IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO en­gine is thriv­ing, nev­er mind the ram­page of the coro­n­avirus cri­sis on R&D time­lines.

On Fri­day, along with syn­thet­ic lethal­i­ty-fo­cused biotech Re­pare Ther­a­peu­tics, an­oth­er Bris­tol My­ers part­ner For­ma Ther­a­peu­tics al­so un­veiled its plans to vault on to the Nas­daq — pen­cil­ing in a tar­get of $150 mil­lion.

Frank Lee

The Wa­ter­town, Mass­a­chu­setts-based com­pa­ny — which poached se­nior Genen­tech ex­ec­u­tive Frank Lee to take over the reins last year af­ter more than a decade un­der founder Steve Tre­gay — raised a plump $100 mil­lion late last year, while shep­herd­ing its sick­le cell dis­ease (SCD) drug through an ear­ly-stage tri­al.

Last No­vem­ber, the FDA ush­ered in the ap­proval of two SCD ther­a­pies, in­ject­ing some op­ti­mism in­to an oth­er­wise bar­ren treat­ment land­scape for pa­tients with the blood dis­or­der that is char­ac­ter­ized by atyp­i­cal he­mo­glo­bin mol­e­cules, which can dis­tort red blood cells in­to a sick­le, or cres­cent, shape. No­var­tis’ ther­a­py, Adakveo, is de­signed to pre­vent pe­ri­od­ic episodes of sear­ing pain called va­so-oc­clu­sive crises (VOCs) that de­prive the de­prive the body of oxy­gen-rich blood, while Glob­al Blood Ther­a­peu­tics’ vox­elo­tor is de­signed to work by in­creas­ing he­mo­glo­bin’s affin­i­ty for oxy­gen.

In­stead of ad­dress­ing symp­toms of SCD, For­ma’s lead ther­a­py, FT-4202, is de­signed to change the course of the dis­ease as an ac­ti­va­tor of the en­zyme pyru­vate ki­nase-R (PKR) to im­prove red blood cell me­tab­o­lism, func­tion and sur­vival, po­ten­tial­ly re­sult­ing in both in­creased he­mo­glo­bin lev­els and few­er VOCs. For­ma is in a crowd­ed field of ther­a­pies in de­vel­op­ment, with oth­er drug­mak­ers in­clud­ing blue­bird bio, Imara, and part­ners CRISPR Ther­a­peu­tics and Ver­tex, al­so work­ing on their own drugs.

Mean­while, For­ma al­so plans to eval­u­ate the use of FT-4202 in be­ta tha­lassemia. The com­pa­ny al­so has a brim­ming pipeline, in­clud­ing an AML drug and a NASH ther­a­py in mid-stage de­vel­op­ment, as well as ear­li­er-stage com­pounds for NASH, NHL (part­nered with Bris­tol My­ers Squibb)  and sol­id tu­mors (in col­lab­o­ra­tion with Boehringer In­gel­heim).

There has been a flur­ry of bio­phar­ma IPO’s in re­cent­ly — Gen­er­a­tion Bio, Avid­i­ty and Vax­cyte set their sights on a com­bined $325 mil­lion and the week be­fore ADC Ther­a­peu­tics raked in $233 mil­lion in an up­sized of­fer­ing — de­spite the gen­er­al pan­de­mo­ni­um on Wall Street due to Covid-19. But the life sci­ences sec­tor has emerged large­ly im­mune from the rout.

Swe­den’s Cal­lid­i­tas, which last week said it was eye­ing a $75 mil­lion raise (a mod­est sum com­pared to some of the splashier pub­lic de­buts seen in re­cent weeks), on Mon­day in­di­cat­ed it was com­menc­ing an in­vestor road­show. The com­pa­ny, which is de­vel­op­ing a ther­a­py for an or­phan kid­ney dis­ease, al­ready has a Swedish list­ing.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Glax­o­SmithK­line moves malar­ia vac­cine pro­duc­tion to In­dia; Nevakar bags Eu­ro­pean part­ner and nine-fig­ure deal

GSK is shifting production of its malaria vaccine to a Covid-19 vaccine developer in India.

Wednesday’s move to Bharat Biotech was made as part of efforts to battle the deadly fever, as GSK’s vaccine is the first to prove effective in combating the disease. Bharat will take over manufacturing of the protein part of the vaccine while GSK continues developing the adjuvant portion of the shot.

The vaccine is currently being piloted in regions of Ghana, Kenya and Malawi under the Malaria Vaccine Implementation Program. More than 500,000 children have received the first dose since the pilots were initiated by the three countries in 2019.

Lil­ly at­tempts to re­vive an old idea for tack­ling pain, li­cens­ing PhI pro­gram from Japan’s Asahi Ka­sei Phar­ma

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.