Michael Yang, ViaCyte CEO

Vi­a­Cyte adds to the war chest in what looks like an IPO-bound ef­fort to bring re­gen­er­a­tive med­i­cine to di­a­betes

Stem cell ther­a­pies have long held promise if pro­vid­ing cu­ra­tive an­swers to chron­ic dis­ease, but the field has tak­en decades to bear fruit de­spite some big hopes. A long ges­tat­ing biotech out of San Diego thinks it has the se­cret sauce to cure type 1 di­a­betes, and now it’s rak­ing in piles of cash with the po­ten­tial for a ma­jor IPO in the off­ing.

Vi­a­Cyte has closed an ad­di­tion­al $45 mil­lion tranche for its Se­ries D, bring­ing its to­tal fundraise for the round to $115 mil­lion with the back­ing of a slate of crossover in­vestors that ap­pear to spell a loom­ing IPO for the long-lived re­gen­er­a­tive med­i­cine play­er, the com­pa­ny said Wednes­day.

It’s a back­sto­ry with few con­tem­po­rary com­para­tors in the go-go world of biotech: Vi­a­Cyte was found­ed back in 1999 and has worked for more than two decades in rel­a­tive ob­scu­ri­ty to bring its stem-cell plat­form in­to type 1 di­a­betes. It’s been a long wait, but not an un­com­mon one for the slow-to-ges­tate stem cell field.

The com­pa­ny’s lead can­di­date, dubbed PEC-En­cap, de­liv­ers pan­cre­at­ic islet pre­cur­sor cells as a re­place­ment ther­a­py and is cur­rent­ly in a Phase II study. Vi­a­Cyte plans to use the fund­ing to ad­vance that pro­gram through the clin­ic as well as two oth­ers: PEC-Di­rect, a ther­a­py for pa­tients with hy­po­glycemia un­aware­ness and/or ex­treme glycemic events that ex­pects a Phase II read­out in the first half of 2022, and PEC-QT, a CRISPR Ther­a­peu­tics-part­nered, gene-edit­ed im­mune-eva­sive cell line. The lat­ter drug is ex­pect­ed to en­ter hu­man tri­als by the end of the year.

Vi­a­Cyte is call­ing its slate of pro­grams “ma­jor ad­vances in find­ing a func­tion­al cure for type 1 di­a­betes and oth­er chron­ic dis­eases in the fu­ture,” CEO Michael Yang said in a state­ment. Big-name in­vestors, mean­while, are buy­ing in.

The newest fundrais­ing tranche in­clud­ed par­tic­i­pa­tion from ex­ist­ing in­vestors in RA Cap­i­tal Man­age­ment, Bain Cap­i­tal Life Sci­ences, TPG Cap­i­tal, Sander­ling Ven­tures and a group of “long-time in­sid­ers,” Vi­a­Cyte said. New in­vestors jump­ing on board in­clude Adage Cap­i­tal Part­ners, In­vus Group, Asym­me­try Ven­tures, and Ar­tis Ven­tures.

Vi­a­Cyte’s lead drug is the prod­uct of a col­lab­o­ra­tion with ma­te­r­i­al sci­ences com­pa­ny W.L. Gore, which the part­ners re-upped in Au­gust. The ex­pand­ed deal aimed to com­bine PEC-En­cap with a Gore-pro­duced mem­brane in what they hope will elim­i­nate the need for im­muno­sup­pres­sive drugs. The prod­uct is de­signed to be im­plant­ed un­der­neath the skin and de­liv­er pan­cre­at­ic prog­en­i­tor cells that can se­crete in­sulin and con­trol blood glu­cose lev­els, in essence be­com­ing func­tion­al tis­sue.

Vi­a­Cyte had at­tempt­ed to pair its stem cell tech­nol­o­gy with a dif­fer­ent mem­brane be­fore, but ran in­to trou­ble when pa­tients’ im­mune sys­tems flared up. That led them to col­lab­o­rate with Gore, which first signed on to an agree­ment in 2017 and then chipped in with $10 mil­lion as part of a larg­er Vi­a­Cyte fund­ing round in No­vem­ber 2018.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.