­cal IBD in­di­ca­tions in ul­cer­a­tive proc­ti­tis and ul­cer­a­tive proc­tosig­moidi­tis, ul­cer­a­tive col­i­tis and Crohn’s dis­ease.

“There is a wealth of clin­i­cal da­ta that sup­ports the an­tivi­ral and an­ti-in­flam­ma­to­ry ca­pa­bil­i­ties of niclosamide,” said James Pen­ning­ton, Azur­Rx CMO. “More re­cent­ly, da­ta gen­er­at­ed by First Wave Bio in ul­cer­a­tive proc­ti­tis sup­port­ed the broad­er po­ten­tial for niclosamide in mul­ti­ple in­flam­ma­to­ry bow­el dis­eases where we be­lieve our niclosamide for­mu­la­tions could of­fer sig­nif­i­cant ad­van­tages over oth­er cur­rent­ly avail­able treat­ments in­clud­ing steroids, 5-ASAs, and bi­o­log­ics – es­pe­cial­ly in the mild-to-mod­er­ate dis­ease stage.”

Sapirstein added that the new First Wave will al­so in­her­it the old First Wave’s man­u­fac­tur­ing process and set­up, al­low­ing for quick scale up.

Oth­er than niclosamide, First Wave will keep Azur­Rx’s lead Phase IIb pro­gram, MS1819, a po­ten­tial treat­ment for se­vere ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy in pa­tients with cys­tic fi­bro­sis.

For Glick, the sale al­lows him to fo­cus on oth­er ven­tures — and the next big thing he’s work­ing on.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to add com­ments by Gary Glick.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 128,900+ biopharma pros reading Endpoints daily — and it's free.

‘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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.