Mary Beth Harler, new head of IGM autoimmunity and inflammation department (Bristol Myers Squibb)

Top Sanofi vac­cine ex­ecs, Bris­tol My­ers vet chart new path for IG­M's an­ti­bod­ies in in­fec­tious dis­eases, au­toim­mu­ni­ty

When IGM Bio­sciences made its pub­lic de­but two years ago, the S-1 pitch was heav­i­ly cen­tered on how its en­gi­neered IgM an­ti­bod­ies could make po­tent can­cer treat­ments. But it al­so buried a ref­er­ence, deep in­side a sec­tion about the plat­form’s po­ten­tial, about how these an­ti­bod­ies may be ap­plied in a va­ri­ety of con­di­tions — cit­ing au­toim­mune dis­eases and in­fec­tious dis­eases as ex­am­ples.

John Shiv­er

The biotech is now cre­at­ing new busi­ness units to ex­pand its work in those ex­act ar­eas. And it’s re­cruit­ed a trio of ex­perts from Big Phar­ma to lead them.

John Shiv­er, the for­mer SVP of vac­cine R&D at Sanofi Pas­teur, is join­ing IGM as chief strat­e­gy of­fi­cer of its in­fec­tious dis­ease unit. His col­league Tong-Ming Fu, who head­ed Sanofi Pas­teur’s vac­cine re­search in North Amer­i­ca, will take up the chief sci­en­tif­ic of­fi­cer spot.

Mean­while, the IGM Au­toim­mu­ni­ty and In­flam­ma­tion de­part­ment will be head­ed up by Mary Beth Harler, most re­cent­ly head of im­munol­o­gy and fi­bro­sis de­vel­op­ment at Bris­tol My­ers Squibb.

Com­pared to tra­di­tion­al IgG an­ti­bod­ies, IGM says its name­sake an­ti­bod­ies have more bind­ing do­mains, lead­ing to stronger bind­ing and en­hanced cel­lu­lar sig­nal­ing.

Tong-Ming Fu

“We be­lieve the suc­cess­es we have achieved clin­i­cal­ly and pre­clin­i­cal­ly this year, to­geth­er with our suc­cess­es with en­gi­neer­ing and man­u­fac­tur­ing IgM an­ti­bod­ies, pro­vide a strong ba­sis for the ex­pan­sion of our re­search and de­vel­op­ment ef­forts be­yond on­col­o­gy,” IGM CEO Fred Schwarz­er said in a state­ment.

Schwarz­er has been shak­ing up the C-suite this year, woo­ing Chris Taki­mo­to from Gilead to fill the CMO post as Dan Chen — him­self a big hire out of Genen­tech — head­ed out.

Then he an­nounced IGM’s for­ay in­to in­fec­tious dis­eases over the sum­mer with pre­clin­i­cal da­ta on a nasal­ly de­liv­ered an­ti­body can­di­date against Covid-19.

Shiv­er had been with Sanofi since 2013 and took a high-pro­file role shep­herd­ing both its re­com­bi­nant and mR­NA coro­n­avirus vac­cine can­di­dates but, ac­cord­ing to his LinkedIn pro­file, qui­et­ly left last De­cem­ber. He be­gan his role with IGM weeks ago.

“IgM an­ti­bod­ies are na­ture’s first line of de­fense against pathogens, and the pre­clin­i­cal da­ta to date sug­gest that en­gi­neered IgM an­ti­bod­ies could be very help­ful in treat­ing and pre­vent­ing COVID-19 and oth­er in­fec­tious dis­eases,” he said.

Both the au­toim­mu­ni­ty/in­flam­ma­tion and in­fec­tious dis­ease groups will be based in the Philadel­phia area, across the coun­try from IGM’s head­quar­ters in Moun­tain View, CA.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty


I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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