Fresh from $102M haul, IGM Bio pitch­es $100M IPO as it plots first-in-hu­man tri­al of new an­ti­bod­ies

IGM Bio­sciences is the lat­est pre­clin­i­cal biotech to shoot for a Nas­daq list­ing, pitch­ing a $100 mil­lion IPO on its unique class of can­cer-fight­ing an­ti­bod­ies.

Just as much as its tech­nol­o­gy and clin­i­cal plans the SEC fil­ing of­fers a win­dow in­to the biotech’s lit­tle known his­to­ry, high­light­ing the role that a Dan­ish chem­i­cal com­pa­ny played.

Fred Schwarz­er IGM

The com­pa­ny now known as IGM Bio­sciences — with head­quar­ters in Moun­tain View, CA — was first born in 1993 with the name of Palin­gen, it wrote. It had been fo­cused on re­search­ing nat­u­ral­ly oc­cur­ring IgM an­ti­bod­ies un­til 2010, when Hal­dor Top­søe Hold­ings came in with an eq­ui­ty in­vest­ment spurring a name change and a piv­ot to en­gi­neer­ing new an­ti­bod­ies that har­ness IgM’s 10 bind­ing do­mains, com­pared to 2 for tra­di­tion­al IgG.

Hal­dor Top­søe, a sto­ried com­pa­ny fo­cused on catal­y­sis, re­mains by far the largest stock­hold­er ahead of the pub­lic de­but; Janus Cap­i­tal, which came on board dur­ing the re­cent $102 mil­lion Se­ries C, holds bare­ly one-tenth of their shares. While Bak­er Bros and Red­mile Group each con­trol more shares than Janus, theirs is non-vot­ing com­mon stock.

Dan Chen IGM

With long­time VC Fred Schwarz­er at the helm and Roche/Genen­tech vets Bruce Keyt and Dan Chen as CSO and CMO, re­spec­tive­ly, IGM is first pur­su­ing a bis­pe­cif­ic T cell en­gager tar­get­ing CD20 on can­cer cells and CD3 on T cells. Ini­tial dos­ing of the drug, IGM-2323, in pa­tients with re­lapsed/re­frac­to­ry B cell non-Hodgkin’s lym­phoma is planned for lat­er in 2019.

Ex­ecs are al­so hope­ful about even­tu­al­ly ex­pand­ing to oth­er hema­to­log­ic ma­lig­nan­cies ex­press­ing CD20, such as chron­ic lym­pho­cyt­ic leukemia as well as treat­ment-naïve lym­phoma.

From the S-1:

In our in vit­ro stud­ies, IgM an­ti­bod­ies bind anti­gens with high avid­i­ty that re­sults in the IgM an­ti­body re­main­ing at­tached to the tar­get for longer pe­ri­ods of time than an IgG an­ti­body. We be­lieve that this durable bind­ing prop­er­ty will trans­late to an in­creased res­i­dence time on can­cer cells and will in­crease the chance that a T cell will find and kill the can­cer cell while the T cell en­gager is bound to the can­cer cell.

Bruce Keyt

IGM is vy­ing for the lead­ing po­si­tion in the red hot field of bis­pecifics and it knows it. Just in the CD20 realm, it lists heavy­weights Re­gen­eron, Gen­mab, Xen­cor and Roche/Genen­tech as com­peti­tors.

“The thing that re­al­ly hooked me was the longterm fu­ture,” Chen, who was cred­it­ed for lead­ing the Tecen­triq pro­gram at Roche, told End­points News when he made the move last Au­gust.

His com­pen­sa­tion pack­age for those four months in 2018 added up to $715, 638, in­clud­ing over $500,000 in stock and op­tion awards, while Schwarz­er bagged $519,214 in­clud­ing op­tion awards and Keyt re­ceived $353,333 just in salary.

Next up in the pipeline is an IgM an­ti­body di­rect­ed to death re­cep­tor 5 (DR5) pro­teins, a mem­ber of the TN­FrSF fam­i­ly no­to­ri­ous for the need of bind­ing in clus­ters of at least three — which IgG is un­able to do due to its bi­va­lent na­ture. IGM not­ed that Ab­b­Vie, In­hi­bRx, Gen­mab and Boehringer In­gel­heim all have pro­grams in the space.

Part of the pro­ceeds will go to­ward en­abling an IND for this un­named pro­gram next year, while some will be al­lo­cat­ed to the build-out of new man­u­fac­tur­ing fa­cil­i­ties to sup­ply their own clin­i­cal and, ul­ti­mate­ly, com­mer­cial ma­te­r­i­al.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.

Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.

Laurie Glimcher and Ansbert Gadicke (Justin Knight, Dana-Farber Cancer Institute)

Ty­ing ba­sic sci­ence to spin­outs, Dana-Far­ber de­buts sis­ter funds to­tal­ing $126M with MPM Cap­i­tal

As one of the most prestigious cancer institutes in the US, Dana-Farber has enjoyed considerable support for its entrepreneurial pursuits, spinning out about 30 companies in the past 12 years.

“Now where we’ve always struggled — where every cancer center struggled — is support of basic science,” Barrett Rollins, chief scientific officer emeritus, told Endpoints News.

And then two of its trustees had an idea. What if they tied philanthropy to investment in Dana-Farber startups, requiring a donation to basic science as a condition for accessing its brightest biotech venture ideas?