Ger­man ra­dio­phar­ma forms an­oth­er Chi­na joint ven­ture; Urovan­t's Gemte­sa pass­es blood pres­sure study

Ger­man biotech ITM is form­ing a joint ven­ture with Chi­nese ra­dio­phar­ma play­er Cheng­du Gao­tong Iso­tope.

This ven­ture fol­lows a strate­gic part­ner­ship be­tween ITM and the Chi­na Iso­tope and Ra­di­a­tion Cor­po­ra­tion (CIRC) which was ini­tial­ly formed in 2010 and fur­ther ex­tend­ed in No­vem­ber 2019.

The new­ly formed com­pa­ny is sched­uled to start op­er­a­tions by the end of the year and will be lo­cat­ed in Cheng­du, Chi­na. This will be ITM’s sec­ond lo­ca­tion in Chi­na af­ter open­ing its first sub­sidiary in Shang­hai ear­li­er this year.

“We are com­mit­ted to fur­ther ex­pand­ing our suc­cess­ful, long-term part­ner­ship with CIRC and are look­ing for­ward to in­creas­ing our glob­al foot­print in Chi­na,” said ITM CEO Stef­fen Schus­ter.

Fur­ther de­tails of the agree­ment were not dis­closed. — Paul Schloess­er

Urovant’s over­ac­tive blad­der drug Gemte­sa pass­es safe­ty test 

Cal­i­for­nia biotech Urovant’s Gemte­sa has no clin­i­cal­ly rel­e­vant ef­fect on blood pres­sure and heart rate, ac­cord­ing to the biotech.

Urovant showed da­ta from an out­pa­tient study at the year­ly meet­ing of the Amer­i­can Uro­log­i­cal As­so­ci­a­tion show­ing blood pres­sure and heart rate be­ing sim­i­lar be­tween two groups of pa­tients: one with a place­bo for 28 days, and the oth­er on dai­ly Gemte­sa.

“We are de­light­ed to present these im­por­tant ad­di­tion­al da­ta con­firm­ing the ef­fi­ca­cy and safe­ty pro­file of Gemte­sa,” said Urovant CMO Cor­nelia Haag-Molken­teller in a state­ment.

Ac­cord­ing to the study, sys­tolic blood pres­sure, di­as­tolic blood pres­sure, and heart rate were gen­er­al­ly sim­i­lar be­tween the two groups. There were no sta­tis­ti­cal­ly sig­nif­i­cant or clin­i­cal­ly rel­e­vant dif­fer­ences in mean day­time or mean 24-hour am­bu­la­to­ry sys­tolic blood pres­sure, di­as­tolic blood pres­sure, or heart rate af­ter 28 days of treat­ment with Gemte­sa com­pared with place­bo.

Part of Vivek Ra­maswamy’s fam­i­ly of com­pa­nies, the biotech’s over­ac­tive blad­der drug Gemte­sa hit the mar­ket late last year as Urovant’s first ap­proved prod­uct. — Paul Schloess­er

MiMedx shows mixed re­sults in md­HACM clin­i­cal stud­ies

Geor­gia re­gen­er­a­tive med­i­cine biotech MiMedx has re­sults from two late-stage clin­i­cal tri­als on its treat­ment (mi­cronized de­hy­drat­ed Hu­man Am­nion Chori­on Mem­brane, or md­HACM) for knee os­teoarthri­tis and plan­tar fasci­itis.

The tri­als, in Phas­es IIb and III, re­spec­tive­ly, did not hit the pri­ma­ry end­points in ei­ther study. The os­teoarthri­tis study did re­veal var­ied ef­fi­ca­cy sig­nals be­tween pa­tients eval­u­at­ed pre- and post-study, which will lead MiMedx to at­tempt con­fir­ma­to­ry stud­ies. As for the study on plan­tar fasci­itis, MiMedx will not pur­sue a BLA with the FDA.

“We look for­ward to fur­ther dis­cus­sions with the FDA un­der the Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py process, and re­view­ing our next steps for con­tin­ued clin­i­cal study of Pu­ri­on processed md­HACM as a plat­form for re­gen­er­a­tive med­i­cine,” said MiMedx CEO Tim­o­thy Wright in a state­ment.

MiMedx was in hot wa­ter late last year af­ter the CEO and the COO at the time were re­spec­tive­ly con­vict­ed of se­cu­ri­ties fraud and con­spir­a­cy. This hap­pened af­ter the FBI al­leged that the com­pa­ny was fraud­u­lent­ly boost­ing its sales. — Paul Schloess­er

Adap­ti­m­mune sees 36% re­sponse rate in Phase I #ES­MO21 tease

Fresh off a $3 bil­lion deal with Roche to de­vel­op off-the-shelf T cell ther­a­pies, Adap­ti­m­mune is cap­i­tal­iz­ing on the mo­men­tum with a new da­ta re­lease it ex­pects to present at #ES­MO21 this week­end.

In a Phase I study look­ing at 22 evalu­able pa­tients with MAGE-A4+ tu­mors “in the con­text of HLA-A*02,” Adap­ti­m­mune saw sev­en par­tial re­spons­es and one com­plete re­sponse, good for an over­all re­sponse rate of 36.4%. The re­spons­es spanned five dif­fer­ent in­di­ca­tions in­clud­ing ovar­i­an, head and neck, esoph­a­gogas­tric junc­tion and blad­der can­cers, as well as syn­ovial sar­co­ma.

“It is no longer a ques­tion of whether our SPEAR T-cells are ef­fec­tive against a range of MAGE-A4 ex­press­ing tu­mors — they un­doubt­ed­ly are,” CEO Adri­an Raw­cliffe said in a state­ment. “Now, our fo­cus is on turn­ing them in­to ap­proved ther­a­pies.”

An­oth­er 11 pa­tients saw their dis­ease sta­bi­lized on the ther­a­py, while three saw dis­ease pro­gres­sion. Adap­ti­m­mune re­port­ed that the da­ta cut­off was Au­gust 2, say­ing 25 to­tal pa­tients had re­ceived the ther­a­py at that point while 22 of the 25 made up Mon­day’s da­ta read­out.

The biotech al­so not­ed it was en­cour­aged by the ini­tial dura­bil­i­ty re­sults. Of the eight re­spon­ders, five re­main pro­gres­sion-free af­ter a min­i­mum of 24 weeks. — Max Gel­man

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.

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.

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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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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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.

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.