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.

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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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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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

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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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.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.