Hai Pan, Sciwind Biosciences CEO

On a quest to chal­lenge No­vo Nordisk in obe­si­ty, transpa­cif­ic start­up picks up $70M — and a pair of sea­soned ex­ecs

Four years af­ter start­ing Terns Phar­ma­ceu­ti­cals to­geth­er in search of an elu­sive NASH win, Wei­dong Zhong and Mar­ti­jn Fe­naux are re­unit­ing at a new start­up.

On pa­per, Sci­wind Bio­sciences — which just raised $70 mil­lion in Se­ries C cash — em­ploys a sim­i­lar set­up as Terns: Both have em­braced the transpa­cif­ic mod­el, tak­ing root in Chi­na but plant­i­ng flags in the US.

Wei­dong Zhong

Zhong was tapped to be pres­i­dent of the San Fran­cis­co-based sub­sidiary back in Ju­ly, on top of as­sum­ing the role as chief strat­e­gy of­fi­cer. Weeks lat­er, Fe­naux has been ap­point­ed SVP, non­clin­i­cal de­vel­op­ment and trans­la­tion­al sci­ence at the par­ent com­pa­ny out of Hangzhou — join­ing the team along­side chief sci­en­tif­ic of­fi­cer Xin­le Wu, who brings ex­pe­ri­ence run­ning R&D for both Eli Lil­ly and Am­gen in Chi­na.

Where­as Terns is fo­cused on NASH and oth­er liv­er dis­eases, Sci­wind po­si­tions it­self as a spe­cial­ist in meta­bol­ic dis­or­ders. The three lead can­di­dates all con­gre­gate around GLP-1 re­cep­tor ag­o­nism, a mech­a­nism that Sci­wind reck­ons is rel­e­vant across fat­ty liv­er, obe­si­ty and di­a­betes.

Mar­ti­jn Fe­naux

The new in­fu­sion marks Sci­wind’s sec­ond fi­nanc­ing in a year, hav­ing bagged $37 mil­lion in Feb­ru­ary to fu­el the clin­i­cal work un­der­way for XW003 (long-act­ing GLP-1 pep­tide ana­log) in type 2 di­a­betes and obe­si­ty. Topline Phase II da­ta are ex­pect­ed in the sec­ond half of 2022.

To reach those mas­sive mar­kets, the biotech would first have to steer past gi­ant ri­vals like No­vo Nordisk, whose GLP-1 pep­tide ana­log semaglu­tide is al­ready ap­proved in the US for both of those in­di­ca­tions.

Then there’s the fol­low-on XW004, which is de­signed for once dai­ly rather than once week­ly ad­min­is­tra­tion, slat­ed for first-in-hu­man tri­als lat­er this year; and XW014, a pre­clin­i­cal small mol­e­cule GLP-1R ag­o­nist.

But IDG Cap­i­tal, Loy­al Val­ley Cap­i­tal and LYFE Cap­i­tal have no trou­ble be­liev­ing in Sci­wind and founder/CEO Hai Pan, lead­ing the lat­est round.

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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René Russo, Xilio CEO (Alicia Petitti for Xilio)

Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

It’s been a busy fall on Wall Street — and this week, we’ve got another biotech going public after Ventyx yesterday.

Massachusetts solid-tumor biotech Xilio Therapeutics made its public debut today, joining 149 other biotechs that have gone public so far this year.

Back on October 1st, Xilio filed its S-1 with the SEC to make its IPO debut for $100 million — the next step in financing after completing a $95 million Series C back in February.