Hugh Rienhoff, Imago

Blood can­cer play­er Ima­go Bio­sciences caps off an $80M Se­ries C with an IPO promise for 2021

A lit­tle less than two years af­ter se­cur­ing $40 mil­lion in a Se­ries B, Ima­go Bio­sciences has re­turned to the ven­ture cap­i­tal well with an even big­ger prize.

The San Fran­cis­co-based biotech has pulled in $80 mil­lion for their Se­ries C on Thurs­day, aim­ing to use the funds for one Phase III tri­al for their lead blood can­cer pro­gram, bomedem­stat. The ex­per­i­men­tal drug is be­ing eval­u­at­ed in two Phase IIb stud­ies, in myelofi­bro­sis and es­sen­tial throm­bo­cythemia.

“We start­ed this crossover cam­paign in the lat­ter part of the sum­mer and it came to­geth­er very quick­ly,” CEO Hugh Rien­hoff told End­points News. “It was over­sub­scribed, but we on­ly want­ed to raise $80 mil­lion.”

Far­al­lon Cap­i­tal Man­age­ment led the round, with new in­vestors in­clud­ing T. Rowe Price, Black­rock, Sur­vey­or Cap­i­tal, Irv­ing In­vestors and King­don Cap­i­tal Man­age­ment.

Rien­hoff’s plan here is to use this fund­ing for a Phase III in ei­ther MF or ET, and then prep an IPO some­time next year to get the cash for the oth­er in­di­ca­tion. Both of the Phase IIb tri­als are ex­pect­ed to be ful­ly en­rolled by the mid­dle of 2021, and since they’re open-la­bel, Ima­go can check every week to see if bomedem­stat has hit the pri­ma­ry end­points, he said.

In the best-case sce­nario, Ima­go will launch both Phase III stud­ies in mid-2022, giv­ing the com­pa­ny rough­ly two years to ob­tain all the nec­es­sary fund­ing for both late-stage tri­als, CBO Ed Barac­chi­ni said. The IPO will like­ly be high­er than Thurs­day’s Se­ries C, Rien­hoff added, though the mon­ey from this raise will car­ry one of the stud­ies through com­ple­tion in 2025.

Ed Barac­chi­ni

Bomedem­stat works by in­hibit­ing LSD1, an en­zyme that plays a piv­otal role in stem cell dif­fer­en­ti­a­tion and re­pro­duc­tion in these types of blood can­cers. The mu­ta­tions picked up in MF and ET are both re­lat­ed to this en­zyme, and by tamp­ing down on the ac­tiv­i­ty Ima­go hopes to kill ma­lig­nant stem cells and re­duce platelet pro­duc­tion gone awry, the lat­ter be­ing a ma­jor prob­lem in ET.

“I’m very op­ti­mistic that we have the right in­di­ca­tions for this tar­get, and I think we have the right drug for this tar­get,” Rien­hoff said. “In oth­er words, not all LSD1 in­hibitors are cre­at­ed equal, and so there have been oth­er LSD1 pro­grams that have failed be­cause the drug got in­to the wrong place or hit the wrong tar­get oth­er than LSD1. So we’re for­tu­nate in that re­gard, and it al­so has a ter­rif­ic safe­ty pro­file.”

Fur­ther down the pipeline, Ima­go is look­ing to test bomedem­stat in com­bi­na­tion with rux­oli­tinib, al­so known as In­cyte’s block­buster JAK in­hibitor Jakafi. The drug, which is ap­proved to treat poly­cythemia ve­ra and forms of myelofi­bro­sis, net­ted sales of near­ly half a bil­lion dol­lars in 2020’s sec­ond quar­ter and $1.7 bil­lion in 2019.

A com­bo ther­a­py of rux­oli­tinib and bomedem­stat could work par­tic­u­lar­ly well for pa­tients just start­ing their treat­ments, Rien­hoff said, be­cause while rux­oli­tinib on its own helps symp­toms of the dis­ease, most pa­tients lose ben­e­fits af­ter two or three years since it doesn’t aid dis­ease pro­gres­sion. That’s where Rien­hoff says Ima­go’s can­di­date can step in.

“We’re fo­cused on those pa­tients that have ex­haust­ed, if you will, the clin­i­cal ben­e­fits of rux­oli­tinib and need some­thing else that has a com­plete­ly dis­tinct mech­a­nism of ac­tion,” Rien­hoff said.

Ima­go is al­so de­vel­op­ing pro­grams for sick­le cell dis­ease and sol­id tu­mors, but those won’t hit the clin­ic un­til 2022 at the ear­li­est.

Ex­ist­ing in­vestors to re­turn for this round in­clud­ed Black­stone Life Sci­ences, Fra­zier Health­care Part­ners, Omega Funds, Am­gen Ven­tures, MRL Ven­tures Fund, High­Light Cap­i­tal, Phar­maron In­vest­ments, Green­spring As­so­ci­ates and Xer­aya Cap­i­tal.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Iain McGill, Quell CEO

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

Amid burgeoning efforts to create a new type of cell therapy out of regulatory T cells — whether by channeling or blocking their immunosuppressive power — Quell Therapeutics wants to shoot for a first.

If everything goes well, the Syncona-backed biotech will be in the clinic early next year, marking what it calls the historic feat of dosing a patient with a CAR-Treg with multiple edited genes.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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