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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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