Af­ter a long, hard slog to the clin­ic, stem cell play­er Vi­a­Cyte fu­els up with $105M for its next big at­tack on di­a­betes

Over the 14 years since 3 com­pa­nies merged to­geth­er to cre­ate the stem cell play­er we now call Vi­a­Cyte in San Diego, the biotech has been op­er­at­ing on a steady stream of cash from the Cal­i­for­nia In­sti­tute of Re­gen­er­a­tive Med­i­cine as well as the non-prof­it JDRF or­ga­ni­za­tion. 

But with one stem cell prod­uct in the clin­ic and a next-gen prod­uct about to go back in­to hu­man test­ing af­ter a re­vamp — plus a new­ly formed col­lab­o­ra­tion with the gene edit­ing spe­cial­ists at CRISPR Ther­a­peu­tics — CEO Paul Laikind is ready to dou­ble down on a strate­gic bet that the crew at Vi­a­Cyte can make some ma­jor clin­i­cal progress over the next 2 to 3 years.

Paul Laikind, Vi­a­Cyte

To­day Laikind is un­veil­ing an $80 mil­lion ven­ture round, the first in years, that brings to­geth­er a set of new in­vestors — Bain Cap­i­tal Life Sci­ences and joined by TPG and RA Cap­i­tal Man­age­ment —who are join­ing Sander­ling and some in­di­vid­ual back­ers on the next leg of the jour­ney. To­geth­er with the $15 mil­lion CRISPR paid them to forge their tie-up and an­oth­er $10 mil­lion from part­ners at WL Gore and As­so­ci­ates, Laikind’s team now has $105 mil­lion to fund this next leg of prod­uct de­vel­op­ment.

“With this new fund­ing we’re re­al­ly open­ing the gate, say­ing ‘lets get this done,’” says the CEO.

“We stuck to our guns of what we want to ac­com­plish here,” adds Laikind. “It’s tak­en 7-8 years to de­vel­op the tech­nol­o­gy for dif­fer­en­ti­at­ing the cells in a reg­u­la­to­ry-com­pli­ant way.” 

Pe­ter Kolchin­sky

Laikind has been woo­ing RA’s Pe­ter Kolchin­sky for some time now. And Kolchin­sky and Bain’s Adam Kop­pel have a long­stand­ing re­la­tion­ship forg­ing deals to­geth­er, which helped get this syn­di­cate to gel.

Like a lot of the stem cell sur­vivors in Cal­i­for­nia, Vi­a­Cyte has seen the burst of glo­ry and hype suc­ceed­ed by the bleak­ness of the marathon run that stem cell R&D has proven to be — just like many oth­er new tech­nolo­gies in biotech. And it’s man­aged to keep plug­ging away at it to get to the re­newed era of op­ti­mism that has been lift­ing the sur­vivor’s prospects over the last cou­ple of years.

Adam Kop­pel

The lead prod­uct at Vi­a­Cyte is called PEC-Di­rect, de­signed to fer­ry pan­cre­at­ic prog­en­i­tor cells from stem cells that can se­crete in­sulin. It’s prob­lem­at­ic, though, trig­ger­ing the kind of im­mune re­sponse that re­quires im­muno­sup­pres­sion — which nec­es­sar­i­ly lim­its its us­es to 10% of high-risk Type 1 di­a­betes pa­tients will­ing to put up with the risks.

PEC-En­cap is an en­cap­su­lat­ed prod­uct that us­es Gore-tex like ma­te­r­i­al to de­liv­er the same pan­cre­at­ic prog­en­i­tor cells with­out spark­ing the for­eign body re­sponse that spurs the body to coat their de­vice with cells. And this can be used with­out im­mune sup­pres­sion, which would sig­nif­i­cant­ly ex­pand the mar­ket for Vi­a­Cyte.

CRISPR Ther­a­peu­tics $CR­SP, one of the lead­ers in CRISPR/Cas9 gene edit­ing with a big in­ter­est in re­gen­er­a­tive med­i­cine, is step­ping in to use their im­mune-eva­sive tech to cre­ate a new line of off-the-shelf cells that can do the job with­out kick­ing in the re­jec­tion re­sponse.

There are 55 staffers at the biotech, which the CEO says will grow now that he has his big fi­nanc­ing pack­age com­plet­ed. Vi­a­Cyte does its own man­u­fac­tur­ing work, and that team will need to ex­pand along with a spe­cial group ded­i­cat­ed to the part­ner­ship with CRISPR.

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.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.