Mus­tang inks a deal for in vi­vo CAR-T tech from the Mayo Clin­ic; How a spilled cup of tea land­ed one biotech $11.7 mil­lion

As part of its push to de­vel­op an off-the-shelf CAR-T ther­a­py, Mus­tang Bio has inked a deal for new tech­nol­o­gy out of the Mayo Clin­ic de­signed to form CAR-T cells in­side the pa­tient.

The two-step ap­proach comes from the lab of Lar­ry Pease, prin­ci­pal in­ves­ti­ga­tor and for­mer di­rec­tor of the Mayo Clin­ic’s Cen­ter for Im­munol­o­gy and Im­mune Ther­a­pies. First, the pa­tient re­ceives a pep­tide that dri­ves the rapid re­pro­duc­tion of the body’s own res­i­dent T cells. Then, a vi­ral CAR con­struct is ad­min­is­tered di­rect­ly in­to the pa­tient’s lymph nodes. That con­struct in­fects the ac­ti­vat­ed T cells, and es­sen­tial­ly forms CAR-T cells in vi­vo. 

“The im­mune cells are ac­ti­vat­ed in vi­vo us­ing the nat­ur­al meth­ods em­ployed by the body to deal with in­fec­tion rather than the ar­ti­fi­cial ac­ti­va­tion used to man­u­fac­ture tra­di­tion­al CAR T cells ex vi­vo,” Pease said in a state­ment. “This could po­ten­tial­ly re­duce the sub­stan­tial tox­i­c­i­ties that are char­ac­ter­is­tic of tra­di­tion­al CAR T ther­a­py.”

Mus­tang is keep­ing mum about the fi­nan­cial terms of the deal for now. Pre­clin­i­cal de­vel­op­ment will con­tin­ue at the Mayo Clin­ic un­til Mus­tang iden­ti­fies a lead con­struct and files an IND.

How a spilled cup of tea land­ed one biotech $11.7M

Some of the biggest ideas come to us by ac­ci­dent. Ac­cord­ing to HA­GAR, a Tel Aviv-based biotech work­ing on non-in­va­sive glu­cose mon­i­tor­ing tech, Ger­ry Wain­traub’s light­bulb mo­ment came when he spilled a cup of tea on a ra­dio fre­quen­cy de­vice dur­ing a rou­tine ex­per­i­ment.

The sug­ar in the tea caused a dra­mat­ic re­ac­tion on the sys­tem’s mon­i­tors, lead­ing Wain­traub to won­der if the tech­nol­o­gy could be used to help di­a­betes pa­tients. That dis­cov­ery led to GWave — a de­vice about a third of the size of a smart­phone that’s de­signed to de­tect glu­cose blood lev­els. And on Thurs­day, HA­GAR reeled in $11.7 mil­lion to con­duct piv­otal tri­als.

GWave mea­sures glu­cose lev­els in the blood rather than from in­ter­sti­tial flu­id, ac­cord­ing to HA­GAR. The com­pa­ny’s lat­est mod­el in de­vel­op­ment, GWave 2.0, is de­signed as a sen­sor that can be in­te­grat­ed in­to a smart­watch.

“RF can pos­i­tive­ly change di­a­betes mon­i­tor­ing and care for good,” Taire Ru­bin, co-founder and VP of busi­ness de­vel­op­ment, said in a state­ment. “We’ve ded­i­cat­ed our­selves to en­sure our tech­nol­o­gy gets smarter, more ef­fi­cient, and in­creas­ing­ly cost-ef­fec­tive to help im­prove the lives of near­ly 500 mil­lion peo­ple liv­ing with di­a­betes to­day.”

Der­ma­ta soaks up $18M for fresh­wa­ter sponge ther­a­py 

Der­ma­ta Ther­a­peu­tics launched in late 2014 to see if a fresh­wa­ter sponge could be used to treat skin con­di­tions like ac­ne, pso­ri­a­sis and rosacea. Now the com­pa­ny’s soak­ing up $18 mil­lion, af­ter pric­ing an IPO at $7 per share —  the low end of an ex­pect­ed $7 to $9 range.

Der­ma­ta’s plat­form is based on Spongilla la­cus­tris, a nat­u­ral­ly grow­ing fresh­wa­ter sponge that’s tra­di­tion­al­ly used as a folk med­i­cine for var­i­ous in­flam­ma­to­ry con­di­tions. How­ev­er, Der­ma­ta be­lieves Spongilla’s nat­ur­al de­fense mech­a­nisms could prove use­ful in treat­ing skin con­di­tions, like ac­ne vul­garis.

A ma­jor­i­ty of the IPO pro­ceeds will go to­ward DMT310, the com­pa­ny’s lead pro­gram that’s head­ed to­ward Phase III for the treat­ment of mod­er­ate to se­vere ac­ne. Der­ma­ta says it plans on ini­ti­at­ing two piv­otal tri­als in the sec­ond half of next year, with topline re­sults ex­pect­ed in the first half of 2024. Some of the funds will al­so be used to con­duct Phase II and Phase I tri­als in rosacea and pso­ri­a­sis, re­spec­tive­ly.

Der­ma­ta says its ex­clu­sive sup­pli­er has been har­vest­ing Spongilla for more than 18 years, and has the re­sources to col­lect and process large enough quan­ti­ties for the re­search.

FDA sets 2022 de­ci­sion date for Der­ma­vant’s pso­ri­a­sis cream

Der­ma­vant’s $330 mil­lion bet on GSK’s top­i­cal plaque pso­ri­a­sis drug could soon pay off.

The FDA has ac­cept­ed Der­ma­vant’s NDA for tap­inarof — the “cos­met­i­cal­ly el­e­gant” van­ish­ing cream Vivek Ra­maswamy’s team plucked from back in 2018 — and set a PDU­FA date for Q2 2022, the com­pa­ny an­nounced on Tues­day.

While drugs like Ste­lara, Skyrizi and Cosen­tyx cur­rent­ly dom­i­nate the plaque pso­ri­a­sis mar­ket, Der­ma­vant CEO Todd Za­vod­nick has a dis­tinct com­mer­cial plan in mind for tap­inarof. He sees the can­di­date as a re­place­ment for steroids in the top­i­cal space, while leav­ing the most se­vere cas­es to the ul­tra-ef­fec­tive bi­o­log­ics, where the cream could act as an add-on ther­a­py.

Reg­u­la­tors will base their de­ci­sion on Phase III da­ta from the PSOAR­ING 1 and 2 tri­als, as well as in­ter­im re­sults from PSOAR­ING 3, a 40-week, open-la­bel safe­ty study.

Back in April, Za­vod­nick an­nounced that around 20% of mod­er­ate to se­vere pa­tients giv­en tap­inarof in PSOAR­ING 1 and 2 achieved 90% dis­ease clear­ance, mea­sured by the Pso­ri­a­sis Area and Sever­i­ty In­dex (PASI 90) at Week 12. Less than 3% of pa­tients on place­bo in each tri­al achieved PASI90, he said at the time.

Za­vod­nick said in a state­ment that Der­ma­vant is al­ready prep­ping for a com­mer­cial launch, should they win FDA ap­proval next year.

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 to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.

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.

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.