Jaime Shamonki, Generate CMO

Al­ready sit­ting on a ma­jor stem cell bank, Gen­er­ate looks to grow its re­gen­er­a­tive med­i­cines busi­ness

Gen­er­ate Life Sci­ences is the largest pri­vate new­born stem cell biorepos­i­to­ry, and with the an­nounce­ment of its own in-house man­u­fac­tur­ing fa­cil­i­ty, the com­pa­ny is look­ing to grow its re­gen­er­a­tive med­i­cine pipeline.

Gen­er­ate has es­tab­lished a fa­cil­i­ty in La Jol­la, CA, to pro­vide end-to-end man­u­fac­tur­ing for new­born stem cell bi­o­log­ics. The site will al­low Gen­er­ate to evolve as it adds a per­son­al­ized ther­a­peu­tics de­vel­op­er to its cur­rent busi­ness mod­el. The new site has been de­signed to har­ness mes­enchy­mal stem cells from the tis­sue of the um­bil­i­cal cord.

“With this fa­cil­i­ty, we will have the in-house ca­pa­bil­i­ty to take these stem cells through the com­plete process of col­lec­tion, cryo­genic stor­age and ul­ti­mate­ly bi­o­log­ics man­u­fac­tur­ing,” CMO Jaime Sha­mon­ki said in a press re­lease. “This will al­low us to pow­er our stud­ies in a much more ef­fi­cient and stream­lined man­ner and help us bet­ter serve the fam­i­lies who have stored over 1.2 mil­lion stem cell units with us.”

Sha­mon­ki and her team have the chance to do some­thing spe­cial: They’re work­ing to find a treat­ment for “long Covid,” or the lin­ger­ing side ef­fects from the dis­ease.

But while com­ing up with a long-term so­lu­tion to a prob­lem that’s sure to im­pact peo­ple around the world for years to come is im­por­tant, there’s an added ben­e­fit to the project. The chief med­ical of­fi­cer for Gen­er­ate Life Sci­ences gets to learn how the cells re­pro­gram the im­mune sys­tem, and di­rect those find­ings to­ward dis­cov­er­ing cures for au­toim­mune dis­eases, Ly­me dis­ease and chron­ic fa­tigue syn­drome.

Ear­li­er in June, Gen­er­ate ac­quired Cell Care in­ter­na­tion­al cord blood bank­ing group, with in­cludes Cell Care in Aus­tralia, and In­scep­tion Lifebank and Cells for Life in Cana­da. The move helps Gen­er­ate be­come more glob­al with its reach, and pro­vides ac­cess to fam­i­lies in Cana­da and Aus­tralia.

The com­pa­ny’s reach now stretch­es across three coun­tries, in­clud­ing the US.

Stem cells from um­bil­i­cal cords of­fer an­ti-in­flam­ma­to­ry and tis­sue repar­a­tive prop­er­ties. Gen­er­ate is in the mid­dle of stud­ies right now that are look­ing at tar­get­ing au­toim­mune dis­ease, neu­ro­log­i­cal dis­eases and lung dis­eases. Af­ter back­ing out of the Covid-19 vac­cine field due to over­crowd­ing, Gen­er­ate es­tab­lished a tri­al for pa­tients with res­pi­ra­to­ry com­pli­ca­tions stem­ming from the virus us­ing a ther­a­py de­rived from new­born stem cells. It’s al­so look­ing at clin­i­cal tri­als for a treat­ment for Type 1 di­a­betes.

“We are see­ing this rapid change in our sci­en­tif­ic ori­en­ta­tion of how they can be used, so pre­vi­ous­ly it was trans­plants but sort of low-in­ci­dence con­di­tions for how things could be treat­ed this way, like thank god child­hood leukemia is not all that com­mon,” Sha­mon­ki said. “But now we’re look­ing at re­gen­er­a­tive med­i­cine in­di­ca­tions.”

The com­pa­ny is try­ing to in­vest in both clin­i­cal tri­als with aca­d­e­m­ic part­ners and their own man­u­fac­tur­ing fa­cil­i­ties, to en­able the donor fam­i­lies to eas­i­ly ac­cess their own units, if need­ed for ther­a­pies in the fu­ture. With Gen­er­ate’s ac­qui­si­tion of Cell Care in­ter­na­tion­al, it will al­low for ex­pand­ed ac­cess to do­nat­ed tis­sue and cord blood from a larg­er pool, as well as uti­lize its sci­en­tif­ic and reg­u­la­to­ry knowl­edge spe­cif­ic to each coun­try.

“It’s re­al­ly all about de­liv­er­ing val­ue to the fam­i­lies who’ve banked new­born stem cells with us, as op­posed to try­ing to get 10 bi­o­log­ics to see what we can get through Phase III and what sticks,” Sha­mon­ki said.

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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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.

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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Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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